As we previously reported, on February 11, 2021, a three-judge panel of the Federal Circuit affirmed the District Court for the District of Delaware’s grant of Sanofi’s motion for judgment as a matter of law that the asserted claims of two of Amgen’s patents, U.S. Patent Nos. 8,829,165 (the “’165 patent”) and 8,859,741 (the “’741 patent”), covering its cholesterol-lowering drug Repatha® (evolocumab) and Sanofi’s Praluent® (alirocumab), were invalid for failing to comply with the enablement requirement.
On April 14, 2021, Amgen petitioned for the full Federal Circuit to rehear the case en banc. In its petition, Amgen argued that the Federal Circuit panel improperly established a new standard for enablement of “genus claims with functional limitations” that “poses high hurdles in fulfilling the enablement requirement” by focusing on the “‘time and effort’” required “to reach the full scope of claimed embodiments,” rather than “whether it would require undue experimentation to practice particular embodiments,” as required by earlier case law. According to Amgen, genus claims with functional limitations are “common in biotechnology and pharmaceutical patents,” and the effect of the test for enablement applied by the panel “is to invalidate virtually any genus claim with functional limitations, even if the disclosure makes generating and testing any single embodiment routine. Amgen argued that rehearing of the case is needed because the panel’s test conflicts with the patent statute as well as Supreme Court precedent. Amgen also argued that en banc review is warranted because the Federal Circuit’s treatment of enablement as a legal issue that the Federal Circuit can decide without deference to findings by a jury or district court judge is inconsistent with the Supreme Court’s treatment of enablement.
The Federal Circuit has invited Sanofi to respond to Amgen’s petition. Sanofi’s response is due by May 28, 2021.
