Pay-for-delay agreements

General antitrust

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

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

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

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

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

The Canadian Competition Bureau issues draft intellectual property 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 Canadian Competition Authority releases "phase II" draft revision of the intellectual property enforcement guidelines
Stikeman Elliott (Ottawa)
Competition Bureau releases "Phase II" Draft Revision of the Intellectual Property Enforcement Guidelines* On June 16, 2015, the Competition Bureau released an updated draft version of the Intellectual Enforcement Property Guidelines (IPEGs), which set out its approach to enforcing the (...)

The Canadian Competition Authority submits a draft of its upcoming intellectual enforcement property guidelines for public comment
U.S. Court of Appeals for the District of Columbia Circuit (Washington DC)
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George Mason University (Fairfax)
Comments of U.S. Federal Trade Commissionner Joshua D. Wright and Judge Douglas H. Ginsburg on the Canadian Competition Bureau’s draft updated intellectual property enforcement guidelines* This comment is submitted in response to the Canadian Competition Bureau’s (the Bureau’s) draft stage 2 (...)

The OECD holds a roundtable on generic pharmaceuticals and competition
OECD - Competition Division (Paris)
Executive summary, by the Secretariat* Considering the roundtable discussion and the delegates’ written contributions, the following key points emerge: (1) The existence of originator drugs and innovation by originator companies is vital to develop new treatments against different illnesses (...)

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

Anticompetitive practices

The US Court of Appeals for the Fifth Circuit upholds the FTC’s ruling regarding an unlawful pay-for-delay agreement in the pharmaceutical sector (Endo / Impax)
Baker Botts (Washington)
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Baker Botts (Washington)
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Baker Botts (Washington)
On April 13, 2021, the U.S. Court of Appeals for the Fifth Circuit upheld the Federal Trade Commission’s (“FTC” or “Commission”) ruling that the “reverse-payment” settlement agreement between Endo Pharmaceuticals Inc. (“Endo”) and Impax Laboratories LLC (“Impax”) violated federal antitrust laws. The (...)

The EU Court of Justice dismisses the appeals of several manufacturers of medicines and upholds the Commission’s decision regarding a pay-for-delay infringement (Lundbeck)
Herbert Smith Freehills (Brussels)
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Herbert Smith Freehills (London)
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Herbert Smith Freehills (Brussels)
On 25 March 2021, the Court of Justice of the EU (“CJEU”) dismissed the appeals by Lundbeck and five producers of generic medicines against the General Court’s (GC) judgments that upheld the Commission’s decision and the fines it had imposed in its first pay-for-delay infringement decision in 2013. (...)

The EU Court of Justice dismisses appeals by several manufacturers of medicines regarding pay-for-delay patent settlement agreements (Lundbeck)
Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
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Van Bael & Bellis (Brussels)
On 25 March 2021, the Court of Justice of the European Union (CJEU) dismissed all appeals against the decision of the European Commission (the Commission) to fine Lundbeck and four generic pharmaceutical companies (Alpharma, Arrow, Merck, and Ranbaxy) for concluding “pay-for-delay” patent (...)

The EU Court of Justice dismisses the appeals of several manufacturers of medicines against the General Court’s judgment upholding the Commission’s pay-for-delay infringement decision (Lundbeck)
Covington & Burling (Brussels)
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Covington & Burling (Brussels)
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Covington & Burling (Brussels)
On 25 March 2021, the Court of Justice of the European Union (“CJEU”) dismissed the appeals by Lundbeck, Merck KGaA (and Generics UK), Arrow, Alpharma (and Xellia) and Ranbaxy, against the General Court’s (“GC”) judgment upholding the European Commission’s (“Commission”) 2013 pay-for-delay (...)

The EU Court of Justice confirms the pay-for-delay infringement decision in the pharmaceutical sector (Lundbeck)
Van Bael & Bellis (Brussels)
On 25 March 2021, the European Court of Justice (“ECJ”) dismissed all appeals against the 2016 rulings of the General Court which had upheld the European Commission’s (“Commission”) decision to fine Lundbeck and four generic pharmaceutical companies (Merck, Alpharma, Arrow and Ranbaxy) for (...)

The EU Court of Justice dismisses the appeals of several pharmaceutical companies involved in an agreement seeking to delay the marketing of the generic antidepressant citalopram (Lundbeck)
European Court of Justice (Luxembourg)
The Court of Justice dismisses the appeals of a number of manufacturers of medicines involved in an agreement seeking to delay the marketing of the genericantidepressant citalopram* The European Commission had imposed on them fines of almost € 150 million From the late 1970’s, the Danish (...)

