Rejection of the Application for Provisional Permission to Use Pharmaceuticals: Landmark Ruling in Patent Law
On August 30, 2018, the German Federal Patent Court (Case No.: 3 LiQ 1/18 (EP)) ruled that a pharmaceutical company would not be granted the requested provisional permission to use a cholesterol-lowering drug. The court decision, which relied on ongoing cancellation proceedings before the European Patent Office (EPO), highlights the complex balancing of patent protection interests and economic concerns in the field of pharmaceutical innovation.
Legal Background and Procedural Status
The Protection Right and Its Disputed Validity
The underlying contested patent protects a pharmaceutical invention that can be used to treat lipid metabolism disorders. In parallel proceedings, the validity of this patent was challenged before the EPO. Due to the pending status of the patent, a third company applied for provisional permission to use the patented technology in order to market the active ingredient in its own products.
Judicial Decision-Making in Light of Pending Proceedings
The German Federal Patent Court examined the application in consideration of the ongoing opposition proceedings. It became apparent that the final validity of the patent had not yet been determined: A provisional use permit, which can be granted in exceptional cases during pending invalidation proceedings, nevertheless requires special prerequisites.
Standards for the Provisional Use Permit
Requirements Under Patent Law
According to established case law, the interim authorization of third-party use constitutes a significant encroachment on the rights of the patent holder. Preconditions for this are, in particular, an overriding probability that the protection right will be declared invalid in the foreseeable future as well as a significant preponderance of public or private interests in immediate use over the patent owner’s interests in continuation of protection.
Balancing of Reciprocal Interests
The court made it clear that neither urgency nor a sufficient likelihood of subsequent revocation of the protection right had been demonstrated. The interest of the patent holder in exclusive exploitation enjoys—so long as the patent remains valid—special protection. Therefore, a provisional permit for use was denied.
Practical Relevance and Implications for Companies
Impact on Generic Manufacturers and the Pharmaceutical Market
The decision has direct implications for companies wishing to bring generics or similar pharmaceuticals to market. The hurdles for obtaining provisional permission to use during pending invalidation proceedings remain high. This applies not only to domestic cases but also to cross-border matters involving international patent disputes.
Signaling Effect for Innovation Protection
With this decision, the German Federal Patent Court emphasizes the importance of the protection of innovation as a central element of industrial property rights. For marketing authorization holders and licensees, the case law provides clear guidance regarding the defense and enforcement of existing patent rights in the pharmaceutical sector.
Outlook and Further Developments
Clarification of the definitive status of the protection right remains reserved to the ongoing opposition proceedings before the European Patent Office. As long as the fate of the patent has not been conclusively determined, a legally binding and enforceable permission to use remains excluded for third parties. In principle, further legal remedies against this decision are available.
Assessment by MTR Legal Rechtsanwalt
The decision of the German Federal Patent Court demonstrates the multifaceted challenges faced by research-driven companies, pharmaceutical manufacturers, and suppliers in the field of industrial property rights. For questions regarding the enforcement or defense of patent rights, an early legal assessment proves to be crucial.
For more in-depth information and an individual assessment of the specific facts and interests in patent disputes, you are welcome to contact MTR Legal Rechtsanwalt with confidence.
Source: German Federal Patent Court, Order of 30.08.2018, Case No.: 3 LiQ 1/18 (EP).
(It should be noted that, at the time of reporting, proceedings had not yet been concluded with legal effect. The presumption of innocence applies unconditionally to all parties involved.)
