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4 July 2019Americas

Federal Circuit refuses to rehear Athena dispute; judges call for reform

The US Court of Appeals for the Federal Circuit has upheld a win for Mayo Collaborative Services after it denied Athena Diagnostics’  petition to have a neurological patent dispute reheard en banc.

In the  decision, issued yesterday, July 3, a 7-5 majority of the court refused to rehear a ruling which had decided that an Athena patent (US number  7,267,820) was ineligible under the US Supreme Court’s ruling in Mayo v Prometheus.

The patent covers a method of diagnosing neurological disorders by detecting antibodies for the muscle-specific tyrosine kinase (MuSK) protein.

In  February, the Federal Circuit held that the patent was directed towards a law of nature, and therefore ineligible based on the Supreme Court’s Mayo ruling.

While a majority voted to deny Athena’s petition, many of the judges agreed that the Mayo ruling posed significant challenges for US patent law.

Circuit Judge Alan Lourie, joined by Circuit Judges Jimmie Reyna and Raymond Chen, concurred in the decision to deny a rehearing, but noted his “concern” at the Supreme Court precedent.

He said that if he could “write on a clean slate”, then he would not direct an exemption to patent eligibility towards uses of natural laws, but only the laws themselves.

Ultimately, however, the Federal Circuit is bound by Supreme Court precedent, Lourie said.

Circuit Judge Todd Hughes, joined by Chief Judge Sharon Prost and Circuit Judge Richard Taranto, also concurred with the majority decision, while noting that the Mayo precedent as it stands is “problematic”.

Hughes wrote that he would welcome further clarification as to the eligibility of diagnostic patents, which he said could come from either the Supreme Court or Congress.

Circuit Judge Timothy Dyk noted that “Mayo left no room for us to find typical diagnostic claims patent eligible”.

Dyk added: “It would be desirable for the Supreme Court to refine the Mayo framework to allow for sufficiently specific diagnostic patent claims with proven utility.”

In a  tweet, Joshua Landau, patent counsel at the Computer & Communications Industry Association (CCIA), said that Dyk’s opinion adopts a point that quite a few in the section 101 patent eligibility debate try to contradict: that the section “has its own function in protecting against overly broad patents”.

Dyk, in his assertion, said that the doctrines of novelty under section 102, obviousness under section 103, and enablement and written description under section 112 cannot adequately guard against the dangers of overclaiming.

“In Mayo, the Supreme Court rejected the argument that ‘other statutory provisions’—specifically sections 102, 103, and 112—could adequately “perform th[e] screening function” served by section 101,” said Dyk.

A group of US legislators are  pushing to reform section 101, by removing the stipulation that a patent-eligible invention must be “new and useful”.

Senators Thom Tillis and Chris Coons, representing North Carolina and Delaware respectively, released the proposals in April. Under the draft framework, the proposals would “simply require that the invention meet existing statutory utility requirements” and scrap the existing “new and useful” requirement for patent-eligible inventions.

In a dissenting opinion, Circuit Judge Kimberly Moore, joined by Circuit Judges Kathleen O’Malley, Kara Stoll, and Evan Wallach, argued that Mayo did not preclude the claims in the Athena patent from eligibility.

“We have turned Mayo into a per se rule that diagnostic kits and techniques are ineligible,” she wrote, arguing that this was an overly broad interpretation that the Supreme Court itself had warned against.

Dennis Crouch, a law professor at the University of Missouri School of Law, said that all eight separate opinions call for Supreme Court or Congressional intervention.

In a post on the  PatentlyO blog, Crouch added that while the judges’ opinions have no direct impact on the law and are all dicta, the opinions are “designed to send a powerful signal to both the Supreme Court and—perhaps more importantly to Congress—that all members of the ‘high patent court’ see a major problem with the law as it stands now”.

He concluded: “Of some interest—the judges were almost uniformly all careful to focus their attention on medical diagnosis inventions—suggesting a targeted solution that would not extend to business methods and other information-based inventions.”

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More on this story

Biotechnology
7 February 2019   In a victory for Mayo Collaborative Services, a US Court has ruled that four claims in a patent, of which Athena Diagnostics is the exclusive licensee, are invalid.
Big Pharma
16 July 2020   A US federal court has thrown out an appeal from Ono Pharmaceutical and a Nobel Prize-winning immunologist, in a dispute over who made groundbreaking discoveries in cancer therapy.
Americas
17 August 2020   The US Court of Appeals for the Federal Circuit has thrown out a patent infringement lawsuit brought by two Illinois doctors against more than 300 hospitals.