Pharma & Anticompetitive practices

Anticompetitive practices

The Australian Competition Authority charges a pharmaceutical ingredient company and its former director for leading a criminal cartel (Alkaloids / Christopher Kenneth Joyce)
Australian Competition and Consumer Commission (Canberra)
Criminal cartel charges laid against pharmaceutical ingredient company and its former export manager.* Alkaloids of Australia Pty Ltd and its former export manager, Christopher Kenneth Joyce, have each been charged with 33 criminal cartel offences, contrary to the Competition and Consumer Act (...)

The EU Commission fines two pharmaceutical companies for pay-for-delay patent settlement agreement (Teva / Cephalon)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
On 26 November 2020, the European Commission (the Commission) brought to an end a long running competition case by finding against Cephalon and Teva on account of a “pay-for-delay” patent settlement agreement involving modafinil, the active substance of a sleeping disorder medicine (see, attached (...)

The EU Commission fines two pharmaceutical companies €60.5 million for delaying the entry of cheaper generic medicine for sleep disorders (Teva / Cephalon)
DG COMP (Brussels)
Antitrust: Commission fines Teva and Cephalon €60.5 million for delaying entry of cheaper generic medicine* The European Commission has fined the pharmaceutical companies Teva and Cephalon €60.5 million for agreeing to delay for several years the market entry of a cheaper generic version of (...)

The EU Commission presents the pharmaceutical strategy for Europe
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
On 25 November 2020, the European Commission (the Commission) unveiled its Pharmaceutical Strategy for Europe (PSE), a wide-ranging document that discusses a series of broad policy statements, tentative considerations and concrete measures to tackle the many challenges faced by the (...)

The UK Competition Authority consults on commitments offered by a pharma company to keep its cheaper bipolar drug in the market at an increased price that is still below the company’s more expensive competing bipolar medication (Essential Pharma)
United Kingdom’s Competition Authority - CMA (London)
CMA takes swift action in bipolar drug investigation* The CMA is consulting on proposed commitments from Essential Pharma to keep a key bipolar drug on the market, and ensure it is affordable to the NHS. The Competition and Markets Authority (CMA) launched a competition law investigation into (...)

The UK Competition Authority consults on proposed commitments from a pharma company to keep bipolar medicine on the market at an affordable price (Essential Pharma)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
Early last month, the Competition and Markets Authority (CMA) started an investigation into Essential Pharma because of suspicions that the firm might have abused an allegedly dominant position by taking steps to withdraw Priadel® from the UK market. This is a lithium based medicine indicated (...)

The Polish Competition Authority conducts dawn raids and initiates explanatory proceedings against pharmaceutical wholesalers for allegations of exchange of information and price fixing (Neuca Spółka Akcyjna / Przedsiębiorstwo Dystrybucji Farmaceutycznej Slawex / Farmacol Serwis / Farmacol Logistyka)
Polish Competition Authority (Warsaw)
Do pharmaceutical wholesalers increase drug prices by exchanging information?* Could unfair market practices, resulting in higher drug prices and restriction of competition, be facilitated by the IT systems used by pharmaceutical wholesalers? President of UOKiK Tomasz Chróstny has initiated (...)

The Polish Competition Authority takes enforcement actions in the pharmaceutical sector
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
The Polish competition authority, the Office of Competition and Consumer Protection ( UOKiK ), has proven to be an energetic enforcer of the competition rules. Over the past few days, UOKiK found itself in the limelight because of two new distinct inquiries in the pharmaceutical sector that (...)

The Finnish Competition Authority publishes its pharmacy market study and proposes measures to reduce the costs of medicines for consumers and society
Finnish Competition and Consumer Authority (Helsinki)
The FCCA pharmacy market study proposes measures to reduce the costs of medicines for consumers and society* The Finnish Competition and Consumer Authority (FCCA) has published an extensive study on the pharmacy market. The study produced a list of proposals that can reduce the pharmaceutical (...)

The Russian Competition Authority confirms that the pharmaceutical company with a dominant position in the wholesale of certain generics ceased its problematic behavior and signed a contract for medicine supply (Ipsen / Biotek)
Russian Federal Antimonopoly Service (Moscow)
Ipsen Company Comply With the Warning of the FAS Russia* Pharmaceutical company made required amendments to the Commercial policy and signed a contract with a distributor to supply their products FAS Russia received a notification of the Ipsen LLC that the company ceased the actions that (...)

The UK Supreme Court hands down a judgment in a competition damage litigation and makes key observations on when a judicial decision of the EU courts is binding in other proceedings (Servier)
Shearman & Sterling (Brussels)
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Shearman & Sterling (London)
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Shearman & Sterling (London)
Holds Findings Made by European Courts Cannot Be Relied on in Different Context in Other Proceedings On November 6, 2020 the U.K. Supreme Court handed down a judgment relating to the Servier U.K. competition damages litigation, in which it made key observations on when a judicial decision of (...)

The Italian Competition Authority announces it is continuing its inquiry into the alleged abuse of dominance by a pharmaceutical company (Leadiant)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
The Italian competition authority, the “Autorità garante della concorrenza e del mercato” ( AGCM ), announced yesterday that it would continue its inquiry into the practices of pharmaceutical company Leadiant Biosciences ( Leadiant ) until 30 June 2021 (see, attached extract from AGCM’s latest (...)

The US FTC imposes conditions on pharmaceutical merger with competition concerns in ten generic drug markets (Mylan / Upjohn)
US Federal Trade Commission (FTC) (Washington)
FTC Imposes Conditions on Combination of Pfizer Inc.’s Upjohn and Mylan N.V.* Pharmaceutical companies Pfizer Inc. and Mylan N.V. have agreed to divest assets and abide by other conditions to settle Federal Trade Commission charges that the proposed combination of Upjohn Inc. and Mylan N.V. (...)

The Russian Competition Authority forcibly returns the equivalent of 14 million EUR into the state budget from former Mayor of Vladivostok, his family, and affiliated companies found guilty of collusion in the auctions for construction materials and supply of medicines (Igor Pushkaryov / MUE Roads of Vladivostok)
Russian Federal Antimonopoly Service (Moscow)
More Than 2.3 Billion Rubles of Illegal Income Was Returned to the State Budget* The funds were obtained as a result of collusions at auctions for the purchase of construction materials (1.4 billion rubles) and the supply of medicines and medical devices (900 million rubles) On October 20, (...)

The Russian Competition Authority approves the first two manufacturers on the maximum selling price of medicine favipiravir used in treating COVID-19 and announces that the price registration will increase its availability for the country’s population Free
Russian Federal Antimonopoly Service (Moscow)
FAS: After Favipiravir Price Registration, Its Retail Price Will Be Reduced at Least Twice* Registering the price of a medicine for treatment of COVID-19 will significantly increase its availability for the Russian population The FAS Russia has approved the first two pharmaceutical (...)

The Russian Competition Authority develops jointly with the Ministry of Health a draft decree that will not allow disappearance of scarce medicine
Russian Federal Antimonopoly Service (Moscow)
FAS is Developing Jointly With the Russian Ministry of Health Draft Decree That Will Not Allow Disappearance of Scarce Medicine* The document is designed to ensure the availability of low-cost life-saving medicine for patients The FAS Russia together with the Ministry of Health of Russia is (...)

The UK Competition Authority investigates on a pharma company for abuse of dominance (Essential Pharma)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
On 6 October 2020, the Competition and Markets Authority ( CMA ) started an inquiry into Essential Pharma to determine whether that company abused an allegedly dominant position when announcing the withdrawal from the UK market of Priadel®, a lithium based medicine indicated for the first line (...)

The UK Competition Authority opens investigation into alleged abuse of dominance in the supply of drugs used to treat bipolar disorder (Essential Pharma)
United Kingdom’s Competition Authority - CMA (London)
CMA to investigate the supply of bipolar drug* The CMA has opened an investigation into suspected anti-competitive practices in the supply of drugs used to treat bipolar disorder. The Competition and Markets Authority (CMA) will investigate whether the pharmaceutical company Essential Pharma (...)

The Russian Competition Authority investigates whether a pharmaceutical company with a dominant position in the wholesale of certain generics unreasonably refused to conclude a contract for medicine supply (Ipsen / Biotek)
Russian Federal Antimonopoly Service (Moscow)
FAS Russia: Ipsen Unreasonably Refused Biotek to Conclude Contract for Medicine Supply* In order not to enter into a contract with a counterparty the pharmaceutical company has repeatedly changed its commercial policy during the review of the distributor’s application. The FAS Russia issued a (...)

The Serbian Competition Authority opens proceedings against a pharmaceutical company for a non-notified merger implemented without authorization (Apoteka Janković)
Serbian Commission for Protection of Competition (Belgrade)
Commission Institutes Proceedings Against Apoteka Janković* The Commission for Protection of Competition instituted ex officio proceedings against company Zdravstvena ustanova Apoteka Janković to investigate a merger implemented before obtaining clearance under the Law on Protection of (...)

The Dutch Competition Authority closes investigation into drug manufacturer after receiving assurances that it will not use its discount schemes to force hospitals into exclusive purchases (AbbVie)
Netherlands Authority for Consumers & Markets (The Hague)
ACM closes investigation into drug manufacturer AbbVie, competitors get more room now* Drug manufacturer AbbVie has stated that it will not force hospitals to purchase exclusively or to a large extent from AbbVie through discount schemes (or rebate programs). AbbVie has made these assurances (...)

The Serbian Competition Authority opens an investigation against a chain of pharmacies for gun jumping (Apoteke Janković / Zrenjanin)
BDK (Belgrade)
The Serbian Commission for Protection of Competition launched its fourth investigation in September 2020. The latest one will look into whether Zdravstvena ustanova Apoteka Janković, a privately owned chain of pharmacies (“ZUA Janković“), breached merger control rules by not notifying the (...)

The EU Commissioner Margrethe Vestager announces new approach to merger review referrals falling below thresholds
McDermott Will & Emery (Brussels)
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McDermott Will & Emery (Brussels)
Under current EU merger control rules, whether a concentration has to be notified to the European Commission (“Commission”) depends, among other things, on the level of revenue generated by the parties worldwide and in the European Union. A key question that has sparked considerable debate in (...)

The Australian Competition Authority is not opposed to a pharmaceutical merger after offered divestments overcome competition concerns (Mylan / Upjohn)
Australian Competition and Consumer Commission (Canberra)
Divestments overcome strong competition concerns with pharmaceutical merger* The ACCC will not oppose Mylan NV’s proposed merger with Pfizer’s Upjohn Inc division, after Mylan and Upjohn offered a court-enforceable undertaking to divest three off-patent branded pharmaceuticals in response to the (...)

The Australian Competition Authority accepts a proposed merger between two pharmaceutical companies despite concerns of a significant reduction in competition in the supply of the products (Mylan / Upjohn)
Ashurst (Sydney)
On 10 September 2020, the Australian Competition and Consumer Commission ("ACCC") decided to not oppose Mylan NV’s ("Mylan") proposed merger with Pfizer’s Upjohn Inc division ("Upjohn"), despite concerns that competition in the supply of pharmaceutical products to treat cardiovascular conditions (...)

The New Zealand Competition Authority clears a pharmaceutical merger subject to a divestment (Mylan / Upjohn)
New Zealand Commerce Commission (Wellington)
Commission grants clearance for Mylan and Upjohn to merge subject to a divestment* The Commerce Commission has granted clearance for Mylan N.V. and Upjohn Inc. (a wholly owned subsidiary of Pfizer Inc) to merge their global pharmaceutical businesses. The clearance is subject to a divestment of (...)

The French Competition Authority fines 3 laboratories for abusive efforts to segment market (Novartis / Roche / Genentech)
Van Bael & Bellis (Brussels)
Background On 9 September 2020, the French Competition Authority (the “FCA”) imposed a fine of € 444 million on Genentech, Novartis and Roche for abusing their collective dominant position on the market for the commercialisation of drugs for the treatment of age-related macular degeneration (AMD) (...)

The Russian Competition Authority reaches an agreement with the HSE Technology Transfer Center to further simplify the terms of technology transfer in the breeding sector after negotiating with a pharma company (Bayer)
Russian Federal Antimonopoly Service (Moscow)
Bayer offered more favorable conditions for transfer of germplasm to russian breeders* Russian breeding companies that receive germplasm transferred by Bayer as part of the FAS Russia’s ruling based on the result of the Bayer&Monsanto transaction will be fully exempt from paying royalties (...)

The US FTC approves a final order imposing conditions on an acquisition between two big pharmaceutical companies (AbbVie / Allergan)
US Federal Trade Commission (FTC) (Washington)
FTC Approves Final Order Imposing Conditions on AbbVie Inc.’s Acquisition of Allergan plc* Following a public comment period, the Federal Trade Commission has approved a final order settling charges that AbbVie’s $63 billion acquisition of Allergan would violate federal antitrust law. According (...)

The Estonian Competition Authority analyses the competition situation in the pharma sector in order to assess the medicine pricing regulation
Estonian Competition Authority (Tallinn)
The price regulation of pharmaceuticals is illusory* The Competition Authority conducted an analysis of the competition situation in order to assess the functioning of the regulation that sets the limits for the prices of medicines. The Competition Authority considers that the current system (...)

The Russian Competition Authority announces they prevented the creation of a cartel in the pharmaceutical market with an income of more than 120 million rubles (Danta / Company Organika)
Russian Federal Antimonopoly Service (Moscow)
Rostov OFAS prevented pharmaceutical cartel with an income of more than 120 million rub* Illegal income of Danta LLC and Company Organika LLC was obtained by colluding at 48 auctions for the supply of medicines Rostov OFAS found that auctions where Danta LLC and Company Organika LLC (...)

The Romanian Competition Authority fines €2.5 million a pharmaceutical company for failure to observe commitments in an abuse of dominance probe (GlaxoSmithKline)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
The Romanian Competition Authority announced on 25 August 2020 that it imposed a fine of 11.9 million lei (approximately EUR 2.5 million) on GlaxoSmithKline (GSK) for its failure to observe in full commitments which it had given earlier to allow the competition authority to terminate an inquiry (...)

The US DoJ charges a seventh generic drug manufacturer in ongoing criminal price-fixing investigation (Teva Pharmaceuticals)
US Department of Justice - Antitrust Division (Washington)
Seventh Generic Drug Manufacturer Is Charged In Ongoing Criminal Antitrust Investigation* Consumers Were Allegedly Overcharged at Least $350 Million Teva Pharmaceuticals USA Inc. (Teva) has been charged with conspiring to fix prices, rig bids, and allocate customers for generic drugs, the (...)

The Romanian Competition Authority fines pharmaceutical company for non-compliance with some of its commitments assumed during the investigation regarding possible abuse of dominant position (GlaxoSmithKline)
Romanian Competition Council (Bucharest)
The Competition Council Sanctioned Glaxosmithkline Srl With Fine of 11.9 Million Lei* The Competition Council sanctioned GlaxoSmithKline (GSK) SRL with fine of lei 11.9 million for non-compliance with some of its commitments assumed during the investigation regarding a possible abuse of (...)

The US Court of Appeals for the Third Circuit upholds a lower Court’s ruling certifying a class of pharmaceutical drug purchasers alleging that the defendant engaged in anticompetitive behaviour to maintain its monopoly over a drug (Suboxone / Indivior)
Hausfeld (Washington)
On July 28, 2020, a Third Circuit Court of Appeals panel unanimously upheld a lower court ruling certifying a class of Suboxone purchasers who alleged that the defendant Indivior Inc. engaged in anticompetitive behavior to maintain its monopoly over the drug. The Third Circuit panel rejected (...)

The US FTC charges a $10 million fine to a company that illegally maintained a monopoly over the Opioid Addiction Treatment Suboxone (Indivior)
US Federal Trade Commission (FTC) (Washington)
Indivior, Inc. to Pay $10 Million to Consumers, Settling FTC Charges that the Company Illegally Maintained a Monopoly over the Opioid Addiction Treatment Suboxone* FTC alleges company used anticompetitive tactics to impede competition from lower-cost generics Indivior, Inc. has agreed to pay (...)

The US DoJ issues a letter for monoclonal antibody manufacturers to expand their production and allows exchange of information during the COVID-19 pandemic Free
US Department of Justice - Antitrust Division (Washington)
Department Of Justice Issues Business Review Letter To Monoclonal Antibody Manufacturers To Expedite And Increase The Production Of Covid-19 Mab Treatments* The United States Department of Justice announced today that it will not challenge proposed efforts by Eli Lilly and Company, AbCellera (...)

The US DoJ charges sixth pharmaceutical company for fixing prices, allocating customers a bid-rigging in the ongoing investigation into the generic pharmaceutical industry (Taro Pharmaceuticals)
US Department of Justice - Antitrust Division (Washington)
Sixth Pharmaceutical Company Charged In Ongoing Criminal Antitrust Investigation* Fifth Company to Admit It Fixed Prices of Generic Drugs Taro Pharmaceuticals U.S.A., Inc. (Taro U.S.A.) has been charged for conspiring to fix prices, allocate customers, and rig bids for generic drugs, the (...)

The French Competition Authority clears merger in the medical biology sector, subject to conditions (Laborizon / Biogroup)
French Competition Authority (Paris)
Medical biology laboratories: the Autorité clears, subject to certain conditions, the acquisition of the Laborizon group by the Biogroup group* Parties to the transaction Biogroup is active in the medical biology sector, with laboratories distributed over more than 550 sites, throughout the (...)

The EU Commission invites comments from all interested parties on commitments offered by pharmaceutical company to address the Commission’s concerns over excessive pricing (Aspen)
Dentons (Brussels)
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DLA Piper (Bucharest)
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DLA Piper (Copenhagen)
Aspen: Quick Fix But Missed Opportunity* What are commitments? The recent effort by the Commission to settle the Aspen case suggests that commitment decisions are the preferred route to settle complex excessive pricing cases at EU-level. Previous commitment cases where high prices have been (...)

The EU Commission invites parties to submit comments regarding a pharma company and its excessive pricing (Aspen)
Van Bael & Bellis (Brussels)
On 14 July 2020, the Commission invited interested parties to submit comments on the commitments offered by global pharma company Aspen to address competition concerns in relation to Aspen’s excessive pricing for six critical off-patent cancer medicines in several national markets (excluding (...)

The EU Commission invites comments on pharmaceutical company’s proposed commitment to reduce the price by 73% for six off-patent cancer medicines to remove the Commission’s excessive pricing concerns (Aspen)
DG COMP (Brussels)
Antitrust: Commission seeks feedback on commitments offered by Aspen to reduce prices for six off-patent cancer medicines by 73% to address Commission’s concerns over excessive pricing* The European Commission invites comments from all interested parties on commitments offered by Aspen to (...)

The EU Commission starts a market test on the proposed commitments offered by a pharmaceutical company to address the Commission’s concerns over excessive pricing for a range of off-patent cancer medicines (Aspen)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
Today, the European Commission (the Commission) started a market test inviting comments from interested parties on commitments offered by Aspen Pharmacare Holdings (Aspen) to address the Commission’s concerns over excessive pricing for a range of off-patent cancer medicines (see, attached (...)

The UK Competition Authority fines 3 pharmaceutical companies £2.3 million for anti-competitive agreement in the supply of life-saving drug fludrocortisone and secures £8 million in damages for the National Health Service (Aspen / Amilco / Tiofarma)
United Kingdom’s Competition Authority - CMA (London)
CMA levies fines of £2.3m and secures £8m for NHS in pharma probe* The CMA has formally concluded that 3 pharmaceutical companies took part in an illegal arrangement in relation to the supply of life-saving medicine. The investigation by the Competition and Markets Authority into the supply of (...)

