The UPC Litigation Forum and the Pharma & Biotech Patent Litigation Europe Summit 2025 held recently in Amsterdam provided invaluable insights into the evolving role of the Unified Patent Court (UPC) and its impact on pharmaceutical and biotech patent litigation. Below are some of the most important takeaways from the discussions:
UPC Gains Traction
- The UPC is increasingly accepted across industries, with stakeholders optimistic about its early decisions.
- Many welcome the Court’s applications of familiar approaches, such as assessing FRAND licensing under standards similar to those used by German national courts (see: First FRAND judgment of the UPC), while also valuing its efforts to incorporate elements from different national jurisdictions, for example, when introducing a novel four-part test for equivalence assessment (see here (external)) or when implementing "saisie-type measures" to preserve evidence under UPC rules.
- Furthermore, the Life Sciences industry has responded positively to new initiatives, such as the proposed Unitary Supplementary Protection Certificate (uSPC) also covering plant protection products, although the fragmented uSPC landscape post-Unitary Patent protection, along with the draft proposal's selection of the EUIPO as the central examination and granting authority, was viewed by many as counterintuitive to the UPC's goal of establishing a single, unified jurisdiction.
Life Sciences Sector Remains Cautious
- Despite the optimistic reception of the UPC's initial decisions throughout all industries, particularly pharmaceutical companies remain hesitant due to the complex regulatory landscape and high stakes involved in life sciences litigation.
- Many in the industry have taken a "wait and see" approach, preferring to let others test the system before committing to it.
- The need for greater legal certainty was a recurring theme, with both industry representatives and judges acknowledging that true harmonization will take time.
Key Priorities: Efficiency and Harmonization
- Often discussed was the Kaldewei v. Bette case, the first decision on the merits, which was resolved within a year, demonstrating the court’s commitment to speed and efficiency (see: UPC grants first permanent injunction)
- Additional judicial appointments, such as the recent appointment of a third judge in the Düsseldorf Local Division (see: Düsseldorf local division gains third judge (external)), which was already hinted at during the conference, underscore the court's determination to scale-up its ability to meet increasing demand.
- Not only industry stakeholders, but also the judges stressed the importance of harmonization, stating that they are closely monitoring each other’s rulings to ensure consistency across UPC divisions, whenever possible.
- For the UPC to continue to gain traction, it will be imperative that it can demonstrate that speed and quality of decisions can be maintained as case numbers continue to rise significantly.
Practical Takeaways for Litigators
- The UPC judiciary strongly advised attendees to file in English whenever possible to enhance case management and allocation efficiency.
- Further, Judges encouraged attendees to focus on key prior art arguments to streamline proceedings and allow the court to adhere to the tight deadlines.
AI's Growing Role in Life Sciences
- Artificial Intelligence (AI) and it's many implications were also highlighted during the conference as it's becoming an increasingly important factor in drug discovery, biotech innovation, and personalized medicine.
- Ensuring sufficiency of disclosure for AI-generated inventions and setting the appropriate benchmark for assessing the inventive step remains a primary challenge (see: The IP in AI – Can patents protect AI-generated inventions?)
- Additionally, AI systems trained on vast datasets may encounter copyright issues, requiring careful, front-loaded analysis of training practices to avoid intellectual property violations. Uncertainties about the protectability of AI-generated results further complicate the legal landscape (see: The IP in AI – Does copyright protect AI-generated works?)
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The articles published on this website, current at the dates of publication set out above, are for reference purposes only. They do not constitute legal advice and should not be relied upon as such. Specific legal advice about your specific circumstances should always be sought separately before taking any action.