Washington Update

U.S. Supreme Court Rules on Association for Molecular Pathology v. Myriad Genetics

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On June 13, 2013, the United States Supreme Court issued an opinion regarding a decision of the United States Court of Appeals for the Federal Circuit that found both isolated DNA and cDNA (a form of DNA artificially synthesized from a messenger RNA template and used in genetic engineering to produce gene clones) patent eligible. Association for Molecular Pathology v. Myriad Genetics (Myriad), 569 U.S. 12-398 (2013), was a case challenging the validity of gene patents in the United States, specifically challenging certain claims in issued patents owned or controlled by Myriad Genetics that cover isolated DNA sequences, methods to diagnose propensity to cancer by looking for mutated DNA sequences, and methods to identify drugs using isolated DNA sequences.

The case was originally heard in Southern District Court of New York which ruled that all the challenged claims were not patent eligible. Myriad then appealed to the United States Court of Appeals for the Federal Circuit. The Federal Circuit overturned the previous decision in part, ruling that isolated DNA which does not exist alone in nature can be patented and that the drug screening claims were valid, and confirmed in part, finding the diagnostic claims unpatentable. The plaintiffs appealed to the Supreme Court, which granted certiorari2 and remanded the case to the Federal Circuit.

In its opinion, the Supreme Court distinguished between the cases of the DNA claims and the cDNA claims of Myraid. With respect to the DNA claims, the Court argued that they do not satisfy the exception to the “new and useful… composition of matter” as it “falls within the law of nature exception.” That is, the Court has found that despite the fact that the discovery of BRCA1 and BRCA2 may be “groundbreaking, innovative or even brilliant,” it is not sufficient to overcome the exceptions of the law of nature. The Court noted that “Myraid did not create or alter either the genetic information encoded in the… genes or the genetic structure of the DNA.” Therefore, the Court concluded that, in the case of the DNA claims, there was merely a discovery of a law of nature, and hence the claims are not patent eligible.

The Court took a different view when examining the case of the cDNA claims. It noted that the cDNA claims do not amount to a “product of nature”; that is, they do not occur naturally and regardless of the teachings made by the inventors. Specifically, the Court noted that “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments.” By contrast, the Court agreed that the cDNA claims result in an exon-only molecule, which is not naturally occurring. Moreover, though the order of the exons within the cDNA “may be dictated by nature,” the fact that the introns were removed from the DNA sequence results in a new composition of matter which is patent eligible.


2. A writ of certiorari orders a lower court to deliver its record in a case so that the higher court may review it. The U.S. Supreme Court uses certiorari to select most of the cases that it hears.

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