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Patents European Commission

Morrison & Foerster LLP

April 2025 Update on Regulation of New Genomic Techniques in the EU

On March 14, 2025, EU Member States agreed in the European Council on a common position to move forward with development of new rules for certain genetically modified plants generated using modern precision breeding methods...more

McDermott Will & Emery

Munich Court Addresses Implementer’s Obligation To Provide Security in FRAND Negotiations

McDermott Will & Emery on

The Munich Higher Regional Court issued a decision concerning the fair, reasonable, and nondiscriminatory (FRAND) negotiation process and an implementer’s obligation to provide security if a license offer for standard...more

Fish & Richardson

Key Insights From the UPC’s First SEP

Fish & Richardson on

In November 2024, the Local Division (LD) Mannheim of the Unified Patent Court (UPC) issued the UPC’s first-ever substantive decision on standard essential patents (SEPs) and fair, reasonable, and non-discriminatory (FRAND)...more

McDermott Will & Emery

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

McDermott Will & Emery on

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

How to commence main proceedings before the UPC: deadlines and court fees

A&O Shearman on

Patent holders must start Unified Patent Court (UPC) proceedings on the merits within a certain period if they do not want to risk the revocation of provisional measures. The UPC has now clarified that filing the statement of...more

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

IP Hot Topic: European Commission Suddenly Withdraws Proposed SEP Regulation

On February 11, 2025, the European Commission withdrew its longstanding, and much debated, proposal for standard essential patent (SEP) regulation. The withdrawal was met with mixed reactions, with SEP holders largely...more

Rothwell, Figg, Ernst & Manbeck, P.C.

CRISPR and Agriculture

Modern gene-editing technology, such as CRISPR/Cas technology, represents a ground-breaking advancement that has transformed our genetic engineering capabilities and has enormous potential for revolutionising medicine, food...more

A&O Shearman

EU Commission issues EUR462.6 million antitrust fine in landmark decision on ‘divisionals game’ and disparagement

A&O Shearman on

On October 31, 2024, the European Commission (EC) fined Teva Pharmaceutical Industries Limited and Teva Pharmaceuticals Europe BV (Teva) EUR462.6 million for abusing a dominant position in several EU Member States on the...more

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

Jones Day

Ban on European Patents for Plants Engineered by "New Genomic Techniques" Nearing Reality

Jones Day on

The European Parliament has adopted an amended European Commission proposal to regulate plants engineered using techniques such as CRISPR/Cas and ban any patenting of plants, plant parts, material, genetic information, or...more

Goodwin

CRISPR Regulatory Updates

Goodwin on

On December 15, 2023, Vertex announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the conditional approval of CASGEVY (exagamglogene autotemcel...more

Hogan Lovells

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

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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

Hogan Lovells

Actualités Législatives et Réglementaires – Septembre 2023

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Le bureau Parisien de Hogan Lovells a le plaisir de vous adresser sa lettre d'information mensuelle qui vous présente les Actualités législatives et réglementaires du mois de septembre 2023. Ces Actualités législatives et...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

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