US Supreme Court Rules Isolated DNA Unpatentable, cDNA Patentable

In Association for Molecular Pathology et al v Myriad Genetics, Inc et al, the US Supreme Court (Court) ruled that isolated DNA, a segment of naturally occurring DNA that has been isolated from surrounding genetic material, is unpatentable subject matter. The Court also held that complementary DNA (cDNA), isolated DNA that has been spliced to remove its non-coding elements (intons) but retain its coding elements (extrons), is patentable subject matter. Myriad Genetics, Inc (Myriad) developed a test to assess whether a patient has an increased risk of breast and ovarian cancer based on mutations it observed in the BRCA1 and BRCA2 genes of a patient, and obtained patents claiming isolated DNA having the genetic sequence of those genes and cDNA created from that DNA. A group of researchers, medical patients and advocacy groups filed a suit seeking a declaration that Myriad’s patents were invalid. A US District Court granted the declaration on the basis isolated DNA was not distinct from naturally-occurring DNA and therefore unpatentable. An Appeals Court reversed the District Court’s ruling, finding isolated DNA was patentable on the basis its chemical structure was distinct from naturally-occurring DNA. On appeal, the Court vacated the judgment of the Appeals Court and remanded the case. On remand, the Appeals Court upheld its prior ruling. On further appeal, Judge Clarence Thomas, writing for the Court, struck down Myriad’s claims to isolated DNA as unpatentable on the basis there was no difference between the genetic information encoded in isolated DNA and that of naturally-occurring DNA. The Court found any differences in chemical structure between the two forms of DNA were insignificant so far as patentability was concerned, for Myriad’s claims focused on the genetic information encoded in the DNA relating to the sequence and location of the BRCA1 and BRCA2 genes, not the chemical structure of the isolated DNA. The Court further held that isolated cDNA was distinct from naturally-occurring DNA, and was therefore patentable:

“…[t]he lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA.”

The Court’s rejection of isolated DNA as unpatentable on the basis the encoded genetic information of isolated DNA was identical to naturally-occurring DNA appears to be in conflict with the Court’s finding cDNA was patentable, for the only difference between isolated DNA and cDNA appears to be the absence of introns (which contain no genetic information) from cDNA. While the long-term implications of the ruling remain to be seen, the American Intellectual Property Law Association (AIPLA) and other commentators have expressed concern the ruling may limit (or perhaps invalidate) some patents in the biotechnology sector, and this may encourage researchers to keep inventions secret as opposed to disclosing them to the public in exchange for patent protection. As one might expect, the ruling has already had a noticeable impact on Myriad. Since the ruling was handed down last week, Myriad’s stock price has dropped by about 20% and competitors are offering tests at a fraction of Myriad’s price. For a link to a statement of the AIPLA on the Myriad case, visit: http://tinyurl.com/kztgmnx Summary by: Darren Hall