The European Unitary Patent System and Unified Patent Court

Life sciences

The innovative products of the biopharmaceutical industry often rely principally on a single European patent to protect an exclusive market position with potential peak sales in the billion-dollar range. Enforcement of such a patent carries a risk of patent revocation in counterclaims for invalidity only country-by-country. The sole risk of pan-EU loss of rights presently lies in the Opposition Division of the EPO.

A Unitary or European patent litigated in the UPC will be subject to possible revocation across all participating Member States or, in the case of the European Patent, all Member States in which the patent was validated. In the absence of an injunction pending appeal of a revocation decision, such pan-EU loss of rights could see competitor/generic market entry irretrievably destroy the innovator market. Given the risk of pan-EU revocation in a venue that may take some time to provide high quality, predictable procedures, it seems unlikely that the biopharma industry will initially choose the UPC for its highest value patent assets.

It will therefore be critical for patentees to prepare well in advance of Unitary Patent and UPC implementation and decide on short- and long-term patent strategies for mitigating risks and optimising benefits from this new system.  Points to consider are set out below.