Pharma & Dominance

Dominance

The UK Competition Authority accepts legally binding commitments from a pharma company to continue supplying a key bipolar drug 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)
The UK Competition and Markets Authority (CMA) published today its decision accepting binding commitments from Essential Pharma (EP) to continue supplying for at least 5 years a medicine for the first line treatment of bipolar disorder and other mental conditions at a price considered (...)

The UK Competition Authority accepts legally binding commitments from a pharmaceutical company (Essential Pharma)
United Kingdom’s Competition Authority - CMA (London)
CMA secures affordable supply of key bipolar drug* The CMA has accepted legally binding commitments from Essential Pharma to continue supplying a key bipolar drug at an affordable price for at least 5 years. In October, the CMA launched an investigation suspecting that the pharmaceutical (...)

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 Russian Competition Authority confirms that the pharmaceutical company with a dominant position in wholesale of certain generics ceased 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 damages 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 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 dominant position in wholesale of certain generics unreasonably refused to conclude 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 US Court of Appeals for the Federal Circuit reverses a judgment that upheld “skinny labels” and allowed a generic to launch on uses not covered by a patent (GlaxoSmithKline / Teva)
Rutgers University (Camden)
On October 2, 2020, the U.S. Court of Appeals for the Federal Circuit vacated a district court’s judgment in favor of defendant Teva in a case involving “skinny labels.” GlaxoSmithKline LLC v. Teva Pharm. USA, Inc., 976 F.3d 1347 (Fed. Cir. 2020). When a drug can be used to treat multiple (...)

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 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 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 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 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 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 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 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 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 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 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 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 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 welcomes the England & Wales Court of Appeal’s judgment, calling it an important step forward in clarifying the legal test for excessive and unfair pricing (Pfizer / Flynn Pharma)
United Kingdom’s Competition Authority - CMA (London)
CMA welcomes Court of Appeal judgment in Phenytoin case* The CMA welcomes today’s Court of Appeal judgment, calling it an important step forward in clarifying the legal test for excessive and unfair pricing. The Competition and Markets Authority (CMA) will now carefully review the elements (...)

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 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 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)
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 rules that pay-for-delay patent settlements may restrict competition ‘by object’ (Generics - UK)
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 clarifies the criteria for the "pay-for-delay" agreements in the pharmaceutical sector (Generics - UK)
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 UK Competition Authority welcomes the EU Court of Justice ruling in a pay-for-delay case (Paroxetine Case)
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 provides guidance on patent settlements between manufacturers of originator and generic medicines (Generics - UK)
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 EU Court of Justice clarifies when patent settlement agreements restricting a generic pharmaceutical company’s ability to enter the market, infringe EU antitrust rules (Generics - UK)
Bird & Bird (Brussels)
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Bird & Bird (Brussels)
Article summary: Settlement Agreements Can Be Anti-Competitive Only If The Involved Companies Are (At Least) Potential Competitors. A Careful Examination Must Determine Whether A Generic Manufacturer Would Have Entered Into The Market Without A "Pay Per Delay" Agreement. The Classification Of (...)

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)
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 (...)

Dominance in the pharmaceutical sector: An overview of EU and national case law
Dechert (Paris)
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Dechert (Paris)
The pharmaceutical sector stands out as being regularly under the scrutiny of competition authorities throughout Europe and has continued to be a key enforcement priority over the past 18 months, with notable developments in pay-for-delay and excessive pricing cases, as well as on market (...)

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 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 Paris Court of Appeal upholds the decision of the Competition Authority to fine a pharma company for abuse of dominance (Jansson-Cilag)
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 US FTC sues e-prescriptions company in rare monopolization case (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 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 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 EU Commission publishes a report on competition enforcement in the pharmaceutical sector between 2009 and 2017
Court of First Instance of 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 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 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 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 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 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 UK Competition Authority extends its timetable of investigations on anti-competitive practices in the pharmaceutical sector
Bryan Cave Leighton Paisner (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 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 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 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 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 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 phar- maceutical sector. Last year, the European Commission opened its first investigation into excessive pricing in the (...)

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)
Bryan Cave Leighton Paisner (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 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 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 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 €25 million on a pharmaceutical laboratory for delaying entry into the market of the generic version of a drug and for hindering its development through disparagement campaigns (Janssen-Cilag)
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 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 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 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 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 Belgian Competition Authority rejects a request for interim measures on the pharmaceutical market (Medicare-Market group)
Belgian Competition Authority (Brussels)
The Belgian Competition Authority (BCA) has rejected a request for interim measures of the Medicare-Market group* The SA Medicare-Market (hereafter Medicare-Market) filed on 2 June 2016 a complaint against the Order of Pharmacists and requested interim measures on 28 April 2017. The (...)

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 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 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 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 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 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 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)
,
Baker Botts (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 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 UK Competition Authority fines 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 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 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 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 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 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 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 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 Belgian Competition Authority rejects an appeal of a pharmacist who claimed abuse of dominance by a competitor in the market of raw materials for magistral preparations and packaging material (Cuyckens / Omega Pharma)
Belgian Competition Authority (Brussels)
On 30 June 2015 the Competition College of the Belgian Competition Authority, rejected an appeal of pharmacist Cuyckens against a dismissal decision of the Investigation and Prosecution Service of 31 March 2015.* Mr Cuyckens filed on 20 November 2002 a complaint with the Competition Council (...)

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 (...)

Dominance in the pharmaceutical sector: An overview of EU and national case law
Bonelli Erede (Rome)
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Bonelli Erede (Rome)
1. Introduction This paper aims to describe abuses of dominant position in the pharmaceutical sector. Pharmaceutical companies are particularly exposed to this type of infringement because they are often in a dominant position with regard to innovative products, as medicinal products are (...)

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 US Court of Appeals for the Second Circuit addresses pharmaceutical “product hopping” in decision barring a producer from pulling older version of drug from shelves (Actavis)
Winston & Strawn (Washington)
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Winston & Strawn (Washington)
Few courts have addressed antitrust challenges to pharmaceutical “product hopping,” i.e., the practice of shifting customers from a drug nearing the end of its patent protection to a modified version that is covered by newer patents and thus is protected from generic competition for a longer (...)

The Chinese NDRC targets price-related illegal conducts in the pharmaceutical sector
King & Wood Mallesons (Beijing)
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Freshfields Bruckhaus Deringer (Beijing)
NDRC Targets Price-related Illegal Conducts in the Pharmaceutical Sector* On May 4, 2015, the NDRC published Notice on Reinforcing Supervision over Medical Prices (“Notice”). In the Notice, the NDRC issued a range of specific opinions on the supervision over medical price, including immediately (...)

The Moscow Arbitration Court confirms the fine imposed on a pharmaceutical laboratory for abuse of dominance (Teva)
Russian Federal Antimonopoly Service (Moscow)
The fine upon TEVA is legitimate* On 1 April 2015, Moscow Arbitration Court pronounced legitimacy of FAS determination (1) to hold TEVA PHARMACEUTICAL INDUSTRIES LIMITED (Israel) administratively liable. Earlier, in December 2013, the antimonopoly body found that TEVA violated Clause 5 Part 1 (...)

The Dutch Competition Authority provides insight into the application of competition law to the pricing and marketing strategies of originator companies
Simmons & Simmons (Brussels)
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Euroclear (Brussels)
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Simmons & Simmons (Amsterdam)
In brief In a policy paper, the Netherlands Authority for Consumers and Markets (ACM) examines how it can deal under competition law with pricing and marketing strategies of originators which impede the market entry of cheaper generic medicines. It focuses in particular on the strategies aimed (...)

