Pharmaceutical companies have taken a cautious approach to the UPC, with most key patents being opted out of the system, driven by concerns about central revocation actions and potentially losing a patent for all territories covered by the UPC.
The earliest disputes were extensions of existing battles between originators, with separate infringement and revocation claims between Sanofi / Regeneron and Amgen over an Amgen patent for PCSK9, an antibody that regulates cholesterol, and between GSK and Pfizer over GSK’s RSV vaccine patent.
Another of the earliest life sciences cases was 10x Genomics’ claim against NanoString. 10x Genomics obtained a preliminary injunction (PI) against NanoString before the Munich local division. However, this was overturned on appeal as the Court of Appeal held that it was likely that the patent lacked inventive step.
PI applications have also been heard in disputes between Novartis and Celltrion and Alexion and Amgen / Samsung Bioepis over biosimilar products. So far, there have been few traditional originator versus generic medicine disputes. An exception is Sanofi’s claims against Accord, Zentiva, Dr Reddy’s and Stada in respect of its patent for the chemotherapy drug Jevtana (cabazitaxel) and, more recently, Boehringer Ingelheim’s claim against Zentiva in relation to a patent for its pulomonary fibrosis drug Ofev (nintedanib). So far, no PIs have been granted in these cases and clarification is still required on what amounts to sufficient threat to launch a biosimilar or generic product as a basis for seeking a PI.
One area that has recently seen activity is in the mRNA vaccine field, with BioNTech having been sued by the non-practising entity Promosome alleging infringement of its patent relating to mRNA sequences by BioNTech’s mRNA SARS-CoV-2 vaccine Comirnaty. Whereas, Moderna has been sued in relation to its SARS-CoV-2 vaccine by Arbutus / Genevant under patents relating to lipid nanoparticle formulations.
As confidence in the UPC grows, it is likely that we will see a significant increase in the number of disputes involving pharmaceutical patents before the court celebrates its third anniversary.
All European Patents will fall within the UPC system after the end of the transition period and its current success suggests that it is unlikely that the transition period will be extended beyond the initial 7 years. So life science patentees wishing to avoid the system in future will need to consider their filing strategies for important new products carefully.
