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.
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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.
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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.
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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).
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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.
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