Pharma & Anticompetitive practices

Anticompetitive practices

Anticompetitive practices in the pharmaceutical sector: An overview of EU and national case law
University of Tilburg
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Van Bael & Bellis (Brussels)
For those following the headlines in the pharmaceutical sector, you will be well aware that the competition authorities in Europe are aggressively prosecuting companies for practices that restrict entry by generic suppliers. Headline cases in the last year include the European Commission’s (...)

The EU Commission opens formal investigation into a pharmaceutical company pricing practices (Aspen Pharma)
European Commission - 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 UK Competition Authority alleges two pharmaceutical companies have concluded a pay-for-delay agreement (Actavis / Concordia)
UK Competition and Markets 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 EU Commission clears a merger, subject to remedies, in the pharmaceutical sector (Alere / Abbott Laboratories)
European Commission - DG COMP (Brussels)
Mergers: Commission approves acquisition of Alere by Abbott Laboratories, subject to conditions* The European Commission has approved under the EU Merger Regulation the acquisition of Alere by Abbott, both suppliers of clinical test systems. The decision is conditional on the divestment of (...)

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

The EU Commission clears a merger, subject to remedies, in the pharmaceutical sector (St Jude Medical / Abbott Laboratories)
European Commission - DG COMP (Brussels)
Mergers: Commission approves acquisition of St Jude Medical by Abbott Laboratories, subject to conditions* The European Commission has approved under the EU Merger Regulation the proposed acquisition of St Jude Medical by Abbott Laboratories, both US based companies that develop and market (...)

The EU Commission clears a merger subject to remedies on the animal health market (Sanofi / Boehringer)
European Commission - DG COMP (Brussels)
Mergers: Commission approves acquisition of Sanofi’s animal health business Merial by Boehringer Ingelheim, subject to conditions* The European Commission has approved under the EU Merger Regulation the acquisition of the animal health business of Sanofi (Merial) of France by Boehringer (...)

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

The EU Commission clears a merger, subject to remedies, in the pharmaceutical sector (Boehringer Ingelheim /Sanofi)
European Commission - DG COMP (Brussels)
Mergers: Commission clears acquisition of Boehringer Ingelheim’s consumer health business by Sanofi, subject to conditions* The European Commission has approved under the EU Merger Regulation the proposed acquisition of the consumer health business of Germany’s Boehringer Ingelheim by Sanofi of (...)

The EU Commission clears a merger, subject to remedies, in the pharmaceutical sector (Meda / Mylan)
European Commission - DG COMP (Brussels)
Mergers: Commission clears acquisition of Meda by Mylan subject to conditions* The European Commission has approved under the EU Merger Regulation the proposed acquisition of Meda AB of Sweden by Mylan N.V. of the Netherlands, subject to conditions. Both companies operate in the pharmaceutical (...)

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

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

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

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

The EU Commission clears a merger, subject to remedies, in the pharmaceutical market (Allergan Generics / Teva)
European Commission - DG COMP (Brussels)
Mergers: Commission approves acquisition of Allergan Generics by Teva, subject to conditions* The European Commission has approved under the EU Merger Regulation the proposed acquisition of the generics business of Allergan of Ireland, by Teva of Israel, subject to conditions. Both companies (...)

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

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

The Chinese National Development and Reform Commission and the Chongqing AIC take separate actions to punish cartel conduct and refusal to supply in the pharmaceutical industry (Allopurinol)
China Competition Bulletin (Beijing)
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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 of its dominance by stopping to supply insulin (Novo Nordisk)
Russian Federal Antimonopoly Service
Cassation Court confirmed: “Novo Nordisk” violated the antimonopoly law* On 21 October 2015, the Arbitration Court of the Moscow District upheld the ruling of the 9th Arbitration Appeal Court of 29 June 2015 and dismissed a cassation appeal of “Novo Nordisk” against the decision of the Federal (...)

The Romanian Competition Authority clears a merger in the pharmacies sector (Centrofarm / Help Net Farma)
Romanian Competition Council (Bucharest)
The Competition Council has authorized the takeover of 19 pharmacies Centrofarm by Help Net* The Competition Council has authorized the take over of 19 pharmacies Centrofarm by Help Net Farma SA. By this transaction, Help Net take over the 19 pharmacies Centrofarm from 10 localities: (...)

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

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

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

The UK Competition Authority imposes remedies to clear an acquisition in the market of personal lubricants (Reckitt Benckiser / Johnson & Johnson)
UK Competition and Markets Authority (CMA) (London)
CMA orders remedy to meet concern over lubricants merger* The CMA has found that Reckitt Benckiser’s anticipated acquisition of the K-Y brand could lead to higher prices for personal lubricants. In its final report published today, the Competition and Markets Authority (CMA) has concluded the (...)

The UK Competition Authority issues statement of objections to a pharmaceutical company and its distributor suspected of abuse of dominance dominance in the market of phenytoin sodium capsules (Pfizer / Flynn)
UK Competition and Markets 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 an 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 Arbitration Appeal Court of Moscow confirms the fine imposed on a pharmaceutical company for abuse of dominance (Novo Nordisk)
Russian Federal Antimonopoly Service
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 Arbitration Court of Moscow confirms the decision of the Russian Competition Authority having concluded that a pharmaceutical company has abused of its dominance (Baxter)
Russian Federal Antimonopoly Service
Cassation Court: FAS decision and determination regarding “Baxter” are legitimate* On 16 June 2015, the Arbitration Court of the Moscow District (Cassation Court) confirmed legitimacy of the decision and determination of the Federal Antimonopoly Service (FAS Russia) as well as the Order to hold (...)

The European Commission clears a merger, subject to remedies, in the pharmaceutical sector (Sigma-Aldrich / Merck)
European Commission - DG COMP (Brussels)
Commission approves acquisition of Sigma-Aldrich by Merck, subject to conditions.* The European Commission has approved the proposed acquisition of Sigma-Aldrich by Merck under the EU Merger Regulation. Both companies are active world-wide in the life science sector. The decision is (...)

The Arbitration Appeal Court of Moscow confirms the fine imposed on a pharmaceutical company for abuse of dominance (Teva)
Russian Federal Antimonopoly Service
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 Canadian Competition Bureau issues draft IP enforcement guidelines that will have practical implications for the pharmaceutical industry
Davies Ward Phillips & Vineberg (Toronto)
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Davies Ward Phillips & Vineberg (Toronto)
Canada’s Updated Draft Intellectual Property Enforcement Guidelines and the Pharmaceutical Industry* I. INTRODUCTION In June 2015, Canada’s Competition Bureau released its updated draft of the Intellectual Property Enforcement Guidelines (“Draft IPEGs”) for public review and consultation. The (...)

The FTC challenges a merger in regional markets for sterilization of products using radiation based on future competition concerns (Steris / Synergy Health)
Doyle, Barlow & Mazard
FTC Challenges Deal Based on Future Competition Concerns* On May 29, 2015, the Federal Trade Commission (“FTC”) issued an administrative complaint alleging that Steris Corporation’s (“Steris”) proposed $1.9 billion acquisition of Synergy Health plc (“Synergy”) would violate the antitrust laws by (...)

The Russian Competition Authority considers that pharmaceutical companies should work in Russia by European rules
Russian Federal Antimonopoly Service
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 (...)

The UK Competition and Markets Authority provisionally judges that an anticipated merger between pharmaceuticals enterprises could lead to higher prices in the personal lubricants market (Reckitt Benckiser / Johnson & Johnson)
UK Competition and Markets Authority (CMA) (London)
CMA sets out provisional concerns over lubricants merger* The CMA has provisionally found that Reckitt Benckiser’s anticipated acquisition of the K-Y brand could lead to higher prices for personal lubricants. Reckitt Benckiser (RB) and Johnson & Johnson (J&J) supply personal lubricants (...)

The Croatian Competition Authority issues an opinion concerning the exclusionary effect of a new prescription drugs reimbursement model
Croatian Competition Agency
Exclusionary effect of the new prescription drugs model* Based on the complaint made by the Croatian Employers’ Association – Pharmaceutical Manufacturers Association, Innovative Medicines Initiative and Generic Drugs Manufacturers Association, the Croatian Competition Agency (CCA) carried out a (...)

The Chinese NDRC targets price-related illegal conducts in the pharmaceutical sector
King & Wood Mallesons (New York)
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King & Wood Mallesons (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 FTC seeks to secure first disgorgement in nearly a decade (Cardinal Health)
Womble Carlyle Sandridge & Rice (Charlotte)
FTC Seeks to Secure First Disgorgement in Nearly a Decade* The FTC announced yesterday that Cardinal Health, Inc. (“Cardinal”) has agreed to pay $26.8 million to resolve its investigation into the company’s alleged anticompetitive behavior. If approved by a federal court, the settlement would (...)

A US district court dismisses claims of conspiracy to protect a monopoly by "product hopping", citing risk to slow or halt pharmaceutical innovation (Mylan / Warner Chilcott)
BakerHostetler (Philadelphia)
Product Hopping and Antitrust: Mylan Court Dismisses Claims on Summary Judgment, Citing Need to Avoid Chilling Pharmaceutical Innovation* A recent summary judgment opinion from the Eastern District of Pennsylvania breaks new ground in the developing antitrust law on “product hopping” claims. (...)

The Moscow Arbitration Court confirms the fine imposed on a pharmaceutical laboratory for abuse of dominance (Teva)
Russian Federal Antimonopoly Service
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 EU Commission conditionally clears a merger following an in-depth investigation (Zimmer / Biomet)
European Commission - DG COMP (Brussels)
Introduction On 30 March 2015, the European Commission conditionally cleared Zimmer’s acquisition of Biomet, following an in-depth investigation. Zimmer and Biomet are two of the five leading competitors in the medical implants industry. The transaction was initially notified on 3 June 2014, (...)

The Competition Commission of Singapore takes a provisional decision to block a proposed acquisition in the radiology and imaging services sector (RadLink-Asia / Fortis Singapore)
Allen & Gledhill
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Allen & Gledhill (Singapore)
On 16 March 2015, the Competition Commission of Singapore (“CCS”) announced that it had taken a provisional decision to block the proposed acquisition of RadLink-Asia Pte Limited (“RadLink”), a wholly owned subsidiary of Fortis Healthcare Singapore Pte. Limited (“Fortis Singapore”) by Medi-Rad (...)

The Pakistan Competition Commission clears a merger, subject to remedies, in the pharmaceutical sector (Novartis / GlaxoSmithKline)
Competition Commission of Pakistan
CCP approves acquisition of global vaccine business (excluding influenza business except in China) by GSK from Novartis* The Competition Commission of Pakistan (CCP) has approved acquisition of the global vaccines business (excluding influenza business except in China) of Novartis AG by (...)

The Netherlands Authority for Consumers and Markets provides insight into the application of competition law to the pricing and marketing strategies of originator companies
Simmons & Simmons (Brussels)
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Simmons & Simmons (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 Arbitration Appeal Court of Moscow confirms that a pharmaceutical company has abused of its dominance (Baxter)
Russian Federal Antimonopoly Service
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 Pakistan Competition Commission clears an acquisition, following an in-depth investigation, in the pharmaceutical sector (Novartis / GlaxoSmithKline)
Competition Commission of Pakistan
The Competition Commission clears phase II review of the proposed acquisition by novartis ag of the business relating to a portfolio of oncology products (excluding manufacturing) from GlaxoSmithKline plc* ISLAMABAD, MONDAY, 09 FEBRUARY 2015: The Competition Commission of Pakistan (...)

The EU Commission conditionally approves deals in the pharmaceutical sector extending its analysis of pipeline pharmaceutical products (GSK / Novartis)
European Commission - DG COMP (Brussels)
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European Commission - DG COMP (Brussels)
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European Commission - DG COMP (Brussels)
"Protecting the drugs of tomorrow : competition and innovation in healthcare"* In a nutshell : In Novartis/GSK Oncology, the Commission extended its analysis of pipeline pharmaceutical products beyond those that are in advanced stages of development (phase III), to fully assess 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 medicament 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 Russian Competition Authority sends a warning to a pharmaceutical company suspected to abuse of its dominance (Roche)
Russian Federal Antimonopoly Service
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 Bulgarian Competition Authority rules on parallel trade of pharmaceuticals products and its 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 fines a pharmaceutical company for refusal to supply insulin (Novo Nordisk)
Russian Federal Antimonopoly Service
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 Competition Commission of India directs for the first time a divestiture of assets in a merger case (Sun-Ranbaxy)
Economic Laws Practice
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Economic Laws Practice
Introduction The Competition Commission of India (“CCI”) for the first time has directed divestitures of assets, before granting its final approval, in a combination relating to merger of Ranbaxy Laboratories Limited (“Ranbaxy”) into Sun Pharmaceutical Industries Limited (“Sun Pharma”) (referred (...)

A US District Court allows “product hopping” claims to proceed based on allegations of removal of prior formulation and disparagement of generic competition (Suboxone)
Patterson Belknap Webb & Tyler
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Patterson Belknap Webb & Tyler
Court Allows “Product Hopping” Claims to Proceed in Suboxone Litigation Based on Allegations of Removal of Prior Formulation and Disparagement of Generic Competition* We’ve previously discussed antitrust claims related to “product hopping”—allegations that pharmaceutical manufacturers have (...)

