Brexit, the UPC, second medical use patents, biologics and digital health were all on the agenda at Managing IP's first European Life Sciences Forum in London
The Forum took place at Le Méridien Piccaddilly and was attended by nearly 100 IP practitioners from across Europe.
The programme combined policy discussions with practical insights into IP protection and litigation strategies.
On the policy side, the Unified Patent Court (UPC) and Unitary Patent prompted a lot of discussion. Penny Gilbert of Powell Gilbert moderated a panel on the UPC that also featured Francis Tierney of AstraZeneca and Peter Thomsen of Novartis.
Despite the uncertainty over the start date of the new system and the composition of the court, the speakers emphasised the need to be prepared. Tierney urged patent practitioners to familiarise themselves with the online system for opting-out patents, pointing out complications that may arise where ownership of a patent portfolio is complicated, or where there are SPCs. The panel also discussed the possibility of a single SPC regime being introduced - and how it might work.
In his panel on Brexit, Jeremy Blum of Bristows focused on several issues that could affect life science companies, including the protection of EU trade marks in the UK, proving acquired distinctiveness for non-traditional marks (such as the GSK inhaler that was the subject of recent litigation) and the approval of drug names. He also flagged up some questions about enforcement, parallel imports and goods in transit.
Paul Chapman of Avidity IP and Jürgen Dressel tackled the topic of SPCs in a bit more depth, focusing on recent and pending cases. Dressel called SPCs "the most important IP rights we have" given that they cover the peak sales period for many products, and stressed the need for legal and business certainty. Unfortunately, the large number of referrals, the review of the SPC Regulation and Brexit all generate uncertainty, and there remain particular questions over follow-on drugs and divisional patents.
One subject that is just beginning to have an impact on IP strategies is digital health. Niklas Mattson of Awapatent and Peter Thomsen of Novartis introduced some case studies and raised some questions in an interactive panel just before lunch. Among the questions asked were: will patent strategies have to be adapted if product lifecycles are much shorter and there are more patents involved? How can data be protected, if at all? What role will trade secrets play? Will patents become less important?
Three sessions looked at various timely issues in litigation and case law.
In a session on biologics, Dean Thomas of Glenmark Pharmaceuticals provided an update on US developments, and the uncertainty arising from the America Invents Act, while Luke Kempton of Gowling WLG offered a European perspective, focusing on the Humira case where an Arrow-type declaration was granted based on what Kempton described as "very unusual facts".
The protection of second medical use patents is an area where courts in different jurisdictions have taken diverse approaches, as Marianne Schaffner of Dechert and David Cottam of Teva Europe explained. Cottam described in detail the pregabalin case in the UK, and said he hoped that the Supreme Court will provide clarification on the construction of second medical use claims. He compared the approaches in Germany, Spain, Denmark and the EPO while Schaffner reviewed recent decisions in the Netherlands and France. Both speakers floated some possible solutions to the second medical use problem.
In a panel focusing on coordinating UK, EU and US patent strategies, Jennifer Roscetti and Erin Sommers of Finnegan discussed Section 101 patentability in the light of recent US Supreme Court cases, focusing in particular on three recent decisions on diagnostic methods at the Federal Circuit. One lesson from these, they said, is for parties in litigation to keep fallback positions for appeals. They also looked at trends in inter partes reviews, noting the large number of challenges to biopharma patents, pointing out that 48% of claims do not survive, with methods of treatment patents faring particularly badly. Finally, they provided some tips on PTAB disputes, including: pay attention to the evidence, think carefully about your experts and remember that if you can get institution denied, that decision cannot be appealed.