The EU Court of Justice dismisses the appeals of several manufacturers of medicines involved in an agreement seeking to delay the marketing of the generic antidepressant citalopram (Lundbeck)
White & Case (Brussels)
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White & Case (Dusseldorf)
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White & Case (Brussels)
On 25 March 2021, the European Court of Justice ("ECJ") dismissed all the appeals against the European Commission’s decision to fine Lundbeck and several other companies for entering into anti-competitive patent settlement agreements. The judgments largely repeat the position taken by the ECJ (...)

The US FTC charges two pharmaceutical companies for preventing competition in the national market for oxymorphone (Endo / Impax)
US Federal Trade Commission (FTC) (Washington)
FTC Again Charges Endo and Impax with Illegally Preventing Competition in U.S. Market for Oxymorphone ER* The FTC is suing Endo Pharmaceuticals Inc., Endo International plc, Impax Laboratories, LLC, and Impax’s owner, Amneal Pharmaceuticals, Inc., alleging that a 2017 agreement between Endo and (...)

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

The EU Commission fines pharmaceutical companies for pay-for-delay agreement (Teva / Cephalon)
Ashurst (London)
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Ashurst (London)
On 26 November 2020, the European Commission ("Commission") announced that it had fined the pharmaceutical companies Teva and Cephalon EUR 60.5 million for agreeing to delay for several years the market entry of a cheaper generic version of Cephalon’s drug for sleep disorders, modafinil, after (...)

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

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

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

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

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

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

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

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

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

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

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

The EU Court of Justice clarifies that when patent settlement agreements restrict a generic pharmaceutical company’s ability to enter the market they infringe EU antitrust rules (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
Bird & Bird (Brussels)
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Bird & Bird (Brussels)
Article summary: Settlement Agreements Can Be Anti-Competitive Only If The Involved Companies Are (At Least) Potential Competitors. A Careful Examination Must Determine Whether A Generic Manufacturer Would Have Entered Into The Market Without A "Pay Per Delay" Agreement. The Classification Of (...)

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

The EU Court of Justice renders a preliminary ruling stating that a dispute between an originator and a generics manufacturer constitutes evidence that they are potential competitors (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
Zepos & Yannopoulos (Athens)
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Zepos & Yannopoulos (Athens)
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Zepos & Yannopoulos (Athens)
On 30 January 2020, the Court of Justice of the EU rendered its preliminary ruling in Case C-307/18 – Generics (UK) and Others v CMA (Paroxetine). The case originated in a preliminary reference made by the UK Competition Appeal Tribunal (CAT) relating to an appeal against a decision of the UK (...)

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

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

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

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

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

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

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

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

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

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

The EU Commission sends statements of objection for alleged pay-for-delay agreement (Teva / Cephalon)
Van Bael & Bellis (Brussels)
On 17 July 2017, the European Commission issued a Statement of Objections against pharmaceutical companies Teva and Cephalon (which is now a subsidiary of Teva) alleging that Teva breached Article 101 TFEU by concluding an agreement with Cephalon not to market a cheaper generic version of a (...)

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

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

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

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

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

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

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

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

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

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

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

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

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

The US FTC reaches a settlement with a pharmaceutical company and continues its march “to set a standard for the industry” in pay-for-delay settlement cases (Cephalon)
Sheppard Mullin (San Francisco)
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Sterlington
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 US FTC reaches a 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 a settlement with a pharmaceutical company in a reverse payment case (Cephalon)
Gibson Dunn (Washington)
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Wilson Sonsini Goodrich & Rosati (San Francisco)
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Debevoise & Plimpton (Washington, D.C.)
This article has been nominated for the 2016 Antitrust Writing Awards. Click here to learn more about the Antitrust Writing Awards. The Federal Trade Commission (“FTC”) has reached a settlement resolving its claims that Cephalon, Inc. violated the antitrust laws by entering into reverse payment (...)

The Californian Supreme Court crafts a 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 Californian Supreme Court delineates a structured rule of reason analysis for evaluating reverse payments or pay-for-delay settlements (Cipro)
Sheppard Mullin (San Francisco)
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Sterlington
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 US District Court for the Eastern District of Pennsylvania sends a second reverse-payment case to trial (Cephalon)
Rutgers University (Camden)
On January 28, 2015, Judge Mitchell Goldberg of the U.S. District Court for the Eastern District of Pennsylvania denied defendants’ summary judgment motions, sending the second reverse-payment-settlement case to trial. In King Drug Company of Florence v. Cephalon, 2015 WL 356913 (E.D. Pa. Jan. (...)

