In a long-awaited and much-anticipated decision, the US Supreme Court today issued a unanimous opinion in Association for Molecular Pathology v. Myriad Genetics, Inc., involving the BRCA1 and BRCA2 genes relevant to detection of increased risk of breast and ovarian cancer. The Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, even despite extensive research efforts that may have been conducted to determine the location of the gene in order to isolate it.
On the other hand, the Court held that complementary DNA (synthetic DNA referred to as “cDNA”) does not present the same obstacles to patentability as naturally occurring, isolated DNA segments becuase “creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring” in that “the non-coding regions have been removed.” The Court concluded that “cDNA is not a ‘product of nature’ and is patent eligible under [35 USC] §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of DNA may be indistinguishable from natural DNA.” Finally, the Court acknowledged that this case did not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes, and many of Myriad’s unchallenged claims are limited to such applications.
The Court’s decision will end the US Patent and Trademark Office’s policy of granting patents on isolated genes, and patent practitioners will need to focus patent protection on the synthetic DNA developments and applications flowing from the discoveries of gene functionality.