Pay-for-delay agreements

Foreword Pay for delay agreements: An overview of EU and US Case Law

Are pay-for-delay agreements still a hot topic for competition authorities and courts? The answer, albeit reckless, is definitely “yes”. As the years go by, competition authorities still seem determined to fight these agreements, which are sometimes referred to as “patent settlements” or “reverse payment settlements”. Fundamentally, there are several reasons why competition authorities on both sides of the Atlantic remain vigilant.

Read more
University of Perpignan
France 39 contributions 33057 visits

General antitrust

 The Belgian Competition Authority carries out an unannounced inspection in the pharmaceutical sector
Belgian Competition Authority (Brussels)
Belgium 120 contributions 24203 visits
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 (...)

The US State of California becomes the first State to enact legislation rendering certain pharmaceutical patent litigation settlement agreements presumptively anticompetitive
White & Case (Washington)
United States 50 contributions 28375 visits
,
Allen & Overy (Washington)
United States 17 contributions 13773 visits
,
White & Case (New York)
United States 12 contributions 6050 visits
…
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 (...)

The EU Commission issues a report on competition enforcement in the pharmaceutical sector covering the years 2009-2017
European Commission - DG COMP (Brussels)
Belgium 1362 contributions 2929776 visits
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 EU Commission publishes a report on competition enforcement in the pharmaceutical sector between 2009 and 2017
Court of First Instance of Namur (Namur)
Belgium 224 contributions 47473 visits
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 (...)

The US Congress implements a law requiring drug manufacturers to disclose biologic patent settlement agreements to antitrust Authorities
Jones Day (Washington)
United States 2 contributions 484 visits
,
Jones Day (Washington)
United States 2 contributions 484 visits
,
Jones Day (Washington)
United States 7 contributions 2315 visits
…
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)
Canada 3 contributions 486 visits
,
Davies Ward Phillips & Vineberg (Toronto)
Canada 21 contributions 4036 visites
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 Canadian Competition Authority submits a draft of its upcoming intellectual enforcement property guidelines for public comment
US Court of Appeals for the DC Circuit (Washington)
United States 21 contributions 27464 visits
,
Lodestar Law & Economics
14 contributions 20160 visits
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)
France 313 contributions 1439252 visits
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 (...)

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)
États-Unis 20 contributions 11513 visites
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 (...)

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)
Luxembourg 331 contributions 110063 visits
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)
United States 2 contributions 203 visits
,
Hausfeld (Philadelphia)
United States 3 contributions 284 visits
,
Hausfeld (Washington)
Chile 1 contribution 107 visits
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 UK Competition Appeal Tribunal upholds an infringement decision for pay-for-delay pharmaceutical deals (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
UK Competition & Markets Authority - CMA (London)
United Kingdom 407 contributions 101241 visits
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 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)
Belgium 19 contributions 7749 visits
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 (...)

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)
United Kingdom 21 contributions 4424 visits
,
Ashurst (London)
United Kingdom 3 contributions 688 visits
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 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)
United States 5 contributions 1064 visits
,
Cleary Gottlieb Steen & Hamilton (Washington)
United States 12 contributions 23598 visits
,
American Antitrust Institute (Washington)
United States 1 contribution 471 visits
…
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 upholds the FTC’s ruling regarding an unlawful pay-for-delay agreement in the pharmaceutical sector (Endo / Impax)
Clifford Chance (Washington)
United States 1 contribution 832 visits
,
LCLD Leadership Council on Legal Diversity (Washington)
United States 3 contributions 1095 visits
,
Baker Botts (Washington)
United States 2 contributions 908 visits
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 (...)

The US Court of Appeals for the Fifth Circuit rules that showing that the reverse payment settlement eliminated the possibility of an earlier generic entry is enough to infer anticompetitive effects (Endo / Impax)
Jones Day (New York)
United States 1 contribution 286 visits
,
Jones Day (Washington)
United States 2 contributions 484 visits
,
Jones Day (Washington)
United States 5 contributions 1042 visits
…
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 (...)

