Practitioners Mostly Agree Amgen Won’t Be a Sea Change, But Some Predict Grim Consequences

“If genus claims meet their demise, what will be ‘retarded’ is not the science, but instead the investment and ensuing research into the critical life-saving human health innovations we will all sorely miss.”  – Ashley Sloat

AmgenYesterday’s oral argument in Amgen v. Sanofi was long-awaited and closely watched by many in the patent community. The Justices seemed skeptical that the U.S. Court of Appeals for the Federal Circuit’s (CAFC’s) decision was a significant departure from existing law, and they repeatedly questioned whether this particular case can be resolved on the facts and by employing current legal tests. During oral argument, Sanofi’s counsel, Paul Clement, admitted that the Court’s affirmance of the CAFC decision could result in the inability to functionally claim a genus in this particular area of antibody science, but said that’s ok because “functional genus claims are terrible. I think they retard the science.”

Commenting yesterday, Judge Paul Michel said that Clement’s guess that genus claims “retard the science” is not what human health innovation policy needs right now; below, some other stakeholders weigh in on the likely outcome of the case based on the arguments, with most agreeing that the Court is unlikely to make any great changes to the Federal Circuit’s approach. 

Thomas Hedemann and Patrick Doyle, Axinn

Justices Thomas, Sotomayor, Jackson, and Gorsuch raised many of the questions during yesterday’s oral argument, generally appearing skeptical that the Federal Circuit’s enablement case law conflicts with the patent statute.

A number of questions were aimed at whether the dispute really concerns the Federal Circuit’s enablement standard or merely its application to the specific facts of this case. Both Amgen and Sanofi affirmed a general agreement with the ‘undue experimentation’ standard and the Wands factors, perhaps increasing the likelihood that the Court will not alter the current standard significantly.

If the Court elects to provide guidance on some aspect of the standard, it may be with respect to what Amgen termed the Federal Circuit’s ‘cumulative-effort’ factor, i.e., the cumulative time and effort it would take a skilled artisan to make every embodiment in a genus. Amgen urged the Court to reject this factor, arguing that the consideration should be the effort required to make embodiments significant to a person of skill in the art. Sanofi argued that the combined effort to make every embodiment should be a consideration, and at least Justice Sotomayor seemed sympathetic.

Many questions concerned the facts of the case, such as the number of potential antibodies covered by the claims, the steps required to make them, and the time and effort to do so in view of high-throughput technology. The Court suggested during the arguments that a remand may be appropriate if the parties’ dispute is factually based.

William H. Milliken, Sterne Kessler

Based on the Justices’ questions—and, maybe more importantly, the advocates’ answers—it seems unlikely that the Supreme Court’s ultimate decision will effect a sea change in enablement law. Both parties and the United States appear to agree on the following: “undue experimentation” is the appropriate standard; the eight Wands factors are a useful guide in determining whether undue experimentation would be required to practice the claimed invention; the full scope of the claims must be enabled; and there is no requirement that a skilled artisan be able to cumulatively identify all embodiments within the claims without undue experimentation for the claims to be enabled. Given the agreement on these principles, the Court is unlikely to disturb any of them, meaning the law after this decision will probably look pretty similar to the law as it stands now. That is not to say the Supreme Court’s decision is unimportant; any time the Court provides guidance on one of the requirements of patentability, it is enormously consequential for patent practitioners. But the tenor of the argument today does suggest that the basic structure of enablement law—along with much of the existing precedent about it—will remain generally intact.

The apparent agreement between the parties and the Court that the 1988 Wands decision provides the proper lens though which to analyze enablement is a particular point of pride for those of us at Sterne Kessler Goldstein & Fox. The firm’s Jorge Goldstein successfully represented Wands in the appeal that led to that seminal decision.

