On May 18, the U.S. Supreme Court in Amgen Inc. v. Sanofi unanimously affirmed the Federal Circuit’s finding that Amgen’s patent claims to cholesterol-lowering antibodies were not enabled under 35 U.S.C. § 112. The Court addressed the question of whether § 112 requires patent specifications to enable the “full scope” of the claims without undue experimentation, or rather whether it is sufficient that the specification teach those skilled in the art to “make and use” the claimed invention. The Court explained that the patent specification must sufficiently enable the “full scope” of the claims, and 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. This is an important decision as it affects the delicate balance that the patent system seeks to strike between incentivizing innovation without overextending the patent monopoly or depriving the public the benefit of those innovations.
Amgen’s patents disclose antibodies capable of reducing levels of low-density lipoprotein (LDL) cholesterol. LDL cholesterol can lead to severe cardiovascular issues. Amgen’s patented antibodies were successful in that they could bind to a proprotein called convertase subtilisin/kexin type 9 (PCSK9) and block PCSK9 from inhibiting the removal of LDL cholesterol. The efficacy of these antibodies is due to their unique amino acid sequences in combination with their unique structural shapes. Amgen successfully created 26 of these antibodies. Rather than claiming only those 26 antibodies, Amgen broadly claimed the entire genus of antibodies that perform this binding and blocking function, encompassing potentially millions of antibodies.
Upon receiving the two issued patents, Amgen filed suit against Sanofi for infringement. Sanofi asserted that Amgen’s patent claims were invalid under § 112 because the patent specifications did not enable the full scope of the claims. Section 112 requires a patent applicant to describe their invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the [invention].” The district court and Federal Circuit both agreed with Sanofi that Amgen’s patents failed to satisfy the enablement requirement in claiming potentially millions of antibodies that they did not teach how to make.
Amgen argued that while not every possible antibody within the genus claimed is specifically disclosed, the two methods claimed in their patents teach one skilled in the art to find every possible antibody. Amgen’s “roadmap” method directs one skilled in the art to (1) generate a range of antibodies in the lab; (2) test those antibodies to determine whether any bind to PCSK9; (3) test those antibodies that bind to PCSK9 to determine whether any bind to the sweet spot as described in the claims; and (4) test those antibodies that bind to the sweet spot as described in the claims to determine whether any block PCSK9 from binding to LDL receptors. Amgen’s “conservative substitution” method directs scientists to (1) start with an antibody known to perform the described functions; (2) replace select amino acids in the antibody with other amino acids known to have similar properties; and (3) test the resulting antibody to see if it also performs the described functions. Sanofi argued that these methods were no more than “trial-and-error” guesswork and required people skilled in the art to engage in undue experimentation to make the claimed antibodies. The Court agreed.
The Court spoke to the “bargain” that the Constitution creates between the government and inventors. Inventors, in exchange for promoting “the Progress of Science and useful Arts” with their invention, receive an exclusive right in their invention for a limited duration. However, inventors are only eligible for the bargain if they successfully disclose their invention and teach others how to produce it. The Court, like the Federal Circuit and district court before it, agreed with Sanofi that Amgen had failed to teach others how to make its invention and, therefore, did not satisfy its end of the bargain.
Reaching far back into its history, the Court analogized this case to ones such as O’Reilly v. Morse, The Incandescent Lamp Patent, and Holland Furniture Co. v. Perkins Glue Co. In Morse, a case from the 1850s, Morse obtained a patent for his revolutionary telegraph. The claims, however, covered not only the physical structure and embodiment of the telegraph, but also all other means of achieving telegraphic communication. The Court held one of Morse’s patent claims invalid because it sought to monopolize an entire field of technology which had yet to be developed and that Morse could not enable.
In Incandescent Lamp, inventors Sawyer and Man obtained a patent for an incandescent lamp disclosing a “carbonized fibrous or textile material” filament. Their lamp, however, was largely defective and fell out of use. After Thomas Edison discovered bamboo provided a more durable filament suitable for lamps, Sawyer and Man alleged that Edison’s lamp infringed their patent, as bamboo falls under the umbrella of fibrous or textile materials. The Court, however, found that Sawyer and Man’s claim was far too broad compared with what it enabled others to make.
In Holland Furniture Co. v. Perkins Glue Co., Perkins Glue had created a starch glue similar enough to animal glue to serve as a substitute. However, instead of claiming only the specific starch glue they created, Perkins Glue claimed all starch glue that utilized any starch ingredients to produce a substance highly similar to animal glue. The patent described the starch ingredient in terms of its function rather than its compositional properties, and the Court determined that this left gluemakers with no option other than to engage in undue experimentation to discover which starch ingredients worked.
The Court noted that its decisions in these historic cases reinforce that “[i]f 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.”
Amgen argued that requiring the full-scope enablement of genus claims is too steep a hill and will impede rather than promote further innovation. Amgen reasoned that once a successful species is created within a broad genus, by not granting the inventor exclusive rights over the genus, competitors will look to change minor details in the existing species to create a distinct and patentable species (i.e., profiting from the ingenuity of the first inventor). Sanofi took an opposite view, arguing that allowing claims to cover an entire genus without requiring enablement of the full scope of the genus will impede innovation. Sanofi reasoned that if an entire genus can be patented, competitors will be prohibited from entering the field to create many of the potential species.
The Court agreed with Sanofi and determined that Amgen sought to monopolize an entire class of antibodies by their function, which went beyond the 26 that Amgen described in its specification. The Court disagreed with Amgen that its “roadmap” and “conservative substitution” approaches enabled the broad claim as those amount to “little more than research assignments.” Emphasizing its role in striking the proper balance between inventor incentivization and public benefit, the Court stated that the more a party claims, the broader monopoly it demands, and therefore the more it must be required to enable. As cleverly noted by the Court, had it not enforced the statutory enablement requirement according to its terms, in Incandescent Lamp, it may have been writing decisions like Holland Furniture in the dark.
With full scope enablement being required, inventors will need to fully enable and teach every species they wish to claim within a genus. Where genus claims are properly enabled and supported, they are entitled to protection. But, where undue experimentation is required to arrive at a species, the genus claim may be invalid for lack for lack of enablement. The Court’s decision emphasizes that inventors seeking to claim more must enable more.
