SCOTUS Clarifies Enablement Requirement

The U.S. Supreme Court affirmed the Federal Circuit’s decision to grant Sanofi’s Motion for Judgment as a Matter of Law for lack of enablement. The Supreme Court analyzed whether Amgen’s claims were enabled. Under Section 112 of the Patent Act, the specification must describe the invention in sufficient detail to enable any person skilled in the art to make and use it. In the Supreme Court’s words “the more a party claims for itself, the more it must enable.” Thus, “[i]f a patent claims an entire class of processes, machines, manufactures, or compositions, the patent's specification must enable a person skilled in the art to make and use the entire class.”

Amgen claimed a class of antibodies defined by their function – namely their ability to inhibit PCSK9 by binding to its “sweet spot.” Amgen’s patents, however, only disclosed the amino acid sequences of 26 exemplary antibodies, along with the “roadmap” and “conservative substitution” methods for finding the remaining members of that functional class. The roadmap consists in randomly generating multiple antibodies followed by successive tests (i) to identify the subset which binds to PCSK9’s sweet spot, and those whose (ii) binding to the sweet spot inhibits PCSK9. Similarly, the conservative substitution method suggests using the disclosed sequences as starting points, then substituting one amino acid at a time, and testing the resulting antibodies to see if they retain the same function. Such testing is necessary because there is no known method of predicting the function of an antibody from the sequence of its amino acids.

The Supreme Court concluded that these methods offer “little more than advice to engage in ‘trial and error,’” finding a disconnect between the breadth of the claims and the scope of enablement. Furthermore, the Supreme Court rejected Amgen’s policy argument that an affirmance would deter innovation, because any deterrence in this case does not exceed the public’s interest. “[I]f an inventor claims a lot, but enables only a little, the public does not receive its benefit of the bargain.”

The take home message from this opinion is that narrower claims are more likely to withstand challenges to their validity, in the context of functionally defined classes of antibodies.