Latest Special issue: Competition in the Pharmaceutical sector

Anticompetitive practices

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

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

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

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

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

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

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

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

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

The EU Court of Justice dismisses appeals against 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 (Brussels)
Under EU case law, an undertaking can be held responsible for the actions of a person who is authorised to act on its behalf, regardless of any action or knowledge on the part of the managers of that undertaking. Consequently, the Commission may impose fines on an undertaking if it has shown (...)

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

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

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

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

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

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

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

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

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

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

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

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

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 (Brussels)
On 17 March 2016, Advocate General Wathelet issued his opinion on a request for a preliminary ruling from the Paris Court of Appeal, which inquired as to whether Article 101 TFEU precludes a licensee from paying royalties pursuant to a licensing agreement when the patent, which is the subject (...)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Italian Competition Authority accepts commitments to amend a co-marketing agreement and closes the antitrust investigation (Novartis / Italfarmaco)
Bonelli Erede (Rome)
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Bonelli Erede (Rome)
With Decision No. 25508 of 4 June 2015, the Italian Competition Authority (the “ICA”), accepted the commitments proposed by Novartis Farma S.p.A. (“Novartis”) and Italfarmaco S.p.A. (“Italfarmaco”, together the “Parties”) and closed the investigation opened following a complaint lodged by the (...)

The Indian Competition Commission fines pharmaceutical companies for bid rigging in a public tender (GlaxoSmithKline, Sanofi)
Amit Sibal (New Delhi)
CCI fines GSK and Sanofi for bid rigging* It has been quite a while since I posted an India update on Cartel Capers. This was partly due to the fact that the CCI has been relatively quiet on the cartel front for the last few months and partly because I have also been relatively busy with (...)

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

The US FTC reaches record $1.2 billion proposed “pay for delay” settlement and injunctive relief restricting future similar settlements of patent infringement cases (Cephalon)
Weil, Gotshal & Manges (New York)
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Weil, Gotshal & Manges (New York)
Federal Trade Commission Reaches Record $1.2 Billion Proposed “Pay for Delay” Settlement with Cephalon and Injunctive Relief Restricting Future Similar Settlements of Patent Infringement Cases* Last week, on the eve of trial, the Federal Trade Commission (“FTC”) reached a proposed settlement in (...)

The US FTC reaches settlement in post-Actavis reverse payment case (Cephalon)
Gibson Dunn (Washington)
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O’Melveny & Myers (Los Angeles)
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Debevoise & Plimpton (Washington, D.C.)
The Federal Trade Commission (“FTC”) has reached a settlement resolving its claims that Cephalon, Inc. violated the antitrust laws by entering into reverse payment settlements to delay generic competition for Provigil. This is the first FTC settlement of a reverse payment case post-Actavis, and (...)

The US FTC reaches a settlement with a pharmaceutical company and continues march “to set a standard for the industry” in pay-for-delay settlements cases (Cephalon)
Sheppard Mullin (Los Angeles)
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Sheppard Mullin (Washington)
Federal Trade Commission Continues March “to Set a Standard for the Industry” with Cephalon Settlement* On May 28, the Federal Trade Commission (“FTC”) announced it had reached a $1.2 billion settlement with Teva Pharmaceuticals, which acquired Cephalon in 2012, over reverse payment for its (...)

The California Supreme Court delineates a structured rule of reason analysis for evaluating reverse payments or pay-for-delay settlements (Cipro)
Sheppard Mullin (Los Angeles)
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Sheppard Mullin (Washington)
California Supreme Court Delineates a Structured Rule of Reason Analysis for Evaluating Reverse Payment or Pay-for-Delay Settlements* On May 7, 2015, the California Supreme Court issued its long-awaited decision in In re Cipro Cases I & II, Case No. S198616 (May 7, 2015) (Cipro). Cipro (...)

The California Supreme Court crafts "structured rule of reason" test for evaluating pay-for-delay settlements (Cipro)
Siemens (New York)
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Patterson Belknap Webb & Tyler (New York)
Following Actavis, California Supreme Court Crafts “Structured Rule of Reason” Test for Evaluating Pay-for-Delay Settlements* Last Thursday the Supreme Court of California decided In re Cipro Cases I & II, No. S198616 (Cal. May 7, 2015), holding that reverse payment, or “pay-for-delay,” (...)

The Mexican Supreme Court of Justice upholds the decision of the Competition Authority concerning a bid-rigging in the pharmaceutical sector (Baxter, Fresenius, Eli Lilly and Pisa)
Mexican Competition Authority (Mexico city)
The Supreme Court of Justice decides on bid rigging in social security public tenders case* The Mexican Supreme Court of Justice (SCJ) confirmed the legality of a resolution issued by the extinct Federal Competition Commission in 2010, against pharmaceutical enterprises Baxter, Fresenius, Eli (...)

The Australian Competition Authority launches its 2015 compliance and enforcement policy, aiming at tougher penalties
Corrs Chambers Westgarth (Sydney)
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Corrs Chambers Westgarth
Striving for tougher penalties: The ACCC’s New Enforcement Priorities 2015 Share* On 19 February 2015, ACCC Chairman, Rod Sims, launched the ACCC’s 2015 Compliance and Enforcement Policy (Policy). The Policy sets out the ACCC’s priority areas for 2015 and factors that will be taken into account (...)

The India Competition Commission clears an alleged cartel for lack of evidence and provides guidance on cross-examination issues (Confederation of Real Estate Developers’ Association of India)
Amit Sibal (New Delhi)
CCI finds no evidence of a cartel amongst builders but still passes strong observations against exploitative and unfair practices adopted by these builders* The CCI recently closed its investigation into an alleged cartel among builders in India finding insufficient evidence of a cartel (...)

The Indian Competition Commission finds that agreements between pharmaceutical companies and trade associations would not qualify as horizontal nor vertical agreements but could nonetheless be examined under the general prohibition on anti-competitive agreements (Himachal Pradesh Chemist and Druggist Association)
Amit Sibal (New Delhi)
Another chemist and druggist association penalised* In its ninth decision against various chemist and druggist trade associations in India, the Competition Commission of India (CCI) fined the Himachal Pradesh (a state in India) Chemist and Druggist Association 10% of its average turnover for (...)

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

The US District Court for the Eastern District of Pennsylvania holds that Actavis does not require plaintiffs to meet any sort of “threshold burden” for establishing that a large reverse payment is unjustified to trigger analysis under the antitrust rule of reason (Modafinil)
Labaton Sucharow (New York)
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Arnold & Porter Kaye Scholer (Washington)
In re Modafinil Litigation Finds No “Threshold Burden” in Reverse Payment Suit* On Wednesday, January 28, in King Drug Company of Florence, Inc. v.Cephalon, Inc. (In re Modafinil), the US District Court for the Eastern District of Pennsylvania held that FTC v. Actavis, 133 S. Ct. 2223 (2013), (...)

The Italian Competition Authority decides that the commitments submitted in order to alleviate concerns in terms of an alleged infringement of Art. 101 TFEU should have been published (Arca / Novartis-Italfarmaco)
DG COMP (Brussels)
The Italian Competition Authority (AGCM) decided that, according to Art. 14-ter of Italian Law 287/1990, the commitments that Novartis and Italfarmaco had submitted in order to alleviate concerns in terms of an alleged infringement of Art. 101 TFEU, should have been published, both in its (...)

The Italian Administrative Tribunal fines two pharmaceutical companies for colluding to create an artificial product differentiation in order to influence the prescriptions of doctors and health services in favor of the more expensive product (Roche, Novartis)
Ashurst (Milan)
Italian court confirms hefty fines on Novartis and Roche* On 2 December 2014, Italy’s Tribunale Amministrativo Regionale del Lazio (“TAR Lazio”) handed down its ruling (only available in Italian) concerning the alleged anticompetitive agreement between Roche and Novartis in the market for (...)

The Italian Administrative Court upholds the condemnation of two pharmaceutical companies for breaching Article 101 TFEU with regard to the marketing (Roche, Novartis)
Desogus Law Office (Cagliari)
By a recent judgment in the case Novartis-Roche/AGCM the Regional Administrative Court of Latium (the Court) has uphold on appeal the decision made by Italian Competition Authority (ICA) in the Roche/Novartis case. The ICA had imposed on Roche and Novartis a fine of Euro 180 million for an (...)

The Competition Commission of India fines chemists trade association for continuing to violate its order (Chemists and Druggists Association)
Amit Sibal (New Delhi)
Competition Commission of India fines chemists trade association for continuing violation of its order* On 27 October 2014, the Competition Commission of India (CCI) following a complaint filed by M/s Xcel Healthcare, a stockist for pharmaceuticals in the state of Goa, found that the Chemists (...)

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

The German Competition Authority following its cartel proceeding forces an association of pharmacists to forego an anticompetitive clause in the sale of blood glucose strips market (AVWL)
German Competition Authority (Bonn)
Bundeskartellamt strengthens competition in the sale of blood glucose strips in Westphalia-Lippe* The Bundeskartellamt has concluded its cartel proceeding against the pharmacists association in Westphalia-Lippe (Apothekerverband Westfalen-Lippe e.V. Apothekerverband Westfalen-Lippe e.V. (...)

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

The US District Court for the District of New Jersey reminds that even if a Court accepts the premise of a reverse non-monetary payment after Actavis, plaintiffs may have to allege facts to allow an estimate of the monetary value of that settlement or risk facing dismissal (Lipitor)
Siemens (New York)
,
Patterson Belknap Webb & Tyler (New York)
Plausibly Alleging Non-monetary Settlements as Reverse Payments After Actavis* In In re Lipitor Antitrust Litigation, No. 12 Civ. 2389 (D.N.J.), U.S. District Judge Peter G. Sheridan has confirmed his prior ruling that under the Supreme Court’s decisions in Twombly, Iqbal, and FTC v. Actavis, (...)

The US FTC files a federal antitrust complaint for the Eastern District of Pennsylvania for entering into an agreement to maintain a monopoly over and restrain generic competition (AbbVie, Abbott, Besins Healthcare and Teva)
Skadden, Arps, Slate, Meagher & Flom (New York)
,
Skadden, Arps, Slate, Meagher & Flom (Washington DC)
,
Skadden, Arps, Slate, Meagher & Flom (New York)
On September 8, 2014, the Federal Trade Commission (FTC) filed a federal antitrust complaint in the United States District Court for the Eastern District of Pennsylvania against defendants AbbVie, Abbott Laboratories, Unimed Pharmaceuticals, Besins Healthcare and Teva Pharmaceuticals alleging (...)

The US FTC files a complaint before the District Court for the Eastern District of Pennsylvania asserting that reverse payments do not have to be cash or monetary in order to violate antitrust laws (AbbVie)
Constantine Cannon (New York)
Regulators Prescribing Higher Dose Of Pharmaceutical Antitrust Enforcement* Antitrust enforcers returned to their offices after Labor Day, refreshed and ready to tackle what they view to be anticompetitive practices by pharmaceutical companies to delay entry of lower-priced generic drugs. In (...)