The Moscow Arbitration Appeal Court confirms that a pharmaceutical company has abused its dominance (Baxter)
Russian Federal Antimonopoly Service (Moscow)
Appeal Court supported FAS arguments on the case against “Baxter” CJSC* On 17 February 2015, the 9th Arbitration Appeal Court confirmed legitimacy of the decision and determination of the Federal Antimonopoly Service (FAS Russia) on the antimonopoly case against “Baxter” CJSC, and a definition on (...)

The US District Court for the Eastern District of Pennsylvania sends second reverse-payment case to trial (Cephalon)
Rutgers University (Camden)
On January 28, 2015, Judge Mitchell Goldberg of the U.S. District Court for the Eastern District of Pennsylvania denied defendants’ summary judgment motions, sending the second reverse-payment-settlement case to trial. In King Drug Company of Florence v. Cephalon, 2015 WL 356913 (E.D. Pa. Jan. (...)

The Louisiana’s Attorney General sues a pharmaceutical company for violating antitrust rules by filing baseless citizen petitions to the US Food and Drug Administration in order to delay the entry of a generic product in the market (GlaxoSmithKline)
DLA Piper Weiss-Tessbach (Vienna)
Louisiana’s Attorney General sues GlaxoSmithKline over delay of generic nasal spray* In December 2014 Louisiana’s attorney general (AG) filed a complaint against GlaxoSmithKline (GSK) alleging that GSK engaged in an anticompetitive scheme to delay the entry of a generic version of its Flonase (...)

The Bulgarian Competition Authority rules on parallel trade of pharmaceutical products and their limitations (Sopharma)
Tsvetkova Bebov Komarevski (Sofia)
Restrictions of Parallel Trade in Pharmaceuticals – Carte Blanche from the Bulgarian Competition Authority?* The Bulgarian Competition Protection Commission (“CPC” or “Commission”) has recently issued an important decision regarding the parallel trade of pharmaceuticals and the possibilities for (...)

The Russian Competition Authority sends a warning to a pharmaceutical company suspected to abuse its dominance (Roche)
Russian Federal Antimonopoly Service (Moscow)
FAS issued a warning to “Roche Diagnostics Rus”* On 17 December 2014, the Federal Antimonopoly Service (FAS Russia) issued a warning to “Roche Diagnostics Rus” Ltd. to stop actions that have elements of violating the antimonopoly law. FAS sees signs that “Roche Diagnostics Rus” Ltd. unreasonably (...)

The Russian Competition Authority fines a pharmaceutical company for refusal to supply insulin (Novo Nordisk)
Russian Federal Antimonopoly Service (Moscow)
FAS imposed a turnover fine upon “Novo Nordisk” for refusal to supply insulin* On 15 December 2014, the Federal Antimonopoly Service (FAS Russia) found that “Novo Nordisk” Ltd. committed an administrative offence and imposed a fine for over $ 30 million RUB. “Novo Nordisk” Ltd. violated the law by (...)

The Italian Competition Authority initiates an investigation to ascertain an abuse of dominant position in the cancer drugs markets (Aspen)
Bonelli Erede (Rome)
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Bonelli Erede (Rome)
With its decision of 19 November 2014, the Italian Competition Authority (“ICA” or the “Authority”) initiated an investigation into Aspa Pharma Trading Ltd and Aspen Italia S.r.l. (“Aspen”) - both belonging to the South African-based Aspen Group, a leading manufacturer of generic medicines - to (...)

The Italian Competition Authority opens an Article 102 TFEU investigation against a producer of generic drugs (Incremento Prezzo Farmaco-Aspen)
Giannino SI (Monserrato)
In the case Incremento Prezzo Farmaco-Aspen (Aspen) the Italian Competition Authority (ICA) has recently opened an Article 102 TFEU investigation against Aspen, a South African manufacturer of generic drugs . Aspen was alleged to have abused its dominance position by imposing excessive prices (...)

The Russian Competition Authority fines a pharmaceutical laboratory having not executed a warning (Teva)
Russian Federal Antimonopoly Service (Moscow)
TEVA is fined for failure to execute FAS determination* On 20th October 2014, the Federal Antimonopoly Service (FAS Russia) held TEVA PHARMACEUTICAL INDUSTRIES LIMITED (Israel) administratively liable for failure to execute a determination and fined the company 300,000 RUB. In December 2013, (...)

The Dutch Competition Authority closes its investigation against a pharmaceutical company suspected of abuse of dominance by differencing the price of its drug sold inside and outside of hospitals (AstraZeneca)
Netherlands Authority for Consumers & Markets (The Hague)
ACM closes investigation into AstraZeneca* The Netherlands Authority for Consumer and Markets (ACM) has carried out an investigation into the large price difference between the price that international pharmaceutical company AstraZeneca asked for heart burn drug Nexium sold inside hospitals, (...)

The Russian Competition Authority concludes that a pharmaceutical company has abused its dominance by refusing to supply medicine without any economic or technological reason (Novo)
Russian Federal Antimonopoly Service (Moscow)
“Novo Nordisk” again violated the antimonopoly law* On 25th August 2014, the FAS Commission found that “Novo Nordisk” Ltd. violated Clause 5 Part 1 Article 10 of the Federal Law “On Protection of Competition” by refusing to supply medicines without any economic or technological reasons. Earlier FAS (...)

The US Court of Appeals for the Tenth Circuit rules that one firm’s ability to break into the relevant market does not foreclose the possibility that another company monopolized or attempted to monopolize that market (Lenox / Medtronic)
Wolters Kluwer (Riverwoods)
Monopoly Claims Can Survive Summary Judgment: Medtronic Must Defend Conduct in “Bone Mill” Market* One firm’s ability to break into the market for “bone mills” used in spinal-fusion surgery did not foreclose the possibility that medical device company Medtronic monopolized or attempted to (...)

The EU Commission fines pharmaceutical companies in pay-to-delay case (Servier / Niche / Unichem / Matrix / Teva / Krka / Lupin)
Ashurst (Milan)
European Commission fines pharmaceutical companies in pay-to-delay case* Last 9 July the European Commission (“Commission”) fined (see press releases here and here) French pharmaceutical company Servier and five generics manufacturers ( Niche/Unichem, Matrix (now part of Mylan), Teva, Krka and (...)

The French Competition Authority fines a pharmaceutical laboratory for abuse of dominance by refusing to sell its medical information database (Euris / Cegedim)
French Competition Authority (Paris)
The Autorité de la concurrence has imposed Cegedim a 5.7 million euros fine for having abusively refused to sell its medical information database to certain pharmaceutical laboratories* The medical databases market To optimise the work of their sales forces, pharmaceutical laboratories use two (...)

The Moscow Arbitration Appeal Court confirms the legitimacy of a warning delivered by the Competition Authority to a pharmaceutical company having abused its dominance (Novo Nordisk)
Russian Federal Antimonopoly Service (Moscow)
Appeal Court confirmed legitimacy of FAS warning to “Novo Nordisk”* On 23rd June 2014, the 9th Arbitration Appeal Court dismissed the appeal of “Novo Nordisk” Ltd. on a judgment of Moscow Arbitration Court that supported a FAS warning issued to “Novo Nordisk” Ltd. with regard to some elements of (...)

The Russian Competition Authority gives its position on a dispute between vaccine producers (GlaxoSmithKline / Pfizer)
Russian Federal Antimonopoly Service (Moscow)
FAS position on a dispute between vaccine producers* The Federal Antimonopoly Service completed surveying product boundaries of the market of pneumococcal vaccines for children aged from 1.5 month to 5 years. The analysis was initiated upon two mutually exclusive petitions from vaccine (...)

