In Ass’n for Molecular Pathology v. Myriad Genetics, Inc., the United States Supreme Court held that a naturally occurring, isolated segment of DNA is a product of nature and is not patentable.1 In contrast, the Supreme Court held that synthetically created DNA (cDNA) is patent eligible because it is not naturally occurring, even if derived from DNA.
The Association for Molecular Pathology filed suit against Myriad Genetics, Inc. seeking a declaration that Myriad’s patents covering naturally occurring DNA segments as well as synthetic DNA were not patentable and therefore invalid under Section 101 of the Patent Act. Myriad Genetics discovered the location and sequence of two human genes, BRCA 1 and BRCA2, mutations of which can increase one’s risk of developing breast and ovarian cancer.2 Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398, 2013 WL 2631062, at 3 (U.S. June 12, 2013). Information regarding the two genes allowed Myriad to develop medical tests that are useful for assessing whether a patient has an increased risk of cancer, id., and Myriad obtained several patents based on its discovery. Id. at 4. Myriad’s composition claims that arise from its various patents “focus on the genetic information encoded in the BRCA1 and BRCA2 genes.” Id. at 9. The patents gave Myriad the “exclusive right to isolate an individual’s BRCA1 and BRCA2 genes by breaking the covalent bonds that connect the DNA to the rest of the individual’s genome . . . [they] also give Myriad the exclusive right to synthetically create BRCA cDNA.” Id. at 5 . Thus, Myriad’s patents covered the BRCA1 and BRCA2 genes, which for women having such mutated genes, can show a significantly higher risk for breast and ovarian cancer.
Myriad asserted that certain tests for mutations in the genes infringed its patents. To begin its analysis, the Supreme Court noted that under that §101 of the Patent Act “laws of nature, natural phenomena and abstract ideas are not patentable.” Id. at 7 (citing Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ––––, 132 S.Ct. 1289). The Supreme Court explained that its decision in Diamond v. Chakrabarty, 447 U.S. 303, 309-310 (1980), was essential to resolving any issues presented by Myriad’s patents: “in Chakrabarty, scientists added four plasmids to a bacterium, which enabled it to break down various components of crude oil . . . the court held that the modified bacterium was patentable. It explained that the patent claim was ‘not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter– a product of human ingenuity having a distinctive name, character [and] use’ . . . the Chakrabarty bacterium was new ‘with markedly different characteristics from any found in nature.’” Id. at 8.
After considering Charkrabarty’s holding and whether a naturally occurring segment of DNA is patent eligible under §101 by virtue of its isolation from the rest of the human genome, the Supreme Court concluded that “Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA. Instead, Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes . . . ” Id. at 8. The Supreme Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible.” Id. at 2.
With respect to Myriad’s medical breakthrough, the Court reasoned that “groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.” Id. at 8. Instead, the case was similar to Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), where a patent applicant combined several nitrogen-fixing bacteria that helped leguminous plants take nitrogen from the air and fix it in the soil. Id. at 8. The Funk Brothers Court “held that the composition was not patent eligible because the patent holder did not alter the bacteria in any way. Id., at 132, 68 S. Ct. 440.”
Therefore, according to the Supreme Court, Myriad’s patent claims just like the patent applicant’s in Funk Brothers, “fall squarely within the law of nature exception . . . Myriad found the location of the BRCA1 and BRCA 2 genes, but that discovery, by itself, does not render the BRCA genes ‘ new compositions of matter,’ §101, that are patent eligible.” Myriad, No. 12-398, 2013 WL 2631062 at 8.
The Supreme Court then turned to the synthetically created DNA known as complementary DNA( cDNA) and noted that “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments” because “creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring . . . 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 . . . .” Id. at 10.
The Supreme Court limited its decision by excluding the patentability of: “an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes.” Id. at 17. Its decision also does not extend to applications of sequences, which Myriad patented and which were not challenged on the basis of patent eligibility under Section 101. Id. at 17-18. Finally, the Supreme Court’s decision did not consider the patentability of DNA “in which the order of the naturally occurring nucleotides has been altered.”
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Thus, while affirming that products of nature are not patentable, the Supreme Court clarified in the context of synthetic DNA that products derived from naturally occurring products continue to be eligible for patent protection.
1 No. 12-398, 2013 WL 2631062 (U.S. June 12, 2013).
2 The human genome consists of approximately 22,000 genes packed into 23 pairs of chromosomes. Each gene is encoded as DNA. BRCA1 and BRCA2 are genes composed of DNA. Myriad, No. 12-398, 2013 WL 2631062 at 2.