Don’t distort enablement law, Amgen tells SCOTUS
Sanofi and Regeneron accused of wanting to change patent system | The US Supreme Court will decide whether a controversial court decision should stand.
Amgen has asked the US Supreme Court to maintain the integrity of enablement law when deciding on whether to uphold or overturn a Federal Circuit judgment that invalidated its antibody patents.
The argument was put forward on Monday, March 6, as part of the high-stakes clash between the US biotech firm and rivals Sanofi and Regeneron.
Amgen accused Sanofi and Regeneron of contradicting themselves and said that the court “should not distort enablement law to serve those who would prefer a patent system different from the one Congress enacted”.
Sanofi and Regeneron succeeded in challenging the validity of Amgen’s monoclonal antibody patents for its cholesterol drug Repatha in the Delaware District Court in 2019. Now, the Supreme Court will determine whether that decision should stand or whether the patents can be resurrected.
French pharma giant Sanofi accused Amgen of attempting to corner the market with its patent that encompasses 26 antibodies, arguing that it broadly claims a genus by function rather than structure.
The case has sparked a debate over enablement and whether it is governed by the statutory requirement that the specification teaches 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.
Genus claims controversy
In its brief filed to the court, Amgen contested that Sanofi and Regeneron have abandoned the Federal Circuit’s view that enablement depends on cumulative time and effort “to reach the full scope” of an invention’s embodiment, despite pressing the “find-all-embodiments test”.
“Abandoning that test, Sanofi-Regeneron now makes up another: A patent with functional elements is not enabled, it says, if there are ‘specific undisclosed embodiments of the claimed invention’ skilled artisans ‘cannot predictably produce’,” Amgen argued.
“That test has no more basis in § 112’s text or this court’s precedent than the reach-the- full-scope test Sanofi-Regeneron repudiates.”
The US Court of Appeals for the Federal Circuit deemed the claims in Amgen’s patents to be invalid because there were too many possible solutions beyond what was disclosed.
Making its case to the Supreme Court, Amgen referred to the “make and use” standard in § 112, which it says requires a practical inquiry into what skilled artisans can do using the patent’s disclosures.
“If those disclosures are sufficient to guide those skilled in the art to successfully apply the invention, the patent is enabled,” the firm said.
“The standard is the same whether there are five embodiments of the invention or 5,000.”
Amgen also accused Sanofi and Regeneron of hypocrisy, arguing that they protect their own inventions through broad genus claims.
Addressing the hotly debated topic of whether allowing Amgen’s patents to be valid stifled or encouraged innovation, Amgen contested that “upholding genus claims for pioneering inventions accelerate the progress of science as inventors seek their own breakthroughs instead of developing ‘me-too’ products (like Sanofi-Regeneron did here).”
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