The Competition Commission of Pakistan opens an in-depth investigation on a merger in the pharmaceutical sector regarding the market of meningococcal vaccines (Novartis / GlaxoSmithKline)
Competition Commission of Pakistan
CCP opens second phase review on the proposed acquisition of vaccines business (excluding influenza vaccines business except in china) of Novartis ag by Glaxosmithkline plc.* Islamabad, Thursday, 13 November 2014: The Competition Commission of Pakistan (CCP) in concluding the first phase (...)

The Russian Competition Authority fines a pharmaceutical laboratory having not executed a warning (Teva)
Russian Federal Antimonopoly Service
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 Moscow Arbitration Court confirms the warning addressed to a pharmaceutical company having refused to supply the unique medicine for treating renal deficiency by peritoneal dialysis (Baxter)
Russian Federal Antimonopoly Service
Actions of “Baxter” CJSC are pronounced unlawful* On 25th September 2014, Moscow Arbitration Court confirmed legitimacy of the decision and determination of the Federal Antimonopoly Service (FAS Russia) in the case against “Baxter” CJSC for violating the antimonopoly law. The company refused to (...)

The Russian Competition Authority concludes that a pharmaceutical company has abused of its dominance by refusing to supply medicines without any economic or technological reasons (Novo)
Russian Federal Antimonopoly Service
“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 Brazilian Administrative Council for Economic Defense renders two legal opinions in investigations related to sham litigation practices (Eli Lilly do Brasil)
Tauil & Chequer (in cooperation with Mayer Brown)
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Tauil & Chequer (in cooperation with Mayer Brown)
On August 20, 2014, the General Superintendence of the Administrative Council for Economic Defense (“CADE”) rendered two legal opinions in investigations related to sham litigation practices recommending to CADE’s Tribunal: (i) the conviction of the companies Eli Lilly do Brasil Ltda. and Eli (...)

The UK Competition and Markets Authority refuses to apply the failing firm defence to clear a merger in phase II (Alliance / IBA)
St John’s Chambers
United Kingdom Merger Control: Recent Developments in the Failing Firm Defence* On 15 August 2014, the Competition and Markets Authority (“CMA”) approved Alliance Medical Group’s completed acquisition of IBA Molecular’s radioactive medical tracer business. Although IBA’s business was loss-making, (...)

The UK Competition and Markets Authority clears an acquisition on the adherence packaging market (Omnicell / SurgiChem)
UK Competition and Markets Authority (CMA) (London)
The Competition and Markets Authority (CMA) has cleared Omnicell/MTS’s proposed acquisition of SurgiChem.* This confirms the CMA’s provisional decision which was published last month and has been made by a group of independent CMA panel members. Omnicell, Inc./MTS Medication Technologies, Inc. (...)

The U.S. Court of Appeals for the Federal Circuit renders a split decision regarding sham patent litigation (Tyco Healthcare / Mutual Pharmaceutical)
Jones Day (Washington)
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Jones Day (Cleveland)
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Jones Day (Washington)
The U.S. Court of Appeals for the Federal Circuit has remanded for further consideration antitrust claims accusing a patent holder of filing a sham infringement suit and a sham citizen petition with the Federal Drug Administration. The case is Tyco Healthcare Group LP v. Mutual Pharmaceutical (...)

A US Court of Appeals 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 said 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 (...)

A US District Court allows a bundling claim to proceed under Sherman Act Section 1, even after dismissing other claims for lack of market or monopoly power (Schuylkill Health Systems / Cardinal Health)
University of Michigan
Can Bundled Discounts Be Illegal If Offered by a Firm Without Market Power?* Bundled discounts are common marketing schemes that normally benefit consumers and competition; however, courts and commentators have found certain circumstances when they might be illegal monopolization. The line (...)

The UK’s Business secretary proposes new safeguards to counteract the threat of foreign takeovers to the national interest (Pfizer/AstraZeneca)
UEA law school - Centre for Competition Policy
Pfizer/AstraZeneca and the Public Interest: Do Vince Cable’s Foreign Takeover Proposals Prescribe the Right Medication?* When US pharmaceutical giant Pfizer sought to acquire its UK-listed counterpart AstraZeneca earlier this year, discussion centred around the supposed adverse impact that the (...)

The New Zealand Commerce Commission publishes statement of preliminary issues following merger notification on the market for pharmacy wholesaling
New Zealand Commerce Commission
Press releases published on New Zealand Commerce Commission Statement of preliminary issues published for CDC Pharmaceutical and Pharmacy Wholesalers merger* CDC Pharmaceuticals and Pharmacy Wholesalers (Central) seek clearance to merge The Commerce Commission has received a joint (...)

The EU Commission fines pharmaceutical companies in pay-to-delay case (Servier)
Stanford University - Stanford Law School
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)
Press Release published on the official website of the French Competition Authority. 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 (...)

The Moscow Arbitration Appeal Court confirms the legitimacy of a warning delivered by the Russian Competition Authority to a pharmaceutical company having abused of its dominance (Novo Nordisk)
Russian Federal Antimonopoly Service
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
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 US District Court for the Northern District of Georgia refuses to grant renewed motion to dismiss based on Noerr-Pennington doctrine, since such a conclusion would have contradicted the decision of the Supreme Court finding that a reverse payment settlement agreement should be subject to antitrust scrutinity (Actavis)
Sheppard Mullin (Los Angeles)
FTC v. Actavis on Remand: A New Chapter* District Court refuses to grant renewed motion to dismiss based on Noerr-Pennington doctrine. In re AndroGel Antitrust Litigation (No. II), MDL No. 2084 (re Federal Trade Commission v. Actavis, Inc., No. 1:09-CV-955-TWT) (N.D. GA April 21, 2014). In (...)

The Russian Competition Authority welcomes the refusal of a pharmaceutical company to challenge its warning (Baxter)
Russian Federal Antimonopoly Service
“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 IMS Health (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
“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 Polish Competition Authority issues conditional clearance for concentration in pharmaceutical sector (Neuca/ACP Pharma)
WKB Wierciński Kwieciński Baehr (Warsaw)
In the decision of 31 March 2014, the President of the Office for Competition and Consumer Protection (hereinafter referred to as the “OCCP President”) approved concentration consisting of Neuca taking control over ACP Pharma. However, Neuca must sell one of its wholesalers located in Bydgoszcz (...)

The Argentinian Commission for the Defense of Competition launches an investigation on the food, cleaning and clothing and related consumer goods in large superficies, raw material and other supplies for the industries, construction materials and related supplies for the construction industry, pharmaceuticals and health service markets
De Dios & Goyena
The National Commission for the Defense of Competition (CNDC), as the acting administrative agency in charge of competition matters in Argentina, has initiated certain market investigations during the last month of February . As we have reported in previous instances, the Argentine Government (...)

The Latvian Competition Council concludes a sector inquiry into the market for manufacturing of circulatory systems drugs
Competition Council of Latvia
The Competition Council concludes sector inquiry into the market of drugs of circulatory system* The Competition Council (CC) has concluded sector inquiry into the market of realization of circulatory systems’ drugs. Within it, the CC analysed the structure and trends of the market, evaluated (...)

The Moscow Arbitration Court upholds the warning delivered by the Russian Competition Authority against a pharmaceutical company aiming to eliminate disadvantageous contract conditions (Novo Nordisk)
Russian Federal Antimonopoly Service
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 Australian Competition and Consumer Commission institutes proceedings in the Federal Court against pharmaceutical producer for alleged misuse of market power and exclusive dealing in relation to its supply of atorvastatin to pharmacies (Pfizer)
Australian Competition and Consumer Commission
ACCC takes action against Pfizer Australia for alleged anti-competitive conduct* The Australian Competition and Consumer Commission has instituted proceedings in the Federal Court of Australia against Pfizer Australia Pty Ltd (Pfizer) for alleged misuse of market power and exclusive dealing in (...)

The Italian Council of State reinstates penalties against pharmaceutical company for filing application for a divisional patent and its related SPC concerning a class of molecules already covered by the main patent (Pfizer)
Stanford University - Stanford Law School
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 Russian Competition Authority delivering a warning against a pharmaceutical company refusing to deal with a medical service provider (Baxter)
Russian Federal Antimonopoly Service
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 (...)

A US District Court dismisses an antitrust class action against two pharma producers regarding an agreement to postpone the production of a generic epilepsy and bipolar disorder drug because no reverse payment with cash was involved to keep the rival off the market (GSK / Teva)
DLA Piper Weiss-Tessbach (Vienna)
U.S. District Court holds that Actavis requires monetary payments for antitrust scrutiny to be applicable* On January 24, 2014 U.S. District Judge William H. Walls dismissed an antitrust class action against GlaxoSmithKline LLC (“GSK”) and Teva Pharmaceutical Industries Ltd. (“Teva”) regarding (...)

The Chinese MOFCOM conditionally approves an acquisition in the biotechnology sector (Thermo Fisher / Life Technologies)
Fingleton Associates (London)
On Tuesday 14th January 2014 MOFCOM conditionally cleared the acquisition of Life Technologies Corporation (“Life Technologies”) by Thermo Fisher Scientific Inc. (“Thermo Fisher”). The review process took 6 months from initial notification, which is relatively quick for an intervention decision by (...)

The Australian Competition and Consumer Commission conditionally approves the proposed acquisition in life science sector (Life Technologies / Thermo Fisher Scientific)
Australian Competition and Consumer Commission
ACCC conditionally approves the proposed acquisition of Life Technologies by Thermo Fisher* The Australian Competition and Consumer Commission has announced that it will not oppose the proposed acquisition of Life Technologies Corporation by Thermo Fisher Scientific Inc after competition (...)

The French Competition Authority fines a pharmaceutical laboratory particularly for abuse of dominance by denigrating its competitors and for implementing anticompetitive agreements with its supplier (Arrow / Schering-Plough)
French Competition Authority (Paris)
Press Release published on the official website of the French Competition Authority. 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®* (...)

The French Competition Authority fines a pharmaceutical company €15.3 M for preventing market entry of a generic (Arrow / Schering-Plough)
Fidal (Lyon)
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 US FTC issues final changes to the premerger notification rules that require companies in the pharmaceutical industry to report certain proposed acquisitions of exclusive patent rights to the FTC and the DoJ for antitrust review
University of Michigan
Is the FTC Picking on the Pharmaceutical Industry Through New HSR Rules?* Effective December 16, 2013, Hart-Scott-Rodino (HSR) coverage of exclusive licenses of patents will change. As HSR practitioners know well, the Federal Trade Commission’s Premerger Notification Office (PNO) has (...)

The England and Wales Court of Appeal refuses interim injunction against alleged refusal to deal as claimant failed to identify any market on which the defendant could conceivably be dominant (Chemistree Homecare / Abbvie)
St John’s Chambers
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 Court of Appeal of England and Wales rules that the making of an order for further information against a French litigant is in the English Court’s discretion, and is not precluded by French Law No. 68-678 or the Council Regulation No 1206/2001 (Secretary of State for Health / Servier Laboratories)
Blackstone Chambers
Curtains for the French Blocking Statute?* Never the most celebrated actor on the stage of English litigation, the French Blocking Statute nonetheless has its fans, particularly among competition lawyers. The recent decision of the Court of Appeal in Secretary of State for Health v Servier (...)

The EU General Court rules that a contracting authority must provide explanations about its reasons not to consider the winning offer as being abnormally low (European Dynamics / EMA)
European Procurement Law Group
3 more instalments in the Evropaïki Dynamiki saga: one successful appeal (T-638/11)* Today (15 October 2013), the General Court has issued three judgments that add to the ’Evropaïki Dynamiki saga’. In two of them (T-474/10 and T-457/10), the famous challenger of EU Institutions’ procurement (...)

The Danish Competition Council conditionally approves acquisition on the market for veterinary drugs (Vilomix / Hatting-KS)
Danish Competition and Consumer Authority (Copenhagen)
Danish Competition Council approves Vilomix Holding A/S’ acquisition of A/S Hatting-KS conditional on commitments* On October 23th 2013 the Danish Competition Council (“DCC”) approved Vilomix Holding A/S’ (Vilomix) acquisition of A/S Hatting-KS (Hatting). The DCC decision is conditional on a (...)

The US Court of Appeals for the 3rd Circuit vacates class certification order on ascertainability grounds in consumer false advertising case (Carerra/Bayer)
Cohen Milstein (Washington)
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Cohen Milstein (New York)
Purchasers of a diet supplement brought a class action asserting that Bayer falsely claimed that the supplement enhanced metabolism by including a green tea extract. The district court certified a class of purchasers in Florida. The Third Circuit vacated the class certification order and (...)

The Bulgarian Competition Authority holds that national health insurance fund is not an undertaking for the purpose of competition law enforcement (NZOK)
University of Technology (Tallinn)
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 MOFCOM conditionally approves the EUR 3 billion acquisition of a medical technology company (Baxter & Gambro)
King & Wood Mallesons (New York)
MOFCOM Conditionally Cleared Baxter’s $4 Billion Acquisition of Gambro* On August 13, 2013, China’s Ministry of Commerce (MOFCOM) announced on its website that it has conditionally approved the $4 billion acquisition of Swedish medical technology company Gambro AB by Baxter International. (...)