The Chinese State Administration Industry & Commerce releases draft of regulations concerning the abuse of IPR for anticompetitive purposes
AnJie Law (Beijing)
SAIC Moves Closer to Antitrust Rules for IP* On June 11, 2014, China’s State Administration for Industry and Commerce (SAIC) released the latest draft of regulations designed to implement the Anti-Monopoly Law (AML) with respect to intellectual property rights—Rules of the Administration of (...)

The US Court of Appeals for the Second Circuit clarifies that a patent holder’s contractual duty to deal is not necessarily subject to an antitrust duty to deal (Louisiana Wholesale Drug Company / Shire)
McDermott Will & Emery (Paris)
Addressing for the first time whether a patent holder under a contractual duty to deal is also subject to an antitrust duty to deal, the U. S. Court of Appeals for the Second Circuit upheld dismissal of a putative antitrust class action challenge to a drug manufacturer’s refusal to fully supply (...)

The Cypriot Competition Authority conducts dawn raids following an investigation ex-officio concerning the terms and prices of supply of equipment and strips for monitoring blood glucose sold to pharmaceutical stores and public bodies
Commission for the Protection of Competition of the Republic of Cyprus (Nicosia)
Press Release by the Commission for the Protection of Competition – Dawn raid carried out at the premises of Panicos Theo Hadjigeorgiou & Co Ltd* The Cyprus Commission for the Protection of Competition (CPC) decided, as per section 31 of the Protection of Competition Laws of 2008 and 2014 (...)

The Russian Competition Authority welcomes the refusal of a pharmaceutical company to challenge its warning (Baxter)
Russian Federal Antimonopoly Service (Moscow)
“Baxter” CJSC refused to challenge a FAS warning* On 17th April 2014, “Baxter” CJSC withdrew an appeal lodged to the 9th Arbitration Appeal Court to invalidate a FAS warning that refusing to supply a unique drug for treating renal deficiency through peritoneal dialysis was unacceptable. The Appeal (...)

The Lisbon Appeal Court revises an arbitral award in a dispute between the national pharmacy association and an information technology company (Associação Nacional de Farmácias and Farminveste / IMS Health)
Eduardo Paz Ferreira & Associados
Replacing a previous contract, the National Pharmacy Association (ANF) executed a contract with IMS Health in 2008, by which it transmitted to the latter data on purchases in its associated pharmacies, in exchange for remuneration. This data was used to provide pharma market intelligence in a (...)

The Russian Competition Authority fines a pharmaceutical company for abuse of dominance in the market of treating renal deficiency through peritoneal dialysis (Baxter)
Russian Federal Antimonopoly Service (Moscow)
“Baxter” unlawfully restricted competition on the market of medicines for treating renal deficiency* “Baxter” CJSC restricted competition and infringed the interests of “Medical Service Company” Ltd. by unlawfully refusing to supply a unique drug for treating renal deficiency through peritoneal (...)

The Moscow Arbitration Court upholds the warning delivered by the Competition Authority against a pharmaceutical company aiming to eliminate disadvantageous contract conditions (Novo Nordisk)
Russian Federal Antimonopoly Service (Moscow)
Moscow Arbitration Court confirmed legitimacy of a FAS warning issued to “NovoNordisk”* On 14th March 2014, Moscow Arbitration Court confirmed legitimacy of a warning issued by the Federal Antimonopoly Service (FAS Russia) to “Novo Nordisk” Ltd. due to elements of violating Clauses 3 and 5 Part 1 (...)

The Italian Council of State reinstates penalties against a company for an abuse of dominant position to artificially extend the patent protection (Pfizer)
Ashurst (Milan)
Italy’s Council of State reinstates the fine imposed on Pfizer for delaying a generic’s market entry* On 12 February 2014, Italy’s Council of State (the “CdS”) dismissed the ruling of the lower administrative court (the “TAR Lazio”) which quashed the decision of Italian Competition Authority (the (...)

The Moscow Arbitration Court upholds the decision of the Competition Authority delivering a warning against a pharmaceutical company refusing to deal with a medical service provider (Baxter)
Russian Federal Antimonopoly Service (Moscow)
Arbitration Court supported FAS Russia: “Baxter” should have listened to warning* On 27th January 2014, Moscow Arbitration Court confirmed legitimacy of the warning issued by the Federal Antimonopoly Service (FAS Russia) to “Baxter” CJSC due to signs of violating the antimonopoly law (Clause 5 (...)

The French Competition Authority fines a pharmaceutical laboratory for abuse of dominance in denigrating its competitors and in implementing anticompetitive agreements with its supplier (Arrow / Schering-Plough)
French Competition Authority (Paris)
The Autorité de la concurrence fines the Schering-Plough pharmaceutical laboratory a total of 15.3 million euro for hindering entry onto the market of the generic of its originator medicinal product Subutex®* Following a complaint filed by the Arrow génériques laboratory, The Autorité de la (...)

The French Competition Authority fines a pharmaceutical company €15.3 million for preventing market entry of a generic (Arrow / Schering-Plough)
Bollé Brands (Paris)
Introduction On 18th December 2013, the French Competition Authority handed down a significant decision in the pharmaceutical sector. The Competition Authority considered that Schering-Plough had abused its dominant position by impeding the entry of the generic product onto the market. In (...)

The UK Court of Appeal refuses interim injunction against the alleged refusal to deal as the claimant failed to identify any market on which the defendant could conceivably be dominant (Chemistree Homecare / Abbvie)
St John’s Chambers (Bristol)
United Kingdom: interim injunctions in competition litigation* Private competition litigation is continuing to develop in the United Kingdom. The courts and the Competition Appeal Tribunal are seeing an increase in the number and complexity of follow-on damages actions, often between foreign (...)

The Bulgarian Competition Authority holds that the national health insurance fund is not an undertaking for competition law enforcement (NZOK II)
University of Macau - Faculty of Law
On 17 July 2013 the Bulgarian Competition Authority (CPC) rejected the abuse of dominance complaints submitted by the pharmaceuticals traders against the National Health Insurance Fund (NZOK). In its two no-infringement decisions the CPC held that NZOK should not be viewed as undertaking in (...)

The Chinese National Development and Reform Commission opens a broad investigation into pharmaceutical pricing
Covington & Burling (Washington)
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Covington & Burling (Washington)
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Covington & Burling (Shanghai)
Earlier this month, China’s National Development and Reform Commission (“NDRC”) announced that it is conducting a wide-ranging probe into the costs and prices of pharmaceutical products sold by more than 60 multinational and domestic companies. NDRC has broad powers to enforce China’s Price Law, (...)

The US Supreme Court rules that reverse patent settlements may violate antitrust law (Actavis)
Womble Bond Dickinson (Washington)
FTC v. Actavis, Inc.: Supreme Court Rules That Reverse Patent Settlements May Violate Antitrust Laws* On June 17, 2013, in FTC v. Actavis, Inc., the Supreme Court ruled that "reverse patent settlements" may violate the Sherman Act even though the anticompetitive effects of the settlement fall (...)

The US Supreme Court reverses the judgment of the eleventh circuit and leaves the structuring of the rule of reason antitrust litigation to the lower courts (Actavis)
Cleveland University - Marshall School of Law
Just What on Earth Did Actavis Really Say? And Does It Mean Something for Section 1 More Broadly?* It’s going to be a strict, nearly-per-se quick look rule, folks, in more or less every reverse-payment case likely to be brought from here on out. Dollars-to-donuts. A few weeks have gone by, (...)

