Companies file amicus brief opposing Athena ruling

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.

On Monday, April 22,  Achillian Pharmaceuticals and biotech company  Freenome Holdings  said the ruling by the US Court of Appeals for the Federal Circuit threatens to “destroy Congress’ law”.

The brief relates to a ruling in February when the Federal Circuit affirmed an earlier decision by a district court that four claims in a patent, of which  Athena Diagnostics is the exclusive licensee, are invalid.

It said claims 6-9 of the patent in dispute were invalid for reciting “ineligible subject matter”.

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 musclespecific tyrosine kinase (MuSK).

In its decision, the Federal Circuit said it employed guidance set forth by the US Supreme Court that “laws of nature, natural phenomena and abstract ideas are not patentable”.

In the latest filing, Achillian and Freenome argued that the court erred in its judgment because it “removed words” from the statute before applying it to the facts.

“Through the application of its judicial exceptions, the court has effectively pencilled out two words of the statute—‘or discovers’,” the filing said.

The companies said removing these words was contrary to how Congress wants to “promote the progress of science and the useful arts”.

The brief said the court’s ruling was “unconstitutional” because it attempted to recreate patent law, which only Congress was authorised to create.

It said that even the Supreme Court “has acknowledged it has not been given such authority” to create or limit a law.

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