Mark Remus and Alexis White of Crowell & Moring

Based on the oral argument, it appears likely that the Court will affirm the Federal Circuit’s decision. The Justices repeatedly noted that there appeared to be little, if any, disagreement between Amgen, Sanofi, and the Federal Circuit regarding the proper legal test for enablement. Specifically, when pressed by the Court, Amgen and Sanofi agreed with the undue experimentation standard and the Wands factors for assessing undue experimentation when those factors are properly applied. As Justice Kagan noted to Amgen’s counsel, “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?” Justice Gorsuch asked Sanofi’s counsel, “if we agree on the law, what’s left for this Court?” Sanofi’s counsel said “nothing” and proposed that the Court dismiss the appeal as improvidently granted (“DIG”), which garnered laughter from those in attendance. While we can’t rule out a DIG, it appears that a DIG is unlikely. Indeed, Justice Sotomayor subsequently asked the Government, if the Court did not want to DIG the case, what could the Court say that the Federal Circuit hasn’t already said. Instead, it appears that the more likely outcome is that the Court will affirm the Federal Circuit. In support of that affirmance, the Court is likely to confirm that undue experimentation and the Wands factors are the proper standard for enablement. The Court is also likely to reject Amgen’s argument that the Federal Circuit improperly treated the amount of effort required to make all embodiments of an invention as dispositive of the enablement question. Amgen’s “cumulative effort” argument did not appear to have any traction with the Court, and Justice Sotomayor noted in pointed questioning of Amgen’s counsel that the Federal Circuit never said the effort factor was dispositive – it simply said “it was appropriate to look at” the amount of effort.

Andrew Schwerin, Saul Ewing

The arguments yesterday were wide-ranging, and with some surprising humor. The Court noted the sheer volume of amicus briefs that the case attracted, and joked that it had a lot of friends.

One of Amgen’s hardest questions was to identify where the dispute was located. When asked whether the parties agreed about the underlying law of enablement, and disagreed about its application to the facts at hand, Petitioner’s counsel seemed to agree. This effort to identify the parties’ dispute suggests that the Court’s decision will not overhaul enablement law, but will offer some slight adjustments to it.

The arguments offered the Court a chance to revisit some of its time-honored precedents on enablement, like Consolidated Electric Light Co. v. McKeesport Light Co., 159 U.S. 465 (1895) (“The Incandescent Lamp Patent”). They also afforded the Court a chance to weigh in on the Federal Circuit’s decision in In Re Wands, whose eight-factor test is the current standard for enablement (under Federal Circuit law). The Court’s endorsement of Wands—or its criticism of it—could offer clarity.

One of the most interesting arguments involved how the enablement doctrine exists alongside other doctrines in patent law. All three parties—Petitioner, Respondent and the Government—offered interesting views on this.

The Solicitor General pointed out that an infringer’s efforts to copy a patented invention but avoid liability through trivial changes could best be addressed by the doctrine of equivalents. The Supreme Court affirmed the viability of this doctrine some 25 years ago, in Warner-Jenkinson Co. v. Hilton Davis Chemical Co., 520 U.S. 17 (1997). When asked whether this would afford the same scope of protection that functional claims would, the Government skillfully conceded this point, and fell back on the point that patent claim scope should be commensurate with disclosure.

Petitioner Amgen, for its part, discussed enablement under § 112(a) in relation to indefiniteness under § 112(b). It seemed to argue that this was really a dispute of claim clarity (under the latter) that was dressed up as one under the former. And finally, Respondent Sanofi invoked Myriad, arguing that Amgen’s claims were effectively claiming natural phenomena, and thus were an end-run around Myriad. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013).

Ashley Sloat PhD, Aurora Consulting LLC

We unfortunately find ourselves in a very patent hostile world, governed and adjudicated by a tragic cocktail of the uninformed and overly influenced.

If genus claims meet their demise, what will be ‘retarded’ is not the science, but instead the investment and ensuing research into the critical life-saving human health innovations we will all sorely miss.

Wiping out genus claims would create a massive runway to drug piracy via easy design arounds. Antibody science has been around for the better part of half a century. Without genus claims, it would be easy to create another antibody that falls outside of a narrower set of species claims that only covers the target drug. Think of it this way: when an animal is immunized, a subset of the B cells in the animal are producing antibodies that are specific for the antigen with which it was immunized. Every single animal that you immunize will provide a different set of B cells based on the species, exposure history, type of adjuvant used, etc. Any one of those B cells can be isolated, and the antibody it is producing can be turned into a therapeutic. Claiming any realistically practical number of species leaves a chasm of potential for easy design around using all the other B cells that are producing antibodies that will also bind to the antigen.


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