The US Southern District of New York certifies a class for liability purposes only (Jacob/Duane Reade)
Cohen Milstein (Washington)
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Cohen Milstein (New York)
Pharmacy store managers brought suit against a retail chain pharmacy, asserting that the pharmacy failed to compensate them for overtime in violation of the Fair Labor Standards Act. The district court concluded that certification of the class for all purposes was inappropriate under Comcast. (...)

The US District Court for the Southern District of New York certifies class for liability purposes only in a lawsuit brought against retail chain pharmacy (Jacob/Duane Reade)
Cohen Milstein (Washington)
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Cohen Milstein (New York)
Pharmacy store managers brought suit against a retail chain pharmacy, asserting that the pharmacy failed to compensate them for overtime in violation of the Fair Labor Standards Act. The district court concluded that certification of the class for all purposes was inappropriate, under Comcast, (...)

The Chinese MOFCOM grants a clearance on the proposed acquisition of a Swedish equipment manufacturer by an American healthcare company (Baxter & Gambro)
AnJie Law (Beijing)
MOFCOM conditionally approves Baxter’s acquisition of Gambro* On 8 August 2013, China’s Ministry of Commerce ("MOFCOM") granted a clearance on the proposed acquisition of the Swedish dialysis equipment manufacturer Gambro AB ("Gambro") by its US rival healthcare company Baxter ("Baxter") in (...)

The US Central District of California denies class certification on California law claims and grants class certification on New York law claims (Guido/L’Oreal)
Cohen Milstein (Washington)
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Cohen Milstein (New York)
Purchasers of a hairstyling product (“Serum”) from L’Oreal brought a class action, asserting that the product was flammable, that its flammability was not adequately disclosed, and that class members would not have bought the product had they known that it was flammable. On that basis, they (...)

The US Supreme Court reverses the judgment of the 11th circuit and leaves the structuring of the rule of reason antitrust litigation to the lower courts (Actavis)
Cleveland-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 US District Court for the Eastern District of Tennesse denies motion to dismiss in antitrust case brought against drug makers (Skelaxin -Metaxalone- Antitrust Litigation)
Cohen Milstein (Washington)
,
Cohen Milstein (New York)
Plaintiff drug purchasers brought suit under federal and state antitrust laws, contending that the defendants had engaged in an unlawful scheme calculated to raise and maintain the prices of the drug Skelaxin through sham litigation, the filing of sham citizen petitions and unlawful horizontal (...)

The French Competition Authority fines a pharmaceutical company for having implemented a strategy of denigrating the generic versions of its branded drug (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 Romanian Competition Authority rejects a complaint regarding on refusal to supply in the pharmaceutical sector (Roche)
Nestor Nestor Diculescu Kingston Petersen (Bucharest)
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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 Romanian Competition Authority follows case law precedent and finds no abuse of dominance on the pharmaceuticals distribution market (Roche)
University of Technology (Tallinn)
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 Irish Competition Authority clears a merger between a pre-wholesaler and a wholesaler of pharmaceutical, healthcare and veterinary products (Uniphar & CMR)
Irish Competition Authority
Competition Authority clears proposed acquisition of CMR by Uniphar* The Competition Authority has cleared the proposed transaction whereby Uniphar plc would acquire Cahill May Roberts Limited. The transaction was notified by the parties under the Competition Act 2002 on 12 December 2012 and (...)

The UK OFT issues statement of objections to certain pharmaceutical companies alleging they acted to delay effective competition in the UK supply of a medicine (GSK / GUK / Alpharma / IVAX)
European Commission (Brussels)
United Kingdom: The OFT issues Statement of Objections in Case involving Pharmaceutical Companies* On 19 April 2013, the Office of Fair Trading (OFT) issued a Statement of Objections to certain pharmaceutical companies alleging they acted to delay effective competition in the UK supply of (...)

The Cypriot Commission for Protection of Competition imposes administrative fines for providing quantitative discounts according to the volumes of vaccines purchased by doctors and pharmacists (Wyeth Hellas & Phadisco)
Commission for the Protection of Competition of the Republic of Cyprus
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 Romanian Competition Council launches sector inquiries into pharmaceutical market and electronic communication services
European Commission (Brussels)
Romania: The Competition Council launches Sector Inquiries into Pharmaceutical Market and Electronic Communication Services* On 19 March 2013, the Romanian Competition Council (RCC) opened by an Order of its President a new sector inquiry to assess possible malfunctions of the pharmaceutical (...)

The French Competition Authority announces the launch of a pharma sector inquiry
JPTT & Partners
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White & Case (Paris)
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Novartis (Rueil-Malmaison)
On 26 February 2013, the French Competition Authority (“Autorité de la concurrence”) announced the launch of a pharma sector inquiry. The Autorité ’s main goal is to address the cost of prescription medicines for social security, the high prices of non-reimbursable medicines, and the low level of (...)

The English 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 (...)

A US Court of Appeals applies “consumer-or-competitor” rule to deny antitrust standing to foreign manufacturer of drug marketed in US by licensee (Ethypharm/Abbott)
Wolters Kluwer (Riverwoods)
Third Circuit Holds the Line on Antitrust Standing* In order to assert an antitrust injury, a plaintiff needs to be a consumer or a competitor in the restrained market, the U.S. Court of Appeals in Philadelphia ruled on January 23, 2013. If a company makes the choice not to compete, then it (...)

The Italian Council of State reinstates a € 5.1 M fine initially imposed on a pharmaceutical company by the NCA for its alleged abuse of dominant position in the market for the production and commercialisation of fosetyl-based fungicides (Bayer)
Van Bael & Bellis
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White & Case (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 NCA’s decision fining 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)
,
University Bocconi
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 (BCS)
University of Naples "Federico II"
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 Portuguese Competition Authority imposes record fine for gun-jumping (Farminveste)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
At the end of December 2012, the Portuguese Competition Authority fined the Portuguese National Pharmacy Association and two subsidiaries of Portuguese company Farminveste € 150,000 for implementing their acquisition of pharmaceutical company ParaRede-Glintt without obtaining prior merger (...)

The EU Court of Justice upholds the abuse of patents system and the procedures for marketing pharmaceutical products in order to prevent or delay the arrival of competing generic medicinal products on the market for proton pump inhibitors (AstraZeneca)
Stanford University - Stanford Law School
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 entirely dismisses pharmaceutical company’s appeal on abusive patent misuse (AstraZeneca)
Mircea & Partners (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 ECJ dismisses pharmaceutical company’s appeal against Commission and EU General Court’s findings that it abused its dominant position by misusing patent systems and pharmaceutical marketing procedures in order to exclude generic competitors from the market and to 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 German Competition Authority prohibits joint venture in chemicals trading sector (Chemie-Vertrieb)
European Commission (Brussels)
Germany: The Bundeskartellamt prohibits Joint Venture in Chemicals Trading Sector* On 21 November 2012, the Bundeskartellamt (BKartA) issued a prohibition decision concerning a joint venture of two chemicals trading companies. The joint venture in question, CVH Chemie-Vertrieb GmbH & Co (...)

The UK Supreme Court rules on the matter of time limits as regards follow-on claims arising from the vitamin cartel (BCL / BASF)
Blackstone Chambers
BCL No.2: The Supreme Court addresses time limits in follow-on claims* The White Paper which first proposed follow-on damages claims promised a “swift” and “streamlined” procedure. The idea was that when a regulator had made an infringement finding, there would be a simple way for victims to claim (...)

US Eastern District Court of New York approves class settlement in a price-fixing lawsuit brought against Vitamin C manufacturers (Vitamin C Antitrust Litigation)
Cohen Milstein (Washington)
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Cohen Milstein (New York)
In determining whether to finally approve a class settlement reached with one defendant, the court considered the objections of several members of the proposed indirect purchaser settlement class regarding class counsel’s decision to forego a monetary distribution to the class and instead make a (...)

The US Northern District of Georgia applies objective baselessness and subjective baselessness (Androgel Antitrust Litigation)
Cohen Milstein (Washington)
,
Cohen Milstein (New York)
Especially in pharmaceutical antitrust class actions, many efforts have been made in recent years to rest cases on Professional Real Estate Investors, Inc. v. Columbia Pictures Indus., Inc., 508 U.S. 49 (1993)("PRE"), which requires that for a claim of so-called "sham litigation" to remove (...)

The Italian Administrative Court of First Instance quashes the NCA’s decision against pharmaceutical company for misuse of patent (Pfizer)
Bonelli Erede Pappalardo (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 Finnish Competition Authority publishes an extensive report on the provision of pharmaceutical products
European Commission (Brussels)
Finland: Report on Provision of Pharmaceutical Products published* The Finnish Competition Authority (FCA) published on 28 August 2012 an extensive report on the provision of pharmaceutical products in Finland, in which several amendments to the current regulation on the Finnish pharmacy (...)

The US FTC proposes revisions to the premerger notification rules for pharmaceutical patent licensing transactions
Crowell & Moring (Washington)
The FTC’s Proposed Revisions to the Premerger Notification Rules for Pharmaceutical Patent Licensing Transactions* Recent developments On August 13, 2012, the Federal Trade Commission (“FTC”) released proposed amendments to the Hart-Scott-Rodino (“HSR”) premerger notification rules relating to the (...)

US antitrust agencies propose new Hart-Scott-Rodino merger control rules to require enhanced reporting of pharma, biological and diagnostic licenses
Thompson Hine (New York)
New FTC/DOJ position will require heightened regulatory reporting of pharma, biological and diagnostic licenses* The Federal Trade Commission and Department of Justice recently announced revisions to the Hart-Scott-Rodino (HSR) Act’s premerger notification rules to require enhanced reporting of (...)

The French Competition Authority issues opinion on draft decree regarding supply of medicinal products for human use
European Commission (Brussels)
France: The Autorité de la concurrence issues opinion on draft decree regarding supply of medicinal products for human use* On 20 July 2012, the Autorité de la concurrence (the Autorité) published an opinion upon request of the French Minister of Social Affairs and Health on a draft Decree (...)

Advocate General Mazak issues his opinion recommending dismissing 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 US Supreme Court issues a decision addressing the pharmaceutical “use codes” and their impact on generic drugs approval process (Caraco)
Gibson Dunn (New York)
New U.S. Supreme Court Decision Addresses Pharmaceutical “Use Codes”* The U.S. Supreme Court recently issued a decision that provides generic pharmaceutical manufacturers with the ability to challenge the “use codes” listed by brand name manufacturers in filings made with the U.S. Food and Drug (...)

The Cyprus Commission for the Protection of Competition imposes a fine to an unnotified concentration in the pharmaceutical sector (Papaellinas / Sophocles Demetriades)
Neocleous
Factual background The present case concerns the possible breaches of articles 9 and 13 of the Law on Control of Concentrations of Enterprises Laws of 1999 and 2000. The concentration in question was brought about following the conclusion of the Share Purchase Agreement dated 17.02.2010, (...)

The President of the Office of Competition and Consumer Protection clears a merger on the pharmaceutical market in Poland under sell-off conditions applicable to three medicaments (Polpharma/Polfa)
Markiewicz & Sroczynski
I. The Facts On 26 October 2011, Polpharma S.A. with its seat in Starogard Gdanski (“Popharma”), a leading Polish producer of pharmaceutical products and active ingredients, notified the President of the Office of Competition and Consumer Protection (“OCCP”) of its intention to acquire control over (...)

The Indian Patents Office grants its first compulsory licence in the pharmaceutical industry (Natco / Bayer)
Shardul Amarchand Mangaldas & Co (New Delhi)
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Indian Competition Commission (New delhi)
The Curious Case of Compulsory Licensing in India* In a move that has alarmed the pharmaceutical industry, in March 2012 the Indian Patents Office granted its first compulsory licence, for the manufacture and sale of Bayer’s patented drug Nexavar, in Natco Pharma Limited v Bayer Corporation (...)

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 fines a leading pharmaceutical company for an infringement of art. 102 TFEU by misusing patent (Pfizer)
University Luiss Guido Carli - GRIF (Rome)
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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 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
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 US FTC issues a report on pharmaceutical patent settlements scrutinizing their interplay with authorized generics
Gibson Dunn (New York)
U.S. FTC Scrutinizes Interplay Between Authorized Generics and Patent Settlements* The U.S. Federal Trade Commission has recently released two reports relating to the pharmaceutical industry. A significant theme in both reports is a concern that brand name pharmaceutical companies are using (...)

The US Supreme Court denies petition for certiorari brought by a drug manufacturer with respect to federal jurisdiction over antitrust class action claims (Lorazepam & Clorazepate Antitrust Litigation)
Wolters Kluwer (Riverwoods)
Antitrust Decision from Supreme Court Unlikely During Current Term* It is beginning to look like the U.S. Supreme Court will not be taking up any antitrust cases in the current term. Last week, the Court denied six petitions for review in antitrust-related matters. Just yesterday, the Court (...)

The European Court of Human Rights confirms that the Italian antitrust fining regime is compatible with human rights (Menarini)
Simmons & Simmons (Milano)
On 27 September 2011 the European Court of Human Rights (ECHR or the Court) ruled the Italian system of antitrust sanctions to be compliant with the law of fundamental rights. Specifically, the ECHR deemed the Italian system, consisting of a decision by the Italian Competition Authority (ICA) (...)

