Sanofi wins enablement showdown at SCOTUS
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.
Sanofi has prevailed at the US Supreme Court in a closely watched clash with Amgen over antibody patents and the proper test for enablement under the Patent Act.
The US’ highest court today, May 18, ruled in a unanimous opinion that antibody patents owned by Amgen were not 'enabled', upholding an earlier ruling by the US Court of Appeals for the Federal Circuit.
The case concerned patents covering antibodies engineered by scientists that help reduce levels of low-density lipoprotein cholesterol, which can lead to cardiovascular disease, heart attacks and strokes.
‘Overly broad claims’
After Amgen sued Sanofi for infringement in 2014, the French pharma firm countered that Amgen’s relevant claims were invalid under the Patent Act’s ‘enablement’ requirement, outlined under Section 112.
That provision requires a patent applicant to describe the invention “in such full, clear, concise, and exact terms as to enable any person skilled in the art…to make and use the [invention]”.
Both the US District Court for the District of Delaware and the Federal Circuit sided with Sanofi and its co-plaintiff, Regeneron.
The Federal Circuit held that Amgen’s patents were invalid because they were overly broad and presented too many possible solutions beyond what was claimed.
Amgen’s unsuccessful bid to overturn the ruling put a spotlight on the ‘enablement’ issue, and whether a patent description should allow a person skilled in the art to reach the full scope of the claim without undue experiment.
Sanofi and Regeneron both made the case for “balance” in the patent system, arguing that the Federal Circuit’s decision provided the right incentives for innovation.
Genentech, AstraZeneca, Bayer, Gilead Sciences and Johnson & Johnson voiced their support for Sanofi in amicus curiae briefs, arguing that the Federal Circuit’s judgment should be upheld.
On the other side of the debate, GlaxoSmithKline and AbbVie both backed Amgen, with the former arguing in an amicus curiae that “competitors could make closely related species or modifications to a patented compound to avoid infringement while still appropriating the heart of the invention”.
Today, SCOTUS agreed that the lower court had correctly concluded that Amgen failed “to enable any person skilled in the art…to make and use the [invention]” as defined by the relevant claims”.
Roadmap fails to convince
Writing for SCOTUS, Justice Neil Gorsuch opined that: “Amgen insists that its claims are nevertheless enabled because scientists can make and use every functional antibody if they simply follow the ‘roadmap’ or ‘conservative substitution’.”
These two approaches, he pointed out, amount to little more than “two research assignments”.
“The ‘roadmap’ merely describes step-by-step Amgen’s own trial-and-error method for finding functional antibodies. Not much different, ‘conservative substitution’ requires scientists to make substitutions to the amino acid sequences of antibodies known to work and then test the resulting antibodies to see if they do too,” he added.
Justice Gorsuch also found that Amgen’s other arguments lacked merit.
“Amgen first suggests that the Federal Circuit erred by conflating 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,” he noted.
But he found that the Federal Circuit made clear that it was not treating as “dispositive the cumulative time and effort” required to make the entire class of antibodies.
SCOTUS also rejected Amgen’s stance that while the Patent Act supplies a single, universal enablement standard, the Federal Circuit applied a higher standard to Amgen’s claims that encompass an entire genus of embodiments defined by their function.
“The court agrees in principle that there is one statutory enablement standard, but the Federal Circuit’s treatment in this case is entirely consistent with Congress’s directive and this court’s precedents,” wrote Gorsuch.
Strong ‘enablement mandate’
Finally, the court went on to dismiss Amgen’s warnings that a ruling against it “risks destroying the incentives that lead to breakthrough inventions”.
Justice Gorsuch observed that since 1790, the US Congress has included an enablement mandate as “one feature among many designed to achieve the balance it wishes to strike between incentivising inventors” and ensuring the “public receives the full benefit” of their innovations.
“In this case, the court’s duty is to enforce the statutory enablement requirement according to its terms,” he concluded.
Commenting on the ruling, Emily Savas, partner at Locke Lorde, noted that the court made it clear that there is only “one statutory enablement standard,” which requires that “the more a party claims for itself, the more it must enable”.
She added: “The court rejected Amgen’s argument (echoed by certain amicus briefs) that invalidating generic claims defined by function and not structure would stifle innovation, noting that ‘striking the proper balance’ on that issue was ‘a policy judgment that belongs to Congress’.”
Steve Trybus, also a partner at Locke Lorde, observed that the takeaway from Amgen is that broad claims defined by the function of what is claimed rather than its structure will need to leave only a “reasonable amount” of experimentation open.
“That factual question will be at the heart of enablement challenges to come, especially in unpredictable arts,” he said. “As the Supreme Court ended its opinion, there is ‘new technology, but the legal principle is the same’ as it has been since 1790.”
