Victory for Mayo in neurological disorder patent dispute

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.

On Wednesday, February 6, The US Court of Appeals for the Federal Circuit affirmed an earlier decision by the US District Court for the District of Massachusetts that claims 6-9 of the patent in dispute were invalid for reciting “ineligible subject matter”.

The court said the claims were invalid because “laws of nature are not patentable”.

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).

The ruling comes amid a long-running dispute between the two companies after Mayo developed two competing tests which Athena alleged infringed one or more claims of the ‘820 patent.

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”.

The court said in order to come to its decision, it had to first determine if the claims were directed to a law of nature. If it found that they were, it would then ask whether the claims had an inventive concept which could “transform the nature of the claim into a patent-eligible application”.

In its argument, Athena said that claims 7-9 were not directed to a natural law and instead they recited innovative, specific and concrete steps”. It said the claims are directed to a “new laboratory technique”.

Mayo argued that the claims were directed to a natural law, which in this case is the correlation between naturally occurring autoantibodies and neurological diseases like MG.

The federal court said that ultimately, it agreed with Mayo.

Once it had established that the claims were directed to a natural law, the court had to determine if the claims improved upon a technological process, or merely added “conventional steps” to a law of nature.

It determined that the additional steps in the claim only recite the “standard techniques” for observing the natural law.

Athena argued that the claims provide an inventive concept. It said that prior to the discovery laid out in the claims, there was no disclosed method to detect MuSK autoantibodies.

Mayo responded that the claims lack an inventive concept and said the steps taken for detecting MuSK antibodies were “standard techniques in the art”.

The Federal Circuit concluded that it could not hold that “performing standard techniques in a standard way” to observe a newly discovered natural law was an inventive concept.

Regarding claim 6 of the patent, Athena argued that the district court did not specifically analyse claim 6, which it said involves a different technology.

Mayo responded that the district court “properly grouped claim 6 with claims 7-9 because Athena grouped them together”. It added that Athena “effectively waived” any separate arguments regarding claim 6 by not specifically addressing the claim during the district court proceedings.

The Federal Circuit said that given this history, it agreed with Mayo.

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