On May 18, 2023, a unanimous U.S. Supreme Court decided
Amgen, Inc. v. Sanofi, a case addressing the enablement
requirement of the Patent Act, 35 U.S.C. §112(a). Section
112(a) requires a patent specification to "enable any person
skilled in the art to which it pertains, or with which it is most
nearly connected, to make and use" the invention. In a ruling
that has significant implications, especially for the
pharmaceutical, chemical and biotech fields, the Supreme Court held
that to satisfy Section 112(a), a patent specification must enable
the person skilled in the relevant art to make and use the full
scope of the claimed invention. It further held that, while a
specification may still be enabling if it requires a
"reasonable degree of experimentation," a specification
that requires "painstaking experimentation" is not.
