Evolving Landscape of Patent Law in Europe: Key Developments Impacting Life Sciences

Recent decisions from the European Patent Office (EPO) and the newly established Unitary Patent Court (UPC) have significantly influenced the evolving landscape of patent law, particularly in the life sciences sector.

One key area of development has been priority entitlement. This issue has surfaced in several major life science cases, including the revocation of the Broad Institute's CRISPR patents (EP2764103, EP2784162, and EP2896697) in 2019. The patents were invalidated due to inconsistencies between the applicants named on the priority and subsequent European patent applications. Since the right to claim priority wasn’t properly transferred, the patents lost their entitlement to priority, ultimately affecting their novelty.

However, the Enlarged Board of the EPO (EBA) took a more pragmatic stance in G1/22 and G2/22, which has reshaped how priority rights are handled. The Board introduced a rebuttable presumption that priority claims are valid, placing the burden on challengers to prove otherwise. This change is likely to reduce the frequency of priority-based formal challenges in EPO proceedings, as evidenced by recent decisions overturning earlier rulings on Broad Institute's patents.

Another significant development relates to post-published evidence used to demonstrate a technical effect and support an inventive step. In G2/21, the EBA allowed the submission of additional data, provided it was derived from the original application’s technical teaching. This decision eliminates the need for a "plausibility" test, simplifying the process for patentees. However, this approach is confined to inventive step assessments and does not apply to sufficient disclosure, which remains critical in life sciences, especially for second medical use claims.

The opening of the Unitary Patent Court (UPC) in June 2023 has also had a notable impact. A landmark decision from July 2024 (Sanofi vs. Amgen) highlighted the UPC's different approach to assessing inventive step. Unlike the EPO's "problem and solution" method, the UPC adopted a strategy reminiscent of German courts, using a "realistic starting point" for analysis and identifying an "underlying problem" from the patent description. This divergence may lead to varied outcomes in parallel opposition proceedings, with ongoing cases at the EPO potentially reaching different conclusions.

Looking ahead, several pending decisions will further shape European patent law. The EBA is expected to clarify the role of patent descriptions in claim interpretation (G1/24) and determine the prior art effect of products that are difficult to analyze or reproduce (G1/23). Additionally, the European Union is progressing toward reforming its Supplementary Protection Certificate (SPC) regime, introducing a unitary SPC to complement the Unitary Patent system, which will have significant implications for the pharmaceutical and life sciences industries.

Overall, European patent law remains dynamic, and developments in both the EPO and UPC will continue to influence the life sciences field in the years to come.

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