Compliance Perspectives: The End of the Privacy Shield
Nota Bene Episode 89: European Q3 Check In - Merger Clearance and Data Protection Court Rulings and Brexit Updates with Oliver Heinisch
Pharmacy compounding is one of the topics in the EU Pharma Law Package that has perhaps received less attention compared to topics such as regulatory exclusivity rights, shortages, and sustainability. The EU Pharma Law...more
The boundary between medicinal products and medical devices remains a recurring issue for companies developing or marketing borderline products and courts, which has already been the subject of numerous decisions. Recently,...more
The German Federal Court of Justice (Bundesgerichtshof), tasked with resolving a conflict between two competing pharmacists, sought guidance from the Court of Justice of the European Union ("CJEU") on interpreting the General...more
Welcome to the Litigation Gazette. Each quarter, BCLP's Paris team will keep you informed of the main litigation news in competition law, commercial litigation, labor law, IP/IT/Data and compliance....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
In two recent landmark decisions, Novartis v. Abacus (C‑147/20) and Bayer v. kohlpharma (C-204/20), the Court of Justice of the European Union (CJEU) strengthened the position of drug manufacturers against repackaging...more
Three cases handed down on 17 November 2022 by the EU’s highest court shed important light on the ability of brand owners to oppose the repackaging of medicinal products, particularly where anti-tampering devices are replaced...more
On 14 July 2022, Advocate General (AG) Kokott delivered her much awaited (non-binding) Opinions in Cases C-176/19 P, Commission v Servier and Others and C-201/19 P, Servier and Others v Commission. ...more
Sovereign Wealth Fund Investment in the Global Healthcare Industry - Sovereign Wealth Funds (SWF) seek out investments that are resilient, conducive to their aims and objectives, and reasonably free from market...more
ANTITRUST AND COMPETITION - The French Competition Authority Imposes a Record Fine of €444 Million on Three Pharma Companies for Collectively Exploiting Their Dominant Position - On 9 September 2020, the French Competition...more
On 11 June 2020, the Court of Justice of the European Union (CJEU) delivered a judgement in case C-786/18 GmbH v. Novartis Consumer Health GmbH. The judgment followed a request for a preliminary ruling by the German Federal...more
ANTITRUST AND COMPETITION - The Court Of Justice Of The EU Rules Provides Clarity On The Assessment Of Pay-For-Delay Agreements - The Court of Justice of the EU (CJEU) has backed the UK Competition and Markets Authority...more
On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more
We are excited to bring you issue 76 of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore what businesses need to consider when making climate-related...more
This month, the Court of Justice of the European Union (CJEU) addressed a case of particular interest for pharmaceutical companies that are in the process of developing a new product. Regulatory and commercial considerations...more
The Court of Justice of the European Union (“Court”) just released its judgement in Case C-1/18 Oribalt Riga concerning the customs valuation methodologies applicable to generic medicines in the framework of consignment...more
This year’s C5’s Pharma Patent Term Extensions Forum arrives at a critical time for the pharmaceutical industry. Overarching developments from the Teva U.K. decision (C-121/17) to the SPC Manufacturing Waiver and the most...more
SPECIAL REPORT - BREXIT: CHALLENGES AND OPPORTUNITIES - In this report, we explain some of the key legal implications associated with the United Kingdom leaving the European Union (EU) without a deal for future...more
CARTELS & RESTRICTIVE AGREEMENTS - CJEU’S EYE-OPENING RULING ON ANTITRUST COMPLIANCE AND OFF-LABEL MISINFORMATION – C 179/16, HOFFMAN-LA ROCHE AND OTHERS V AGCM, 23 JANUARY 2018 – On 23 January 2018, the CJEU...more
In principle, patents confer protection for a maximum of 20 years. In Europe, however, the patent terms for pharmaceutical products that meet the conditions necessary for supplementary protection certificates (“SPC”) can be...more
AG rejects core inventive advance and scope of protection tests in favour of a disclosure-based approach to Art 3(a) SPC Regulation - If the CJEU adopts AG Wathelet’s opinion, it will likely be more difficult for patentees...more
The European Commission (EC) and other national competition authorities (NCAs) have traditionally shied away from investigating allegations of excessive pricing and appearing as price regulators. Commissioner Vestager warned...more
A recent decision of the CJEU in Europe raises concerns for pharmaceutical companies who wish to supplement the protection of their products with SPCs. With its decision C 567/16 the court follows a strict approach and...more
The International Product Liability Review provides quality updates and comment from around the world on legal developments in the field of product liability and product safety. ...more