The US FTC files a complaint against five pharmaceutical companies for pay-for-delay settlements (AbbVie)
Skadden, Arps, Slate, Meagher & Flom (New York)
,
Skadden, Arps, Slate, Meagher & Flom (Washington DC)
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Skadden, Arps, Slate, Meagher & Flom (New York)
On September 8, 2014, the Federal Trade Commission (FTC) filed a federal antitrust complaint in the United States District Court for the Eastern District of Pennsylvania against defendants AbbVie, Abbott Laboratories, Unimed Pharmaceuticals, Besins Healthcare and Teva Pharmaceuticals alleging (...)

The U.S. District Court for the District of Rhode Island issues concerning ruling on drug patent settlements (Loestrin)
Rutgers University
On September 4, 2014, Judge William Smith of the U.S. District Court for the District of Rhode Island issued a concerning ruling on drug patent settlements. In In re Loestrin 24 FE Antitrust Litigation, 2014 WL 4368924 (D.R.I., Sept. 4, 2014), Judge Smith misapplied the Supreme Court’s landmark (...)

The US District Court for the Eastern District of Pennsylvania holds that a firm which has engaged in fraud on the patent office cannot stand on its patent to defend reverse payment antitrust claims (Cephalon)
Sheppard Mullin (San Francisco)
,
Paul Hastings (Washington)
Last year in a landmark decision, the Supreme Court ruled that pharmaceutical “reverse payment” settlements in Hatch-Waxman Act “Paragraph 4” patent litigation are subject to challenge, departing from the rule that most Circuits had adopted. FTC v. Actavis, 133 S.Ct. 2223 (2013). In these cases, (...)

The EU Commission imposes a fine of € 427.7 million on a French pharma manufacturer and five generic companies as regards pay-for-delay settlements impeding price competition on the market for blood pressure medicines (Servier)
University of East Anglia - CCP (Norwich)
Article published on Centre for Competition Policy blog. The EU Commission Decision against Servier – a New Dimension to European Pharmaceutical Antitrust?* On 9 July 2014 the European Commission announced its decision to impose a fine of €427.7 million on French drug maker Servier and five (...)

The US FTC files an amicus brief in the Court of Appeals explaining that commitment not to compete raises the same antitrust concerns as the reverse-payment patent settlements (King Drug / SmithKlineBeecham)
DLA Piper Weiss-Tessbach (Vienna)
U.S. FTC files an amicus brief in the Court of Appeal urging to reverse the District Court finding in the Lamictal Direct Purchase Antitrust Litigation* On 28 April, 2014 the Federal Trade Commission (“FTC”) filed an amicus brief in the Court of Appeals for the Third Circuit in the (...)

The Supreme Arbitration Court of the Russian Federation refuses to transfer a claim in a case on bid-rigging at an auction for supplying anti-tuberculosis drugs (Medical Leasing Consulting)
Russian Federal Antimonopoly Service (Moscow)
The Supreme Arbitration Court of the Russian Federation drew a line in a case on bid-rigging at an auction for supplying anti-tuberculosis drugs* On 31st March 2014, the Supreme Arbitration Court of the Russian Federation refused to transfer a claim of “Medical Leasing Consulting” Ltd. to the (...)

The Moscow Appeal Court upholds the decision of the Russian Competition Authority having sanctioned two pharmaceutical companies for bid-rigging (Rosta and Pharmstandart)
Russian Federal Antimonopoly Service (Moscow)
An Appeal Court confirmed legitimacy of a 200-million RUB fine imposed upon “Pharmstandart” OJSC for bid-rigging* On 24th March 2014, the 9th Arbitration Appeal Court pronounced legitimacy of holding “Pharmstandart” OJSC administratively liable and fining the company over 201 million RUB. In (...)

The Russian Competition Authority proposes solutions to resolve problems in the pharmaceutical market
Russian Federal Antimonopoly Service (Moscow)
FAS solutions to the problems on the pharmaceutical market* On 28th February 2014, at the 13th Global Competition Forum, of the Organization for Economic Cooperation and Development (OECD) in Paris, Deputy Head of the Federal Antimonopoly Service (FAS Russia), Andrey Tsyganov, moderated a (...)

The Italian Competition Authority establishes an anticompetitive agreement in the market for ophthalmic drugs used to treat vascular eyesight diseases (Roche / Novartis)
Ashurst (Milan)
Italian Competition Authority imposes hefty fines on Roche and Novartis* On 27 February 2014, the Italian Competition Authority (“ICA”) issued a decision (in Italian only) finding that Roche and Novartis entered into an anticompetitive agreement in the market for ophthalmic drugs used to treat (...)

The Italian Competition Authority fines a pharmaceutical company for having “artificially differentiated” their medicinal products in breach of Article 101 TFEU (Roche-Novartis/Farmaci Avastin e Lucentis)
Bonelli Erede (Rome)
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Bonelli Erede (Rome)
In its decision of 27 February 2014, the Italian Competition Authority (the “ICA” or the “Authority”), following the complaints lodged by the Italian Ophthalmological Society (“SOI” - Società oftalmologica italiana) and an association of private healthcare hospitals (“AIUDAPDS” - Associazione Italiana (...)

The New Zealand Commerce Commission issues warning over no discounting clause implemented by community pharmacies association (DHB / Pharmacy Guild)
Steve Szentesi Law Corporation (Vancouver)
Antitrust & Associations: Recent New Zealand Case a Reminder that Voluntary Industry Associations are Not Price Regulators* A New Zealand association related case announced today is a recent reminder that voluntary industry associations are not price regulators (see: Commission issues (...)

The New Zealand Commerce Commission issues warning pursuant to the removal of the restrictive clause from the community pharmacy services agreement (DHB / Pharma Association)
New Zealand Commerce Commission (Wellington)
Press releases published on New Zealand Commerce Commission Commission issues warning over ‘no discounting’ clause* The Commerce Commission has warned all New Zealand District Health Boards (DHBs) and pharmacies nationwide that “no discounting” clauses in the 2012 Community Pharmacy Services (...)

The Italian Competition Authority opens an Article 101 TFEU investigation into bid-rigging practices in the health sector (Octreotid Supplies)
Desogus Law Office (Cagliari)
The Italian Competition Authority (ICA) will investigate into bid rigging practices that are thought to have affected a number of tender procedures organized by some regional health authorities for the award of contracts for the supply of a tumour drug (Case I770 Octreotid Supplies). The facts (...)

The Lithuanian Competition Council closes an investigation and accepts remedies on vertical restraints implemented by several pharmaceutical undertakings and gives a recommendation to the Ministry of Health on ways to promote parallel imports of pharmaceuticals
Max Planck Institute for Innovation and Competition (Munchen)
On 21 July 2011 the Competition Council terminated the investigation on compliance of actions of several pharmaceutical undertakings with Article 5 of the Law on Competition and Article 101 TFEU by accepting commitments (Article 30(2) point 2 [now Article 28(3) point 2] of the Law on (...)

The EU Commission imposes fines of € 16M on pharmaceutical companies for delaying market entry of generic pain-killer (Johnson & Johnson and Novartis)
European Commission
European Commission imposes Fines of € 16 000 000 on Johnson & Johnson and Novartis for delaying Market Entry of generic Pain-Killer Fentanyl* On 10 December 2013, the European Commission imposed fines of € 10 798 000 on the US pharmaceutical company Johnson & Johnson (J&J) and € 5 (...)

The EU Commission publishes its fourth report on the monitoring in Europe of patent settlements
White & Case (Brussels)
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White & Case (Brussels)
Executive Summary On 9 December 2013, DG Comp published its fourth report on the monitoring in Europe of patent settlements. Like its predecessors, the report welcomes the continuously low level of settlements that may give rise to antitrust concerns and trumpets that the overall number of (...)

The Canadian Competition Bureau announces new regulatory intervention efforts into the regulation of pharmacists in Alberta
Steve Szentesi Law Corporation (Vancouver)
Competition Bureau Announces First New Advocacy Initiative: Self-regulated Professions (Pharmacist Inducements in Alberta): Patient Care v. Competitive Markets* On September 10th, the Canadian Competition Bureau announced a public consultation for suggestions where it should intervene in (...)

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)
University of Bristol - Law School
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 Slovenian Competition Authority finds that pharmaceutical wholesalers engaged in illegal price fixing and market sharing in selling medicines for human use to public pharmacies (Kemofarmacija, Salus, Farmadent and Gopharm)
European Commission
Slovenia: Agreement/Concerted practice in the Pharmaceutical Sector* On 14 October 2013, the Slovenian Competition Protection Agency (CPA) issued a decision finding that four Slovenian wholesalers of pharmaceuticals, namely Kemofarmacija, Salus, Farmadent and Gopharm, infringed Article 6 of (...)

The Moldovan Competition Authority investigates the actions of the Customs Service concerning attribution of tariff positions to certain pharmaceutical products (Serviciul Vamal al Republicii Moldova)
Faculty of Law - University of Macau
On 26 September 2013 the Moldovan Competition Authority (CC) closed its investigation into the alleged anti-competitive actions of the Customs Service of the Republic of Moldova concerning the determination of the tariff positions for certain imported pharmaceuticals. The CC’s investigation (...)

The French Civil Supreme Court misinterprets the Pierre Fabre ECJ jurisprudence and quashes a distribution agreement provision on the basis of Article 101 TFEU (Pierre Fabre Dermo-Cosmétique)
Skadden, Arps, Slate, Meagher & Flom (Brussels)
In a decision issued on September 24, 2013, the French Court of Cassation decided a case about vertical restraints involving Pierre Fabre dermo-cosmétique (PFDC) and three of its distributors: Caribéenne de diététique et santé (CDS), Compagnie de diététique du marin (CDM) and Martinique alimentation (...)

The Shanghai Higher Court decides on the first private antitrust action involving vertical agreements (Rainbow / Johnson & Johnson)
AnJie Law (Beijing)
On August 1 2013, Shanghai People’s High Court (the Court) handed down judgment on the first private antitrust action involving vertical agreements under the minimum resale price maintenance (RPM) clause of China’s Anti-monopoly Law (AML). The Court rescinded the judgment of the first instance (...)

The Shanghai Higher Court and one of China’s antitrust regulators issues decisions that resale price maintenance violated China’s Anti-Monopoly Law (Rainbow / Johnson & Johnson)
Jones Day (Beijing)
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Gibson Dunn (Hong Kong)
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Jones Day (Beijing)
Within the same week, the Shanghai Higher Court and one of China’s antitrust antitrust regulators have issued decisions that resale price maintenance ("RPM") violated China’s Anti-Monopoly Law ("AML"). The decision of the Shanghai Higher Court involved an agreement between Johnson & Johnson (...)

The Danish Competition Council accepts commitments from a purchasing association for pharmacists in relation to decision to exclude a member (Uldum Apotek / A-apoteket)
Danish Competition and Consumer Authority (Copenhagen)
Competition Council accepts commitments from Denmark’s largest purchasing association for pharmacists* On 26 June 2013 the Danish Competition Council accepted commitments from A-apoteket – a purchasing association for pharmacists – on the basis of concerns that a decision taken by the association (...)

The EU Commission fines pharmaceutical companies for delaying market entry of generic medicines (Lundbeck)
Ashurst (Milan)
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RSM US (New York)
European Commission fines Lundbeck and other pharmaceutical companies for delaying market entry of generic medicines* On 19 June 2013 the European Commission issued a press release stating that it had imposed fines in the amount of € 93,8 million on Lundbeck (a Danish pharmaceutical company) (...)

