Search results - Concurrences

28 Mar 2019

The FTC reverses Administrative Law Judge decision, finding Section 5 violation for reverse-payment settlement (Impax)

Michael A. Carrier • March 2019

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 (...)

28 mars 2019

États-Unis : La Federal Trade Commission juge que deux laboratoires pharmaceutiques ont conclu un accord de report d’entrée illégal (Impax Laboratories)

Walid Chaiehloudj • N° 2-2019 • pp. 208

Aucun relâchement à l’égard des accords de report d’entrée, telles semblent être les consignes données aux agents de la FTC. Dans son Opinion rédigée par Noah Joshua Phillips, l’autorité américaine de la concurrence a jugé à l’unanimité le 28 mars dernier que le laboratoire générique Impax a conclu un accord (...)

18 Mar 2019

The United States District Court For The Northern District Of Illinois receives a class action complaint against a pay-for-delay agreement (Abbvie)

James J. Kovacs • March 2019

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. (...)

25 Feb 2019

The US Court of Appeals for the Third Circuit Court dismisses a complaint only based on past conduct against a pharmaceutical company (Shire Viropharma)

Thomas J. Miller, George Gordon • February 2019

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 (...)

28 Jan 2019

The EU Commission issues a Report on Competition enforcement in the pharmaceutical sector covering the years 2009-2017

European Commission • January 2019

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 (...)

28 Jan 2019

The EU Commission publishes a report on competition enforcement in the pharmaceutical sector between 2009 and 2017

Martin Favart • January 2019

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

9 janv. 2019

Les accords de report d’entrée Introduction

Walid Chaiehloudj

W. Chaiehloudj – Les accords de report d’entrée 1 INTRODUCTION Le champ magnétique de la concurrence. Dans un article publié en 1995, le professeur Pirovano faisait remarquer que la concurrence produit un champ magnétique qui, écrivait-il, « attire à lui des domaines qui naguère lui échappaient : les (...)

9 janv. 2019

Les accords de report d’entrée Partie I. L’émergence des accords de report d’entrée
Titre I. La genèse des accords de report d’entrée
Chapitre 1. L’apparition des accords de report d’entrée par l’instrumentalisation de la loi Hatch-Waxman aux États-Unis

Walid Chaiehloudj

W. Chaiehloudj – Les accords de report d’entrée 19 PARTIE I L’ÉMERGENCE DES ACCORDS DE REPORT D’ENTRÉE TITRE PREMIER. La genèse des accords de report d’entrée.............................................. p. 23 TITRE SECOND. La diversité des accords de report (...)

9 janv. 2019

Les accords de report d’entrée Chapitre 2. Les accords hors litige de brevet, l’instrument subsidiaire du report de l’entrée

Walid Chaiehloudj

W. Chaiehloudj – Les accords de report d’entrée 217 Chapitre 2 Les accords hors litige de brevet, l’instrument subsidiaire du report de l’entrée L’utilisation des accords de copromotion pour retarder l’entrée des géné - riques sur le marché. Pour retarder l’entrée des génériques sur le marché, les (...)

9 janv. 2019

Les accords de report d’entrée Partie II. Le contrôle des accords de report d’entrée
Titre I. Le rejet partiel des accords de report d’entrée, de lege lata
Chapitre 1. Le contrôle des accords de report d’entrée au moyen du droit des ententes

Walid Chaiehloudj

W. Chaiehloudj – Les accords de report d’entrée 269 PARTIE II LE CONTRÔLE DES ACCORDS DE REPORT D’ENTRÉE TITRE PREMIER. Le rejet partiel des accords de report d’entrée, de lege lata................................ p. 273 TITRE SECOND. L’admission souhaitable des accords de report d’entrée, de lege (...)

9 janv. 2019

Les accords de report d’entrée Chapitre 2. Les moyens techniques de l’admission

Walid Chaiehloudj

W. Chaiehloudj – Les accords de report d’entrée 407 Chapitre 2 Les moyens techniques de l’admission Les propositions envisagées pour résoudre le problème des pay-for-delay. À ce jour, le débat autour des accords pay-for-delay dans l’Union européenne porte systématiquement sur les principes du droit de la (...)

13 Dec 2018

Competition in the pharmaceutical sector: An overview of EU and national case law

Margaret Kyle • Competition in the Pharmaceutical sector

The pharmaceutical sector regularly attracts the attention of competition authorities, who note persistently high profits, waves of merger activity, and declining research productivity in the presence of concerns about affordable access to treatments. The reliance on intellectual property (...)

