By CRG Staff
Topic Update: Gene Patents

A U.S. federal appeals court has once again affirmed the right of Myriad Genetics, Inc. to patent two genes linked to breast and ovarian cancer, after the U.S. Supreme Court ordered it to take another look at the high profile case.

Earlier this spring, the US Supreme Court had set aside the Federal Circuit's July 2011 decision favoring Myriad and directed that court to review the case again in light of its unanimous ruling in Mayo v. Prometheus. In that case the Court had found invalid Prometheus Labs' patents on methods of evaluating patients' drug responses, finding that they were not permitted to patent observations about natural phenomena. Myriad, alternatively, revolves around product patents and the "products of nature" doctrine-a different legal theory, though based on quite similar arguments. Indeed the American Civil Liberties Union, which brought the case against Myriad, made that very argument: that Prometheus reaffirmed the Court's well established precedent of finding laws of nature and natural phenomena not patentable.

However, the Federal Circuit was not persuaded to change its ruling and ruled in favor of Myriad again 2-1. The language of its current ruling changed little from its prior one.

Writing for the majority, Judge Alan Lourie said: "Everything and everyone comes from nature, following its laws, but the compositions here are not natural products. They are the products of man, albeit following, as all materials do, laws of nature."

Judge Moore agreed, finding that invalidating such patents would cause irreparable harm to industry: "(W)e must be particularly wary of expanding the judicial exception to patentable subject matter where both settled expectations and extensive property rights are involved."

However, in his dissent Judge Bryson said:

Just as a patent involving a law of nature must have an "inventive concept" that does "significantly more than simply describe natural relations," a patent involving a product of nature should have an inventive concept that involves more than merely incidental changes to the naturally occurring product. In cases such as this one, in which the applicant claims a composition of matter that is nearly identical to a product of nature, it is appropriate to ask whether the applicant has done "enough" to distinguish his alleged invention from the similar product of nature. Has the applicant made an "inventive" contribution to the product of nature? Does the claimed composition involve more than "well-understood, routine, conventional" elements? Here, the answer to those questions is no.

What's next? The Myriad case is likely far from over. There is a strong possibility of either an en banc rehearing by the full 12-member Federal Circuit Court, a grant of certiorari by the US Supreme Court, or both. Stay tuned.

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