U.S. Chemical & Life Science Patents Q4 – 2025 Newsletter
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The Q4 edition of the Harness IP Chemical & Life Sciences Newsletter highlights several significant developments shaping patent strategy for pharmaceutical and life science innovators. This issue covers recent Federal Circuit decisions impacting skinny labels and written description requirements, important USPTO policy updates and pilot programs, and the renewed push for patent eligibility reform under PERA 2025—each with practical takeaways for both brand and generic companies.
– Federal Circuit decisions on skinny labels and induced infringement (GSK v. Teva, Lundbeck v. Lupin, Amarin v. Hikma)
– Corcept v. Teva and the risk of direct infringement blocking FDA approval of generics
– Duke University v. Sandoz and heightened written description requirements for chemical genus claims
– Practical guidance on method-of-use patents, skinny label drafting, and written description support
USPTO Policy, Leadership, and Practice Updates
– Appointment of USPTO Director John Squires and evolving subject matter eligibility guidance under §101
– Launch of the Automated Search Pilot Program and AI-generated prior art search reports (ASRN)
– Proposed USPTO rules limiting repeat IPR challenges and strategic considerations for pharma companies
– Streamlined Claim Set Pilot Program for expedited examination
– Clarification of USPTO examiner interview policies and best practices for effective interviews
Legislative Developments – Patent Eligibility Reform
– PERA 2025 and its expanded eligibility framework for diagnostic methods
– Clarification of patent eligibility for human-involved diagnostics, natural products, and biologics
– Claim drafting strategies to strengthen eligibility under the proposed PERA framework
For more updates on Chemical and Life Science law read the previous CLS Newsletters here.
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