Cell therapy products in the U.S. are estimated to be worth approximately $4.5 billion currently and expected to grow to over $30 billion in the next ten years. As market value increases litigation is bound to heat up.

Recently, Fate Therapeutics and the Whitehead Institute sued Shoreline Biosciences in the Southern District of California for allegedly infringing six patents directed to composition and methods relating to induced pluripotent stem cells (iPSCs) directly under 35 U.S.C. §§ 271(a) and (g), and for inducing infringement. Fate’s infringement theories included both literal infringement and infringement under the Doctrine of Equivalents. The court granted summary judgment of noninfringement to Shoreline for all asserted claims.

In Apple v. Qualcomm, Federal Circuit Finds No Standing to Challenge Validity of a Few Patents When Many Were Licensed

The development timeline for small-molecule drugs and biologics is lengthy, estimated to take between 10 and 15 years. As a result, pharmaceutical companies need to consider freedom to operate issues long before they receive FDA approval or market their new product. These considerations might lead a company to take a license, seek to invalidate a competitor’s patent, or some combination of the two. The Patent Trial and Appeal Board (“PTAB”) is a popular venue for challenging patent validity and in 2020, Bio/Pharma and Chemical Patents accounted for 12% of petitions filed at the PTAB.

In the recent case of Amgen Inc. v. Sanofi, Aventisub LLC, the Federal Circuit affirmed the district court’s invalidation of certain of Amgen’s antibody patent claims, concluding that the claims were not “enable[d]” under 35 U.S.C. § 112. This decision establishes that it is more difficult to satisfy the enablement requirement for antibody claims that use functional language to describe the antibody. (The court granted Amgen’s motion to extend the deadline for filing a petition for panel rehearing and/or rehearing en banc until April 14, 2021. See id., Order (March 8, 2021).)