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Goodwin

Antitrust and Competition Life Sciences Quarterly Update Q2 2024

Goodwin on

To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more

McDermott Will & Emery

The Vifor Case: Disparagement Reloaded?

McDermott Will & Emery on

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

WilmerHale

FRAND Quarterly: Navigating the Global SEP Landscape - July 2024

WilmerHale on

This is the third issue of WilmerHale’s FRAND Quarterly: Navigating the Global SEP Landscape, a bulletin that highlights developments about the licensing, litigation, and regulation of patents that are or are claimed to be...more

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

WilmerHale

The Interplay Key Decisions at the Intersection of Antitrust and Life Sciences - June 2024

WilmerHale on

Court Orders Delisting of Patents from Orange Book and Denies Motion to Dismiss Antitrust Counterclaims for Improper Orange Book Listings. On June 10, Judge Stanley Chesler of the District of New Jersey entered judgment on...more

Jones Day

EU Parliament Adopts SPC Reform Proposals: Clarifying the Protection Scope for Biologics

Jones Day on

On February 28, 2024, following the European Commission's four 2023 proposals, the European Parliament adopted a legislative resolution on the amended proposal to create a Unitary Supplementary Protection Certificate ("USPC")...more

Morgan Lewis

Disparagement Alleged in Iron Medicine Market: EU Commission Seeks Public Feedback on Company’s Proposed Commitments

Morgan Lewis on

The European Commission on April 19 opened a public consultation on commitments proposed by Vifor Pharma in response to a formal investigation into allegations of anticompetitive practices related to disparaging claims about...more

Goodwin

European Commission’s First-Ever Abuse of Dominance Probe for Shelving of a Novel Pipeline Therapy

Goodwin on

The European Commission (EC) has launched a formal investigation under its abuse of dominance rules into US life sciences company Zoetis in the area of novel veterinary medicines. The EC alleges that the discontinuation of a...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

WilmerHale

Why US Should Help European Efforts to Fix SEP Licensing

WilmerHale on

The U.S. Patent Office, the National Institute of Standards and the International Trade Administration are all currently seeking input to establish U.S. policy on foreign standard-essential patent licensing regulatory regimes...more

A&O Shearman

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

A&O Shearman on

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

Kidon IP

Commentary and Concerns About the European Commission’s Proposed Regulation of SEP Licensing

Kidon IP on

This Summer, the European Commission asked for comments on the proposed regulations that are wending their way through the European Parliament (see, e.g.), and I (here for mine) and some 150 other individual and entities...more

Seyfarth Shaw LLP

A Proposed European Commission Regulation Would Dramatically Alter How Standards Organizations and their Members Approach Standard...

Seyfarth Shaw LLP on

The European Commission's ("EC") Proposal for a Regulation of the European Parliament and of the Council on Standard Essential Patents COM(2023) 232 final (27 Apr 2023) (the "Proposed Regulation") was issued by the Commission...more

A&O Shearman

European Commission publishes proposal for an EU regulation on the Compulsory Licensing of Patents

A&O Shearman on

On 27 April 2023, the European Commission (the Commission) published its Proposal for a Regulation of the European Parliament and of the Council on compulsory licensing for crisis management (the Proposed Compulsory Licensing...more

McDermott Will & Emery

The EU’s Draft Regulations on SEP Licensing: Additional Context from the Impact Assessment Report

McDermott Will & Emery on

We recently reported on the European Commission’s leaked draft regulations concerning the fair, reasonable and non-discriminatory (FRAND) licensing of standard essential patents (SEPs). Since the publication of that piece, we...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

K2 Integrity

Sanctions Against Russia: The Week in Review - May 2022

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The Week in Review delivers the impact and analysis for the public, private, and non-profit sectors from our regular reporting of the evolving global sanctions campaign against Russia. This week, we reviewed the recent...more

McDermott Will & Emery

SEP Regulation: European Union Calls for Stakeholders’ Views

McDermott Will & Emery on

Following public consultation rounds on the regulation of standard-essential patents (SEPs) in the United States and the United Kingdom, the European Union followed suit and published a “Call for Evidence” concerning an...more

McDermott Will & Emery

The Net Is Tightening on European SEP Regulation

McDermott Will & Emery on

The regulation of standard-essential patents (SEPs) has increasingly attracted the attention of policymakers in recent years. This includes the European Commission, which institutes multiple projects to profoundly review the...more

McDermott Will & Emery

International News: Healthcare - Spotlight on the Industry - May 2021

Sovereign Wealth Fund Investment in the Global Healthcare Industry - Sovereign Wealth Funds (SWF) seek out investments that are resilient, conducive to their aims and objectives, and reasonably free from market...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

K&L Gates LLP

Brussels Regulatory Brief: March 2021

K&L Gates LLP on

ANTITRUST AND COMPETITION - The European Commission Opens a New Investigation in the Pharma Sector - On 4 March 2021, the European Commission (Commission) has opened a formal investigation into alleged misuses of patent...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

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