Germany

German Federal Court of Justice maintains patent-compulsory license for HIV medicine

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The HIV medicine Isentress from Merck may be further distributed.  On 11 July 2017, the German Federal Court of Justice confirmed a decision by the Federal Patent Court (reference X ZB 2/17).  This had determined that the Japanese pharmaceutical company Shionogi must grant the competitor Merck a compulsory license to its European patent (EP 1 Read More

Second medical use claims in Germany: No manifest preparation necessary for infringement

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Second medical use patent claims protect a specific therapeutic use of a known substance. Such claims are of particular relevance once substance protection for a medicament has expired. Since the judgment of the Regional Court Hamburg of 2 April 2015 – 327 O 67/15 – Mittelbare Patentverletzung durch Beitritt zu Rabattvertrag found an indirect patent Read More

German Court Issues Compulsory License for Isentress®

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On 31 August 2016, the third senate of the Federal Patent Court (ref. no. 3 LiQ 1/16(EP) has issued a compulsory license to Merck for the antiretroviral HIV/AIDS product Isentress®. The compulsory license has been issued in preliminary proceedings and allows the use of the German part of EP 1 422 218 owned by Shionogi Read More

Düsseldorf Court refers to CJEU on applicability of Specific Mechanism during extended SPC term

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Last December the Regional Court Düsseldorf referred questions for a preliminary ruling to the CJEU (docket number C-681/16) concerning the applicability of the Specific Mechanism during the term of an SPC extended in accordance with the Paediatric Regulation. Factual background is that the plaintiff owning an SPC for a pharmaceutical product wanted to prevent parallel Read More

Fourth Act amending German Medicinal Law and other Regulations entered into force on 24 December 2016

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Regulation (EU) No. 536/2014 on clinical trials with pharmaceuticals for human use (EU Regulation) establishes by directly applicable law binding requirements throughout the European Union (EU) for the approval, the conduct and the monitoring of clinical trials. This made adjustments to the German Medicinal Products Act and the abolition of the German GCP Regulation necessary. Read More