LSPN 19: Courts need to revisit patentability of diagnostic tests
US courts need to revisit the patentability of diagnostic tests under section 101, according to Memorial Sloan Kettering Cancer Center’s chief IP counsel.
Shilpi Banerjee was speaking on the panel “Best Practice In Patenting Precision Medicine” at yesterday’s Life Sciences Patent Network in Boston.
She said: “I think it’s a terrible thing that diagnostic methods are not patentable. If they’re not protectable, you really have to think how a company can make money on these tests.”
John Sninsky, chief scientific officer of transplant diagnostics company CareDx, added: “To develop highly accurate tests, substantial investments have to be made. Investments aren’t justified if that innovation isn’t protected … I hope that somebody comes to the fore and addresses this chaos.”
The panel was discussing Athena Diagnostics v Mayo, a US Court of Appeals for the Federal Circuit decision which invalidated four claims of an Athena-owned patent because “laws of nature are not patentable”.
Athena’s patent (US number 7,267,820) covers methods for diagnosing neurological disorders, such as Myasthenia gravis (MG) by detecting autoantibodies to a protein called musclespecific tyrosine kinase (MuSK).
In coming to its decision, the Federal Circuit said it used guidance set out by the US Supreme Court that “laws of nature, natural phenomena and abstract ideas are not patentable”.
Earlier this month, Athena appealed against the decision, requesting the Federal Circuit to revisit its decision which Athena claimed was “precisely the evisceration of patent law against which the US Supreme Court has long warned”. Amicus briefs have been filed by biotech and pharmaceutical companies, urging the appeals court to rethink the ruling.
Brian Slater, partner and chair of life sciences at Pierce Bainbridge in New York and moderator of the panel, said that in this case, “after skewering the claim, [the majority] said that providing patent protection would promote the progress of science, but then went on to say that their hands are tied”.
He said that it was “quite unusual for the majority to have struck down a claim and then say we don’t like [doing it]..”
The panel also discussed Vanda Pharmaceuticals v West-Ward Pharmaceuticals, a Federal Circuit decision from April 2018.
In its ruling, the Federal Circuit found that Vanda’s patent, which relates to a method of treating schizophrenia patients with iloperidone where the dosage range is based on the patient’s genotype, was patentable.
West-Ward had argued that the claims were indistinguishable from those held invalid in Mayo, but the court disagreed.
The Federal Circuit said that the claims in Mayo were not directed to a novel method of treating a disease, but were instead directed to a diagnostic method.
A petition for certiorari has not yet been granted by the Supreme Court, but the solicitor general has been invited to file a brief in this case.
Banerjee suspects the Supreme Court won’t take up the case.
“The way it’s going, I’m afraid if the court does take it up, other things will go out the window of section 101. The court tends not to be patent friendly.”
Slater summed up the panel’s sentiment: “We all share the hope that we’ll get tailored medicine as we age, but section 101 has been getting in the way of that. However, we’re building up to a crescendo where something has to give.”
Conor McDonough, partner at Pierce Bainbridge, also sat on the panel.
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