12 déc. 2018

“Pay-for-delay” : Le Tribunal de l’Union européenne confirme pour l’essentiel, dans huit arrêts totalisant près de 900 pages, les décisions de la Commission européenne sanctionnant des transactions “pay-for-delay” conclues entre un laboratoire fabricant un médicament princeps et plusieurs génériqueurs, mais réduit la sanction infligée dans une affaire, et annule partiellement deux des décisions (Biogaran ; Teva UK ; Lupin ; Mylan ; Krka. ; Servier ; Niche ; Unichem)

Michel Debroux • N° 1-2019 • pp. 73-76

Deux ans après son arrêt “Lundbeck” (Trib. UE 8 sept. 2016, T-472/13, voy. “L’affaire Lundbeck et le concept de concurrence potentielle”, Concurrences n° 2-2017, p. 24-50), le Tribunal se penche à nouveau, dans huit arrêts totalisant près de neuf cents pages, sur la question complexe de l’articulation (...)

12 Dec 2018

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 and so reduces the fine imposed on a pharmaceutical company (Servier)

Marion Provost, Mélanie Thill-Tayara, Simon Hetsch, Sophie Pele • December 2018

On 12 December 2018, the General Court (“Court”) partially annulled the European Commission’s decision of 9 July 2014 in the Servier case and consequently reduced Servier’s fine by more than 30%, from €330.99 million to €228.32 million. After the Lundbeck judgment of 8 September 2016, this second (...)

12 Dec 2018

The EU General Court offers a mixed review of patent settlement agreements in the pharmaceutical sector (Servier)

Peter L’Ecluse • December 2018

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 (...)

12 déc. 2018

Brevet : Le Tribunal de l’Union Européenne confirme que certains accords de règlement amiable en matière de brevets peuvent être restrictifs de concurrence par l’objet (Groupe Servier)

Jean-Michel Vertut • N° 1-2019

Le Tribunal de l’UE a rendu un arrêt illustrant une pratique d’entraves d’accès au marché dans le secteur du médicament (V. par ex., au niveau interne, sous un angle procédural, Crim. 26 oct. 2016, n°15-83477 : Lettre distr. décembre 2016, nos obs.). Aux termes d’un long arrêt, le Tribunal, confirmant (...)

12 Dec 2018

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)

Enzo Marasà • December 2018

The Servier judgments: patent settlements may be deemed “pay-for-delay” agreements, and thus by-object infringements of Article 101 TFEU only if Commission substantiates strong indication of “reverse payment” or “abnormal inducement” from the originator to the generic; further, the originator cannot (...)

29 Nov 2018

Dominance in the pharmaceutical sector: An overview of EU and national case law

Marion Provost, Mélanie Thill-Tayara • Pharma & Dominance

The pharmaceutical sector stands out as being regularly on the radar of competition authorities throughout Europe, with no less than 7 decisions adopted within the last 18 months and multiple on-going investigations, covering a wide range of practices, from excessive pricing to pay for delay, (...)

1 Nov 2018

Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law, Amalia ATHANASIADOU

Stéphane Rodrigues • N° 4-2018 • p. 247

This section selects books on themes related to competition laws and economics. This compilation does not attempt to be exhaustive but rather a survey of themes important in the area. The survey usually covers publication over the last three months after publication of the latest issue of (...)

18 Oct 2018

Antitrust in the pharmaceutical sector: An overview of US case law

Michael A. Carrier • US Pharmaceutical sector

The issues presented by pharmaceutical antitrust law are vital to national economies and patients’ lives. They implicate patent law, antitrust law, and various regulations. They occur in unique markets in which the entity prescribing the drug is not the one paying for it. And they rely on (...)

10 Oct 2018

The U.S. Congress implements a new law requiring drug manufacturers to disclose biologic patent settlement agreements to antitrust Authorities (Patient Right to Know Drug Prices Act)

Jonathan Berman, Rosanna McCalips, Julia McEvoy, Larissa Bergin • October 2018

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 (...)

1^er sept. 2018

Les accords de report d’entrée. Contribution à l’étude de la relation du droit de la concurrence et du droit des brevets, Walid CHAIEHLOUDJ

Perrine Perez • N° 3-2018 • p. 216

Cette rubrique recense et commente les ouvrages et autres publications en droit de la concurrence, droit & économie de la concurrence et en droit de la régulation. Une telle recension ne peut par nature être exhaustive et se limite donc à présenter quelques publications récentes dans ces (...)

1 May 2018

Susan JONES (Novartis): Navigating competition law enforcement around the world - an in-house perspective

Bernd Meyring, Susan Jones • N° 2-2018

Having worked in a competition law authority, in private practice and now as an in-house lawyer, I view the latter as the most challenging and interesting. As an in-house lawyer, I feel responsible for safeguarding the long-term success and reputation of the company. So, it is important to (...)