The US Court of Appeals for the Fifth Circuit upholds the FTC’s ruling finding a generic drugmaker liable for anticompetitive infringements through a “reverse payment” settlement with a brand manufacturer (Endo / Impax)
Hausfeld (Philadelphia)
United States 1 contribution 289 visits
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 judgment of the General Court that the pay-for-delay agreements concluded between originator and generics manufacturers were by-object restrictions (Lundbeck)
Ashurst (Brussels)
Belgium 37 contributions 9279 visits
The European Court of Justice ("ECJ") confirmed the judgment of the General Court ("GC") upholding the European Commission’s pay-for-delay decision. The ruling held that the originator and generics manufacturers must be considered potential competitors despite Lundbeck’s process patents, and (...)

The EU Court of Justice dismisses appeals by several manufacturers of medicines regarding pay-for-delay patent settlement agreements (Lundbeck)
Van Bael & Bellis (Brussels)
Belgium 61 contributions 26136 visits
,
Van Bael & Bellis (Brussels)
Belgium 19 contributions 7749 visits
,
Van Bael & Bellis (Brussels)
Belgium 163 contributions 56333 visits
…
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 involved in an agreement seeking to delay the marketing of the generic antidepressant citalopram (Lundbeck)
White & Case (Brussels)
Belgium 35 contributions 13514 visits
,
White & Case (Düsseldorf)
Germany 38 contributions 15493 visits
,
White & Case (Brussels)
Belgique 39 contributions 66168 visites
…
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 (...)

The EU Court of Justice dismisses the appeals of several pharmaceutical companies involved in an agreement seeking to delay the marketing of a generic antidepressant (Lundbeck)
European Court of Justice (Luxembourg)
Luxembourg 331 contributions 110063 visits
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 and upholds the Commission’s decision regarding a pay-for-delay infringement (Lundbeck)
Herbert Smith Freehills (Brussels)
Belgium 121 contributions 74002 visits
,
Herbert Smith Freehills (London)
United Kingdom 3 contributions 1602 visits
,
Herbert Smith Freehills (Brussels)
Belgium 22 contributions 7295 visits
…
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 (...)

The EU Court of Justice confirms the pay-for-delay infringement decision in the pharmaceutical sector (Lundbeck)
Van Bael & Bellis (Brussels)
Belgium 33 contributions 6075 visits
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 against the General Court’s judgment upholding the Commission’s pay-for-delay infringement decision (Lundbeck)
Covington & Burling (Brussels)
Belgium 2 contributions 1106 visits
,
Latham & Watkins (Brussels)
Belgium 4 contributions 983 visits
,
Norton Rose Fulbright (Brussels)
United Kingdom 26 contributions 23230 visits
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 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)
Belgium 43 contributions 8021 visits
,
McDermott Will & Emery (Paris)
France 136 contributions 68522 visits
,
McDermott Will & Emery (Paris)
France 33 contributions 8093 visits
…
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 confirms the General Court’s judgment and Commission’s decision on pharmaceutical pay-for-delay agreements (Lundbeck)
Portolano Cavallo (Milan)
Italy 63 contributions 10332 visits
,
Portolano Cavallo (Milan)
Italy 36 contributions 7113 visits
,
Portolano Cavallo (Milan)
Italy 3 contributions 871 visits
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 confirms the decision of the Commission to impose fines on several pharmaceutical companies (Lundbeck)
Hogan Lovells (Düsseldorf)
Germany 4 contributions 1219 visits
,
Hogan Lovells (Düsseldorf)
Germany 11 contributions 4278 visits
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 (...)

The US FTC charges 2 pharmaceutical companies for the second time with preventing competition in the national market for oxymorphone (Endo / Impax)
US Federal Trade Commission (FTC) (Washington)
United States 182 contributions 43085 visits
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 (...)

The EU Commission fines two pharmaceutical companies for a pay-for-delay patent settlement agreement (Teva / Cephalon)
Van Bael & Bellis (Brussels)
Belgium 163 contributions 56333 visits
,
Van Bael & Bellis (Brussels)
Belgium 64 contributions 28592 visits
,
Van Bael & Bellis (Brussels)
Belgium 63 contributions 27745 visits
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, (...)

The EU Commission fines pharmaceutical companies for pay-for-delay agreement (Teva / Cephalon)
Ashurst (London)
Royaume-Uni 14 contributions 2594 visites
,
Ashurst (London)
United Kingdom 21 contributions 4424 visits
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)
European Commission - DG COMP (Brussels)
Belgium 1362 contributions 2929776 visits
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 having an anti-competitive agreement in the supply of the life-saving drug fludrocortisone and secures £8 million in damages for the National Health Service (Aspen / Amilco / Tiofarma)
UK Competition & Markets Authority - CMA (London)
United Kingdom 407 contributions 101241 visits
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 (...)

