The United States Supreme Court has released its much anticipated decision in the case of Association for Molecular Pathology v. Myriad Genetics, Inc. In a decision that will have a significant impact on the biotechnology industry, the Supreme Court unanimously decided that naturally occurring DNA segments are products of nature and are not patent eligible merely because they have been isolated, but cDNA is patent eligible because it is not naturally occurring.
By way of background, Myriad Genetics, Inc ("Myriad") discovered the precise location and sequence of what are known as the BRCA1 and BRCA2 genes. Mutations in these genes can dramatically increase an individual's risk of developing breast and ovarian cancer. This information enabled Myriad to develop medical tests capable of detecting mutations in a patient's BRCA 1 and 2 genes and permitting the assessment of a patient's risk of developing cancer. The isolated BRCA 1 and 2 DNA molecules and diagnostic tests were patented by Myriad. Some years later, the Association for Molecular Pathology ("AMP"), representing medical patients, advocacy groups and doctors, sought a declaration that Myriad's patents are invalid under 35 U.S.C. §101 because the claims are directed to patent-ineligible products of nature.
The Supreme Court acknowledged Myriad's valuable discovery, but sided with AMP and found that identification of the precise sequence and location of the BRCA1 and BRCA2 genes, by itself, does not render the BRCA genes new compositions of matter that are patent eligible under §101: "Myriad did not create anything. To be sure it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of an invention. Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry". The isolation of the DNA from the human genome does not render the genes patentable either, because the Court took the view that "Myriad's claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular DNA. Instead, the claims understandably focus on the genetic information encoded by the BRCA1 and BRCA2 genes".
The Court, however, ruled that cDNA does not present the same obstacles to patentability. cDNA differs from natural DNA in that the non-coding regions have been removed and the resulting cDNA molecule created is not naturally occurring. Accordingly, the Court decided that "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. In that situation a short strand of cDNA may be indistinguishable from natural DNA". The Court chose not to express an opinion as to whether cDNA satisfies other statutory requirements of patentability, such as novelty and nonobviousness.
It should be noted that the Court limited the implications of its decision to certain facts and circumstances such that diagnostic methods may still be patentable, with the Court noting that "there are no method claims before this Court […] this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes […] Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications" [emphasis in original]. Nor does the decision apply to the patentability of DNA that has been manipulated to contain non-naturally occurring mutations.
Comments: This decision, together with last year's Supreme Court's decision in Mayo v. Prometheus (refer to our bulletin U.S. Supreme Court Raises the Patent-Eligibility Bar for Diagnostic Methods), will have a significantly negative impact on the biotechnology industry. By ruling that isolated genes are no longer patentable, the Court is disrupting 30 years of established practice and calling into question the validity of many tens of thousands of issued patents and pending applications directed to DNA molecules. The U.S. Patent and Trademark Office (USPTO) reacted almost immediately by issuing on the day of the decision a memorandum instructing all of its Examiners to reject, from now on, product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not.
In addition to the scientific and technological weakness of the Court's opinion, the decision is not clear in many respects and raises many uncertainties in relation to the patentability of cDNA and other biological products. For instance, with respect to cDNA molecules, the decision seems to indicate that patent eligibility may depend on a minimal size or on distinctiveness of the sequence compared to naturally occurring DNA. In addition, the Court's reasoning seems to indicate that, even if something is synthetically created, it may not be patent eligible if it is identical to what is produced in nature. If this reasoning is applied more broadly, the decision may impact all types of composition claims, not only genetic sequences. For instance, it is not clear if naturally occurring pharmaceutical molecules such as antibiotics, anticancer drugs, antibodies, botanical extracts, etc. which have been "isolated" from their natural environment, would be considered non-patentable "products of nature" or "human-made inventions" eligible for patent protection.
In light of the uncertainties raised by the Supreme Court, it may be up to Congress to implement policies in order to ensure that companies continue to have incentives to innovate in these areas of importance to human health. In the meantime, in view of Myriad, companies should review their patent portfolios to assess the impact of the Supreme Court's decision and adjust their existing claim strategy to maximise chances of patentability of DNA-based inventions and other naturally-occurring products.