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15 December 2022FeaturesAmericasTimothy Sendek

Amgen v Sanofi: Big Pharma awaits SCOTUS decision

The Supreme Court recently granted a petition for a writ of certiorari in a case concerning an issue of significant importance in the pharmaceutical and chemical technology industry.

The November 4, 2022 grant in the case of Amgen v Sanofi addresses the following question:

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—ie, to cumulatively identify and make all or nearly all embodiments of the invention without substantial “time and effort”.

The patents at issue in Amgen deal with a special class of drugs (monoclonal antibodies) and a special class of patent claims (“functional” or “genus” claims). This type of claim covers a genus or category of solutions to a problem when the patent describes and enables a subset of such solutions. For example, in Amgen, the patents at issue claimed monoclonal antibodies which bind to certain naturally-occurring protein.

“Amgen’s petition for certiorari argues that the Federal Circuit has “done it again” on enablement, and that the “full scope” and “undue experimentation” tests must go.”

The patents identified 26 antibodies which would bind as claimed by the patent, but there are millions of other candidate antibodies that might also function to bind to the claimed protein. This is the basic question before the Supreme Court—does the “make and use [the invention]” language mean that an inventor has to describe how to make and use every possible permutation of “the invention” if that is what is claimed? The trial court and a panel from the US Court of Appeals for the Federal Circuit said that Amgen’s claims were invalid (even though the jury found that the patents were sufficiently enabled) because there are too many possible solutions claimed beyond what was disclosed by the patents.

Interpreting enablement

Amgen, and a significant cadre of amici, argue that the Federal Circuit was too rigid in applying the enablement requirement, and that the requirement to “reach the full scope” of the claims without “substantial time and effort” is inconsistent with the statute. Rather, Sanofi and the amici argue that as long as the specification provides some working examples, that disclosure can be enough to enable a genus claim.

Amgen and the amici also focus on the impact for pharmaceutical and life sciences technologies of the Federal Circuit’s interpretation of the enablement requirement. Amgen says “it has devastating consequences for innovation, particularly in the critical biotech and pharmaceutical sectors”. An amicus brief by a group of law professors says “the central feature of patent law in the life sciences industries is the genus claim” and without the ability to make broader claims a competitor could make a minor change to the invention and avoid liability.

On issues of obviousness, indefiniteness, venue, injunctive relief, attorneys’ fees, and patent eligibility, the Supreme Court has established a recent and steady history of striking down tests formulated by the Federal Circuit that it deems to go beyond the text of the statute.

Amgen’s petition for certiorari argues that the Federal Circuit has “done it again” on enablement, and that the “full scope” and “undue experimentation” tests must go.

But Sanofi argues that the Federal Circuit did not create a “special test” at all, but rather the “full scope” requirement is one that flows from the language of the statute itself. The Supreme Court has also found some statutes to carry implicit requirements based on historical context, such as when a court may award treble damages.

The court’s decision on Amgen will have significant importance for the pharmaceutical and life sciences industries. A win for Amgen would make it easier for drug companies to obtain broader protection for therapeutic discoveries, while a win for Sanofi would create opportunities for generic manufacturers to challenge such patents.

Timothy Sendek is a partner at Akerman. He can be contacted at tim.sendek@akerman.com


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