Event
Kisaco Life Sciences Strategy Summit on IP & Exclusivity 2025
Fish & Richardson attorneys Christina Brown-Marshall, Dexter Whitley, and Brian Coggio will speak at the Kisaco Life Sciences Strategy Summit on IP & Exclusivity on October 14 and 15. Fish is proud to support this premier life sciences intellectual property (IP) event that brings together leading pharmaceutical, biotech, and legal professionals to explore the latest developments in legal exclusivity challenges for life sciences products. Session details are below.
Protecting Commercial Exclusivity Surrounding Clinical Trials in Europe and Further Afield | Christina Brown-Marshall
Clinical trials are fundamental to exclusivity discussions within the life science sector and a point of important intersection between regulatory and IP experts. There have been several regulatory and patentability changes, which should affect a company's strategy towards the commercial exclusivity of their product. This panel will discuss these features and show you how to implement a corporate strategy regarding clinical trials.
- Discuss the importance of the new European regulations regarding clinical trials and why the end of the deferral mechanism is important for your overall strategy.
- Understand the rhythm to filing your patent applications in the context of clinical trials.
- Discuss the interplay between confidential disclosure and patent applications.
- Compare and contrast the position in the USA regarding clinical trials and exclusivity protection.
- Determine the view of the patent offices regarding the legal status of the unitary SPC.
Roundtable: Doctrine of Equivalents Update for the Life Sciences Sector | Brian Coggio
Explore the latest developments in the doctrine of equivalents and its implications for patent enforcement in life sciences. This roundtable will examine key case law, evolving interpretations, and strategies to strengthen patent portfolios in light of recent rulings.
Second Medical Uses and Skinny Labels: Determining a Successful Exclusivity Strategy | Dexter Whitley
Second medical use claims are legally and commercially important, and their complexity plays at the interface between prosecution and litigation teams within the life science sector. This industry-led session will explore the position of second medical use and skinny label claims within Europe and the USA and look at the ensuing litigation landscape.
- Discuss the patentability intricacies of second medical use claims in different European jurisdictions and the USA:
- What is the filing strategy of second medical use claims?
- What is your IP strategy in the context of repurposing — is regulatory exclusivity sufficient?
- Understand the enforceability of second medical uses and skinny labels and the implications of Sun/Novartis (2018) and MSD/Teva (2018).
- What has been the impact of the Unified Patent Court for second medical use claims?
- Understand the intersection between competition law and IP within skinny label and second medical use claims.