The Mexican Competition Authority sanctions pharmaceutical companies for failing to comply with the commitments to restore competition in the pharma market (Moench Coöperatif / Luis Doporto Alejandre)
Mexican Competition Authority (Mexico City)
COFECE sanctions Moench Coöperatif and Luis Doporto for failing to comply with the commitments made to totally and permanently eliminate any possible link between Nadro and Marzam, in the market for the distribution of pharmaceutical products* The commitments were accepted by the Board of (...)

The US DoJ charges fifth pharmaceutical company in ongoing criminal antitrust investigation into fixing prices of generic drugs (Glenmark Pharmaceuticals)
US Department of Justice - Antitrust Division (Washington)
Fifth Pharmaceutical Company Charged In Ongoing Criminal Antitrust Investigation* Glenmark Pharmaceuticals Inc., USA was charged for conspiring to fix prices for generic drugs, the Department of Justice announced today. The charge, filed today in the U.S. District Court in Philadelphia, (...)

The Dutch Competition Authority extends its investigation into abuse of dominance by manufacturer of orphan drug CDCA (Leadiant)
Netherlands Authority for Consumers & Markets (The Hague)
ACM extends its investigation into orphan drug CDCA-Leadiant* The Netherlands Authority for Consumers and Markets (ACM) extends its investigation into the orphan drug CDCA manufactured by Leadiant. The investigation focuses on the question whether the manufacturer abuses a dominant position in (...)

The UK Government introduces measures allowing it to intervene in merger transactions to mitigate the effects of public health emergencies following the COVID-19 outbreak Free
Cleary Gottlieb Steen & Hamilton (London)
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Cleary Gottlieb Steen & Hamilton (London)
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Cleary Gottlieb Steen & Hamilton (Brussels)
On 22 June 2020, the UK Government introduced new measures allowing it to intervene in merger transactions “to maintain in the United Kingdom the capability to combat, and to mitigate the effects of, public health emergencies." The Government will be able to intervene on these grounds in any (...)

The UK Competition Authority opens investigations against four pharmacies and convenience stores for suspected breaches of antitrust rules by charging excessive and unfair prices for hand sanitiser products during the COVID-19 outbreak Free
Morgan Lewis (London)
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Morgan Lewis (London)
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Morgan Lewis (London)
The UK Competition and Markets Authority on June 19 announced that it had opened investigations against four pharmacies and convenience stores in relation to suspected breaches of antitrust rules by charging excessive and unfair prices for hand sanitiser products during the coronavirus (...)

The Peruvian Supreme Court confirms the Competition’s Authority sanctions imposed on a medical oxygen cartel for bid-rigging by a national health insurer’s public tenders (Messer Gases / Linde Gas / Praxair)
Peruvian Competition Authority - INDECOPI (Lima)
The Supreme Court of Justice confirmed the sanction imposed by Indecopi to the Medical Oxygen Cartel* The Permanent Constitutional and Social Law Chamber of the Supreme Court has declared unfounded the cassation appeals filed by the companies Messer Gases del Perú S.A., Linde Gas Perú S.A. and (...)

The Cypriot Competition Authority initiates proceedings against national pharmaceutical association for prima facie infringements of national and EU competition laws regarding fixing of prices and other trade conditions (Cyprus Pharmaceutical Association)
Commission for the Protection of Competition of the Republic of Cyprus (Nicosia)
The Commission for the Protection of Competition announces the notification of a Statement of Objections to the Cyprus Pharmaceutical Association regarding prima facie infringements of Section 3(1)(a) of the Protection of Competition Laws of 2008 and 2014 and Article 101(1) of the Treaty for (...)

The EU Commission approves, subject to conditions, an acquisition of global pharma company’s animal health division by animal health company subject to divestments (Bayer / Elanco Animal Health)
DG COMP (Brussels)
Mergers: Commission approves acquisition of Bayer’s animal health division by Elanco, subject to conditions* The European Commission has approved, under the EU Merger Regulation, the proposed acquisition of Bayer AGs animal health division by Elanco Animal Health Inc. The decision is (...)

The US District Court for the Northern District of Illinois dismisses antitrust case challenging patent thicket (Humira)
Rutgers University (Camden)
On June 8, 2020, the U.S. District Court for the Northern District of Illinois granted defendants’ motion to dismiss an antitrust case challenging behavior arising out of a massive collection of patents known as a “patent thicket.” In re Humira (Adalimumab) Antitrust Litigation, 2020 WL 3051309 (...)

The New Zealand Competition Authority fines a pharmacy $344,000 and its director $50,000 for price fixing (Prices Pharmacy 2011 / Stuart Hebberd)
New Zealand Commerce Commission (Wellington)
Nelson pharmacy fined $344,000 and director $50,000 for price-fixing* The Wellington High Court has ordered Prices Pharmacy 2011 Limited and a director of the company, Stuart Hebberd, to pay fines of $344,000 and $50,000 respectively, after they admitted engaging in price-fixing in breach of (...)

The EU Commission conditionally clears an acquisition between two global developers and suppliers of veterinary pharmaceuticals (Elanco / BAH)
Van Bael & Bellis (Brussels)
On 8 June 2020, the Commission announced its conditional clearance of Elanco’s purchase of Bayer’s animal health division (“BAH”). Both Elanco and BAH are global developers and suppliers of veterinary pharmaceuticals, and the transaction will establish the largest animal health company worldwide. (...)

The EU Commission approves €5 billion French “umbrella” scheme to support research and development as well as testing infrastructures and production of COVID-19 relevant products Free
DG COMP (Brussels)
State aid: Commission approves €5 billion French “umbrella” scheme to support research, development, testing infrastructures and production of coronavirus relevant products* The European Commission has approved a €5 billion French “umbrella” scheme to support research and development, testing and (...)

The UK Competition Authority secures disqualification of pharmaceutical company director for 5 years for breaching competition law (Amit Patel / Auden McKenzie / Amilco)
United Kingdom’s Competition Authority - CMA (London)
Pharma company director disqualified for competition law breaches* The CMA has secured the disqualification of pharmaceutical company director Amit Patel after he admitted his role in arrangements that broke competition law. Amit Patel has signed undertakings that ban him from holding a (...)

The UK Competition Authority secures binding competition disqualification undertakings by a director involved in two separate anticompetitive arrangements relating to the supply of pharmaceuticals (Amit Patel / Auden McKenzie / Amilco)
Bird & Bird (London)
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Bird & Bird (London)
On 4 June 2020, the Competition Markets Authority (“CMA”) announced that it had secured binding competition disqualification undertakings by Mr Amit Patel, not to act as a director of any UK company for five years from 13 July 2020, in consequence of his involvement in two separate (...)

The EU Court of Justice Advocate General Kokott proposes to uphold the fine of almost €94 million imposed on a pharmaceutical group in the context of agreements intended to delay the marketing of generic versions of its antidepressant medicinal product citalopram (Lundbeck)
European Court of Justice (Luxembourg)
Advocate General Kokott proposes that the Court of Justice should uphold the fine of almost €94 million imposed on the Lundbeck pharmaceutical group in the context of agreements intended to delay the marketing of generic versions of its antidepressant medicinal product citalopram* The Advocate (...)

The UK High Court rules that complying with a court-ordered disclosure in patent infringement proceedings between pharmaceutical companies does not breach competition law (Teva / Chiesi)
Van Bael & Bellis (Brussels)
On 2 June 2020, the UK High Court delivered a judgment in a case pitting pharmaceutical companies Teva UK Limited (“Teva”) against Chiesi Farmaceutici (“Chiesi”) in which Mr Justice Birss ruled that complying with a court-ordered disclosure in patent infringement proceedings does not breach Article (...)

The Italian Competition Authority approves a distribution scheme allowing disposable surgical masks to be sold in pharmacies and health retail outlets as a response to the COVID-19 pandemic Free
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
On 1 June 2020, the Italian competition authority (“L’Autorità Garante della Concorrenza e del Mercato”) authorised a scheme that would allow disposable surgical masks to be distributed and sold in pharmacies and health product retail outlets (see, attached press release). It did so at the request (...)

The Italian Competition Authority allows cooperation among competing pharmacies in purchasing and selling surgical masks, and common moratorium scheme for consumer credit among competing financial services providers, both as special measures allowed due to COVID-19 Free
Italian Competition Authority (Rome)
ICA: competitive compatibility verified of the cooperation agreements between businesses for the distribution of masks and the moratorium scheme for consumer credit prepared by Assofin* The Authority has applied for the first time the Communication, approved last April, on cooperation (...)

The Italian Competition Authority approves a joint purchasing agreement of surgical masks via pharmacies and drugstores pursuant to its temporary rules on cooperation between companies during the COVID-19 pandemic Free
Ashurst (Milan)
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Ashurst (Brussels)
On 1 June 2020, the Italian Competition Authority ("ICA") approved a joint purchasing agreement of surgical masks via pharmacies/drugstores and a moratorium scheme on loan repayments agreed within ASSOFIN (the Italian Association of Consumer Credit and Mortgage Lending) pursuant to its (...)

The US FTC finishes public consultation period and clears a pharmaceutical merger subject to divestments in highly concentrated markets that supply biopharmaceutical companies with key inputs (Danaher / GE Biopharma)
US Federal Trade Commission (FTC) (Washington)
FTC Approves Final Order Settling Charges that Danaher Corporation’s Acquisition of GE Biopharma Was Anticompetitive* Following a public comment period, the Federal Trade Commission has approved a final order settling charges that Danaher Corporation’s acquisition of GE Biopharma would likely (...)

The EU Commission waives all structural remedies committed to by merging pharmaceutical parties due to new significant permanent changes in market conditions during the divestiture process (Takeda / Shire)
DG COMP (Brussels)
Mergers: Commission waives the commitments made by Takeda to obtain clearance of its acquisition of Shire* The European Commission has waived, under the EU Merger Regulation, the commitments made by Takeda to obtain clearance of its acquisition of Shire. The Commission approved the (...)

The Dutch Competition Authority allows hospitals and pharmaceutical wholesalers to collaborate during COVID-19 outbreak to prevent or reduce any shortages of essential drugs Free
Netherlands Authority for Consumers & Markets (The Hague)
ACM: room for collaboration involving the distribution of essential drugs for COVID-19 patients* Hospitals, hospital pharmacies, and pharmaceutical wholesalers are allowed to collaborate closely with each other during the current coronavirus (COVID-19) outbreak in order to prevent or reduce (...)

The Portuguese Competition Authority issues guidance aimed at three business associations in the pharmaceutical and financial sectors to reaffirm the need to apply competition rules during the COVID-19 pandemic (National Association of Pharmacies / Portuguese Banking Association / Association of Specialized Credit Institutions) Free
Portuguese Competition Authority (Lisbon)
Covid-19: AdC warns associations of the need to comply with competition rules* The Competition Authority (AdC) issued guidance aimed at three business associations in the pharmaceutical and financial sectors, in the context of the Covid-19 pandemic, reaffirming the need to apply competition (...)

The German Government tightens national foreign direct investment screening regime to better protect security-relevant businesses in the health sector from non-EEA take-overs in light of COVID-19 outbreak Free
Morgan Lewis (Washington)
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Morgan Lewis (Frankfurt)
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Morgan Lewis (Frankfurt)
A recent amendment to Germany’s foreign direct investment ordinance adds new businesses to the existing catalogue of critical infrastructures—in particular, in the health sector—that will be subject to foreign direct investment screening going forward. Germany is taking several legislative (...)

The German Government tightens foreign direct investment control in light of COVID-19 following the guidance from the EU Commission on possible increased risk of attempts to acquire healthcare capacities Free
Jones Day (Brussels)
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Jones Day (Frankfurt)
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Jones Day (London)
On May 20, 2020, the German Federal government adopted the 15th amendment to the Foreign Trade and Payments Ordinance (AWV). The changes to the AWV will be effective shortly, after publication in the Federal Gazette. Prompted by the COVID-19 pandemic, the amendment expands the scope of (...)

The US DoJ announces its first approval of a COVID-19 competitor collaboration which is not involving medical supplies Free
Robins Kaplan (New York)
DOJ Signs Off On First COVID-Related Competitor Collaboration Not Involving Medical Supplies* On May 15, 2020, the Antitrust Division of the Department of Justice announced its first approval of a COVID-19 competitor collaboration that does not involve equipment or medications directly related (...)

The EU Commission approves a €25 million Belgian State aid scheme to support COVID-19 related research and development activities in Wallonia Free
DG COMP (Brussels)
State aid: Commission approves €25 million Belgian aid scheme to support coronavirus related research and development activities in Wallonia* The European Commission has approved a €25 million Belgian aid scheme to support coronavirus related research and development (R&D) in Wallonia.The (...)

The EU Commission approves €11.5 million Maltese scheme to support investments in the production of COVID-19-relevant products Free
DG COMP (Brussels)
State aid: Commission approves €11.5 million Maltese scheme to support investments in the production of coronavirus-relevant products* The European Commission has approved a Maltese aid scheme of €11.5 million to support investments in the production of productsthat are relevant to the (...)

The US DoJ fines generic pharmaceutical company $24.1million for fixing price of widely used cholesterol medication and files for deferred prosecution agreement (Apotex)
US Department of Justice - Antitrust Division (Washington)
Generic Pharmaceutical Company Admits to Fixing Price of Widely Used Cholesterol Medication* Apotex Corp. Agrees to Pay a $24.1 Million Criminal Penalty Apotex Corp., a generic pharmaceutical company headquartered in Florida, was charged with fixing the price of the generic drug pravastatin, (...)

The EU Commission approves €7.3 million Czech scheme to support research and development activities related to COVID-19 outbreak Free
DG COMP (Brussels)
State aid: Commission approves €7.3 million Czech scheme to support research and development activities related to coronavirus outbreak* The European Commission has approved a CZK 200 million (approximately €7.3 million) Czech aid scheme to support research and development (R&D) activities (...)

The US FTC clears merger of two big pharma companies after they agreed to divest 3 drugs businesses (AbbVie / Allergan)
US Federal Trade Commission (FTC) (Washington)
FTC Imposes Conditions on AbbVie Inc.’s Acquisition of Allergan plc* Agency requires companies to divest three drugs Pharmaceutical companies AbbVie Inc. and Allergan plc have agreed to divest assets to settle Federal Trade Commission charges that AbbVie’s proposed $63 billion acquisition of (...)

The EU Commission approves German “umbrella” scheme to support research, development and testing as well as production of COVID-19 relevant products Free
DG COMP (Brussels)
State aid: Commission approves German “umbrella” scheme to support research, development, testing and production of coronavirus relevant products* The European Commission has approved a German “umbrella” scheme to support research, development, testing and production of coronavirus relevant (...)

The EU Commission approves €4 million Belgian scheme to support COVID-19 related research and development projects in the Brussels-Capital region Free
DG COMP (Brussels)
State aid: Commission approves €4 million Belgian scheme to support coronavirus related research and development projects* The European Commission has approved a €4 million Belgian direct grant scheme for the Brussels-Capital region to support coronavirus related research and development (...)

The UK Competition Authority publishes update on its COVID-19 taskforce including a number of excessive pricing complaints and investigations Free
United Kingdom’s Competition Authority - CMA (London)
CMA publishes update on COVID-19 Taskforce* The CMA has today published an update from its COVID-19 Taskforce, set up to monitor and respond to consumer and competition problems arising from the pandemic. As part of the Taskforce’s work, it asked the public for information about businesses (...)

The Italian Competition Authority releases a notice on cooperation agreements between businesses with special emphasis on the pharmaceutical, agri-food and health sector within the framework of the COVID-19 emergency Free
Italian Competition Authority (Rome)
ICA: Notice on cooperation agreements between businesses within the framework of the coronavirus emergency* Following the crisis caused by the spread of COVID-19 and the needs of the production system to cope with it, the Autorità Garante della Concorrenza e del Mercato (Italian Competition (...)

The EU Commission approves €5.3 million Maltese scheme to support research and development related to COVID-19 outbreak Free
DG COMP (Brussels)
State aid: Commission approves €5.3 million Maltese scheme to support research and development related to coronavirus outbreak* The European Commission has approved a €5.3 million Maltese direct grants scheme to support investment in research and development (R&D) related to the coronavirus (...)

The EU Commission conditionally clears an acquisition between a pharmaceutical company and an off-patent medicines producer and distributor (Milan / Upjohn)
Van Bael & Bellis (Brussels)
On 22 April 2020, the Commission conditionally cleared Dutch pharmaceutical company Mylan’s acquisition of Upjohn, a division of Pfizer. Upjohn, which is based in China, produces and distributes off-patent branded and generic medicines. Mylan is also active in the production and distribution of (...)

The EU Commission clears merger of generic Big Pharma company with a competitor’s generic division, subject to the divestment of business for certain generic medicines (Mylan / Upjohn)
DG COMP (Brussels)
Mergers: Commission approves the merger of Mylan and Pfizer’s Upjohn division, subject to conditions* The European Commission has approved, under the EU Merger Regulation, the proposed merger between the global pharmaceutical company Mylan and Upjohn, a business division of Pfizer, which (...)

The US Court of Appeals for the Third Circuit overturns a district court decision certifying a class of direct purchaser plaintiffs without undertaking a rigorous analysis in order to resolve factual disputes, assess competing evidence or weigh conflicting expert testimony (Lamictal)
McDermott Will & Emery (New York)
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Crowell & Moring (Washington)
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McDermott Will & Emery (Chicago)
The US Court of Appeals for the Third Circuit recently concluded in In re Lamictal Direct Purchaser Antitrust Litigation that a district court’s reliance on average prices to determine class-wide impact was insufficient. Instead, courts must conduct a rigorous analysis of the facts, evidence and (...)

The US DoJ issues a second business review letter to show that it is still open to creative solutions to combat COVID-19 to get medical supplies where they are needed the most Free
McDermott Will & Emery (Chicago)
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McDermott Will & Emery (Chicago)
The United States Department of Justice Antitrust Division (DOJ) has issued a second Business Review Letter pursuant to the expedited review process it announced on March 24, 2020 to review conduct related to COVID-19 within seven days. The letter released on April 20, 2020 issued to (...)

The US DoJ issues positive Business Review Letter to drug wholesale company and announces it will not challenge collaborative efforts in procuring healthcare supplies used to treat COVID-19 patients (AmerisourceBergen) Free
US Department of Justice - Antitrust Division (Washington)
Justice Department Issues Business Review Letter to AmerisourceBergen Supporting Distribution of Critical Medicines Under Expedited Procedure for COVID-19 Pandemic Response* The Department of Justice announced today that it will not challenge collaborative efforts of AmerisourceBergen (...)

The US FTC adds 6 State Attorneys General as co-complainants in suit against anticompetitive scheme to protect list-price increase of more than 4,000 percent for life-saving drug Daraprim (Vyera Pharmaceuticals / Martin Shkreli / Phoenixus / Kevin Mulleady)
US Federal Trade Commission (FTC) (Washington)
Six More States Join FTC and NY Attorney General’s Case Against Vyera Pharmaceuticals, Martin Shkreli, and Other Defendants* Defendants engaged in anticompetitive scheme to protect list-price increase of more than 4,000 percent for life-saving drug Daraprim The Federal Trade Commission has (...)

The US DoJ publishes a business review letter to pharmaceutical and medical distributors in order to provide insights into the antitrust enforcer’s views on competitor collaborations and to improve product access to fight the COVID-19 pandemic Free
McDermott Will & Emery (Chicago)
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McDermott Will & Emery (Washington)
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McDermott Will & Emery (Chicago)
A recent business review letter issued by the US Department of Justice Antitrust Division to five pharmaceutical and medical/surgical distributors offers insights into the antitrust enforcers’ views on competitor collaborations aimed at improving product access to respond to the Coronavirus (...)

