The Court of Justice of the European Union ("CJEU") recently issued an important ruling in the case of Società Italiana Lastre SpA (SIL) v. Agora SARL (C-537/23). The decision addresses the validity criteria of asymmetric...more
5/5/2025
/ Business Litigation ,
Choice-of-Law ,
Commercial Litigation ,
Contract Disputes ,
Contract Terms ,
Court of Justice of the European Union (CJEU) ,
Dispute Resolution ,
Enforcement Actions ,
EU ,
Jurisdiction ,
Litigation Strategies
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
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 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: 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
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: 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
The Situation: The European Commission ("Commission") has requested that the European Chemicals Agency ("ECHA") investigate the need for an EU-wide restriction on "intentionally added' micro-plastic particles.
The...more
11/29/2018
/ Chemicals ,
Cosmetics ,
ECHA ,
EU ,
European Commission ,
Landfills ,
Manufacturers ,
Member State ,
Nanomaterials ,
Public Consultations ,
Public Health ,
REACH
The Situation: The German Parliament has approved the Act on Model Declaratory Proceedings ("Act"), which introduces, for the first time, class action-style litigation for consumer claims.
The Plan: The Act will give...more
7/5/2018
/ Class Action ,
Collective Actions ,
Collective Redress ,
Consumer Protection Laws ,
Declaratory Judgments ,
EU ,
European Commission ,
Germany ,
Injunctive Relief ,
Member State ,
New Legislation ,
Settlement Offer
The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more
6/18/2018
/ Biosimilars ,
EU ,
European Commission ,
Exports ,
Generic Drugs ,
Intellectual Property Protection ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Regulatory Oversight ,
Regulatory Requirements ,
Supplementary Protection Certificate ,
Transparency
The Situation: On May 28 and 29, 2018, the European Commission ("Commission") published two studies aimed at examining the economic and legal impacts of the European Union's regime on Supplementary Protection Certificates...more
6/18/2018
/ EU ,
Incentives ,
Intellectual Property Protection ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
R&D ,
Regulatory Agenda ,
Regulatory Requirements ,
Research and Development
The Situation: Currently, European law provides only for representative actions to stop or prohibit infringements of EU consumer law, but not for collective redress. As a result, significant differences exist in the...more
6/13/2018
/ Class Action ,
Collective Redress ,
Consumer Protection Laws ,
Cross-Border ,
Declaratory Judgments ,
Disclosure Requirements ,
EU ,
European Commission ,
Injunctive Relief ,
Member State ,
Proposed Legislation
On April 26, 2018, the French administrative Supreme Court (Conseil d'Etat) issued a ruling that annulled Decree 2016-1716 of December 13, 2016 ("2016 Decree") related to the summary of characteristics for medical devices....more
5/24/2018
/ Disclosure Requirements ,
Distributors ,
EU ,
France ,
French National Drug and Health Product Agency (ANSM) ,
Manufacturers ,
Medical Devices ,
Member State ,
Pharmaceutical Industry ,
Popular ,
Regulatory Standards ,
Sanctions
The Situation: As agreed in the Coalition Contract of the current German government, the Federal Ministry of Justice officially presented the Act on Model Declaratory Proceedings ("Draft Act") on May 9, 2018, after protracted...more
The Situation: The recent EU Commission proposal for a tightening of consumer protection regulations envisages, in one of its pillars, to step up government enforcement of EU consumer rules, including by introducing a...more
A proposal released by the European Commission for tightening consumer protection regulations in the European Union includes an expansion of both class actions and enforcement powers. The proposal, titled "The New Deal for...more