The EU Commission imposes fines totalling € 145 M on Danish pharmaceutical group over “pay-for-delay” agreements (Lundbeck)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
On 19 June 2013, the European Commission announced that it had imposed a fine of € 93.8 million on Danish pharmaceutical group Lundbeck and fines totalling € 52.2 million on several generic medicines producers over their conclusion of so-called “pay-for-delay” agreements intended to hinder the (...)

The EU Commission fines pharmaceutical companies for delaying market entry of generic medicines through pay-for-delay agreements (Lundbeck)
European Commission
European Commission: Lundbeck and other Pharmaceutical Companies fined for delaying Market Entry of Generic Medicines through pay-for-delay Agreements* On 19 June 2013, the European Commission (the Commission) imposed a fine on the Danish pharmaceutical company Lundbeck and a number of (...)

The EU General Court dismisses appeals in aluminium fluoride cartel case (Fluorsid, Minmet and Société des Industries Chimique du Fluor)
Van Bael & Bellis (Brussels)
On 18 June 2013, the General Court (“GC”) dismissed appeals by three companies implicated in the aluminium fluoride cartel against a European Commission decision of June 2008 imposing fines on them for infringing Article 101(1) TFEU. In its decision, the Commission found that, in July 2000, (...)

The US Supreme Court holds that “reverse payment” patent settlements between brand-name drug manufacturers and would-be generic competitors should be reviewed under the antitrust rule of reason (Actavis)
Arnold & Porter Kaye Scholer (Brussels)
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Latham & Watkins (San Francisco)
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Arnold & Porter Kaye Scholer (Washington)
On Monday, June 17, the Supreme Court handed down a decision in FTC v. Actavis, Inc., bringing some clarity to the antitrust treatment of so-called reverse payment patent settlements between brand-name drug manufacturers and would-be generic competitors, but leaving many open questions as (...)

The US Supreme Court issues first ruling on antitrust legality of reverse-payment drug patent settlements (Actavis)
Rutgers University
On June 17, 2013, in FTC v. Actavis, the U.S. Supreme Court for the first time examined the antitrust legality of agreements by which brand-name drug companies pay generics to delay entering the market. Justice Stephen Breyer wrote the majority opinion for five Justices, concluding that these (...)

The US Supreme Court establishes a rule that blurs the lines between antitrust and patent law (Actavis)
Sheppard Mullin (Chicago)
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Sheppard Mullin (Washington)
FTC v. Actavis: What Does It Mean for Reverse-Payment Settlements?* On June 17, 2013, the United States Supreme Court announced a rule that blurs the lines between antitrust and patent law in the context of Hatch-Waxman litigation. In FTC v. Actavis, 570 U.S. 756 (2013), the Federal Trade (...)

The US Supreme Court holds that reverse-payment patent settlements should be reviewed under the antitrust rule of reason (Actavis)
Gibson Dunn (Washington)
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O’Melveny & Myers (Los Angeles)
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O’Melveny & Myers (Los Angeles)
But Decision Raises as Many Questions as it Answers The Supreme Court yesterday held that it may be unlawful under the antitrust laws for a brand-name drug manufacturer to resolve patent litigation against an allegedly infringing generic drug maker by paying the generic to forestall market (...)

The US Supreme Court opens reverse payment patent settlement agreements to antitrust challenge (Actavis)
Wolters Kluwer (Riverwoods)
A “reverse payment” settlement agreement is not entitled to “near-automatic antitrust immunity” simply because its anticompetitive effects fall within the scope of the exclusionary potential of the patent, the U.S. Supreme Court ruled earlier this week in a five-to-three decision. Although such (...)

The US Supreme Court rules that a payment by a patentee to a generic manufacturer may constitute an infringement of antitrust law (Actavis)
Orrick, Herrington & Sutcliffe (San Francisco)
Why FTC v. Actavis Won’t Shift the Border Between IP and Antitrust Law* The Supreme Court’s recent decision in Federal Trade Commission v. Actavis, Inc., No. 12-416, ___ U.S. ___ (2013), has generated a lot of commentary recently. Some articles have suggested that the decision may expose certain (...)

The US Supreme Court holds that patent protection does not confer immunity from antitrust attack (Actavis)
Ashurst (Milan)
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RSM US (New York)
U.S. Supreme Court reverses Eleventh Circuit opinion in FTC v. Actavis, Inc* On 17 June 2013, the U.S. Supreme Court (“the Court”) reversed a decision by the Court of Appeals (Eleventh Circuit). The Court of Appeals had upheld a dismissal of a complaint made by the Federal Trade Commission (...)

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 CNECT (Brussels)
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 (London)
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 US FTC asks the Eleventh Circuit to overturn a lower court’s decision to allow a reverse-payment settlement between branded and a generic pharmaceutical manufacturers (Watson Pharmaceuticals)
Vinson & Elkins (Washington)
,
Reese Gordon Marketos
A growing consensus among federal courts that so-called “reverse-payment” settlements rarely violate antitrust law has not tempered antitrust enforcement authorities’ opposition to such deals. In the pharmaceutical industry, brand-name drug manufacturers may file patent infringement lawsuits (...)

The German Competition Authority issues a fining decision against manufacturers of drugstore products (KWR working group)
Steve Szentesi Law Corporation (Vancouver)
Associations & Information Exchanges – German Case Highlights Importance of Commonsense Precautions to Reduce Competition Risk* Readers of my blog will know that I do a lot of work with trade and professional associations. In this regard, a topic that perennially arises (and which I (...)

The US Eastern District of New York Federal Court awards plaintiffs $162 million in first-ever civil price-fixing verdict against Chinese companies (Vitamin C Cartel)
Quinn Emanuel Urquhart & Sullivan (Brussels)
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Office of the New York State Attorney General (New York)
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Shearman & Sterling (New York)
On March 14, 2013, a federal jury in Brooklyn, New York returned a verdict in In re Vitamin C Antitrust Litigation, No. 1:06-md-1738 (E.D.N.Y.), finding that two Chinese companies had unlawfully fixed prices and controlled the supply of vitamin C exports from China to the United States. (...)

The US FTC files amicus curiae brief supporting generics’ claim in patent dispute (Actelion Pharms / Apotex)
DLA Piper Weiss-Tessbach (Vienna)
U.S. FTC files amicus curiae brief supporting generics’ claim in patent dispute* On 11 March 2013 the U.S. Federal Trade Commission (“FTC”) filed an amicus curiae brief in the case Actelion Pharms Ltd. V. Apotex Inc. which is being heard in the U.S. District Court for New Jersey supporting the (...)

The Italian Supreme Court holds that the violation of an anticompetitive agreement did not constitute unfair competition (Ordine dei Farmacisti della Provincia di Caserta)
Cleary Gottlieb Steen & Hamilton (Rome)
On 8 February 2013, the Italian Supreme Court (the “Court”) quashed a decision by the [Commissione centrale per gli esercenti le professioni sanitarie] (the national commission for healthcare operators; the “National Commission”), which, in turn, had upheld a ruling by the [Ordine dei Farmacisti (...)

The Italian Competition Authority launches an investigation against a cartel allegedly carried out by two pharmaceutical companies (Roche, Novartis)
Desogus Law Office (Cagliari)
The Italian Competition Authority launches an investigation against a cartel allegedly carried out by Roche and Novartis in the pharmaceutical market (Roche Novartis) The facts of the case The Italian Competition Authority (ICA) has opened an Article 101 TFEU proceedings against Roche and (...)

The Italian Competition Authority opens investigation against pharmaceutical companies over suspected cartel in ophthalmologic medicines market (Novartis and Roche)
Van Bael & Bellis (Brussels)
On 14 February 2013, the Italian Competition Authority (the “Authority”) announced that it had opened an investigation against Genentech Inc., Hoffmann-La Roche Ltd, Novartis AG, Novartis Farma S.p.A. and Roche S.p.A., over suspicions that these may have been operating an illegal cartel in (...)

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

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

The EU Commission sends SOs to two pharmaceutical companies over possible delayed entry of generic (Johnson & Johnson and Novartis)
Van Bael & Bellis (Brussels)
On 31 January 2013, the European Commission announced that it had sent a Statement of Objections (“SO”) to pharmaceutical companies Johnson & Johnson (“J&J”) and Novartis over suspicions that an agreement between their Dutch subsidiaries in relation to Fentanyl (a strong pain killer (...)

The Paris Court of Appeal dismisses an action from a cosmetics manufacturer against a decision of the French Competition Authority that sanctioned it for prohibiting its authorised distributors from Internet sales (Pierre Fabre Dermo-Cosmétique)
Kalliopé Société d’Avocats (Paris)
On 31 January 2013, the Paris Court of Appeal ("the Court") dismissed an action by Pierre Fabre Dermo-Cosmétique SAS ("Pierre Fabre") against a decision of the French Competition Authority ("the FCA") dated 29 October 2008 ("the Decision") ordering Pierre Fabre to amend its selective (...)

The US FTC releases a summary of its new report on pharma patent litigation finding an increase in "reverse payment" settlements based on expanded definition of "payments"
Jones Day (Washington DC)
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Jones Day (Washington DC)
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Jones Day (Chicago)
With the Supreme Court set to address the validity of "reverse payment" settlements of pharmaceutical patent litigation, the FTC released a summary of its new report, announcing that in 2012 drug companies entered "a record number" of such settlements. However, the underlying data and analysis (...)

The US Supreme Court grants certiorari to consider the legality of reverse payment settlements (Actavis)
Stanford University - Stanford Law School
U.S. Supreme Court grants certiorari to consider the legality of reverse payment settlements* On 7 December 2012 the U.S. Supreme Court granted a petition to consider whether reverse payment settlement agreements are per se lawful or presumptively anti-competitive. In the case (U.S. Federal (...)

The US Supreme Court reviews Eleventh Circuit’s decision regarding reverse payment patent settlements (AndroGel)
Gibson Dunn (New York)
Important U.S. Developments Relating to “Reverse Payment” Patent Settlements* There have been two key recent developments in the U.S. relating to the legal dispute over patent settlements including so-called “reverse payments.” First, the U.S. Supreme Court has agreed to review an Eleventh Circuit (...)

A US District Court holds that “No-AG” agreements are not “Reverse Payments” (Lamictal litigation)
Gibson Dunn (New York)
Important U.S. Developments Relating to “Reverse Payment” Patent Settlements* There have been two key recent developments in the U.S. relating to the legal dispute over patent settlements including so-called “reverse payments.” First, the U.S. Supreme Court has agreed to review an Eleventh Circuit (...)

The Spanish National Court annuls CNC Decision closing pharmaceutical dual pricing case (European Association of Euro-Pharmaceutical Companies, Pfizer, Novartis, Sanofi-Aventis)
Cuatrecasas, Goncalves Pereira (Madrid)
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Cuatrecasas, Goncalves Pereira (Barcelone)
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Allen & Overy (Madrid)
On December 5, 2012, the Spanish National Court (Audiencia Nacional or “AN”) annulled the decision of the Spanish Competition Commission (formerly called Comisión Nacional de la Competencia or “CNC”), to close file S/0017/07. The AN considered that the CNC should have further investigated whether (...)

