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Originator vs Generika – Pharmapatente im Spannungsfeld des einstweiligen Verfügungsverfahrens, PharmR Heft 6/2022, Heft 8/2022

In the issue 6/2022 of Pharma Recht, Dr Marco Stief and Dr Christian Meyer review and summarise the rather game-changing legal and factual developments in the practical enforcement of pharmaceutical patents in preliminary injunction proceedings in Germany. From an economical point of view, enormous sums are often at stake. Accordingly, originator companies are vigorously attempting to defend their monopolistic position against the market entry of so-called generics. Whereas, up until the beginning of 2000, there were still doubts regarding the general applicability of preliminary injunction proceedings in the field of life sciences and pharmaceuticals, and courts tended to dismiss preliminary injunctions applications, not least due to the complexity of the subject matter. This trend has been reversed in recent years, with the result that some district courts now grant preliminary injunctions even in difficult or even, ambiguous patent infringement and/or patent validity situations, sometimes within a few days and without a prior hearing for the defendant.

In issue 8/2022 of PharmR, the second part of the article on the enforcement of pharmaceutical patents in the context of preliminary injunction proceedings by Dr Marco Stief and Dr Christian Meyer was published. In this article the focus is on the assertion of claims that are outside the scope of the Patent Act, in particular Sections 826, 1004 German Civil Code (BGB) and the Unfair Competition Act (UWG), as well as the assertion of claims against other defendants (such as IFA GmbH, wholesalers or sick funds). Furthermore, the article discusses the balancing of interests in the particular context of enforcement of first or second generation pharmaceutical patents. Finally, they discuss the defence options available to the generic manufacturers against ex parte injunctions by for example the submission of preemptive briefs.

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