Germany

New legislative proposals in Germany to encourage the use of biosimilars

Eda Zhuleku

The German Federal Ministry of Health recently released draft legislation on the safety of medicinal products – “Gesetz für mehr Sicherheit in der Arzneimittelversorgung” – GSAV In the wake of several recent safety issues, for example,  the release of contaminated pharmaceuticals with potentially carcinogenic substances in 2018, the government aims to improve the safety of medicines by stricter Read More

German Court rules that promotion of prescription-only medicines is justified to refute a “social media storm”

Stefanie Günther

The Higher Regional Court of Cologne held in a recent decision that a pharmaceutical company could defend itself against a “social media storm” via a post in social media, even though the post qualified as promotion of a prescription-only medicine. The promotion of prescription-only medicines vis-à-vis the public is prohibited in the EU. The German courts Read More

UPC ratification process in Germany put on hold following constitutional complaint

Joachim Feldges

In March 2017, a constitutional complaint was filed against both the German bill for ratifying the UPC Agreement and the UPC Agreement itself with the German Federal Constitutional Court (“Bundesverfassungsgericht”). Many stakeholders have been speculating on the grounds for this constitutional complaint. Now, the German Federal Constitutional Court has disclosed the main line of argumentation Read More

SPC protection for a derivative of an active substance in Germany – Paliperidonpalmitat

Birgit Kramer

In its decision file no. 14 W (pat) 25/16 of 5 September 2017, the German Federal Patent Court had to decide under which circumstances an own SPC can be obtained for a derivative of a pharmaceutical active substance. The context is Art. 3c Reg. no. 469/2009 (that there may not be more than one SPC Read More

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

Birgit Kramer

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