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US Supreme Court Declines to Hear Case on Patent Eligibility of Diagnostics

NEW YORK – The US Supreme Court said on Monday that it would not review Athena Diagnostics' unsuccessful suit against Mayo Collaborative Services.

The decision means that the ruling by the US Court of Appeals for the Federal Circuit that Mayo Collaborative Services (also known as Mayo Medical Laboratories) did not infringe on Athena's patent claims on a method of diagnosing myasthenia gravis (MG) will stand.

The case has been closely watched by diagnostics stakeholders as it could have significant implications for the industry. At root is the question of whether diagnostics that rely solely on applying a law of nature can be patented, with the appeals court's decision indicating that they cannot be.

Quest Diagnostics subsidiary Athena exclusively licensed a patent, No. 7,267,820, covering the use of autoantibodies to muscle-specific kinase (MuSK) to diagnose certain cases of MG and sued Mayo for patent infringement when it began selling a competing test in 2015. However, the US Court of Appeals for the Federal Circuit last year upheld a district court's judgment that the patents claims are invalid because they are directed to a natural law and lack an inventive concept, and denied a rehearing.

Athena then asked the Supreme Court to take up the case, which it today declined to do.