Supreme Court Unanimously Upholds Federal Circuit’s Decision in Amgen Inc. v. Sanofi

Written June 15, 2023

On May 18, 2023, the Supreme Court unanimously upheld the U.S. Court of Appeals for the Federal Circuit’s decision finding Amgen’s patent invalid. This ruling is consistent with the amicus brief filed by AIPLA on February 10, 2023. To read the opinion of the Court, please click here
Amgen Inc., an American multinational biopharmaceutical company, owns several patents on monoclonal antibodies used to treat high cholesterol. The initial patents claimed the antibodies structurally, but Amgen later obtained patents that claimed the antibodies generically according to their function of “binding” with certain amino acids. In 2014, Amgen sued Sanofi, a French multinational pharmaceutical and healthcare company, for infringing the functionally claimed patent on the antibodies.  

A first jury declined to find invalidity based on inadequate written description and enablement disclosures, but the U.S. Court of Appeals for the Federal Circuit reversed and remanded because of an erroneous jury instruction. On remand, a second jury again declined to find invalidity for inadequate enablement, but the district court reversed with an invalidity judgment as a matter of law. The Circuit Court affirmed, ruling that the scope of the claims to the functionally defined monoclonal antibodies was not adequately enabled.

Amgen sought Supreme Court review on two questions:

1. Whether enablement is "a question of fact to be determined by the jury," Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1846), as this Court has held, or "a question of law that [the court] review[s] without deference," Pet. App. 6a, as the Federal Circuit holds. 

2. 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). 

The Supreme Court granted certiorari as to the second question only.
Justice Gorsuch delivered the unanimous opinion of the Court, affirming the Federal Circuit’s decision that Amgen's generic claims to antibodies based on their function to bind with certain amino acids are invalid for lack of enablement under 35 U.S.C. 112, writing that "Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation.” 

The claimed invention is intended to state that the antibodies bind with a certain protein that blocks that protein from interfering with the liver’s ability to remove LDL cholesterol. The Court affirmed the Federal Circuit’s ruling that the scope of the generic claims to the functionally defined antibodies was not adequately enabled.

After reviewing case law on enablement, the Court held that the Federal Circuit was faithful to the statute and the Court decisions. Justice Gorsuch stated that the sweep of the generic claims extends well beyond the specific antibodies described in the patent, even allowing for a reasonable degree of experimentation.

The Court rejected Amgen's argument that an experimentation "roadmap" set out in the patent was sufficient to make and use any antibodies not specifically listed. Forcing scientists to undertake "painstaking experimentation" to "see what works" is not enablement, Justice Gorsuch wrote. The Court also disagreed with the patent owner's contention that the Federal Circuit had reduced enablement to a measure of the time and effort it takes to make every embodiment within the claim, explaining that the Federal Circuit simply held that advice on how to engage in "trial and error" is not enough for enablement.

Finally, Amgen warned that an affirmance risks “destroy[ing] incentives for breakthrough inventions.” The Court, however, defers to Congress on striking a balance between incentivizing inventors and ensuring the public receives the full benefit of their innovations.