By Kevin E. Noonan –
The Supreme Court heard oral argument in Amgen v. Sanofi last week in an extended session with argument from the parties and the U.S. government. Petitioner was represented by Jeffrey Lamken, Respondents by Paul Clement, and the Government by Colleen Sindak.
The Justices showed a great deal of interest, albeit with some difficulty, in making sure that they properly understood the complexity of the genus at issue. Justice Thomas, for example, began the Court's questioning by asking how many antibodies were invented, suggesting it was 26 and after Mr. Lamken explained that Amgen contended the actual number was about 400, the Justice said, "in other words, you can't say how many." Justice Thomas later returned to the question at the end of Petitioner's counsel's time requesting clarification. Justice Jackson also queried Mr. Lamken, who expanded on his answer to Justice Thomas by saying "we got 3,000 [antibodies], which were filtered down to 384 [antibodies]. The 26 [antibodies] are something different. The 26 are the ones where we went through and figured out the exact amino acid sequence and then listed them in the patent." He then drew the distinction that "there's a reason why you don't go and do 384 amino acid sequences for every one of them in the patent. Patent law has never required it, you go from the 3,000 to the 384 that bind the sweet spot and stop."
The answers to the question (depending on who was answering) was the 26 expressly disclosed (Respondent) to ~400 (Petitioner) based on the number Amgen isolated, with Respondent emphasizing the "millions and millions" allegedly falling within the scope of the claims (saying "the numbers don't lie"). Petitioner reminded the Court that these estimates included antibodies having "conservative substitutions" in the amino acid sequence expected to yield equivalent antibodies in structure and claimed function (calling them the "swapped amino acid species," Mr. Lamken said they were "99.99% identical and routine to make"). Regarding the conservative substitution species, Mr. Clement challenged the assertion that antibodies differing from the disclosed sequences by any amino acid sequence change could be assumed to be functional, saying "You have to go through that whole experimental process again to confirm that it binds in the right place" and referring the Court to Sir Gregory Winter's amicus brief in this regard. When asked by Justice Gorsuch, Mr. Clement stated that only the 26 identified antibodies were enabled. The Government agreed, stating that the only antibodies that were enabled were those for which Amgen had provided the amino acid sequence (indeed, when asked by Justice Gorsuch whether there was anything in Mr. Clement's argument the government disagreed with, Ms. Sindzak said there wasn't).
Missing from the argument was a reminder that, to the extent Amgen's genus claims can be analogized to a conventional pharmaceutical genus claim any particular, undisclosed antibody that is patentably distinct from the genus can be independently patentable and Amgen does not "own" those antibodies (although their patent may be a dominating patent).
The Justices asked both parties' counsel whether this was at root a factual issue, Justice Gorsuch specifically asking Mr. Lamken whether there were any disagreements of law other than the appropriateness of the cumulative effort test, and if not "why isn't this just a fact-bound dispute?" (Mr. Lamken responded in the negative, based on the Federal Circuit's "full scope" test wherein "it would be necessary to first generate and then screen each candidate antibody to determine whether it meets the double function limitations, that's a statement saying you've [sic] got to be able to make them all. That can't be right"). The Justice asked Mr. Clement whether there was any dispute on the law (as opposed to how the law had been applied to the facts at the Federal Circuit). Justice Kagan asked, "do you understand the parties now all to agree on the appropriate legal test, and are we simply arguing now about how that test applies in this case?" to which Mr. Lamken replied, "I think the parties all agree that the cumulative effort, the idea of reach the full scope, that that cannot be sustained." Mr. Clement was less sanguine on the scope of the parties' agreement, telling Justice Kagan that "there must be" disagreement on the law because Amgen's assessment is that it is enough to "consign people skilled in the art to Sisyphean tasks forever" in making the antibodies falling within the scope of the claim and "what skilled artisans want is not to randomly generate something within the broad range that's claimed, but they want to be able to pick a specific embodiment, not a hypothetical one, but a specific one" contrary to Petitioner's position.
As often happens in arguments before the Court, analogies abounded, with Petitioner arguing that James Watt did not need to disclose every possible embodiment of a steam engine to enable claims to one. Mr. Lamken's argument motivated Justice Thomas to remark that this case was perhaps more akin to claiming using steam pressure to produce mechanical work, much like Claim 8 in the Morse patent invalidated in O'Reilly v. Morse (i.e., using electricity to produce "writing at a distance"). Mr. Clement used as an analogy claims to paints of different colors, where if robin's egg blue paint was disclosed it would be enabled whereas it would not if the public needed to make mixtures of different dyes and wait to find one that produced that color. Even the Court (Justice Kavanaugh) raised the government's analogies in its brief to recipes for cake, bread, and stew. And later Ms. Sindzak analogized to knowledge by the skilled artisan that pine was not a suitable type of wood from which to make a baseball bat and thus a claim to making bats from wood would not be invalidated due to this one, art-recognized exception.