The French Competition Authority fines a pharmaceutical company for having implemented a strategy of denigrating the generic versions of its branded drugs (Sanofi-Aventis)
European Commission (Brussels)
France: The Autorité de la Concurrence fines Sanofi-Aventis € 40 600 000 for denigrating Generic Versions of branded Drug Plavix* On 14 May 2013, following a complaint from the generics manufacturer Teva Santé, the Autorité de la concurrence (the Autorité) imposed a fine of € 40 600 000 on (...)

The French Competition Authority fines a pharmaceutical company for disparaging competing generics (Sanofi-Aventis)
Vogel & Vogel (Paris)
The French Competition Authority has handed down a fine of EUR 40 million to the Sanofi-Aventis Laboratory for implementing a practice of driving out competition by disparaging generic versions of its flagship product Plavix® to healthcare professionals in order to favor sales of the original (...)

The Romanian Competition Authority follows case law precedent and finds no abuse of dominance on the pharmaceuticals distribution market (Roche)
University of Macau - Faculty of Law
On 8 May 2013 the Romanian Competition Authority (CC) concluded its investigation into the alleged abuse of dominant position in the pharmaceuticals wholesale market. Finding no evidence that would demonstrate that the manufacturer attempted to prevent the re-importation of its products into (...)

The Romanian Competition Authority rejects a complaint regarding the refusal to supply in the pharmaceutical sector (Roche)
Nestor Nestor Diculescu Kingston Petersen (Bucharest)
,
Nestor Nestor Diculescu Kingston Petersen (Bucharest)
On 19 May 2013, following the principles established by the European preliminary ruling in GlaxoSmithKline, the Romanian Competition Council (“RCC”) held that La Roche (“Roche”) did not abuse its dominant position on the pharmaceuticals distribution market. On 24 September 2010, SC Relad (...)

The Cypriot Competition Authority imposes administrative fines for providing quantitative discounts according to the volumes of vaccines purchased by doctors and pharmacists (Panayotou / Wyeth Hellas / Phadisco)
Commission for the Protection of Competition of the Republic of Cyprus (Nicosia)
The Commission for the Protection of Competition (CPC) with its decision No. 36/2013 imposed an administrative fine of €206,168 on Phadisco Ltd and an administrative fine of €8,234 to Wyeth Hellas SA (Cyprus Branch), through its successor Pfizer Hellas S.A. (Cyprus Branch), regarding the (...)

The UK High Court dismisses interim injunction in abuse of dominance case concerning refusal to supply in HIV prescription medicines market (Chemistree Homecare / Abbvie)
Van Bael & Bellis (Brussels)
On 11 February 2013, the English High Court dismissed an application for an interim injunction in an abuse of dominance case concerning an alleged refusal to supply a patented HIV prescription medicine. Chemistree Homecare Ltd (the “claimant”) had applied for an interim injunction against (...)

The Italian Competition Authority launches an investigation against pharmaceutical companies suspected of restricting drug sales (Roche / Novartis)
Studio Legale Scoccini (Rome)
On February 6, 2013, the Italian Competition Authority ("ICA") launched a cartel investigation against Hoffmann-La Roche ("Roche"), Novartis, their respective Italian subsidiaries, and Genentec, a US company controlled by Roche and in which Novartis holds a 33% shareholding. The companies (...)

The Italian Competition Authority opens proceedings against pharmaceutical companies in relation to an alleged anticompetitive agreement for restricting drug sales (Roche / Novartis)
Ashurst (Milan)
Roche and Novartis investigated for an alleged cartel in Italy* On 6 February 2013 the Italian Competition Authority opened proceedings against the Roche Group and the Novartis Group in relation to an alleged anticompetitive agreement for excluding the ophthalmic use of Roche’s Avastin in order (...)

The Italian Council of State reinstates a € 5.1 million fine initially imposed on a pharmaceutical company by the Competition Authority for its alleged abuse of dominant position in the market for the production and commercialisation of fosetyl-based fungicides (Bayer)
Van Bael & Bellis (Brussels)
,
Polybius (Brussels)
On 22 January 2013, it was reported that the Italian Council of State – Italy’s highest jurisdiction in competition cases – had reinstated a € 5.1 million fine against Bayer initially imposed on the company by the Italian Competition Authority (“ICA”) for its alleged abuse of dominant position (...)

The Italian Supreme Administrative Court reinstates the Competition Authority’s decision finning a pharmaceutical group for abuse of dominant position in the market for the production and commercialisation of fosetyl-based fungicides against downy mildew in grapes (Bayer)
Covington & Burling (Brussels)
,
United Kingdom Competition Authority (London)
With decision of 11 January 2013, the Italian Supreme Administrative Court (Consiglio di Stato) quashed a judgment of the Italian Administrative Court of First Instance (TAR Lazio) and upheld the 2011 Italian Competition Authority’s (ICA) decision fining Bayer CropScience AG and Bayer (...)

The Italian Council of State rules on the issue of dominant firms’ duty to supply essential information beyond the requirements of sector regulation (Bayer)
University of Naples
Italy’s highest administrative court handed down an important ruling on the issue of the dominant firms’ duty under Article 102 TFEU to grant their competitors access to essential information when sector regulation encourages such a disclosure. By its judgment of 11 January 2013, no. 548 (the (...)

The EU Court of Justice upholds the abuse of patent systems and the procedures for marketing pharmaceutical products to prevent or delay the arrival of competing for generic medicinal products on the market for proton pump inhibitors (AstraZeneca)
Ashurst (Milan)
ECJ rejects appeal relating to abuse of the patent system and the procedures for marketing of drugs* On 6 December 2012, the European Court of Justice (“ECJ”) handed down its ruling rejecting AstraZeneca’s (“AZ”) appeal in relation to the Losec case. In the first instance, the General Court largely (...)

The EU Court of Justice dismisses pharmaceutical company’s appeal against the Commission and EU General Courts’ findings that it abused its dominant position by misusing patent systems and pharmaceutical marketing procedures to exclude generic competitors from the market and restrict parallel imports (AstraZeneca)
Herbert Smith Freehills (Brussels)
,
Herbert Smith Freehills (London)
1. Introduction The Court of Justice of the EU (ECJ) has dismissed AstraZeneca’s appeal against the Commission’s and General Court’s findings that the company abused its dominant position under Article 102 TFEU by misusing the patent system and pharmaceutical marketing procedures in order to (...)

The EU Court of Justice entirely dismisses pharmaceutical company’s appeal on abusive patent misuse (AstraZeneca)
Mircea (Bucharest)
I. Introduction On 6 December 2012, the CJEU issued its judgment in the long-running AstraZeneca litigation. The General Court’s judgment has been upheld in its entirety. The only victorious battle scored by the appellant refers to what type of conduct before the national regulatory authorities (...)

The Italian Administrative Court of First Instance quashes the Competition Authority’s decision against a pharmaceutical company for misuse of a patent (Pfizer)
Bonelli Erede (Rome)
In its judgment delivered on 3 September 2010, the Italian Court of First Instance (‘TAR Lazio’) quashed the decision by which the Italian Competition Authority (‘ICA’) fined Pfizer EUR 10.6 million for having abused its dominant position in the visual glaucoma medicine market, by blocking or (...)

The EU Commission sends statements of objections to more than a dozen companies in connection with investigations in the pharmaceutical sector (Perindopril)
Ashurst (Milan)
European Commission issues Statements of Objections against several pharmaceutical companies* On 25 and 30 July 2012, in relation to the Citalopram case and the Perindopril case respectively, the European Commission sent statements of objections (“SOs”) to more than a dozen companies in (...)

