Overview
Enablement under §112 of the Patent Act is one of several requirements for obtaining a patent, and generally requires that a patent specification adequately describe how to make and use the claimed invention. The U.S. Supreme Court was set to hear Amgen, Inc. v. Sanofi in 2023 to address the issue of whether a patent can cover a class of related compounds (genus) when the specification only describes some of the members of the genus (species). The lower courts found Amgen’s patents on the monoclonal antibody Repatha® to be invalid due to lack of enablement for essentially claiming patent protection for a large class of antibodies while only describing some of them.
Amgen argues that the decision overly extends the existing enablement requirement by requiring the specification to describe virtually all the possible embodiments (the “full scope”) of the claimed invention rather than enabling a person skilled in the art to “make and use” the claimed invention as recited in the relevant statute. Sanofi argues the opposite, saying that the patentee has to describe how to make and use the entire invention, not simply part of the invention.
The upcoming Supreme Court review was expected to be significant for the patent system as it would clarify the scope of the enablement requirement for obtaining a patent with genus claims.
