While the genus antibody claim was effectively killed by the U.S. Supreme Court in Amgen v. Sanofi, it lives on in Europe despite a few recent setbacks at the European Patent Office ("EPO") and the Unified Patent Court...more
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
Amending prior requirements, medical device manufacturers and importers have two years to comply with FDA's Quality Management System Regulation final rule, a similar approach to prior good manufacturing practices but with...more
The European Patent Office ("EPO") has committed to specific timelines for its new practice of accelerating opposition proceedings....more
The UPC, a single patent court for European Union Member States, has published the first statistics on its case load since its establishment in 2023. Between June 1, 2023, and January 31, 2024, a total of 196 cases were filed...more
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
2/20/2024
/ Biotechnology ,
CRISPR ,
European Commission ,
European Parliament ,
European Patent Convention ,
GMO ,
Intellectual Property Protection ,
Life Sciences ,
New Regulations ,
Patent Applications ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Plant Based Products ,
Public Health ,
Regulatory Reform
The Background: There has been a growing trend to invalidate European patents by challenging their formal priority and using intervening prior art. The Technical Boards of Appeal of the European Patent Office ("EPO") referred...more
In Short -
The Situation: The transition to the new so-called Medical Device Regulation ("MDR") and In Vitro Diagnostic Regulation ("IVDR"), which establish new rules for the placing on the market of medical devices...more
In Short -
The Situation: European Union ("EU") trademark law permits the repackaging of pharmaceuticals that are imported or traded in parallel from one Member State to another only in limited circumstances. In view of...more
Since the United Kingdom implemented the National Security and Investment Act in January 2022 ("NSI Regime"), there has been a significant increase in state intervention in, and review of, business transactions in the United...more
In Short -
The Situation: With the introduction of the Unified Patent Court ("UPC") system in Europe, the co-ownership of patents will have material effect on patents with unitary effect ("Unitary Patent")....more
In Short -
The Situation: While the national case laws of most Unified Patent Court ("UPC") Member States generally accept infringement actions by licensees, the scope and requirements of such actions differ greatly. The...more
On 31 January 2022, the English High Court delivered its judgment in Stadler v Currys Group Limited (EWHC 160 (QB)); the latest in a series of rulings which appear set to constrain the relatively nascent UK data breach claims...more
2/25/2022
/ Corporate Counsel ,
Cybersecurity ,
Damages ,
Data Breach ,
Data Protection ,
Emotional Distress Damages ,
General Data Protection Regulation (GDPR) ,
Personal Data ,
UK ,
UK Data Protection Act ,
UK Supreme Court
The Situation: The health care sector is currently going through a digital transformation phase with the promise of achieving improved patient care and higher efficiency—and the implementation of cloud-based services is a...more
The Situation: The United States federal government—including Congress, the Department of Labor, the Department of Homeland Security, and the Department of the Treasury—continues to ramp up efforts to address reports of...more
The Situation: Companies are facing increased pressure by U.S. Customs and Border Protection ("CBP") and other federal agencies to demonstrate that goods imported into the United States were produced without the use of forced...more
At long last, the new French health care anti-gift regime, modified in 2017, should be applicable as of October 1, 2020, thanks to implementing regulations adopted over the summer.
The French anti-gift regime, which...more
The Situation: Negotiators for the European Parliament and the Council of the European Union (the "Council") have reached an agreement on new European rules on collective consumer action. The Council has thus published a...more
In response to the novel coronavirus ("COVID-19") pandemic, the European Union ("EU"), various Member States and the United Kingdom have adopted trade control measures aimed at avoiding shortages and ensuring the availability...more
The Situation: Spain currently has a system that allows the filing of collective actions but it has not been employed frequently to date, and most consumer-related issues are still litigated on an individual...more
The Situation: Belgian class actions are currently available to consumers, as well as small and medium-sized enterprises ("SMEs") seeking damages from businesses for violations of a number of EU and Belgian...more
The Situation: Under the new Italian framework, class actions will no longer be limited to consumer protection matters, and collective redress may be sought through simplified proceedings.
The Developments: A recently...more
The Situation: In 2018, Germany introduced a model declaratory action giving qualified institutions the right to raise liability claims on behalf of groups of consumers in a representative action. Once the court has issued a...more
The Situation: The Netherlands has a comprehensive system for collective actions and the collective settlement of claims but currently, there is no possibility to seek monetary damages in collective actions.
The...more
The Situation: In a recent decision, the French Supreme Court clarified the surveillance obligations of notified bodies—independent entities accredited by an EU Member State's national health authority to determine whether a...more
1/31/2019
/ Criminal Liability ,
Disclosure Requirements ,
Distributors ,
Emotional Distress Damages ,
EU ,
France ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Regulatory Standards ,
Supreme Court of France