The Chinese State Administration for Market Regulation fines three pharmaceutical companies for abuse of dominance in the distribution of injectable drug and confirms that medical devices sectors continue to be an enforcement priority amid the COVID-19 outbreak (Kanghui / Puyunhui / Taiyangshen) Free
Herbert Smith Freehills (Shanghai)
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Herbert Smith Freehills (Hong Kong)
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Herbert Smith Freehills (Hong Kong)
On 9 April 2020, China’s State Administration for Market Regulation (SAMR) fined 3 pharmaceutical companies for abuse of dominance in the distribution of injectable calcium gluconate Active Pharmaceutical Ingredient (API). The three companies were found to be in breach of the PRC’s Anti-Monopoly (...)

The Chinese State Administration for Market Regulation fines three domestic pharmaceutical companies for abuse of dominance in the sale of injectable pharmaceutical ingredient (Kanghui / Puyunhui / Taiyangshen)
FenXun Partners (Beijing)
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Baker McKenzie (Beijing)
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Baker McKenzie (Beijing)
On 9 April 2020, China’s State Administration for Market Regulation (SAMR) fined three domestic pharmaceutical companies Shandong Kanghui Medicine Company Limited ("Kanghui"), Weifang Puyunhui Pharmaceutical Company Limited ("Puyunhui") and Weifang Taiyangshen Company Limited Pharmaceutical (...)

The EU Commission provides antitrust guidance to companies cooperating in response to urgent COVID-19 related matters especially in the health sector for critical hospital medicines and medical equipment Free
Morgan Lewis (London)
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Morgan Lewis (London)
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Morgan Lewis (Brussels)
The European Commission has provided antitrust guidance to companies cooperating in response to urgent coronavirus (COVID-19) related matters, particularly in the health sector for critical hospital medicines and medical equipment, and has also exceptionally issued a “comfort letter” on a (...)

The EU Commission publishes its first comfort letter to foster cooperation among businesses in the pharmaceutical sector during COVID-19 pandemic Free
Morgan Lewis (London)
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Morgan Lewis (Brussels)
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Morgan Lewis (Brussels)
The European Commission published its first comfort letter in nearly 20 years on April 29, in an effort to foster cooperation among businesses during the coronavirus (COVID-19) pandemic. Here is what companies should know about the specific practices permitted under the comfort letter, as well (...)

The EU Commission increases leeway for cooperation between pharma and medical equipment companies during the COVID-19 crisis Free
Bird & Bird (Belgium)
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Bird & Bird (Copenhagen)
Competition rules are aimed at safeguarding healthy competition between companies. For more than half a century the EU and its Member States have vigorously defended effective competition by pursuing and sanctioning anti-competitive agreements and abuses of dominant positions. The pharma sector (...)

The EU Commission releases a Temporary Framework communication providing a more comprehensive antitrust guidance to companies cooperating in response to the COVID-19 crisis Free
BDK (Podgorica)
Following the joint statementof 23 March 2020 by the European Competition Network (ECN), consisting of the European Commission, the European Surveillance Authority and the national competition authorities of each EU/EEA Member States on the joint approach to the application of competition law (...)

The EU Commission issues a Temporary Framework Communication on allowing limited cooperation among businesses, and a comfort letter especially for critical hospital medicines during the COVID-19 outbreak Free
DG COMP (Brussels)
Antitrust: Commission provides guidance on allowing limited cooperation among businesses, especially for critical hospital medicines during the coronavirus outbreak* The European Commission has published a Temporary Framework Communication to provide antitrust guidance to companies cooperating (...)

The US DoJ issues its first business review letter under the DoJ-FTC expedited COVID-19 competitor collaboration review procedures, blessing several medical supply companies to work together to produce and distribute protective equipment Free
White & Case (Washington)
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White & Case (New York)
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White & Case (Washington)
On April 4, 2020, the Antitrust Division of the Department of Justice issued its first Business Review Letter under the DOJ-FTC joint expedited COVID-19 competitor collaboration review procedures, blessing several medical supply companies to work together to produce and distribute personal (...)

The Australian Competition Authority grants conditional interim authorisation for medicine manufacturers to coordinate on COVID-19 response Free
Australian Competition and Consumer Commission (Canberra)
Medicine manufacturers to coordinate on COVID-19 response* The ACCC has granted conditional interim authorisation for Medicines Australia (MA), the Generic and Biosimilar Medicines Association (GBMA) and their members to work together to support the continued supply of essential medicines (...)

The Dutch Competition Authority expresses its satisfaction with commitments made by a pharmaceutical company regarding the supply of testing material for a drug test (Roche)
Van Bael & Bellis (Brussels)
On 3 April 2020, the Dutch competition authority (Autoriteit Consument en Markt or “ACM”) published a press release expressing its satisfaction with commitments made by Roche Diagnostics (“Roche”) regarding the supply of testing materials for the SARS- CoV-2 test. Roche, which the ACM says has a (...)

The Australian Competition Authority authorises medicine wholesalers to cooperate and to facilitate distribution of essential medication and pharmacy products during COVID-19 crisis Free
Australian Competition and Consumer Commission (Canberra)
Medicine wholesalers to co-operate on access to pharmaceutical products* Wholesalers of medicines will be able to co-operate to facilitate distribution of essential medication and pharmacy products after being granted interim authorisation by the ACCC. This follows an application by the (...)

The Bulgarian Competition Authority announces it will focus on allowing and monitoring collaborations among competitors in the markets for public health products and pharmaceuticals as well as food and commerce important for fighting the COVID-19 outbreak Free
Bulgarian Commission for the Protection of Competition (Sofia)
Message by the CPC on the application of antitrust rules in the state of emergency situation concerning COVID-19* The Commission for protection of competition supports the joint position of the European Commission and the national competition authorities within the European Competition Network (...)

The EU Commission consults with Member States on extending the State aid Temporary Framework for COVID-19 outbreak with 5 new measures Free
DG COMP (Brussels)
Coronavirus: Commission Statement on consulting Member States on the proposal to extend State aid Temporary Framework* This evening, the European Commission has sent to Member States for consultation a draft proposal to extend the State aid Temporary Framework adopted on 19 March 2020 to (...)

The EU Commission opens an in-depth investigation relating to a merger in the pharmaceutical sector (Tachosil / Johnson & Johnson)
DG COMP (Brussels)
Mergers: Commission opens in-depth investigation into proposed acquisition of Tachosil by Johnson & Johnson* The European Commission has opened an in-depth investigation to assess the proposed acquisition of Tachosil by Johnson & Johnson, under the EU Merger Regulation. The Commission (...)

The EU Commission issues guidelines to protect against predatory buyers during the COVID-19 outbreak Free
Morgan Lewis (Frankfurt)
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Morgan Lewis (Brussels)
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Morgan Lewis (Frankfurt)
The European Commission on March 25 issued guidelines addressed to its member states outlining an EU-wide approach for foreign direct investment screening. The guidelines seek to protect EU companies as well as critical assets that are essential for the EU’s security and public order, (...)

The EU Commission publishes its first official guidance on the application of the FDI Regulation and states that during the COVID-19 crisis there could be an increased risk of attempts to acquire healthcare capacities Free
Norton Rose Fulbright (Brussels)
On March 25, 2020, the European Commission (EC) published its first official guidance (the Guidance) on the application of Regulation 2019/452 (the FDI Regulation), which created a new framework for screening foreign direct investments (FDI) into the European Union (EU). The EC noted that, in (...)

The UK Competition Authority writes an open letter to the pharmaceutical, food and drink industries warning them not to exploit the COVID-19 outbreak to charge prices that might be deemed excessive Free
United Kingdom’s Competition Authority - CMA (London)
Coronavirus (COVID-19): CMA open letter to pharmaceutical and food and drink industries.* The Competition and Markets Authority has published an open letter for businesses in the pharmaceutical and food and drink industries. Details We have written an open letter to the pharmaceutical and (...)

The UK Competition Authority launches a COVID-19 taskforce to both ensure compliance in the markets affected by the public health emergency and advises the Government on competition law matters during the Covid-19 outbreak Free
United Kingdom’s Competition Authority - CMA (London)
CMA launches COVID-19 taskforce* The CMA is today launching a taskforce to tackle negative impacts within its remit of the COVID-19 pandemic. The outbreak of COVID-19 is an unprecedented and rapidly evolving challenge that has prompted many concerns that businesses might exploit the situation (...)

The UK Competition Authority investigates four pharmacies and convenience stores for excessive and unfair pricing of hand sanitiser products during the COVID-19 pandemic Free
Bird & Bird (London)
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Bird & Bird (London)
The Competition and Markets Authority (CMA) is investigating four pharmacies and convenience stores for suspected breaches of competition law. The investigations, under Chapter II of the Competition Act 1998 (CA 98), relate to suspected charging of excessive and unfair prices for hand sanitiser (...)

The US FTC clears a global biopharmaceutical merger subject to several divestments in highly concentrated product markets for ten products that companies use to manufacture biopharmaceutical drugs (Danaher Corporation / GE Biopharma)
US Federal Trade Commission (FTC) (Washington)
FTC Imposes Conditions on Danaher Corporation’s Acquisition of GE Biopharma* Merger likely to reduce competition in highly concentrated markets that supply biopharmaceutical companies with key inputs Danaher Corporation has agreed to divest assets to settle Federal Trade Commission charges (...)

The Italian Competition Authority initiates a proceeding against the sale of a generic drug for the treatment of HIV infections sold as a remedy to fight the COVID-19 virus (Kaletra) Free
University of Turin (Turin)
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University of Turin (Turin)
1.Introduction The spread of the Covid-19 pandemic is unfortunately accompanied by the equally rapid one of unfair commercial practices in Italy. A worrying scenario, also for potential, serious effects on people’s health, on which the Italian Competition Authority (‘ICA’) continues to keep the (...)

The Ukrainian Competition Authority issues recommendations to pharmacies and retailers against excessive prices for masks, examines price hikes for airline tickets and monitors prices for disinfectants and consumption basket products Free
Redcliffe Partners (Kyiv)
As with other competition authorities, the Antimonopoly Committee of Ukraine (the "AMC") is responding promptly during the coronavirus outbreak. On 13 March 2020, the AMC announced that it would investigate any unjustified price hikes for medicines, face masks and other personal health (...)

The Italian Supreme Administrative Court rejects an appeal lodged by a multinational drug company against a previous decision ascertaining it as having abused its dominant position by imposing unfair prices for drugs (Aspen)
Bird & Bird (Rome)
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Bird & Bird (Rome)
On 13 March, the Italian Supreme Administrative Court ("Consiglio di Stato") rejected the appeal lodged by the multinational Aspen Group against the decision of the Regional Administrative Court of Lazio (“TAR”), which fully upheld the decision adopted by the Italian Competition Authority (“ICA”) (...)

The UK Court of Appeal seeks to reinstate record fines totalling £89.4million imposed on pharmaceutical companies for abuse of dominant position through excessive and unfair pricing of an anti-epilepsy drug (Pfizer / Flynn)
Herbert Smith Freehills (London)
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Herbert Smith Freehills (Brussels)
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Herbert Smith Freehills (London)
On 10 March 2020 the UK Court of Appeal handed down its hotly anticipated judgment in Flynn Pharma Limited & Anr vs Competition and Markets Authority. The UK Competition and Markets Authority (CMA) was seeking to reinstate record fines totalling £89.4m imposed on pharmaceutical companies (...)

The UK Court of Appeal provides guidance regarding the legal test to determine whether pricing is excessive and unfair in the pharmaceutical market (Flynn Pharma / Pfizer)
Covington & Burling (Brussels)
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Covington & Burling (Brussels)
The UK Court of Appeal Clarifies the Legal Test for Excessive Pricing* Under Article 102 of the Treaty on the Functioning of the European Union (“TFEU”), an undertaking may abuse its dominant position by “directly or indirectly imposing unfair purchase or selling prices”. The UK Court of Appeal (...)

The UK Court of Appeal imposes agency discretion in the methodology to establish the unfairness of prices, thereby increasing the burden of proof on companies to avoid a finding of excessive pricing (Flynn / Pfizer)
Skadden, Arps, Slate, Meagher & Flom (Brussels)
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Skadden, Arps, Slate, Meagher & Flom (Brussels)
The UK Court of Appeal Overturns the CAT & Imposes Agency Discretion on Excessive Price Benchmark* On March 10, 2020, the England and Wales Court of Appeal (CoA) handed down a significant ruling that reintroduces agency discretion in the methodology used to establish the unfairness of (...)

The UK Court of Appeal upholds the Competition Appeal Tribunal’s quashing of the Competition Authority’s decision against pharmaceutical undertakings who had abused their dominant position by pricing their epilepsy drug unfairly (Pfizer / Flynn Pharma)
White & Case (Brussels)
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White & Case (Brussels)
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White & Case (London)
On 10 March 2020 the Court of Appeal upheld the Competition Appeal Tribunal’s (CAT) quashing of the Competition and Markets Authority’s (CMA) decision that Pfizer and Flynn Pharma (Flynn) had abused their dominant positions in the market by pricing their epilepsy drug unfairly. Among other (...)

The UK Court of Appeal dismisses the Competition Authority’s appeal against the Competition Appeals Tribunal ruling quashing fines imposed on two pharmaceutical companies for charging excessive and unfair prices for an anti-epilepsy drug (Pfizer / Flynn)
Van Bael & Bellis (Brussels)
On 10 March 2020, the UK’s Court of Appeal dismissed the Competition and Market Authority’s (“CMA”) appeal against a 2018 ruling by the Competition Appeals Tribunal (“CAT”) that quashed the CMA’s 2016 fine imposed on Pfizer and Flynn for charging excessive and unfair prices for phenytoin sodium (an (...)

The UK Court of Appeal provides guidance on the legal test for excessive and unfair pricing after finding that an undertaking is charged unfairly high prices for phenytoin sodium capsules (Flynn / Pfizer)
Covington & Burling (Brussels)
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Covington & Burling (Brussels)
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Covington & Burling (Brussels)
Under Article 102 of the Treaty on the Functioning of the European Union (“TFEU”), an undertaking may abuse its dominant position by “directly or indirectly imposing unfair purchase or selling prices”. The UK Court of Appeal recently provided guidance regarding the legal test to determine whether (...)

The UK Court of Appeal considers the test for excessive pricing after an undertaking had charged unfairly high prices for phenytoin sodium capsules (Pfizer / Flynn)
Bristows (London)
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Bristows (London)
Introduction In December 2016, the UK’s Competition and Markets Authority (CMA) found that Pfizer and Flynn had charged unfairly high prices for phenytoin sodium capsules, an important anti-epilepsy drug, in breach of competition law. The CMA imposed fines totalling £90 million. Pfizer and Flynn (...)

The UK Competition Authority fines four pharmaceutical companies a total of £3,4 million for breaching competition law in relation to the supply of the antidepressant drug for market sharing and exchanging sensitive information (King Pharmaceuticals / Auden Mckenzie / Lexon / Alissa Healthcare)
Van Bael & Bellis (Brussels)
On 4 March 2020, the UK’s Competition and Markets Authority (“CMA”) fined four pharmaceutical companies a total of £ 3.4 million for breaching competition law in relation to the supply of the antidepressant drug nortriptyline. The companies involved in the infringement were King Pharmaceuticals, (...)

The UK Competition Authority closes its pharma probe by fining 4 companies more than £3.4 million and requiring a payment of £1 million directly to the NHS for breaches of competition law in relation to the supply of an antidepressant (King Pharmaceuticals / Accord-UK / Lexon / Alissa Healthcare Research)
United Kingdom’s Competition Authority - CMA (London)
Over £3m in fines and £1m for NHS in CMA pharma probe* Following an investigation, the CMA has found that 4 pharmaceutical companies broke competition law in relation to the supply of an antidepressant. The probe by the Competition and Markets Authority (CMA) into the supply of nortriptyline, a (...)

The Danish Maritime and Commercial Court finds a medicine distributor guilty of abusing its dominant position (CD Pharma)
Bird & Bird (Copenhagen)
On 3 March 2020, the Danish Maritime and Commercial Court found a medicine distributor, CD Pharma AB, guilty of having abused its dominant position back in 2014. Due to its dominant position, the undertaking in question had a special responsibility not to harm competition – a responsibility that (...)

The US DoJ reaches deferred prosecution agreement with pharma company fined a record criminal penalty for a domestic antitrust case (Sandoz)
US Department of Justice - Antitrust Division (Washington)
Major Generic Pharmaceutical Company Admits to Antitrust Crimes: Sandoz Inc. Agrees to Pay a $195 Million Criminal Penalty, the Largest for a Domestic Antitrust Case* Sandoz Inc., a generic pharmaceutical company headquartered in New Jersey, was charged for conspiring to allocate customers, (...)

The Belgian Competition Authority publishes its annual enforcement priorities for 2020
Bird & Bird (Brussels)
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Bird & Bird (Brussels)
On 26 February 2020, the Belgian Competition Authority (“BCA”) published its annual enforcement priorities, which are largely similar to those of 2019: Telecommunications - the BCA notes that the increased reliance on bundled offers in the telecom retail markets has the effect of increasing (...)

The US FTC and the FDA issue a joint statement and plan seeking to advance biosimilar competition and combat deceptive and anticompetitive practices in the biologic marketplace
White & Case (Washington)
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White & Case (Washington)
On February 3, 2020, the Federal Trade Commission ("FTC") and the Food and Drug Administration ("FDA") issued a joint statement and plan seeking to advance biosimilar competition and combat deceptive and anticompetitive practices in the "biologic marketplace." As discussed below, the FTC and (...)

The EU Court of Justice clarifies the conditions for a pay-for-delay agreement to be qualified as a restriction of competition by object (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
Ashurst (Brussels)
On 30 January 2020 (case C-307/18), the European Court of Justice ("ECJ") issued a preliminary ruling that sheds more light on the circumstances in which an agreement settling a patent dispute between a pharmaceutical patent holder and a company intending to launch a competing generic product (...)

The UK Competition Authority welcomes the EU Court of Justice’s ruling in a pay-for-delay case (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
United Kingdom’s Competition Authority - CMA (London)
CMA welcomes EU Court ruling in pay-for-delay drug case* The CMA welcomes a ruling from the EU Court of Justice in relation to its case that drug companies supplying an antidepressant called paroxetine broke the law. The ruling, released today, follows appeals from GlaxoSmithKline and other (...)

The EU Court of Justice clarifies for the first time when patent settlement agreements that restrict a generic pharmaceutical company’s ability to enter the market infringe the EU antitrust rules (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
Baker Botts (Brussels)
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Baker Botts (Brussels)
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Baker Botts (Brussels)
In a major judgment handed down on 30 January 2020 in Generics (UK) and Others, the EU Court of Justice (the Court) – the EU’s highest court – clarified for the first time the analytical framework for assessing when patent settlement agreements that restrict a generic pharmaceutical company’s (...)

The EU Court of Justice clarifies the criteria for the pay-for-delay agreements in the pharmaceutical sector (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
Herbert Smith Freehills (Brussels)
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Herbert Smith Freehills (Brussels)
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Herbert Smith Freehills (London)
On 30 January 2020 the European Court of Justice (“ECJ”) clarified for the first time the criteria governing whether so-called “pay-for-delay” agreements entered into between originator and generic pharmaceutical companies fall foul of EU competition law rules. Such agreements are a form of patent (...)

The EU Court of Justice clarifies the conditions under which pay-for-delay agreements preventing generic versions of a patented medicine from entering the market or delaying such entry may constitute a restriction of competition ‘by object’ or ‘by effect” as well as an abuse of dominant position (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
University of Liège
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University of Liège
On 30 January 2020, the Court of Justice of the EU (‘CJEU’) ruled on the applicability of competition law to settlement agreements between a holder of a pharmaceutical patent and manufacturers of generic medicines. In a judgment issued only a week after Advocate General Kokott delivered her (...)

The EU Court of Justice rules that pay-for-delay patent settlements may restrict competition by object (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
Van Bael & Bellis (Brussels)
On 30 January 2020, the Court of Justice of the European Union (the “ECJ”) handed down its judgment in Case C-307/18, Generics (UK) and Others. This case marks the first time the ECJ has ruled on patent settlement agree- ments between originator pharmaceutical companies and generic producers. (...)

