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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

Commission Plans Liberalization Of New Genomic Techniques (NGTS) In The EU

After undergoing an extensive three-year consultation process, the EU Commission’s proposal for a regulation on plants obtained by certain new genomic techniques like CRISPR-Cas (the “Proposal”) is finally available for...more

EU MDR And IVDR Implementation: European Commission Publishes Full Proposal For Amending Transitional Regime

Following up on its announcement in the EU Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) Meeting, the European Commission (Commission) released on January 6, 2023, a proposal (Proposal) to amend the...more

EU: IN VITRO Diagnostic Regulation Entered Into Force (Part 1 OF 3)

In vitro diagnostic medical devices (IVDs), hence devices used for medical tests on samples such as blood or tissue that have been taken from the human body, have become the center of attention in the public eye during the...more

A Long Courtship For Unity – As Europe’s Unitary Patent System Is Going Live Soon, Consultations About A Unitary Supplementary...

After a myriad of challenges, delays, and hurdles, the setting up of the pan-European patent court, the Unified Patent Court (UPC), is finally gaining traction. On January 19, 2022, the UPC came into existence as an...more

The European Commission’s Take On Novel Genomic Techniques (NGTs) In Light Of CJEU’s Ruling In Case C-528/16

The decision of the Court of Justice of the European Union (CJEU) in case C-528/16 essentially banning novel genomic techniques (NGTs), in particular novel mutagenesis technologies such as CRISPR-Cas9, left the community in...more

The European Commission’s New Pharmaceutical Strategy For Europe

On November 25, 2020, the European Commission (the “Commission”) published its “Pharmaceutical Strategy for Europe” which outlines the Commission’s multi-year vision for a more patient-centered pharmaceutical system. The...more

Huawei v. ZTE Revisited – German Automotive Patent Wars To Reshape Sep Litigation In Europe

On November 26, the Dusseldorf Regional Court handed down a long awaited decision in the so-called automotive patent wars (case ID 4c O 17/19). The court referred heatedly debated questions in connection with the enforcement...more

The EU General Court’s Ruling on Pay for Delay - Why Patent Settlement Agreements May Violate EU Antitrust Laws

The EU General Court (“Court”) reduced the fines imposed on Servier SAS and its subsidiaries (“Servier”) from a total of €428 million to €315 million (see press release no. 194/18), thereby partially annulling a European...more

The European Court of Justice on Enforcement of FRAND Patents: Huawei v. ZTE

The European Court of Justice (ECJ) rendered its highly anticipated ruling in Huawei v. ZTE on the enforcement of standard essential patents (SEPs) which are subject to a FRAND commitment. SEPs play a significant role in the...more

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