14 févr. 2018

Etats-Unis : La Cour d’appel du troisième circuit adopte une approche restrictive de l’intérêt antitrust à agir (Wellbutrin XL Antitrust Litigation Indirect Purchaser Class)

Walid Chaiehloudj • N° 1-2018 • pp. 209-211

En imposant aux juridictions inférieures la règle de raison pour contrôler les accords de report d’entrée, l’arrêt Actavis n’a pas résolu toutes les difficultés posées par les pay-for-delay (Federal Trade Commission v. Actavis, 133 S. Ct 2223, 2013, Concurrences n° 3-2013, p. 180, obs. J.-C. Roda). En (...)

1 Sep 2017

Recent developments in pharma antitrust

Alessandra Tonazzi, Elina Koustoumpardi, Mélanie Thill-Tayara, Raphaël De Coninck • N° 3-2017

The authors of this On-Topic focus on the latest developments in the pharmaceutical sector. According to Ms Thill-Tayara, author of the first contribution and lawyer with Dechert Paris, if the competition agencies’ activism is partly motivated by the need to limit the expenses of national health (...)

21 Aug 2017

The U.S. Court of Appeals for the Third Circuit applies an appropriate post-Actavis pleading standard (Lipitor)

Michael A. Carrier • August 2017

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 (...)

17 Jul 2017

The EU Commission sends a statement of objection to a pharmaceutical company regarding possible pay-for-delay agreement (Teva / Cephalon)

European Commission • July 2017

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 (...)

17 Jul 2017

The EU Commission sends statement of objections for alleged pay-for-delay agreement (Teva)

Peter L’Ecluse • July 2017

On 17 July 2017, the European Commission issued a Statement of Objections against pharmaceutical companies Teva and Cephalon (which is now a subsidiary of Teva) alleging that Teva breached Article 101 TFEU by concluding an agreement with Cephalon not to market a cheaper generic version of a (...)

14 Jun 2017

Anticompetitive practices in the pharmaceutical sector: An overview of EU and national case law

Evelyne Friedel, Mathias Kuhn • Pharma & Anticompetitive practices

The Pharmaceutical sector remains under scrutiny of the competition authorities. Since 2014, a large range of practices has been sanctioned, especially with regard to article 102 of the TFEU prohibiting abuses of dominant position. In particular, competition authorities are increasingly (...)

1 May 2017

The Lundbeck case and the concept of potential competition

Derek Ritzmann, Knut Fournier, Niamh Dunne, Sandra Marco Colino, Sofia Païs • N° 2-2017 • pp. 24-50

Antitrust rules have been brought into play in situations whereby a company tries to prevent, or at least delay, the entry into the market of potential competitors. This issue has gained prominence in the context of patents and intellectual property (IP) rights in the pharmaceutical industry. (...)

3 Mar 2017

The UK Competition Authority alleges two pharmaceutical companies have concluded a pay-for-delay agreement (Actavis / Concordia)

UK Competition Authority • March 2017

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 (...)

15 nov. 2016

Développements récents en droit de la concurrence appliqués au secteur pharmaceutique

Alessandra Tonazzi, Laurent Flochel, Mélanie Thill-Tayara, Paul Csiszar, Thierry Dahan

Déjeuner Droit & Économie organisé par la Revue Concurrences en partenariat avec Dechert et Charles River Associates.

8 Sep 2016

The EU General Court confirms the decision of the Commission concerning its first pharma pay-for-delay case (Lundbeck)

Sven Gallasch • September 2016

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

8 Sep 2016

The EU General Court upholds the Commission’s landmark patent settlement agreement decision (Lundbeck)

Kyle Le Croy, Patrick Harrison • September 2016

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 (...)

8 sept. 2016

“Pay for delay” : Le Tribunal de l’Union européenne confirme les amendes de près de 150 millions d’euros infligées à plusieurs sociétés dans le cadre d’un accord visant à retarder la commercialisation du générique d’un antidépresseur (Sun Pharmaceutical Industries et Ranbaxy, Arrow Group et Arrow Generics, Generics (UK), Merck, Xellia Pharmaceuticals et Alpharma, Lundbeck)

Ludovic Bernardeau • Nº 4-2016 • pp. 90-92

Un laboratoire pharmaceutique de princeps (pour les non-spécialistes, des médicaments non génériques), très largement brevetés, enfreint-il le droit de la concurrence en concluant avec des laboratoires de médicaments génériques, chichement rémunérés à ce titre, un accord aux fins de retarder la (...)

