News & Analysis as of

Generic Drugs Patents European Union

McDermott Will & Emery

European Commission Fines Teva €462.6 Million for Misusing Divisional patents and Disparaging Generic Competitors in the Copaxone...

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On October 31, 2024, the European Commission (the Commission) delivered its long-awaited decision in the Teva Copaxone case (which was published on April 8, 2025). Teva, a global pharmaceutical company, was fined EUR 462.6...more

A&O Shearman

European Commission sanctions first ever pharmaceuticals cartel and scores victory in pay-for-delay appeal

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The European Commission (EC) has fined five pharmaceutical companies a total of EUR13.4 million for participating in a cartel concerning N-Butylbromide Scopolamine/Hyoscine (SNBB) – an active pharmaceutical ingredient (API)...more

Proskauer - The Patent Playbook

Preparing for Europe’s Unified Patent Court

After years of contemplation and delays, Europe’s Unified Patent Court will be operational in about one year. U.S.-based Life Sciences patent applicants should start preparing now to ensure that their applications withstand...more

A&O Shearman

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

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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

A&O Shearman

Patent settlements and competition law – guidance from Europe’s top court

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On 25 March 2021, the European Court of Justice (ECJ) ruled for the second time on a “pay-for-delay” settlement. These are settlements of a patent dispute that involve payments or other value transfers from the originator...more

Hogan Lovells

[Webinar] Antitrust today: Emerging issues affecting the life sciences industry - March 12th, 9:00 am - 10:00 am PST

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Join the Hogan Lovells Antitrust and Competition team on Friday, March 12, 2021 to discuss hot antitrust topics in the life sciences industry, including: - What life sciences companies should expect with respect to...more

Skadden, Arps, Slate, Meagher & Flom LLP

Investment in Possible Future Generic Marketing Excludes Legitimate Basis for Pharma Settlement, Suggests EU Advocate General

In her opinion issued on June 4, 2020, Advocate General (AG) Juliane Kokott recommended that the European Court of Justice (ECJ) dismiss in its entirety the appeal by Lundbeck A/S and Lundbeck Ltd against the General Court’s...more

White & Case LLP

Court of Justice ruling in Paroxetine

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The European Court of Justice's ruling in Paroxetine, handed down in record time just before Brexit, confirms the narrow interpretation of restrictions by object given in other recent cases. It also clarified certain issues...more

Hogan Lovells

The Court of Justice of the European Union provides clarifications on the assessment under competition law of pay-for-delay deals...

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On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more

Hogan Lovells

EU: New developments in the SPC manufacturing waiver legislative process

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Following the European Commission’s draft proposal for implementing the so-called SPC manufacturing waiver the Committee on Legal Affairs of the European Parliament published a draft report on presenting its suggested...more

McGuireWoods LLP

European Competition Law Newsletter – January 2019

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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

American Conference Institute (ACI)

[Event] 11th Pharma & Biotech Patent Litigation - February 26 - 27, 2019 - Radisson Blu Hotel, Amsterdam

The annual gathering exploring the inherently complex and continually contentious pharma and biotech patent litigation - Life Science patent litigation filings are predicted to rise at new levels. Be part of the only event...more

Hogan Lovells

Patent law in Europe: What pharmaceutical companies need to know

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Increasing competition within Europe’s pharmaceutical space makes knowing the market and understanding available patent protections more critical than ever for both well established and new market players. Andreas von Falck...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Bolar Exemption in Europe and Asia

Bolar exemption in Europe - The Bolar exemption is governed by European Directive 2001/83/EC on the Community Code relating to medicinal products for human use. Article 10(6) excludes from infringement of patent rights or...more

Smart & Biggar

Rx IP Update - July 2017

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Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

Hogan Lovells

Italian time-machine : Limitation of the duration of an SPC may be decided by the Italian Patent Office

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The Board of Appeal of the Italian Patent Office (Commissione dei Ricorsi), by decision published on June 26, 2017, acknowledged the right of the patent holder to ask the Italian Patent Office for the limitation of the...more

McDermott Will & Emery

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

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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

McDermott Will & Emery

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

McDermott Will & Emery on

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

McDonnell Boehnen Hulbert & Berghoff LLP

MBHB Snippets: A review of developments in Intellectual Property Law - Volume 14, Issue 2 (Spring 2016)

Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more

McGuireWoods LLP

More on Patent Settlements Including Litigation at the European Courts

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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

McDonnell Boehnen Hulbert & Berghoff LLP

News from Abroad: UK Court of Appeal Rules on Interim Injunctions

The Court of Appeal recently issued a decision concerning the issues that should be considered when granting an interim injunction. The proceedings related to Novartis' product zoledronic acid, which was used to treat...more

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