The EU Court of Justice Advocate General Mazak supports the General Court’s refusal of appeal in case involving an abuse of dominant position (AstraZeneca)
Covington & Burling (Brussels)
On 15 May 2012, the Advocate General of the EU Court of Justice issued his opinion on the appeal of the General Court’s judgment in AstraZeneca v. Commission. The Advocate General largely agreed with the reasoning and holdings of the General Court, and recommended that the Court of Justice (...)

The EU Court of Justice Advocate General Mazak issues his opinion recommending to dismiss an appeal against pharma company’s abuse of dominance (AstraZeneca)
Baker McKenzie (Brussels)
AstraZeneca v Commission, Advocate-General Mazak’s Opinion of 15 May 2012* On 15 May 2012, Advocate-General Mazák delivered his long awaited Opinion to the European Court of Justice in the long-running AstraZeneca litigation. Practitioners hoping for an opinion that tempered some of the more (...)

The Italian Competition Authority fines a leading pharmaceutical company €10.6 million for abusing its dominant position (Pfizer)
DG COMP (Brussels)
The Italian Competition Authority (AGCM) has fined the Pfizer group, a multinational company in the pharmaceutical sector, a total of 10.6 million euro for abusing its dominant position in the market for commercializing glaucoma medicines based on the active ingredient latanoprost. The Pfizer (...)

The Italian Competition Authority fines anti-competitive practices aimed at delaying market entry for generic medicines (Pfizer)
European Commission (Brussels)
Italy: The Competition Authority fines anti-competitive Practices aimed at delaying Market Entry for generic Medicines* On 11 January 2012, the Italian Competition Authority (ICA) sanctioned the multinational pharmaceutical group Pfizer (Pfizer) for a violation of Article 102 TFEU and imposed (...)

The Italian Competition Authority sanctions company for abuse of dominance challenging divisional patent filing in the visual glaucoma drugs industry resting on effects-based approach (Pfizer)
Gatti Pavesi Bianchi (Milan)
Evolution or Revolution? The Italian Competition Authority and the Pfizer Decision: A Reply to Thomas Graf* In his last post, Thomas Graf pointed out, as brilliantly and persuasively as he customarily does, the key features and implications of the Jan. 11, 2012 decision of the Italian (...)

The Italian Competition Authority fines company for abuse of dominance relating to visual glaucoma drugs challenging divisional patent filings (Pfizer)
Cleary Gottlieb Steen & Hamilton (Brussels)
Italian Competition Authority Challenges Patent Measures* The Italian Competition Authority started the New Year with a bang by imposing a fine of more than EUR 10 million on Pfizer for alleged abuses of the patent system in violation of Article 102 TFEU. The decision is available here. The (...)

The Italian Competition Authority fines a leading pharmaceutical company for an infringement of Art. 102 TFEU by a misusing patent (Pfizer)
Luiss Guido Carli University (Rome)
,
OECD - Competition Division (Paris)
Introduction On the 11th of January 2012 the Italian Competition Authority (ICA), with decision no. 23194, closed its investigation against Pfizer, initiated in October 2010 following a complaint by Ratiopharm Italia, a generic drug producer. Pfizer had been accused of putting in place a (...)

The Italian Competition Authority fines a pharmaceutical undertaking for abusing its dominant position in the market for the treatment of visual glaucoma products (Pfizer)
Ashurst (Milan)
Italian Competition Authority fines Pfizer for abuse of dominance relating to visual glaucoma drugs* On 11 January 2012 the Italian Competition Authority (“ICA”) issued a decision fining Pfizer Euro 10.6 million for abusing its dominant position in the market for products for that treat visual (...)

The Chinese National Development & Reform Commission fines two pharmaceutical companies for abusing dominant position (Shandong Weifang Shuntong Pharmaceutical / Weifang Huaxin Medicine Trade)
Covington & Burling (San Francisco)
,
Covington & Burling (London)
,
Covington & Burling (San Francisco)
China’s National Development & Reform Commission (“NDRC”) announced this week that it has fined two domestic pharmaceutical companies for monopolizing bulk sales of promethazine hydrochloride in violation of the country’s Anti-Monopoly Law (“AML”). The decision, NDRC’s first AML action in the (...)

The EU Commission announces the closure of its antitrust investigation in the pharmaceutical sector (Almirall / Boehringer)
Van Bael & Bellis (Brussels)
On 6 July 2011, the European Commission announced that it has closed its antitrust investigation into allegations by Spanish pharmaceutical company Almirall that the German pharmaceutical company Boehringer Ingelheim filed for unmeritous patents in the area of new treatments for lung diseases (...)

The German Competition Authority orders a producer of laboratory chemicals to cease discriminatory treatments amongst its customers (Merck)
Van Bael & Bellis (Brussels)
,
Practising Law Institute (New York)
On 19 May 2011, the German Federal Cartel Office (“FCO”) found that Merck KGaA (“Merck”) had abused its dominant position in the markets for several laboratory chemical products by discriminating among its customers. According to the FCO, Merck provided more favourable sales conditions to its (...)

The Belgian Competition Authority returns a case to the College of Prosecutors for having failed to consider the repeated nature of an abuse of dominance in the pharmaceutical sector (Omega Pharma)
Lexing (Liège)
,
Arendt & Medernach (Luxembourg)
I. The parties The plaintiff is an independent Belgian dispensing chemist. The defendant is Omega Pharma NV (here after “Omega Pharma”) an important supplier of raw material and packaging products also active in the field of “Over-The-Counter” products (OTC-products). The decision analysed is (...)

The UK Department of Health seeks antitrust damages after abuse of dominant position in the pharmaceutical sector (Reckitt Benckiser)
Van Bael & Bellis (Brussels)
According to press reports, the UK Department of Health, together with 10 health authorities and 144 primary care trusts, has launched an action for damages against Reckitt Benckiser in the High Court. This follows the OFT’s decision to fine Reckitt Benckiser £ 10.2 million for abusing its (...)

The UK Competition Authority reaches early resolution agreement in abuse of dominance investigation in the pharmaceutical sector (Reckitt Benckiser / Gaviscon)
European Court of Justice (Luxembourg)
On 15 October 2010, the UK Office of Fair Trading (OFT) announced that it had reached an early resolution agreement with Reckitt Benckiser whereby the OFT agreed to reduce the fine it would impose on Reckitt Benckiser in return for the company’s admission of infringement of the Chapter II (...)

The UK Competition Authority agrees to reduce the fine imposed against a pharmaceutical firm for abuse of its dominant position (Reckitt Benckiser)
European Commission (Brussels)
United Kingdom: Early Resolution Agreement in Reckitt Benckiser Abuse Case On 15 October 2010, the OFT announced that it had agreed to reduce the proposed fine by £ 1,800,000 (about € 1,162,040) to £ 10,200,000 (about € 6,584,893), following Reckitt Benckiser’s admission and decision to co-operate (...)

The Italian Competition Authority investigates the allegations of foreclosure of market access for a new generic drug for treating visual glaucoma (Pfizer)
Ashurst (Milan)
Italian Competition Authority investigates Pfizer’s effort to obstruct market access for a new generic drug for treating visual glaucoma* On 13 October 2010, the Italian Competition Authority (“ICA”) opened an investigation to ascertain whether Pfizer’s attempt to prolong the patent protection for (...)

The Italian Competition Authority investigates on infringement of Art. 102 TFEU for misuse of a patent (Pfizer)
Bonelli Erede (Rome)
On 13 October 2010, the Italian Competition Authority (the “ICA”) decided to initiate proceedings against Pfizer to assess whether the company had abused its dominant position in the market for medicines to treat visual glaucoma, by blocking or delaying the market entry of generic versions of its (...)

