June 26, 2013
In Association for Molecular Pathology v. Myriad Genetics, Inc., the U.S. Supreme Court held Myriad’s claims to “isolated” BRCA “genes and the information they encode are not patent eligible matter under [35 U.S.C.] § 101 simply because they have been isolated from the surrounding genetic material,” whereas since manmade cDNA “is not naturally occurring,” it is patent eligible, “except insofar as … a short strand of cDNA may be indistinguishable from natural DNA.”
In the lead-up to this Supreme Court decision, organizations and individuals, including patients, challenged Myriad’s patents to isolated BRCA1 and isolated BRCA2 genes in district court. These two genes are associated with hereditary forms of breast cancer. The trial court granted summary judgment that “isolated DNA” was a product of nature, and patent claims to those isolated DNAs were invalid under 35 U.S.C. § 101. On appeal, the Federal Circuit reversed in a divided decision, holding isolated DNA did not exist as such in nature and was therefore patent eligible. The Federal Circuit further held that, because complementary DNA (cDNA) was a synthetic genetic material, it was also eligible subject matter under § 101.
After summarizing the technology, the Court adverted to its long-standing judicial gloss that “[l]aws of nature, natural phenomena, and abstract ideas are not patentable,” but cautioned that applying the gloss too broadly “could eviscerate patent law” (quoting Mayo Collaborative Services v. Prometheus Labs, Inc.). The Court recognized that “patent protection strikes a delicate balance between creating ‘incentives that lead to creation, invention, and discovery’ and ‘imped[ing] the flow of information that might permit, indeed spur, invention’” (quoting Mayo).
Turning to Myriad’s patent claims directed to “isolated” DNA, the Court observed that Myriad neither created nor altered the genetic information encoded in the claimed isolated genes, thus leaving intact the location and order of the nucleotides as they existed in nature. In other words, the patent-ineligible claims to isolated BRCA genes (isolated DNA) had the same order of nucleotides, including both coding sequences (exons) and non-coding sequences (introns), as the naturally occurring gene.
By comparison to Diamond v. Chakrabarty, the Court explained Chakrabarty’s bacterium, modified with additional plasmids, was not naturally occurring and had “markedly different characteristics from any found in nature,” whereas “Myriad did not create anything” by uncovering the location and sequences of the two genes. And, “separating [each] gene from its surrounding genetic material is not an act of invention” and did not make the ‘isolated’ genes a “new . . . composition of matter” under §101.
The Court stated, “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry” to introduce its discussion of the patent to the claimed composition of nitrogen fixing bacteria in Funk Brothers Seed Co. v. Kalo Inoculant Co. Unlike the situation in Chakrabarty, the composition of four nitrogen-fixing bacteria in a single inoculant in Funk Brothers “was not patent eligible because the patent holder did not alter the bacteria in any way.” That patent claim “fell squarely within the law of nature exception.” Myriad’s locating the BRCA1 and BRCA2 genes is a discovery, but does not make the isolated genes patentable. The Court noted Myriad’s patent specifications described an iterative process, which reflected an extensive, and perhaps intensive, research effort, to determine the location of the BRCA genes, but that “extensive effort alone is insufficient to satisfy the demands of §101.”
In the process of isolating the BRCA genes to arrive at the claimed isolated DNA, various chemical bonds may be broken, which was cited and relied upon in one of the Federal Circuit opinions in finding patent-eligible subject matter. However, the Court rejected that rationale. The Court said Myriad’s patent claims to “isolated” DNA were not patent eligible even if isolating the DNA from the human genome severed chemical bonds and even if that created a non-naturally occurring molecule. This rationale should probably be read in context with the Court’s earlier comments that the isolated DNA left intact the naturally occurring location and order of nucleotides and the Court’s evident concern that Myriad’s claims would provide exclusionary rights “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.”
The Court’s subsequent sentence 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 section of DNA” could be read together with the Court’s statement that Myriad’s claim is “concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.” Even so, did the Court mean to refer to chemical composition in the sense of a man-made composition formulated from “isolated” DNA plus another constituent? Did the Court mean to refer to claims crafted like certain synthetic “polymer” claims? Or, did the Court mean to imply claims might have been drafted in more conventional format for compounds? Nonetheless, the point about chemical changes resulting from isolation does instruct those drafting patent specifications to include more than simply isolating the DNA to characterize the product for which protection is being sought.
Myriad’s argument that denying patent eligibility for isolated DNA would upset reliance on the practice sanctioned and encouraged by the U.S. Patent and Trademark Office (USPTO) that DNA can be claimed in the “isolated” DNA format fell flat. The Court refused deference to the USPTO’s approach, observing that Congress had not legislatively endorsed this approach. The Court further observed that the amicus brief filed by the United States argued against the USPTO practice.
On the other hand, complementary DNA (cDNA) that differs from natural DNA strands is patent-eligible subject matter under § 101. The Court explained that while cDNA “retains the naturally occurring exons of DNA,” it “is distinct from the DNA from which it was derived” because “‘the non-coding regions [introns] of the DNA have been removed.’”
The Court was keenly aware that its decision could have far-reaching consequences and sought to limit its impact. The Court stressed, “It is important to note what is not implicated by this decision” (emphasis in original), further explaining, “Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent.” But methods for manipulating genes “are not at issue in this case.” Nor are methods involving application of the genes. The Court specifically quoted Judge Bryson’s decision that “many of [Myriad’s] unchallenged claims are limited to such applications.” (Myriad claims to have at least eight patents with claims to detecting mutation in BRCA alleles.) Furthermore, the Court expressed no opinion about the application of § 101 to scientifically altered genetic code, as that “presents a different inquiry.”
In the aftermath of this decision, will there be increased competition? Already in the days after the Court’s ruling, a diagnostic company and a university each announced their intention to introduce cancer detection tests for hereditary breast cancer.
In the intellectual property arena, some patent holders are no doubt assessing the decision’s impact on their patent portfolios, whether any patents with claims to isolated DNA can be reissued, and how to go about protecting their technology going forward. How and what to claim in the patent, and what to include in the patent specification to ensure sufficiency of written description, will be among the important ongoing considerations for DNA-related inventions. Some observers are even speculating the Court’s decision may provide incentives to rely more on trade secret protection with the consequent loss of information to the public. Meanwhile, the USPTO promptly issued a memorandum providing initial instruction to the Patent Examining Corps. Practitioners anticipate that the USPTO will issue further, more-detailed guidance.
If you have questions regarding this decision, please contact Fitch Even partner Kendrew H. Colton, the author of this alert.
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