shutterstock_2179492463_jhvephoto
JHVEPhoto / Shutterstock.com
28 March 2023FeaturesAmericasMuireann Bolger

Amgen v Sanofi: Scotus grapples with enablement

The showdown between Amgen and Sanofi concerning the proper test for enablement under Section 112 of the US Patent Act has finally taken place at the US Supreme Court.

The patents at the heart of the high-profile dispute between the two pharma companies deal with a special class of drugs (monoclonal antibodies) and a special class of patent claims (functional or genus claims).

Yesterday, on March 27, the court examined the following question:

“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—ie, to cumulatively identify and make all or nearly all embodiments of the invention without substantial ‘time and effort’.”

The issue arose when the  US Court of Appeals for the Federal Circuit affirmed a finding that Amgen’s claims were invalid for lack of enablement, prompting the pharma company to appeal to the US’ top court.

In November, the Supreme Court granted certiorari.

Reactions to the hearing

Mark Remus and  Alexis White, partners, Crowell & Moring. “What could the court say that the Federal Circuit hasn’t already said?”

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.

Justice Elena Kagan asked Amgen’s counsel: “Do you understand the parties now all agree on the appropriate legal test, and are we simply arguing now about how that test applies in this case?”

Justice Neil Gorsuch then queried: “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 drew laughter from those in attendance. While we can’t rule out a DIG, it appears that it is unlikely.

Indeed, Justice Sonia 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.

William Milliken, director, Sterne Kessler’s Trial & Appellate Group, and co-chair of the firm's appellate practice. “A seachange in enablement law is unlikely”

Based on the Justices’ questions—and, maybe more importantly, the advocates’ answers—it seems unlikely that the Supreme Court’s ultimate decision will deliver a sea change in enablement law.

Both parties and the US 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 practise the claimed invention.

Meanwhile, they seemed to concur that 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 does suggest that the basic structure of enablement law—along with much of the existing precedent about it—will remain generally intact.

Nathan Mutter, partner, Holland & Hart. “Does enablement require a recipe or a roadmap?”

A key point of debate in the oral arguments was whether enablement requires a ‘recipe’ that teaches a person having ordinary skill in the art how to produce a particular species within a claimed genus, as Sanofi and the government suggested.

Or conversely, whether enablement is satisfied, as Amgen argues, with a “roadmap” that instructs that person how to produce all species within the genus, even though some experimentation and unpredictability may be required.

The justices’ questions indicated some scepticism towards the ‘recipe’ standard, at one point suggesting that this interpretation would “go beyond” the undue experimentation rule.

At the heart of the ‘recipe’ versus “roadmap” discussion was the role of the person having ordinary skill in the art, where Amgen emphasised that such a person in the antibody synthesis space can tolerate some unpredictability, while Sanofi suggested that enablement instead requires a higher level of certainty for them.

The justices also sought clarification on whether the amount of time or type of effort required to produce all the species within a genus was dispositive.

The parties seemed to agree that ‘cumulative effort’ wasn’t the key consideration, but Sanofi seemed to weigh the factor of cumulative effort heavily, whereas Amgen emphasised only the time and effort required to generate a single species within the genus.

The justices seemed concerned about the potential financial and innovation implications of this case in the biotechnology field, referencing the high number of amicus briefs, and looked to other doctrines, such as the doctrine of equivalents, to supplement the enablement standard and even suggested that Congress would be better suited to formulate an enablement rule specific to biotechnology.

Christopher Cowles, partner, Withers. “Sanofi's counsel appeared to have fully aligned all justices behind its position.”

Amgen's counsel was in the unenviable position of attempting to support Amgen's enablement of all such claimed antibodies, with Justice Thomas' opening query—“would you take a minute and tell us exactly what the invention is?”—immediately showing the ambiguity and weakness of Amgen's position.

While Amgen's counsel asserted that Amgen had initially identified a class of 384 antibodies that would fall under the scope of Amgen's contested claims, it yet then only fully defined 26 different antibodies in Amgen's patent filings.

The court was decidedly hostile to Amgen's assertion that Amgen's identification of a “sweet spot” in the naturally-occurring PCSK9 protein entitled Amgen to monopoly protection of the full scope of all antibodies encompassed by the composition-of-matter claims of Amgen's US Patent numbers 8,829,165 and 8,859,741 patents.

The court was much more receptive to Sanofi counsel's characterisation of both the law (enablement requires that a skilled artisan would be able to make and use the claimed invention, without reliance upon undue experimentation) and the science (notably referring to an expert declaration penned by Sir Gregory Winter).

Both respectively undermine Amgen's assertions regarding the predictability of the genus of antibodies claimed, thereby highlighting the lack of enablement of Amgen's disputed claims.

Sanofi's counsel appeared to have fully aligned all Justices behind its position, and it would now be shocking for the court to overturn the Federal Circuit's decision.


More on this story

Big Pharma
9 March 2023   Sanofi and Regeneron accused of wanting to change patent system | The US Supreme Court will decide whether a controversial court decision should stand.
Big Pharma
20 April 2023   Court affirms decision that two Otezla patents are not invalid | Apremilast generics set for 2028 release.
Big Pharma
18 May 2023   Case concerned the interpretation of a key requirement of the US Patent Act | Amgen’s ‘roadmap’ held to describe step-by-step its own trial-and-error method for finding functional antibodies.

More on this story

Big Pharma
9 March 2023   Sanofi and Regeneron accused of wanting to change patent system | The US Supreme Court will decide whether a controversial court decision should stand.
Big Pharma
20 April 2023   Court affirms decision that two Otezla patents are not invalid | Apremilast generics set for 2028 release.
Big Pharma
18 May 2023   Case concerned the interpretation of a key requirement of the US Patent Act | Amgen’s ‘roadmap’ held to describe step-by-step its own trial-and-error method for finding functional antibodies.