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 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
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
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: 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 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 UK's Competition Appeal Tribunal (the "CAT") has overturned a finding of abuse of dominance against Pfizer Inc. and Flynn Pharma Ltd. The ruling followed appeals by those companies against a 2016 Competition & Markets...more
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: 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
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
The Situation: German law does not provide a means of collective redress for consumer claims. Attempts to introduce a corresponding act in the previous legislative term were made; however, no political agreement was reached...more
In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more
6/20/2017
/ Anti-Competitive ,
Antitrust Investigations ,
Antitrust Violations ,
Competition Authorities ,
Enforcement Actions ,
EU ,
European Commission ,
Generic Drugs ,
Italy ,
Pay-For-Delay ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Price Gouging ,
Spain ,
Treaty on the Functioning of the European Union (TFEU) ,
UK Competition and Markets Authority (CMA)
On April 27, 2017, the European Medicines Agency ("EMA") held a meeting with the heads of the National Competent Authorities ("NCAs") of the European Union ("EU")/European Economic Area ("EEA") Member States to discuss the...more
5/12/2017
/ Biosimilars ,
EU ,
European Commission ,
European Economic Area (EEA) ,
European Medicines Agency (EMA) ,
Life Sciences ,
Medical Devices ,
Member State ,
Pharmaceutical Industry ,
Regulatory Standards ,
UK Brexit