The Moscow Arbitration Court upholds the Competition Authority’s ruling on cartel during online open tenders (Eske, Borodina, Sirius, Blitz)
Simmons & Simmons (London)
Background & Proceedings On the 11/08/2011 theFederal Antimonopoly Service of Russian Federation began investigation of the alleged breach of the Federal Law 26.07.2006 № 135-ФЗ "On Protection of Competition" by private entrepreneur Eske, (Еске Н.Ю.), private entrepreneur Borodina (Бородинa М.А.), (...)

The Competition Authority of Bosnia and Herzegovina prosecutes the Government of the Federation of Bosnia and Herzegovina for favouring domestic companies on the market for pharmaceuticals reimbursed under the national health insurance system
Faculty of Law - University of Macau
On 4 October 2012 the Competition Authority of Bosnia & Herzegovina (KV) qualified the actions of the Government of Federation of Bosnia and Herzegovina (the Government) that accorded preferential treatment to the domestically produced medicines under the national health insurance scheme as (...)

The Argentinean Federal Court of Appeals confirms fines against cartel’s members in the sector of liquid and gas oxygen used for medical purposes (Air Liquid, Messer Argentina, Praxair, AGA, Indura)
De Dios & Goyena (Buenos Aires)
The Civil and Federal Court of Appeals of the City of Buenos Aires (FCA), 3rd Division, has confirmed a cartel investigation and the sanctioning imposed by the Argentine National Commission for Defense of Competition (CNDC) against certain key players in the field of liquid and gas oxygen used (...)

The EU Commission sends statement of objections to pharmaceutical companies over “pay-for-delay” agreements (Lundbeck, Servier)
Van Bael & Bellis (Brussels)
On 25 July 2012, the European Commission announced that it had sent a formal Statement of Objections (“SO”) to Danish pharmaceutical company Lundbeck over its conclusion of so-called “pay-for-delay” agreements with four generic producers of citalopram, a antidepressant medicine. In its SO, (...)

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

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

The Hellenic Competition Commission issues an interim measures order prohibiting a collective boycott by a pharmacists association (Infant Milk)
Mikroulea, Staikouras & Associates (Athens)
Introduction On 27 July 2012, the Hellenic Competition Commission (Elliniki Epitropi Antagonismou, hereafter: HCC) issued an interim measures order prohibiting the implementation of a collective boycott relating to infant milk products of certain companies. The boycott was adopted by the (...)

The US Court of Appeals for the Third Circuit rejects Scope-of-Patent test in antitrust challenge to patent settlements (K-Dur)
Wolters Kluwer (Riverwoods)
Third Circuit Rejects Scope-of-Patent Test in Antitrust Challenge to K-Dur Patent Settlement* Reverse payments settlements between patent holders and would-be generic competitors in the pharmaceutical industry should be reviewed under a “quick look” rule of reason analysis based on the economic (...)

A US Court of Appeals rejects the “scope of the patent” test in favor of a “quick look” rule of reason analysis when reviewing reverse payment settlements between patent holders and would be generic competitors in the pharmaceutical industry (Schering-Plough)
Vinson & Elkins (Dallas)
Citing the dire consequences for companies seeking to comply with antitrust law in the wake of a direct circuit split, major pharmaceutical makers are asking the Supreme Court to review a Third Circuit decision that declared settlement payments by brand-name pharmaceutical companies to (...)

A US Court of Appeals holds that although reverse payment settlements between brand-name and generic pharmaceutical manufacturers are not illegal per se, they are presumptively unlawful under the rule of reason (Schering-Plough)
Arnold & Porter Kaye Scholer (Washington)
,
Hooper Hathaway
On July 16, 2012, in an opinion authored by Judge Sloviter, the Third Circuit issued its decision in the K-Dur “reverse payments” case, holding that although such settlements are not illegal per se, they are presumptively unlawful under the rule of reason. In so doing it rejected the approach (...)

A US Court of Appeals applies a quick look rule of reason and rejects scope of the patent test when considering whether pharma patent settlement violates the antitrust laws (Schering-Plough)
Hyman, Phelps & McNamara
In our post, “Hot Ticket Item – Patent Settlement Agreement Challenges,” we provided a round-up of the latest and greatest from ongoing litigation concerning patent settlement agreements (or “pay-for-delay” agreements if you prefer that term – we don’t). It’s only been about three weeks since that (...)

The US Third Circuit, by adopting a quick look rule of reason analysis for evaluating the legality of reverse payment settlements, rejects the prevailing "scope of patent" test and creates a Circuit split on this issue (Louisiana Wholesale Drug Company, Schering, Upsher-Smith)
Gill Jennings & Every LLP
On 16 July 2012, the US Third Circuit Court of Appeals rejected the scope of the patent test used by the New Jersey District Court in concluding that the patent settlement agreements (“Agreements”), providing for payments from Schering-Plough Corporation (“Schering”) (subsequently acquired by Merck (...)

The Lisbon Court of Appeal upholds first instance decision on competition authority’s pharmaceutical companies case (Baxter – Médico Farmacêutica and Glintt)
European Commission
Portugal: The Lisbon Court of Appeal upholds First Instance Decision on Competition Authority’s Pharmaceutical Companies Case * On 10 July 2012, the Lisbon Court of Appeal (2nd instance Court) rejected the appeal lodged by Baxter– Médico Farmacêutica, Lda., and Glintt – Business Solutions, Lda., (...)

The Hellenic Competition Commission finds a pharmacists association guilty of concerted agreements and grants interim measures (Pharmacists Association of Achaia)
European Commission - DG CNECT (Brussels)
Introduction On June 22, 2012 the Hellenic Competition Commission found the Pharmacists Association of Achaia, whose members are all the owners of pharmacies in Achaia, (hereinafter: PAA), the Pharmacists Union of Achaia and Islands (hereinafter: PUAI), Panagiota Karousos-Akrivi Asprogeraka (...)

The Competition Commission of India fines an association of pharmaceutical distributors for price-fixing and limiting competition on the basis of the Competition Act (Varca Chemist and Druggist, Chemists and Druggists Association, Goa)
University of Delhi (New Delhi)
In two cases decided in 2012, the Competition Commission of India (CCI) found evidence of collusion amongst wholesale and retail distributors of pharmaceuticals in particular regions of India. We analyze one case (Varca Chemist and Druggist and others vs Chemists and Druggists Association, Goa) (...)

A US Court of Appeals rejects the FTC’s latest “Pay-For-Delay” challenge (FTC v. Watson)
Mayer Brown (Washington)
,
US Federal Trade Commission (FTC) (Washington DC)
On April 25, 2012, the U.S. Court of Appeals for the Eleventh Circuit affirmed a lower court’s dismissal of the Federal Trade Commission’s (“FTC”) complaint against four pharmaceutical companies: Solvay Pharmaceuticals, Watson Pharmaceuticals, Par Pharmaceuticals, and Paddock Laboratories. The (...)

A US Court of Appeals rejects FTC’s approach to "pay-for-delay" settlement between brand name and generic drug companies as an unlawful agreement not to compete under S. 5 of the FTC Act (Watson Pharmaceuticals)
Wolters Kluwer (Riverwoods)
Eleventh Circuit Rejects FTC’s Approach to Pay-for-Delay Settlements as “Turducken Task”* The U.S. Court of Appeals in Atlanta rejected on April 25, 2012 the Federal Trade Commission’s challenge to a patent litigation settlement between brand name and generic drug companies as an unlawful (...)

The US Court of Appeals for the 11th Circuit reaffirms that the “scope of the patent” test is the proper standard of antitrust review of the reverse payment settlements among pharmaceutical companies (Solvay/Watson/Paddock)
United First Partners
Introduction In FTC v. Watson Pharmaceuticals, Inc. (“Watson”), the Eleventh Circuit reaffirmed its long line of precedents and held that, absent sham litigation or fraud in obtaining the patent, the “scope of the patent” test should be used to evaluate antitrust challenges to the reverse payment (...)

The Serbian Competition Authority confirms fines against 12 pharmaceutical companies for entering into a restrictive agreement (Hemofarm)
Kinstellar (Belgrade)
,
Kinstellar
On 26 January 2012 the Commision for the Protection of Competition of the Republic of Serbia (the "Competition Authority") issued a decision setting the amount of fines for 12 pharmaceutical companies (Hemofarm a.d., Galenika a.d., Zdravlje Leskovac a.d., Jugoremedija a.d., Slaviamed d.o.o., (...)

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 (...)

An Italian administrative court upholds the Competition Authority granting of full immunity and fine reductions to participants in the cosmetic and health care products cartel under the leniency programme (Reckitt Benckiser)
Desogus Law Office (Cagliari)
On appeal on the Cartel of large retailers for cosmetics and health care products decision of the Italian Competition Authority (ICA) the Regional Administrative Tribunal of Latium (Tar Latium) examined full immunity and fine reductions granted to a number of cartelists pursuant to the ICA (...)

The Romanian Competition Council fines two suppliers of prescription-only medicines and their distributors for parallel export restrictions (Baxter / Belupo)
Peli Filip (Bucharest)
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Peli Filip (Bucharest)
On 28 October 2011, the Romanian Competition Council (the “Council”) published Decisions n° 51 and 52/28.10.2011 sanctioning two suppliers of prescription-only medicines - Belupo Iijekovi & kozmetica d.d. Croatia (“Belupo”) and Baxter AG Switzerland (“Baxter”) - and their distributors on the (...)

The Romanian Competition Authority imposes fines on pharmaceutical companies and their distributors (Baxter and Belupo)
European Commission
Romania: The Competition Council imposes Fines on Pharmaceutical Companies Baxter, Belupo and their Distributors* On 28 October 2011, the Competition Council sanctioned Baxter AG (Switzerland), Belupo (Croatia) and their distributors with fines amounting to € 1 800 000 for the conclusion of (...)

The Eastern District Court of New York holds that Chinese law did not compel the defendants in a cartel case to reach agreements on price and output (Vitamin C cartel)
Sheppard Mullin (San Francisco)
,
Paul Hastings (Washington)
In a recent, strongly worded federal antitrust decision, pleas for international comity by China’s nationalized vitamin industry and its regulatory overseer, China’s foremost trade industry, fell short in a showdown with U.S. domestic antitrust laws. The case indicates that foreign compulsion (...)

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
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 Spanish National Court applies the ECJ "dual pricing" ruling to quash a decision by the Spanish Competition Commission concerning prices imposed to wholesalers by pharmaceutical company (Pfizer)
CMS Albiñana y Suárez de Lezo (Madrid)
The Spanish National Court has applied the landmark ECJ dual pricing ruling to quash a decision by the Spanish Competition Commission dismissing a complaint against Pfizer’s pricing policy for pharmaceutical products. On 13 June 2011, the Spanish National Court («Audiencia Nacional« or «the (...)

The Moldovan Competition Authority finds bid rigging practices in purchases of anti-diabetic medicines (Medicines Agencies)
Faculty of Law - University of Macau
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 EU Commission opens investigation against two pharmaceutical companies on account of patent settlement agreement (Cephalon / Teva)
Van Bael & Bellis (Brussels)
On 28 April 2011, the European Commission opened of its own motion formal competition proceedings against Cephalon, Inc. (“Cephalon”) and Teva Pharmaceutical Industries, Inc. (“Teva”) on account of a patent settlement agreement between the parties. Under the agreement, Teva undertook not to sell (...)