The EU Court of Justice provides guidance on patent settlements between manufacturers of the originator and generic medicines (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
Hausfeld (London)
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Hausfeld (Berlin)
On 30 January 2020, the European Court of Justice released its judgment relating to a patent dispute between the pharmaceutical patent-holder, GlaxoSmithKline (GSK), and a generic drug maker concluding that originators and generics are in fact “potential competitors” if the generic drugmaker has (...)

The UK Competition Authority publishes guidance on its functions to explain the effects of Brexit on the application of competition law in the UK during and after the transition period
Baker Botts (Brussels)
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University of Tilburg
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Baker Botts (London)
The EU and the UK have now both set out their negotiating mandates for the forthcoming trade negotiations. On 25 February 2020, the Council of the EU adopted a formal decision authorising the commencement of trade negotiations with the UK, together with a revised version of the European (...)

The US FTC files a complaint against an undertaking seeking permanent injunctive relief and equitable relief, including monetary relief, for an anticompetitive scheme to preserve a monopoly for a drug (Vyera Pharmaceuticals / Pharma Bro)
Wolters Kluwer (Riverwoods)
WILL THE SUPREME COURT LIMIT THE FTC’S USE OF SECTION 13(B) COURT ACTIONS?* The FTC’s authority to seek permanent injunctive relief and monetary relief under Section 13(b) of the FTC Act is being called into question. While more commonly used in consumer protection cases, Section 13(b) has been (...)

The EU Court of Justice confirms the right of access to documents contained in the file of a marketing authorisation application for a medicinal product (PTC Therapeutics / MSD Animal Health)
European Court of Justice (Luxembourg)
The Court confirms the right of access to documents contained in the file of a marketing authorisation application for a medicinal product* An objection to such access must explain the nature, purpose and scope of the data whose disclosure would undermine commercial interests In the judgments (...)

The EU Commission clears a merger subject to remedies in the pharmaceutical sector (AbbVie / Allergan)
DG COMP (Brussels)
Mergers: Commission approves AbbVie’s acquisition of Allergan, subject to conditions* The European Commission has approved, under the EU Merger Regulation, the proposed acquisition of Allergan by AbbVie. The approval is conditional on the divestment of a product under development by Allergan to (...)

The Belgian Court of Appeal upholds the Competition Authority’s decision for imposing a fine over the exclusion of a company from the pharmaceutical sector (Order of Pharmacists)
Bird & Bird (Brussels)
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Bird & Bird (Brussels)
In a judgment dated 8 January 2020, the Court of Appeal upheld the decision of the Belgian Competition Authority ("BCA") in which it imposed a fine on the Order of Pharmacists for excluding Medi-Market from the market for pharmacy services (see July edition of Competitive Edge). The Court, (...)

The UK Competition Authority cancels its phase II investigation following an abandon merger in the DNA sequencing systems market (Illumina / PacBio)
United Kingdom’s Competition Authority - CMA (London)
Illumina/PacBio abandon merger* Illumina has abandoned its anticipated $1.2 billion takeover of PacBio after an in-depth CMA merger probe highlighted serious competition concerns. The Competition and Markets Authority (CMA) has therefore today confirmed that it will be cancelling its Phase 2 (...)

The EU Commission clears a merger subject to remedies in the biotechnologies market (Danaher / GE Healthcare Life Sciences’ Biopharma Business)
DG COMP (Brussels)
Mergers: Commission approves Danaher’s acquisition of GE Healthcare Life Sciences’ Biopharma Business, subject to conditions* The European Commission has approved, under the EU Merger Regulation, the proposed acquisition of General Electric’s Healthcare Life Sciences Biopharma Business by Danaher (...)

The Hong Kong Competition Authority clarifies its approach to information exchange in a case involving the pharmaceutical sector (Hong Kong Association of the Pharmaceutical Industry)
Linklaters (Hong Kong)
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Linklaters (Hong Kong)
This article has been nominated for the 2020 Antitrust Writing Awards. Click here to learn more about the Antitrust Writing Awards. The Hong Kong Competition Commission (“HKCC”) recently published its decision relating to a proposed market sales survey by the Hong Kong Association of the (...)

The Belgian Competition Authority fines the national pharmacists order for taking disciplinary measures limiting the ability to advertise and apply rebates to para pharmaceutical products (Order of Pharmacists)
Ashurst (Brussels)
On 16 October 2019, the Belgian Competition Authority ("BCA") fined the national Order of Pharmacists €225,000 for taking disciplinary measures limiting the ability of pharmacists to advertise and apply rebates to parapharmaceutical products. WHAT YOU NEED TO KNOW - KEY TAKEAWAYS The BCA’s (...)

The Belgian Competition Authority fines €225,000 the national association of pharmacists for limiting the ability of pharmacists to advertise para pharmaceutical products online (Order of Pharmacists)
Bird & Bird (Brussels)
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Bird & Bird (Brussels)
On 15 October 2019, the Belgian Competition Authority ("BCA") imposed a fine of EUR 225,000 on the national Order of Pharmacists for adopting, maintaining and implementing provisions of its Deontological Code that limit the ability of pharmacists to advertise para-pharmaceutical products, in (...)

The Italian Competition Authority opens an abuse of dominance investigation into orphan drugs pricing (Leadiant Biosciences / Farmaco per la cura della Xantomasi cerebrotendinea)
Giannino SI (Monserrato)
On 8 October 2019 the Italian Competition Authority (ICA) has opened an Article 102 TFEU investigation against several pharmaceutical companies belonging to the Leadiant group. The ICA’s attention was drawn by the selling prices applied by the parties to an orphan drug because it feared that (...)

The Belgian Competition Authority carries out an unannounced inspection in the pharmaceutical sector
Belgian Competition Authority (Brussels)
The Belgian Competition Authority is conducting inspections in the pharmaceutical sector* The Investigation and Prosecution Service of the Belgian Competition Authority (BCA) is currently conducting inspections at the premises of companies suspected of having implemented restrictive practices (...)

The US State of California becomes the first State to enact legislation rendering certain pharmaceutical patent litigation settlement agreements presumptively anticompetitive
White & Case (Washington)
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White & Case (Washington)
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White & Case (New York)
This article has been nominated for the 2020 Antitrust Writing Awards. Click here to learn more about the Antitrust Writing Awards. On October 7, 2019, California became the first state to enact legislation— Assembly Bill 824 (“AB 824”)—rendering certain pharmaceutical patent litigation settlement (...)

The UK Competition Authority issues a statement of objections to three pharmaceutical companies over pay-for-delay agreements (Aspen / Amilco / Tiofarma)
Bird & Bird (Amsterdam)
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Bird & Bird (London)
On 3 October 2019 the Competition and Markets Authority (CMA) issued a Statement of Objections (the “SO”) to three pharmaceutical companies over pay-for-delay agreements in the market for Addison’s disease treatment. In its SO the CMA sets out its provisional view that, in 2016, pharmaceutical (...)

The Dutch Competition Authority publishes a sector report on the impact of biosimilars on competition between TNF-alfa inhibitors
Bird & Bird (The Hague)
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Bird & Bird (The Hague)
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Bird & Bird (The Hague)
Dutch competition authority ACM publishes a sector report on the impact of biosimilars on competition between TNF-alfa inhibitors* The Dutch competition authority, ACM, initiated a market study in 2018 into the effect of the introduction of biosimilars on the competition between TNF alfa (...)

The Dutch Competition Authority publishes a report on the market study about the effects on competition of the introduction of biosimilars
Bird & Bird (The Hague)
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Bird & Bird (Amsterdam)
On 24 September 2019 the Dutch Authority for Consumers and Markets (ACM) published its report on the 2018 initiated market study about the effects the introduction of biosimilars had on competition between TNF alfa inhibitors on the Dutch market. ACM did not establish violations of competition (...)

The EU Commission Commission opens in-depth investigations to assess whether “excess profit” tax rulings granted by Belgium to 39 multinational companies are in line with EU State aids rules
DG COMP (Brussels)
State aid: Commission opens in-depth investigations into individual “excess profit” tax rulings granted by Belgium to 39 multinational companies* The European Commission has opened separate in-depth investigations to assess whether “excess profit” tax rulings granted by Belgium to 39 multinational (...)

The UK Competition Authority invites interested parties to comment on its intention to accept commitments over an agreement that allegedly prevented the entry of a competing version in the drug fludrocortisone market (Aspen)
Bird & Bird (Amsterdam)
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Bird & Bird (London)
On 14 August 2019 the Competition & Market Authority ("CMA") invited interested parties to comment on its intention to accept commitments from Aspen over an agreement that allegedly prevented the entry of a competing version of the drug fludrocortisone in the UK. The CMA suspected Aspen (...)

The Italian Council of State confirms the €180 million fine imposed on a pharmaceutical cartel for entering into an anticompetitive agreement by object (Hoffman-La Roche / Novartis)
Bird & Bird (Rome)
On July 17th, the Council of State dismissed the appeals presented by F. Hoffman-La Roche Ltd. and Roche S.p.A. ("Roche") and from Novartis Farma S.p.A. and Novartis AG ("Novartis") against the judgement issued by Regional Administrative Court of First Instance rejecting the appeals against the (...)

The Italian Council of State confirms the national Antitrust Authority’s fine of €180 million to a pharmaceutical company for having “artificially differentiated” their medicinal products when entering into an anticompetitive agreement by object (Roche / Novartis)
White & Case (Milan)
1. Introduction The Italian Council of State, with its judgment No. 4990 of 2019, rejected the appeal proposed by F. Hoffmann-La Roche Ltd, Roche S.p.A., Novartis AG and Novartis Farma S.p.A. against the first-instance judgement by which the Regional Administrative Court of Latium (the (...)

The Paris Court of Appeal upholds the decision of the Competition Authority to fine a pharma company for abuse of dominance (Jansson-Cilag / Johnson & Johnson)
Dechert (Paris)
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Dechert (Paris)
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Dechert (New York)
More particularly, the Court affirmed the FCA’s conclusion that Janssen infringed competition law by, on the one hand, disparaging competing fentanyl specialties towards health professionals, emphasizing the risks associated with a switch from Durogesic© to a generic version and, on the other (...)

The EU Commission clears a merger subject to remedies in the pharmaceutical market (GSK / Pfizer Consumer Health Business)
DG COMP (Brussels)
Mergers: Commission approves GlaxoSmithKline’s acquisition of Pfizer’s Consumer Health Business, subject to conditions* Commission has approved, under the EU Merger Regulation, the acquisition of Pfizer’s Consumer Health Business by GlaxoSmithKline. The decision is conditional upon the global (...)

The Indian Competition Authority finds that an association of medicine dealers has collected charges that are illegal under national competition law (Jalgaon District Medicine Dealers Association)
Shardul Amarchand Mangaldas (New Delhi)
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Shardul Amarchand Mangaldas (New Delhi)
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Shardul Amarchand Mangaldas (New Delhi)
In a case against the Jalgaon District Medicine Dealers Association (Association), [1] the CCI found that the Association had collected Product Information Service (PIS) charges from manufacturers of pharmaceutical products. The CCI found that payment of the PIS charges was mandatory and, (...)

The Australian Competition Authority publishes draft guidelines on the application of competition laws to IP rights following the removal of the exception with particular significance for the pharmaceutical and life sciences sectors
Norton Rose Fullbright (Sydney)
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Norton Rose Fullbright (Sydney)
This article has been nominated for the 2020 Antitrust Writing Awards. Click here to learn more about the Antitrust Writing Awards. Introduction Conditions attached to the licensing or assignment of intellectual property (IP) have benefited from an exception to certain provisions of the (...)

The Indian Competition Authority fines a state medicine dealers association for restricting the supply of medicines in the market by requiring payment to publish about the medicines in its "Product Information Service" bulletin (Jalgaon District Medicine Dealers Association)
Vaish Associates Advocates (New Delhi)
CCI penalizes Jalgaon District Medicine Dealers Association for imposing PIS charges on pharma companies* CCI, by way of order dated 20.06.2019, has imposed a penalty of INR 80,185/- on Jalgaon District Medicine Dealers Association (“JDMDA/OP”) in the State of Maharashtra, India for collecting (...)

The UK Competition Authority provisionally finds that four pharmaceutical companies broke competition law by fixing the quantities and the prices of an anti-depressant drug (Auden Mckenzie / King / Alissa / Lexon)
United Kingdom’s Competition Authority - CMA (London)
Suppliers of antidepressants accused of illegal anti-competitive conduct* The CMA has provisionally found that 4 pharmaceutical companies broke competition law in relation to the supply of an anti-depressant drug. The Competition and Markets Authority (CMA) has accused competitors King and (...)

The UK Competition Authority finds that pharmaceutical companies took part in a market sharing arrangements (Lexon / Medreich)
Bird & Bird (London)
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Bird & Bird (London)
In recent years, the UK CMA has focussed many of its investigations on the pharmaceutical sector. This is partly due to the fact that in the UK, the National Health Service is a public funded body which bears most of the cost of the majority of medicines. Therefore, going after anti-competitive (...)

The Mexican Competition Authority notifies economic agents of their probable responsibility for collusion in the pharmaceutical market following an investigation in the health sector
Mexican Competition Authority (Mexico City)
COFECE notifies economic agents of a statement of probable responsibility for collusion in the market for pharmaceuticals* • The Investigative Authority concluded their probe and issued a statement indicating probable collusion. • The notification of a statement of probable responsibility (...)

The Mexican Competition Authority prohibits a concentration between a retail company and a company offering logistical services to retailers (Walmart / Cornershop)
Mexican Competition Authority (Mexico City)
COFECE blocked Walmart/Cornershop concentration* • The proposed deal could generate incentives to unduly displace or block competitors’ access to the Cornershop platform and/or hinder the development of new platforms. • The new economic agent resulting from the transaction would gain sufficient (...)

The Competition Commission of India finds two chemist associations and two pharmaceutical companies to have used no-objection certificates (Madhya Pradesh Chemists and Distributors Federation / Madhya Pradesh Chemists and Druggist Association)
Shardul Amarchand Mangaldas (New Delhi)
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Shardul Amarchand Mangaldas (New Delhi)
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Shardul Amarchand Mangaldas (New Delhi)
India Competition Law Roundup: June 2019 The Competition Commission of India (CCI) found that two chemist associations and two pharmaceutical companies had engaged in a system of no-objection certificates (NOC) under which the associations prescribed which stockist could stock a company’s (...)

The Indian Competition Authority fines pharmaceutical associations and companies for imposing anticompetitive conditions on their retailers (Madhya Pradesh Chemists and Distributors Federation / Madhya Pradesh Chemists and Druggist Association)
Vaish Associates Advocates (New Delhi)
CCI imposes penalty on chemists and druggist associations in Madhya Pradesh and two pharmaceutical companies* By way of order dated 03.06.2019, CCI imposed penalty on Madhya Pradesh Chemists and Druggist Association (“MPCDA”) and Indore Chemists Association (“ICA”) (collectively ‘chemists and (...)

The Indian Competition Authority finds that pharmaceutical companies and their trade association infringe competition law so orders them to organise competition awareness programmes (Madhya Pradesh Chemists and Distributors Federation / Madhya Pradesh Chemists and Druggist Association)
National Law University (Punjab)
Indian competition authority finds that pharmaceutical companies and their trade association infringe competition law* Background On 3rd June 2019, CCI delivered yet another order, wherein it held the Madhya Pradesh Chemists & Druggists Association along with other district-level (...)

The Indian Competition Commission finds that chemist associations and pharmaceutical companies had engaged in a system of no-objection certificates under which the associations prescribed which stockist could stock a company’s products
Shardul Amarchand Mangaldas (New Delhi)
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Shardul Amarchand Mangaldas (New Delhi)
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Shardul Amarchand Mangaldas (New Delhi)
The Competition Commission of India (CCI) found that two chemist associations and two pharmaceutical companies had engaged in a system of no-objection certificates (NOC) under which the associations prescribed which stockist could stock a company’s products.1 The associations and certain of (...)

The US DoJ Antitrust Division enters into a rare deferred prosecution agreement, and a first one with a company that is not a bank (Heritage Pharmaceuticals)
Baker Botts (San Francisco)
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Baker Botts (Washington)
The Department of Justice (DOJ) routinely relies on deferred prosecution agreements (DPAs) and non-prosecution agreements (NPAs) to resolve corporate criminal investigations. Since 2004, the DOJ has entered into an average of 33 such agreements per year. These agreements allow companies to (...)

The Belgian Competition Authority fines a pharmaceutical company for implementing anticompetitive practices aimed at excluding another association of pharmacies from the market (Order of Pharmacists)
Bird & Bird (Brussels)
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Bird & Bird (Brussels)
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Bird & Bird (Brussels)
The Belgian Competition Authority ("BCA") fined the national Order of Pharmacists EUR 1 million on 28 May 2019, for the use of anticompetitive practices aimed at excluding the Medi-Market Group, an association of (para)pharmacies, from the market for pharmacy services. Previously, the market (...)

The Belgian Competition Authority fines an undertaking up to €1 million for implementing restrictive practices aimed at hindering the development on the market for pharmacists’ services by other undertakings (Order of Pharmacists)
Belgian Competition Authority (Brussels)
The Competition College of the Belgian Competition Authority condemns “l’Ordre des pharmaciens – Orde der apothekers” for having tried to hinder the development of the MediCare-Market group and imposes a fine of 1 million euros* The Competition College of the Belgian Competition Authority (BCA) (...)

The UK Competition Authority provisionally finds that four pharmaceutical companies broke competition law by agreeing not to compete in the supply of an anti-nausea drug (Alliance Pharmaceuticals / Focus / Lexon / Medreich)
United Kingdom’s Competition Authority - CMA (London)
Drug firms accused of illegal market sharing over anti-nausea tablets* The CMA has provisionally found that 4 pharmaceutical companies broke the law by agreeing not to compete in the supply of an anti-nausea drug in the UK. In a statement of objections issued today, the Competition and (...)

The US FTC sues e-prescriptions company for an illegal monopolization on two e‑prescribing markets (Surescripts)
Jones Day (Washington DC)
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Jones Day (Washington DC)
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Jones Day (Chicago)
This article has been nominated for the 2020 Antitrust Writing Awards. Click here to learn more about the Antitrust Writing Awards. In Short The Situation: The Federal Trade Commission ("FTC") recently filed a rare monopolization case, alleging that a health information technology company (...)

The Danish Competition Authority announces that 45 retail and online stores received injections to remove all illegal payment-card fees that were charging on consumers
Bird & Bird (Copenhagen)
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Bird & Bird (Copenhagen)
On 5 April 2019, the Danish Competition and Consumer Authority ("Authority") announced that 45 retail and online stores (including pharmacies, shops, cafés, restaurants and online stores) have received injunctions from the Authority to remove all illegal payment-card fees they were charging (...)

The French Competition Authority delivers its opinion on the distribution of medicinal products and biomedical laboratories
French Competition Authority (Paris)
4 April: Distribution of medicinal products and biomedical laboratories: the Autorité delivers its opinion After several months of investigation and a large public consultation, the Autorité de la concurrence releases the findings of its healthcare sector inquiry. The medicinal product (...)

The US FTC reverses Administrative Law Judge decision, finding Section 5 violation for reverse-payment settlement (Endo / Impax)
Rutgers University (Camden)
In FTC v. Actavis, the Supreme Court ruled that settlements by which brand drug companies pay generics to delay entering the market could violate antitrust law. In In the Matter of Impax Laboratories, the Federal Trade Commission (FTC or Commission) offered its first elaboration upon this (...)