The US District Court for the District of Minnesota rules against the FTC by holding that it has failed to prove the relevant market requirement in a pharmaceutical merger case (Lundbeck)
Wolters Kluwer (Riverwoods)
FTC Loses Suit against Drug Maker over 2006 Acquisition* The Federal Trade Commission recently suffered a significant setback in its merger enforcement efforts when the federal district court in Minneapolis rejected an action brought by the agency along with the State of Minnesota against (...)

The EU General Court fines a company for abuse of a dominant position in the pharmaceutical sector addressing the issues of market definition and dominance analysis (AstraZeneca)
Cleary Gottlieb Steen & Hamilton (Brussels)
The General Court’s Judgment In AstraZeneca, Lessons For Market Definition And Dominance Analysis* On July 1, 2010, the European General Court rendered its judgment in the AstraZeneca case, dismissing for the most part AstraZeneca’s appeal against the Commission’s infringement decision of June (...)

The EU General Court upholds “novel” approach to abuse of dominance in pivotal pharma appeal (AstraZeneca)
Linklaters (Brussels)
,
Linklaters (Brussels)
,
Linklaters (Brussels)
On July 1, 2010, the General Court ruled in an appeal against the European Commission’s first ever finding of abuse of a dominant position by a pharma company. The Court has broadly upheld a Decision the Commission itself characterised as “novel”, but reduced the €60 million fine on AstraZeneca to (...)

The EU General Court confirms abuse of dominance by preventing the market entry or the parallel imports of generic medicinal products (AstraZeneca)
Ashurst (Milan)
ECJ upholds European Commission decision against AstraZeneca* On 1 July 2010, the European Union’s General Court (or “GC”, formerly the Court of First Instance) handed down its judgment against the AstraZeneca Group (“AZ”) for having abused its dominant position by preventing the market entry or (...)

The Bulgarian Competition Authority fines the National Health Insurance Fund for imposing maximum retail margins for medicines sold under the national health insurance scheme (National Health Insurance Fund)
University of Macau - Faculty of Law
On 7 July 2010 the Bulgarian Competition Authority (CPC) established that the National Health Insurance Fund (NZOK) has abused its dominant position on the market for medicines reimbursed under the national health insurance scheme by imposing the maximum retail margins to be applied by the (...)

The French Competition Authority opens in-depth investigation of alleged abuse of dominance as regards the exclusion of generic competition (Sanofi-Aventis)
Ashurst (Milan)
French Competition Authority probes Sanofi-Aventis alleged abuse against generic manufacturers* On 17 May 2010, the French Autorité de la concurrence (French Competition Authority, “FCA”) determined to open a fully fledged investigation (under Article 102 TFEU) into Sanofi-Aventis allegedly (...)

The French Competition Authority rejects a claim for interim measures but holds that a pharmaceutical company may be at fault for promoting the differences between its product and competing for generic products whereas such differences have no therapeutic value (Sanofi-Aventis)
Vogel & Vogel (Paris)
Since 1998, the Sanofi-Aventis France laboratory has been marketing an antiplatelet medication, Plavix(r), whose intellectual property protection expired on 15 July 2008 in Europe, with the exception of the rights protecting clopidogrel salt used in Plavix(r) and the clopidogrel-aspirin (...)

The UK Competition Authority issues a statement of objections for alleged abuse of a dominant position in the pharmaceutical sector (Reckitt Benckiser)
European Commission (Brussels)
United Kingdom: The Office of Fair Trading (OFT) Issues Statement of Objections for Alleged Abuse of a Dominant Position in the Pharmaceutical Sector On 23 February 2010, the OFT issued a Statement of Objections alleging that Reckitt Benckiser abused its dominant position in the market for the (...)

The Romanian Competition Authority rejects a complaint regarding the market entry of generics and price-fixing in the healthcare sector (Actavis / Novartis Pharma / Novartis)
Musat & Asociatii (Bucharest)
On January the 20th 2010 the Romanian Competition Council (the ‘Council’) issued the Decision 03/2010 rejecting a complaint filed by Actavis Group PTC (‘Actavis’) against two companies belonging to the Novartis Group - Novartis Pharma GmbH and Novartis AG (‘Novartis’) alleging a breach of the (...)

The French Competition Authority dismisses allegation of abuse against a pharmaceutical company (Sanofi-Aventis)
Van Bael & Bellis (Brussels)
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Practising Law Institute (New York)
In a recently published decision of 14 January 2010, the French Competition Authority dismissed the allegation of the French Minister for the Economy against Sanofi-Aventis (“Sanofi”) concerning that firm’s pricing practices on the market for the supply of low-molecular-weight heparins (“LMWHs”) (...)

The US Court of Appeals for the Second Circuit states that direct purchasers of antidiuretic medicine have antitrust standing in patent infringement suit (DDAVP)
Stanford University - Stanford Law School
2nd Circuit finds DDAVP purchasers stated Walker Process and related claims and had antitrust standing* On 16 October 2009 the Court of Appeals for the Second Circuit held (In re: DDAVP Direct Purchaser Antitrust Litigation) that direct purchasers of desmopressin acetate tablets, sold under (...)

The French Competition Authority rejects request for interim measures in the pharmaceutical sector (Ratiopharm / Janssen-Cilag France)
Van Bael & Bellis (Brussels)
,
Practising Law Institute (New York)
In a decision of 31 July 2009, which was made public on 7 September 2009, the French Competition Authority rejected German generic pharmaceutical company Ratiopharm‘s request for interim measures against Janssen-Cilag France (“Janssen”), the maker of Durogesic. The move follows a complaint lodged (...)

The Athens Administrative Court of Appeal partially annuls the decision of the Competition Commission on the parallel trade of pharmaceuticals (GlaxoSmithKline)
Mikroulea, Staikouras & Associates (Athens)
I. Introduction On 30 June 2009, the Athens Administrative Court of Appeal (Dioikitiko Efeteio Athinon, hereafter: the Court) delivered Decision No 2019/2009 annulling partially Decision No 318/V/2006 of the Hellenic Competition Commission (Elliniki Epitropi Antagonismou, hereafter: HCC) to (...)

The Cypriot Competition Authority holds two pharmaceutical companies as having abused their dominant position in the vaccines market through quantitative reductions and the free distribution of vaccines (Panayotou / Wyeth Hellas / Phadisco)
Antoniou McCollum & Co. (Nicosia)
The Cyprus Commission for the Protection of Competition (“CPC”) found the Wyeth Hellas A.E.B.E. Pharmaceutical Products (Cyprus branch) (“Wyeth”) and Phadisco Ltd (“Phadisco”) to have abused its dominant position in the market of pneumonococcus vaccines, in violation of article 6(1)(d) of the (...)

The Belgian Competition Authority confirms refusal by the Competition Auditor to adopt interim measures following alleged abuse of dominance by 10 pharmaceutical companies concerning pharmaceuticals parallel imports (Bofar)
Sheppard, Mullin, Richter & Hampton (Brussels)
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Adyen (Amsterdam)
,
European Court of Justice (Luxembourg)
Introduction On 2 April 2009, the President of the Belgian Competition Council rejected the appeal by Bofar NV ("Bofar") against the decision of the Competition Auditor, which rejected Bofar’s request for interim measures following an alleged abuse of dominance by 10 pharmaceutical companies. (...)

The French Supreme Court upholds dismissal of the Competition Authority’s decision sanctioning predatory pricing in the market for sodic cefuroxime (GlaxoSmithKline)
Juliette Goyer Avocat (Paris)
,
Belgium Competition Authority (Brussels)
On 17 March 2009, the French Supreme Court confirmed a case dated 8 April 2008 in which the Paris Court of Appeal overruled a decision by the French NCA (the “NCA”) sanctioning GlaxoSmithLine (“GSK”) for predatory pricing in the market for sodic cefuroxime. Background This case does not reflect (...)

