This Report summarizes cases granted review on November 4 and 10, 2022

Case Granted Review: Amgen Inc. v. Sanofi, 21-757

Amgen Inc. v. Sanofi, 21-757. Section 112 of the Patent Act requires an inventor applying for a patent to provide a “written description of the invention, and of the manner and process of making and using it” that is sufficiently clear “to enable any person skilled in the art . . . to make and use the” invention. 35 U.S.C. §112(a). This requirement to provide directions for skilled artisans to make and use the invention is called the “enablement” requirement. Markman v. Westview Instruments, Inc., 517 U.S. 370, 379 (1996). The Court limited the cert grant to the second question presented, which is: “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,” as the Federal Circuit held, it must enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—in other words, without substantial “time and effort.” 987 F.3d 1080, 1088 (emphasis added).

The case concerns Amgen’s patents for antibodies that lower cholesterol. Amgen sued respondents Sanofi and Regeneron for patent infringement. Sanofi and Regeneron stipulated to infringement but asserted invalidity defenses under §112, including lack of enablement. The case went to trial and the jury found the patents valid. Sanofi appealed and the Federal Circuit reversed, holding that the district court had erred in its evidentiary rulings and jury instructions on enablement. After a second trial, the jury again found the patents valid. Sanofi then moved for judgment as a matter of law on lack of enablement, and the district court granted the motion and held the patents invalid. Amgen appealed to the Federal Circuit, which affirmed. 987 F.3d 1080. It recited its precedent holding that a claim satisfies the enablement requirement only if its disclosures enable skilled artisans “to make and use the full scope of the claimed” invention without “undue experimentation.” It explained that although an inventor need not “describe how to make and use every possible variant of the claimed invention, when a range is claimed, there must be reasonable enablement of the scope of the range.” The court added that the parties disputed exactly how broad Amgen’s patent claims were, but held it was clear that Amgen had provided directions for recreating too small a portion of the antibodies covered by its claims.

Amgen argues that the Federal Circuit is imposing a requirement not contained in the Patent Act. This atextual “reach the full scope” requirement, it argues, “frustrates the purposes of patent law” because “[i]t invalidates patents for breakthrough inventions” by “demanding disclosure about theoretical ‘far corners.’” Further, Amgen argues, the Federal Circuit’s test cannot be reconciled with Supreme Court precedent. In a case called Minerals Separation v. Hyde, the patent concerned “‘improvements in the process for the concentration’” of metallic ores. 242 U.S. 261, 263 (1916). The invention involved adding oil to ore and agitating it. The “amount of oil and the extent of agitation necessary” varied depending on the metal, but the patent did not explain how to adjust these variables for each of the “infinite[]” varieties of ore. Nonetheless, the Court upheld that patent. Amgen argues the same result should obtain here. Finally, it claims that reversing the Federal Circuit will not lead to overbroad patents because, if a patent is truly overbroad, the challenger should be able to point to embodiments that the claim does not provide directions for. Sanofi and Regeneron did not do that here.