The US FTC concludes that a pharma company entered into an illegal pay-for-delay agreement (Endo / Impax)
Hausfeld (Philadelphia)
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Hausfeld (Washington)
On March 28, 2019, the Federal Trade Commission (the “Commission”) issued a landmark opinion in the agency’s case against Impax Laboratories Inc. regarding its patent settlement with Endo Pharmaceuticals Inc., marking the first time that the Commission has weighed in on the proper application of (...)

The US District Court for the Northern District of Illinois receives a class action complaint against a pay-for-delay agreement (Abbvie)
Constantine Cannon (Washington)
Plaintiffs Targeting Biologic-Biosimilars Settlements with Pay-for-Delay Antitrust Claims* Antitrust principles that can invalidate certain pay-for-delay settlements will be expanding into the new frontier of biologic and biosimilar drugs if plaintiffs in several new suits are successful. (...)

The UK Competition Authority closes its investigation into an allegedly abusive discount scheme in the pharmaceutical sector (Remicade)
White & Case (Brussels)
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White & Case (Brussels)
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White & Case (Brussels)
This article has been nominated for the 2020 Antitrust Writing Awards. Click here to learn more about the Antitrust Writing Awards. The CMA Remicade decision: discount schemes and abuse of dominance – effects matter!* Summary On 14 March 2019, the UK Competition and Markets Authority (CMA) (...)

The Canadian Competition Authority publishes a revised version of its IP enforcement guidelines with particular importance for pharmaceutical companies
Norton Rose Fulbright (Toronto)
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Norton Rose Fulbright (Toronto)
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Norton Rose Fulbright (Toronto)
This article has been nominated for the 2020 Antitrust Writing Awards. Click here to learn more about the Antitrust Writing Awards. On March 13, the Competition Bureau published a revised version of its IP Enforcement Guidelines (IPEGs). The IPEGs clarify the Bureau’s approach to conducting (...)

The Danish Competition Authority issues a study on excessive pricing in pharmaceutical markets
Danish Competition and Consumer Authority (Copenhagen)
Excessive Pricing in Pharmaceutical Markets* Intervention against possible exploitative and excessive prices should always be considered carefully. However, the dynamics of pharmaceutical markets makes it particularly relevant for competition authorities to prioritise cases on unfair (...)

The US Court of Appeals for the Third Circuit dismisses a complaint only based on past conduct against a pharmaceutical company (Shire Viropharma)
Dechert (Philadelphia)
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Dechert (Philadelphia)
On February 25, 2019, the Third Circuit held that the Federal Trade Commission cannot bring litigation in federal court based on past conduct, absent factual allegations demonstrating that a defendant “is violating or is about to violate” the laws enforced by the FTC. In doing so, the court (...)

The Belgian Competition Authority publishes its enforcement priorities for 2019
Bird & Bird (Brussels)
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Bird & Bird (Brussels)
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Bird & Bird (Brussels)
On 1 March 2019, the Belgian Competition Authority (“BCA”) published its annual enforcement priorities, which are largely similar to those of 2018: Telecommunications – the BCA notes that the increased reliance on bundled offers in the telecom retail markets has the effect of increasing consumer (...)

The Australian Federal Court imposes a fine of $1,05 million in a gun jumping case in the pharmaceutical case (Cryosite / Cell Care)
Bird & Bird (Sydney)
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Bird & Bird (Sydney)
In July 2018, the Australian Competition and Consumer Commission (“ACCC”) brought its first gun jumping cartel case against Cryosite Limited (“Cryosite”). Gun jumping occurs when parties to a merger or acquisition coordinate their activities prior to the completion of their transaction. This (...)

The EU Commission publishes a report on competition enforcement in the pharmaceutical sector between 2009 and 2017
Court of First Instance of Namur (Namur)
On 28 January 2019, the European Commission adopted a report on competition enforcement in the pharmaceutical sector between 2009 and 2017. The report provides an overview on the enforcement of antitrust and merger rules in the pharmaceutical sector and describes how competition law enforcement (...)

The EU Commission issues a report on competition enforcement in the pharmaceutical sector covering the years 2009-2017
DG COMP (Brussels)
Report on Competition enforcement in the pharmaceutical sector (2009-2017)* On 28 January 2019, the European Commission adopted the Report ‘European competition authorities working together for affordable and innovative medicines’ on competition enforcement in the pharmaceutical sector. The (...)

The Indian Competition Authority approves merger of multinational companies with non-exclusive consignment selling agency arrangement in OTC and oral healthcare markets (Hindustan Unilever / GlaxoSmithKline Consumer Healthcare)
Vaish Associates Advocates (New Delhi)
CCI approves amalgamation of GlaxoSmithKline into Hindustan Unilever Limited* The Commission, by way of order dated 23.01.2019, has approved the amalgamation of GlaxoSmithKline Consumer Healthcare Limited (“GSKCH”) into Hindustan Unilever Limited (“HUL”) and subsequently cleared HUL to enter into (...)

The Indian Competition Authority re-imposes fines on a professional association for limiting supply with its certification requirements in the pharmaceutical industry (Vedanta Bio Sciences Vadodara / Chemists and Druggists Association of Baroda)
Vaish Associates Advocates (New Delhi)
CCI Imposes Penalty on Chemists and Druggists Association of Baroda* CCI, by way of order dated 15.01.2019 has found the Chemists and Druggists Association of Baroda (‘CDAB’) to be in contravention of the Act by indulging in the activity of limiting and controlling the supply of drugs and (...)

The Dutch Competition Authority clears a merger subject to remedies in the pharmaceutical sector (Apotex / Aurobindo)
Netherlands Authority for Consumers & Markets (The Hague)
ACM clears merger between pharmaceutical companies Aurobindo and Apotex* The Netherlands Authority for Consumers and Markets (ACM) has cleared the acquisition of pharmaceutical company Apotex by rival company Aurobindo. The clearance was granted after the companies had proposed to sell (...)

The EU General Court offers a mixed review of patent settlement agreements in the pharmaceutical sector (Servier)
Van Bael & Bellis (Brussels)
On 12 December 2018, the General Court (“GC”) once again passed judgment on a number of patent settlement agreements in the pharmaceutical sector. It had already reviewed such agreements in September 2016 when it upheld the decision of the European Commission (the “Commission”) in the Lundbeck (...)

The EU General Court holds that patent settlements may be deemed pay-for-delay agreements only if there are reverse payments, and the originator may not be held dominant if the market is not assessed rigorously (Servier)
Portolano Cavallo (Milan)
The Servier judgments: patent settlements may be deemed “pay-for-delay” agreements, and thus by-object infringements of Article 101 TFEU only if Commission substantiates strong indication of “reverse payment” or “abnormal inducement” from the originator to the generic; further, the originator cannot (...)

The EU General Court rules that pay-for-delay patent settlements can be illegal agreements but annuls abuse of dominance finding (Servier)
Freshfields Bruckhaus Deringer (London)
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Freshfields Bruckhaus Deringer (London)
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Freshfields Bruckhaus Deringer (Rome)
The General Court has given eight judgments on a Commission fining decision concerning patent settlements entered into by Servier and five competitor producers of generic drugs, reducing the fines from a total of € 428 million to € 315 million. The Court broadly upheld the fines based on Article (...)

The Italian Competition Authority provides useful guidance on under what circumstances an incumbent may associate with a competitor in a public tender for blood derivatives (Kedrion / Grifols)
Portolano Cavallo (Milan)
In January 2018 the AGCM launched an investigation for a possible breach of Article 101 TFEU against two international manufacturers of blood-based pharmaceuticals – Kedrion S.p.A (“Kedrion”) and Grifols Italia S.p.A (“Grifols”) – for participating as a joint venture to a public tender (issued by a (...)

The EU General Court annuls a decision of the Commission for wrongly qualifying agreements as "pay for delay" and improperly qualifying an abuse of dominance, thus reducing the fine imposed on a pharmaceutical company (Servier)
Dechert (Paris)
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Dechert (Paris)
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Dechert (Paris)
The General Court annuls in part the European Commission’s decision finding the existence of restrictive agreements and an abuse of a dominant position on the market for perindopril, a medicine used to treat hypertension and heart failure* On 12 December 2018, the General Court (“Court”) (...)

The Danish Competition Appeals Tribunal upholds decision fining a pharmaceutical distributor for excessive pricing (CD Pharma)
Van Bael & Bellis (Brussels)
On 29 November 2018, the Danish Competition Appeals Tribunal upheld a 31 January 2018 decision of the Danish Competition Authority (“DCA”) finding that CD Pharma abused its dominant position on the Danish market by charging excessive prices for the sale of oxytocin, a hormone that acts as a (...)

The Indian Competition Authority does not find "product information service" charges anticompetitive in the pharmaceutical industry because they are not mandatory (RDCA Retail / Dispensing Chemists Association)
Vaish Associates Advocates (New Delhi)
CCI exonerates RDCA of anti-competitive conduct in pharmaceutical market- disagrees with findings of the DG* The CCI, by way of an order dated November 8, 2018 exonerated Retail and Dispensing Chemists Association, located in Mumbai (“RDCA”) on allegations of limiting and controlling free supply (...)

The US Congress expands requirements for pharmaceutical companies to file agreements with the FTC and DOJ
Covington & Burling (Washington)
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Covington & Burling (Washington)
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Covington & Burling (Washington)
What occurred and why does it matter? President Trump on October 24 signed the SUPPORT for Patients and Communities Act (H.R. 6), which together with the Patient Right to Know Drug Prices Act (S. 2554), signed October 10, expands the scope of pharmaceutical product-related agreements subject (...)

The Australian High Court dismisses the Competition Authority leave to appeal against a first instance decision finding no anti-competitive exclusive dealing in its sales and distribution in the pharmaceutical sector (Pfizer)
Herbert Smith Freehills (Sydney)
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Herbert Smith Freehills (Melbourne)
We have previously published an update on the Full Court decision in ACCC v Pfizer, where the Full Court dismissed an appeal by the ACCC, upholding a first instance decision that Pfizer had not misused its market power or engaged in prohibited anti-competitive exclusive dealing in its sales and (...)

The Mexican Competition Authority accepts commitments by pharmaceutical companies to restore competition in the pharma market (Moench Coöperatif / Luis Doporto Alejandre)
Ritch Mueller (Mexico City)
Through a decision issued by the plenary session of Cofece on August 13, 2015 on case file CNT-074-2015 (the ’Decision’), the Mexican antitrust authority decided to unconditionally clear the acquisition, by Dutch fund Moench Coöperatif of a major pharmaceutical distributor in Mexico, Marzam. The (...)

The US Congress implements a law requiring drug manufacturers to disclose biologic patent settlement agreements to antitrust Authorities
Jones Day (Washington DC)
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Jones Day (Washington DC)
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Jones Day (Washington DC)
New Law Requires Disclosure of Biologic Patent Settlement Agreements to Antitrust Authorities* Last week, the Patient Right to Know Drug Prices Act ("Act") became law. The Act requires pharmaceutical companies to disclose to antitrust agencies agreements between biologic and biosimilar (...)

The US District Court of Delaware spotlights the importance of antitrust risk-shifting provisions in merger agreements in the pharmaceutical sector (Akorn / Fresenius)
Gibson Dunn (Washington)
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Baker Botts (Brussels)
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Baker Botts (Washington)
As counsel involved in negotiating mergers, acquisitions, or other transactions know, provisions that allocate antitrust risk between buyer and seller, or between joint venture (JV) partners, are a common feature of merger and JV agreements. Such provisions are increasingly important in today’s (...)

The Turkish Competition Authority publishes a decision on export bans in the pharmaceutical sector (Roche)
ACTECON (Istanbul)
Introduction On 27 September 2018, Turkish Competition Authority (“TCA”) published its decision concerning the allegations that Roche Müstahzarları A.Ş. (“Roche”) had violated articles 4 and 6 of the Law on the Protection of Competition (“Competition Act”). Within this scope, the TCA re-evaluated (...)

The Brazilian Competition Authority requests the submission of a below-threshold transaction between two distributors of pharmaceutical supplies (All Chemistry / SM Empreendimentos)
Caminati Bueno Advogados (São Paulo)
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Caminati Bueno Advogados (São Paulo)
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Caminati Bueno Advogados (São Paulo)
1. INTRODUCTION During the trial session of September 5, 2018, the Tribunal of the Brazilian Competition Authority (“CADE”) requested the submission of a transaction that did not trigger the mandatory notification thresholds.- In short, the transaction concerns the acquisition of All Chemistry (...)

The French Competition Authority fines wholesale distributors of veterinary medicinal products and their professional association for anticompetitive practices (Alcyon / Coveto / Centravet)
French Competition Authority (Paris)
Distribution of veterinary medicinal products* The Autorité de la concurrence fines wholesale distributors of veterinary medicinal products and their professional association nearly 16 million euros for anticompetitive practices The Autorité de la concurrence, which began proceedings ex officio (...)

The Russian Competition Authority exposes the first cartel in Dagestan in the medicine sector (Medpharmasnab / RegionPharma / Dagmedtechnika / Globalmedtech)
Russian Federal Antimonopoly Service (Moscow)
FAS exposed the first cartel in Dagestan* A group of FAS specialists arrived to Dagestan on invitation of Acting Head of Dagestan, Vladimir Vasiliev To pursue the National Competition Development Plan approved by No. 618 Order of the President of Russia on 21.12.2017, FAS jointly with (...)

The UK Competition Authority extends its timetable of investigations on anti-competitive practices in the pharmaceutical sector
Rosenblatt Limited (London)
UK COMPETITION & MARKETS AUTHORITY PROVIDES UPDATES ON ITS PHARMACEUTICAL SECTOR INVESTIGATIONS* On 12th July 2018 Competition and Markets Authority (CMA) announced it was extending its timetable in relation to a number of its ongoing investigations involving anti-competitive practices in (...)

The Indian Competition Authority fines state chemists’ association and 3 pharma companies for anticompetitive practice of "No Objection Certificates" prior to appointment of stockists (Alis Medical Agency / Federation of Gujarat State Chemists & Druggists Associations)
Vaish Associates Advocates (New Delhi)
CCI imposes penalties on the Chemists’ Associations in State of Gujarat and three pharma companies for indulging in practice of “No Objection Certificate” before appointment of stockists* The Competition Commission of India (“CCI”) by way of an order dated 12 July 2018 has imposed penalty on the (...)

The Hellenic Competition Authority fines a pharmaceutical company for reducing supplies of medicines to wholesalers (GlaxoSmithKline)
Van Bael & Bellis (Brussels)
On 11 July 2018, the Hellenic Competition Commission (“HCC”) adopted a decision (the “Decision”) fining Glaxosmithkline (“GSK”) a total of €4.1 million for abusing its dominant position in relation to two pharmaceutical products: Imigran (an anti-migraine product) and Lamictal (an anticonvulsant). (...)

The Hellenic Competition Authority fines a pharmaceutical company for abuse of dominance in the market of migraine medicines (GlaxoSmithKline)
Hellenic Competition Authority (Athens)
Decision concerning GLAXOSMITHKLINE SA and GLAXOSMITHKLINE plc’s supply policy of medicinal products LAMICTAL, IMIGRAN and SEREVENT in the Greek market, following the partial referral of the case back to the Hellenic Competition Commission (HCC) by the Athens Administrative Court of Appeals and (...)

The Dutch Competition Authority launches a sector inquiry into anti-rheumatic drugs
Netherlands Authority for Consumers & Markets (The Hague)
ACM has launched a sector inquiry into anti-rheumatic drugs* The Netherlands Authority for Consumers and Markets (ACM) has launched a sector inquiry into TNF inhibitors, a type of drug mainly used to treat rheumatism. TNF inhibitors are, in the Netherlands and globally, a type of prescription (...)

The Russian Competition Authority reduces prices on 11 medicines of a dominant pharmaceutical company from the list of vital and essential medicines (AstraZeneca)
Russian Federal Antimonopoly Service (Moscow)
FAS reduced prices on 11 medicines of “Astrazeneca” from the list of vital and essential medicines* Prices for the medicines aimed at treating socially important diseases reduced on average 12 to 92% As a result of a constructive dialogue between FAS and “AstraZeneca” the maximum ex-works prices (...)

The US Supreme Court states that a federal court is not bound by the official interpretation of the foreign law even if it is relevant (Animal science products / Hebei welcome pharmaceutical)
Wolters Kluwer (Riverwoods)
Supreme Court Clarifies Deference Owed a Foreign Government* In a decision that will have a significant impact on antitrust enforcement, particularly private damages actions against international cartels, a unanimous Supreme Court ruled that a federal court considering a case in which foreign (...)

The US Supreme Court holds that federal courts should accord respectful consideration to foreign government submissions when analyzing comity issues but are not bound by them (Animal Science products / Hebei welcome pharmaceutical)
Crowell & Moring (Washington)
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McDermott Will & Emery (Washington)
Supreme Court Clarifies Principles of International Comity in Vitamin C Ruling* Alert: The Supreme Court clarified the principles of international comity this week in a ruling pertaining to the long-running vitamin C antitrust class action litigation. International comity is the recognition a (...)

The US Supreme Court says that judges who determine foreign law in federal courts are not strictly bound by foreign government’s statements (Animal Science Products / Hebei Welcome Pharmaceutical)
Bona Law (San Diego)
In an antitrust case deciding a non-antitrust-specific issue, the US Supreme Court held in Animal Science Products, Inc. v. Hebei Welcome Pharmaceutical Co.(the Vitamin C Antitrust Litigation) that to determine foreign law in federal courts, judges are not strictly bound by that foreign (...)

The UK Competition Appeal Tribunal finds an incorrect application of the legal test for dominance and quashes the Competition Authority’s record fines imposed to two pharmaceutical companies for charging excessive prices for an anti-epilepsy drug (Pfizer / Flynn)
Rosenblatt Limited (London)
EXCESSIVE PRICE? COMPARED TO WHAT?* On 7 June 2017, the Competition Appeal Tribunal (“CAT”) set aside parts of the Competition & Market Authority’s (“CMA”) decision in relation to the CMA’s finding that Pfizer and Flynn charged excessive and unfair prices for phenytoin sodium capsules and (...)

The UK Competition Appeal Tribunal announces its provisional judgment in an appeal against the Competition Authority’s infringement decision in an excessive price case (Pfizer / Flynn)
White & Case (Brussels)
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White & Case (Brussels)
I. Introduction In the last couple of years, there has been a trend for antitrust watchdogs around the world to investigate excessive pricing, especially in the pharmaceutical sector. Last year, the European Commission opened its first investigation into excessive pricing in the pharmaceutical (...)

The UK Competition Appeal Tribunal partly annuls the Competition Authority’s decision that pharmaceutical companies abused their dominant position by setting excessive and unfair prices for an epilepsy drug (Pfizer / Flynn)
Norton Rose Fulbright (London)
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Norton Rose Fulbright (Brussels)
This article has been nominated for the 2019 Antitrust Writing Awards. Click here to learn more about the Antitrust Writing Awards. On 7 June 2018, the Competition Appeal Tribunal (CAT) set aside in part the 2016 decision of the Competition and Markets Authority (CMA) that Pfizer and Flynn (...)

The UK Competition Appeal Tribunal partially sets aside the Competition Authority’s decision fining two undertakings nearly £90 million for charging unfairly high and excessive prices for anti-epilepsy drugs (Pfizer / Flynn)
Freshfields Bruckhaus Deringer (London)
On 7 June 2018, the UK’s Competition Appeal Tribunal (CAT) partially set aside the Competition and Market Authority’s (CMA’s) decision fining Pfizer and Flynn nearly £90 million for charging unfairly high, or excessive, prices for phenytoin sodium capsules (an anti-epilepsy drug) in breach of EU (...)

The Australian Federal Court dismisses an appeal by the Competition Authority against a judgement establishing market power in the pharmaceutical sector (Pfizer)
Herbert Smith Freehills (Melbourne)
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Herbert Smith Freehills (Melbourne)
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Herbert Smith Freehills (Sydney)
The Full Court of the Federal Court of Australia has dismissed an appeal by the ACCC against an earlier judgment in relation to pharmaceutical company Pfizer. While the Full Court upheld the single judge decision that Pfizer had not misused its market power or engaged in prohibited (...)