8 Sep 2016

The EU General Court rules on the legitimacy of settlement agreements in the pharmaceutical sector (Lundbeck)

Emma Ruane, Jason Woodland • September 2016

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

8 Sep 2016

The EU General Court confirms the decision of the EU Commission concerning its first pharma pay-for-delay case (Lundbeck)

European Commission • September 2016

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 (...)

7 Jul 2016

The EU Court of Justice rules that payment of royalties under a licence agreement where the patent was held invalid may be compatible with Article 101 TFEU (Genentech / Hoechst)

Ajay Ratan • July 2016

License fees, invalid patents and Article 101 TFEU: Genentech v Hoechst and Sanofi Aventis* Consider an agreement under which a license fee is payable for use of a patented technology even if it transpires that the patent is invalid. Is such an agreement contrary to Article 101 TFEU? The answer (...)

22 Jun 2016

US Supreme Court and antitrust: An overview of the leading cases and opinions

Eric Citron, Kevin Russell • US Supreme Court

During its October Term of 2012 —a period running from October 2012 to June 2013—the Supreme Court decided four important cases for United States antitrust law. Since then, the Court has decided only one major case involving federal antitrust. This is a familiar pattern: The relative glut of (...)

1 Jun 2016

Antitrust in Emerging and Developing Countries: Featuring Africa, Brazil, China, India, Mexico - Conference Papers 2nd Edition Implementing Effective Competition Law in the Pharmaceutical Industry in Mexico

Carlos Mena-Labarthe

ANTITRUST IN EMERGING AND DEVELOPING COUNTRIES | 2015 E DITION 85 Implementing Effective Competition Law in the Pharmaceutical Industry in Mexico CARLOS M ENA -LABARTHE * cmena@cofece.mx Head of the Investigative Authority Comisión Federal de Competencia Económica Abstract In the case of Mexico, (...)

14 avr. 2016

Secteur pharmaceutique et droit de la concurrence — Stratégies visant à freiner l’entrée des génériques

Emmanuel Combe, Koen Platteau, Ombline Ancelin, Philippe Février

Petit-déjeuner Droit & Économie organisé par la Revue Concurrences en partenariat avec Simmons & Simmons et MAPP.

22 Feb 2016

The U.S. FTC urges the Court of Appeals for the First Circuit to consider that a reverse payment need not be in cash (Loestrin)

Nicole Daniel • February 2016

U.S. FTC urges the Appeals Court to revive the Loestrin Suit* On December 7, 2015, during oral argument, the U.S. FTC urged the Court of Appeals for the First Circuit to revive the Loestrin suit. The case concerns a so-called reverse payment settlement. In 2009 Watson Pharmaceuticals agreed (...)

22 Feb 2016

The US Court of Appeals for the First Circuit concludes that a reverse payment need not be in cash (Loestrin)

Rosa M. Morales • February 2016

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 (...)

22 Feb 2016

The US Court of Appeals for the First Circuit concludes that a reverse payment need not be in cash (Loestrin)

Michael A. Carrier • February 2016

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 (...)

12 Feb 2016

The UK Competition Authority fines several pharmaceutical companies for pay-for-delay settlements (GlaxoSmithKline)

UK Competition Authority • February 2016

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 (...)

12 Feb 2016

The UK Competition and Markets Authority fines pharmaceutical companies for pay-for-delay deals (GSK)

Irene Fraile, Richard Pike • February 2016

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

1 Dec 2015

Ian Forrester - A Scot Without Borders Liber Amicorum Vol. II Should reverse payment patent settlements be prohibited per se?

Jorge Padilla, Valérie Meunier

271 Ian S. Forrester | A Scot without Borders - Liber Amicorum - Volume II Should reverse payment patent settlements be prohibited per se? V ALERIE M EUNIER AND JORGE P ADILLA * Using the same competition test and counterfactual that has been used in the economic literature that is often cited (...)

22 Sep 2015

The US District Court for the Southern District of New York dismisses lawsuit over patent settlement where generics were granted early-entry licenses with acceleration clauses (Takeda Pharmaceuticals)

Deirdre McEvoy, Jake Walter-Warner • September 2015

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 (...)

30 Jul 2015

The US District Court for the District of Massachusetts rejects a request for a new trial to challenge a “pay-for-delay” agreement (Nexium)

Jeffrey May • July 2015

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

17 Jul 2015

The US District Court for the Northern District of California upholds assignment of antitrust claims to indirect purchasers (United Food / Teikoku Pharma)

David S. Kleban, Robert P. LoBue • July 2015

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 (...)

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