Patent Settlements

Anticompetitive practices

The EU Court of Justice AG Kokott proposes that the Court should set aside the ruling of the General Court and declare that the pay-for-delay agreements concluded by a pharmaceutical firm constituted an abuse of dominance (Servier)
European Court of Justice (Luxembourg)
Marketing of perindopril: Advocate General Kokott proposes that the Court of Justice should rule that all agreements concluded by the Servier group with generic pharmaceutical companies constituted restrictions of competition by object and that it should set aside the General Court’s findings (...)

The US District Court for the District of Columbia dismisses the FTC’s claims of anticompetitive horizontal agreement involving opioid medication (Endo / Impax)
Hausfeld (Washington)
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Hausfeld (Philadelphia)
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Hausfeld (Washington)
On March 24, 2022, Judge Royce C. Lamberth of the U.S. District Court for the District of Columbia dismissed the Federal Trade Commission’s (the “Commission”) complaint against Endo Pharmaceuticals Inc. (“Endo”), Impax Laboratories, LLC (“Impax”) and Impax’s owner, Amneal Pharmaceuticals, Inc. (...)

The US District Court for the Eastern District of California holds that California’s anti-reverse payment law is enforceable, but only against settlements negotiated or completed in California (Association for Accessible Medicines / Rob Bonta)
White & Case (Washington)
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White & Case (Washington)
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White & Case (Washington)
In February 2022, the US District Court for the Eastern District of California held that California Assembly Bill 824—which established a first-of-its kind presumption that certain pharmaceutical patent settlements are anticompetitive and which the California Attorney General had previously been (...)

The UK Competition Appeal Tribunal confirms a pay-for-delay infringement decision but reduces the fines (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
Van Bael & Bellis (Brussels)
On 10 May 2021, the UK’s Competition Appeal Tribunal (“CAT”) issued its final decision in GSK (Paroxetine) – the long-running saga concerning pay-for-delay patent settlement agreements between GSK and several generics. The CAT upheld the Competition and Markets Authority’s (“CMA”) finding of an (...)

The UK Competition Appeal Tribunal confirms infringement in paroxetine pay-for-delay case but slashes fines (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
Ashurst (London)
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Ashurst (London)
The judgment was handed down by the Competition Appeal Tribunal ("CAT") in the paroxetine pay-for-delay case in 2018. However, the CAT decided to wait for a preliminary ruling from the European Court of Justice ("ECJ") on certain questions before determining the remaining grounds of appeal. (...)

The UK Competition Appeal Tribunal upholds an infringement decision for pay-for-delay pharmaceutical deals (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
United Kingdom’s Competition Authority (CMA) (London)
CAT upholds infringement decision for pay for delay pharma deals* The Competition Appeal Tribunal has upheld the CMA decision that GlaxoSmithKline and some generic suppliers of the anti-depressant paroxetine broke competition law. The Competition Appeal Tribunal (Tribunal) has, however, (...)

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 US Court of Appeals for the Fifth Circuit upholds the FTC’s decision in the first fully litigated reverse payment decision against generic pharmaceutical companies (Endo / Impax)
Cleary Gottlieb Steen & Hamilton (Washington)
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Cleary Gottlieb Steen & Hamilton (Washington)
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Cleary Gottlieb Steen & Hamilton (Washington)
On April 13, the U.S. Court of Appeals for the Fifth Circuit affirmed the Federal Trade Commission’s decision that Impax Laboratories entered an anticompetitive “reverse payment” settlement with Endo Pharmaceuticals. This case was the FTC’s first fully litigated reverse payment case since the (...)

The US Court of Appeals for the Fifth Circuit rules that showing the reverse payment settlement eliminated the possibility of an earlier generic entry is enough to infer anticompetitive effect (Endo / Impax)
Jones Day (New York)
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Jones Day (Washington)
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Jones Day (Washington)
In Short The Background: In the Supreme Court’s landmark 2013 decision in FTC v. Actavis, the Court determined that large payments by branded drugmakers to potential generic entrants to settle patent disputes could be anticompetitive. It instructed district courts to apply the "rule of reason" (...)

The US Court of Appeals for the Fifth Circuit upholds the FTC’s ruling finding liability against a generic drug maker for anticompetitive infringements through “reverse payment” settlement with a brand manufacturer (Endo / Impax)
Hausfeld (Philadelphia)
On April 13, 2021, the U.S. Court of Appeals for the Fifth Circuit upheld the Federal Trade Commission’s ruling that generic drug maker Impact Laboratories, LLC (now owned by Amneal Pharmaceuticals) engaged in an anticompetitive “reverse payment” settlement with brand manufacturer Endo (...)

The EU Court of Justice confirms the decision of the Commission to impose fines on several pharmaceutical companies (Lundbeck)
Hogan Lovells (Dusseldorf)
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Hogan Lovells (Dusseldorf)
In the much-anticipated Lundbeck case (i.a. C-591/16 P), the European Court of Justice (“ECJ”) on 25th March 2021 confirmed the decision of the European Commission (“Commission”) to impose fines on Lundbeck and several generics companies. The case concerns a pay-for-delay agreement dating back to (...)

The EU Court of Justice confirms the General Court’s judgment and Commission’s decision on pharmaceutical pay-for-delay agreements (Lundbeck)
Portolano Cavallo (Milan)
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Portolano Cavallo (Milan)
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Portolano Cavallo (Milan)
On March 25, 2021, the Court of Justice of the European Union (ECJ) ruled on appeal in the Lundbeck case, confirming the previous judgement of the General Court (GC) that upheld the decision of the European Commission (Commission) on pharmaceutical “pay-for-delay” agreements (Case AT.39226 — (...)

The EU Court of Justice dismisses all appeals brought by a Danish pharmaceutical company and five generic manufacturers against the judgments of the General Court and upholds a decision of the Commission on patent settlement agreements between the companies (Lundbeck)
McDermott Will & Emery (Brussels)
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McDermott Will & Emery (Brussels)
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McDermott Will & Emery (Paris)
On 25 March 2021, the CJEU dismissed all the appeals brought by Danish pharmaceutical company H. Lundbeck A/S and five generic manufacturers against the judgments of the GCEU, thus upholding a decision of the EC on patent settlement agreements between Lundbeck and five generic manufacturers (...)

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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Latham & Watkins (Brussels)
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Norton Rose Fulbright (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 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 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 EU Commission fines two pharmaceutical companies for a 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 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 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 for the first time when patent settlement agreements restricting a generic pharmaceutical company’s ability to enter the market infringes 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 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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Linklaters (Düsseldorf)
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 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 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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Strelia (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 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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Amazon (Brussels)
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Herbert Smith Freehills (London)
This article has been nominated for the 2021 Antitrust Writing Awards. Click here to learn more about the Antitrust Writing Awards. 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 (...)

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