A US District Court denies a motion to dismiss an antitrust counterclaim in a patent infringement action in the wake of defendant having filed an ANDA with the FDA (Shionogi Pharma / Mylan)
Sheppard Mullin (Los Angeles)
ANDA Automatic Stay of FDA Approval Does Not Defeat Standing in Sham Litigation Antitrust Counterclaim* The District of Delaware recently denied a motion to dismiss an antitrust counterclaim in a patent infringement action in the wake of defendant Mylan, Inc. ("Mylan") having filed an (...)

The US FTC issues its final report on the effect of authorized generic drugs (AGs) on competition in the prescription drug market
Wilson Sonsini Goodrich & Rosati (Washington)
This article has been selected for the business category, general antitrust section of the 2012 Antitrust Writing Awards. Click here to learn more about the Antitrust Writing Awards. On August 31, the Federal Trade Commission (FTC) issued its final report on the effect of authorized generic (...)

The US FTC issues a report on authorized generic drugs expressing concern that they are being used to delay generic competition
Gibson Dunn (New York)
U.S. FTC Scrutinizes Interplay Between Authorized Generics and Patent Settlements* The U.S. Federal Trade Commission has recently released two reports relating to the pharmaceutical industry. A significant theme in both reports is a concern that brand name pharmaceutical companies are using (...)

The US Eighth Circuit rejects FTC’s market definition (Lundbeck)
Cohen Milstein (Washington)
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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 (...)

A US Court of Appeals rejects the FTC’s attempt to identify a relevant product market in a pharmaceuticals related merger (Lundbeck)
Cleveland-Marshall School of Law
FTC v. Lundbeck: Why, God, Why?* What really has the world come to when a merger to monopoly followed by a 1300% price increase survives Section 7 challenge? That, sadly, seems to be the final result in Federal Trade Commission v. Lundbeck, which the Eighth Circuit affirmed last Friday. (...)

The US Court of Appeals for the 8th Circuit upholds a lower court’s finding that the FTC failed to show the relevant market in a case concerning the acquisition of two drugs treating a similar heart defect (Lundbeck)
Scharf Banks Marmor
What Is a Relevant Market Anyhow?* The Eight Circuit, in FTC v. Lundbeck, Inc., No. 10-3458/3459 (Aug. 19, 2011), upheld the district court’s finding that the FTC failed to show a relevant market, and thus was unable to challenge the acquisition of the drug NeoProfen. It already owned a drug (...)

The Lithuanian Competition Council accepts commitments by eight pharmaceutical companies after an investigation into possible anticompetitive vertical agreement (Berlin Chemie Menarini Baltic, GlaxoSmithKline Lietuva)
European Commission (Brussels)
Lithuania: The Competition Council accepts Commitments by eight pharmaceutical Companies* On 21 July 2011, the Lithuanian Competition Council (the CC) closed an investigation into possible anticompetitive vertical agreements between producers/suppliers and wholesalers of pharmaceuticals with (...)

The Italian Competition Authority fines a leading chemical company €5 M for refusal to grant access to research data (Bayer CropSciences)
Van Bael & Bellis
On 5 July 2011, it was announced that the Italian Competition Authority (“ICA”) has fined Bayer CropSciences and Bayer Italia AG (together, “Bayer”) € 5.1 million for abuse of their dominant position on the market for the production and commercialisation of fosetyl-based fungicides (i.e., pesticides (...)

The Moldovan Competition Authority finds bid rigging practices in purchases of anti-diabetic medicines (Medicines Agencies)
University of Technology (Tallinn)
On 9 June 2011 the Moldovan Competition Authority (ANPC) established the existence of bid rigging practices at the public tenders organized by the Medicines Agency (AMED) for the purchase of anti-diabetic medicines. In Moldova the purchase of pharmaceuticals for the needs of public hospitals (...)

The German Competition Authority orders a producer of laboratory chemicals to cease discriminatory treatment of its customers (Merck)
Van Bael & Bellis (Brussels)
,
Practising Law Institute
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 German Competition Authority orders a producer of laboratory chemicals to cease discriminatory treatment of its customers (Merck)
Van Bael & Bellis (Brussels)
,
Practising Law Institute
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 German Competition Authority orders a producer of laboratory chemicals to cease discriminatory treatment of its customers (Merck)
Van Bael & Bellis (Brussels)
,
Practising Law Institute
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 German Competition Authority orders a producer of laboratory chemicals to cease discriminatory treatment of its customers (Merck)
Van Bael & Bellis (Brussels)
,
Practising Law Institute
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 EU Commission clears a joint venture in the pharmaceutical sector, after examining possible coordination between Chinese State-owned companies (DSM / Sinochem)
Van Bael & Bellis (Brussels)
In a decision of 19 May 2011, the European Commission unconditionally cleared the creation of a joint venture between Dutch pharmaceutical company DSM and Chinese State-owned conglomerate Sinochem. The joint venture will be active primarily in antibiotics and other anti-infective products. In (...)

The Romanian Competition Council publishes its report on the inquiry into the wholesale market of pharmaceuticals (Wholesale market of pharmaceuticals)
European Commission (Brussels)
Romania: Sector Inquiry Report on the Wholesale of Pharmaceuticals* In May 2011, the Romanian Competition Council (the RCC) published its report on the inquiry into the wholesale market of pharmaceuticals. The RCC opened the sector inquiry into the wholesale market of pharmaceuticals as a (...)

The European Commission waives commitment imposed on a merger in the DNA probes sector (Hoffmann-La Roche/Boehringer Mannheim)
Van Bael & Bellis (Brussels)
In a recently published decision of 3 May 2011, the European Commission waived certain commitments imposed as a condition of its approval of the acquisition of Boehringer Mannheim by Hoffman-La Roche in February 1998. In the 1998 decision, the Commission found that Hoffman-La Roche’s dominant (...)

The Belgian Competition Council 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)
Philippe & Partners (Brussels)
,
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 Italian Competition Authority issues an opinion on the potential anticompetitive effect of a draft bill concerning the purchase of biological medicines by public procurement (DDL n. 1875/2011)
European Commission (Brussels)
Italy: The Competition Authority’s (ICA’s) Opinion on the Public Procurement Discipline for Biopharmaceutical Products* On 16 March 2011, the ICA addressed to the Italian government an opinion on the potential anticompetitive effect of a draft bill concerning the purchase of biological medicines (...)

A US District Court denies FTC request for a preliminary injunction in medical laboratory merger case (LabCorp)
Skadden, Arps, Slate, Meagher & Flom (New York)
,
Skadden, Arps, Slate, Meagher & Flom (Palo Alto)
,
Kirkland & Ellis (New York)
In a decision broadly critical of the Federal Trade Commission’s case challenging the acquisition of Westcliff Medical Laboratories, Inc., a medical laboratory company, by Laboratory Corporation of America (LabCorp), Judge Andrew Guilford of the U.S. District Court for the Central District of (...)

The Bulgarian Competition Authority proposes amendments to regulation on wholesale trade in medicines
European Commission (Brussels)
Bulgaria: The Competition Authority proposes Amendments to Regulation on Wholesale Trade in Medicines* On 17 February 2011, the Commission on Protection of Competition (CPC) proposed amendments to the Regulation obliging producers/importers of medicines to designate which wholesalers will (...)

The UK Department of Health seeks antitrust damages after an abuse of dominant position in the pharmaceutical sector (Reckitt Benckiser)
Van Bael & Bellis
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 Department of Health seeks antitrust damages after an abuse of dominant position in the pharmaceutical sector (Reckitt Benckiser)
Van Bael & Bellis
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 (...)

A US District Court dismisses indirect purchaser class actions challenging proposed reverse payment agreements as anticompetitive on an allegation of preventing a cheaper generic medicine to enter the market sooner (Plavix Indirect Purchaser)
Sheppard Mullin (San Francisco)
Indirect Purchaser Plavix Class Actions Tossed for Lack of Antitrust Standing* On January 31, 2011, the District Court for Southern District of Ohio granted defendants’ Rule 12(b)(6) motion, dismissing indirect purchaser class actions that challenged proposed reverse payment agreements as (...)

A US Court of Appeals rejects antitrust lawsuit that challenged premerger planning and information exchanges between two health insurers (Omnicare/UnitedHealth)
Jones Day (Washington)
,
Jones Day (Houston)
This article has been selected for the business category, mergers section of the 2012 Antitrust Writing Awards. Click here to learn more about the Antitrust Writing Awards. Last week the U.S. Court of Appeals for the Seventh Circuit rejected an antitrust lawsuit by institutional pharmacy (...)

The US FTC and the State of Minnesota appeal the district court’s decision on relevant market issue in a pharmaceutical merger case (Lundbeck)
Cleveland-Marshall School of Law
Some Reflections on the Lundbeck Appeal: Will Pharmaceuticals Get a Blanket Antitrust Immunity? And Is Quality Competition No Longer Protected by Antitrust?* A decision to watch for this year is the Eighth Circuit’s pending consideration of FTC v. Lundbeck, Inc., 2010-2 Trade Cases ¶77,160; 2010 (...)

The Hungarian Parliament amends its Competition Act
European Commission (Brussels)
* Article published in ECN Brief 01/2011. The original title of this article appears below the e-Competitions title. Please note that the ECN is not the actual "author" of this case summary, but the mere source. As mentioned by the ECN : "The information provided by the ECN Brief is for (...)

The UK Office of Fair Trading holds that merger between two laboratories does not require referral to the Competition Commission under the Enterprise Act 2002 (Reckitt Benckiser)
University of Southampton
I. Introduction The Office of Fair Trading (OFT) has decided the merger between Reckitt Benckiser Inc. (Reckitt) and Combe Incorporated (Combe) will not substantially lessen competition in the market for the supply of certain pharmaceutical products. The merger does not have to be referred to (...)

The Netherlands Competition Authority clears pharmacies merger, subject to divestiture of four pharmacies (Brocacef/Lloyds Nederland)
Liberty Global (Amsterdam)
The merger The merger involved the acquisition of Lloyds Nederland BV («Lloyds») by Brocacef Holding NV («Brocacef»). Lloyds operated 63 pharmacies in the Netherlands at the time of the decision by the Netherlands competition authority («NMa») and is a subsidiary of the German group Celesio AG. (...)

The UK Court of Appeal holds that the UK Competition Appeal Tribunal has no discretion to extend limitations period for follow-on actions against alleged cartelists (BCL, BASF)
Morgan Lewis (London)
,
4-5 Gray’s Inn Square
,
Cadwalader Wickersham & Taft (Brussels)
On 12 November 2010, the Court of Appeal for England and Wales ruled that the UK Competition Appeal Tribunal (CAT) does not have discretion to extend the time period within which follow-on actions for damages may be commenced. The Court of Appeal’s judgment provides important clarification of (...)

The China’s State Council approves the merger between the largest pharmaceutical and healthcare group under the State-Assets Supervision and Administration Commission and a centrally-administered state-owned enterprise (CNSC / Sinopharm)
China Competition Bulletin (Beijing)
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China Competition Bulletin (Beijing)
,
Institute of American Studies
The China National Service Corporation for Chinese Personnel Working Abroad (CNSC, 中 国出国人员服务总公司), a centrally-administered state-owned enterprise, has merged with the China National Pharmaceutical Group Corporation (Sinopharm, 国药集团). The State Council approved the merger. Sinopharm is the largest (...)

The UK OFT reaches early resolution agreement in abuse of dominance investigation in the pharmaceutical sector (Reckitt Benckiser, Gaviscon)
UK Competition Appeal Tribunal (London)
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 OFT 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)
Stanford University - Stanford Law School
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 TFUE for misuse of patent (Pfizer)
Bonelli Erede Pappalardo (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 (...)

A French Court of Appeal, upon referral from the Supreme Court, puts an end to the debate on whether the tax on direct sales amounts to State aid on the basis of article 108.1 TFEU (Glaxosmithkline, Boiron, Bristol Myers Squibb)
CMS Bureau Francis Lefebvre (Paris)
,
CMS Bureau Francis Lefebvre (Paris)
In three decisions handed down on 2 September 2010, the Court of Appeal of Versailles ruled that the tax on direct sales failed to comply with the “Altmark test” designed by the European Court of Justice (now the Court of Justice of the European Union, hereinafter “the Court of Justice”) in order (...)

A US district court rules against the FTC holding that it has failed to prove the relevant market in 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 US District Court for the District of Minnesota dismisses FTC complaint seeking divestiture and disgorgement remedy in consummated acquisition in the healthcare industry (Lundbeck)
Jones Day (Washington)
,
Jones Day (Washington)
,
Jones Day (Washington)
In a decision that was filed under seal in late August but released publicly just last week, the U.S. District Court for the District of Minnesota dismissed with prejudice the complaint filed by the Federal Trade Commission (FTC) and the State of Minnesota challenging the already-consummated (...)

The US DoJ and FTC issue new merger guidelines suggesting increased focus on deals in high tech and pharmaceutical sectors
Gibson Dunn (New York)
New U.S. Merger Guidelines Suggest Increased Focus on Deals in High Tech and Pharmaceutical Sectors* In August 2010, the U.S. antitrust agencies released the final version of their revised Horizontal Merger Guidelines, which they use to analyze the competitive implications of mergers between (...)