The US District Court for the Northern District of Illinois dismisses antitrust case challenging patent thicket (Humira)
Rutgers University (New Brunswick)
États-Unis 26 contributions 25633 visites
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 (...)

The UK Competition Authority secures binding competition disqualification of pharmaceutical company director involved in two separate anticompetitive arrangements relating to the supply of drugs over a five year period (Amit Patel / Auden McKenzie / Amilco)
Bird & Bird (London)
Royaume-Uni 28 contributions 3599 visites
,
London Legends FC
4 contributions 660 visits
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 UK Competition Authority secures disqualification of pharmaceutical company director for 5 years for breaching competition law (Amit Patel / Auden McKenzie / Amilco)
UK Competition & Markets Authority - CMA (London)
United Kingdom 407 contributions 101241 visits
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)
Luxembourg 331 contributions 110063 visits
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 EU Court of Justice clarifies the conditions under which pay-for-delay agreements 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)
Belgian Competition Authority (Brussels)
Belgium 3 contributions 873 visits
,
German Competition Authority (Bonn)
Germany 1 contribution 568 visits
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 rules that pay-for-delay patent settlements may restrict competition by object (Generics - UK / GlaxoSmithKline / Actavis / Xellia Pharmaceuticals / Merck / Alpharma)
Van Bael & Bellis (Brussels)
Belgium 163 contributions 56333 visits
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)
Belgium 121 contributions 74002 visits
,
Amazon (Brussels)
Belgium 3 contributions 588 visits
,
Herbert Smith Freehills (London)
United Kingdom 15 contributions 4628 visits
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 (...)

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)
UK Competition & Markets Authority - CMA (London)
United Kingdom 407 contributions 101241 visits
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 (...)

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)
Belgium 37 contributions 9278 visits
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)
Belgique 7 contributions 1394 visites
,
Allen & Overy (Brussels)
Belgique 28 contributions 3368 visites
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 (...)

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)
United Kingdom 20 contributions 5366 visits
,
Hausfeld (Berlin)
Germany 7 contributions 1166 visits
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 (...)

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)
Greece 35 contributions 3753 visits
,
Linklaters (London)
United Kingdom 34 contributions 3241 visits
,
Zepos & Yannopoulos (Athens)
Greece 29 contributions 2538 visits
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 UK Competition Authority issues a statement of objections to three pharmaceutical companies over pay-for-delay agreements (Aspen / Amilco / Tiofarma)
KPN (Amsterdam)
Netherlands 33 contributions 7351 visits
,
Bird & Bird (London)
United Kingdom 28 contributions 3599 visits
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, (...)

The US FTC reverses Administrative Law Judge decision, finding Section 5 violation for reverse-payment settlement (Endo / Impax)
Rutgers University (New Brunswick)
États-Unis 26 contributions 25633 visites
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 FTC concludes that a pharma company entered into an illegal pay-for-delay agreement (Endo / Impax)
Hausfeld (Philadelphia)
United States 3 contributions 284 visits
,
Hausfeld (Washington)
United States 2 contributions 203 visits
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 (...)

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)
United States 4 contributions 698 visits
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 rules that pay-for-delay patent settlements can be illegal agreements but annuls abuse of dominance finding (Servier)
Freshfields Bruckhaus Deringer (London)
United Kingdom 8 contributions 19134 visits
,
UCL (London)
United Kingdom 1 contribution 185 visits
,
Freshfields Bruckhaus Deringer (Rome)
Italie 17 contributions 67517 visites
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 (...)

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)
France 8 contributions 9359 visits
,
Dechert (Paris)
France 47 contributions 71564 visits
,
Dechert (Paris)
France 20 contributions 24324 visits
…
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 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)
Italy 63 contributions 10332 visits
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 (...)

The EU General Court offers a mixed review of patent settlement agreements in the pharmaceutical sector (Servier)
Van Bael & Bellis (Brussels)
Belgium 163 contributions 56333 visits
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 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)
France 34 contributions 21995 visits
,
McDermott Will & Emery (Paris)
France 136 contributions 68522 visites
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 (...)

