SCOTUS asks for SG’s view on enablement in antibody dispute
The US Supreme Court has asked the Solicitor General to wade in on a case centring on the legal concept of enablement that is the crux of an antibody patent dispute between Amgen and Sanofi.
The court issued the order to Elizabeth Prelogar on Monday, April 18.
In February 2021, the US Court of Appeals for the Federal Circuit invalidated two Amgen patents, which cover cholesterol-lowering antibodies, for a lack of enablement.
Raising the bar
The Federal Circuit ruling marked a win for Sanofi, which pursued the invalidation of the Amgen patents through litigation at the US District Court for the District of Delaware.
In an earlier decision, the federal court in Delaware court had granted Sanofi summary judgment on a lack of enablement, prompting Amgen to appeal to the Federal Circuit.
The appeals court held that Amgen’s functional patent claims suffered a disadvantage when it came to the issue of enablement: “While functional claim limitations are not necessarily precluded in claims that meet the enablement requirement, such limitations pose high hurdles in fulfilling the enablement requirement for claims with broad functional language,” it stated.
Writing on behalf of the Federal Circuit panel, Justice Alan Lourie had noted that use of functional claims as broad as those in the Amgen patents “raises the bar for enablement”.
Substantial experimentation
According to the district court’s summary judgment, and the Federal Circuit opinion, the patents would still require “substantial” experimentation by people of ordinary skill in the art to meet the claimed embodiments.
In November 2021, Amgen filed for a writ of certiorari in which it asked SCOTUS to consider:
whether enablement for purposes of Section 112 of the Patent Act is “a question of fact to be determined by the jury,” as the Supreme Court has held, or “a question of law that [the court] review[s] without deference,” as the US Court of Appeals for the Federal Circuit holds.
It has also asked the court to determine whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 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”.
Amgen’s position has garnered the support of other pharma companies including GlaxoSmithKline, Bristol-Myers-Squibb and Biogen who filed amicus curiae backing the drug-maker.
They have collectively argued that the Federal Circuit’s decision erodes the ability of innovators to secure and enforce patents with an effective scope of protection for innovations that are critical to the delivery of ground-breaking products to the market—ranging from innovative medicines providing cures for cancer to remarkable consumer devices
“If left unchanged, the decision below could slow the pace of research and development and hinder innovation, to the detriment of patients and the public at large,” they warned.
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