Ass’n for Molecular Pathology v. Myriad Genetics
By Alex Shank – Edited by Kathleen McGuinness
Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (569 U.S. ___ June 13, 2013)
Slip opinion
[caption id="attachment_3408" align="alignleft" width="150"] Photo By: Stew Dean - CC BY 2.0[/caption]
In a unanimous decision, the Supreme Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398, slip op. at 1 (U.S. June 13, 2013). However, “cDNA is patent eligible because it is not naturally occurring.” Id. The Court thus affirmed in part and reversed in part the Court of Appeals for the Federal Circuit’s prior opinion upholding the patent eligibility of isolated DNA.
Bloomberg provides perspectives from groups with a special interest in the case—including the ACLU, university researchers, diagnostic testing companies, the Biotechnology Industry Organization, and Angelia Jolie—and speculates on the impact of the opinion on personalized medicine. Professor Paul Cole, writing for Patently-O, discusses the mismatch between the Supreme Court’s holding and the international consensus on the patentability of isolated DNA. JDSupra highlights the narrowness of the holding and the Supreme Court’s failure to clarify the bounds of patentable subject matter under 35 U.S.C. § 101.
Myriad Genetics, Inc. (“Myriad”) discovered the “precise location and sequence of two human genes,” BRCA1 and BRCA2, “mutations of which can substantially increase the risks of breast and ovarian cancer.” Id. Genes occupy distinct segments of DNA molecules. The nucleotides—basic molecular building blocks of DNA—at either end of a gene demarcate its “precise location” in a strand of DNA. Myriad obtained several patents based on its discovery of the BRCA genes’ locations, giving it the exclusive rights to isolate any individual’s BRCA genes and to make diagnostic testing kits based on those genes.
In three of its patents, Myriad claimed “isolated DNA” corresponding the BRCA1 gene (“Claim 1”). Id. at 5. Myriad also claimed complementary DNA (“cDNA”) corresponding to the same gene (“Claim 2”). Id. Unlike naturally occurring DNA, which contains both coding regions (“exons”) and non-coding regions (“introns”), cDNA lacks introns. cDNA is synthetically created in a lab and does not exist naturally. Additionally, Myriad claimed all DNA and cDNA sequences having at least 15 of the nucleotides of the DNA and cDNA sequences listed in Claim 1 and Claim 2. Id. at 6.
Medical patients, advocacy groups, and doctors originally filed a declaratory judgment action against Myriad in the United States District Court for the Southern District of New York (“S.D.N.Y.”) in 2009, asserting the invalidity of its claims to the BRCA genes. The case made its way to the Federal Circuit, the Supreme Court, and back to the Federal Circuit before oral arguments were heard before the Supreme Court again earlier this year. At each stage, the courts wrestled with whether “naturally occurring” DNA is patent eligible under 35 U.S.C. § 101.
After explaining the fundamental molecular genetics of protein expression, the Supreme Court found that “separating [a] gene from its surrounding genetic material is not an act of invention” deserving of patent protection. Id. at 12. Although 35 U.S.C. § 101 provides that “any new and useful . . . composition of matter, or any new and useful improvement thereof, may obtain a patent,” id. at 10, the Supreme Court has “long held that [Section 101] contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable,” id. at 11 (quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S.Ct. 1289, 1293 (2012)).
The Court distinguished Myriad from Diamond v. Chakrabarty. Unlike a bacterium injected with foreign genetic material, isolated DNA does not “markedly differ” from DNA in a cell. Id. at 12. Instead, the Court found that Myriad’s claims to isolated DNA “fell squarely within the law of nature exception,” analogizing to the claims invalidated in Funk Brothers Seed Co. v. Kalo Inoculant Co., which pertained to mixtures of nitrogen-fixing bacteria. The Court also refused to “save” Myriad’s claims under the justification that isolating DNA severs chemical bonds, especially given that Myriad’s claims did not “rely in any way on the chemical changes that result from the isolation of a particular section of DNA.” Id. at 14. The Court emphasized that while “Myriad found an important and useful gene,” “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Id. at 12. The Court accorded no deference to the “PTO’s past practice of awarding gene patents.” Id. at 15.
In contrast, the Supreme Court found that “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments.” Id. at 16. Although the Court admitted that the “nucleotide sequence of cDNA is dictated by nature, not by the lab technician,” it maintained that “the lab technician unquestionably creates something new when cDNA is made.” Id. at 17. Except for cases in which “a very short strand of cDNA may be indistinguishable from natural DNA,” the Court held that “cDNA is not a ‘product of nature’ and is patent eligible under § 101.” Id. Importantly, the Court noted that its decision did not implicate method claims, “new applications of knowledge about the BRCA1 and BRCA2 genes,” “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered,” or “whether cDNA satisfies the other statutory requirements of patentability.” Id. at 17–18.
Justice Scalia briefly concurred in part and concurred in the judgment. He attributed his partial concurrence to his inability “to affirm those [fine details of molecular biology] on [his] own knowledge or even [his] own belief.” Id. at 19.
In light of the Court’s opinion, the market for BRCA-based diagnostic tests will likely expand as biotechnology companies introduce alternatives to Myriad’s kits. However, the opinion upholds some existing barriers to conducting basic genetic research, which routinely involves experimentation with cDNA. To adapt to the ruling, patent practitioners seeking to claim a naturally occurring substance will avoid language that “simply detail[s] the iterative process of discover[ing]” that substance. Id. at 14.