The Korean FTC plans to strengthen enforcement against abuse of intellectual property rights by IT and pharmaceutical companies
Jones Day (Beijing)
,
Winston & Strawn (New York)
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Jones Day (Tokyo)
On December 18, 2008, the primary competition law agency of Korea, the Korea Fair Trade Commission (« KFTC »), submitted to the President of Korea the KFTC’s business plan for 2009. Among other priorities, the KFTC stated that it plans to « strengthen enforcement against abuse of intellectual (...)

The Turkish Competition Authority re-evaluates a complaint of abuse of dominant position in the pharmaceutical sector upon the annulment of the State Council’s decision (Roche)
Erdem & Erdem (Istanbul)
The Turkish Competition Board (hereinafter referred to as “CB”) had re-evaluated the allegations about the abuse of dominant position by Roche Mustahzarları A.S. (hereinafter referred to as “Roche”), upon the annulment decision of the 13th Chamber of the State Council numbered 31.03.2008 and (...)

The EU Court of Justice issues judgment on restrictions of parallel trade in the pharmaceutical sector (Lélos kai Sia)
Van Bael & Bellis (Brussels)
,
Practising Law Institute (New York)
On 16 September 2008, the European Court of Justice (“ECJ”) handed down its judgment in Joined Cases C-468-478/06, answering the questions posed by the Athens Court of Appeals in proceedings against a decision finding that Glaxo Smith Kline (“GSK”) had not abused its dominant position by limiting (...)

The Swiss Competition Authority closes an investigation on the publication of information on drugs following commitment (Documed)
International Committee of the Red Cross (Geneva)
The Swiss Competition Commission (the “Comco”) closed in July 2008 an investigation on the publication of information on drugs through an amicable agreement with the company Documed SA (“Documed”). Documed, a company of the pharmaceutical group Galenica, collects and edits information on drugs, (...)

The EU Court of Justice Advocate General Colomer gives his opinion on abuse of dominant position in the pharmaceutical sector (Lélos kai Sia)
Van Bael & Bellis (Brussels)
,
Practising Law Institute (New York)
On 1 April 2008, Advocate General Colomer gave his opinion in Joined Cases C-468/06 to C-478/06 Sot. Lélos Kai Sia EE (and Others) v GlaxoSmithKline AEVE.The case relates to a long series of disputes in Greece where GlaxoSmithKline has been accused of abusing its dominant position by reducing (...)

The Belgian Prosecutor refuses a request for preliminary measures in a pharmaceutical “refusal to supply” case (Bofar)
Altius (Brussels)
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Johnson & Johnson (Brussels)
Decision On 26 March 2008, the Belgian Prosecutor refused a request for preliminary measures made by Bofar NV (‘Bofar’). In December 2007, Bofar had filed a complaint against nine pharmaceutical companies for infringing Articles 81 and 82 EC Treaty and their Belgian equivalents, Articles 2 and 3 (...)

The Paris Court of Appeal confirms interim measures imposed by the Competition Authority in an abuse of dominance case in the generic pharmaceutical sector (Arrow / Schering-Plough)
Van Bael & Bellis (Brussels)
On 5 February 2008, the Paris Court of Appeal rejected Schering-Plough’s appeal against the French Competition Council’s interim decision of 11 December 2007. In that decision, the Competition Council had ordered Schering-Plough to publish a text in two medical magazines confirming the (...)

The German Competition Authority imposes fine on association of pharmaceutical companies for participating in price fixing among pharmacists (OTC pharmaceuticals)
Eberhard Karls University of Tübingen
I. The facts of the case The decision of the Federal Cartel Office (FCO) deals with the pharmaceutical sector in Germany. In 2004 the German market for non-prescription pharmaceuticals was further liberalized. According to the new pharmaceutical law the prices for non-prescription (...)

The French Competition Authority accepts some commitments to address competition concerns on the sector of distribution of medicines (GlaxoSmithKline) (Pfizer)
French Competition Authority (Paris)
Press Release published on the official website of the French Competition Authority. Distribution of medicines: GlaxoSmithKline and Pfizer commit themselves in front of the Conseil on the operating of their medicine quota system for wholesale distributors.* History of the case Following (...)

The French Competition Authority issues a landmark interim decision on competition between princeps and generics (Arrow / Schering-Plough)
Fréget (Paris)
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Novartis (Basel)
By a decision of 11 December 2007, the Competition Council issued yet another decision concerning the (difficult) competition between princeps and generics at the time when the latter enter a market which becomes accessible upon expiry of the former’s intellectual property rights. Although this (...)

The French Competition Authority orders interim measures particularly to address denigration practices implemented in the pharmaceutical sector (Arrow / Schering-Plough)
French Competition Authority (Paris)
The Conseil de la concurrence orders Schering Plough laboratory to remind doctors and pharmacists the exact bioequivalence of its brand name drug Subutex® with competing generic drugs* Following a complaint by Arrow Génériques company for practices implemented by Schering Plough laboratory, at (...)

The French Competition Authority fines predatory pricing aimed at preventing entry of generic drugs in hospitals on the basis of both EC and national competition provisions (GlaxoSmithKline France)
Sofina (Brussels)
In the decision n° 07-D-09 dated March, 14 2007, the French Competition Council imposed a 10 million € fine on GlaxoSmithKline laboratory for practices aiming at preventing generic drugs from entering the hospital medicines market by conducting a predatory policy. That was considered by the (...)

The Paris Court of Appeal rejects the complaint of a French wholesaler-exporter of pharmaceutical products and allows quotas and refusals to sell (Pharma-Lab)
Total (London)
On 23 January 2007, the Paris Court of Appeal (hereinafter the “Court”) issued a judgment in which it dismissed an appeal filed against a decision rendered by the French Competition Council (the “Council”) pursuant to Articles 81 and 82 EC and national provisions similar to those articles. In this (...)

The Brussels Court of Appeal gives its opinion on the relationship between merger control and the Belgian equivalents of Art. 101 and 102 TFEU in what may be its last preliminary ruling (Rocco)
Altius (Brussels)
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Altius (Brussels)
On 15 December 2006, the Brussels Court of Appeal ruled on the relationship between the merger control rules and the general rules on restrictive practices. The court’s judgment followed a request for a preliminary ruling to the Court from the Commercial Court of Namur. Background The (...)

The Hellenic Competition Authority rules that the decision of a dominant pharmaceutical firm to stop supplying the wholesalers and distribute the pharmaceuticals itself breaches the Competition Act but not Art. 82 EC despite the effect on trade between Member States (GlaxoSmithKline / Syfait)
Stavros Niarchos Foundation Cultural Center (SNFCC) (Kallithea)
THE FACTS The dispute between GlaxoSmithKline (hereinafter “GSK”) and the Greek pharmaceutical wholesalers has its routes in 2000, when associations of the latter (amongst them “Sineterismos Farmakopion Etolias & Akarnanias”, “SYFAIT”) submitted numerous complaints to the Hellenic Competition (...)

The Italian Competition Authority obliges a pharmaceutical company to grant a drug production license (Glaxo - Principi attivi)
Freshfields Bruckhaus Deringer (Rome)
On 8 February 2006, the Italian Antitrust Authority (IAA) closed a one-year long Article 82 investigation in relation to Glaxo refusal to grant a production license to FIS (Fabbrica Italiana Sintetici), for manufacturing in Italy an active compound essential for the production of triptans (...)

