A Narrow Ruling on Broad Patent Claims: Baxalta v. Genentech Elongates the Amgen v. Sanofi Line of Authority
The United States Court of Appeals for the Federal Circuit recently delivered a precedential opinion in Baxalta v. Genentech, affirming the invalidity of patent claims directed to a genus of antibodies—defined solely by their function—for lack of enablement. The decision can largely be seen as an affirmance that the enablement requirement of 35 U.S.C. §112 remains unchanged post-Amgen v. Sanofi, but it can also be viewed as a distillation of Amgen’s most important takeaways for patent holders hoping to assert genus claims in the life science fields. This seems evident given the Federal Circuit’s statement that the facts of Baxalta are “materially indistinguishable from those in Amgen.” For patent holders and innovators alike, the silver lining is that this decision seems to be fairly narrow and stops short of foreclosing patent protection on genus claims altogether.