The US FTC conditionally clears a merger subject to divestitures in the pharmaceutical market (Amneal / Impax)
Weil, Gotshal & Manges (Washington)
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Weil, Gotshal & Manges (Washington)
FTC Applies its Merger Remedy Best Practices and Announces a New Divestiture Principle in Recent Pharmaceutical Enforcement Action* On April 27, 2018, the Federal Trade Commission (“FTC”) announced a proposed consent agreement with Amneal Pharmaceuticals LLC (“Amneal”) and Impax Laboratories, Inc. (...)

The Romanian Competition Authority clears a merger subject to remedies in the pharmaceutical sector (A&D Pharma / Glebi)
Romanian Competition Council (Bucharest)
THE COMPETITION COUNCIL AUTHORIZED WITH CONDITIONS THE TAKING OVER OF A&D PHARMA HOLDINGS NV BY GLEBI HOLDINGS PLC* The Competition Council authorised with conditions the transaction by which Glebi Holdings PLC takes over A&D Pharma Holdings NV. Glebi Holdings PLC is part of Penta (...)

The Turkish Competition Authority provides explanations on the calculation of the fine after its first decision was annulled on appeal in the pharmaceutical sector (Turkish Pharmacists Association)
ELIG Gürkaynak Attorneys-at-Law (Istanbul)
A. Introduction The Competition Board (“Board”) has recently published its reasoned decision in its reassessment of the Turkish Pharmacists Association (Türk Eczacıları Birliği) (“TPA”) case, following the annulment decision rendered by the 13th Chamber of the High State Court (“High State Court”). (...)

The Danish Competition Authority fines a pharmaceutical company for abuse of dominance by charging unfair prices (CD Pharma)
Danish Competition and Consumer Authority (Copenhagen)
CD Pharma has abused its dominant position by increasing their price by 2,000 percent* On 31 January 2018, the Danish Competition Council (“DCC”) ruled in a case concerning CD Pharma’s (a pharmaceutical distributor) abuse of dominant position by charging unfair prices for the drug Syntocinon. (...)

The EU Court of Justice clarifies the application of competition law to the pharmaceutical sector in relation to off-label use of medicine and the dissemination of misleading information about product characteristics (Hoffman-La Roche)
McDermott Will & Emery (Brussels)
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McDermott Will & Emery (Paris)
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Norton Rose Fulbright (Brussels)
On 23 January 2018, the CJEU rendered its judgment in the case Hoffman-La Roche and Others v AGCM, providing clarification on important aspects of competition law in the pharmaceutical sector. The CJEU rendered its judgment pursuant to a request for a preliminary ruling by the Italian Council (...)

The EU Court of Justice holds that colluding to disseminate information constitute a restriction of competition "by object" (Roche / Novartis)
Portolano Cavallo (Milan)
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Portolano Cavallo (Milan)
On January 23rd, 2018, the ECJ delivered its preliminary ruling on theRoche/Novartis v. Commissioncase (C-179/16), concerning the compatibility of an agreement entered into between Roche and Novartis with Article 101 TFEU. The controversy originated before of the ICA, which on 27 February 2014 (...)

The EU Court of Justice rules that the dissemination of misleading information is a restriction by object and excludes exemption under Article 101 §3 TFEU (Roche / Novartis)
Almain (Paris)
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Simmons & Simmons (Paris)
On 23 January 2018, the Court of Justice of the European Union delivered its decision on the preliminary ruling referred to it by the Italian Council of State in the dispute between Roche and Novartis on the one hand and the Italian competition authority (AGCM) on the other. In 2014, Roche and (...)

The Arbitration Appeal Court of Moscow upholds the judgement of the Arbitration Court in a case on an anticompetitive agreement between medicinal drug suppliers (Pharm SKD)
Russian Federal Antimonopoly Service (Moscow)
Appeal court supported fas in a case on an anticompetitive agreement of medicinal drug suppliers* The 9th Arbitration Appeal Court upheld the judgment of Moscow Arbitration Court that pronounced legitimacy and reasonableness of FAS decision on the case against “Pharm SKD” Ltd. and “Novopharm” (...)

The French Competition Authority fines €25 million a pharmaceutical laboratory for having first prevented then restricted the development of generic versions of a drug (Janssen-Cilag / Johnson & Johnson)
French Competition Authority (Paris)
The Autorité de la concurrence imposes a fine of 25 million euros on Janssen-Cilag laboratory and its parent company Johnson & Johnson for having first prevented then restricted the development of generic versions of Durogesic, its originator medicinal product.* Background Following a (...)

The French Competition Authority fines pharmaceutical laboratories for preventing and restricting the development of generic drugs (Janssen-Cilag / Johnson & Johnson)
Van Bael & Bellis (Brussels)
On 20 December 2017, the French Competition Authority (“FCA”) imposed a fine of € 25 million on Janssen-Cilag laboratory and its parent company Johnson & Johnson for preventing and then restricting the development of a generic version of its analgesic Durogesic (the “Decision”). Ratiopharm, now (...)

The French Competition Authority fines a pharmaceutical laboratory €25 million for delaying entry into the market of the generic version of a drug and for hindering its development through disparagement campaigns (Janssen-cilag / Johnson & Johnson)
Franklin (Paris)
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McDermott Will & Emery (Paris)
THE FRENCH COMPETITION AUTHORITY FINES A PHARMACEUTICAL LABORATORY EUR 25 MILLION FOR ANTI-GENERIC PRACTICES* On 20 December 2017, the French Competition Authority (the FCA) imposed a EUR 25 million fine on a pharmaceutical laboratory, for delaying entry onto the market of the generic version (...)

The UK Competition Authority accuses a pharmaceutical company of having abused its dominant position (Concordia)
United Kingdom’s Competition Authority - CMA (London)
Drug company accused of abusing its position to overcharge the NHS* The CMA has provisionally found that Concordia abused its dominant position to overcharge the NHS by millions for an essential thyroid drug. The Competition and Markets Authority (CMA) has been investigating how much the (...)

The French Competition Authority expresses interest in the discounts granted by generics firms to pharmacies (Pharmaceutical sector inquiry)
NERA (Paris)
During the launch of its pharmaceutical sector inquiry in November 2017, the French Competition Authority (FCA) expressed interest in the discounts granted by generics firms to pharmacies. The FCA quoted the decision issued following the previous sector inquiry carried out in 2013, which "had (...)

The Polynesian Competition Authorithy issues an opinion on the functioning of the pharmaceutical distribution sector
Polynesian Competition Authority (Papeete)
Opinion n°2017-A-03 dated November the 6th 2017 dealing with the functioning of the pharmaceutical distribution sector* The Polynesian Competition Authority took the initiative for an opinion on the functioning of the pharmaceutical distribution sector. The scope of the opinion was limited to (...)

The US Government Accountability Office publishes the results of its study into the prescription drug industry
Baker Botts (Washington)
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Baker Botts (Brussels)
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Gibson Dunn (Washington)
Prior to the year-end holiday season, the United States Government Accountability Office (“GAO”) released the results of its long-awaited study into the prescription drug industry’s “Profits, Research and Development Spending, and Merger and Acquisition Deals.” The report responds to Congressional (...)

The Indian Competition Authority fines state association of chemists and issues advisory to pharmaceutical companies to cooperate in ceasing the practice of "No Objection Notices" (All Kerala Chemists & Druggists Association)
Vaish Associates Advocates (New Delhi)
CCI issues advisory to Pharma companies while imposing penalty on All Kerala Chemists & Druggists Association and its office bearers* The Competition Commission of India vide its recent order dated 31.10.2017, while imposing penalty on the All Kerala Chemists & Druggists Association (...)

The EU Commission finds that Finnish measures which benefited a pharmacy are not State aid, because they were an exercise of regulatory functions for which a fee does not have to be demanded (Yliopiston Apteekki Oy)
College of Europe (Bruges)
Article published on StateAidHub: http://stateaidhub.eu, republished in e-Competitions with the courtesy of the author. The original title of this article appears below the e-Competitions title. Authors are welcome to write an alternative article on this case/text, provided they have no (...)

The EU Court of Justice Advocate General Saugmandsgaard Øe indicates that providing misleading information aimed at undermining the reputation of one drug to the benefit of another drug might constitute a restriction by object (Hoffmann-La Roche)
Latham & Watkins (Brussels)
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Liège University (Liège)
On 21 September 2017 Advocate General Saugmandsgaard Øe (‘AG’) issued his opinion in F. Hoffmann-La Roche vs Autorità Garante della Concurrenza e del Mercato (AGCM). In his opinion the AG provides guidance to the Court of Justice of the European Union (‘CJEU’) on the various questions raised by the (...)

The US Court of Appeals for the Third Circuit applies an appropriate post-Actavis pleading standard (Lipitor)
Rutgers University (Camden)
On August 21, 2017, the Third Circuit overturned a decision that had applied excessive pleading standards against plaintiffs challenging reverse-payment settlements. Writing for a unanimous panel, Chief Judge Smith held that, in the wake of FTC v. Actavis, 133 S. Ct. 2223 (2013), courts should (...)

The Chinese NDRC proposes new rules to deal with perceived anti-competitive practices in the pharmaceutical industry
Hogan Lovells (Beijing)
China proposes new rules to address perceived anti-competitive practices n the pharmaceutical industry* On 14 August 2017, the National Development and Reform Commission (“NDRC“) released a draft of the Guidelines on Pricing Conduct by Business Operators for Drugs in Shortage and Active (...)

The Chinese NDRC fines two pharmaceutical companies for excessive pricing and refusal to deal (Zhejiang Second Pharma / Tianjin Handewei Pharmaceuticals)
University of Melbourne
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Hogan Lovells (Beijing)
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University of Melbourne
On 31 July 2017, the NDRC publicly announced its decision to sanction Zhejiang Second Pharma (an affiliate of a central-level SOE under the purview of the State-owned Assets Supervision and Administration Commission (SASAC)) and Tianjin Handewei Pharmaceuticals for abusing their dominance. In (...)

The Italian Regional Administrative Court for Latium upholds the infringement decision made by the Competition Authority against a pharmaceutical laboratory for excessive pricing (Aspen)
Giannino SI (Monserrato)
By the judgement handed down in Aspen v AGCM , the Regional Administrative Court of Latium (the Court) has recently determined the appeal lodged by a South African manufacturer of generic drugs, Aspen, against the 2016 decision made by Italian Competition Authority (ICA), rejected all the (...)

The Indian Competition Authority dismisses allegations of abuse of dominance against a pharmaceutical manufacturer due to lack of evidence of dominance (Sanofi)
Vaish Associates Advocates (New Delhi)
CCI closes allegation of abuse of dominance against Sanofi* CCI vide its order dated July 19, 2017 has closed an allegation of abuse of dominant position against Sanofi India Limited (Sanofi). The Informant in the case sought confidentiality of his identity and hence was not named. The (...)

The EU Commission sends a statement of objection to a pharmaceutical company regarding a possible pay-for-delay agreement (Teva / Cephalon)
DG COMP (Brussels)
Antitrust: Commission sends Statement of Objections to Teva on ’pay for delay’ pharma agreement* The European Commission has informed pharmaceutical company Teva of its preliminary view that an agreement concluded with Cephalon was in breach of EU antitrust rules. Under the agreement, Teva (...)

The Spanish Competition Authority closes abuse of dominance proceedings through a commitments decision against a pharmaceutical company (IMS Health)
Callol, Coca & Asociados (Madrid)
On 13 July 2017, the NMCC closed the Article 102 TFEU and Article 2 of the Spanish Competition Act (Competition Act) proceedings related to the supply of pharmaceutical marketing data to IMS Health (IMS) by means of a commitments decision. The NMCC initiated the investigation, as a result of (...)

The Russian Competition Authority’s Head calls for stronger cooperation in cross-border investigations and exchange of classified information at UNCTAD’s 16th session of the intergovernmental group of experts on competition law and policy
United Nations Conference on Trade and Development (UNCTAD)
Russia’s perspective on International Competition law and policies by of Mr. Igor Artemiev, Head of Federal Antimonopoly Service of the Russian Federation* The 16th session of the Intergovernmental Group of Experts on Competition Law and Policy took place in Geneve from 5-7 July 2017. Q: What (...)

The EU Commission sends three separate statements of objections to companies alleging procedural breaches of the EU Merger Regulation (Merck / Sigma-Aldric ; GE / LM Wind ; Canon / Toshiba Medical Systems)
Van Bael & Bellis (Brussels)
On 6 July 2017, the European Commission sent three separate statements of objections (“SO”) to companies alleging procedural breaches of the EU Merger Regulation. Provision of misleading information The first SO concerns the Merck/Sigma-Aldrich transaction, which was conditionally cleared by (...)

The EU Commission sends statements of objection to three undertakings regarding possible breach of EU merger procedural rules (Merck / Sigma-Aldric ; GE / LM Wind ; Canon / Toshiba Medical Systems)
DG COMP (Brussels)
Mergers: Commission alleges Merck and Sigma-Aldrich, General Electric, and Canon breached EU merger procedural rules* The Commission has sent three separate Statements of Objections to Merck and Sigma-Aldrich, General Electric and Canon alleging they breached EU merger rules: General Electric, (...)

The EU Commission clears the acquisition of a pharmaceutical company by a global conglomerate subject to a commitment that clinical development of innovative insomnia drugs will not be adversely affected by the merger (Johnson & Johnson / Actelion)
DG COMP (Brussels)
J&J/Actelion - falling asleep fast and deeply while staying fully awake on innovation * In a nutshell: The Commission found competitive concerns due to the combination of two development programmes for insomnia drugs, currently in Phase II of clinical trials. These pipeline drugs are based (...)

The EU Commission opens formal investigation into a pharmaceutical company for excessive pricing practices (Aspen Pharma)
DG COMP (Brussels)
Antitrust: Commission opens formal investigation into Aspen Pharma’s pricing practices for cancer medicines* The European Commission has opened a formal investigation into concerns that Aspen Pharma has engaged in excessive pricing concerning five life-saving cancer medicines. The Commission (...)

The Chinese Administration for Industry and Commerce of Hubei Province decides that a company attained market dominance through multiple contractual arrangements (Xinxing Jingying Pharmaceuticals)
Global Law Office (Beijing)
From 2015 to 2017, Wuhan Xinxing Jingying Pharmaceuticals, LLC ("Xinxing Pharmaceuticals") monopolized methyl salicylate active pharmaceutical ingredients (APIs) market of China through multiple contractual arrangements. In January 2017, Xinxing Pharmaceuticals was fined RMB2.2 million by the (...)

The UK Competition Authority alleges that two pharmaceutical companies have concluded a pay-for-delay agreement (Actavis / Concordia)
United Kingdom’s Competition Authority - CMA (London)
CMA alleges anti-competitive agreements for hydrocortisone tablets* The CMA today alleged that Concordia and Actavis signed illegal agreements which enabled high prices for a life-saving drug to be prolonged. The Competition and Markets Authority (CMA) alleges that between January 2013 and (...)

The Indian Competition Authority finds a professional pharmaceutical association guilty of anticompetitive conduct but refrains from imposing a fine because the association has already recently been fined for similar conduct (Karnataka Chemists and Druggists Association)
Vaish Associates Advocates (New Delhi)
CCI finds Karnataka Chemist and Druggists Association (KCDA) in violation of Section 3(3) of the Act* CCI by its order dated March 2, 2017 has found that KCDA violated Section 3(3) of the Act. Being prima-facie satisfied by the information filed, the CCI ordered investigation into the matter. (...)

The EU Court of Justice dismisses appeals against the General Court’s judgement in a cartel case confirming the responsibility of undertakings for the actions of their representative (Paraffin Wax)
Van Bael & Bellis (Brussels)
Under EU case law, an undertaking can be held responsible for the actions of a person who is authorised to act on its behalf, regardless of any action or knowledge on the part of the managers of that undertaking. Consequently, the Commission may impose fines on an undertaking if it has shown (...)

The Spanish Competition Authority opens an investigation for possible abusive practices consisting of a refusal to supply certain pharmaceuticals and for excessive prices (Aspen)
Callol, Coca & Asociados (Madrid)
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Callol, Coca & Asociados (Madrid)
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Callol, Coca & Asociados (Madrid)
On 3 February 2017, the SCA has initiated proceedings against Aspen Pharma Ireland Ltd, Aspen Pharmacare Holdings Limited and Aspen Pharma Trading Limited (Aspen) for possible abusive practices consisting on a refusal to supply certain pharmaceuticals and for excessive prices. The SCA also (...)

The Spanish Competition Authority clears a dual pricing system (Pfizer / Cofares)
Callol, Coca & Asociados (Madrid)
On 19 January 2017 the Spanish Competition Authority (SCA) issued a decision clearing PFIZER of antitrust charges and blessing PFIZER’s dual pricing system (SCA Decision). In 2009, the SCA decided (First Decision) to close the antitrust investigation against COMPAÑÍA FARMACÉUTICA ESPAÑOLA, S.A. (...)

The US FTC challenges a merger using a monopolization theory to allege that the merger would eliminate nascent competition in the therapeutic adrenocorticotropic hormones (Questcor Pharmaceuticals / Mallinckrodt)
McDermott Will & Emery (Washington)
The Federal Trade Commission (FTC) challenged a consummated transaction using a monopolization theory to allege that the acquisition would eliminate “nascent” competition for therapeutic adrenocorticotropic hormones (ACTH) in the United States. WHAT HAPPENED: Questcor Pharmaceuticals, Inc.’s (...)

The Indian Competition Authority fines merging parties for failure to disclose global acquisition of the healthcase antisepsis business (Schulke / ASP Division of Ethicon)
Vaish Associates Advocates (New Delhi)
CCI penalizes Schulke and Mayr GmBH (Schulke) for delayed filing in relation to the acquisition of Healthcare Antisepsis Solutions (HAS) business of Johnson & Johnson Private Limited (JJPL)* CCI, by its order dated January 13, 2017 has imposed a penalty of INR 25,00,000 on Schulke on (...)

The Shandong Price Bureau fines a pharmaceutical company for obstructing antitrust investigation (Weifang Longshunhe Pharmaceutical)
China Competition Bulletin (Beijing)
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University of Melbourne
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Hogan Lovells (Beijing)
The NDRC recently announced that, on 25 December 2016, the Shandong Price Bureau imposed a fine of RMB 120,000 on Weifang Longshunhe Pharmaceutical for obstructing an investigation under the AML. The NDRC and the Shandong Price Bureau was jointly investigating Weifang Longshunhe Pharmaceutical (...)

The UK Competition Authority provisionally finds that a pharmaceutical company has broken competition law by charging excessive prices to the NHS for hydrocortisone tablets (Actavis)
United Kingdom’s Competition Authority - CMA (London)
Pharmaceutical company accused of overcharging NHS* The pharmaceutical company Actavis UK (formerly Auden Mckenzie) has increased the price of 10mg hydrocortisone tablets by over 12,000% compared to the branded version of the drug which was sold by a different company prior to April 2008. For (...)

The Turkish High State Court annuls the Competition Authority’s decision concerning parallel export restrictions in a vertical agreement (Roche / Corena)
ELIG Gürkaynak Attorneys-at-Law (Istanbul)
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ELIG Gürkaynak Attorneys-at-Law (Istanbul)
This case summary includes an analysis of the annulment decision of 13th Chamber of the High State Court (2010/4617 E., 2016/4241 K) (“High State Court”). The High State Court cancelled the Turkish Competition Board’s (the “Board”) decision on parallel export restrictions in vertical agreements. In (...)

