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ARTICLE · 27 JULY 2026

Protecting Antibody Innovations Beyond Composition Claims

Recent court decisions have fundamentally altered the antibody patent landscape, making composition-of-matter claims increasingly vulnerable while elevating the strategic importance of method-of-treatment...

United StatesIntellectual Property
ARTICLE SUMMARY
  • Recent case law has narrowed the scope of antibody composition claims, increasing the importance of broader IP strategies.
  • Method-of-treatment and manufacturing process patents are emerging as valuable tools for protecting antibody innovations against biosimilar competition.
  • A layered patent portfolio, supported by staged filings as clinical and manufacturing data emerge, can provide more durable protection across the product lifecycle.

Antibody therapeutics remain one of the most commercially significant classes of biologic drugs. In 2025, the FDA approved 12 biologics, including nine monoclonal antibodies and two antibody-drug conjugates. With billions in revenue at stake and biosimilar competition intensifying, a robust IP strategy for antibody products has never been more important.

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