[2] Amgen held two patents for antibodies that bind to specific amino acids on PCSK9, a protein involved in regulating LDL cholesterol.

[3] This statute requires a patent applicant to describe their invention ““in such full, clear, concise, and exact terms as to enable any person skilled in the art” to make and use the invention.”[3] In August 2019, the United States District Court for the District of Delaware granted Sanofi judgment as a matter of law, concluding that the claims at issue “are not enabled.”[2] The United States Court of Appeals for the Federal Circuit affirmed.

[5] The Court granted certiorari on November 4, 2022[5] and heard oral arguments from Amgen and Sanofi[6] and US Department of Justice (amicus curiae) on March 27, 2023.

"[11] “Nor is a specification necessarily inadequate just because it leaves the skilled artist to engage in some measure of adaptation or testing.”[11] On January 10, 2024, the United States Patent and Trademark Office (USPTO) issued guidelines for evaluating enablement under 35 U.S.C.

[15][16] These guidelines state that USPTO will continue to use the eight In re Wands factors to ascertain whether the amount of experimentation required to enable the full scope of the claimed invention is reasonable.