Genes cannot be patented.  Following oral argument on April 15, 2013 in Assoc. for Molecular Pathology v. Myriad Genetics, Inc. (see my April 25th blog post), the United States Supreme Court unanimously held yesterday (June 13, 2013) that a sequence of DNA molecules isolated from its natural state is not eligible for patent protection.  The Court held that a naturally occurring segment of DNA is a product of nature and not eligible for patent protection simply because it has been isolated from a genome.  The Court held that in the case of isolated DNA nothing is created.  Instead, there is only the discovery of the location and order of nucleotides that already existed in nature.

However, the Court held that cDNA is eligible for patent protection.  Unlike isolated DNA (which contains introns and exons), cDNA is a synthetic form of DNA that contains only exons and is not naturally occurring.  The Court held that something new is created when cDNA is made and, therefore, cDNA is patentable unless a very short series of DNA has no intervening introns to remove when creating cDNA (in which case a short strand of cDNA may be no different than natural DNA).

The Court’s decision in the case is limited in scope.  The Court did not consider the patentability of DNA in which naturally occurring nucleotides have been re-ordered.  Also, patent claims to methods of using isolated DNA to conduct genetic testing remain valid and enforceable.  For example, Myriad Genetics, Inc.’s methods of testing for mutations in the BRCA1 and BRCA2 genes (which are associated with certain forms of breast and ovarian cancer) remain patent-protected.

Click here to read the Court’s opinion in the case (Assoc. for Molecular Pathology v. Myriad Genetics, Inc., U.S., No. 12-398, 6/13/2013).