• Myriad: How It Impacts DNA Testing Labs
  • June 20, 2013 | Authors: Richard S. Cooper; David B. Cupar; Dale R. Vlasek
  • Law Firm: McDonald Hopkins LLC - Cleveland Office
  • In a unanimous opinion issued on June 13, 2013, the U.S. Supreme Court distinguished between isolated naturally-occurring DNA, which is non-patentable, and a synthetic version of DNA, complementary cDNA, which is patentable. Association for Molecular Pathology v. Myriad Genetics.

    In this case, Myriad owned several key patents that gave it the exclusive right to isolate the BRCA1 and BRCA2 genes on human chromosomes for genetic testing. Through isolating these genes, Myriad was also able to change the genetic sequence, resulting in cDNA, a non-naturally occurring DNA sequence.

    Applying 35 U.S.C. ยง101, the Court held that the isolated DNA was not patentable. The mere act of separating a gene from its surrounding genetic material is not an act of invention and, therefore, is not patentable. The Court reached a different result for cDNA, holding that since researchers create something new from the original DNA when cDNA is produced, cDNA is not a product of nature and is therefore patentable.

    This decision will have a significant impact on DNA testing laboratories, genomics companies and research institutions. The compromise reached by the decision allows opportunity for researchers to develop technology utilizing the isolated DNA sequence as it is not patent protected. Conversely, patent protection still exists for synthetic DNA (such as cDNA) and the processes used to carry out related tests, such as cancer screenings. This protection affords the biotechnology industry and equity investors incentive to invest research in this field.