Amgen Inc. v. Sanofi, Aventisub LLC


Question(s) Presented

“Section 112 of the Patent Act provides that a patent’s ‘specification shall contain a written description of the invention, and of the manner and process of making and using it,’ sufficient ‘to enable any person skilled in the art . . . to make and use the’ invention. 35 U.S.C. § 112(a). The requirement that the specification teach skilled artisans ‘to make and use’ the invention is referred to as the ‘enablement’ requirement. Markman v. Westview Instruments, Inc., 517 U.S. 370, 379 (1996). The questions presented are:”

  1. “Whether enablement is ‘a question of fact to be determined by the jury,’ Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1846), as this Court has held, or ‘a question of law that [the court] review[s] without deference,’ Pet. App. 6a, as the Federal Circuit holds.”
  2. “Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to ‘make and use’ the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art ‘to reach the full scope of claimed embodiments’ without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial ‘time and effort,’ Pet. App. 14a (emphasis added).”


Proceedings and Orders
January 5, 2022
DISTRIBUTED for Conference of 1/21/2022.
January 11, 2022
Response Requested. (Due February 10, 2022)
January 14, 2022
Motion to extend the time to file a response is granted and the time is extended to and including March 14, 2022.
March 29, 2022
DISTRIBUTED for Conference of 4/14/2022.
April 18, 2022
The Solicitor General is invited to file a brief in this case expressing the views of the United States.
October 5, 2022
DISTRIBUTED for Conference of 10/28/2022.
October 31, 2022
DISTRIBUTED for Conference of 11/4/2022.
November 4, 2022
Petition GRANTED limited to Question 2 presented by the petition.
November 29, 2022
Consent to the filing of amicus briefs received from counsel for Sanofi, et al. submitted.
December 1, 2022
Blanket Consent filed by Petitioner, Amgen Inc., et al.