2025 Life Sciences IP Tool Kit

Intellectual property (IP) strategy in the life sciences evolves as rapidly as the scientific breakthroughs driving the industry. Since the America Invents Act reshaped the U.S. patent system more than a decade ago, courts and policymakers have continued to refine how its provisions apply, particularly in areas critical to life sciences, such as patent subject matter eligibility, biosimilar development, and regulatory exclusivities. Protecting innovation in this environment requires more than strong patents. Life sciences companies must also safeguard trade secrets, secure trademarks that reinforce brand identity, and anticipate how competitors may challenge or design around their IP.

At Sterne Kessler, we have spent almost five decades helping life sciences companies of all sizes—from emerging biotechnology companies to global pharmaceutical leaders—protect and advance their innovations. Our team combines deep technical knowledge with a sophisticated understanding of how the United States Patent and Trademark Office, courts, and the Patent Trial and Appeal Board approach IP rights. We work closely with clients to develop strategic IP portfolios and ensure their innovations are well positioned for commercialization and enforcement.

This Life Sciences IP Tool Kit was created as a practical reference to highlight some of the strategies and best practices our professionals apply every day. As the landscape continues to shift in 2025 and beyond, we stand ready to help life sciences companies protect their discoveries, maximize the value of their IP, and stay ahead in a competitive market.

Table of Contents

• • Patenting the Product Label
  • Obviousness-Type Double Patenting
  • Polymorph Patents
  • Patent Term Adjustment
  • Patent Term Extension
  • Patenting Antibodies – The Latest Case Law and What Biotech Companies Need to Know
  • Federally Funded Inventions and Compliance with the Bayh-Dole Act
  • Avoiding Sequence Listing Pitfalls Under ST.26
  • Protecting Your Life Sciences Trade Secrets
  • Trademark Strategies for Life Sciences Companies
  • Small Entity Status for Life Sciences Companies — Determining Number of Employees