The Chinese MOFCOM conditionally clears a merger in the pharmaceutical industry (Novartis / Alcon)
Linklaters (Beijing)
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Linklaters (London)
,
Linklaters (Brussels)
On 13 August 2010, the Ministry of Commerce of the People’s Republic of China (“MOFCOM”) issued a conditional approval for the proposed acquisition of Alcon (“Alcon”) by Novartis AG (“Novartis”). The decision was issued after a merger review of just under four months (one month for Phase One review (...)

The Chinese MOFCOM imposes conditions on merger in pharmaceutical industry (Novartis / Alcon)
Jones Day (Beijing)
,
Gibson Dunn (Hong Kong)
,
Jones Day (Beijing)
After a four-month review, on 13 August 2010, China’s Ministry of Commerce (“MOFCOM”) authorized Novartis‘ acquisition of Alcon subject to conditions. Taking different approaches than one would see in the U.S. or European Union, MOFCOM’s decision is notable for the demanding view it takes of (...)

The European Commission rejects legal privilege protection for correspondence between outside counsel of opposing companies (Servier, Teva)
Van Bael & Bellis (Brussels)
The European Commission has recently published the non-confidential version of a decision adopted on 23 July 2010 regarding a claim by a pharmaceutical company, Les Laboratoires Servier, and its parent company Servier SAS (“Servier”), that a document seized during an unannounced inspection in (...)

The EU General Court confirms abuse of dominance by preventing the market entry or the parallel imports of generic medicinal products (AstraZeneca)
Stanford University - Stanford Law School
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 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 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 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 Technology (Tallinn)
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)
Stanford University - Stanford Law School
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 NCA 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 generic products whereas such differences have no therapeutic value (Sanofi Aventis)
Vogel & Vogel
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 (...)

A US District Court reaffirms importance of market definition in antitrust merger analysis (Golden Gate Pharmacy / Pfizer)
Skadden, Arps, Slate, Meagher & Flom (Washington)
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Skadden, Arps, Slate, Meagher & Flom (New York)
On April 16, 2010, Judge Maxine M. Chesney of the U.S. District Court for the Northern District of California dismissed a complaint raising a private antitrust challenge to the merger of Pfizer, Inc. and Wyeth Pharmaceuticals, because she concluded that the complaint failed sufficiently to (...)

The US District Court for the Eastern District of Pennsylvania adopts "scope of patent" test for analyzing Hatch-Waxman patent settlements (Cephalon)
Skadden, Arps, Slate, Meagher & Flom (Washington)
,
Skadden, Arps, Slate, Meagher & Flom (Washington)
,
Skadden, Arps, Slate, Meagher & Flom (New York)
On March 29, 2010, Judge Mitchell S. Goldberg upheld antitrust lawsuits filed by the Federal Trade Commission (FTC) and private plaintiffs against drug maker Cephalon, Inc. (Cephalon), alleging that Cephalon conspired with four generic drug manufacturers to delay generic competition for the (...)

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 French Supreme Court reaffirms its case law on the parties’ right of access to documents in the framework of the commitments procedure (CRSP)
Van Bael & Bellis (Brussels)
In three judgments of 2 February 2010 (all published on 23 February 2010) the French Supreme Court annulled the judgments of 26 November 2008, whereby the Paris Court of Appeal had annulled commitments decisions adopted by the French Competition Authority in the pharmaceutical sector. This case (...)

The US FTC imposes remedies before clearing a merger affecting multiple markets for animal health and pharmaceutical products (Pfizer / Wyeth)
Akin Gump Strauss Hauer & Feld (Dallas)
The FTC entered into a consent agreement with Pfizer Inc. and Wyeth, requiring divestiture of one entity’s U.S. operations in over 20 markets for various animal health and pharmaceutical products. The consent order, established on January 25, 2010, sets forth the divestiture of Wyeth’s U.S. (...)

The Romanian Competition Council rejects a complaint regarding market entry of generics and price fixing in 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)
,
Practising Law Institute
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 Romanian Competition Council carries out dawn raid on suspicion of “gun-jumping” infringement (Advent, Ozone Laboratories)
Van Bael & Bellis (Brussels)
According to a press release of 19 November 2009, the Romanian Competition Council carried out unannounced inspections (so-called “dawn raids”) at the premises of Advent and Ozone Laboratories, in the framework of its investigation of a notified merger between these two companies. Although the (...)

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 Serbian Competition Authority advises the Government to review the list of medicines provided under the national health insurance scheme (Medicines provided under the national health insurance scheme)
University of Technology (Tallinn)
On 2 October 2009 Serbian Competition Authority (KZK) issued an opinion concerning the Government’s decision to reduce the number of medicines purchased by the medical institutions under the national health insurance scheme. KZK initiated its investigation following a complaint lodged by a law (...)

The Chinese MOFCOM conditionally clears major overseas transaction in the pharmaceuticals industry (Pfizer / Wyeth)
WilmerHale (Beijing)
,
WilmerHale (Beijing)
China’s Ministry of Commerce (MOFCOM) has just cleared two major overseas transactions, Pfizer’s acquisition of Wyeth in the pharmaceuticals industry and General Motors’ reacquisition of elements of auto parts manufacturer Delphi on September 28 and 29, respectively. Both clearances were subject (...)

The Estonian Competition Authority proposes to amend the distribution of non prescription drugs market
European Commission (Brussels)
Estonia: The Estonian Competition Authority proposes to amend Medicines Market Regulation On 18 September 2009, the Estonian Competition Authority has made a final proposal to the Ministry of Economic Affairs and Communications with the view to improve the competitive situation in the (...)

The French Competition Authority rejects request for interim measures in pharmaceutical sector (Ratiopharm, Janssen-Cilag France)
Van Bael & Bellis (Brussels)
,
Practising Law Institute
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 European Commission considers generic competition and pipeline products in the human-health pharmaceutical sector in unconditionally clearing the merger (Pfizer/Wyeth)
Van Bael & Bellis
On 17 July 2009, the European Commission approved the acquisition by Pfizer Inc. USA («Pfizer») of Wyeth USA. In its decision, the Commission identified substantial horizontal overlaps in the parties’ human health pharmaceutical operations, as well as in the parties’ animal health operations, (...)

The European Commission publishes final results of its inquiry in the pharmaceutical sector
European Commission - DG COMP (Brussels)
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EU Delegation to the OECD and UNESCO (Paris)
"Final results of the Commission pharmaceutical sector inquiry: competition and regulatory concerns to address"* On 8 July 2009, the Commission presented the final results of its sector inquiry into pharmaceuticals. The inquiry examined the competitive relationship between originator and (...)

The EU Commission’s pharmaceuticals sector inquiry report signals future antitrust actions
Gibson Dunn (Hong Kong)
,
Jones Day (Amsterdam)
,
Jones Day (Frankfurt)
The pharmaceuticals sector in the European Union will remain under close antitrust scrutiny in the coming years. This is confirmed by the Communication the European Commission released yesterday in which it summarizes the main conclusions from its sector inquiry that started in January 2008. (...)

The Athens Administrative Court of Appeal partially annuls the decision of the Hellenic Competition Commission on the parallel trade of pharmaceuticals (GlaxoSmithKline)
Bank of Greece
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 US FTC files a complaint to stop a proposed merger between two leading producers of plasma-derivative protein therapies (CSL, Talecris)
Jones Day (Washington)
Just two weeks after the FTC filed a complaint seeking an injunction to stop the proposed $3.1 billion acquisition by Australia-based CSL Limited of Talecris Biotherapeutics Holding Corporation, the parties have withdrawn their plans for a merger. The announcement, made on June 8, 2009, came (...)

The Cypriot Commission for the Protection of Competition holds two pharmaceutical companies as having abused their dominant position in the vaccines market throught quantitative reductions and free distribution of vaccines (Akis Panayiotou - Wyeth Hellas - Phadisco)
Antoniou Advocates
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 (...)

As part of a second phase investigation, the Swedish Competition Authority cleared a merger between the only two companies selling the same active pharmaceutical ingredient in the OTC market in Sweden (GlaxoSmithKline Dungarvan /AstraZeneca Tika)
Maersk (Copenhagen)
The parties to the transaction, i.e., GlaxoSmithKline Dungarvan ("GSK") and AstraZeneca Tika ("AZT") are active in Sweden within the field of, inter alia, consumer health. The Swedish Competition Authority ("SCA") divided the sale of pharmaceuticals into the following three markets; personal (...)

The President of the Belgian Competition Council 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 (Brussels)
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Hogan Lovells (Amsterdam)
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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 confirms rebutting of an appeal against an NCA’s decision sanctioning predatory pricing in the market for sodic cefuroxime (GlaxoSmithKline)
White & Case (Paris)
,
Cullen International
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 Macedonian Administrative Court confirms a merger prohibition decision in the market for retail distribution of pharmaceutical products (Zegin)
University of Technology (Tallinn)
On 1 June 2006 Zegin, leading distributor of the pharmaceuticals on the territory of Skopje municipality agreed with two other retail distributors of medicines - Alkaloid and Pharma Corp. to acquire joint control over City Pharmacy in Skopje , which owned a network of pharmacies in the (...)

The French Supreme Court confirms interim publication measures imposed on a pharmaceutical company (Schering-Plough)
Van Bael & Bellis (Brussels)
On 13 January 2009, the French Supreme Court rejected Schering-Plough‘s appeal against the judgment of the Paris Court of Appeal of 5 February 2008 upholding in its entirety a French Competition Council interim decision of 11 December 2007. In that decision, the Competition Council had ordered (...)

The European Commission gives conditional clearance to an acquisition in the production of generic medicines (Teva/Barr Pharmaceuticals)
,
European Commission - DG COMP (Brussels)
"Mergers: main developments between 1 September and 31 December 2008"* On 19 December the Commission gave conditional approval to the proposed acquisition of Barr Pharmaceuticals of the US by Teva Pharmaceutical Industries of Israel. Both companies produce generic medicines. To remedy the (...)

The Korean Fair Trade Commission plans to strenghten enforcement against abuse of intellectual property rights by IT and pharmaceutical companies
Jones Day (Beijing)
,
Winston & Strawn (New York)
,
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 US FTC seeks disgorgement remedy in challenge against pharma company for illegally acquiring drugs used to treat premature babies with life-threatening heart condition (Ovation)
Skadden, Arps, Slate, Meagher & Flom (Washington)
,
Skadden, Arps, Slate, Meagher & Flom (New York)
Continuing a trend of increasing aggressiveness in antitrust enforcement, the Federal Trade Commission (FTC) is seeking disgorgement in a challenge to Ovation Pharmaceutical Inc.’s acquisition of the drug NeoProfen®, filed in the Minnesota District Court on Dec. 16, 2008. In the past, the FTC has (...)

The European Commission presents its preliminary findings on its inquiry into competition in the pharmaceutical sector
Van Bael & Bellis (Brussels)
On 26 September 2008, the European Commission announced that it will present its preliminary findings on its inquiry into competition in the pharmaceuticals sector at a conference on 28 November 2008. The final results are expected in the spring of 2009. The sector inquiry, which was launched (...)

The European Commission presents its preliminary results concerning the pharmaceutical sector inquiry raising competition concerns
European Commission - DG COMP (Brussels)
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EU Delegation to the OECD and UNESCO (Paris)
,
European Commission - DG COMP (Brussels)
"Preliminary results of Commission pharmaceutical sector inquiry raise competition concerns"* On 28 November 2008, the Commission presented the preliminary findings of its sector inquiry into pharmaceuticals. The report shows that originator companies engage in practices that can contribute to (...)

The Turkish competition board re-evaluates a complaint of abuse of dominant position in the pharmaceutical sector upon the annulment decision of the State Council (Roche Mustahzarlar)
Erdem & Erdem
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 US FTC places a price cap on intra-company prices as a condition precedent to clearing a merger in the market for iron sucrose administrated intravenously (Fresenius / Daiichi)
Weil, Gotshal & Manges (Washington)
,
US Federal Trade Commission (FTC) (Washington)
On September 15, 2008, the FTC announced that it challenged a manufacturing, distribution, and supply agreement between Fresenius Medical Care Ag & Co. KGaA (Fresenius) and Daiichi Sankyo Company, Ltd. (“Daiichi”) based on allegations that the proposed transaction would violate U.S. (...)

The European Commission closes its investigation on an alleged obstruction of an inspection in the pharmaceuticals sector (Sanofi-Aventis)
Van Bael & Bellis (Brussels)
On 16 October 2008, the Commission decided to close its investigation into Sanofi-Aventis’ alleged obstruction of a Commission inspection in the framework of the pharmaceuticals sector inquiry. During the inspection, Sanofi-Aventis denied Commission inspectors access to certain documents until a (...)

