Medical diagnostic test can't be patented, appeals court rules: 6 things to know

A U.S. appeals court has ruled that a diagnostic test licensed to Quest Diagnostics' Athena unit that's used to diagnose a severe neurological disorder can't be patented, Bloomberg reports.

Six things to know:

1. Quest Diagnostics developed a method of diagnosing neurological disorders by linking certain antibodies with an autoimmune disease known as Myasthenia gravis.

2. Quest sued Mayo Clinic in 2015 for royalties on tests conducted at its Rochester, Minn.-based facility that used its method.

3. Mayo's argument centered on a 2012 Supreme Court decision that established limits on the kinds of diagnostic tests that could be patented. Mayo argued that Quest's patent covered a law of nature, which cannot be patented, although applications of the law can be.

4. In a 2-1 ruling Feb. 6, the appeals court sided with Mayo.

"This correlation exists in nature apart from any human action. There can thus be no dispute that it is an ineligible natural law," Circuit Judge Alan Lourie wrote for the majority. "The claims at issue here involve both the discovery of a natural law and certain concrete steps to observe its operation.

"Claiming a natural cause of an ailment and well-known means of observing it is not eligible for patent because such a claim in effect only encompasses the natural law itself. … But claiming a new treatment for an ailment, albeit using a natural law, is not claiming the natural law," the judge said.

5. Hans Sauer, deputy general counsel for biotechnology industry trade group BIO, was not involved in the case but told Bloomberg that "If anything can be learned from this decision, it is that the law of so-called patent-eligible subject matter is simply too unstable to offer any guidance to inventors, innovative businesses, patent examiners and judges," adding that Congress must step in to provide clarity.

6. William Atkins, another lawyer with Pillsbury Winthrop Shaw Pittman who was not involved with the case, told the publication the ruling "could adversely affect the life sciences and biotech industries where a lot of inventions deal with identifying and dissecting things found in nature."

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