On June 13th, 2013, the U.S. Supreme Court unanimously held in Association for Molecular Pathology v. Myriad Genetics that isolated DNA is not eligible for patent protection.
Myriad Genetics owns a series of patents directed to the BRCA1 and BRCA2 genes, and its primary business is offering genetic testing for a mutation in these genes, which if present, generally relates to a 50-80% chance of developing breast cancer and a 20-50% chance of developing ovarian cancer.
A handful of plaintiffs, including a physician who had patients tested for this mutation, the ACLU, various individuals who had sought testing for this mutation, and the Association for Molecular Pathology sought a declaratory action in the U.S. District Court for the Southern District of New York seeking to invalidate the patents. The District Court found the patent claims directed to isolated DNA to be ineligible for patent protection. The U.S. Court of Appeals for the Federal Circuit reversed. The Supreme Court of the United States directed the Federal Circuit to reconsider its decision in view of the Supreme Court’s interim decision in Mayo v. Prometheus, where the court struck down certain patent claims directed to methods of personalized medicine. The Federal Circuit upheld its previous ruling that isolated DNA is patentable subject matter, but struck down a number of Myriad’s claims directed to diagnostic methods of testing for the BRCA gene mutation in view of Prometheus. The Supreme Court again granted certiorari leading to the present decision.
The only question for the Supreme Court in this case was whether isolated DNA is patentable subject matter. 35 U.S.C. § 101 provides the definition for what constitutes patentable subject matter and includes “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” There are some judicially created exceptions to the types of subject matter that can be patented, namely abstract ideas, natural phenomenon, and products of nature. Central to the Myriad case was the “product of nature” exception. In other words, the ultimate question for the court was whether isolated DNA is a product of nature.
Justice Clarence Thomas drafted the relatively brief and direct opinion of the court, holding that isolated DNA is a product of nature and, therefore, ineligible for patent protection. The Supreme Court dismissed Myriad’s arguments that DNA isolated from a cell is chemically and structurally distinct from that as it exists in nature. In doing so, the high court characterized the chemical structure of DNA by its nucleotide sequence, thereby leading to the conclusion that the claimed isolated DNA is exactly the same as it exists in nature. Although Myriad’s significant contribution in identifying the location and identity of the genes was acknowledged, the justices held that “groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the [patent eligibility] inquiry.”
In contrast to the holding on isolated DNA, the court ruled that Myriad’s patent claims directed to complementary DNA (cDNA) are directed to patentable subject matter. Their decision relied on the fact that cDNA is not a product of nature and can only be synthetically produced. Moreover, the court noted that cDNA does not contain certain portions of sequence found in the endogenous gene, which suggests that DNA having a sequence altered from that as found in nature may be patentable.
From a business prospective, the decision may have an impact on investment in the development of genetic tests, since patents directed to isolated DNA offered powerful intellectual property protection for companies. However, patents can still be obtained in the form of method claims, but the scope of these types of claims is continuously being narrowed by the courts (e.g., Mayo v. Prometheus) and often present more hurdles in enforcement than do composition claims (e.g., isolated DNA). As a result, start-up biotech companies that are built around the exploitation of a particular gene may face some challenges in the near future. On the other side, larger companies with greater resources may be able to take advantage quickly by developing genetic tests to compete with those in the market who may have loss patent exclusivity based on the precedential effect of the Myriad decision.
The primary beneficiary of the Myriad decision, at least in the short term, may be patients who are seeking cheaper options for genetic testing. However, as alluded to previously, the long-term effects in this area may depend on the level of future investment being poured into genetic testing technologies in the absence of the broad intellectual property protection provided by patents directed to isolated DNA.
The one viewpoint that seems to be shared by many proponents of the Myriad decision is that research will flourish without the threat of gene patents. However, Myriad presented evidence that approximately 10,000 research reports relating to the BRCA genes have been published in peer-reviewed scientific journals since the Myriad patents issued. Based on this evidence alone, it seems possible that basic and clinical research involving the BRCA genes has been moving at a steady pace irrespective of Myriad’s patents.
It will be interesting to see whether Myriad’s surviving patent claims, including methods for identifying the presence of mutations in the BRCA genes and compositions comprising BRCA cDNA, will carry equal weight in the genetic testing world. One thing that is certain in view of the decision is that attorneys in this area will be forced to come up with novel ways to draft patent claims to protect genetic discoveries.