UPC Legal Compass: Imminent infringement in the pharmaceutical sector: UPC's emerging jurisprudence and its implications

In infringement proceeding before the Unified Patent Court (UPC), the assessment of an imminent infringement of a patent in the pharmaceutical sector presents unique and complex challenges, due to the highly regulated framework and the industry-specific dynamics. The determination of an imminent infringement is key for obtaining injunctive relief against potential infringers pursuant to Article 62 UPCA. However, the absence of a uniform interpretation of the imminent infringement standard across different European jurisdictions complicates the patent holder’s ability to assess the chances of success in securing interim relief. 

Since its inauguration, the UPC has issued three significant decisions, which provide valuable initial guidance on the criteria for the assessment of an imminent infringement in the pharmaceutical sector. According to said case law, the imminent infringement must be assessed on a case-by-case basis. Further, there must be concrete indications in the overall circumstances, which indicate that the potential infringer is more likely than not to offer or place the product on the market before the patent expires. Hence, there must be compelling evidence to conclude that all regulatory and administrative market-entry requirements have been completed in such a way that a product could be marketed at any time.

Notably, the UPC clarifies that the imminent infringement must be assessed independently based on the interpretation of the UPCA and not on national patent legislation. However, even the UPC ultimately refers to the national regulatory market entry requirements when assessing imminent infringement in individual cases, as these determine which administrative steps are still required for a market entry of the specific medicinal product. This demonstrates that national legislation and administrative procedures must always be considered when assessing imminent danger in the pharmaceutical sector under the UPCA.