Photo By: Stew Dean - CC BY 2.0[/caption]
In a unanimous decision, the Supreme Court held that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398, slip op. at 1 (U.S. June 13, 2013). However, “cDNA is patent eligible because it is not naturally occurring.” Id. The Court thus affirmed in part and reversed in part the Court of Appeals for the Federal Circuit’s prior opinion upholding the patent eligibility of isolated DNA.
Bloomberg provides perspectives from groups with a special interest in the case—including the ACLU, university researchers, diagnostic testing companies, the Biotechnology Industry Organization, and Angelia Jolie—and speculates on the impact of the opinion on personalized medicine. Professor Paul Cole, writing for Patently-O, discusses the mismatch between the Supreme Court’s holding and the international consensus on the patentability of isolated DNA. JDSupra highlights the narrowness of the holding and the Supreme Court’s failure to clarify the bounds of patentable subject matter under 35 U.S.C. § 101.
Myriad Genetics, Inc. (“Myriad”) discovered the “precise location and sequence of two human genes,” BRCA1 and BRCA2, “mutations of which can substantially increase the risks of breast and ovarian cancer.” Id. Genes occupy distinct segments of DNA molecules. The nucleotides—basic molecular building blocks of DNA—at either end of a gene demarcate its “precise location” in a strand of DNA. Myriad obtained several patents based on its discovery of the BRCA genes’ locations, giving it the exclusive rights to isolate any individual’s BRCA genes and to make diagnostic testing kits based on those genes.
In three of its patents, Myriad claimed “isolated DNA” corresponding the BRCA1 gene (“Claim 1”). Id. at 5. Myriad also claimed complementary DNA (“cDNA”) corresponding to the same gene (“Claim 2”). Id. Unlike naturally occurring DNA, which contains both coding regions (“exons”) and non-coding regions (“introns”), cDNA lacks introns. cDNA is synthetically created in a lab and does not exist naturally. Additionally, Myriad claimed all DNA and cDNA sequences having at least 15 of the nucleotides of the DNA and cDNA sequences listed in Claim 1 and Claim 2. Id. at 6.
Medical patients, advocacy groups, and doctors originally filed a declaratory judgment action against Myriad in the United States District Court for the Southern District of New York (“S.D.N.Y.”) in 2009, asserting the invalidity of its claims to the BRCA genes. The case made its way to the Federal Circuit, the Supreme Court, and back to the Federal Circuit before oral arguments were heard before the Supreme Court again earlier this year. At each stage, the courts wrestled with whether “naturally occurring” DNA is patent eligible under 35 U.S.C. § 101.
After explaining the fundamental molecular genetics of protein expression, the Supreme Court found that “separating [a] gene from its surrounding genetic material is not an act of invention” deserving of patent protection. Id. at 12. Although 35 U.S.C. § 101 provides that “any new and useful . . . composition of matter, or any new and useful improvement thereof, may obtain a patent,” id. at 10, the Supreme Court has “long held that [Section 101] contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable,” id. at 11 (quoting Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S.Ct. 1289, 1293 (2012)).
The Court distinguished Myriad from Diamond v. Chakrabarty. Unlike a bacterium injected with foreign genetic material, isolated DNA does not “markedly differ” from DNA in a cell. Id. at 12. Instead, the Court found that Myriad’s claims to isolated DNA “fell squarely within the law of nature exception,” analogizing to the claims invalidated in Funk Brothers Seed Co. v. Kalo Inoculant Co., which pertained to mixtures of nitrogen-fixing bacteria. The Court also refused to “save” Myriad’s claims under the justification that isolating DNA severs chemical bonds, especially given that Myriad’s claims did not “rely in any way on the chemical changes that result from the isolation of a particular section of DNA.” Id. at 14. The Court emphasized that while “Myriad found an important and useful gene,” “[g]roundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Id. at 12. The Court accorded no deference to the “PTO’s past practice of awarding gene patents.” Id. at 15.
In contrast, the Supreme Court found that “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments.” Id. at 16. Although the Court admitted that the “nucleotide sequence of cDNA is dictated by nature, not by the lab technician,” it maintained that “the lab technician unquestionably creates something new when cDNA is made.” Id. at 17. Except for cases in which “a very short strand of cDNA may be indistinguishable from natural DNA,” the Court held that “cDNA is not a ‘product of nature’ and is patent eligible under § 101.” Id. Importantly, the Court noted that its decision did not implicate method claims, “new applications of knowledge about the BRCA1 and BRCA2 genes,” “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered,” or “whether cDNA satisfies the other statutory requirements of patentability.” Id. at 17–18.
Justice Scalia briefly concurred in part and concurred in the judgment. He attributed his partial concurrence to his inability “to affirm those [fine details of molecular biology] on [his] own knowledge or even [his] own belief.” Id. at 19.
In light of the Court’s opinion, the market for BRCA-based diagnostic tests will likely expand as biotechnology companies introduce alternatives to Myriad’s kits. However, the opinion upholds some existing barriers to conducting basic genetic research, which routinely involves experimentation with cDNA. To adapt to the ruling, patent practitioners seeking to claim a naturally occurring substance will avoid language that “simply detail[s] the iterative process of discover[ing]” that substance. Id. at 14.