Law \ Legal

Specification Must Enable the Entire Genus

by Dennis Crouch

The Solicitor General’s new brief in Amgen v. Sanofi shrugs off the case–identifying petitioner’s arguments as meritless:

Petitioners contend that the court of appeals erred by treating enablement as a question of law and by examining the full scope of the claims in assessing whether they are fully enabled. Those arguments lack merit and further review is not warranted.

Gov’t CVSG Brief in Amgen Inc. v. Sanofi, 21-757 (Supreme Court 2022).

The petition argued that genus claims–especially those functionally claimed–are being asked to comply with a heightened enablement standard.  The Gov’t agreed that at times it may be difficult to enable an entire genus, but not because of any heightened standard.  Rather, “broad claims naturally require more extensive enablement” since the patent’s disclosure “must be commensurate with the scope of its claims. . . . When, as here, a patent claims an entire genus based on its function, the patent must enable that entire genus.” The brief cites to Consolidated Electric Light Co. v. McKeesport Light Co., 159 U.S. 465 (1895) and Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245 (1928) as representative.  In those cases, the Supreme Court used to enforce patents whose scope encompassed, but far exceeded, the examples given in the specification.  Of course, the Brief’s bold statements fail to contend with the reality that enabling the “entire genus” will effectively curtail genus claims, and the resulting policy shifts.  I expect that a Supreme Court decision in the the case would not go as far as suggested by the Gov’t Brief, but the middle ground might not be enough to flip the result here.

The Gov’t Brief also explains enablement as a mixed question of fact and law.  Although the jury sided with the patentee, the district court judge rejected the verdict on JMOL  — holding that the claims lacked enablement.  That JMOL determination was affirmed on appeal.  The Government brief does not delve deeply into the issues raised but simply states:

Petitioners complain about the formulation the court of appeals used in articulating the standard of review, but they do not identify any practical implications flowing from that disagreement.

Id.

Usually, the SG brief is the most important amicus brief at predicting certiorari.  However, that might no longer be true for today’s 6-3 conservative majority hearing remarks from a liberal administration.


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