The US District Court for the Eastern District of Pennsylvania holds the practice of a pharmaceutical company that does not require plaintiffs to meet any “threshold burden” in establishing a large reverse payment as unjustified in triggering analysis under antitrust rules of reason (Cephalon)
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 EU Court of Justice invites to rethink the approach to pay-for-delay settlements in its case law (Groupement des Cartes Bancaires)
University of East Anglia (Norwich)
European Pharmaceutical Antitrust after Groupment des Cartes Bancaires – Time to Rethink the Approach to Pay For Delay Settlements?* Over the last year the European Commission has stepped up its enforcement efforts against pay for delay settlements. In June 2013 they imposed a fine for the (...)

The EU Court of Justice provides further clarity on when an agreement has the object of restricting competition (Groupement des Cartes Bancaires)
St John’s Chambers (Bristol)
Restrictions by object: duck and elephant hunting with the Court of Justice* Inductive reasoning is sometimes explained by using either the ‘duck test’ (“if it looks like a duck, swims like a duck and quacks like a duck, then it probably is a duck”) or the ‘elephant test’ (“it is difficult to (...)

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)
,
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 money 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 EU Commission imposes a fine of € 427.7 million on a French pharma manufacturer and five generic companies for pay-for-delay settlements impeding price competition on the market for blood pressure medicines (Servier)
University of East Anglia (Norwich)
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 generic companies in relation to so-called ‘pay for delay’ (...)

The US District Court for the Eastern District of Pennsylvania dismisses allegations of hub-and-spoke conspiracy against 5 pharmaceutical companies in the market for narcolepsy drugs (Apotex / Cephalon)
McDermott Will & Emery (Washington)
On Monday, June 23, 2014, a Federal Judge in the Eastern District of Pennsylvania granted summary judgment for five pharmaceutical companies on horizontal conspiracy claims brought by Apotex Inc. and direct purchaser and end payor plaintiffs regarding the popular narcolepsy drug Provigil. (...)

The US FTC files an amicus brief before 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 US FTC appeals the US District Court for the District of New Jersey decision that a “no authorized generic” agreement cannot be an antitrust violation (King Drug / SmithKlineBeecham)
McDermott Will & Emery (Paris)
On May 2, 2014, the Federal Trade Commission (FTC) filed an amicus brief with the U.S. Court of Appeals for the Third Circuit requesting that the court reverse the district court’s decision in Lamictal Direct Purchaser Antitrust Litigation, finding that a “no authorized generic” agreement between (...)

The EU Commission imposes fines totaling €16 million on pharmaceutical companies for delaying market entry of generic pain-killer (Johnson & Johnson / Novartis)
European Commission (Brussels)
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 US FTC submits brief amicus curiae in a pay-for-delay case in which it supports the absence of a cash payment is not determinative in the pharmaceutical sector (In Re Effexor XR)
McDermott Will & Emery (Washington)
The Federal Trade Commission’s (FTC) battle against “reverse-payment” settlements continues. In an amicus brief recently submitted in the case of In re Effexor XR Antitrust Litigation, the FTC advanced a broad interpretation of the Supreme Court’s decision in FTC v. Actavis that looks beyond the (...)

The EU Commission fines pharmaceutical companies for delaying market entry of generic medicines (Lundbeck)
Ashurst (Milan)
,
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 totaling up to €145 million on a Danish pharmaceutical group over pay-for-delay agreements (Lundbeck)
Van Bael & Bellis (Brussels)
,
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 (Brussels)
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 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 an antitrust attack (Actavis)
Ashurst (Milan)
,
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 establishes a rule that blurs the lines between antitrust and patent law (Actavis)
Sheppard Mullin (Chicago)
,
Sterlington
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 rules that the “pay for delay” settlements in the pharmaceutical sector are to be analyzed under the rule of reason (Actavis)
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 US Supreme Court holds that reverse-payment in patent settlements should be reviewed under the antitrust rule of reason (Actavis)
Gibson Dunn (Washington)
,
Wilson Sonsini Goodrich & Rosati (San Francisco)
,
O’Melveny & Myers (Washington DC)
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 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)
,
Latham & Watkins (San Francisco)
,
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 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 UK OFT issues statement of objections to four pharma companies alleging they acted to delay effective competition in the national supply of 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 UK OFT issues a statement of objections to four pharmaceutical 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 certain pharmaceutical companies alleging they acted to delay effective competition in the UK supply of medicine (GSK / GUK / Alpharma / IVAX)
European Commission (Brussels)
United Kingdom: The OFT issues Statement of Objections in Case involving Pharmaceutical Companies* On 19 April 2013, the Office of Fair Trading (OFT) issued a Statement of Objections to certain pharmaceutical companies alleging they acted to delay effective competition in the UK supply of (...)