The EU Commission sends a statement of objection to a pharmaceutical company regarding a possible pay-for-delay agreement (Teva / Cephalon)
European Commission - DG COMP (Brussels)
Belgium 1362 contributions 2929776 visits
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)
UK Competition & Markets Authority - CMA (London)
United Kingdom 407 contributions 101241 visits
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 confirms the EU Commission’s decision concerning its first pharma pay-for-delay case (Lundbeck)
European Commission - DG COMP (Brussels)
Belgium 1362 contributions 2929776 visits
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 the Commission’s decision concerning its first pharma pay-for-delay case (Lundbeck)
University of East Anglia
United Kingdom 3 contributions 2033 visits
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 (...)

The EU General Court upholds the EU Commission’s landmark patent settlement agreement decision (Lundbeck)
Sidley Austin (London)
United Kingdom 6 contributions 4512 visits
,
Willkie Farr & Gallagher (London)
United Kingdom 3 contributions 396 visits
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 EU General Court rules on the legitimacy of settlement agreements in the pharmaceutical sector (Lundbeck)
Peters & Peters (London)
United Kingdom 1 contribution 389 visits
,
Peters & Peters (London)
United Kingdom 1 contribution 389 visits
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 (...)

The EU General Court confirms fines imposed on an undertaking and generic drug manufacturers for entering into anticompetitive pay-for-delay agreements (Lundbeck)
UK Competition & Markets Authority - CMA (London)
United Kingdom 20 contributions 7988 visits
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 (...)

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)
Belgium 20 contributions 5679 visits
,
McDermott Will & Emery (Paris)
France 136 contributions 68522 visites
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 (...)

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)
United Kingdom 3 contributions 1602 visits
,
Herbert Smith Freehills (Brussels)
Belgium 121 contributions 74002 visits
,
Simmons & Simmons (London)
United Kingdom 13 contributions 3212 visits
…
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 US Court of Appeals for the First Circuit concludes that a reverse payment need not be in cash (Loestrin)
Crowell & Moring (New York)
États-Unis 3 contributions 620 visites
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 (New Brunswick)
États-Unis 26 contributions 25633 visites
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)
États-Unis 12 contributions 5962 visites
,
Alston & Bird (London)
United Kingdom 2 contributions 2418 visits
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 (...)

The UK Competition Authority fines £45 million to several pharmaceutical companies for pay-for-delay settlements (GlaxoSmithKline)
UK Competition & Markets Authority - CMA (London)
United Kingdom 407 contributions 101241 visits
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 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)
États-Unis 5 contributions 1209 visites
,
Patterson Belknap Webb & Tyler (New York)
United States 1 contribution 211 visits
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 (...)

A U.S. 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)
Autriche 26 contributions 7679 visites
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 (...)

The US FTC reaches a settlement with a pharmaceutical company in a reverse payment case (Cephalon)
Milbank (Washington)
United States 7 contributions 5815 visits
,
Wilson Sonsini Goodrich & Rosati (San Francisco)
United States 3 contributions 2597 visits
,
Debevoise & Plimpton (Washington)
United States 3 contributions 1372 visits
…
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 (...)

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)
United States 13 contributions 3070 visits
,
Robinson & Cole (New York)
United States 6 contributions 1844 visits
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)
United States 2 contributions 1262 visits
,
STOP - Surveillance Technology Oversight Project (New York)
United States 2 contributions 1719 visits
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 (...)

The Californian Supreme Court crafts a structured rule of reason test for evaluating pay-for-delay settlements (Cipro)
Siemens (New York)
États-Unis 21 contributions 7698 visites
,
Office of the New York State Attorney General (New York)
United States 2 contributions 588 visits
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 cements vigorous scrutiny of reverse-payment settlements (Cipro)
Rutgers University (New Brunswick)
États-Unis 26 contributions 25633 visites
On May 7, 2015, in the first appellate reverse-payment ruling since the U.S. Supreme Court’s decision in FTC v. Actavis, 133 S. Ct. 2223 (2013), the California Supreme Court overturned a lower court decision granting summary judgment for defendants. On behalf of all seven Justices, Justice (...)

