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Will the SCOTUS Actually Resolve Genetic Patents This Time?

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By Robyn Hagan Cain on April 08, 2013 3:59 PM

The Supreme Court will start its final sitting of the 2012 Term with what might be the most controversial intellectual property case of the year, Association for Molecular Pathology v. Myriad Genetics, Inc.

The case presents a simple question about a complex process: Are human genes patentable?

The Federal Circuit Court of Appeals has twice ruled that they are, but the Supreme Court’s decision last year in Mayo v. Prometheus Laboratories casts doubt on that theory.

Federal law provides, "Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title." In Mayo, the Court held that patents on processes that help doctors administering thiopurine drugs determine whether a given dosage level is too low or too high were invalid because they claimed underlying laws of nature.

In Association for Molecular Pathology, the Court will resolve whether seven existing patents on two genes associated with increased breast and ovarian cancer risk -- BRCA1 and BRCA2 -- are also products of nature.

Myriad Genetics, the company that holds the BRCA1 and BRCA2 patents, claims that the act of isolating the genes from a person produces a new material that has utility beyond the DNA that naturally occurs in the human body. According to Myriad, extracting the genome makes it patentable.

The Federal Circuit Court of Appeals agrees with Myriad that Mayo either isn't applicable or is outweighed by the longstanding U.S. Patent and Trademark Office policy on granting patents on isolated genes, Reuters reports.

But does that ruling conflict with Mayo? Not necessarily.

Professor Rebecca Eisenberg notes in the Yale Law Journal that Mayo "left considerable uncertainty as to the boundaries of patentable subject matter for molecular diagnostic inventions" and that Federal Circuit's analysis in Association for Molecular Pathology "found limited guidance ... in Mayo ... Each opinion drew primarily upon prior cases on the exclusion for natural products and processes that the Court had largely ignored."

Perhaps the 2012 Term will offer the clarity in this field that 2011 lacked. If not, we can expect more cases in the genetic testing vein in future terms.

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