The EU Commission sends statements of objections to two pharmaceutical companies over a possible delayed entry of a generic pain-killer (Johnson & Johnson / 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 US FTC releases a summary of its new report on pharma patent litigation finding an increase in reverse payment settlements based on an expanded definition of payments
Jones Day (Washington DC)
,
Jones Day (Washington DC)
,
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 EU Commission sends statements of objections to more than a dozen companies concerning investigations in the pharmaceutical sector (Citalopram / 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 a statement of objections to pharmaceutical companies over pay-for-delay agreements (Lundbeck)
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 US Court of Appeals for the Third Circuit holds that reverse payment settlements between brand name and generic pharmaceutical manufacturers may be unlawful under the rule of reason (Schering-Plough)
Arnold & Porter Kaye Scholer (Washington)
,
Hooper Hathaway (Michigan)
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 (...)

The US Court of Appeals for the Third Circuit 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 potential 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 (...)

The US Court of Appeals for the Third Circuit applies the rule of reason and rejects the "scope of the patent" test when pharma patent settlement violates the antitrust laws (Schering-Plough)
Hyman, Phelps & McNamara (Washington DC)
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 Court of Appeals for the Third Circuit rejects the "scope of the patent" test in an antitrust challenge to patent settlements (Schering-Plough)
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 (...)

The US Court of Appeals for the Eleventh Circuit rejects the FTC’s approach to a pay-for-delay settlement between a brand name and generic drug companies as an unlawful agreement not to compete (Solvay / Watson / Paddock)
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 Eleventh Circuit rejects the FTC’s latest pay-for-delay challenge (Solvay / Watson / Paddock)
Mayer Brown (Washington)
,
US Federal Trade Commission (FTC) (Washington)
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 (...)

The US Court of Appeals for the Eleventh Circuit reaffirms that the "scope of the patent" test is the proper standard for antitrust review of reverse payment settlements among pharmaceutical companies (Solvay / Watson / Paddock)
United First Partners (New York)
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 Italian Competition Authority fines a pharmaceutical undertaking for abusing its dominant position in the market for the treatment of visual glaucoma products (Pfizer)
Ashurst (Milan)
Italian Competition Authority fines Pfizer for abuse of dominance relating to visual glaucoma drugs* On 11 January 2012 the Italian Competition Authority (“ICA”) issued a decision fining Pfizer Euro 10.6 million for abusing its dominant position in the market for products for that treat visual (...)

The EU Commission opens an investigation against two pharmaceutical companies on account of a 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 US Court of Appeals holds that reverse payment agreements between a patentee and generic pharma manufacturers that do not exceed the "scope of the patent" are not illegal under the federal antitrust laws (Bayer)
McDonnell Boehnen Hulbert & Berghoff (Chicago)
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 French Competition Authority issues a favorable opinion regarding three derogating inter-professional agreements relative to the rules on payment timeframes in the toy, do-it-yourself, watch-making and jewelry sectors
French Competition Authority (Paris)
Press Release published on the official website of the French Competition Authority. Payment timeframes: The Conseil de la concurrence has issued a favourable opinion regarding the derogating agreements signed in the toy, DIY and watch making-jewellery sectors.* Referred to by the Minister of (...)

The US Court of Appeals for the Second Circuit 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 US Court of Appeals holds that the reverse payment settlement between a 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 US Court of Appeals holds that if the terms of pay for delay settlements between the brand name and generic pharma companies are within the "scope of the patent" antitrust law is not implicated (Abbott / Geneva / Zenith)
Hill, Kertscher & Wharton (Atlanta)
,
Eversheds Sutherland (Atlanta)
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 Eleventh Circuit holds that a reverse payment agreement between a brand name pharmaceutical company and a potential competitor is to be analyzed under the "scope of the patent" test to determine antitrust liability (Abbott / Geneva / Zenith)
United First Partners (New York)
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 (...)

The US Court of Appeals holds that a reverse payment agreement between a brand name pharmaceutical manufacturer and a potential competitor is a per se antitrust violation because the agreement exceeded the "scope of the patent" (Cardizem)
United First Partners (New York)
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 (...)

