Yesterday, the Supreme Court issued its highly anticipated opinion in Association for Molecular Pathology v. Myriad Genetics, Inc., unanimously holding that claims that cover isolated genomic DNA were not patent eligible under 35 U.S.C. § 101, but that the challenged claims to complimentary DNA ("cDNA") were patent eligible under § 101. This result is consistent with the expectations of most observers following oral argument, and is the outcome the Solicitor General advocated.
It was unquestioned that Myriad, the patent owner, had engaged in "extensive research" to identify two genes—BRCA1 and BRCA2—implicated in cancer diagnosis. Slip op. at 4-5, 14. At issue before the Court were two types of patent claims defining compositions of matter. Id. at 5-6. The first type of claim covered a naturally occurring BRCA gene sequence (or fragment thereof) which still retained the introns (i.e., segments of a gene that do not code for protein). Id. at 2-3, 5-6. The second type of claim was limited to cDNA—a derivative nucleic acid sequence containing only the "coding" portions of the BRCA gene sequence (i.e., a sequence where the introns had been removed). Id. at 2-3, 5.
Justice Clarence Thomas, writing for a unanimous Court, explained at some length why the genomic DNA patent claims were ineligible to be patented under § 101. Slip op. at 10-16. The Court used as its primary guideposts its prior decisions in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012), Diamond v. Chakrabarty, 447 U. S. 303 (1980), and Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948). In Mayo, the Court decided that giving a drug to a patient and adjusting the dosage based on metabolite levels was not patent-eligible under § 101. In Chakrabarty, the Court had held that a bacterium to which scientists had added four short loops of DNA to the bacterial DNA was patentable because it was a "nonnaturally occurring . . . composition of matter." Slip op. at 12 (quoting Chakrabarty). In contrast, in Funk Bros., the Court had held that a mixture of four types of naturally occurring nitrogen-fixing bacteria was not patentable because "the patent holder did not alter the bacteria in any way." Id. at 13. The Court found Myriad's claims to isolated genomic DNA to be much closer in form to the claims in Funk Bros. Id. Specifically, it noted that "Myriad did not create anything," id. at 12, observing in dicta likely to cause some future mischief that "separating that [BRCA1] gene from its surrounding genetic material is not an act of invention." Id.
In arriving at this conclusion, the Court discounted Myriad's contention that breaking chemical bonds to isolate a gene from a chromosome achieved the required alteration to make the gene fragment patent eligible. Id. at 14. The Court noted that the claims were not phrased in terms of a chemical composition, and assumed that in enforcing the patent claims Myriad would focus on the genetic sequence rather than the chemical composition of any accused DNA molecule. Id. at 14-15. The Court also rejected Myriad's concerns regarding the amount of work that went into the discovery, saying "extensive effort alone is insufficient to satisfy the demands of § 101." Slip op. at 14. Finally, the Court discounted the settled expectations of patent holders who had obtained similar patents for decades, and the Patent Office's long-standing practice of granting patents directed to isolated genomic DNA. Id. at 15-16 & n.7.
The Court provided less guidance on why the asserted claims involving cDNA did satsify § 101. The Court simply stated that cDNA was "not naturally occurring" and that "the lab technician unquestionably creates something new when cDNA is made." Slip op. at 16-17. Given that isolated genomic DNA is also, strictly speaking, a non-naturally occurring substance the Court has left uncertain exactly where the line may be drawn in the future between patent-ineligible products of nature and patent-eligible inventions. Moreover, Justice Thomas noted that some cDNA may not be patent eligible, e.g., when the corresponding genomic DNA has no introns. Id. at 17.
The Court took special pains to point out what its holding did not address. First, the Court hinted strongly that claims to "an innovative method of searching for" genes would be patent eligible. Id. at 17. Similarly, the Court suggested that "patents on new applications of knowledge about" genes would likely satisfy § 101. Id. at 17. Lastly, the Court stated that it was not addressing "the patentability of DNA in which the order of the naturally occurring nucleotides has been altered." Id. at 18.
Going forward, the following is apparent from the Court's decision:
Claims to novel proteins (including antibodies) should remain patent-eligible. A key distinction between patent eligible and ineligible nucleic acids was the Court's finding an alteration of the chemical structure of the nucleic acid beyond changes incidental to isolation of the DNA sequence. Proteins that do not occur in nature are far removed from the naturally occurring nucleotide sequences found ineligible in Myriad. It seems implausible that a court, applying Myriad, would find unpatentable a claim to non-naturally occurring protein—either because it has an amino acid sequence that does not occur in nature or because it has other properties, such as post-translational modifications, not found in a naturally occurring variant of that protein. Thus, for example, a new antibody generated by a scientist in a lab would be patent eligible under the Myriad standard.
Production of genetically engineered proteins is beyond the scope of Myriad. Again, Myriad should not be seen as affecting the validity of patent claims in this area. Such claims would fall within the Court's example of permissible patents on applications of knowledge about genes.
Claims to applications using genes are not affected by Myriad. The Court was careful to state that the Myriad claims did not concern the use of genes, such as for diagnostic methods. It distinguished these "applications" of knowledge from the claims it held to be patent ineligible.
Transformed host cells remain patent-eligible. The Court expressly endorsed as patent eligible the transformed bacteria in Chakrabarty. This suggests that host cells transformed with a synthesized nucleic acid construct should continue to be patent eligible after Myriad.
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