The EU Court of Justice issues judgment on restrictions of parallel trade in pharmaceuticals (Lélos kai Sia)
Van Bael & Bellis (Brussels)
,
Practising Law Institute
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 Commission closes an investigation on the publication of information on drugs following commitment (Documed)
Comité International de la Croix-Rouge
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 Dutch Trade and Industry Appeals Tribunal confirms that a fair and public hearing within a reasonable time according to Art. 6 ECHR can be interpreted as meaning a period of up to two years or longer in an antitrust procedure (Aesculaap)
Skadden, Arps, Slate, Meagher & Flom (Brussels)
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Freshfields Bruckhaus Deringer (Amsterdam)
Introduction The Aesculaap case concerns an infringement of Article 6 of the Dutch Competition Act ("Mw") on the grounds that AUV - the procurement collective and wholesaler of veterinary pharmaceuticals -, and Aesculaap - the only other wholesaler of veterinary pharmaceuticals - had adopted a (...)

The Polish Competition Authority adopts a more economic approach to antitrust law as applied to pharmaceuticals (Richter Gedeon / Polpharma case)
Dentons (Warsaw)
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Dentons (Warsaw)
Over the last few years, seldom did we have a chance to observe the Chairperson of the Polish Office for Competition and Consumer Protection (“UOKiK”) commenting broadly on the definition, structure or mechanisms of pharmaceutical markets. How surprising it was to find that in the decision of 3 (...)

The French Civil Court of Appeal of Basse-Terre holds that third parties cannot request a national court to statute on the alleged incompatibility of a State aid measure but confirms national courts’ jurisdiction for claims for damages (Primistères Reynoird)
Sheppard Mullin (Brussels)
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European Court of Justice (Luxembourg)
Factual Background The society Primistères Reynoird imports goods from the continental part of France and other Member States of the European Union to Guyana and paid the levies in relation to the dock dues and an additional tax for the period between 1 October 1991 and 31 December 1992. In (...)

The Estonian Competition Authority issues its first merger prohibition taking into account both previous acquisitions and potential future acquisitions in the pharmacy services sector (Terve Pere Apteek/Saku Apteek)
Jesse & Kalaus Attorneys
On 8 May 2008, the Director General of the Estonian Competition Authority (hereinafter the “ECA”) adopted a decision on the prohibition of the proposed acquisition of control over OÜ Saku Apteek (hereinafter “Saku Apteek”) by Terve Pere Apteek OÜ (hereinafter “TPA”). Since this is the first decision (...)

EU Court of Justice Advocate General Colomer gives opinion on an abuse of dominant position in the pharmaceutical sector (Lélos kai Sia)
Van Bael & Bellis (Brussels)
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Practising Law Institute
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 Paris Court of Appeal confirms interim measures imposed by French NCA in an abuse of dominance case in the generic pharmaceutical sector (Arrow / Schering-Plough)
Van Bael & Bellis (Brussels)
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Practising Law Institute
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 European Commission launches sector inquiry into pharmaceuticals
European Commission - DG COMP (Brussels)
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European Commission - DG EMPL
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European Commission - DG COMP (Brussels)
"Commission launches sector inquiry into pharmaceuticals"* On 15 January 2008, the Commission initiated an inquiry into the pharmaceutical sector. As a first step, the Commission undertook unannounced inspections at the premises of a number of pharmaceutical companies in the EU. It was (...)

The Estonian Competition Authority raises doubt on its discretion to initiate in-depth merger investigations (Terve Pere Apteek/Saku Apteek)
Jesse & Kalaus Attorneys
On 8 January 2008 the Director General of the Estonian Competition Authority (“ECA”) adopted a decision on the initiation of supplementary proceedings (so-called in-depth investigation) with respect to a concentration whereby Terve Pere Apteek OÜ (“TPA”) would acquire control over OÜ Saku Apteek (...)

The French Competition Authority orders interim measures particularly to address denigration practices implemented in the pharmaceutical sector (Arrow / Schering-Plough)
French Competition Authority (Paris)
Press Release published on the official website of the French Competition Authority. 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 (...)

The UK OFT makes recommendations to government on UK medicines distribution
Linklaters (London)
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Linklaters (London)
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Linklaters
On 11 December 2007, the OFT issued the results of its market study into the distribution of medicines in the UK. The review was initiated after Pfizer announced it would be introducing a Direct to Pharmacy (DTP) distribution model, appointing Unichem as its exclusive Logistics Service (...)

The French Competition Council renders a landmark interim decision on competition between princeps and generics (Arrow / Schering-Plough)
Fréget - Tasso de Panafieu Avocats (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 UK High Court rules that exemplary damages are not available to claimants bringing actions against cartelists that have already been fined by the EU Commission, even if their fine has been commuted due to an immunity or leniency application (Devenish Nutrition / Sanofi-Aventis)
Freshfields Bruckhaus Deringer (London)
Exemplary damages are not available to claimants bringing actions against cartelists that have already been fined by the European Commission, even if their fine has been commuted due to an immunity or leniency application. Similarly, restitutionary relief or an account of profits are most (...)

The European Commission conditionally clears a merger in the human and animal healthcare sector (Schering-Plough / Organon BioSciences)
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European Commission - DG COMP (Brussels)
"Mergers: Main developments between 1 September and 31 December 2007"* On 11 October the Commission cleared the proposed acquisition of Organon BS of the Netherlands, a subsidiary of Akzo Nobel active worldwide in human and animal health, by the global pharmaceutical company Schering-Plough (...)

The European Commission conditionally clears a merger in the healthcare nutrition products sector (Nestle/Novartis)
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European Commission - DG COMP (Brussels)
"Merger control: Main developments between 1 May and 31 August 2007"* In June the Commission approved the proposed acquisition of Novartis‘ Medical Nutrition business by Nestle. The approval was granted subject to the fulfilment of certain conditions. Nestle is active in the production, (...)

The French Civil Supreme court applies the ECJ State aid Boiron case law and rules that national courts have an obligation to take all the necessary measures when national procedural rules are not sufficiently favorable for a claimant wishing to demonstrate the existence of overcompensation for public service obligations (Laboratoires Boiron)
Sheppard Mullin (Brussels)
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European Court of Justice (Luxembourg)
Factual Background The company Laboratoires Boiron appeals the judgment of the Court of appeal of Lyon in litigation concerning a provision of the French Code de la santé publique (Public Health Code). The appellants which is a pharmaceutical laboratory specialising in homeopathic medicines (...)

The French Supreme Administrative Court annuls a State’s decision discriminating the reimbursement’s rate between princeps and generic drugs (GlaxoSmithKline)
Fréget - Tasso de Panafieu Avocats (Paris)
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Novartis (Basel)
1. The Regulatory Context: positive discrimination as a starting point and the TFR a possible end to it Sales of reimbursable medicines to consumers are heavily regulated in France, from the level of the pharmaceutical company manufacturing them all the way through to the ultimate individual (...)

The US FTC seeks divestiture of rights and assets to five different medications before approving a merger, which would affect the markets for generic injectable pharmaceuticals (Hospira / Mayne)
Akin Gump Strauss Hauer & Feld (Dallas)
The FTC entered into a consent decree with Hospira Inc. and Mayne Pharma Ltd. on May 21, 2007 imposing divestitures on the firms prior to clearing their merger. The consent decree required Mayne to divest its current business in one type of generic pharmaceuticals, as well as the assets (...)

The Italian Competition Authority accepts commitments presented by a pharmaceutical company authorising potential competitors’ access to its products, with, inter alia, a free licence to manufacturers of generic pharmaceuticals (Merck - Principi Attivi)
National University of Singapore
The Autorità Garante della Concorrenza e del Mercato (the Italian Competition Authority, hereinafter also the “Authority”) recently closed proceedings in the pharmaceutical sector by accepting the commitments presented by Merck. The investigation against the American pharmaceutical company (...)

The French Civil Supreme Court applies the ECJ Boiron State aid case law on burden of proof and annuls the judgment of the Versailles Court of Appeal dismissing the application by a pharmaceutical producer (Glaxosmithkline)
Sheppard Mullin (Brussels)
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European Court of Justice (Luxembourg)
Factual Background This case is one in a series of cases against pharmaceutical producers and wholesale distributors concerning a provision of the French Code de la santé publique (Public Health Code). The relevant provision obliges pharmaceutical wholesalers to stock enough medical products to (...)

The French Competition Council fines predatory pricing aimed at preventing entry of generic drugs in hospitals on the basis of both EC and national competition provisions (GlaxoSmithKline France)
Gide Loyrette Nouel
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 UK Hight Court rules on interim unjunction for an alleged unlawful refusal to supply in the pharmaceutical sector (AAH Pharmaceuticals/Pfizer-UniChem)
King’s College (London)
This note considers one of the two cases recently heard by the “ordinary” courts (the High Court and Court of Appeal) (See also A. Jones, The UK Court of Appeal rejects an allegation of unreasonable refusal to supply and unlawful discriminatory pricing (Attheraces/British Horseracing Board), (...)

The Portuguese Competition Authority clears a merger between a pharmacist and a wholesale and retail pharmacy group (Alliance/Unichem)
Morais Leitão, Galvão Teles, Soares da Silva & Associados (Porto)
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Morais Leitão, Galvão Teles, Soares da Silva & Associados (Porto)
I. Introduction On December 23, 2005, the Portuguese Competition Authority (PCA) was notified of a concentration under which Alliance Santé Europe, S.A. (Alliance Santé), Farmindústria – Investimentos, Participações e Gestão, S.A. (Farmindústria) and José de Mello Participações II, SGPS, SA (JMP) (...)

A French Court refuses to grant damages to alleged victim of the vitamin cartels (Juva/Hoffmann La Roche)
Freshfields Bruckhaus Deringer
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Freshfields Bruckhaus Deringer
On 26 January 2007, the Paris Commercial Court dismissed one of the still infrequent private actions claiming compensation for damage allegedly suffered as a result of anticompetitive behaviour. In a decision dated 21 November 2001, the European Commission imposed fines totalling €855.23 (...)

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 (...)

An UK Competition Court 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 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 Italian Competition Authority accepts commitments aims at facilitating competitors’ access to patented drugs (Merck - Principi Attivi)
London School of Economics
Article 5 of Council Regulation (EC) n° 1/2003, of 16 December 2002, on the implementation of the rules on competition laid down in Articles 81 and 82 of the Treaty (OJEU L 1, 4 January 2003, p. 1-25) allowed National Competition Authorities to accept commitments in proceedings concerning the (...)

The UK Competition Appeal Tribunal grants interim damages of £ 2 M in a case of abusive drugs price setting (Healthcare at Home / Genzyme)
Hogan Lovells
Background GenzymeLimited ("Genzyme”) is the manufacturer of Ceredase and Cerezyme, drugs used in the treatment of Gaucher disease. Genzyme also provided home care services to administer its drugs. The home care services were initially subcontracted, firstly to Caremark and then to Healthcare (...)

The UK Competition Appeal Tribunal awards for the first time ever interim damages in an abuse of dominant position case on the drugs market (Healthcare at Home / Genzyme)
Sanoma
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 (...)

The European Court of Justice rules that pharmaceutical laboratories liable to a tax on direct sales of medicines are entitled to claim the reimbursement of the tax where the exemption of wholesale distributors constitute an illegal State aid (Boiron)
Kramer Levin Naftalis & Frankel (Paris)
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Eversheds (Paris)
Opinion of Advocate General Antonio Tizzano, 30 March 2006, Case C-526/04, Laboratoires Boiron SA v. Agence centrale des organismes de sécurité sociale (ACOSS) ECJ, 7 September 2006, Laboratoires Boiron, Case C-526/04. In a preliminary ruling requested by the French Civil Supreme Court in 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 Greek Competition Act but not Art. 82 EC despite effect on trade between Member States (GlaxoSmithKline / SYFAIT)
Agora Trading
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 UK Office of Fair Trading clears a merger in the retail pharmacy services sector, subject to the divestment of four retail pharmacies (Admenta Lloyds/IPCC)
Eli Lilly and Company (London)
The operation Lloyds is owned by Admenta Holdings Limited, a subsidiary of the German company Celesio AG, which also owns the pharmaceutical wholesaler AAH. Independent Pharmacy Care Centres plc (IPCC) comprises 34 retail pharmacies and one drug store (the latter does not have an NHS (...)

The Spanish Competition Authority conditionally clears in phase II a merger in the wholesale distribution to pharmacy stores sector (Cofares/Hefame)
RBB Economics
The operation The operation involved the merger of Cofares and Hefame to create a new wholesale distributor of pharmacy products. Both Cofares and Hefame specialised in the wholesale distribution of pharmacy and parapharmacy products. They also provided other complementary services to (...)

A French Court of Appeal applies the "Boiron" case law relating to the burden of proof and dismisses a claim by a pharmaceutical producer on the ground that it failed to show the existence of an advantage obtained from the exemption enjoyed by the wholesale distributors as set by the national regulation (Laboratoires Bristol Myers Squibb)
Sheppard Mullin (Brussels)
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European Court of Justice (Luxembourg)
Factual Background This case is one of a series of cases against pharmaceutical producers and wholesale distributors concerning a provision of the French Code de la santé publique (Public Health Code). This provision obliges pharmaceutical wholesaler to keep a permanent stock of medicinal (...)

The European Commission approves, subject to divestiture, an acquisition in the insurance sector (Gerling/Talanx)
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European Commission - DG COMP (Brussels)
"Mergers — Main developments between 1 January and 30 April 2006"* On 5 April the proposed acquisition of the German insurance group Gerling by the insurer Talanx was approved. Talanx Aktiengesellschaft (‘Talanx‘) is a German holding company. Its subsidiaries offer life and non-life insurances to (...)

