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U.S. Supreme Court Holds cDNA Is Patent Eligible But Isolated DNA Is Not

The U.S. Supreme Court has held that isolated DNA is a product of nature which is not eligible for patenting, but that synthetically-created genetic materials such as cDNA are patent eligible. See Association for Molecular Pathology v. Myriad Genetics Inc., No. 12-398 (June 13, 2013).

In an unanimous decision written by Justice Clarence Thomas, the Court held that the extracted and isolated DNA from an organism is not statutory subject matter under 35 U.S.C. §101 because it is a "product of nature." The Court noted that the portion of DNA isolated from its natural state is identical to that portion of the DNA in its natural state, and that it was "undisputed that Myriad did not create or alter any of the genetic information encoded in the [specific] genes." Complementary DNA, or cDNA, according to the Court, are synthetic creations that are "not naturally occurring," and thus would be statutory subject matter under Section 101.

The Court also emphasized that this decision "does not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered."

Patent claims covering the BRCA1 and BRCA2 genes, which correlate with a likelihood of breast and ovarian cancer, were at issue in the case. Current BRCA testing is typically priced at over $3,000, but, shortly after the decision, one company announced that it would offer a BRCA test at $995. See Houston Chronicle, "Court Ruling May Open Up Breast Cancer Gene Tests."

Justice Antonin Scalia wrote a one-paragraph concurrence in which he joined the judgment, but expressly did not join the portions of the opinion describing the underlying science of molecular biology.