Two amicus briefs were discussed, one by Professor Lemley and the other by Sir Gregory Winter, the latter brief being sufficiently (potentially) persuasive on the underlying scientific facts that Mr. Lamken characterized it as "the functional equivalent of an expert report," while the Ms. Sindzak noted that in footnotes to two recent papers Professor Lemley had suggested that Amgen's claims could be invalid for non-enablement. Mr. Clement dismissed the Lemley brief by telling the Court the Federal Circuit had not invalidated all biotechnology claims on enablement grounds (citing Bayer Healthcare LLC v. Baxalta Inc.) and said the Justices should rely on the Winter brief "for the science." Mr. Clement posited that "it may be that in this particular area of antibody science given the current state of the science that you may not have an ability to functionally claim a genus, and that's kind of at some level nobody's fault, it's just the way the science works."
Mr. Clement also reiterated a line of argument from the Winter brief in suggesting to the Court that these claims could be considered an effort to make an "end run" around the Court's precedent in Assoc. Molec. Pathol. v. Myriad Genetics, insofar as the "sweet spot" in PCSK9 could not itself be patented under that precedent because it was naturally occurring (a clever way of persuading the Court against the claims outside the strict bounds of enablement law itself). Mr. Clement also took from the Winter brief the argument that the "roadmap" does not facilitate identifying antibodies falling within the scope of the claim because in addition to the routine experiments required to produce them it then "adds additional steps that somebody skilled in the art wouldn't want to do and are just basically an additional step, additional test they have to run to see whether they infringe, because the people skilled in the art don't really care where it binds. They care that it blocks." These steps "slow down others in the field" accordingly.
In his only engagement at any length, Justice Alito asked Mr. Lamken whether there was "something unique in this decision or has the CAFC been doing this all along? And if so, why now?" The response was that the Federal Circuit has shown a "basic hostility to the breadth of claims, and I think that this is basically the apogee, we've reached an endpoint where, frankly, the industry can't take it any longer because you can't invest $2.6 billion if the breadth of your claims is such that it means you can't get adequate protection because, if you cover everything you invented, then it's invalid because it's too hard to make them all." The Justice challenged this answer by asking whether the Federal Circuit's decisions had been inhibiting research for antibody-based pharmaceuticals and Mr. Lamken cited Professor Lemley's article (Dmitry Karshtedt, Mark A. Lemley & Sean B. Seymore, The Death of the Genus Claim, 35 HARV. J. L. & TECH. 1, 23-35 (2021)) in support of the assertion. Justice Alito also inquired whether the "roadmap" disclosed in the patents was not (just) a research plan to which Mr. Lamken responded the patent disclosed "these two new antibodies that didn't exist before our invention" and "they allow you to find everything that will bind to the sweet spot in PCSK9 because they cover it completely."
Justice Jackson evinced an appreciation regarding the burdens of proof below and the issue of whether the District Court and the Federal Circuit had properly overruled the jury determination that respondents had not satisfied the clear and convincing evidence standard. Mr. Lamken stated that the Respondents had not shown even one antibody falling within the scope of the claim that could not have been made using the "roadmap" in Amgen's specification. In reply Mr. Clement relied on the "millions and millions" of antibodies that fall within the scope of Amgen's claims and the amount of trial-and-error experimentation needed to produce them. In this regard Justice Gorsuch expressed agreement with Mr. Clement that the cumulative effort needed to produce all species in a claimed genus is not dispositive but a relevant consideration.
With regard to the relevance of the amount of effort it takes to practice the invention, Justice Sotomayor asked whether Mr. Lamken agreed with the statement in the Federal Circuit opinion that "It was 'appropriate' to look at the amount of effort needed to obtain embodiments outside the scope of the disclosed examples." The eventual answer from Mr. Lamken was that "if it said an embodiment, that would be correct. Embodiments means that you're looking at . . . what [the Federal Circuit] called reaching the full scope, and I think that is incorrect" and "the effort to make every single embodiment within the invention simply means that if you have an invention of any scope, it's not going to be enabled. There may be millions of ways to make the James Watts steam engine, but you're not invalidated simply because it would take a long time to make all of those different variants of the steam engine."
Several of the Justices asked what remedy the parties wanted (Justice Jackson frankly asking "what is the one thing we can do?") and how the Court would provide clarification in the law, the Chief Justice inquiring on the amount of disclosure that would be considered reasonable under the Court's Minerals Separation, Ltd. v. Hyde decision, Justice Gorsuch asking counsel about the continuing relevance of the Wands factors, and Justices Jackson, Alito, and Barrett inquiring on what could be considered undue experimentation. Mr. Lamken's responded to Justice Gorsuch that "at the very least, we should have a remand so that we try again under the proper standard without the reach the full scope standard or try to hypothesize how long it takes to make millions of antibodies and then test each of them." Justice Barrett asked "why" and Mr. Lamken stated that "the Federal Circuit could not possibly have gotten it right because of what I just read to you from [the record], where it looks at the effort to make each and every antibody of the potential millions" [and] "somebody who's trying to overturn a PTO-issued patent and two jury verdicts should at least say here's an actual antibody, an actual embodiment, that is difficult to make. It requires undue experimentation to get there." Justice Kavanaugh in a similar vein asked Mr. Lamken whether there was disagreement with any of the Court's precedent (counsel wisely responding "no").