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)
United States 13 contributions 3070 visits
,
Robinson & Cole (New York)
United States 6 contributions 1844 visits
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 U.S. 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)
Washington and Lee University School of Law (Lexington)
États-Unis 11 contributions 9271 visites
,
Sheppard Mullin (Washington)
United States 1 contribution 271 visits
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 (...)

The US District Court for the Eastern District of Pennsylvania sends a second reverse-payment case to trial (Cephalon)
Rutgers University (New Brunswick)
États-Unis 26 contributions 25633 visites
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)
DiCello Levitt (New York)
United States 1 contribution 358 visits
,
Arnold & Porter Kaye Scholer (Washington)
United States 1 contribution 358 visits
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 (...)

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
United Kingdom 3 contributions 2033 visits
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)
Royaume-Uni 15 contributions 5663 visites
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 (...)

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)
États-Unis 3 contributions 1079 visites
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. (...)

The US FTC files a complaint against five pharmaceutical companies for pay-for-delay settlements (AbbVie)
Moses & Singer LLP (New York)
6 contributions 1987 visits
,
Skadden, Arps, Slate, Meagher & Flom (Washington)
États-Unis 30 contributions 9669 visites
,
Skadden, Arps, Slate, Meagher & Flom (New York)
United States 21 contributions 5750 visits
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 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
United Kingdom 3 contributions 2033 visits
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 (...)

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)
United States 16 contributions 3167 visits
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 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)
France 136 contributions 68522 visites
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 (...)

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)
Autriche 26 contributions 7679 visites
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 EU Commission imposes fines totaling €16 million on pharmaceutical companies for delaying market entry of generic pain-killer (Johnson & Johnson / Novartis)
European Commission - DG COMP (Brussels)
Belgique 714 contributions 220300 visites
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 (...)

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 (Dusseldorf)
Germany 12 contributions 2013 visits
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 EU Commission fines pharmaceutical companies for delaying market entry of generic medicines (Lundbeck)
Ashurst (Milan)
Italie 103 contributions 30182 visites
,
RSM US (New York)
United States 3 contributions 943 visits
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)
Belgique 15 contributions 4417 visites
,
British American Tobacco (Stockholm)
Sweden 1 contribution 1080 visits
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 - DG COMP (Brussels)
Belgique 714 contributions 220300 visites
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)
Dechert (San Francisco)
États-Unis 26 contributions 9101 visites
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)
Italie 103 contributions 30182 visites
,
RSM US (New York)
United States 3 contributions 943 visits
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)
Belgium 4 contributions 1873 visits
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” patent settlements between brand-name drug manufacturers and would-be generic competitors should be reviewed under the antitrust rule of reason (Actavis)
Competition Appeal Tribunal (London)
United Kingdom 2 contributions 706 visits
,
Latham & Watkins (San Francisco)
United States 2 contributions 364 visits
,
Arnold & Porter Kaye Scholer (Washington)
United States 2 contributions 670 visits
…
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 holds that reverse-payment in patent settlements should be reviewed under the antitrust rule of reason (Actavis)
Milbank (Washington)
United States 7 contributions 5815 visits
,
Wilson Sonsini Goodrich & Rosati (San Francisco)
United States 3 contributions 2597 visits
,
O’Melveny & Myers (Washington)
United States 1 contribution 441 visits
…
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 establishes a rule that blurs the lines between antitrust and patent law (Actavis)
Sheppard Mullin (Chicago)
United States 1 contribution 267 visits
,
Robinson & Cole (New York)
United States 6 contributions 1844 visits
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 opens reverse payment patent settlement agreements to antitrust challenge (Actavis)
Wolters Kluwer (Riverwoods)
États-Unis 78 contributions 39175 visites
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 (...)

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)
Italie 103 contributions 30182 visites
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 (...)

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)
United Kingdom 8 contributions 1907 visits
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 (...)

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 - DG COMP (Brussels)
Belgique 714 contributions 220300 visites
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)
Belgium 163 contributions 56333 visits
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 (...)

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)
États-Unis 20 contributions 6509 visites
,
Jones Day (Washington)
United States 6 contributions 3135 visits
,
Jones Day (Chicago)
United States 7 contributions 1828 visits
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 EU Commission sends statements of objections to more than a dozen companies concerning investigations in the pharmaceutical sector (Citalopram / Perindopril)
Ashurst (Milan)
Italie 103 contributions 30182 visites
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)
Belgium 163 contributions 56333 visits
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 (...)

