In its May 18 ruling, the U.S. Supreme Court sided with Sanofi in Amgen v. Sanofi, 598 U.S. ____ (2023), a dispute concerning broad functional genus claims for antibodies. The Supreme Court held that under 35 U.S.C. § 112(a), "Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation." 598 U.S. ____, at *15. The Court noted that the claims at issue covered "the entire genus" of antibodies that (1) "bind to specific amino acid residues on PCSK9," and (2) "block PCSK9 from binding to See more +
In its May 18 ruling, the U.S. Supreme Court sided with Sanofi in Amgen v. Sanofi, 598 U.S. ____ (2023), a dispute concerning broad functional genus claims for antibodies. The Supreme Court held that under 35 U.S.C. § 112(a), "Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation." 598 U.S. ____, at *15. The Court noted that the claims at issue covered "the entire genus" of antibodies that (1) "bind to specific amino acid residues on PCSK9," and (2) "block PCSK9 from binding to [LDL receptors]." Id. at *5. The unanimous opinion states, "If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent's specification must enable a person skilled in the art to make and use the entire class." Id. at *13.
On Tuesday, June 6, join Principals Martina Hufnal and Nicole Williams to learn more about this decision. Martina and Nicole will cover:
- An overview of Amgen v. Sanofi
- The Supreme Court's enablement standard for genus claims
- The functional claiming of antibodies
- Guidance for enablement moving forward See less -