Regarding the question of the undue experimentation standard, Justice Gorsuch asked Mr. Lamken whether he agreed that "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?" (answer: "yes") and if the Wands factors were valuable in making an undue experimentation assessment. To this latter question Mr. Lamken responded that "the Wands factors can be useful in particular cases when properly applied" [but they have] "become something of a checklist that's abstracted and therefore replaces the ultimate statutory standard." To the Justice's question "do you agree that the broader the patent the more difficult it is to prove enablement" Mr. Lamken responded, "not necessarily" because "'harder' and 'broader' are not necessarily synonymous." And to Justice Jackson's question on finding undue experimentation as to a species, Mr. Lamken responded "if you just have a one-off that doesn't mean anything to skilled artisans, you're not going to invalidate the patent." The Justice then asked, "How many of these 'one-offs' can you have?" to which Mr. Lamken stated, "if you have so many that it means 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 –it is that trial and error for years on end, it's Edison and Consolidated Electric."
In his responses Mr. Clement gave full-throated voice to the opinion that "functional claims are terrible because the retard science," using Morse claim 8 and the patentee's position in Consolidated Electric v. Edison, but he also said he did not think the test should be "zero-tolerance" regarding at least "some" experimentation. In responding to Justice Alito, he stated that both "time and effort" and the nature of the effort were relevant and that if the claims had recited the amino acid sequences of the disclosed sequences there would have been no need for experimentation.
Ms. Sindzak spoke at considerable length compared with the brief expository remarks both Mr. Lamken and Mr. Clement made in their presentations. While the government's argument paralleled the respondent's, the assistant solicitor general emphasized the amino acid sequence as the "recipe" for an antibody, without which a claim is not properly enabled ("it really is that simple"). Ms. Sindzak asserted that it was dangerous to relax the enablement rules because the antibody field is unpredictable and there may be other unknown antibodies that "work[] better than everything else, or the one that's going to be tolerated by more patients or the one that's going to be cheaper to manufacture" (not considering independently patentable species). The government also referred to the doctrine of equivalents as the proper way under the statute to protect antibodies structurally indistinct enough from the expressly recited antibodies to be deemed infringing (a position advocated by at least one amicus brief). The Chief Justice posited that the doctrine might be less protective (something Mr. Lamken asserted in rebuttal) to which Ms. Sindzak responded that to the extent a patentee hasn't invented something "I don't think the doctrine of equivalents is going to get them things they haven't invented yet."
With regard to In re Wands, Ms. Sindzak stated that precedent cannot be relied upon because at the time antibodies were not defined by amino acid sequence but by functional properties and satisfied the enablement requirement by deposit. (Unmentioned was the fact that had Amgen deposited the 384 antibodies they would have been enabled at least those antibodies.) The government also agreed with Justice Kavanaugh that an affirmance would quell arguments that the Federal Circuit had erred and leave any further remedy to Congress. In response to Justice Gorsuch asking if you could, for example, every single time get a winner, then the fact that it would require a long time to get them all wouldn't — wouldn't necessarily defeat a patent, would it?" Ms. Sindzak said "it can be relevant, and I think it can particularly be relevant if, for example, you figure out that . . . there's a million types of ammonia in the world and 10 of them . . . can be used instead of gasoline to run superefficient cars, right? But you don't know which 10, so you just claim the genus of ammonia that can be used to run cars, and then what you're saying is you have to go out there and try them. And you may actually have to try all a million of them so — to get to those 10. And so there the cumulative effort is relevant because you're going to be there testing and testing and testing."
On rebuttal Mr. Lamken reasserted Petitioner's most straightforward argument, that "The key fact in this case is that Sanofi has not identified one antibody that would require undue experimentation to make."
Both the respondent's counsel (jokingly) and the assistant solicitor general (more earnestly) suggested that the Court dismiss the certiorari writ as having been improvidently granted (which the Petitioner's counsel warned would have the same consequence as an affirmance, mentioning that the PTAB had relied on the Federal Circuit's decision in two recent cases). The Justices' focus on the factual predicates of the case makes this outcome not as unlikely as it might otherwise be.
In view of the argument, if the Court does rule, it is likely to provide "guidance" (as requested by the petitioner) on the proper scope of the inquiry (without rejecting the "full scope" test per se) and send the matter back to the Federal Circuit on remand for reconsideration on that basis. This would be consistent with the Court's stance in other cases (Arthrex v. U.S. and Minerva Surgical v. Hologic, for example) and generally with its exercise of its role in supervising and where necessary (in the Court's estimation) correcting the Federal Circuit's application of U.S. patent law.
On March 16, the Copyright Office published guidance in the Federal Register relating to works produced at least in part by generative artificial intelligence (AI). This is the latest in a series of policy decisions and statements that the Office has made to applicants attempting to register such works.
