Select IP with Hogan Lovells | Webinar no. 20: Cross-over topics: Patent & regulatory topics II

Our 20th session was on “Cross-over topics: Patent & regulatory topics II”. This is the second part of our two-part series that continued to cover practical, strategic and comparative issues at the intersection of patents and regulatory affairs, including patent and non-patent exclusivities and related topics.

As you may know, on 26 April 2023, the EU ‘Pharma Law Package’ was proposed by the European Commission that addresses the availability, accessibility and affordability of medicines within the European states (see here). Further, on 27 April 2023, the EU ‘Patent Package’ was proposed by the European Commission, which complements the new Unitary Patent system and focuses on standard essential patents (SEPs), compulsory licensing of patents in crisis situations, and the revision of the legislation on supplementary protection certificates (SPCs) (see here).

In the light of the importance of these proposals, in this session, we covered the Pharma Law Review by the European Commission and the proposals for amendment of the EU Pharma Legislation by the Commission in the EU Pharma Law Package and the EU Patent Package.

Also, from a U.S. perspective, we discussed the recent U.S. Supreme Court decision in the high-profile Amgen v. Sanofi patent dispute and highlight issues in respect of functional claim language for antibody inventions and the law on enablement. In addition, we covered the abbreviated approval pathway for companies wishing to market biological products pursuant to the Biologics Price Competition and Innovation Act (BPCIA) and, in particular, the framework for addressing patent infringement concerns (the so-called biosimilar “patent dance”).

This session, co-hosted by Dr Frederick Ch'en, Gary L. Veron, Kristin Anne Connarn, Stephen Bennett and Bert Oosting, addressed these cross-over topics from the perspective of the U.S., the UK and Continental Europe.

If you were unable to join us for the webinar, the recording is available upon request.

Please feel free to contact [email protected].

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