March 26, 2023
The U.S. Supreme Court will hear oral arguments tomorrow in Amgen v. Sanofi, an important biotech enablement case. The case is especially important for a large class of therapeutics called biologics. Many of our most valuable recent therapeutics are a type of biologic called an antibody (e.g. Keytruda and Humira). The claims at issue are directed to antibodies having specific functional properties that relate to lowering bad cholesterol. The case is important to patent law even outside of biotechnology because of its relevance to enablement of genus claims and composition claims having functional language.
Question to which Sup Ct granted cert:
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).
Catch the oral arguments live at 10AM Eastern here:
Or listen to the recording or read the transcript after the arguments by starting here:
Here's a link to the docket/documents
Here's a link to the Fed Circuit Opinion