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9 April 2019Big Pharma

Athena asks for rehearing on invalidated neurological disorder patent

Athena Diagnostics has asked the US Federal Circuit to revisit its decision earlier this year, which found four claims in one of its patents to be invalid.

The petition for en banc was  filed yesterday, April 8 at the US Court of Appeals for the Federal Circuit, after a  February ruling by the same court invalidated the claims because “laws of nature are not patentable”.

In its petition, Athena said the court’s decision was “precisely the evisceration of patent law against which the US Supreme Court has long warned”.

The patent (US number  7,267,820) covers methods for diagnosing neurological disorders, such as Myasthenia gravis (MG) by detecting autoantibodies to a protein named muscle-specific tyrosine kinase (MuSK).

In its argument, Athena said the patent covers a method, and “methods applying natural law have always been eligible”.

It said the Court of Appeals wrongly held the claims of the patent ineligible, as “directed to” a law of nature, despite acknowledging that the claims recite multi-step laboratory methods.

Additionally, it said the claims require “novel, man-made substances”, “do not preempt natural laws” and “serve a new and useful purpose of diagnosing serious diseases”.

“In plain terms, the claims recite a process”, Athena said.

According to the filing, prior to the ‘820 patent, diagnoses of Myasthenia gravis were only effective for approximately 80% of patients.

Athena said the patent inventors discovered that the un-diagnosable patients generated autoantibodies to MuSK.

That discovery, the first linking MuSK autoantibodies to MG, motivated the inventors to develop the first-ever assay for MuSK autoantibodies. Athena said this was “an integral part of a new and useful diagnostic method”.

It said that prior to its invention, no one had ever immunoprecipitated MuSK antibodies, and labeled MuSK was novel. Therefore, it said the method in the patent is innovative and achieves a previously unknown result.

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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
25 April 2019   Biotech and pharmaceutical companies have submitted an amicus brief urging an appeals court to rethink a ruling, which invalidated a patent exclusively licensed by Athena Diagnostics.

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
25 April 2019   Biotech and pharmaceutical companies have submitted an amicus brief urging an appeals court to rethink a ruling, which invalidated a patent exclusively licensed by Athena Diagnostics.