The European patent landscape is evolving rapidly, particularly in the pharmaceutical/biotech sector, where the Unified Patent Court (UPC) and the European Patent Office (EPO) are shaping litigation strategies. The expectation that UPC proceedings will automatically be stayed pending EPO opposition outcomes is not very factual. Instead, the UPC asserts its independence, prioritizing timely justice over lengthy administrative processes.

UPC’s Approach: No Automatic Stay for EPO Oppositions

The UPC has positioned itself as a competent and efficient forum for resolving patent disputes, including validity challenges. While an EPO opposition decision may influence the UPC, the court does not automatically pause its proceedings. Instead, it prioritizes speed and efficiency, avoiding delays caused by lengthy EPO processes.

Clearly evident from Meril Life Sciences Pvt. Ltd. & Anor v Edwards Lifesciences Ireland Ltd & Anor (UPC_CoA_320/2023), where the UPC Court of Appeal clarified that stays are discretionary, not mandatory. The court retains the authority to proceed with infringement or revocation actions even if an EPO opposition is pending.

Recent Pharma Case Law: Conflicting Outcomes Between UPC and EPO

The potential for divergent decisions between the UPC and EPO is real. A case involving Amgen’s EP 3 666 797, covering its cholesterol-lowering drug Repatha, illustrates this complexity. The EPO Opposition Division upheld the patent, rejecting challenges from Sanofi and Regeneron. However, the UPC central division invalidated the patent, demonstrating how outcomes can shift depending on procedural timing.

Strategic Considerations for Pharma Patent Holders

Pharmaceutical/biotech companies must carefully evaluate whether to pursue an EPO opposition or a UPC action, depending on their objectives:

  • EPO Opposition: A cost-effective way to challenge a patent centrally across all EPC contracting states. It is ideal for parties seeking technical scrutiny without immediate litigation risks.
  • UPC Action: A faster route for pan-European enforcement or validity challenges. Suitable for patentees facing infringement or alleged infringers seeking rapid certainty.

Which Path to Choose and Why?

  • For any party who wishes to - solely invalidate a patent without the immediate threat of infringement litigation, and where speed is not the absolute priority: An EPO opposition remains a strong, cost-effective choice for a central validity challenge. It is a well-trodden path with deep technical scrutiny.
  • For a patentee facing infringement or wishing to enforce their rights across multiple European states quickly, or for a party seeking rapid certainty on validity with pan-European effect, A UPC action is likely the preferred route. Its ability to combine infringement and validity, offer pan-European injunctions, and potentially deliver faster outcomes makes it a powerful tool.
  • For an alleged infringer who is sued before the UPC: Challenging validity via a counterclaim in the UPC is standard. They might also file or maintain an EPO opposition as a parallel defensive strategy, though a stay in the UPC is not guaranteed.

Final thoughts

The assumption that UPC proceedings will wait for EPO outcomes is outdated. The UPC asserts its role as an efficient judicial body, requiring pharmaceutical/biotech companies to adapt their strategies accordingly. The system of UPC is no doubt evolving for betterment and may regain its new shape in coming days for the interest of Patent holders. Patent owners must prepare for parallel litigation, while alleged infringers must recognize the UPC as an immediate threat despite ongoing EPO challenges.

Authors:

Nisha Wadhwa, Principal Associate

Disclaimer: The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.