On June 13, 2013, the United States Supreme Court issued a highly anticipated decision in Association for Molecular Pathology v. Myriad Genetics, Inc. (“Myriad”) concerning the patent eligibility of human genes.
The Supreme Court unanimously found:
• Isolated DNA per se is not patent eligible;
• cDNA (a man-made construct) satisfies the requirements of patent-eligible subject matter set forth in 35 U.S.C. § 101.
In Myriad, the American Civil Liberties Union filed suit on behalf of a collection of cancer patients, scientists, and medical and research organizations to invalidate the claims of various patents directed to breast cancer susceptibility genes 1 and 2 (BRCA1 and BRCA2) owned or licensed by Myriad Genetics, Inc. The issued claims were based on a discovery that mutant forms of the BRCA genes correlate with an increased risk of breast and ovarian cancer. Women with mutations in both genes have up to an 85% cumulative risk of breast cancer, as well as up to a 50% cumulative risk of ovarian cancer.
The question presented to the Supreme Court in Myriad was whether the claimed DNA molecules were eligible for patent protection. There were claims to BRCA1 and BRCA2 DNA that was isolated from the human genome (the “Isolated DNA Claims”) and claims to complementary DNA synthesized from the isolated DNA (the “cDNA Claims”). The Court acknowledged that § 101 has been limited through case precedent to exclude fundamental principles, such as “laws of nature, natural phenomena, and abstract ideas,” but cautioned that “[p]atent protection strikes a delicate balance between creating incentives that lead to creation, invention, and discovery and impeding the flow of information that might permit, indeed spur, invention.”
Isolated DNA is Not Patent Eligible
The Court held that the Isolated DNA Claims were directed to naturally occurring DNA that was merely isolated from the human genome and therefore fell squarely within the “law of nature” exception. The mere isolation of a naturally occurring DNA sequence does not satisfy the patent eligibility standard of § 101, notwithstanding the fact that isolation of DNA involves breaking the chemical bonds holding the gene in place. In writing the opinion, Justice Thomas focused on the genetic information encoded by the isolated DNA molecule, and held that the composition did not have “markedly different characteristics from any found in nature.” The Court stated that the principle contribution was to identify the precise location of the BRCA1 and BRCA2 genes within the human genome, but according to the Court, “that discovery, by itself, does not render the BRCA genes ‘new…composition[s] of matter’” under § 101.
The Court gave short shrift to the argument that the U.S. Patent and Trademark Office’s decades-long practice of granting patents on isolated DNA should be given deference, stating that Congress had not endorsed the USPTO’s practice.
cDNA is Patent Eligible
The Court held that the cDNA Claims contained patent eligible subject matter. The creation of cDNA (synthetic DNA) from mRNA removes the non-coding regions (introns) of the molecule, thereby producing a non-naturally occurring, exons-only molecule. The Court acknowledged that nature dictates the nucleotide sequence of cDNA; however, the Court concluded that “the lab technician unquestionably creates something new when cDNA is made… except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA.”
The Court was quick to note that it did not opine on the patent eligibility of 1) method claims; 2) new applications of knowledge about the BRCA1/BRCA2 genes; or 3) DNA in which the order of the naturally occurring nucleotides has been altered. The Court also left the door open for obtaining patent protection for DNA isolates expressed in terms of a chemical composition and for the chemical changes resulting from the isolation of a particular DNA section.
By excluding only “isolated DNA” from patent-eligible subject matter, while upholding the patent-eligibility of “cDNA,” and providing examples of claims that might satisfy a § 101 inquiry, this decision may render a number of old patents invalid while providing some new guidelines for obtaining patent protection in the future. While the decision may be seen by some as weakening some areas of biotechnology, it may ultimately strengthen the biotechnology industry by providing new patent incentives. The interplay of this relatively narrow decision with the Supreme Court’s earlier decision, Mayo Collaborative Services v. Prometheus Laboratories, 132 S.Ct. 1289 (2012), particularly as it applies to the diagnostics industry, will require additional observation. However, it appears that man-made constructs and uses, such as DNA probes and assays, should still satisfy the standards of patent eligibility.
Whether the Supreme Court’s decision will ultimately have a draconian impact on biotechnology patents and patent applications remains to be seen. In light of the Court’s decision, applicants and patentees should review their portfolios to determine their susceptibility to § 101 rejections by the U.S. Patent and Trademark Office and to potential § 101 challenges by third parties.