The Athens Court of Appeal seeks a preliminary reference in the case of a pharmaceutical company denying the supply of certain drugs to Greek wholesale (GlaxoSmithKline)
University College London
Factual background The plaintiff was a company operating at the wholesale level, in the pharmaceutical sector, supplying pharmacies and hospitals with drugs and other products related to that sector. The defendant was the Greek Subsidiary of the GlaxoSmithKline Company incorporated in the UK. (...)

The Italian NCA imposes a pharmaceutical company to grant a drug production license (Glaxo - Principi attivi)
Freshfields Bruckhaus Deringer (Rome)
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GiusPubblicisti Associati
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 UK Office of Fair Trading clears a merger in the market for the supply of retail pharmacy services, subject to the divestment of a large number of stores (Boots/Alliance Unichem)
Added Value Capital Partners (AVCP)
The operation Boots operates 1,423 health and beauty stores in the UK and operates pharmacies in 1,350 of these stores. It intended to acquire Alliance UniChem, an international pharmaceutical distribution company, which operates 958 pharmacies in the UK. The market(s) The OFT considered the (...)

The French Competition Authority hands down a non-suit decision regarding alleged abuses of dominant position in the parallel trade of medicines (Pharma-Lab / GlaxoSmithKline)
French Competition Authority (Paris)
Press Release published on the official website of the French Competition Authority. 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 (...)

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 French Competition Council deems that pharmaceutical companies can, under certain conditions, impose quotas restricting parallel exports (Pharma-Lab / GlaxoSmithKline)
European Court of Justice (Luxembourg)
Summary This decision of the French Competition Council concerns the quota systems put in place by pharmaceutical companies in the framework of wholesaling, here limited to exporter wholesalers. The Plaintiffs were : Pharma-Lab, Pharmajet, Pharmadex TMC, European Trade Company and AD Pharm. (...)

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)
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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 European Commission imposes a € 60 M fine against two companies in the pharmaceutical sector for abuse of a dominant position (AstraZeneca)
Danish Competition and Consumer Authority (Copenhagen)
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European Commission - 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 (...)

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 launches an investigation in the pharmaceutical sector for generics under Art. 82 EC (Merck-Principi attivi, Imipenem Cilastatina)
Studio Legale DDPV
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Studio Legale
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 (...)

An Estonian Court of appeal confirms the right of third parties to challenge merger decisions, but upheld the Competition Authority’s merger clearance concerning the acquisition of a company controlling a chain of pharmacies by an Estonian dominant wholesaler of pharmaceuticals (Parimex Invest/Magnum Medical)
COBALT Legal
On 14 June 2005, the Tallinn Circuit Court (a court of appeal) issued a judgment upholding the Estonian Competition Authority’s (ECA) merger clearance concerning the acquisition of OÜ Parimex Invest, a company controlling a chain of pharmacies, by AS Magnum Medical, an Estonian dominant (...)

A US District Court holds that a drug manufacturer rebates to pharmacy benefits managers (PBM) for exclusive formulary listing do not violate the Sherman Act (Wyeth, J.B.D.L)
Jones Day (Washington)
A U.S. District Court in Ohio granted summary judgment for defendants in a class action suit alleging that a drug manufacturer’s rebates to pharmacy benefit managers in order to obtain an exclusive listing in the PBMs’ drug formulary violated Section 1 of the Sherman Act. The plaintiffs, (...)

The European Court of Justice rules that the Greek Competition Authority is not a “court or tribunal” in the meaning of Art. 234 EC and therefore can not apply for an ECJ preliminary ruling (Syfait / GlaxoSmithKline)
White & Case (Brussels)
On 31 May 2005 the European Court of Justice (ECJ) delivered its judgment in Case C-53/03, Syfait and others v. GlaxoSmithKline AEVE and GlaxoSmithKline plc (“Syfait”), which raises the question of whether a dominant pharmaceutical undertaking is under a duty to supply unlimited quantities of (...)

The European Commission conditionally clears a merger leading to the creation of the largest European producer of generic medicines (Hexal/Eon Labs)
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European Commission - DG COMP (Brussels)
"Mergers — Main developments between 1 May and 31 August 2005"* The Commission authorised the acquisition of Hexal, a German producer of generic medicines, and its US sister company Eon Labs by Novartis, in a deal which creates the largest European producer of generic medicines. The clearance (...)

The French Supreme Court refers to the ECJ for a preliminary ruling concerning (i) the repayment of a mandatory contribution based on the turnover of pharmaceutical laboratories and (ii) national rules of procedure leading to State aid classification (Laboratoires Boiron)
Schmitt Avocats
By decision of 14 December 2004, the French Cour de Cassation referred to the European Court of Justice (ECJ) for a preliminary ruling concerning the classification as state aid of the contribution instituted by Article L. 245-6-1 of the Social Security Code and the way to obtain its (...)

The Italian competition authority imposes for the first time interim measures on the basis of Art. 82 EC (Merck, Carbapenem)
Freshfields Bruckhaus Deringer (Rome)
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Freshfields Bruckhaus Deringer
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 (See also on this Case, e-Competitions, July (...)

The UK’s Competition Appeal Tribunal decides for the first time on claims for damages for breach of Art. 81 EC under national competition provision (Vitamins)
White & Case (London)
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Ince & Co
Background These two cases, heard concurrently before the UK’s Competition Appeal Tribunal (“CAT” or “Tribunal”) were the first (and so far the only) claims for damages to be brought pursuant to Section 47A of the Competition Act 1998 (the “Act”). Section 47A of the Act is a significant legislative (...)

The French Cour de Cassation refers questions to ECJ relating to social security exemptions for French laboratories (Laboratoires Boiron)
Sheppard Mullin (Brussels)
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Maersk (Copenhagen)
Brief description of the facts and legal issues A laboratory filed an action for the refund of a Sociàl Security contribution arguing that this contribution was unlawful State aid, because certain laboratories were exempt. Referring to the Banks case (Joined Cases C-390/98, Banks & Co v (...)

The French Civil Supreme Court requested a preliminary ruling from the ECJ with regards to the implementation of the Ferring case law : Advocate General Tizzano supports the reimbursement of the tax on direct sales paid by French pharmaceutical laboratories (Boiron/ACOSS)
Kramer Levin Naftalis & Frankel (Paris)
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Eversheds (Paris)
Background Law n° 97-1164, of 19 December 1997, on social security funding for 1998 set up a special 2.5 % tax payable only by pharmaceutical laboratories on sales of medicines made directly to pharmacies. Proceeds from the tax were aimed at financing the social security system. However, (...)

La Cour de cassation confirme que, même lorsqu’il applique les articles 81 et 82 CE, le Conseil de la concurrence doit mettre en ?uvre les règles françaises de procédure (Pharma Lab, GlaxoSmithkline et Pfizer)
Freshfields Bruckhaus Deringer (Paris)
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Eversheds (Paris)
Dans l’affaire Pharma Lab, GlaxoSmithkline et Pfizer la société Pharma-Lab, grossiste-exportateur en spécialités pharmaceutiques, avait dénoncé auprès du Conseil de la concurrence des pratiques qu’elle estimait constitutives de refus de vente en vue de restreindre le commerce parallèle de médicaments. (...)

The European Commission authorises an acquisition in the OTC industry creating the largest European OTC consumer health company (Roche / Bayer)
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European Commission - DG COMP (Brussels)
"Merger control: Main developments between 1 September and 31 December 2004"* In November the Commission decided to authorise the acquisition of the worldwide Roche OTC business by Bayer in a deal which creates the largest European OTC consumer health company. The operation raised serious (...)

A US Court of Appeals holds that American courts have authority to hear antitrust claims brought by foreign plaintiffs against foreign defendants over foreign conduct (Empagran)
Hughes Hubbard & Reed (Washington)
The twenty years since the enactment of the Federal Trade Antitrust Improvements Act (the FTAIA) in 1982 have seen steady progress in the cooperation of antitrust authorities worldwide. Prior to the FTAIA’s passage, the US’s extraterritorial application of its antitrust laws created international (...)

The US FTC employs an uncommon remedy to resolve the anticompetitive concerns of a merger-to-monopoly by requiring the merged firm to license a generic form of its breakthrough cancer pain drug to a third party (Cephalon/CIMA)
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BakerHostetler (Washington)
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Pillsbury Winthrop Shaw Pittman (New York)
In two recent decisions involving pharmaceutical mergers – Cephalon/Cima, in August 2004, and Genzyme/Novazyme, in January 2004, a divided Federal Trade Commission was accused by dissenting Commissioners of breaking with precedent and allowing acquisitions involving innovator pharmaceuticals (...)

The US FTC requires divestiture of three brand drugs in order to grant approval to a merger between two pharmaceutical companies (Sanofi-Synthelabo/Aventis)
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BakerHostetler (Washington)
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Pillsbury Winthrop Shaw Pittman (New York)
In two recent decisions involving pharmaceutical mergers – Cephalon/Cima, in August 2004, and Genzyme/Novazyme, in January 2004, a divided Federal Trade Commission was accused by dissenting Commissioners of breaking with precedent and allowing acquisitions involving innovator pharmaceuticals (...)

The Polish Competition Authority clears a merger in the pharmaceuticals sector, subject to a divestment remedy (Sanofi Synthelabo/Aventis)
Clifford Chance (Warsaw)
The operation The acquisition of Aventis by Sanofi-Synthelabo was performed by a public bid. The President of the OCCP, on 18 May 2004, cleared the merger, which led to the establishment of one of the largest pharmaceutical groups in the world (pages 3-5). The market(s) The President of the (...)

Several German courts of first instance decide on damages claims brought by the customers of the vitamins cartel (Vitaminpreise)
Freshfields Bruckhaus Deringer (Berlin)
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Freshfields Bruckhaus Deringer (Berlin)
Following the European Commission’s decision regarding the vitamin cartel (Commission Decision 2003/2/EC, of 21 November 2001, relating to a proceeding pursuant to Article 81 of the EC Treaty and Article 53 of the EEA Agreement (Case COMP/E-1/37.512 - Vitamins), OJEC L 6, 10 January 2003, pp. (...)

The European Commission conditionally clears a merger in the medical devices market (GE Medical Systems / Instrumentarium)
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European Commission - DG COMP (Brussels)
"Merger Control: Main developments between 1st September 2003 and 31st December 2003"* In September the Commission approved, subject to conditions, the acquisition by GE Medical Systems of the Finnish firm Instrumentarium. The proposed acquisition was notified to the Commission on 28 February (...)

The Czech Competition Office clears a merger in the chemical sector subject to termination of an exclusive cooperation and business divestiture (DSM/Roche)
Clifford Chance
The operation On the basis of the share and property purchase agreement concluded between DSM N.V. ("DSM") and Roche Holding AG, Roche Finanz AG, Roche Vitamins Inc., Roche Farma SA, Roche Pharmaholding B.V., Roche Deutschland Holding GmbH and Hoffmann - La Roche France SAS, DSM acquired (...)

The French Competition Authority sanctions a laboratory for having abused of its dominant position in the market for certain medicinal products intended for hospitals (Sandoz laboratories)
French Competition Authority (Paris)
Press Release published on the official website of the French Competition Authority. 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 (...)

The European Commission clears the acquisition of the vitamins and fine chemicals division of a Swiss pharmaceutical company by a Dutch company after a detailed investigation (Roche/DSM)
European Commission - DG COMP (Brussels)
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European Commission - DG COMP (Brussels)
"Merger control: main developments between 1st May and 31st August 2003"* On 23 July 2003, the European Commission cleared the proposed acquisition of the Vitamins and Fine Chemicals division of Swiss company Roche by Dutch-based company DSM after a detailed investigation. The Commission had (...)

The Czech Competition Office clears in a landmark decision in phase II a merger in the pharmaceutical sector subject to several structural and behavioural remedies, including transfer and divestment of trademarks and termination of a license agreement (Zentiva/S. L. Pharma)
Clifford Chance
The operation On the basis of share transfer agreement concluded on 20 January 2003, ZENTIVA B.V. ("Zentiva") acquired 100 % of shares in S.L. PHARMA HOLDING GESELLSCHAFT M.B.H. ("SLP") and therefore gained a sole control over the company. Zentiva operates in Czech Republic mainly through (...)

The Hungarian Competition Authority clears a merger in the sector of pharmacies with a posteriori condition including limited termination of control (UTA Pharma Beteiligungs/Pharma Concept)
lakatos, koves and partners
The operation Both UTA Pharma and Pharma Concept are trust and investment companies targeting to get indirect limited partnership in pharmacies and to finance them. The pharmacies in Hungary are established in the form of partnership with limited liability. The newly created merger would (...)

The EU Commission conditionally clears the merger of the medical ventilators, anaesthesia delivery systems and patient monitoring businesses of two German companies (Siemens / Drägerwerk)
European Commission - DG ECFIN
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European Commission - DG COMP (Brussels)
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European Commission - DG GROW
"Merger Control: Main developments between 1st January 2003 and 30th April 2003"* On 30 April 2003, the Commission approved, subject to conditions, the merger of the medical ventilators, anaesthesia delivery systems and patient monitoring businesses of Siemens AG and Drägerwerk AG, two German (...)

