This morning, the Supreme Court issued its opinion in Amgen Inc. v. Sanofi, Aventisub LLC, a patent case that presented the Court with the opportunity to decide “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 it must instead enable those skilled in the art ‘to reach the full scope of claimed embodiments’ without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial ‘time and effort.’” In a unanimous decision, the Court affirmed the Federal Circuit’s judgment of invalidity and found a patent “specification must enable the full scope of the invention as defined by its claims.” Justice Gorsuch authored the Court’s opinion. This is our opinion summary.
Justice Gorsuch began by presenting the context of the case:
This case concerns patents covering antibodies that help reduce levels of low-density lipoprotein cholesterol, sometimes called LDL cholesterol (for the obvious reason) or bad cholesterol (because it can lead to cardiovascular disease, heart attacks, and strokes).
Justice Gorsuch then described the factual background of the case:
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.
Justice Gorsuch described how the district court and the Federal Circuit agreed with Sanofi and invalidated the asserted patent claims.
Justice Gorsuch then discussed the nature of antibodies. He stated that “some scientists estimate that there may be as many unique antibodies as there are stars in the galaxy.” He noted that the diversity of antibodies can be seen in both their structure and their functionality. And he remarked that, “despite recent advances, aspects of antibody science remain unpredictable.” He then turned to discuss the nature of the patent claims at issue. He noted that, “[i]n these claims, Amgen did not seek protection for any particular antibody described by amino acid sequence.” Rather, he explained, “Amgen purported to claim for itself ‘the entire genus’ of antibodies that (1) ‘bind to specific amino acid residues on PCSK9,’ and (2) ‘block PCSK9 from binding to [LDL receptors].’”
Justice Gorsuch then noted how Amgen in its patent gave scientists only “two methods make other antibodies that perform the binding and blocking functions it described.” He then described the first method, which Amgen called the “roadmap”:
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.
He also describes the second method, which Amgen called “conservative substitution”:
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.
After devoting this significant portion of the opinion to the factual background of the case, Justice Gorsuch turned to discuss the court’s analysis of the law governing enablement.
He began by explaining how the Constitution grants Congress the power to “promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” He described the “patent bargain” as the idea that, “in exchange for bringing ‘new designs and technologies into the public domain through disclosure,’ so they may benefit all, an inventor receives a limited term of ‘protection from competitive exploitation.’”
He then turned to the patent statute. He described how Congress, since the Patent Act of 1790, has exercised its authority and crafted this bargain. Specifically, with respect to the enablement requirement, Justice Gorsuch explained how the first Patent Act “required the applicant to deposit with the Secretary of State a ‘specification . . . so particular . . . as not only to distinguish the invention or discovery from other things before known and used, but also to enable a workman or other person skilled in the art or manufacture . . . to make, construct, or use the same.’” He explained how, “even as Congress has revised the patent laws over time, it has left [the enablement disclosure] obligation largely intact.” He noted that the current law as expressed in 35 U.S.C § 112 “requires a specification to include ‘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 make and use the same.’”
He next discussed the Court’s precedent regarding the enablement requirement. He focused on three prior Supreme Court cases, discussing these cases in significant detail. After discussing them, he explained how they support the broad idea 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.” In short, he explained how “the more one claims, the more one must enable.”
Justice Gorsuch then made note of two limitations to the enablement test. He explained how the test does not say “a specification always must describe with particularity how to make and use every single embodiment within a claimed class.” Further, he explained, a specification is also not “necessarily inadequate just because it leaves the skilled artist to engage in some measure of adaptation or testing.” He clarified that “a specification may call for a reasonable amount of experimentation to make and use a patented invention,” and that “what is reasonable in any case will depend on the nature of the invention and the underlying art.”
With these principles in mind, Justice Gorsuch then applied this law to the case at hand. He noted that “Amgen’s specification enables the 26 exemplary antibodies it identifies by their amino acid sequences.” He noted, however, that the claims in question are far broader, covering much more than just these 26 antibodies. He ultimately agreed with the lower courts “that Amgen has failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation.” In reaching this conclusion, Justice Gorsuch highlighted how the two methods Amgen provided in its patent specification for making the antibodies, the “roadmap” and “conservative substitution,” were insufficient, amounting “to little more than two research assignments.”
The opinion then addressed and rejected Amgen’s alternative arguments.
Justice Gorsuch, first, highlighted the argument that the Federal Circuit “conflated the question whether an invention is enabled with the question how long may it take a person skilled in the art to make every embodiment within a broad claim.” Justice Gorsuch agreed that “enablement is not measured against the cumulative time and effort it takes to make every embodiment within a claim,” but said he is “not so sure the Federal Circuit thought otherwise.”
Justice Gorsuch, second, considered the argument that “the Federal Circuit erroneously ‘raise[d] the bar” for enablement of claims that, like Amgen’s, encompass an entire ‘genus’ of embodiments defined by their function.’” He found this argument unpersuasive.
He, third, addressed the argument that “an affirmance risks ‘destroy[ing] incentives for breakthrough inventions.’” He indicated “Congress has included an enablement mandate as one feature among many designed to achieve the balance it wishes,” and noted that the Court’s duty is to apply the standards set by Congress in a faithful manner.
In sum, the Court 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.” As a result of its analysis, the Court affirmed the Federal Circuit’s judgment that Amgen’s claims are invalid for failure to comply with the enablement requirement.