Procedures

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

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

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

The US District Court for the Southern District of New York dismisses a lawsuit over patent settlement where generics were granted early-entry licenses with acceleration clauses (Takeda Pharmaceuticals)
Siemens (New York)
,
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 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 District of New Jersey notes that even if a Court accepts the premise of a reverse non-monetary payment, plaintiffs may 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 Court of Appeals for the Federal Circuit finds that antitrust liability can be attached to sham administrative petitions as the sham litigation exception is not limited to court litigation (Tyco Healthcare / Mutual Pharmaceutical)
McDermott Will & Emery (Paris)
Addressing whether the “sham” exception to Noerr-Pennington immunity is limited to sham litigation in courts, the U.S. Court of Appeals for the Federal Circuit vacated a lower court’s summary judgment of no antitrust liability, finding that antitrust liability can attach to sham administrative (...)

The US District Court for the Northern District of Georgia refuses to grant a renewed motion to dismiss based on the Noerr-Pennington doctrine given such a conclusion would contradict the Supreme Court’s decision finding that a reverse payment settlement agreement should be subject to antitrust scrutiny (Actavis)
Sheppard Mullin (Los Angeles)
FTC v. Actavis on Remand: A New Chapter* District Court refuses to grant renewed motion to dismiss based on Noerr-Pennington doctrine. In re AndroGel Antitrust Litigation (No. II), MDL No. 2084 (re Federal Trade Commission v. Actavis, Inc., No. 1:09-CV-955-TWT) (N.D. GA April 21, 2014). In (...)

The US District Court for the District of New Jersey issues formalistic ruling on reverse-payment settlements after ’Actavis’ (GSK / Teva)
Rutgers University (Camden)
On January 24, 2014, Judge William Walls of the U.S. District Court for the District of New Jersey issued one of the first rulings interpreting the Supreme Court’s landmark decision in FTC v. Actavis, 133 S. Ct. 2223 (2013). The Court in Actavis made clear that settlements by which brand-name (...)

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

The US FTC files an amicus brief arguing that pharmaceutical patent litigation settlements with ’no authorized generic’ provisions are anticompetitive (GSK / Louisiana Wholesale Drug)
McDermott Will & Emery (Washington)
EXTENDING K-DUR’S REACH? FTC FILES AMICUS BRIEF ARGUING THAT PHARMACEUTICAL PATENT LITIGATION SETTLEMENTS CONTAINING “NO-AG” PROVISIONS ARE ANTICOMPETITIVE* The Federal Trade Commission (FTC) filed an amicus brief on October 9 in U.S. District Court (D.N.J.). In it, the FTC spells out its (...)

The US Supreme Court declines to review a Second Circuit ruling permitting a reverse-payment settlement between a branded and generic pharmaceutical manufacturer (Lousiana Wholesale Drug / Bayer)
Vinson & Elkins (Washington)
,
Reese Gordon Marketos (Dallas)
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 US District Court for the Southern District of Ohio dismisses indirect purchasers’ class action challenging proposed reverse payment agreements as anticompetitive on an allegation of preventing a cheaper generic medicine to enter the market sooner (Plavix)
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 US District Court for the Eastern District of Pennsylvania allows the reverse payment suits to proceed when finding that the agreements extended beyond the scope of the concerned patent (Cephalon)
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 (...)

The US District Court for the Eastern District of Pennsylvania holds that reverse payments cases will proceed to discovery in a patent litigation in the pharmaceutical sector (Cephalon)
Covington & Burling (Washington)
,
Covington & Burling (Washington)
,
Covington & Burling (Washington)
In the latest development in the Federal Trade Commission’s efforts to challenge Hatch-Waxman patent litigation settlements, earlier this week a federal district court in Pennsylvania denied in part defendants’ motions to dismiss antitrust complaints challenging a series of such settlements. The (...)

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

The US District Court for the Northern District of Georgia dismisses the FTC’s pay-for-delay antitrust lawsuit ruling that the contested settlements are not an unreasonable restraint of trade (Androgel)
Skadden, Arps, Slate, Meagher & Flom (Washington DC)
,
Skadden, Arps, Slate, Meagher & Flom (Washington DC)
,
Fordham Competition Law Institute - FCLI (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 (...)

The US District Court for the Northern District of Georgia dismisses antitrust claims on reverse payment on the pharma market (Androgel)
Sheppard Mullin (San Francisco)
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 US District Court for the Northern District of Georgia grants defendants’ motions to dismiss antitrust claims submitted by the FTC regarding 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 (...)

The US DoJ files an 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 US Court of Appeals for the Federal Circuit dismisses antitrust claims against a reverse payment agreement between pharmaceutical companies (Ciprofloxacin Hydrochloride)
ArbJournal (Richmond)
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 (...)

The 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”) (...)

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