The Slovak Antimonopoly Office approves a merger in the sector of pharmacy with remedies including the divestiture of a business unit designated for a production of specific medicaments (Pfizer/Pharmacia)
Čechová & Partners
The operation By a decision dated 23 04 2003, the Antimonopoly Office of the Slovak Republic approved the acquisition of exclusive control of the undertaking Pfizer over the undertaking Pharmacia by a merger between the 100% subsidiary of Pfizer - company Pilsner Acquisition Sub Corp. and (...)

The European Commission conditionally clears a merger in the pharmaceutical sector creating the largest pharmaceutical company in the world in terms of sales and R&D spending (Pfizer/Pharmacia)
European Commission - DG ECFIN
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European Commission - DG COMP (Brussels)
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European Commission - DG GROW
"Merger Control: Main developments between 1st January 2003 and 30th April 2003"* The European Commission authorised, subject to conditions, the acquisition of Pharmacia Corporation (Pharmacia) by Pfizer Inc. (Pfizer) in a deal creating the largest pharmaceutical company in the world in terms (...)

The 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)
Agora Trading
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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 US FTC imposes divestiture of assets for one product and licensing of patents for two other products prior to approving a merger in the pharmaceuticals industry (Amgen / Immunex)
Akin Gump Strauss Hauer & Feld (Dallas)
Amgen Inc. and Immunex Corporation entered into a consent decree with the FTC on September 3, 2002 in order to proceed with the merger of the two pharmaceutical giants. To obtain clearance from the FTC, Amgen and Immunex agreed to divest Immunex’s business concerning the production of one (...)

The Netherlands Competition Authority establishes the illegal character of the resale prohibition imposed by pharmaceutical company on hospitals (AstraZeneca)
Netherlands Authority for Consumers & Markets (The Hague)
NMa: Prohibition by AstraZeneca on Sales to Third Parties Contravenes Competition Act* The prohibition against supplying parties outside the premises of hospitals, imposed on hospitals and pharmacies by AstraZeneca, contravenes the Competition Act. NMa made this ruling in a decision relating (...)

The Hungarian Competition Office approves an acquisition in the pharmacy market with remedies including non-discrimination obligations and reporting commitments (Hungaropharma / Richter Gedeon)
lakatos, koves and partners
The operation The HCO authorized the acquisition of Hungaropharma by the consortium of Richter, Egis, Béres and Magyar Gyógyszer. Hungaropharma is owned by the Hungarian State. A sale and purchase agreement ("Agreement") was concluded by and between APV Rt and the Consortium. According to the (...)

The Hungarian Competition Office clears a merger in the pharmacies wholesale market sector with remedies including non-discrimination and reporting obligations (Hungaropharma)
lakatos, koves and partners
The operation The HCO authorized the acquisition of Hungaropharma by the consortium of Richter, Egis, Béres and Magyar Gyógyszer. Hungaropharma is owned by the Hungarian State. A sale and purchase agreement ("Agreement") was concluded by and between APV Rt and the Consortium. According to the (...)

The European Commission clears an acquisition in the markets for crop protection, professional pest control and animal health products subject to substantial divestitures (Bayer/Aventis/Crop Science)
European Commission - DG ECFIN
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European Commission - DG COMP (Brussels)
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Financial Conduct Authority (FCA)
"Merger Control: Main developments between 1st January 2002 and 30th April 2002"* The Commission decided to clear Bayer‘s acquisition of Aventis Crop Science (ACS), subject to substantial divestitures. As initially notified, the operation would have led to the creation or strengthening of (...)

The French administrative supreme Court ruled that a new tax aimed at replacing an unlawful State aid is not by itself an other unlawful State aid (SNIP)
Schmitt Avocats
French Administrative Supreme Court (Conseil d’État), 3 December 2001, Syndicat National de l’Industrie Pharmaceutique, Case n° 226514 This French State’s Council case Syndicat National de l’Industrie Pharmaceutique is well known for its contribution to the relationship between EC law and French (...)

The German Competition Authority prohibits the concentration plans that would have led to firms involved gaining dominant positions on certain markets in the wholesale pharmaceutical sector (Sanacorp / Andreae-Noris Zahn)
German Competition Authority (Bonn)
Bundeskartellamt prohibits Sanacorp/Andreae-Noris Zahn concentration* The Bundeskartellamt has prohibited the concentration plans of Sanacorp e.G. Pharmazeutische Grosshandlung, Planegg, (turnover in Germany approximately DM 3.89 billion) to acquire a majority holding in Andreae-Noris Zahn AG, (...)

The European Commission exceptionally orders the licensing of a copyright to safeguard competition in the German pharmaceutical sales reports market (IMS Health)
British Embassy to the DRC
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European Commission - DG COMP (Brussels)
"Commission exceptionally orders the licensing of a copyright to safeguard competition in the German pharmaceutical sales reports market"* 1. Introduction On 3 July 2001 the Commission adopted an interim measures Decision finding that IMS Health, a US company selling pharmaceutical sales (...)

The French Competition Authority fines laboratory for preventing entry of generics in the market for anesthetic drug (Abott France)
French Competition Authority (Paris)
Press release published on the official website of the French Competition Authority. 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 (...)

The Turkish Competition Authority clears a merger in the pharmaceuticals sector subject to limitation of the non-compete clause (Abbott-BASF)
Esin
The operation Abbott is a USA based public company which is active in the field of discovery, improvement, manufacture and marketing of certain pharmaceutical products. Abbott holds 99.9% of its Turkish subsidiary which is also active in the pharmaceutical sector. BASF is a German public (...)

The Dutch Competition Authority suspects that a cooperative association to which 90% of veterinarians in the Netherlands are affiliated infringed competition law (Coöperatieve Nederlandse Veterinair-Farmaceutische Groothandel / Aesculaap)
Netherlands Authority for Consumers & Markets (The Hague)
NMa Draws up a Report on Veterinary Medicine Wholesalers* After carrying out an investigation, the Dutch Competition Authority (NMa) has reason to believe that Coöperatieve Nederlandse Veterinair-Farmaceutische Groothandel U.A. (in short, AUV) has contravened the Competition Act. Until the end (...)

The European Commission approves, subject to remedies, a joint venture between UK and German pharmaceuticals companies (Smith & Nephew/Beiersdorf)
European Commission - DG ECFIN
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European Commission - DG COMP (Brussels)
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Financial Conduct Authority (FCA)
"Merger Control: Main developments between 1st January 2001 and 30th April 2001"* At the end of January the Commission gave regulatory clearance to a proposed joint venture between British undertaking Smith & Nephew plc and Beiersdorf AG of Germany after the parties made substantial (...)

The Turkish Competition Authority clears a merger in the chemicals sector subject to transfer of products licenses to a third party (Glaxo-SmithKline)
Esin
The operation Prior to the transaction Glaxo was a public company which was engaged in research, development, production and marketing in the pharmaceuticals sector. Glaxo had a Turkish subsidiary named Glaxo Wellcome Ilaclarý San. A.S. (“Glaxo Turkey”) through which Glaxo carried out its (...)

The Turkish Competition Authority cleared with remedy a merger in the pharmaceuticals sector subject to remedies, including transfer of licences to third parties (Glaxo-SmithKline)
Esin
The operation Prior to the transaction Glaxo was a public company which was engaged in research, development, production and marketing in the pharmaceuticals sector. Glaxo had a Turkish subsidiary named Glaxo Wellcome Ilaclarý San. A.S. (“Glaxo Turkey”) through which Glaxo carried out its (...)

The European Commission clears an acquisition in the crop production industry (Astra Zeneca/Novartis)
Service européen pour l’action extérieure (EEAS)
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Financial Conduct Authority (FCA)
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European Commission - DG COMP (Brussels)
"Merger Control: main developments between 1st May 2000 and 31st August 2000"* In this operation, which will lead to the world.s leading crop protection business, Astra-Zeneca, itself created through the merger between Astra AB and Zeneca Group PLC in spring 1999, and Novartis, resulting from (...)

The European Commission approves a merger leading to the creation of one of the largest pharmaceutical company (Pfizer/Warner-Lambert)
Service européen pour l’action extérieure (EEAS)
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Financial Conduct Authority (FCA)
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European Commission - DG COMP (Brussels)
"Merger Control: main developments between 1st May 2000 and 31st August 2000"* Resulting from the merger between Glaxo Wellcome and SmithKline Beecham, the new company, Glaxo SmithKline, will be the world’s biggest pharmaceuticals firm with 7.3% of global sales. The deal raised concerns about (...)

The European Commission conditionally approves a merger in the pharmaceutical sector leading to the creation of the world’s largest pharmaceuticals company (Glaxo Wellcome/SmithKline Beecham)
Service européen pour l’action extérieure (EEAS)
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Financial Conduct Authority (FCA)
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European Commission - DG COMP (Brussels)
"Merger Control: main developments between 1st May 2000 and 31st August 2000"* Resulting from the merger between Glaxo Wellcome and SmithKline Beecham, the new company, Glaxo SmithKline, will be the world’s biggest pharmaceuticals firm with 7.3% of global sales. The deal raised concerns about (...)

A French Tribunal in charge of social security cases applied to the ECJ for a preliminary ruling asking whether a taxation’s exemption can be considered as not constituting State aid but mere compensation of public service costs (Ferring)
CRDEI - Centre de Recherche et de Documentation Européennes et Internationales
The important case law of the ECJ often finds its origin in a preliminary question raised by national judges of first instance (e. g. ECJ, April 30th, 1986, Asjes a. o., Joined Cases 209/84 209/84, 210/84, 211/84, 212/84, 213/84 and 213/84, [1986] ECR 1425, “Nouvelles Frontières”, preliminary (...)

The European Commission revokes its decision to clear a merger in the pharmaceutical sector because the clearance was based on incorrect information (Sanofi/Synthélabo)
European Commission - DG TRADE
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European Commission - DG TRADE
"Mergers: Recent developments and important decisions"* Pursuant to Article 6(3)(a) of the EC Merger Regulation, the European Commission revoked its decision of 15 March 1999, which cleared the merger of Sanofi, controlled by the Elf-Aquitaine group and Synthélabo, controlled by the L’Oréal (...)

The European Commission requires for the first time remedies to clear a concentration in the pharmaceutical sector (Astra/Zeneca)
European Commission - DG TRADE
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European Commission - DG TRADE
"Mergers: Recent developments and important decisions"* The decision in Astra/Zeneca marks the first time in the pharmaceutical sector where commitments were required to clear the concentration. In view of the ongoing consolidation of the pharmaceutical industry, such situations may become (...)

The EU Commission approves the creation of a joint venture in the pharmaceutical sector between a French company and a US company (Sanofi / Bristol-Myers Squibb)
European Commission - DG COMP (Brussels)
"Mergers : other developments"* The Commission approved the creation of a joint venture in the pharmaceutical sector between the French company Sanofi and the US company Bristol-Myers Squibb. The purpose of the cooperation is the development, manufacture and commercialisation of two new (...)

The European Commission clears, subject to divestiture, a merger in the pharmaceutical industry (Hoffmann-La Roche/Boehringer Mannheim)
European Commission - DG TRADE
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"Mergers Recent important decisions" In September 1997, the Swiss pharmaceutical company Hoffmann-La Roche proposed to acquire Corage Ltd., ultimate parent company of the Boehringer Mannheim Group (BM). After a preliminary appreciation of the case the Commission concluded that in clinical (...)

The European Commission approves, subject to remedies, a merger in the health care, animal feed, crop protection and seeds sectors (Ciba-Geigy / Sandoz)
European Commission - DG GROW
"Mergers : Summary of the most important recent developments"* On 17th July, after four months of extensive investigations, the Commission approved the proposed merger between Ciba-Geigy and Sandoz into Novartis. The decision was granted under the condition that the parties comply with an (...)

The European Commission refers a proposed concentration in the wholesale and retail of pharmaceutical products to the competent UK authorities (GEHE/Lloyds)
"Mergers : Summary of the most important recent developments"* On 22nd March the Commission decided that the public bid by GEHE for Lloyds the Chemists should be referred to the competent United Kingdom authorities for further investigation. Through its AAH subsidiary, GEHE is currently the (...)

The European Commission acknowledges commitments offered by Danish pharmaceutical company in a case of abuse of dominant position in the market for insulin (Novo Nordisk)
European Commission - DG COMP (Brussels)
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European Commission - 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 (...)

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

The Belgian Competition Authority carries inspections at several undertakings active in the wholesale distribution of pharmaceutical and para-pharmaceuticals products to pharmacies
Belgian Competition Authority (Brussels)
The Belgian Competition Authority confirms inspections at several companies active in the wholesale distribution of pharmaceutical and para-pharmaceuticals products to pharmacies* The Investigation and Prosecution Service of the Belgian Competition Authority (hereafter “BCA”) confirms that the (...)

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

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

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

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

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

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

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

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

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

The Belgian Competition Authority raids several undertakings active in the sale of over-the-counter products pharmacies
Belgian Competition Authority (Brussels)
The Belgian Competition Authority confirms inspections at several undertakings active in the sale of non-prescription products in pharmacies* The Investigation and Prosecution Service of the Belgian Competition Authority (hereafter “BCA”) confirms that the BCA has conducted inspections this week (...)

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

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

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

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

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

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

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

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