The Paris Court of Appeal fines a pharmaceutical company € 17 M for unfair competition when launching a new drug (Ipsen/Mylan)
EDHEC (Lille)
1. Summary Mylan, the generic pharmaceutical company (formerly Merck Génériques), was ordered by the Paris Court of Appeal to pay €17 million in damages to Ipsen for unfair competitive practices and economic parasitism by marketing Vitalogink to pharmacists as an "equivalent" to Tanakan and (...)

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
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 (...)

The US Supreme Court declines to review a Second Circuit ruling permitting a reverse-payment settlement between branded and a generic pharmaceutical manufacturers (Lousiana Wholesale Drug / Bayer)
Vinson & Elkins (Washington)
,
Reese Gordon Marketos
A growing consensus among federal courts that so-called “reverse-payment” settlements rarely violate antitrust law has not tempered antitrust enforcement authorities’ opposition to such deals. In the pharmaceutical industry, brand-name drug manufacturers may file patent infringement lawsuits (...)

The Latvian Competition Council concludes its sector inquiry finding that existing regulation impedes price competition in medicine market
Konkurences padome (Riga)
Existing Regulation impedes Price Competition in Medicine Market On 1 February 2011, the Competition Council of Latvia (CC) published its conclusions of the Sector Inquiry into the pricing system in medicine market in Latvia. In its report, the CC draws attention to the existing problems in (...)

The Bulgarian Commission for Protection of Competition closes a probe into alleged bid-rigging among suppliers of pharmaceuticals without establishing an infringement (Alta Pharmaceuticals, Roche)
Kinstellar (Sofia)
The Bulgarian Commission for Protection of Competition (the «CPC») closed an investigation into alleged bid-rigging practices among suppliers of pharmaceuticals absent collaborative evidence of price coordination and with further regard to the transparency-enhancing effects of the domestic (...)

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)
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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 (...)

The California Supreme Court rejects "Pass-On" Defense for antitrust damages (Pfizer)
Jones Day (Los Angeles)
,
Jones Day (Los Angeles)
In its July 12, 2010, decision in Clayworth v. Pfizer, Inc., the California Supreme Court rejected the « pass-on » defense for claims brought under California’s antitrust law, the Cartwright Act. Defendants have used the pass-on defense to argue that direct purchasers of goods sold by allegedly (...)

A US Court of Appeals holds that reverse payment agreements between a patentee and a generic pharma manufacturers that do not exceed the scope of the patent are not illegal under the federal antitrust laws and refuses to conduct post hoc determination of patent validity (Bayer)
McDonnell Boehnen Hulbert & Berghoff
On April 29th, the U.S. Court of Appeals for the Second Circuit ruled that the "pay-for-delay" agreement between defendants Bayer AG and several generic drugmakers (including The Rugby Group, Watson Pharmaceuticals Inc., and Barr Laboratories Inc.) were not illegal under U.S. antitrust law and (...)

The Belgian Civil Supreme Court upholds the decision of the Appeal committee of the Pharmacists professional body (V.D.F.M/Ordre des pharmaciens)
Fidal (Lyon)
1. Introduction In its judgment of 11 December 2009, the Belgian Civil Supreme Court (Cour de Cassation) confirmed the decision of the Appeal Committee of the Ordre des pharmaciens which ruled that competition can be restricted by a College of Pharmacists for the protection of the public (...)

A US District Court allows the reverse payment suits to proceed finding that the agreements extended beyond the scope of the concerned patent (Provigil)
Stanford University - Stanford Law School
U.S. District Court allows Provigil reverse payment suits to proceed* On 29 March 2010 the U.S. District Court for the Eastern District of Pennsylvania rejected defendants’ motions to dismiss in suits concerning reverse payment settlements between the brand name manufacturer of the (...)

A US District Court grants defendants’ motions to dismiss antitrust claims brought by the FTC as regards reverse payments settlements and related commercial arrangements (Androgel)
Stanford University - Stanford Law School
U.S. District Court dismisses AndroGel reverse payment antitrust claims* On 22 February 2010 the U.S. District Court for the Northern District of Georgia (Atlanta Division) granted defendants’ motions to dismiss antitrust claims brought by the Federal Trade Commission (“FTC”) among others that (...)

A US District Court dismisses the FTC’s "pay-for-delay" antitrust lawsuit ruling that the contested settlements are not an unreasonable restraint of trade (Androgel Litigation)
Skadden, Arps, Slate, Meagher & Flom (Washington DC)
,
Skadden, Arps, Slate, Meagher & Flom (Washington DC)
,
The Brattle Group (New York)
On February 22, 2010, Judge Thomas W. Thrash, Jr. dismissed the Federal Trade Commission’s (FTC) antitrust lawsuit alleging that Solvay Pharmaceuticals (Solvay) conspired with generic drug makers Watson Pharmaceuticals (Watson) and Par Pharmaceuticals (Par) to delay generic competition for the (...)

A US District Court dismisses antitrust claims on reverse payment on the pharma market (Androgel Antitrust Litigation)
Sheppard Mullin (Los Angeles)
FTC Gets Shut Down – Once Again – In Its Bid To Change How Courts View Reverse Payment Settlements* As previously reported on this blog, in January 2009, the Federal Trade Commission launched its latest challenge to the legality of reverse payment settlements in the pharmaceutical industry, this (...)

The EU Commission monitors whether patent settlements concluded between pharmaceutical companies infringe EU antitrust rules
Morgan Lewis (London)
,
Squire Patton Boggs (London)
On 12 January 2010, the European Commission sent an information request to a number of pharmaceutical companies, seeking copies of their patent settlement agreements, to check their compliance with EU antitrust rules (Official Press Release IP/10/12), as a follow up to its pharmaceutical sector (...)

The Lisbon Commerce Court confirms decision against bid-rigging cartel by pharmaceutical companies but substantially reduces fines (Abbott, Menarini and Johnson & Johnson)
University of Lisbon
,
Abreu Advogados (Lisbon)
On 7 January 2010 the Lisbon Commerce Court upheld a 2008 decision by the Portuguese Competition Authority (PCA) imposing a € 13.4 million fine on pharmaceutical companies Abbott, Menarini and Johnson & Johnson for participating in a bid-rigging cartel. Back in 2005 the PCA fined the (...)

The Lisbon Commercial Court holds pharmaceutical companies guilty of 63 breaches on Portuguese competition law (Abbott Laboratórios, Menarini Diagnóscitos and Johnson & Johnson)
The Lisbon Commercial Court, confirming the decision of the Portuguese Competition Authority, held that the undertakings of Abbott Laboratórios Lda., Menarini Diagnóscitos Lda. and Johnson & Johnson Lda. were proven to be guilty of 63 breaches of the Portuguese competition law rules. (...)

The Swiss Competition Authority imposes fines on three pharmaceutical companies for resale price maintenance (Pfizer, Lilly, Bayer)
Van Bael & Bellis (Brussels)
According to a press release of 1 December 2009, the Swiss Competition Authority has imposed fines totaling approximately € 3.7 million on three pharmaceutical companies (Pfizer, Lilly and Bayer) for engaging in resale price maintenance with their distributors. It appears that the three (...)

The Swiss Competition Commission issues a prohibition order and fined three producers of medicine (treatment of erectile dysfunction) for publishing recommended prices leading to RPM (Pfizer/Eli Lilly/Bayer)
Agon Partners (Zurich)
,
Zurich District’s Prosecutor
Description of the impugned case Three pharmaceutical manufacturers issued recommended retail prices (RRP) which were integrated into a widely used IT-Database or/and communicated to all resellers (e.g. pharmacies). 63% of all resellers adopted a pricing policy according to the price (...)

The EU Court of Justice reverses the Commission decision regarding the legality of dual pricing arrangments between leading pharmaceutical undertaking and Spanish wholesalers (GlaxoSmithKline)
Morgan Lewis (London)
,
Cadwalader Wickersham & Taft (Brussels)
On 6 October 2009, the European Court of Justice (ECJ) issued its judgment in the long-running wrangle regarding the legality of GlaxoSmithKline’s (GSK) dual pricing arrangements with Spanish pharmaceutical wholesalers. As a result of the judgment, the European Commission (Commission) will have (...)

The ECJ confirms Commission must assess whether an agreement to limit parallel trade in medicines has pro-competitive benefits (GlaxoSmithKline)
Linklaters (Paris)
,
Linklaters (London)
,
French Competition Authority (Paris)
On 6 October, the European Court of Justice (‘ECJ’) issued another “score draw” judgment in the long-running battle of R&D-based pharmaceutical companies to limit parallel trade in medicines across the EU. While the ECJ required the European Commission to conduct an in-depth examination of (...)

The German Federal Cartel Office fines € 11.5 million a contact lens provider for fixing minimum resale prices and restricting Internet and wholesale sales of its products (CIBA)
Fried Frank Harris Shriver & Jacobson (London)
On September 25, 2009, the German Federal Cartel Office (FCO) levied a fine of €11.5 million against contact lens provider CIBA Vision Vertriebs GmbH (CIBA) for fixing minimum resale prices and restricting Internet and wholesale sales of its products. This is the third decision imposed by the (...)

The US DoJ files amicus brief on reverse payment settlements on the market for broad spectrum antimicrobial medicines (Arkansas Carpenters Health / Bayer, Hoechst, Watson)
Stanford University - Stanford Law School
U.S. DOJ files amicus brief on reverse payment settlements* On 6 July 2009 the U.S. Department of Justice filed an amicus brief in a reverse payment settlement case on appeal before the 2nd Circuit (In re Ciprofloxacin Hydrochloride Antitrust Litigation). The filing is in response of an (...)

The German Competition Authority imposes € 1.2 M fine on several pharmacy associations for collective boycott in Germany (Gehe)
Van Bael & Bellis (Brussels)
The German Federal Cartel Office (FCO) has imposed a € 1.2 million fine on several German pharmacy associations for calling on pharmacists to boycott the pharma wholesaler Gehe after Gehe’s parent company Celesio acquired the internet pharmacy Doc Morris in April 2007. The German pharmacy (...)

The German Competition Authority imposes fines on pharmaceutical companies for price fixing (Grünenthal and Infectopharm)
Van Bael & Bellis (Brussels)
According to a press release of 7 May 2009, the German Federal Cartel Office (FCO) refrained from imposing a fine on two pharmaceutical companies, Grünenthal GmbH and Infectopharm GmbH, which had illegally agreed on prices for colistin-based antibiotics. Following Grünenthal GmbH’s leniency (...)

The French Competition Authority sanctions a professional association for having urged to territorial monopolies for dispensing pharmacists (Ordre des pharmaciens de Basse-Normandie)
French Competition Authority (Paris)
Press Release published on the official website of the French Competition Authority. The Autorité de la concurrence condemns the Regional Council of the Ordre des pharmaciens de Basse-Normandie for urging a retirement home to use the pharmacies that are closest to it.* Referred to by a (...)