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)
United States 2 contributions 670 visits
,
Hooper Hathaway (Michigan)
United States 1 contribution 339 visits
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 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)
United States 1 contribution 262 visits
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 (...)

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)
United States 1 contribution 264 visits
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 rejects the "scope of the patent" test in an antitrust challenge to patent settlements (Schering-Plough)
Wolters Kluwer (Riverwoods)
États-Unis 78 contributions 39175 visites
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 (...)

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)
United States 11 contributions 7096 visits
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 (...)

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)
États-Unis 78 contributions 39175 visites
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)
United States 1 contribution 502 visits
,
US Federal Trade Commission (FTC) (Washington)
United States 1 contribution 502 visits
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 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)
Italie 103 contributions 30182 visites
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 (...)

The EU Commission opens an investigation against two pharmaceutical companies on account of a patent settlement agreement (Cephalon / Teva)
Van Bael & Bellis (Brussels)
Belgium 163 contributions 56333 visits
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 (...)

The U.S. FTC asks the 11th Circuit to overturn a lower court’s decision to allow a reverse payment settlement between branded and generic pharmaceutical manufacturers (Watson Pharmaceuticals)
Vinson & Elkins (Washington)
United States 2 contributions 617 visits
,
Reese Gordon Marketos (Dallas)
United States 2 contributions 617 visits
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 (...)

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)
United States 1 contribution 206 visits
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
Autorité de la concurrence (Paris)
France 747 contributions 409160 visites
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 (...)

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)
United States 3 contributions 788 visits
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 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)
United States 3 contributions 788 visits
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)
United States 1 contribution 401 visits
,
Eversheds Sutherland (Atlanta)
United States 1 contribution 401 visits
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)
United States 11 contributions 7096 visits
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 (...)

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)
United States 11 contributions 7096 visits
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 (...)

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)
Belgium 29 contributions 49498 visits
,
Baker Botts (Brussels)
Belgique 28 contributions 21295 visites
,
Baker Botts (Brussels)
Belgium 15 contributions 5341 visits
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 (...)

Unilateral Practices

 The US FTC files an amicus brief arguing that a company has used unlawful strategies to delay the entry of a generic-brand drug into the market for the treatment of Parkinson’s disease (Sage Chemical / TruPharma / Supernus Pharmaceutical)
US Federal Trade Commission (FTC) (Washington)
United States 182 contributions 43086 visits
FTC Files Amicus Brief in Sage Chemical vs. Supernus Pharmaceutical Supporting Competition in the Market for Drug Used to Treat Advanced Parkinson’s Disease* The Federal Trade Commission filed a brief as Amicus Curiae in the U.S. District Court for the District of Delaware in a case related (...)

Regulatory

 The US President Joe Biden signs an executive order seeking to increase competition in industries including Big Tech, healthcare and agriculture with 72 specific initiatives
Linklaters (New York)
United States 4 contributions 11988 visits
,
Linklaters (New York)
United States 3 contributions 580 visits
,
Cravath Swaine & Moore (New York)
United States 1 contribution 84 visits
This article has been nominated for the 2022 Antitrust Writing Awards. Click here to learn more about the Antitrust Writing Awards. On July 9, 2021 the White House released President Biden’s “Executive Order on Promoting Competition in the American Economy”. The Order’s purview stretches (...)

The US President Joe Biden issues an executive order to promote competition in the American economy that includes 72 initiatives targeting the labor, healthcare, agriculture, transportation, internet service, technology, banking, and consumer finance sectors
Covington & Burling (Washington)
United States 20 contributions 12227 visits
,
Covington & Burling (Washington)
United States 8 contributions 2590 visits
,
Covington & Burling (Washington)
United States 10 contributions 4991 visits
President Biden today signed an expansive Executive Order to promote competition that includes 72 initiatives targeting the labor, healthcare, agriculture, transportation, internet service, technology, and banking and consumer finance sectors. In the Order, President Biden calls on the (...)

Procedures

 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)
United States 1 contribution 328 visits
,
White & Case (Washington)
United States 11 contributions 1799 visits
,
White & Case (Washington)
United States 9 contributions 3698 visits
…
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 (...)

