Pharma & Dominance

Anticompetitive practices

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

The French Competition Authority carries out an inquiry in the area of prescription medicine distribution in private practices
French Competition Authority (Paris)
Press Release published on the official website of the French Competition Authority. The Autorité de la concurrence is submitting to public consultation an initial assessment in which it has identified several potential sticking points* Medicinal products are the second-largest (...)

The US Supreme Court rules that the “pay for delay” settlements in the pharmaceutical sector are to be analyzed under the rule of reason (Actavis)
European Commission - DG Internal Market and Services
Facts In 1999, Solvay Pharmaceuticals filed a New Drug Application (NDA) for a topical testosterone hormone drug, called Androgel. In 2003, Solvay obtained patent protection for it. Subsequently, the generic companies Actavis (before Watson Pharmaceuticals) and Paddock Laboratories filed an (...)

The UK OFT issues a statement of objections to four pharma manufacturers for anticompetitive agreements over the supply of paroxetine (GSK / GUK / Alpharma / IVAX)
Ashurst (Milan)
UK OFT investigates GSK and generics manufacturers over pay for delay deals* On 19 April 2013 the UK Office of Fair Trading (“OFT”) issued a Statement of Objections to GlaxoSmithKline (“GSK”) and three generics manufacturers (Alpharma Limited, Generics UK Limited and Norton Healthcare Limited) (...)

The UK OFT issues statement of objections to four pharma companies alleging they acted to delay effective competition in the national supply of an antidepressant medicine (GSK / GUK / Alpharma / IVAX)
Blackstone Chambers
To fight or not to fight: pharmaceutical patent settlements* On 19 April 2013, the OFT announced that it had issued a Statement of Objections following its investigation into patent litigation settlement agreements (PLSAs) in the pharmaceutical sector. The underlying factual complaint related (...)

The French Competition Authority issues an opinion on the generalisation of complementary health insurance
French Competition Authority (Paris)
Press Release published on the official website of the French Competition Authority. The Autorité de la concurrence recommends that each company remain free to choose its complementary health insurance body*. On 1 February 2013, the Association pour la promotion de l’assurance collective (APAC) (...)

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

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

The French Competition Council authorises pharmaceutical laboratories’ practices concerning drugs parallell imports and exports on the basis of both French and EC provisions (Pharma-Lab / GlaxoSmithKline)
Gide Loyrette Nouel (Paris)
Pharma-Lab, Pharmajet, Pharmadex TMC, European Trade Company (ETC) and AD Pharm export drugs bought at the government-fixed price from pharmaceutical laboratories and sell them abroad for a higher price. These companies claimed to suffer from delivery restrictions, discriminatory commercial (...)

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

Dominance

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 (...)

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 (...)

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 (...)

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

The 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 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)
Ashurst (Milan)
Italy’s Council of State reinstates the fine imposed on Pfizer for delaying a generic’s market entry* On 12 February 2014, Italy’s Council of State (the “CdS”) dismissed the ruling of the lower administrative court (the “TAR Lazio”) which quashed the decision of Italian Competition Authority (the (...)

The 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 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 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 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 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
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 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
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 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 (...)

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)
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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 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)
Ashurst (Milan)
ECJ rejects appeal relating to abuse of the patent system and the procedures for marketing of drugs* On 6 December 2012, the European Court of Justice (“ECJ”) handed down its ruling rejecting AstraZeneca’s (“AZ”) appeal in relation to the Losec case. In the first instance, the General Court largely (...)

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

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

The Italian Competition Authority fines 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 (...)

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 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 German Competition Authority orders a producer of laboratory chemicals to cease discriminatory treatment of its customers (Merck)
Van Bael & Bellis (Brussels)
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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 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)
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Arendt & Medernach (Luxembourg)
I. The parties The plaintiff is an independent Belgian dispensing chemist. The defendant is Omega Pharma NV (here after “Omega Pharma”) an important supplier of raw material and packaging products also active in the field of “Over-The-Counter” products (OTC-products). The decision analysed is (...)