The Court of Appeal of Brussels upholds the NCA’s ruling holding that the opening days/hours and advertising provisions for pharmacy outlets, as set by the Belgian Pharmacists Association, were contrary to competition law (Ordre des pharmaciens)
Philippe & Partners (Brussels)
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Praetica (Bruxelles)
1. The Parties The parties to the matter were: L’Ordre des pharmaciens (the Belgian Pharmacists Association, “BPA”), a public body established in Brussels; Mrs. E. Servais, pharmacist in Grez-Doiceau; Les Pharmacies Mont-Saint-Pont, a private corporation established in Braine l’Alleud; (...)

US District Courts grapple with novel legal issues relating to Chinese companies sued in U.S. for antitrust violations (Vitamin C and Magnesite cartel)
Sheppard Mullin (San Francisco)
,
Paul Hastings (Washington)
As the world economy grows increasingly interconnected, plaintiffs’ lawyers in the US are searching for ways to sue foreign companies in US courts for anticompetitive behavior. Several recent Sherman Act cases have been brought against consortiums of partially government owned Chinese (...)

The Hungarian Competition Council prohibits restrictive clauses in cooperation agreements between a wholesaler of pharmaceutical products and pharmacies (Hungaropharma)
Baker McKenzie (Budapest)
The Hungarian Competition Council found that cooperation agreements concluded between Hungaropharma, a wholesaler of pharmaceutical products, and a number of pharmacies contained clauses which were incompatible with Art. 81 EC and Section 11 of the Hungarian Competition Act. The Competition (...)

The Hungarian Competition Authority condemns vertical resale price fixing agreement concluded between a wholesaler of medicines and pharmacies but without imposing a fine (Hungaropharma)
Oppenheim (Budapest)
,
Oppenheim (Budapest)
Description of the impugned case The case concerned a straightforward RPM arrangement, where the pharmacies, in their agreements concluded with a wholesaler of medicines (Hungaropharma), agreed to maintain (discounted) resale prices. Due to the wording and context of the arrangement, the HCO (...)

The Serbian Competition Authority adopts a decision against fifteen pharmaceutical companies for fixing trade conditions (Hemofarm, Galenika, Zdravlje and others)
University of Belgrade
Following a complaint by a distributor of pharmaceutical products Radakom d.o.o., the Serbian Competition Authority (“Komisija za zastitu konkurencije”) started an investigation concerning fixing of trade conditions in pharmaceutical sector against fifteen companies in Serbia : Hemofarm a.d., (...)

The EU Commission presents its preliminary report into the pharmaceutical sector
Linklaters (London)
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French Competition Authority (Paris)
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The European Commission presented its Preliminary Report into the pharmaceutical sector (which runs to 426 pages) at a public hearing on 28 November. The deadline for comments on the Report is 31 January 2009. Click here for a copy of the Report, the Commission’s press release and the opening (...)

The Hungarian Competition Authority closes case against a professional association (Hungarian Chamber of Pharmacists)
Van Bael & Bellis (Brussels)
By an order of 4 November 2008, which has recently become publicly available, the Hungarian Competition Authority (“GVH”) decided to terminate its investigation into alleged anti-competitive practices by the Hungarian Chamber of Pharmacists (the “Chamber”) on the market for pharmaceuticals. The (...)

The Turkish Competition Board confirms lack of anticompetitive conduct in the bio-tech pharmaceuticals market despite evidence of bid rigging brought by criminal proceedings (Roche)
University of Leeds
The Turkish Competition Board (TCB) confirmed its previous finding of lack of anticompetitive conduct by Roche in the bio-tech pharmaceuticals market in Turkey. The decision of the TCB comes after its original decision being annulled by the Council of State for not having taken into (...)

The US Federal Circuit dismisses antitrust claims against reverse payment agreement between pharmaceutical companies (Ciprofloxacin Hydrochloride)
ArbJournal
On 15 October 2008 the Federal Circuit affirmed the grant of summary judgment by the Court for the Eastern District of New York that patent settlement agreements («Agreements») entered into between Bayer AG and Bayer Corp (collectively «Bayer») and several manufacturers of generic drugs providing (...)

A US Court of Appeals holds the use of cash payments to settle Hatch-Waxman patent litigation does not violate the antitrust laws if the settlement does not exceed the scope of patent and claim for patent validity is not a sham (Bayer/Barr)
Jones Day (Washington DC)
,
Jones Day (Washington DC)
On October 15, 2008, the Federal Circuit joined the growing list of federal courts to hold that the use of cash payments to settle Hatch-Waxman patent litigation does not violate the antitrust laws as long as (1) the settlement excludes no more competition than would the patent itself and (2) (...)

The UK Court of Appeal decides on restitutionary damages in an action for damages resulting from a cartel (Devenish Nutrition / Sanofi-Aventis)
University of Exeter
By its decision of 14 October 2008, the Court of Appeal dismissed the appeal of the claimant, Devenish Nutrition Ltd, against the decision of Lewison J of 19 October 2007 . As a result, claimants seeking damages in a private action against a cartel, for losses based on a finding of an (...)

The UK Court of Appeal holds that compensatory damages are adequate and that a restitutionary reward is not available in an action for damages resulting from a cartel (Devenish Nutrition / Sanofi-Aventis)
McDermott Will & Emery (Brussels)
Introduction In view of the fact that Community law regulates competition, English law is required to provide remedies for violations to persons injured thereby. Indeed, as the European Court of Justice stated in Courage v. Crehan, "the full effectiveness of Article 81 of the Treaty and, in (...)

The ECJ Advocate General Sharpston issues opinion on the repackaging of parallel-traded pharmaceuticals (The Wellcome Foundation)
Van Bael & Bellis (Brussels)
On 9 October 2008, Advocate General Sharpston issued her opinion in Case C-276/05 (The Wellcome Foundation Ltdv Paranova Pharmazeutika Handels), a preliminary reference to the European Court of Justice (“ECJ”) from the Austrian Supreme Court. These proceedings add yet another episode to the (...)

The Spanish Competition Authority declares that five pharmaceutical companies are not coordinating their distribution systems in Spain (Laboratorios Farmacéuticos)
European Court of Justice (Luxembourg)
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Garrigues (Brussels)
During the last two years, a number of important pharmaceutical manufacturers active in the Spanish market have introduced significant changes in their distribution systems. Under the new terms of these systems, the pharmaceutical companies select a reduced number of wholesalers to work with, (...)

A US District Court rejects the allegation according to which inducement by a drug wholesaler of a drug price publisher to inflate the wholesale price may constitute a per se violation (New England Carpenters Health Benefits Fund / McKesson)
Sheppard Mullin (Los Angeles)
Twombly Meets Leegin. Failure of Plaintiff to Allege “Plausible” Entitlement to Relief Constitutes Failure to Allege “Antitrust Injury.”* In New England Carpenters Health Benefits Fund v. McKesson Corp., 573 F.Supp.2d 431 (Aug. 26, 2008), the District Court for the District of Massachusetts (...)

The Turkish Competition Board grants individual exemption to an exclusive distribution agreement (GlaxoSmithKline / Pfizer)
University of Leeds
In an interesting decision on 20 June 2008, the Turkish Competition Board (TCB) has granted an individual exemption to an exclusive distribution agreement between GlaxoSmithKline Pharmaceuticals Co. and Pfizer Pharmaceuticals Ltd after refusing to grant negative clearance to the agreement under (...)

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)
,
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 Italian Competition Authority condemns a local association of pharmacies for price-fixing arrangements regarding the retail prices of over-the-counter pharmaceuticals (Federfarma Teramo)
Desogus Law Office (Cagliari)
The Italian Competition Authority (ICA) fined Federfarma Teramo, an association regrouping pharmacies located in the province of Teramo, Central Italy, for fixing the retail prices of a number of over-the-counter (OTC) pharmaceuticals via a circular detailing the maximum discounts applicable to (...)

The German Federal Competition Office imposes a fine on a pharmaceuticals distributor for having influenced in an anticompetitive way the resale prices for non-prescription pharmaceuticals (Bayer Vital)
Linklaters (Dusseldorf)
Description of the impugned case The case deals with an indirect RPM clause: Bayer Vital concluded target agreements with several pharmacies according to which Bayer promised an additional rebate to the pharmacies for the positioning of the Bayer products as premium products and the (...)

The Paris Court of Appeal rebuts the decision of the Competition Council regarding practices in the market of distribution of pharmaceutical products (GlaxoSmithKline)
RBB Economics (Paris)
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SNCF Réseau
Presentation 1. For the first time of its existence, on 14 March 2007, the French Competition Council (thereafter “CC”) had decided to sanction a firm for predatory pricing, namely GlaxoSmithKline (thereafter “GSK“) for an amount of 10 million euro. GSK appealed to this Decision. On 8 April 2008, (...)

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 (...)

The Romanian Competition Council fines EUR 22.6 M distributors and manufacturer for sharing insulin portfolio (Eli Lilly, A&A Medical, Mediplus Exim, Relad Pharma)
Peli Filip (Bucharest)
,
Peli Filip (Bucharest)
The Romanian Competition Council (the “Council”) continued in 2008 the series of decisions dedicated to the malfunctioning of the Romanian pharmaceutical market, by sanctioning through its decision 15/2008 (i) the insulin producer Eli Lilly Export SA and three of its distributors, A&A Medical (...)

The Romanian Competition Council fines a pharmaceutical producer and three distributors for participation into a market-sharing cartel active on the insulin market (Eli Lilly Export, A&A Medical, Mediplus Exim and Relad Pharma)
Nestor Nestor Diculescu Kingston Petersen (Bucharest)
Following an investigation initiated in July 2005 and which has lasted for almost 3 years, the Romanian Competition Council (RCC) has fined one pharmaceutical producer and three distributors for participation into a market-sharing cartel active between April 2003 and May 2005, imposing fines in (...)

The Italian Supreme Administrative Court qualifies the independence criteria applicable to the agent pursuant to EU law upholding the appeal filed by a pharmaceutical company to revoke an antitrust fine imposed by the Italian Antitrust Authority (AstraZeneca)
Rucellai & Raffaelli (Milan)
Upholding the appeal filed by the claimant AstraZeneca, the Italian Supreme Administrative Court (hereinafter also the “Court”) ruled that the illicit conduct of the agent Pan Service - operating in the market for several principals and bearing all the related economical and financial risks - (...)

The US Federal Trade Commission again moves forward against "reverse payment settlements" in pharmaceutical patent settlements (Cephalon)
Allen & Overy (New York)
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RPCK Rastegar Panchal
On February 13th, 2008 the Federal Trade Commission (“FTC”) filed a complaint in the U.S. District Court for the District of Columbia charging Cephalon, Inc. with illegally preventing competition to its branded drug Provigil. In its complaint the FTC alleges that Cephalon, through patent (...)

The Portuguese Competition Authority adopts a new decision concerning a cartel of pharmaceutical companies following a decision of the Lisbon Commercial Court (Abbot, Bayer, Johnson & Johnson, Menarini)
Luís Silva Morais & Associados (Lisbon)
On 17 January 2008 the Portuguese Competition Authority (hereinafter ‘CA’) has approved a new decision concerning two previous cases, which have now been appended, and referring to two cartels on the pharmaceutical sector involving the companies Abbott, Bayer, Menarini and Johnson & Johnson. (...)

