QJ 52.2 - Wobbling Section 112(a) Standards and Their Impact on Antibody Patents

WOBBLING 35 U.S.C. § 112(A) STANDARDS AND THEIR IMPACT ON ANTIBODY PATENTS 

The provision of 35 U.S.C. § 112(a) sets forth three requirements for a patent disclosure— written description, enablement, and best mode. The interpretation of section 112(a) has become an area of hot debate as applied to rapidly developing technologies such as biotechnology, pharmaceutics, and chemistry. Antibodies have unique diversity due to their biological process of formation and warrant special consideration with respect to enablement and written description requirements.  The disclosure requirements of antibodies and antibody-related molecules have changed over time as the scientific understanding of antibody biology has advanced. Comparison of the recent approaches taken in the U.S., Europe, and Japan in cases related to Amgen Inc. v. Sanofi, 598 U.S. 594 (2023) shows global trend in limiting the scope of antibody patent protection, although the approaches and reasonings of each jurisdiction is different from each other. In the U.S., there are still remaining questions related to determination of enablement, including how to apply Wands factors to determine if “undue experimentation” is necessary to make and use the claimed invention and enablement requirement is satisfied. For future analysis of antibody cases using Wands factors, the author proposes to distinguish the inherent labor intensiveness of the biological research and ingenuity required in making and using the invention. In addition, how to decide the extent of patent protection, or “a ring of equivalence,” a disclosure of one antibody can provide needs to be defined.