The UK Department of Health seeks antitrust damages after 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 (...)

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
United Kingdom: Early Resolution Agreement in Reckitt Benckiser Abuse Case On 15 October 2010, the OFT announced that it had agreed to reduce the proposed fine by £ 1,800,000 (about € 1,162,040) to £ 10,200,000 (about € 6,584,893), following Reckitt Benckiser’s admission and decision to co-operate (...)

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

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

The EU General Court upholds “novel” approach to abuse of dominance in pivotal pharma appeal (AstraZeneca)
Linklaters (Brussels)
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Linklaters (Brussels)
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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)
Ashurst (Milan)
French Competition Authority probes Sanofi-Aventis alleged abuse against generic manufacturers* On 17 May 2010, the French Autorité de la concurrence (French Competition Authority, “FCA”) determined to open a fully fledged investigation (under Article 102 TFEU) into Sanofi-Aventis allegedly (...)

The French 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 (...)

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

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

The French Competition Authority rejects request for interim measures in pharmaceutical sector (Ratiopharm, Janssen-Cilag France)
Van Bael & Bellis (Brussels)
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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 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 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 (...)

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

The Turkish competition 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 (Istanbul)
The Turkish Competition Board (hereinafter referred to as “CB”) had re-evaluated the allegations about the abuse of dominant position by Roche Mustahzarları A.S. (hereinafter referred to as “Roche”), upon the annulment decision of the 13th Chamber of the State Council numbered 31.03.2008 and (...)

The EU Court of Justice issues judgment on restrictions of parallel trade in 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, (...)

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)
,
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)
,
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 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 French Competition Council renders a landmark interim decision on competition between princeps and generics (Arrow / Schering-Plough)
Fréget - Tasso de Panafieu Avocats (Paris)
,
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 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 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 Paris Court of Appeal rejects the complaint of a French wholesaler-exporter of pharmaceutical products and allows quotas and refusals to sell (Pharma-Lab)
Total (London)
On 23 January 2007, the Paris Court of Appeal (hereinafter the “Court”) issued a judgment in which it dismissed an appeal filed against a decision rendered by the French Competition Council (the “Council”) pursuant to Articles 81 and 82 EC and national provisions similar to those articles. In this (...)

The 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 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 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)
,
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 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)
,
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)
,
European Commission - DG COMP
"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
,
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 (...)

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 Italian competition authority imposes for the first time interim measures on the basis of Art. 82 EC (Merck, Carbapenem)
Freshfields Bruckhaus Deringer (Rome)
,
Freshfields Bruckhaus Deringer
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 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 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
,
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 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 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
,
European Commission - DG COMP
"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 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 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
,
European Commission - DG COMP
"Novo Nordisk"* Undertakings have been accepted from Novo Nordisk, the Danish pharmaceutical company, which are designed to ensure competition in the markets for components of Novo Nordisk‘s insulin self-injection delivery systems. Novo Nordisk is Europe’s leading insulin producer. In 1985 Novo (...)

Procedures

The 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 UK Competition Appeals Tribunal receives the first claim for damages based on abuse of dominant position (Healthcare at Home / Genzyme)
White & Case (London)
,
White & Case (London)
Healthcare at Home Limited (“HH”) has brought a claim for damages before the Competition Appeals Tribunal (“CAT”) against Genzyme Limited (“GL”) pursuant to section 47A of the Competition Act 1998. This is the third claim for damages to have been brought before the CAT pursuant to section 47A of the (...)

Regulations

The French Competition Authority issues an opinion on the deployment of optical fibre networks in moderately dense areas
French Competition Authority (Paris)
Press Release published on the official website of the French Competition Authority. The Autorité de la concurrence is in favour of a regulation that reconciles investment incentives and the preservation of competition*. After having issued an opinion in September 2009 at the request of the (...)

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