The German Federal Cartel Office imposes a fine on associations of pharmacists and pharmaceutical manufacturers for organising and accomplishing a lecture series intended to convince pharmacists to refrain from price competition (Arzneimittelhersteller)
Gleiss Lutz (Munich)
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Milbank, Tweed, Hadley & McCloy (Munich)
On 21 December 2007, the German Federal Cartel Office (FCO) imposed a fine on nine state associations of pharmacists, five pharmaceutical companies and the Federal Association of Pharmaceutical Manufacturers for organising and accomplishing a lecture series intended to convince pharmacists to (...)

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

The Belgian Competition Council clears a local opening hours scheme for pharmacists (F.N.H. / Ordre des pharmaciens - GLEP 30)
Liège University - IEJE
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Liège University - IEJE
I. Parties This case arose from a complaint lodged by a retail pharmacy outlet (“the applicant”) before the Belgian Competition Council (“the Council”) Initially, the complaint targeted the Belgian Pharmacists Association (“BPA”), but the Council subsequently decided on its own motion to extend the (...)

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 Belgian Competition Council assesses the validity of opening days/hours and advertising provisions for pharmacy outlets as set by the pharmacists professional associations (Belgian Pharmacists Associations)
Liège University - IEJE
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Liege Competition and Innovation Institute
1. Parties The present case arose from three complaints lodged in 1998 by several retail pharmacy outlets before the Belgian Competition Council (“the Council”). The complaints were directed against the Belgian Pharmacists Association as well as various local pharmacists association (...)

The UK High Court finds that following an infringement decision by the European Commission, the appropriate claim is for compensatory and not exemplary or restitutionary damages (Devenish Nutrition / Sanofi-Aventis)
DG COMP (Brussels)
The High Court’s judgment is the first time that an English court has to consider what type of damages can be obtained in claims following from an infringement decision by the European Commission in competition cases. According to the judgment, a claimant is only entitled to compensatory damages (...)

The Italian Competition Authority fines undertakings in the wholesale distribution market of drugs for refusal of supply (“Distribuzione di farmaci senza obbligo di ricetta alle parafarmacie”)
National University of Singapore
On 20 September 2007, the Italian Competition Authority (hereinafter the “Authority”) fined different companies in the wholesale distribution market of drugs, for breach of art. 2 legge n° 287/90, the national provision similar to Article 81 EC. Parties of the case Investigations started in 2006 (...)

The French Competition Authority accepts the commitments proposed by four pharmaceutical laboratories making the medicine quota system he more flexible for wholesale distributors (Boehringer-Ingelheim & Sanofi-Avantis)
French Competition Authority (Paris)
Press Release published on the official website of the French Competition Authority. Distribution of medicines: The Conseil accepts the commitments proposed by four pharmaceutical laboratories making the medicine quota system more flexible for wholesale distributors.* History of the case (...)

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 Polish competition authority finds pharmaceuticals companies and their distributors not guilty of price fixing and market sharing on the EPO medicines market (Johnson & Johnson, Roche)
Greenberg Traurig Grzesiak (Warsaw)
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PKN Orlen
On 14 June 2007, the Polish President of the Office for Competition and Consumer Protection (“OCCP") issued a decision concerning alleged price fixing and market sharing of medicines containing human recombined erythropoietin (EPO). The OCCP had decided that agreements between Johnson & (...)

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 Romanian Competition Council imposes fines in insulin cartel case (Eli Lilly Export, A&A Medical, Relad Pharma, Mediplus Exim)
Van Bael & Bellis (Brussels)
On 5 March 2007, the Romanian Competition Council fined four companies for operating a market-sharing arrangement affecting the supply of insulin in Romania. The total fine of € 22.6 million is the second highest ever imposed by the Romanian Competition Council, after the € 27 million fine (...)

The Czech Competition Office imposes a fine on pharmaceuticals distributors for coordinating suspension of their supplies to public Czech hospitals (Alliance UniChem, Gehe Pharma Praha, Pharmos, Phoenix)
Dentons (Prague)
The Czech Office for the Protection of Competition (the “Office”) imposed by its first-instance decision a fine in the aggregate amount of cca 113 million CZK (cca 4 million EUR) on a group of four largest distributors of pharmaceuticals in the Czech Republic. The four companies, together (...)

The Italian Competition Authority opens proceedings against pharma-companies in the wholesale distribution market of drugs (“Distribuzione di farmaci senza obbligo di ricetta alle parafarmacie”)
National University of Singapore
On 27 September 2006 the “Autorità Garante della Concorrenza e del Mercato” (hereinafter “AGCM”) opened proceedings against different companies in the wholesale distribution market of drugs, for alleged breach of Article 2 of Law n° 287/90, the national provision similar to Article 81 EC. On one (...)

A German court sanctions price-fixing among retailers after discontinuation of drugs regulatory retail price maintenance (OTC-Praparate)
DG COMP (Brussels)
Background According to German competition law, companies which exchange information about their future market activity might be found to be in breach of competition law rules. Article 1 of the German Competition Act (GWB) includes a prohibition of ‘concerted practices’ the effect or objective (...)

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 Sutherland (Paris)
Opinion of Advocate General Antonio Tizzano, 30 March 2006 EU Court of Justice, Laboratoires Boiron, Case C-526/04, 7 September 2006 In a preliminary ruling requested by the French Civil Supreme Court in the Boiron case, the ECJ rules that pharmaceutical laboratories liable to a tax on direct (...)

A US Court of Appeals holds that the reverse payment settlement between branded and generic pharma companies did not violate the antitrust laws because the exclusionary effect of the agreement did not exceed the scope of the patent (Tamoxifen Citrate)
Axinn Veltrop & Harkrider (Hartford)
Over the past decade, practitioners, policy makers and commentators have increasingly debated the issues involved when the antitrust laws intersect with patent rights. Both the antitrust and patent laws are designed to promote competition and, as a result, societal wellbeing. However, the (...)

The Polish Court of Appeals quashes the NCA’s decision and considers that an agreement limiting distribution of a drug to selected distributors does not restrict competition (Johnson & Johnson’s)
Allen & Overy (Warsaw)
Polish Court of Appeals, 25 July 2006, Decision issued in the case initiated by Jacek Nowakowski, who runs a warehouse for Pharmaceutical and Sanitary Products Hurtofarm in Sosnowiec and Johnson & Johnson Polska Sp. z o. o. in Warsaw against the President of the Office for Competition and (...)

The Bulgarian Commission on Protection of Competition grants individual exemption of an exclusive distribution agreement (GlaxoSmithKline)
ArbJournal
In the beginning of 2006 GlaxoSmithKline Ltd, Bulgaria, (GSK) notified the Commission on Protection of Competition (CPC) about an exclusive distribution agreement (Agreement) entered into between GSK and Agroengineering-90 Ltd (Agroengineering) on 21 December 2005. Subject of the agreement are (...)

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 Italian antitrust authority, after an investigative coordination with a criminal court, imposed EUR 3.7 million fines to antiseptic and disinfectant product distributors for infringement of Art. 81 EC (Prodotti disinfettanti)
Studio Legale DDPV (Rome)
The Italian Antitrust Authority (Autorità Garante della Concorreza e del Mercato, the “Authority”) has fined producers and distributors of disinfectant and antiseptic products (Astrazeneca S.p.A., Bergamon S.r.l., B. Braun Milano S.p.A., Esoform S.p.A., Farmec S.r.l., Nuova Farmec S.r.l., Germo (...)

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 Finnish competition authority states that rebates granted by pharmaceutical companies to pharmacies are unlawful on the basis of both EC and national competition provisions
Smartflats
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Liège University - IEJE
In Finland, pharmaceutical companies very often offer to pharmacies rebates on the wholesale price of drugs. Typically, they try to attract pharmacies by granting them generous additional rebates on all their products. As such, rebates granted by a furnisher to its distributors do not raise (...)

The Danish Competition Council found an insolvency agreement between three medical wholesale dealers and the Danish Pharmaceutical Association to be incompatible with Art. 81 EC and relevant national competition law provision (Nomeco, Tjellesen, Max Jenne and Danmarks Apotekerforening)
Liège University - IEJE
Facts In 1997, the Danish Pharmaceutical Association (“DPA”) entered into a so-called “Insolvency Agreement” with the three wholesalers of medicinal products (“the wholesalers”) active in Denmark. The agreement sought to help insolvent pharmacies - those incurring debts superior to 1 million Danish (...)

The Portuguese Competition Authority publishes a report in favour of liberalising the distribution of pharmaceutical products at retail level
London School of Economics
The Economics Department of the Catholic University of Portugal carried out a Report for the Portuguese Autoridade da Concorrência (hereinafter, “the NCA”) concerning the liberalisation of the resale of pharmaceuticals at retail level. The Report sought to: Identify barriers to entry arising (...)

A Polish Court overturns the NCA decision against a pharmaceutical company and its distributor for customer allocation due to lack of anticompetitive effects on the market (Johnson & Johnson - Hurtofarm)
Greenberg Traurig Grzesiak (Warsaw)
Background The Polish Competition and Consumers’ Protection Court (“Sad Ochrony Konkurencji i Konsumentów”) on September 5, 2005 issued a decision on the appeal lodged by Johnson & Johnson Poland and Hurtofarm against the decision of the President of the Office of Competition and Consumer (...)

A US District Court holds that a pharmacy benefits manager’s (PBM) contracts should be analyzed under the rule of reason (North Jackson Pharmacy, Caremark)
Jones Day (Washington DC)
The Northern District Court of Illinois, in a decision issued August 12, held that a PBM’s arrangements with health plan sponsors are not per se unlawful and should be analyzed under the rule of reason. North Jackson Pharmacy, an independent retail pharmacy, filed suit against Caremark Rx, a (...)

A US Court of Appeals holds that the reverse payment settlement between branded and generic pharma companies did not violate the antitrust laws because the exclusionary effect of the agreement did not exceed the scope of the patent (Schering-Plough)
Axinn Veltrop & Harkrider (Hartford)
Over the past decade, practitioners, policy makers and commentators have increasingly debated the issues involved when the antitrust laws intersect with patent rights. Both the antitrust and patent laws are designed to promote competition and, as a result, societal wellbeing. However, the (...)

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 Sutherland (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, (...)

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 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 US Supreme Court rules that the Sherman Act does not apply to claims arising solely out of the foreign effect of a global cartel (Hoffman-LaRoche / Empagran)
Jones Day (Washington DC)
As economic globalization marches on, one question that emerges repeatedly is how far the U.S. legal system can and should reach beyond its own borders. Answering that question has become particularly urgent in antitrust enforcement, as the effects of cartels and business practices increasingly (...)

The Polish Competition Authority fines € 457.000 a pharmaceutical company and its distributor for price fixing and supply limiting agreements (Johnson & Johnson - COMPOL)
French National Research Agency - ANR (Paris)
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Orrick, Herrington & Sutcliffe (Washington)
Johnson & Johnson Poland, member of the worldwide group of producing, import-exporting and selling of pharmaceuticals, is in charge of the distribution in Poland of a Swiss made medicine, Eprex. This medicine is used in the treatment of anemia provoked by an insufficient level of (...)

