The patent “bargain” describes the exchange that takes place when an inventor receives a limited term of “protection from competitive exploitation” in exchange for bringing “new designs and technologies into the public domain through disclosure” for the benefit of all. Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U. S. 141, 150. As part of the benefit of this bargain for the public, there is an “enablement” requirement for the specification of a patent.

A patent's specification must describe the invention and “the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains . . . to make and use the same.” 35 U.S.C. § 112(a). For enablement, “the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation” in view of the nature of the invention and the underlying art. MagSil Corp. v. Hitachi Glob. Storage Techs., Inc., 687 F.3d 1377, 1380 (Fed. Cir. 2012) (internal quotation marks omitted).

Old Supreme Court Precedent

Supreme Court decisions in O'Reilly v. Morse, 15 How. 62, The Incandescent Lamp Patent, 159 U. S. 465, and Holland Furniture Co. v. Perkins Glue Co., 277 U. S. 245, have addressed the enablement requirement.

In Morse, the Court held that one of the claims in Morse's patent for a telegraphic system was “too broad, and not warranted by law.” 15 How., at 113. The problem was that the claim covered all means of achieving telegraphic communication, yet Morse's specification did not describe how to make or use them all. See id., at 113–117.

In Incandescent Lamp, inventors of an “electric lamp” with an “incandescing conductor” made of “carbonized paper” claimed that a lamp created by Thomas Edison infringed their patent because it used bamboo as a conductor. The Court sided with Edison because the rival inventors, rather than confining their claim to carbonized paper, “made a broad claim for every fibrous and textile material.” 159 U. S., at 472. That broad claim “might” have been permissible, the Court allowed, if the inventors had disclosed “a quality common” to fibrous and textile substances that made them “peculiarly” adapted to incandescent lighting, but they did not. Ibid.

And in Holland Furniture, a company that had developed a starch glue that was similar enough to animal glue to be used for wood veneering included a claim in its patent covering all “starch glue which, [when] combined with about three parts or less . . . of water, will have substantially the same properties as animal glue.” 277 U. S., at 251. The specification described the key input—the “starch ingredient”—in terms of its “use or function” rather than its “physical characteristics or chemical properties.” Id., at 256. The problem, as the Court put it, was that “[o]ne attempting to use or avoid the use of [the] discovery as so claimed and described functionally could do so only after elaborate experimentation” with different starches. Id., at 257.

Enabling Antibodies

In Amgen Inc. v. Sanofi, No. 21-757, __ U.S. __ (May 18, 2023), the Supreme Court has reiterated that if a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent's specification must enable a person skilled in the art to make and use the entire class.

The case involved engineered antibodies that help reduce levels of low-density lipoprotein (LDL) cholesterol by inhibiting PCSK9—a naturally occurring protein that binds to and degrades LDL receptors responsible for extracting LDL cholesterol from the bloodstream.

Amgen's patent claimed “the entire genus” of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors].” 872 F. 3d 1367, 1372. As part of its submission to the patent office, Amgen identified the amino acid sequences of 26 antibodies that perform these two functions. Amgen then described two methods—one Amgen called “the roadmap” and a second it called “conservative substitution”—that scientists could use to make other antibodies that perform the binding-and-blocking functions described in the claims.

Sanofi characterized the methods Amgen outlined for generating additional antibodies as little more than a trial-and-error process of discovery, which fails to meet the enablement requirement. According to Sanofi, potentially millions more antibodies could be covered than what the patent had taught persons skilled in the art to make. Both the district court and the Federal Circuit, and now the Supreme Court, sided with Sanofi.

The Court found that Amgen's claims bear more than a passing resemblance to the broadest claims in Morse, Incandescent Lamp, and Holland Furniture. While Amgen seeks to monopolize an entire class of things defined by their function—every antibody that both binds to particular areas of the sweet spot of PCSK9 and blocks PCSK9 from binding to LDL receptors—the record reflects that this class of antibodies does not include just the 26 that Amgen has described by their amino acid sequences, but a vast number of additional antibodies that it has not.

Rejecting Amgen's argument that scientists can make and use every functional antibody if they simply follow the “roadmap” or “conservative substitution,” the Court characterized these two approaches as little more than “research assignments.”

The “roadmap” merely describes step-by-step Amgen's own trial-and-error method for finding functional antibodies. And “conservative substitution” requires scientists to make substitutions to the amino acid sequences of antibodies known to work and then test the resulting antibodies to see if they do too.

[T]he more a party claims, the broader the monopoly it demands, the more it must enable. That holds true whether the case involves telegraphs devised in the 19th century, glues invented in the 20th, or antibody treatments developed in the 21st.

Concluding that “Section 112 of the Patent Act reflects Congress's judgment that if an inventor claims a lot, but enables only a little, the public does not receive its benefit of the bargain,” the Court affirmed that the overly broad claims in Amgen's patents were invalid.

The patent attorneys at Thomas P. Howard, LLC enforce patents and defend against infringement in litigation nationwide including in Colorado.