News & Analysis as of

European Commission European Union Pharmaceutical Patents

Skadden, Arps, Slate, Meagher & Flom LLP

EU Court of Justice Takes a Firm Stance Against Patent Settlement Agreements

The European Union’s Court of Justice (ECJ) has rendered its two long-awaited judgments in the European Commission’s (EC’s) perindopril case. The 27 June 2024 judgments concern: - The EC’s appeal of the General Court’s...more

Dechert LLP

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

Dechert LLP on

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

Hogan Lovells

JPM2024: transactional considerations in view of a (proposed) broader Bolar exemption in EU

Hogan Lovells on

Recent European Commission (Commission) proposals, including a broadening of the so-called ‘Bolar exemption’, would substantially change various incentive schemes related to medicinal product approvals, with the stated goal...more

Goodwin

European Biologics Regulatory Updates

Goodwin on

Bayer’s aflibercept 8 mg recommended for approval in Europe: On November 10, 2023, Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - November 2023

WilmerHale on

European Commission Orders Unprecedented Unwinding Of Illumina’s Acquisition of GRAIL. For the first time, the European Commission has ordered reversal of a consummated transaction, Illumina Inc.’s 2021 acquisition of GRAIL...more

A&O Shearman

European Commission investigation into Teva’s potential abuse of dominance – misuse of patent procedures and disparagement

A&O Shearman on

On 10 October 2022, the European Commission (EC) sent a Statement of Objections to Teva Pharmaceutical Industries Limited and Teva Pharmaceuticals Europe BV (Teva). The EC has provisionally found that Teva abused its dominant...more

A&O Shearman

Beyond “pay-for-delay” – the EU-Commission’s investigation into patent filing practices and communication measures

A&O Shearman on

On 4 March 2021, the European Commission (Commission) opened a formal investigation into alleged anti-competitive conduct by the pharmaceutical company Teva. The Commission suspects Teva of having deployed a strategy with the...more

McDermott Will & Emery

‘Pay-for-Delay’ Agreements can be Restrictions of Competition by their very Nature

McDermott Will & Emery on

On 25 March 2021 the European Court of Justice (ECJ) dismissed all the appeals brought by Danish pharmaceutical company H. Lundbeck A/S (Lundbeck) and five generic manufacturers against the judgments of the General Court of...more

MoFo Life Sciences

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

MoFo Life Sciences on

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

White & Case LLP

The ECJ’s Lundbeck judgment offers little new on patent settlements but gives birth to an interesting principle: sector inquiries...

White & Case LLP on

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...more

A&O Shearman

The Collision Of Biologics – Emerging Competition And What To Expect

A&O Shearman on

On 11 March 2021, GCR hosted a series of interactive webinars. Our global co-head of antitrust, Elaine Johnston, participated in the panel that looked at the development of biologics and the role that antitrust has to play in...more

A&O Shearman

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

A&O Shearman on

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

McGuireWoods LLP

European Competition Law Newsletter – January 2019

McGuireWoods LLP on

Clothing Manufacturer Fined for Restrictions in Distribution Agreements - On 17 December 2018, the European Commission announced a €40 million fine on clothing company Guess for imposing illegal restrictions in its...more

Dechert LLP

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

Dechert LLP on

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

Jones Day

The Proposed SPC Export Manufacturing Waiver: Really a Balanced Approach?

Jones Day on

The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more

Hogan Lovells

European Commission proposes SPC waiver for EU biosimilars or generics manufactured solely for export from the EU

Hogan Lovells on

On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more

Jones Day

European Commission Sets its Sights on Allegedly Excessive Drug Prices

Jones Day on

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

McGuireWoods LLP

More on Patent Settlements Including Litigation at the European Courts

McGuireWoods LLP on

Last week I posted on the European Commission’s (EC) latest report into patent settlement agreements between originator and generic companies in the European Union (EU). The EC says each time it produces these reports that...more

McGuireWoods LLP

Patent Settlement Update for Pharmaceutical Cases in Europe

McGuireWoods LLP on

Ever since the publication in July 2009 of the report on its antitrust inquiry into the pharmaceutical sector, the European Commission (EC) has been monitoring patent settlement agreements between originator and generic...more

Cooley LLP

Alert: Top 10 Antitrust Developments and Trends to Watch in 2016

Cooley LLP on

Attention in the US during 2016 will be on the presidential campaign, and the election in November will bring a change in the "antitrust guard" at the top of the DOJ and FTC – even if a Democrat wins – that will drive the...more

McGuireWoods LLP

European Competition Law Newsletter – January 2016

McGuireWoods LLP on

On 16 December 2015, the UK Supreme Court handed down a judgment on the definition of a merger for the purposes of UK merger control law. This issue is crucial for determining when the regulator may intervene under UK law and...more

McDermott Will & Emery

New IP Enforcement Policy in the EU

McDermott Will & Emery on

Given that strategic importance of IP-sensitive industries for the EU economy, the European Commission (Commission) has introduced a new initiative with a view to strengthen the protection of EU-based IP rights by working...more

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