The Supreme Court heard oral argument this week in a patent case decided by the Federal Circuit, Amgen Inc. v. Sanofi, Aventisub LLC. In this case, the Court is considering “[w]hether 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.’” This is our argument recap.
Jeffrey Lamken presented Amgen’s arguments. He began by saying the Federal Circuit “invoked something that no one will defend is even relevant here: the cumulative effort to make all or some large group of an invention’s potentially myriad variations.” He then argued that the Supreme Court’s cases, by contrast, reflect the “pragmatic boots-on-the-ground focus on enabling skilled artisans who want to practice the invention on a concrete action, making and using the invention.”
As part of her line of questioning, Justice Sotomayor asked why Amgen only specified 26 antibodies when it could have disclosed close to 400. Lamken responded by arguing that “a skilled artisan in this area isn’t looking for every possible antibody.” He explained skilled artisans are “just looking for ones that bind to the right place and, therefore, block,” and then their job is done. Further, he argued, “in this art, it’s understood all of [the antibodies] are enabled” because a “bunch” of antibodies work to bind to the sweet spot and block.
Justice Gorusch asked a series of questions seeking to identify correct statements of the governing law. He first asked whether “a patent fails the enablement test if it would force a person skilled in the art to undertake undue experiment to produce the claimed invention,” and Lamken agreed. Justice Gorsuch then asked if the Federal Circuit’s Wands factors are “useful” and whether the Court should endorse them. Lamken responded that the factors are sometimes useful, but qualified that they have become “something of a checklist that’s abstracted and therefore replaces the ultimate statutory standard.” Finally, Justice Gorsuch asked whether “the broader the patent, the more difficult it is to prove enablement.” Lamken responded “not necessarily.” He explained that “you could have a relatively broad patent and you just need to have enablement commensurate with its scope.”
Justice Roberts asked Lamken to discuss what “reasonably” means in context of “reasonably make and use variations.” Lamken responded by arguing that you “always look at [reasonableness] from the perspective of the skilled artisan.” Lamken continued, saying “the answer is it always depends.” He explained that, under his view of the case, the operative question is “what is a skilled artisan in this art willing to do.” In this case, he maintained, “if someone’s going to say it’s undue experimentation to take these 3,000 antibodies that the mice produce, and put it in a machine and wait for it to [complete its analysis] at a cost of $30, that is very odd.”
Justice Jackson asked Lamken to clarify whether the question of undue experimentation is applied to every species of a genus claim. Lamken responded that that is not the case: “If you find undue experimentation to make a particular species, the next question is does that matter to the skilled artisan, or is this just an outlier.” He argued that if you have so many “one-offs” that you’re searching for a “needle in a haystack” and “you don’t have instructions on how to do it so that it’s trial and error for years on end . . . then [the claim] would not be enabled.”
Justice Kagan asked Lamken what the parties don’t agree on with respect to principles of law. In response, Lamken argued that “[t]he government would propose a requirement that you have a structure that unifies your genus, and I don’t think that can be sustained under the law.”
Justices Gorsuch, Barrett, and Sotomayor then sought to determine whether the Federal Circuit used the proper enablement standard, and whether a remand is in order. Lamken argued that a remand is in order because “the Federal Circuit could not possibly have gotten it right because . . . it looks at the effort to make each and every antibody of the potential millions.” Lamken criticized the Federal Circuit’s approach, saying that “if you have an invention of any scope, it’s not going to be enabled.”
Justice Kavanaugh asked Lamken to provide clarity in reference to hypotheticals provided by the Solicitor General. Lamken argued that if super-immunizing mice, taking the results, and filtering them down to workable antibodies results in “every embodiment within the claim or every embodiment that anybody cares about,” the claim is enabled.
Paul Clement argued for Sanofi. He began by arguing that “[t]he Federal Circuit has long enforced that basic principle by requiring the patentee to enable the full scope of the patent without undue experimentation.” He maintained that Amgen has “over-claimed” and “under-enabled,” with ther result that its “patent is invalid.”
Justice Thomas asked Clement to expand upon the statement that “the more you claim, the more you have to enable.” In response, Clement argued that Amgen has “claimed millions and millions of antibodies” and that “part of the problem here is these are purely functional claims.” According to Clement, Amgen’s patent does not enable a skilled artisan to “produce what they want every single time.” What Amgen’s patent gives, he argued, is “their roadmap [to use] trial and error.”
Justice Kagan asked Clement if there are any points of law on which he and Lamken disagree. In response, Clement argued that Lamken’s contention that the experiments will produce the antibody every time “can’t be right.” He argued that “what skilled artisans want is not to randomly generate something within a broad range that’s claimed, but they want to be able to pick a specific embodiment.” Admittedly, he argued, if you give skilled artisans an infinite amount of time, they will produce everything in the range, and he argued that Lamken “seems to think that that’s good enough as a matter of law to enable his patent.”
Justice Alito asked Clement to clarify what the relevance of time and effort are. Clement argued that “they’re both sort of relevant evidence that gets to the ultimate inquiry, which is, [whether there] is . . . undue experimentation.”
Justice Jackson asked how to determine whether required steps are undue for the purpose of the enablement standard. Clement responded with examples, arguing steps that are “really just sort of tweaks at the margins” are “reasonable.” In contrast, he argued, “it seems quite strange . . . when you’re claiming compositions of matter and millions and millions of them, that the only way that you can get there is to essentially replicate the experimental process.”
Justice Kagan sough to summarize Clement’s argument as to why he believes Profesor Lemley’s amicus brief is wrong. Clement argued that Professor Lemley could be wrong for two reasons: “he could be wrong to say that the Federal Circuit test is going to basically invalidate all these patents, or he could be wrong in thinking that these patents are valuable.”
Colleen Sinzdak argued for the government as amicus curiae. She argued that “this is not an enabled genus” because Amgen has “not given the information that a person skilled in the art would need to make and use all of the antibodies within the genus.” Focusing on what she perceived as Lamken’s argument, Sinzdak responded that it is “very dangerous” to start asking questions such as “do you really need a particular antibody” because “the truth is we don’t know if it matters.” According to Sinzdak, the government does “not think that the Federal Circuit said anything wrong here.” Characterizing Lamken’s argument as creating a unique approach in the field of antibodies, she maintained that, “to the extent . . . that antibodies are just different and basic patent rules don’t work then the body that needs to make a special antibody exception is going to be Congress, not this Court.”
In his rebuttal, Lamken argued that “Sanofi has not identified one antibody that would require undue experimentation to make.” He maintained that “the roadmap makes it much easier” to find relevant antibodies. He argued that “functional claiming [is] not a 112(a) question of enablement.” Moreover, he contended, “this claim really isn’t functional in the relevant sense.”
We’ll report more when the Court decides the case.