The French Competition Authority hands down a non-suit decision regarding alleged abuse of dominant position in the parallel trade of medicines (Pharma-Lab / GlaxoSmithKline)
French Competition Authority (Paris)
Parallel trade in medicines: Pharmaceutical laboratories do not abuse their dominant position when they restrict or refuse deliveries of medicines to exporters, who seek to purchase products in France at an administered price,in order to then sell them on in another country at a higher price.* (...)

The Austrian Supreme Court accepts a dominant undertaking’s refusal to deal as objectively justified (Penicillin G Sodium)
Salzburg University
On 20 December, 2005, the Austrian Supreme Court ruled that a dominant undertaking`s refusal to supply a potential customer is objectively justified by lack of trust. This was due to the potential customer`s negotiation behaviour. Background Since 1999, Defendant has been the sole producer of (...)

The UK Competition Appeal Tribunal issues a key judgement on margin squeeze and rebates in the pharmaceuticals sector (Healthcare at Home / Genzyme)
Freshfields Bruckhaus Deringer (London)
,
King’s College (London)
In Genzyme Limited v. OFT, 29 September 2005, the UK Competition Appeal Tribunal (the “CAT”) tackled the difficult question of how to bring an abusive margin squeeze to an end and to ensure it was not repeated. The background to the proceedings was that the OFT had issued a decision (Director (...)

The Italian Competition Authority launches an investigation in the pharmaceutical sector for generics under Art. 82 EC (Merck-Principi attivi / Imipenem Cilastatina)
Studio Legale DDPV (Rome)
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Studio Legale Merusi Toscano (Rome)
The “Autorità Garante della Concurrenza e del Mercato” - the Italian national competition authority (the “Authority”) - recently started an investigation in the pharmaceutical sector under article 82 of the EC Treaty. The issue is to determine whether Merck is in a dominant position in the market (...)

The EU Commission imposes a €60 million fine against two companies in the pharmaceutical sector for abuse of dominant position (AstraZeneca)
Danish Competition and Consumer Authority (Copenhagen)
,
DG COMP (Brussels)
ASTRAZENECA: THE FIRST ABUSE CASE IN THE PHARMACEUTICAL SECTOR* 1. Introduction On 15 June 2005 the Commission adopted a decision (‘Decision’) fining the Swedish company AstraZeneca AB and the UK company Astra-Zeneca Plc (together ‘AZ‘) 60 million euros due to their infringements of Article 82 of (...)

The Italian Competition Authority adopts an interim measure ordering that a firm, dominant in the market for the production of a certain antibiotic, must grant a license for the production of a key ingredient of the antibiotic (Merck / Carbapenem)
Shearman & Sterling (Rome)
Merck manufactures, and holds the patent of, a key active ingredient necessary for the production of an antibiotic (carbapenem) used in the treatment of particular types of infection. Merck’s patent rights have expired in most European countries and outside the EU (except the US) but, due to the (...)

The Italian Competition Authority imposes for the first time interim measures on the basis of Art. 82 EC (Merck / Carbapenem)
Freshfields Bruckhaus Deringer (Rome)
,
Freshfields Bruckhaus Deringer (Rome)
The Italian competition authority (“Authority”) recently issued an interim decision against Merck & Co Inc (“Merck”) obliging it to license the manufacture of antibiotic Imipenem Cilastatina, the active ingredient in the manufacture of Carbapenemens. This decision is very interesting from an (...)

The French Competition Authority sanctions a laboratory for having abused its dominant position in the market for certain medicinal products intended for hospitals (Sandoz laboratories)
French Competition Authority (Paris)
Laboratoires SANDOZ sanctioned for abusing their monopoly in the cyclosporin market.* In a decision dated 24th July, 2003, the Conseil de la concurrence imposed sanctions on laboratoires SANDOZ (which has now become NOVARTIS Pharma SA) for abuse of a dominant position, and fined them a sum of (...)

The UK Competition Authority imposes a £6.8 million fine for abusive bundling and margin squeeze (Healthcare at Home / Genzyme)
RBB Economics (London)
In March 2003 the OFT decided that Genzyme had infringed the UK Competition Act’s Chapter II prohibition (the UK analogue of EC Article 82) by bundling its product with associated home care services, and by imposing a margin squeeze on competing firms . Based on the case law and the OFT’s (...)

The Greek Court of First Instance of Athens rejects the claim that a pharmaceutical company abused its dominant position by limiting the supply of certain drugs to the distributors in Greece in order to avoid parallel exports of its products (GlaxoSmithKline)
Stavros Niarchos Foundation Cultural Center (SNFCC) (Kallithea)
,
University of Reading
The facts In 2001 a distributor of pharmaceutical products lodged a complain to the Court of First Instance of Athens against its supplier claiming that the latter’s decision to stop supplying it with drugs (as it had been doing for 20 years) and to establish a new distribution network in the (...)

The French Competition Authority fines a laboratory for preventing the entry of generics in the market for anaesthetic drugs (Abbott France)
French Competition Authority (Paris)
ABBOTT FRANCE ABUSED THE DOMINANT POSITION IT HELD IN THE MARKET FOR ISOFLURANE* In a decision dated 10th May 2001, following a referral by the Delegate Minister of Finance and External Trade, the Conseil de la concurrence ruled that the laboratory Abbott France had abused the dominant (...)

The EU Commission acknowledges commitments offered by a Danish pharmaceutical company in a case of abuse of dominant position in the market for insulin (Novo Nordisk)
DG COMP (Brussels)
,
DG COMP (Brussels)
NOVO NORDISK* Undertakings have been accepted from Novo Nordisk, the Danish pharmaceutical company, which are designed to ensure competition in the markets for components of Novo Nordisk‘s insulin self-injection delivery systems. Novo Nordisk is Europe’s leading insulin producer. In 1985 Novo (...)

Procedures

The US Court of Appeals for the Eighth Circuit rejects FTC’s market definition (Lundbeck)
Cohen Milstein (Washington)
,
Cohen Milstein (New York)
In this case, the Eighth Circuit affirmed a trial court’s rejection of a case brought by the Federal Trade Commission based on rejection of the FTC’s proposed market definition, even in the face of clear evidence that the challenged conduct had in fact led directly to vastly increased prices, and (...)

The UK Competition Appeal Tribunal grants interim relief in ’follow on’ damages claim (Healthcare at Home / Genzyme)
King’s College (London)
The Competition Appeal Tribunal’s (the “CAT”) judgment in Healthcare at Home Ltd v Genzyme Limited, 15 November 2006, concerned a claim for “interim payment” in proceedings brought by Healthcare at Home (the “claimant”) against Genzyme Limited (“Genzyme”). Under section 47A of the UK Competition Act (...)

The UK Competition Appeal Tribunal awards interim damages in an abuse of dominant position case on the drugs market (Healthcare at Home / Genzyme)
Sanoma (Helsinki)
Introduction On 15 November 2006, the UK Competition Appeal Tribunal (CAT) awarded an interim payment of £ 2 millions to Healthcare at Home Limited (HH) in respect of its damages claim against Genzyme Limited (Genzyme) for infringement of the Chapter II prohibition (abuse of a dominant (...)

Regulatory

The Russian Competition Authority considers that pharmaceutical companies should work in Russia by European rules
Russian Federal Antimonopoly Service (Moscow)
Pharmaceutical companies should work in Russia by European rules* On 25 May 2015, FAS Expert Council on developing competition in the social sphere and health care discussed a draft Code of Conduct of pharmaceutical producers, devised by the Working Group under the auspices of the Health and (...)

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