A US Court of Appeals holds that antitrust law is not implicated provided that the terms of “pay for delay” settlements between the brand name and generic pharma companies are within the scope of the patent (Valley Drug/Abbott Laboratories)
Hill, Kertscher & Wharton (Atlanta)
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Sutherland
A recent 11th Circuit case, Valley Drug Co. v. Geneva Pharmaceuticals, Inc., sheds light on the complex intersection of patent and antitrust law in the context of a settlement agreement between a name brand pharmaceutical manufacturer and two allegedly infringing generic manufacturers that (...)

The US Court of Appeals for the 11th Circuit holds that a reverse payment agreement between a brand-name pharmaceutical company and a generic would-be competitor should be analyzed under the “scope of the patent” test to determine antitrust liability (Abbott/Geneva/Zenith)
United First Partners
Introduction In Valley Drug Co. v. Geneva Pharm., Inc. (“Valley Drug”), the Eleventh Circuit adopted the “scope of the patent” test to evaluate validity of reverse payment agreements between a brand-name pharmaceutical manufacturer and generic would-be competitors. The court viewed the case in (...)

A US Court of Appeals holds that a reverse payment agreement between a brand-name pharmaceutical manufacturer and a generic would-be competitor is a per se antitrust violation because the agreement exceeded the scope of the patent (Cardizem CD Antitrust Litigation)
United First Partners
Introduction In re Cardizem CD Antitrust Litigation (“Cardizem”) is one of the first in a long line of cases challenging the so-called reverse payment or pay-for-delay settlement agreements between the pharmaceutical companies. In Cardizem, the U.S. Court of Appeals for the Sixth Circuit held (...)

The Netherlands Competition Authority imposes fines on a procurement collective and a wholesaler of veterinary pharmaceuticals for setting in place a system of exclusion of certain veterinarians (AUV / Aesculaap)
Netherlands Authority for Consumers & Markets (The Hague)
NMa Fines Veterinary Cooperative for Cartel Agreements* The Netherlands Competition Authority (NMa) has imposed a fine of EUR 9.7 million on Coöperatieve Nederlandse Veterinair-Farmaceutische Groothandel A.U. (AUV) [Netherlands Veterinary Pharmaceutical Wholesale Cooperative A.U.] and a fine of (...)

The US FTC publishes a report on generic drug entry prior to patent expiration raising issues on patent-shortening settlement agreements
White & Case (Washington)
The Federal Trade Commission’s recent report, Generic Drug Entry Prior to Patent Expiration (Federal Trade Commission, Generic Drug Entry Prior to Patent Expiration: An FTC Study, July 2002, ("FTC Report")), raises a number of competition issues that merit further discussion and research. This (...)

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 European Commission fines pharmaceutical companies for participating in eight distinct secret market sharing and price-fixing cartels affecting vitamin products (Vitamins cartel)
European External Action Service (Brussels)
"Commission adopts eight new decisions imposing fines on hard-core cartels 2. The vitamin cartels"* Following-up on two Decisions adopted earlier in the year 2001 (DecisionsSAS-MaerskandGraphite electrodes, both adopted on 18 July 2001: see Competition Newsletter 2001, Issue n°3), the (...)

A US Federal Circuit Court finds that the district court exceeded its authority in shortening the statutory stay of entry by a generic competitor which was challenged by a pharmaceutical patent-holder manufacturer in a patent infringement suit (Andrx/Biovail)
Cabot (Boston)
Judges: Dyk (author), Bryson, and Linn In Andrx Pharmaceuticals, Inc. v. Biovail Corp., No. 01-1650 (Fed. Cir. Jan. 17, 2002), the Federal Circuit vacated and remanded a lower court’s order (1) shortening the statutory thirty-month delay of FDA approval of Andrx Pharmaceuticals, Inc.’s (“Andrx”) (...)

The UK Restrictive Practices Court orders the removal of the legal protection from price fixing on certain branded over-the-counter medicines (OTC Medecines)
Addleshaw Goddard (London)
Description of the impugned case Branded prescription only medicines and branded OTC medicines were granted an exemption in 1970 from the general prohibition of resale price maintenance in the Resale Prices Act 1964. After reviewing the position in 1995, the OFT decided to apply to the (...)

The European Commission files an appeal before the European Court of Justice against the annulment by the Court of First Instance of its decision to fine a German pharmaceuticals company for prohibiting exports (Bayer)
DG COMP (Brussels)
"Appeal against the annulment by the Court of First Instance (CFI) of a 1996 Commission decision fining German pharmaceuticals company Bayer"* On 5 January 2001, the European Commission filed an appeal with the European Court of Justice (ECJ) in Luxembourg against the annulment by the Court of (...)

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 considers that the new pricing regime imposed by a pharmaceutical company for contraceptive pills is contrary to article 85 EC Treaty (Organon)
DG COMP (Brussels)
"Parallel imports of pharmaceutical products : Organon"* ORGANON is a British subsidiary of AKZO (Netherlands) which specializes in the manufacture and marketing of contraceptive pills. On 4 Mai 1994, ORGANON changed the price regime applicable to MERCILON and MARVELON, the latter being one (...)

The US Supreme Court holds it is per se illegal for a manufacturer to set minimum resale prices in agreements with independent resellers (Dr. Miles Medical / John D. Park & Sons)
Baker Botts (Washington)
In 1911, the U.S. Supreme Court in Dr. Miles Medical Co. v. John D. Park & Sons Co. held that a manufacturer’s setting the minimum prices at which independent resellers may resell its products was unlawful under the common law and Section 1 of the Sherman Act.That result spawned the (...)

Unilateral Practices

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Belgian Competition Authority rejects a request for interim measures on the pharmaceutical market (Medicare-Market group)
Belgian Competition Authority (Brussels)
The Belgian Competition Authority (BCA) has rejected a request for interim measures of the Medicare-Market group* The SA Medicare-Market (hereafter Medicare-Market) filed on 2 June 2016 a complaint against the Order of Pharmacists and requested interim measures on 28 April 2017. The (...)

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

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

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

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

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

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

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

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

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

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

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

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

The UK Competition Authority issues 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)
British Competition Authority - CMA (London)
CMA issues statement of objections to Pfizer and Flynn Pharma in anti-epilepsy drug investigation* The CMA has today issued a statement of objections to the pharmaceutical suppliers Pfizer and Flynn Pharma alleging that they have breached competition law. The Competition and Markets (...)

The Belgian Competition Authority rejects an appeal of a pharmacist who claimed 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 (Moscow)
Appeal Court confirmed: “Novo Nordisk” violated the antimonopoly law* On 22 June 2015, the 9th Arbitration Appeal Court upheld the judgment of the Court of First Instance and pronounced legitimacy of the decision of the Federal Arbitration Service (FAS Russia) that “Novo Nordisk” Ltd. had (...)

The 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 (Moscow)
Cassation Court: FAS decision and determination regarding “Baxter” are legitimate* On 16 June 2015, the Arbitration Court of the Moscow District (Cassation Court) confirmed legitimacy of the decision and determination of the Federal Antimonopoly Service (FAS Russia) as well as the Order to hold (...)

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

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

The 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 (Moscow)
The fine upon TEVA is legitimate* On 1 April 2015, Moscow Arbitration Court pronounced legitimacy of FAS determination (1) to hold TEVA PHARMACEUTICAL INDUSTRIES LIMITED (Israel) administratively liable. Earlier, in December 2013, the antimonopoly body found that TEVA violated Clause 5 Part 1 (...)

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

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

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

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

The 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 (Moscow)
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 (Moscow)
“Novo Nordisk” again violated the antimonopoly law* On 25th August 2014, the FAS Commission found that “Novo Nordisk” Ltd. violated Clause 5 Part 1 Article 10 of the Federal Law “On Protection of Competition” by refusing to supply medicines without any economic or technological reasons. Earlier FAS (...)

The 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 (...)

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 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 (Moscow)
Appeal Court confirmed legitimacy of FAS warning to “Novo Nordisk”* On 23rd June 2014, the 9th Arbitration Appeal Court dismissed the appeal of “Novo Nordisk” Ltd. on a judgment of Moscow Arbitration Court that supported a FAS warning issued to “Novo Nordisk” Ltd. with regard to some elements of (...)

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

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

The Lisbon Appeal Court revises an arbitral award in a dispute between the National Pharmacy Association and IMS Health (Associação Nacional de Farmácias and Farminveste / IMS Health)
New University of Lisboa - Faculty of Law
Replacing a previous contract, the National Pharmacy Association (ANF) executed a contract with IMS Health in 2008, by which it transmitted to the latter data on purchases in its associated pharmacies, in exchange for remuneration. This data was used to provide pharma market intelligence in a (...)

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

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

The 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 (Canberra)
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 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 (Moscow)
Arbitration Court supported FAS Russia: “Baxter” should have listened to warning* On 27th January 2014, Moscow Arbitration Court confirmed legitimacy of the warning issued by the Federal Antimonopoly Service (FAS Russia) to “Baxter” CJSC due to signs of violating the antimonopoly law (Clause 5 (...)

The French Competition Authority fines a pharmaceutical 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 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 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 (Bristol)
United Kingdom: interim injunctions in competition litigation* Private competition litigation is continuing to develop in the United Kingdom. The courts and the Competition Appeal Tribunal are seeing an increase in the number and complexity of follow-on damages actions, often between foreign (...)

The Bulgarian Competition Authority holds that national health insurance fund is not an undertaking for the purpose of competition law enforcement (NZOK)
Faculty of Law - University of Macau
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 follows case law precedent and finds no abuse of dominance on the pharmaceuticals distribution market (Roche)
Faculty of Law - University of Macau
On 8 May 2013 the Romanian Competition Authority (CC) concluded its investigation into the alleged abuse of dominant position in the pharmaceuticals wholesale market. Finding no evidence that would demonstrate that the manufacturer attempted to prevent the re-importation of its products into (...)

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

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

The Italian Competition Authority fines a leading pharmaceutical company for an infringement of art. 102 TFEU by misusing patent (Pfizer)
LUISS Guido Carli University (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 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 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 European Commission announces the closure of its antitrust investigation in the pharmaceutical sector (Almirall/Boehringer)
Van Bael & Bellis (Brussels)
On 6 July 2011, the European Commission announced that it has closed its antitrust investigation into allegations by Spanish pharmaceutical company Almirall that the German pharmaceutical company Boehringer Ingelheim filed for unmeritous patents in the area of new treatments for lung diseases (...)

The Italian Competition Authority fines a leading chemical company €5 M for refusal to grant access to research data (Bayer CropSciences)
Van Bael & Bellis (Brussels)
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 (New York)
On 19 May 2011, the German Federal Cartel Office (“FCO”) found that Merck KGaA (“Merck”) had abused its dominant position in the markets for several laboratory chemical products by discriminating among its customers. According to the FCO, Merck provided more favourable sales conditions to its (...)

The Belgian Competition 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 (Brussels)
According to press reports, the UK Department of Health, together with 10 health authorities and 144 primary care trusts, has launched an action for damages against Reckitt Benckiser in the High Court. This follows the OFT’s decision to fine Reckitt Benckiser £ 10.2 million for abusing its (...)

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

The EU General Court 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 (...)