News & Analysis as of September 17, 2024

Pharmaceutical Industry

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The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -

The Vifor Case: Disparagement Reloaded?

McDermott Will & Emery on 8/21/2024

On July 22, 2024, the European Commission (EC) accepted commitments proposed by Vifor Pharmaceuticals to address disparagement concerns under Article 102 TFEU. This is the EC’s first pure disparagement case and its second...more

Affaire Servier : la Cour de justice de l’Union censure l’arrêt du Tribunal et lui renvoie la balle

Dechert LLP on 7/16/2024

Le 27 juin 2024, le laboratoire pharmaceutique Servier – qui, entre 2005 et 2007, avait conclu plusieurs accords transactionnels en matière de brevets impliquant des paiements inversés avec des génériqueurs (Niche/Unichem,...more

The Servier Case: The Game isn’t Over Yet

Dechert LLP on 7/15/2024

The ECJ confirms its intolerance against conduct that is viewed as originator companies buying off competition from generic companies about to enter the market and thereby unduly prolonging their monopoly. Such conduct, which...more

Antitrust M&A Snapshot - Q4 2023

McDermott Will & Emery on 2/14/2024

IN THIS FEBRUARY 2024 ISSUE - UNITED STATES - New Merger Guidelines Released - The US Federal Trade Commission (FTC) and US Department of Justice Antitrust Division (DOJ) issued their updated Merger Guidelines on...more

ΑG opines that all of Servier’s pay-for-delay deals were restrictions of competition by object

A&O Shearman on 8/4/2022

On 14 July 2022, Advocate General (AG) Kokott delivered her much awaited (non-binding) Opinions in Cases C-176/19 P, Commission v Servier and Others and C-201/19 P, Servier and Others v Commission. ...more

Proposed EU Competitor Cooperation Guidelines Tougher on Information Sharing, but Scope Provided for Sustainability Agreements

Skadden, Arps, Slate, Meagher & Flom LLP on 3/30/2022

The European Commission (Commission) is accepting public comment on its proposed revisions to European Union regulations and guidance on common competitor cooperation arrangements, which are due to expire on 31 December 2022....more

Pay-For-Delay Has A Tough (Antitrust) Time At EU Top Court

MoFo Life Sciences on 4/20/2021

In recent years, there have been various antitrust investigations in the pharmaceutical sector resulting in decisions of the European Commission (EC) and the European Courts. In two recent rulings – “Lundbeck and...more

Pay-for-delay: Review of the ECJ judgment in Lundbeck (Citalopram)

Latham & Watkins LLP on 3/29/2021

The Court of Justice of the European Union (ECJ) has confirmed that pay-for-delay agreements with generic manufacturers ready to enter the market violate EU antitrust rules. ...more

European Commission completes current cycle of pay-for-delay probes with fines imposed on Teva and Cephalon

A&O Shearman on 12/8/2020

On 26 November 2020, the European Commission (Commission) issued a decision fining pharmaceutical companies Teva and Cephalon EUR60.5 million for infringing Article 101 TFEU by agreeing to delay the entry of a cheaper generic...more

COVID-19: The Return of the ‘Comfort Letter’

Morgan Lewis on 5/4/2020

The European Commission published its first comfort letter in nearly 20 years on April 29, in an effort to foster cooperation among businesses during the coronavirus (COVID-19) pandemic. ...more

More Affordable and Innovative Medicines and Treatments in Europe – Has the Competition Enforcement Met the 2009 Objective?

Orrick, Herrington & Sutcliffe LLP on 3/19/2019

A decade ago, the European Commission conducted a thorough sectoral inquiry into the European pharmaceutical sector that identified antitrust shortcomings impeding access to more affordable and innovative medicines and...more

Annual EU Competition Review 2018

McDermott Will & Emery on 2/19/2019

CARTELS & RESTRICTIVE AGREEMENTS - CJEU’S EYE-OPENING RULING ON ANTITRUST COMPLIANCE AND OFF-LABEL MISINFORMATION – C 179/16, HOFFMAN-LA ROCHE AND OTHERS V AGCM, 23 JANUARY 2018 – On 23 January 2018, the CJEU...more

The Servier Judgment: A Breath of Fresh Air for Pharmaceutical Companies?

Dechert LLP on 12/21/2018

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...more

EU General Court Dismisses Parallel Trade Group’s Dual-Pricing Complaint Against GSK

Skadden, Arps, Slate, Meagher & Flom LLP on 10/5/2018

On September 26, 2018, the EU General Court (the Court) upheld the European Commission’s refusal to reinvestigate GlaxoSmithKline SA’s (GSK) Spanish “dual-pricing” distribution arrangements, 20 years after the alleged conduct...more

Excessive Pricing, ‘Pay-For-Delay’ and Rebates: A New Era of Enforcement in the Pharmaceutical Industry

A&O Shearman on 4/26/2018

The European Commission (EC) and other national competition authorities (NCAs) have traditionally shied away from investigating allegations of excessive pricing and appearing as price regulators. Commissioner Vestager warned...more

European Commission Sets its Sights on Allegedly Excessive Drug Prices

Jones Day on 6/20/2017

In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more

EU Court Confirms European Commission’s Decision on Pay-for-Delay Agreements

McDermott Will & Emery on 9/30/2016

On 8 September 2016, the General Court of the European Union upheld the European Commission’s decision in which the antitrust regulator imposed fines of approximately EUR 150 million on Lundbeck and a number of generic...more

General Court of the EU Confirms Fines Imposed on Lundbeck and Generic Drug Manufacturers for Entering into Patent Settlements

McDermott Will & Emery on 9/23/2016

On 8 September 2016, the General Court of the EU (GCEU) handed down five judgments upholding a decision by the Commission of 19 June 2013 imposing fines on Lundbeck, an originator company, and Merck (the parent company of...more

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European Union › Treaty on the Functioning of the European Union (TFEU) › Pharmaceutical Industry

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