In May 2022, the European Commission published a proposal to establish a European Health Data Space (“EHDS”). The Commission’s EHDS proposal aims to improve access by individuals to their health data (primary use) and facilitate the re-use of health data for societal good across the European Union (secondary use). The European Commission’s aim is to adopt the EHDS by the end of its current mandate (October 31, 2024). The European Commission expressed its hope that the provisions of the regulation will enter into force across all EU member states in 2025. Businesses operating in the health and pharma sectors should therefore carefully consider how the EHDS might affect them.
On 4 June 2019, the German Federal Court of Justice upheld a ruling by the German Federal Patent Court in which the latter court denied an application for a compulsory license under a patent related to the treatment of cholesterol-related disorders (Case X ZB 2/19). This decision is in line with previous German jurisprudence that has, with a few exceptions, been restrictive to grant compulsory licenses.
Continue Reading German Federal Court of Justice Denies Compulsory License on Anti-Cholesterol Drug Patent
On 21 November 2017, the German Federal Patent Court decided about a license fee for the HIV-Drug Isentress for which it has granted a compulsory license in 2016.
Continue Reading German Federal Patent Court Determines License Fee for a Compulsory License under HIV Drug Patent
On 18 November 2016, the European Commission published a notice on the application of certain key provisions within Regulation (EC) No. 141/2000 on orphan medicinal products (the “Orphan Regulation”). Orphan medicinal products are medicinal products that are used for the diagnosis, prevention or treatment of rare diseases. An orphan designation allows a pharmaceutical company to benefit from EU incentives to develop a medicinal product, such as fee waivers for the regulatory procedures or a ten year market exclusivity.
Continue Reading European Commission Publishes Revised Guidelines on Criteria for Orphan Designations of Medicinal Products
On 15 November 2016, the US Federal Trade Commission (“FTC” or the “Commission”) issued an “Enforcement Policy Statement” (“Policy Statement”) to provide guidance about its enforcement policy on marketing claims for over-the-counter (“OTC”) homeopathic remedies. The FTC concluded that marketing claims that OTC homeopathic products have a therapeutic effect (beyond placebo) lack a scientific basis. Consumers were therefore likely to be deceived by labels that do not disclose the lack of “adequately substantiated evidence” that those products have the claimed treatment effects.
Continue Reading US Federal Trade Commission Wants Marketers of Homeopathic Remedies to Disclose Lack of Scientific Evidence
On 31 August 2016, the German Federal Patent Court issued a compulsory license under a patent that protects an HIV drug to affiliates of Merck & Co. (Case 3 LiQ 1/16). It was only the second time in the history of the court that a compulsory license has been granted and the first time that such license was granted in an emergency procedure. The Federal Patent Court’s first decision to grant a compulsory license dates back to 1991 (Case 3 Li 1/90) and did not survive appeal to the Federal Court of Justice (Case X ZR 26/92).
Continue Reading German Federal Patent Court Grants Compulsory License on HIV Drug Patent
On 14 June 2016, the German Federal Court of Justice (X ZR 29/15 “Pemetrexed”) confirmed prior decisions in which it held that patent infringement under the doctrine of equivalents can, in principle, not be assumed, if the patent discloses various ways that a certain technical result can be achieved, but only one of those possibilities has found its way into the claims.
Continue Reading German Federal Court of Justice Rules on Patent Infringement Under the Doctrine of Equivalents