The Enablement Requirement Requires More Than Just “Two Research Assignments,” says SCOTUS

112 Enablement patent

On May 18, 2023, the U.S. Supreme Court released its long-awaited decision in Amgen Inc. v. Sanofi,[1] which touches on a formal requirement for patentability, the enablement requirement.  In a unanimous ruling, the Supreme Court held that where a patent claims an entire genus, the specification must enable one skilled in the art to make and use the entire genus. 

The opinion was written by Justice Neil Gorsuch.

Section 112(a) of the Patent Act reads:

The specification shall contain a . . . manner and process of making and using it [the invention], in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same. . . .

35 U.S.C. §112(a).

Both Amgen and Sanofi had patents issued which were directed to treatment of lowering cholesterol.  Amgen’s patents claimed the antibody, PCSK9, which is a naturally occurring protein that binds to and allows the removal of the so-called bad cholesterol, LDL, from the bloodstream.  Amgen’s two patents in particular, U.S. Patent No. 8,829,165 (“‘165 patent”) and U.S. Patent No. 8,859,741 (“’741 patent”) were at-issue in this case.  After Sanofi released its drug, Amgen sued Sanofi for patent infringment.

While Amgen’s claims were not directed to a particular antibody, it purportedly claimed the “entire genus of antibodies that both binds to specific amino acid residues on PCSK9, and blocks PCSK9 from binding to the LDL receptors.”[2]  Sanofi had argued the specification did not properly cover the entire genus of antibodies.  In response, Amgen identified 26 amino acid sequences that perform the two processes, but only allowed two methods for its research team to develop, a “roadmap” and a “conservative substitution.”

Justice Gorsuch noted that the enablement requirement has been in the Patent Act, including the current Act, and can be traced back to the first Patent Act first enacted by Congress in 1790.  In citing previous Supreme Court precedence on enablement, he wrote:

Our decisions in Morse, Incandescent Lamp, and Holland Furniture[3] reinforce the simple statutory command.  If a patent claims an entire class of processes, machines, manufactures, or compositions or matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.  In other words, the specification must enable the full scope of the invention as defined by its claims.  The more one claims, the more one must enable. (Emphasis added.)

Gorsuch, J., Amgen Inc. v. Sanofi, 598 U.S.___ (2023).

He defines the contours of the rule by stating the specification does not need to “describe with particularity” each and every single embodiment within a claimed class.  However, there must be some “general quality . . . running through” the class that gives it a “particular fitness for a particular purpose.”[4]  A specification is not inadequate, either, merely because it requires a person skilled in the art (POSITA) to conduct some level of experimentation. 

Justice Gorsuch further noted Amgen’s claims were much broader than the 26 antibodies, and the specification failed to enable anything broader than those antibodies even allowing for some reasonable level of experimentation.  He describes Amgen’s two methods – roadmap and conservative substitution – as nothing more than “two research assignments,” that either document a trial-and-error process or an abstractual substitution process that was too abstract given the state of the art.

As such, the Court held that the specification did not enable the claims at such a breadth as claimed.  The Federal Circuit’s decision was affirmed.

For more information on the enablement requirement in patent prosecution, or for more information on the patenting process in general, please contact Yonaxis I.P. Law Group.

[1] 598 U.S.___ (2023), aff’g 872 F.3d 1367 (Fed. Cir. 2017).

[2] Id. at 5 (slip op.); 872 F.3d at 1372.

[3] See O’Reilly v. Morse, 15 How. 62 (1854); The Incandescent Lamp Patent, 159 U.S. 465 (1894); Minerals Separation, Ltd. v. Hyde, 242 U.S. 261 (1916); Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245 (1928).

[4] Id. at 13 (slip op.); Incandescent Lamp, 159 U.S. at 475.