The Spanish Competition Authority declares exempt retail price maintenance practices by a cosmetics laboratory on the basis of the de minimis theory (Laboratorio Martí Tor)
CMS Albiñana y Suárez de Lezo (Madrid)
The Spanish Competition Authority (“SCA”) has considered in a decision dated 15 December 2016 that certain retail price maintenance (“RPM”) practices carried out by cosmetic laboratory Martí Tor was not capable of significantly affecting competition, and thereby, of infringing Article 1 of the (...)

The UK Competition Authority fines two pharmaceutical companies for charging excessive prices concerning an anti-epilepsy drug (Pfizer / Flynn)
United Kingdom’s Competition Authority - CMA (London)
CMA fines Pfizer and Flynn £90 million for drug price hike to NHS* The CMA has fined pharma companies Pfizer and Flynn Pharma nearly £90 million for charging excessive prices to the NHS for an anti-epilepsy drug. The Competition and Markets Authority (CMA) has imposed a record £84.2 million fine (...)

The UK Competition Authority publishes full decision on excessive pricing in the pharmaceutical sector and focuses on intention and evidence (Pfizer / Flynn)
Simmons & Simmons (London)
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Simmons & Simmons (London)
The CMA’s decision relies heavily on evidence of the parties’ intentions in applying competition rules. On 15 June 2017, the UK Competition and Markets Authority (CMA) published the full non-confidential version of its decision to fine Pfizer and Flynn a record £84.2m for their excessive and (...)

The Indian Competition Appellate Tribunal reverses the fine against a professional association and its compliant pharmaceutical member company due to anticompetitive agreements (Maruti & Company / KCDA Karnataka Chemists & Druggists Association / Lupin)
Vaish Associates Advocates (New Delhi)
COMPAT set asides penalty imposed on Lupin and its office bearers* COMPAT vide order dated December 07, 2016 while setting aside the order dated July 28, 2016 of CCI has quashed the penalty of Rs 73 Crores imposed on Lupin Ltd. (“Lupin”) and its two officials for alleged anticompetitive (...)

The Turkish Competition Authority publishes a reasoned decision on the pharmaceutical industry (Pharmacists Association)
ELIG Gürkaynak Attorneys-at-Law (Istanbul)
Introduction The Competition Board recently published a reasoned decision (December 6 2016; 16-42/699-313) following its investigation into whether the Pharmacists’ Association (TEB) and the Pharmacists’ Association Commercial Enterprise (TEBII) had violated Article 6 of Law 4054 on the (...)

The EU Commission clears a merger subject to remedies in the pharmaceutical sector (Abbott Laboratories / St Jude Medical)
DG COMP (Brussels)
MERGERS: COMMISSION APPROVES ACQUISITION OF ST JUDE MEDICAL BY ABBOTT LABORATORIES, SUBJECT TO CONDITIONS* The European Commission has approved under the EU Merger Regulation the proposed acquisition of St Jude Medical by Abbott Laboratories, both US based companies that develop and market (...)

The EU Commission clears a merger subject to remedies in the animal health market (Boehringer Ingelheim / Sanofi)
DG COMP (Brussels)
MERGERS: COMMISSION APPROVES ACQUISITION OF SANOFI’S ANIMAL HEALTH BUSINESS MERIAL BY BOEHRINGER INGELHEIM, SUBJECT TO CONDITIONS* The European Commission has approved under the EU Merger Regulation the acquisition of the animal health business of Sanofi (Merial) of France by Boehringer (...)

The Indian Competition Appellate Tribunal reverses the Competition Authority’s fine on pharmaceutical companies in a bid-rigging case (GlaxoSmithKline / Sanofi)
Vaish Associates Advocates (New Delhi)
COMPAT sets aside penalty against GSK Pharmaceuticals Ltd. (GSK) and Sanofi Ltd. (Sanofi) for alleged bid-rigging in procurement of meningitis vaccine for Haj and Umrah pilgrims by Ministry of Health and Family Welfare* COMPAT by its order dated November 8, 2016, has set aside the penalty (...)

The French Supreme Court confirms fines imposed on undertaking for abusive limitation of generic entry (Sanofi-Aventis)
Van Bael & Bellis (Brussels)
On 18 October 2016, the French Supreme Court upheld the decision of the French Competition Authority (“FCA”) which had fined the pharmaceutical company Sanofi-Aventis over € 40 million for having abused its dominant position on the market for the active ingredient clopidogrel. Sanofi-Aventis was (...)

The US Court of Appeals for the Third Circuit recognizes that a product hopping in the face of a “patent cliff” can constitute conduct in violation of the antitrust laws (Mayne / Warner Chilcott / Mylan)
Hausfeld (Philadelphia)
The Third Circuit’s recent product-hopping decision in Mylan Pharm. Inc. v. Warner Chilcott Pub. Ltd. Co (“Doryx”) has been widely criticized by commentators as breaking with established antitrust precedent. Mylan, the last remaining plaintiff in the case following a series of settlements at the (...)

The US Court of Appeals for the Third Circuit offers misguided analysis of product hopping (Mayne / Warner Chilcott / Mylan)
Rutgers University (Camden)
On September 28, 2016, the U.S. Court of Appeals for the Third Circuit issued a misguided ruling granting defendants’ motion for summary judgment and ignoring the regulatory framework relevant to “product hopping,” by which a drug company switches from one version of a drug to another, sometimes (...)

The US Court of Appeal for the Second Circuit reverses a price-fixing cartel verdict against Chinese defendants on international comity grounds (Vitamin C)
Cleary Gottlieb Steen & Hamilton (Rome)
Second Circuit reverses a price-fixing cartel verdict against Chinese defendants on international comity grounds* On 20 September 2016, the United States Court of Appeals for the Second Circuit (the “Appeals court”) in New York reversed a federal district court judgment in an antitrust lawsuit (...)

The EU General Court confirms fines imposed on an undertaking and generic drug manufacturers for entering into anticompetitive pay-for-delay agreements (Lundbeck)
United Kingdom’s Competition Authority - CMA (London)
GENERAL COURT OF THE EU CONFIRMS FINES IMPOSED ON LUNDBECK AND GENERIC DRUG MANUFACTURERS FOR ENTERING INTO PATENT SETTLEMENTS* On 8 September 2016, the General Court of the EU (GCEU) handed down five judgments upholding a decision by the Commission of 19 June 2013 imposing fines on Lundbeck, (...)

The EU General Court confirms the EU Commission’s decision concerning its first pharma pay-for-delay case (Lundbeck)
DG COMP (Brussels)
Antitrust: Commission welcomes General Court judgments upholding its Lundbeck decision in first pharma pay-for-delay case Today the General Court upheld the Commission’s Lundbeck decision and ruled for the first time that pharma pay-for-delay agreements breach EU antitrust rules. In such (...)

The EU General Court upholds the EU Commission’s fine of €150 million on undertakings for entering into reverse settlement agreements which delayed the entry of cheaper generic versions of a blockbuster antidepressant (Lundbeck)
Norton Rose Fulbright (Brussels)
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McDermott Will & Emery (Paris)
EU COURT CONFIRMS EUROPEAN COMMISSION’S DECISION ON PAY-FOR-DELAY AGREEMENTS* On 8 September 2016, the General Court of the European Union upheld the European Commission’s decision in which the antitrust regulator imposed fines of approximately EUR 150 million on Lundbeck and a number of generic (...)

The EU General Court confirms the Commission’s decision concerning its first pharma pay-for-delay case (Lundbeck)
University of East Anglia (Norwich)
General Court’s pay for delay judgment in Lundbeck – some guidance, but worries remain*On 8 September, the General Court handed down its eagerly awaited decision in Lundbeck – the first ever European judgment concerning so-called pay for delay settlements. The Commission’s decision in this case was (...)

The EU General Court upholds the EU Commission’s landmark patent settlement agreement decision (Lundbeck)
Sidley Austin (London)
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Willkie Farr & Gallagher (London)
EU General Court upholds Commission’s landmark Patent Settlement Agreement decision* In a much-anticipated series of judgments, running to some 579 pages, the EU’s General Court on 8 September 2016 upheld a 2013 decision of the European Commission that imposed fines of almost €150 million on the (...)

The EU General Court hands down a judgment concerning an appeal brought by an undertaking and several generic companies against an EU Commission decision which found that the parties had breached Article 101 TFEU by agreeing to delay the market entry of a generic drug (Lundbeck)
Herbert Smith Freehills (London)
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Herbert Smith Freehills (Brussels)
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Herbert Smith Freehills (London)
On 8 September 2016 the General Court (GC) handed down its judgments in relation to the appeals brought by Lundbeck and a number of generic companies (Sun Pharma (Ranbaxy), Arrow, Generics UK, Merck and Xellia/Alpharma) against a European Commission (Commission) decision finding that the (...)

The EU General Court rules on the legitimacy of settlement agreements in the pharmaceutical sector (Lundbeck)
Peters & Peters (London)
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Peters & Peters (London)
Lundbeck - Buying off the competition* On 8 September 2016, the ECJ handed down its judgment in the latest battle between pharmaceutical companies and competition authorities over “pay for delay” agreements. The appeal of H Lundbeck A/S and Lundbeck Ltd (together “Lundbeck”) against the decision (...)

The Hungarian Competition Authority fines providers of medical products and medical devices for bid rigging (Chirmax)
Hungarian Competition Authority (Budapest)
The GVH imposed fines for coordination of bids in tenders of hospitals* In its decision the Gazdasági Versenyhivatal (Hungarian Competition Authority) established that, in order to influence the tender notice, share the market and fix prices, B. Braun Medical Magyarország Orvostechnológiai Kft., (...)

The EU Commission clears a merger subject to remedies in the pharmaceutical sector (Boehringer Ingelheim / Sanofi)
DG COMP (Brussels)
MERGERS: COMMISSION CLEARS ACQUISITION OF BOEHRINGER INGELHEIM’S CONSUMER HEALTH BUSINESS BY SANOFI, SUBJEC TO CONDITIONS* The European Commission has approved under the EU Merger Regulation the proposed acquisition of the consumer health business of Germany’s Boehringer Ingelheim by Sanofi of (...)

The Hungarian Competition Authority fines five suppliers of medical suture products for bid rigging and exempts one of them under the leniency provisions (Braun Medical / Chairman / Johnson&Johnson / Staplecare / SurgiCare / Variomedic)
Hungarian Competition Authority (Budapest)
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Oppenheim (Budapest)
The Competition Authority of Hungary (GVH) has in August 2016 imposed fines on five suppliers of medical suture products (needles and threads for medical/hospital use) for bid rigging in an amount of around EUR 770.000, exempting one of them under the leniency provisions. The infringement was (...)

The EU Commission clears acquisition that creates global number two animal health company, subject to fix-it-first remedy including a technology transfer of vaccines (Boehringer Ingelheim / Sanofi)
DG COMP (Brussels)
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Sullivan & Cromwell (Brussels)
BOEHRINGER INGELHEIM/SANOFI ANIMAL HEALTH - THE TIMELY INJECTION OF A FIX-ITFIRST REMEDY* In a nutshell: The acquisition of Sanofi’s animal health business by Boehringer Ingelheim led to competition concerns in a number of animal vaccine and pharmaceutical markets. The remedy put forward (...)

The Indian Competition Authority fines a professional association and its compliant pharmaceutical member company for anticompetitive agreements (Maruti & Company / KCDA Karnataka Chemists & Druggists Association / Lupin)
Vaish Associates Advocates (New Delhi)
CCI again fines Pharma Company for Anti-Competitive Activities * The Competition Commission of India (“CCI/ Commission”) by way of its order dated 28.07.2016 has found the Karnataka Chemists and Druggist Association (“KCDA”) , Lupin Ltd. (“Lupin”) and their Office bearers to be in contravention of (...)

The China’s National Development and Reform Commission fines three manufacturers of an insomnia drug for refusing to supply its pharmaceutical ingredients to other competitors and for raising its prices (Huazhong / Xinyi / Siyao)
Freshfields Bruckhaus Deringer (London)
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Freshfields Bruckhaus Deringer (Hong Kong)
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Fangda (Hong Kong)
China’s National Development and Reform Commission (NDRC), one of China’s three agencies responsible for antitrust enforcement, recently published its decisions to fine three Chinese companies active in the manufacture of estazolam (a drug commonly used to treat insomnia) for refusing to supply (...)

The Chinese NDRC sanctions three pharmaceutical companies for price fixing and joint boycotts (Huazhong Yaoye / Shandong Xinyi / Changzhou Siyao)
China Competition Bulletin (Beijing)
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University of Melbourne
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University of Melbourne
On 22 July 2016, the NDRC sanctioned 3 pharmaceutical companies for engaging in price fixing and joint boycotts in relation to estazolam tablets and active pharmaceutical ingredients (API), in breach of Articles 13(1)(1) and 13(1)(5) of the Anti-Monopoly Law (AML). The 3 companies (Huazhong (...)

The EU Court of Justice rules that royalties for unpatented technology are not necessarily anticompetitive (Genentech)
McDermott Will & Emery (Paris)
EU COURT RULES THAT ROYALTIES FOR UNPATENTED TECHNOLOGY ARE NOT NECESSARILY ANTICOMPETITIVE* On 7 July 2016, the Court of Justice of the European Union (CJEU) handed down a judgment on whether Article 101 of the Treaty on the Functioning of the European Union (TFEU) must be interpreted as (...)

The EU Court of Justice rules that payment of royalties under a licence agreement where the patent was held invalid may be compatible with Article 101 TFEU (Genentech / Hoechst)
Blackstone Chambers (London)
License fees, invalid patents and Article 101 TFEU: Genentech v Hoechst and Sanofi Aventis* Consider an agreement under which a license fee is payable for use of a patented technology even if it transpires that the patent is invalid. Is such an agreement contrary to Article 101 TFEU? The answer (...)

The EU Court of Justice rules that payment of royalties under a licence agreement where the patent was held invalid may be compatible with Article 101 TFEU (Genentech / Hoechst)
Van Bael & Bellis (Brussels)
On 7 July 2016, the Court of Justice of the European Union (the “ECJ”) issued its judgment on a request for a preliminary ruling from the Paris Court of Appeal, which had enquired whether Article 101 TFEU precludes a licensee from paying royalties pursuant to a licensing agreement when the patent (...)

The Romanian Competition Authority launches a public consultation concerning its report on pharma market
Romanian Competition Council (Bucharest)
The Competition Council launched for public consultation the report on sector inquiry on pharma market* One of the conclusions of the sector inquiry on pharma sector carried out by the Competition Council is that the generic medicines, although are with 35% less expensive than the innovative (...)

The Indian Competition Appellate Tribunal cancels a fine for anticompetitive agreement against a pharmaceutical company due to lack of evidence of the said agreement (Alkem / AKCDA)
Vaish Associates Advocates (New Delhi)
COMPAT sets aside CCI’s penalty on Alkem Laboratories for indulging in anti-competitive practices* COMPAT by its order dated May 10, 2016 has set-aside the order of CCI in so far as it had held that Alkem Laboratories Limited (Alkem) for violation of Section 3(1) of the Act and had imposed a (...)

The US Court of Appeals for the Third Circuit rejects antitrust claims predicated on a supplier’s market-share discount program and other promotional tactics (Eisai / Sanofi)
Baker Botts (Washington)
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Baker Botts (Washington)
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Gibson Dunn (Washington)
On May 4, 2016, the U.S. Court of Appeals for the Third Circuit announced its decision in Eisai, Inc. v. Sanofi Aventis U.S., LLC, rejecting antitrust claims predicated on a supplier’s market-share discount program and other promotional tactics. While the court’s decision adds some definition to (...)

The US Court of Appeals for the Third Circuit declines to apply the price cost test to a loyalty discount case in the pharmaceutical sector (Eisai / Sanofi)
Hausfeld (Philadelphia)
On May 4, 2016, the Third Circuit—following the principles it set forth in LePage’s, Dentsply, and ZF Meritor—affirmed a decision by District of New Jersey Judge Mary L. Cooper granting summary judgment in favor of the defendant in Eisai, Inc. v. Sanofi-Aventis U.S., LLC. Eisai is the latest in a (...)

The Chinese MOFCOM releases three decisions sanctioning companies for failure to notify their transactions for antitrust review (Dade Holdings / Jilin Sichang Pharmaceutical) (New United Group / Bombardier Transportation Sweden) (Beijing CNR / Hitachi)
University of Melbourne
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China Competition Bulletin (Beijing)
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University of Melbourne
On 4 May 2016, the MOFCOM released 3 decisions in which it sanctioned various companies for failure to notify their transactions for antitrust review. The decisions were all made on 21 April 2016. In each case, the MOFCOM determined that the transaction constituted a concentration under Article (...)

The US Court of Appeals for the Third Circuit rules on bundling in the pharmaceutical sector (Eisai / Sanofi)
Constantine Cannon (New York)
Third Circuit Shows No Love For Lovenox® Bundling Theory*Citing the well-known maxim that the antitrust laws are concerned with “the protection of competition, not competitors,” the U.S. Court of Appeals for the Third Circuit on Wednesday affirmed summary judgment for Defendant Sanofi Aventis on (...)

The French Competition Authority issues an unfavorable opinion concerning draft orders for online sales of medicinal products
French Competition Authority (Paris)
The Autorité de la concurrence issues an unfavourable opinion to the government.* The envisaged "good practice" create a discriminatory system in comparison with the conditions required for over-the-counter sales, removing all interest in the sale medicinal products on the Internet, both for (...)

The Chinese Sandong and Ningxia Administrations for Industry and Commerce fines a public undertaking for forcing several companies to purchase goods (Jinan Public Transportation / Yinchuan Public Transportation)
University of Melbourne
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China Competition Bulletin (Beijing)
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Hogan Lovells (Beijing)
On 21 April 2016, the SAIC reported a case where the Shandong AIC and the Ningxia AIC fined local bus companies for breaching Article 6 of the AUCL, which provides that public enterprises and other state- sanctioned monopolies must not force others to purchase goods from designated parties and (...)

The German Higher Regional Court of Celle finds that limited resale price maintenance does not amount to an appreciable restriction of competition (A-Vitalkost)
Van Bael & Bellis (Brussels)
On 7 April 2016, the Higher Regional Court of Celle held that resale price maintenance in the framework of a promotion offered to pharmacies for the sale of a dietary product did not constitute an appreciable restriction of competition and therefore did not infringe competition law. In 2014, (...)

The German Higher Regional Court of Celle court finds that a minimum resale price campaign does not result in an appreciable restriction of competition given the campaign’s limited timeframe and scope (Almased Wellness)
Commeo (Frankfurt)
In its judgement of 7 April 2016, the Celle Higher Regional Court (“the Court”) found that resale price maintenance (“RPM”) does not per se result in an appreciable restriction of competition. The Court held that the setting of a minimum resale price in the framework of a promotion offered to (...)

The Dutch Competition Authority clears a merger between two rivals in the pharmaceutical sector (DA group / Holland Pharma)
Netherlands Authority for Consumers & Markets (The Hague)
ACM CLEARS ACQUISITION OF DA GROUP BY RIVAL HOLLAND PHARMA* The Netherlands Authority for Consumers and Markets (ACM) has cleared the acquisition of the DA group by Holland Pharma Exploitatie B.V. Both Holland Pharma and DA are wholesale companies that trade in drugstore items. In addition, DA (...)

Advocate General Wathelet concludes that payment of royalties under a licence agreement where the patent was held invalid may be compatible with Article 101 TFEU (Genentech / Hoechst)
Van Bael & Bellis (Brussels)
On 17 March 2016, Advocate General Wathelet issued his opinion on a request for a preliminary ruling from the Paris Court of Appeal, which inquired as to whether Article 101 TFEU precludes a licensee from paying royalties pursuant to a licensing agreement when the patent, which is the subject (...)

