What is “Patent Enablement” and is it required to procure a Patent?
For a Patent to be valid, the Patent’s Specification shall, “contain a written description of the invention, and of 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, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.”
-35 United States Code 112(a)
Defendants in a patent infringement suit can argue that the Patent is invalid because it does not enable one skilled in the art to make or use the invention claimed. In short, the Patent is missing Patent enablement.
What the US Supreme Court Says About Patent Enablement
The United States Supreme Court Revisits Patent Enablement in Amgen Inc. et al. v. Sanofi et al (May 18, 2023)
Justice Gorsuch delivered a unanimous decision of the United States Supreme Court.
On pages 5-6, the Court writes:
“The case comes to us this way. Several years ago, petitioners (Amgen) obtained two patents. Together, these patents claim a monopoly over all antibodies that (1) bind to specific amino acids on a naturally occurring protein known as PCSK9, and (2) block PCSK9 from impairing the body’s mechanism for removing LDL cholesterol from the bloodstream. Soon after receiving these patents, Amgen sued respondents (Sanofi) for infringement. In response, Sanofi argued that the patents were invalid under §112 of the Patent Act. That provision requires a patent applicant to describe its invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the [invention].” 35 U. S. C. §112(a). Sanofi contended that Amgen’s patents failed to meet this standard because they sought to claim for Amgen’s exclusive use potentially millions more antibodies than the company had taught scientists to make. In the end, both the district court and Federal Circuit sided with Sanofi. The question we face is whether to disturb their judgment.”
On pages 9-10 of Amgen, it is written:
“As part of its submission to the patent office, Amgen identified the amino acid sequences of 26 antibodies that perform these two functions, and it depicted the three-dimensional structures of two of these 26 antibodies. 987 F.3d, at 1083. But beyond that, Amgen only offered scientists two methods to make other antibodies that perform the binding and blocking functions it described. The first method is what Amgen calls the “roadmap.” Brief for Petitioners 13. At a high level, the roadmap directs scientists 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. See id., at 13-14. The second method is what Amgen calls “conservative substitution.” Id., at 14, 17. This technique requires 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. See id., at 14-15. Amgen Inc. v. Sanofi (2023)”
On page 19, the Court wrote:
“Decisions such as Wood and Minerals Separation establish that a specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art. See Minerals Separation, 242 U.S., at 270-271; see also Mowry v. Whitney, 14 Wall. 620, 644 (1872) (“[T]he definiteness of a specification must vary with the nature of its subject. Addressed as it is to those skilled in the art, it may leave something to their skill in applying the invention.”). But in allowing that much tolerance, courts cannot detract from the basic statutory requirement that a patent’s specification describe the invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art” to “make and use” the invention. §112(a). Judges may no more subtract from the requirements for obtaining a patent that Congress has prescribed than they may add to them. See Bilski v. Kappos, 561 U.S. 593, 602-603, 612 (2010). Amgen Inc. v. Sanofi (2023)”
On page 20, Justice Gorsuch concluded:
“While the technology at the heart of this case is thoroughly modern, from the law’s perspective Amgen’s claims bear more than a passing resemblance to those this Court faced long ago in Morse, Incandescent Lamp, and Holland Furniture. 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. 987 F.3d, at 1085, 1088; see 2019 WL 4058927, *8 (“at least millions of candidates”); see also Tr. of Oral Arg. 52-53. Much as Morse sought to claim all telegraphic forms of communication, Sawyer and Man sought to claim all fibrous and textile materials for incandescence, and Perkins sought to claim all starch glues that work as well as animal glue for wood veneering, Amgen seeks to claim “sovereignty over [an] entire kingdom” of antibodies. Incandescent Lamp, 159 U.S., at 476.”
“That poses Amgen with a challenge. For if our cases teach anything, it is that the 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. Amgen Inc. v. Sanofi (2023)”
On page 23, Justice Gorsuch held:
“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. For more than 150 years, this Court has enforced the statutory enablement requirement according to its terms. If the Court had not done so in Incandescent Lamp, it might have been writing decisions like Holland Furniture in the dark. Today’s case may involve a new technology, but the legal principle is the same. The judgment is Affirmed.”
If you find this a little complex and need assistance to make sure your Patent meets the Patent enablement requirement, please contact Business Patent Law, PLLC.
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