The UK Supreme Court hands down a judgment in a competition damages lawsuit and makes key observations on when a judicial decision of the EU courts is binding in other proceedings (Secretary of State for Health / Servier Laboratories)
Shearman & Sterling (Brussels)
Belgium 21 contributions 10375 visits
,
Shearman & Sterling (London)
United Kingdom 30 contributions 14313 visits
,
Financial Conduct Authority (London)
United Kingdom 2 contributions 581 visits
…
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)
États-Unis 5 contributions 1506 visites
,
Dechert (Philadelphia)
États-Unis 6 contributions 1962 visites
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 holds the FTC must show defendants are ‘about to violate’ the law for injunctive relief and disgorgement (Shire Viropharma)
Skadden, Arps, Slate, Meagher & Flom (Washington)
États-Unis 17 contributions 2991 visites
,
Skadden, Arps, Slate, Meagher & Flom (Washington)
États-Unis 22 contributions 6843 visites
,
Skadden, Arps, Slate, Meagher & Flom (Washington)
United States 6 contributions 1889 visits
On February 25, 2019, in FTC v. Shire ViroPharma, Inc., the U.S. Court of Appeals for the Third Circuit confirmed that the Federal Trade Commission (FTC) cannot plead its way into federal court via Section 13(b) of the FTC Act in the absence of specific allegations that a defendant “is (...)

The US Court of Appeals for the Third Circuit applies an appropriate post-Actavis pleading standard (Lipitor)
Rutgers University (New Brunswick)
États-Unis 26 contributions 25633 visites
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)
États-Unis 21 contributions 7698 visites
,
Patterson Belknap Webb & Tyler (New York)
United States 2 contributions 1951 visits
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)
États-Unis 78 contributions 39175 visites
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 (...)

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)
États-Unis 21 contributions 7698 visites
,
Patterson Belknap Webb & Tyler (New York)
United States 5 contributions 1298 visits
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. (...)

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)
France 136 contributions 68522 visites
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)
États-Unis 46 contributions 8036 visites
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’ (GlaxoSmithKline / Teva)
Rutgers University (New Brunswick)
États-Unis 26 contributions 25633 visites
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 (GlaxoSmithKline / Teva)
DLA Piper Weiss-Tessbach (Vienna)
Autriche 26 contributions 7679 visites
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”) (...)

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)
United States 7 contributions 844 visits
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)
United States 2 contributions 617 visits
,
Reese Gordon Marketos (Dallas)
United States 2 contributions 617 visits
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 (...)

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)
United States 4 contributions 1126 visits
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 adopts the "scope of patent" test for analyzing Hatch-Waxman patent settlements (Cephalon)
Skadden, Arps, Slate, Meagher & Flom (Washington)
États-Unis 11 contributions 3739 visites
,
Skadden, Arps, Slate, Meagher & Flom (Washington)
États-Unis 30 contributions 9669 visites
,
Fordham Competition Law Institute - FCLI (New York)
États-Unis 16 contributions 12679 visites
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 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)
IPR University Center (Helsinki)
Finlande 29 contributions 5531 visites
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)
United States 20 contributions 12227 visits
,
Covington & Burling (Washington)
United States 15 contributions 2248 visits
,
Rule Garza Howley (Washington)
United States 9 contributions 2369 visits
…
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 US District Court for the Northern District of Georgia dismisses antitrust claims on reverse payment on the pharma market (Androgel)
Sheppard Mullin (San Francisco)
United States 13 contributions 3070 visits
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, (...)

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)
IPR University Center (Helsinki)
Finlande 29 contributions 5531 visites
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 (...)

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)
États-Unis 11 contributions 3739 visites
,
Skadden, Arps, Slate, Meagher & Flom (Washington)
États-Unis 30 contributions 9669 visites
,
Fordham Competition Law Institute - FCLI (New York)
États-Unis 16 contributions 12679 visites
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 DoJ files an amicus brief on reverse payment settlements on the market for broad-spectrum antimicrobial medicines (Arkansas Carpenters Health / Bayer / Hoechst / Watson)
IPR University Center (Helsinki)
Finlande 29 contributions 5531 visites
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 (In Re Ciprofloxacin Hydrochloride Antitrust Litigation)
ArbJournal (Richmond)
United States 2 contributions 2259 visits
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 (...)

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)
United States 1 contribution 233 visits
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 (...)