The Italian Council of State refers to the EU Court of Justice for a preliminary ruling in a case regarding an agreement to artificially differentiate competing drugs (Roche / Novartis)
Bonelli Erede (Rome)
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Bonelli Erede (Rome)
By its decision of 11 March 2016 , the Italian Administrative Court of Last Instance (“Council of State”) referred to the European Court of Justice certain preliminary questions raised by Novartis and Roche in the appeals brought against the judgment of the Administrative Court of First Instance, (...)

The EU Commission clears acquisition of a fourth largest global manufacturer of generic medicines by the largest global competitor, subject to complex remedies and monitoring, including addressing concerns about vertical relationships between parties for the first time in a generics merger (Teva / Allergan Generics)
DG COMP (Brussels)
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DG COMP (Brussels)
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DG COMP (Brussels)
Teva/Allergan Generics: An unprecedented generics merger* In a nutshell While the Commission has had significant experience dealing with mergers in the generic medicines industry, the sheer scale of Teva/Allergan Generics, combining two of the top four players globally, posed a number of (...)

The EU Commission clears a merger, subject to remedies, in the pharmaceutical market (Teva / Allergan Generics)
DG COMP (Brussels)
MERGERS: COMMISSION APPROVES ACQUISITION OF ALLERGAN GENERICS BY TEVA, SUBJECT TO CONDITIONS The European Commission has approved under the EU Merger Regulation the proposed acquisition of the generics business of Allergan of Ireland, by Teva of Israel, subject to conditions. Both companies (...)

The US FTC urges the Court of Appeals for the First Circuit to hold that a reverse payment need not be in cash (Loestrin)
DLA Piper Weiss-Tessbach (Vienna)
U.S. FTC urges the Appeals Court to revive the Loestrin Suit* On December 7, 2015, during oral argument, the U.S. FTC urged the Court of Appeals for the First Circuit to revive the Loestrin suit. The case concerns a so-called reverse payment settlement. In 2009 Watson Pharmaceuticals agreed (...)

The US Court of Appeals for the First Circuit concludes that a reverse payment need not be in cash (Loestrin)
Crowell & Moring (New York)
First Circuit boosts antitrust challenges to pay-for-delay settlements by finding non-cash deals subject to Actavis scrutiny*Antitrust challenges to so-called “pay-for-delay” settlements—in which brand-name drug makers temporarily keep generics out of the market by making payments to would-be (...)

The US Court of Appeals for the First Circuit concludes that a reverse payment need not be in cash (Loestrin)
Rutgers University (Camden)
On February 22, 2016, in the second federal appellate drug patent settlement ruling since the Supreme Court’s decision in FTC v. Actavis, 133 S. Ct. 2223 (2013), the U.S. Court of Appeals for the First Circuit vacated a lower court decision granting a motion to dismiss for defendants. Writing (...)

The UK Competition Authority fines pharmaceutical companies for pay-for-delay deals (GlaxoSmithKline)
Constantine Cannon (London)
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Constantine Cannon (London)
UK Antitrust Watchdog slaps $65 million fine on Pharma Companies in UK’s first pay-for-delay case* On 12 February 2016, the Competition and Markets Authority (“CMA”), UK’s competition regulator, fined a number of pharma companies for anti-competitive conduct and agreements in relation to the supply (...)

The UK Competition Authority fines £45 million to several pharmaceutical companies for pay-for-delay settlements (GlaxoSmithKline)
United Kingdom’s Competition Authority - CMA (London)
CMA fines pharma companies £45 million* The CMA has fined a number of pharmaceutical companies for anti-competitive conduct and agreements in relation to the supply of paroxetine. The CMA’s decision relates to conduct and agreements between 2001 and 2004 in which GlaxoSmithKline plc (GSK), the (...)

The Indian Competition Authority approves acquisition of pharmaceutical company’s business by foreign venture capital firm (FIL Capital Investments (Mauritius) II / Cipla Health)
Vaish Associates Advocates (New Delhi)
CCI approves proposed combination notice filed by FIL Capital Investments (Mauritius) II Limited* The CCI, by its order dated January 15, 2016 has approved the proposed combination relating to the acquisition of 26.11% shareholding of the paid-up equity share capital of the Cipla Health by (...)

The Indian Competition Appellate Tribunal cancels a fine for anticompetitive conduct against a pharmaceutical association due to infringement of the principles of natural justice during an investigation by the Competition Authority (Rohit Medical Store / HPCDA Himachal Pradesh Chemist & Druggist Alliance)
Vaish Associates Advocates (New Delhi)
COMPAT sets-aside penalty imposed on Himachal Pradesh Chemist & Druggist Alliance (HPCDA) on account of failure to observe principles of natural justice during investigation by the DG* COMPAT, by its order dated January 13, 2016, has set-aside the penalty imposed by the CCI on HPCDA and (...)

The Portuguese Competition Authority fines an association of pharmacists for abuse of dominance on the pharmacies’ commercial data market (ANF)
Portuguese Competition Authority (Lisbon)
The Portuguese Competition Authority fined ANF Group for abusing its dominant position* The Portuguese Competition Authority (PCA) has imposed fines of € 10.340.000 on ANF (Associação Nacional das Farmácias) and three companies of the ANF Group (Farminveste – S.G.P.S., S.A., Farminveste – (...)

The Estonian Competition Authority issues proposal on the establishment of pharmacies and the prohibition of connection with wholesale sellers to medicinal products
Estonian Competition Authority (Tallinn)
New restrictions on establishment of pharmacies significantly harm free competition* The Estonian Competition Authority made a proposal for revision of the pharmacist-owner requirement and the prohibition of connection with wholesale sellers to medicinal products, and for annulment of the (...)

The Indian Competition Appellate Tribunal cancels fine due to the lack of evidence against individual executive member of charged association and investigation errors (Swapan Kumar Karak)
Vaish Associates Advocates (New Delhi)
COMPAT quashes penalty for individual liability imposed on a member of Executive Committee of a pharmaceutical distributors’ association* COMPAT vide its order dated December 7, 2015 set-aside the penalty of INR 47, 63,579/- imposed by CCI on Shri Swapan Kumar Karak (Director, Karak (...)

The Indian Competition Appellate Tribunal cancels a fine for boycott by a pharmaceutical association due to the wholesaler’s own conduct and lack of anticompetitive effect (Arora Medical Hall / Ferozepur Chemists & Druggists Association)
Vaish Associates Advocates (New Delhi)
Competition Appellate Tribunal sets aside the penalty imposed by CCI against Chemist and Druggist Association, Ferozepur* COMPAT by its judgment dated 30 October 2015 over-ruled the order penalizing Chemist and Druggist Association, Ferozepur, Punjab in a case filed by Arora Medical Hall, (...)

The Chinese NDRC and the Chongqing AIC take separate actions to punish cartel conduct and refusal to supply in the pharmaceutical industry (Allopurinol)
University of Melbourne
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China Competition Bulletin (Beijing)
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Hogan Lovells (Beijing)
Both the NDRC and the Chongqing Administration for Industry and Commerce (Chongqing AIC) have recently taken enforcement action to address anticompetitive conduct involving allopurinol. Allopurinol tablets are a common treatment for gout (known as hyperuricemia), widely used in clinical (...)

The Irish Competition Authority clears the first otherwise anticompetitive merger using the failing firm defence (Baxter / Fannin)
Trinity College Dublin
Introduction 1 On 21 October 2015 the Competition and Consumer Protection Commission (CCPC), Ireland’s competition agency, cleared the acquisition by Baxter Healthcare Limited (Baxter) of Fannin Compounding Limited (Fannin), a business division of Fannin Limited which was, in turn, a subsidiary (...)

The Moscow Arbitration Court confirms that a pharmaceutical company has abused its dominance by stopping to supply insulin (Novo Nordisk)
Russian Federal Antimonopoly Service (Moscow)
Cassation Court confirmed: “Novo Nordisk” violated the antimonopoly law* On 21 October 2015, the Arbitration Court of the Moscow District upheld the ruling of the 9th Arbitration Appeal Court of 29 June 2015 and dismissed a cassation appeal of “Novo Nordisk” against the decision of the Federal (...)

The Romanian Competition Authority clears a merger in the pharmaceutical sector (Centrofarm / Help Net Farma)
Romanian Competition Council (Bucharest)
THE COMPETITION COUNCIL HAS AUTHORIZED THE TAKEOVER OF 19 PHARMACIES CENTROFARM BY HELP NET * The Competition Council has authorized the take over of 19 pharmacies Centrofarm by Help Net Farma SA. By this transaction, Help Net take over the 19 pharmacies Centrofarm from 10 localities: (...)

The Italian Competition Authority opens an investigation into the tender procedures for oxygen-therapy and ventilo-therapy services at home (Gare ossigenoterapia e ventilopterapia)
Bonelli Erede (Rome)
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Bonelli Erede (Rome)
With a decision of 7 October 2015, following the complaints lodged by one of the local health units in the city of Milan (“ASL Milan”) and the purchasing consortium of the Campania Region (“Soresa”), the Italian Competition Authority (“ICA”) opened an investigation into 14 companies (“Parties”) (...)

The Chinese MOFCOM fines several undertakings for breaches of merger notification rules (FJEI / FPID) (Nanjing Puzhen / Bombardier Sweden) (BestTv / Microsoft)
AnJie Law (Beijing)
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AnJie Law (Beijing)
Warning from MOFCOM: Second Wave of Penalties Imposed for Breaches of Concentration Notification Rules* On September 29th 2015, the Ministry of Commerce of the P.R.C (“MOFCOM”) published four administrative decisions on penalties for illegal activities involved in the concentration of (...)

The US District Court for the Southern District of New York dismisses a lawsuit over patent settlement where generics were granted early-entry licenses with acceleration clauses (Takeda Pharmaceuticals)
Siemens (New York)
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Patterson Belknap Webb & Tyler (New York)
Better Early than Never: SDNY Dismisses Lawsuit over Patent Settlement where Generics were Granted Early-Entry Licenses with Acceleration Clauses* On September 22, Judge Ronnie Abrams of the Southern District of New York dismissed an antitrust lawsuit against Takeda Pharmaceuticals and three (...)

The Hungarian Competition Authority fines several pharmaceutical laboratories for cartel (Hungaropharma)
Hungarian Competition Authority (Budapest)
The GVH imposed fines for pharma cartel* The Hungarian Competition Authority (GVH) established in its decision that three pharmaceutical wholesalers, with the active collaboration of two consultant companies, had committed an infringement. The wholesalers influenced the medicine public (...)

The Romanian Competition Authority launches a market test concerning a possible abuse of dominance in the pharmaceutical sector (GlaxoSmithKline)
Romanian Competition Council (Bucharest)
The Competition Council launches for public debates the commitments formulated by S.C. GLAXOSMITHKLINE S.R.L.* The Competition Council launches for public debates the commitments formulated by S.C. GlaxoSmithKline (GSK) S.R.L. within the investigation on possible abuse of dominant position of (...)

The Indian Competition Authority clears structural separation of global pharmaceutical company’s bioscience business into separate new pharmaceutical company (Baxter India / Baxalta India)
Vaish Associates Advocates (New Delhi)
CCI clears Baxter-Baxalta merger deal* CCI vide its order dated September 8, 2015 has approved the proposed transfer of Baxter India’s bioscience business and related assets to its wholly-owned subsidiary Baxalta India, after finding that the transaction would not have an appreciable adverse (...)

The Russian Competition Authority prevents growth of prices of some drugs (Ozon)
Russian Federal Antimonopoly Service (Moscow)
FAS prevented growth of prices for medicinal drugs under the frame of arrangements for manufacturers’ ex-works ceiling prices* The same drugs with different characteristics, which, however, do not affect therapeutical qualities, are registered at significantly overrated prices. The Federal (...)

The US FTC subjects to public comment the consent agreement proposed by two pharmaceutical companies that implemented an unlawful agreement not to compete (Concordia and Par)
US Federal Trade Commission (FTC) (Washington)
Pharmaceutical companies settle ftc charges of an illegal agreement not to compete, which resulted in higher prices for generic version of ADHD drug* Pharmaceutical companies Concordia Pharmaceuticals Inc. and Par Pharmaceutical, Inc. have settled FTC charges that they entered into an unlawful (...)

The Chinese NDRC finds that a municipal health and family planning commission has abused its administrative power in its drug procurement practices (Bengbu Health Commission)
University of Melbourne
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China Competition Bulletin (Beijing)
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Hogan Lovells (Beijing)
On 17 August 2015, the NDRC found that the Bengbu Municipal Health and Family Planning Commission (Bengbu Health Commission) had abused its administrative power in its drug procurement practices. This is the NDRC’s first published antitrust enforcement decision in the pharmaceutical industry (...)

The Russian Competition Authority welcomes the payment of the fine imposed on a pharmaceutical company for failure to execute a determination (Teva)
Russian Federal Antimonopoly Service (Moscow)
TEVA Pharmaceutical Industrie Limited paid a fine for failure to execute a FAS determination* TEVA PHARMACEUTICAL INDUSTRIES LIMITED (TEVA, Israel) notified the Federal Antimonopoly Service (FAS Russia) about paying a 300,000 RUB administrative fine for failure to execute a determination (...)

The UK Competition Authority orders licensing remedy to meet concerns over horizontal unilateral effects resulting from a merger in the personal lubricants market (Reckitt Benckiser / Johnson & Johnson)
Herbert Smith Freehills (Brussels)
Introduction and background On 4 November 2015, the UK Competition and Markets Authority ("CMA") accepted final undertakings from Reckitt Benckiser Group plc ("RB") and Johnson & Johnson ("J&J") in relation to RB’s proposed acquisition from J&J of the K-Y brand of personal lubricant (...)

The UK Competition Authority imposes remedies to clear an acquisition in the market of personal lubricants (Reckitt Benckiser / Johnson & Johnson)
United Kingdom’s Competition Authority - CMA (London)
CMA ORDERS REMEDY TO MEET CONCERN OVER LUBRICANTS MERGER * The CMA has found that Reckitt Benckiser’s anticipated acquisition of the K-Y brand could lead to higher prices for personal lubricants. In its final report published today, the Competition and Markets Authority (CMA) has concluded the (...)

The UK Competition Authority issues statements of objection to a pharmaceutical company and its distributors suspected of abuse of dominance in the market of phenytoin sodium capsules (Pfizer / Flynn)
United Kingdom’s Competition Authority - CMA (London)
CMA issues statement of objections to Pfizer and Flynn Pharma in anti-epilepsy drug investigation* The CMA has today issued a statement of objections to the pharmaceutical suppliers Pfizer and Flynn Pharma alleging that they have breached competition law. The Competition and Markets (...)

The EU Commission clears acquisition of a pharmaceutical company, with effects in the market for biosimilars, subject to remedies that ensure innovation competition (Pfizer / Hospira)
DG COMP (Brussels)
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DG COMP (Brussels)
Pfizer / Hospira: Through the lookingglass: assessing competition by biosimilars* In a nutshell In Pfizer/Hospira, the Commission assessed biosimilar drugs in detail for the first time. Biosimilars aim to have the same therapeutic mechanism as, and be clinically equivalent to, original (...)

The US District Court for the District of Massachusetts rejects a request for a new trial to challenge a pay-for-delay agreement (Nexium)
Wolters Kluwer (Riverwoods)
Judgment for Drug Companies Unlikely the End of the Road in Nexium Case* The federal district court in Boston has rejected a request from purchasers of AstraZeneca LP’s heartburn medication Nexium for a new trial to challenge a “reverse payment” or “pay-for-delay” agreement between AstraZeneca and (...)

The US District Court for the Northern District of California upholds assignment of antitrust claims to indirect purchasers (United Food / Teikoku Pharma)
Patterson Belknap Webb & Tyler (New York)
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Patterson Belknap Webb & Tyler (New York)
Northern District of California Upholds Assignment of Antitrust Claims to Indirect Purchasers* Portions of a reverse payment suit against Endo Pharmaceuticals and others were recently dismissed by Judge William H. Orrick of the Northern District of California. The case [1] was brought by (...)

The US Court of Appeals for the Third Circuit concludes that the Actavis ruling applies to non-cash payments (Lamictal)
Rutgers University (Camden)
On June 26, 2015, in the first federal appellate drug patent settlement ruling since the Supreme Court’s decision in FTC v. Actavis, 133 S. Ct. 2223 (2013), the U.S. Court of Appeals for the Third Circuit overturned a lower court decision granting a motion to dismiss for defendants. Writing for (...)

A U.S. appellate panel questions whether reverse payments need to be in cash to put the patent settlement under the scrutiny of antitrust laws (GlaxoSmithKline)
DLA Piper Weiss-Tessbach (Vienna)
Reverse payments can be non-cash according to appellate judges* On 19 November 2014 in a hearing regarding the possible reopening of a lawsuit over whether GlaxoSmithKline (GSK) unfairly extended the monopoly on its drug Lamictal, an appellate panel of the Third Circuit suggested that reverse (...)

The Moscow Arbitration Appeal Court confirms the fine imposed on a pharmaceutical company for abuse of dominance (Novo Nordisk)
Russian Federal Antimonopoly Service (Moscow)
Appeal Court confirmed: “Novo Nordisk” violated the antimonopoly law* On 22 June 2015, the 9th Arbitration Appeal Court upheld the judgment of the Court of First Instance and pronounced legitimacy of the decision of the Federal Arbitration Service (FAS Russia) that “Novo Nordisk” Ltd. had (...)

The Moscow Arbitration Court confirms the decision of the Competition Authority having concluded that a pharmaceutical company has abused its dominance (Baxter)
Russian Federal Antimonopoly Service (Moscow)
Cassation Court: FAS decision and determination regarding “Baxter” are legitimate* On 16 June 2015, the Arbitration Court of the Moscow District (Cassation Court) confirmed legitimacy of the decision and determination of the Federal Antimonopoly Service (FAS Russia) as well as the Order to hold (...)

The EU Commission conditionally approves the acquisition of a life science company affecting the market for laboratory chemicals (Merck / Sigma-Aldrich)
DG COMP (Brussels)
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DG COMP (Brussels)
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DG COMP (Brussels)
Merck/Sigma-Aldrich: the 200,000 products case* In a nutshell: In the life science case Merck/Sigma-Aldrich, the Commission focused for the first time on "laboratory chemicals", a term that covers hundreds of thousands of specialty chemicals. The Commission identified concerns regarding the (...)

The Moscow Arbitration Appeal Court confirms the fine imposed on a pharmaceutical company for abuse of dominance (Teva)
Russian Federal Antimonopoly Service (Moscow)
Appeal Court confirmed legitimacy of the fine upon TEVA* On 11 June 2015, the 9th Arbitration Appeal Court dismissed the appeal filed by TEVA PHARMACEUTICAL INDUSTRIES LIMITED (Israel) against FAS definition (1) to hold TEVA administratively liable for failure to execute a determination. In (...)

The Indian Competition Authority approves a merger of two global pharmaceutical companies because they operate in separate markets in the country (Pfizer / Hospira / Perkins)
Vaish Associates Advocates (New Delhi)
CCI approves merger of Pfizer, Hospira, Inc. and Perkins Holding Company* CCI by its order dated June 11, 2015 approved the execution of an Agreement and Plan of Merger between Pfizer, Hospira, Inc. (Hospira) and Perkins Holding Company (Perkins), a wholly owned subsidiary of Pfizer. The (...)

The Court of Appeal for the District of Columbia rejects a challenge to an FTC rule that makes the HSR Act reporting requirements cover pharmaceutical patent licenses that transfer all commercially significant rights (PhRMA)
Jones Day (Washington DC)
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Sheppard Mullin (Washington)
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Jones Day (Chicago)
The D.C. Circuit has rejected a challenge by the Pharmaceutical Research and Manufacturers of America ("PhRMA") to an FTC rule that makes the HSR Act reporting requirements cover pharmaceutical patent licenses that transfer "all commercially significant rights." The rule, adopted in 2013, (...)