In Association for Molecular Pathology v. Myriad Genetics, Inc., the Supreme Court effectively reversed decades of U.S. Patent and Trademark Office (USPTO) practice by holding that claims to naturally occurring BRCA gene sequences are products of nature and therefore are not eligible for patent protection under 35 U.S.C. §101. On the other hand, the Supreme Court also held that manmade cDNA that differs from its native counterpart is patent eligible. The decision is a mixed result for the biotechnology industry, potentially putting at risk patents covering isolated genetic sequences that do not differ from native sequences, but giving some assurance to those companies whose patent portfolio includes claims to modified genetic sequences.
Patent Eligibility of Naturally Occurring DNA Segments
Writing for the Court, Justice Thomas recognized that patent protection strikes a "delicate balance" between creating incentives that foster invention and hindering the flow of information necessary for innovation. Slip op. at 11. The Court applied this standard to determine whether Myriad’s patents claimed no more than naturally occurring phenomena.
Turning first to naturally occurring DNA, the Court explained that Myriad neither created nor altered the genetic information encoded in the BRCA1 and BRCA2 genes. Recognizing that human genomic DNA contains protein coding sequences interspersed with non-coding sequences ("introns"), the Court focused on the fact that the patent-ineligible isolated BRCA genes contain the same sequence of nucleotides—including both coding and intron sequences—as is found in nature. The Court therefore characterized Myriad's contribution as simply determining the precise location and genetic sequence of the BRCA1 and BRCA2 genes.
Looking to Diamond v. Chakrabarty, 447 U.S. 303 (1980), Court distinguished the patented bacterium in Chakrabarty from the claims to isolated BRCA1 and BRCA2 genes in Myriad's patents. Unlike Chakrabarty, "Myriad did not create anything" worthy of patent protection because separating a gene from its surrounding environment "is not an act of invention." Slip op. at 12.
The Court instead relied upon Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), to find that isolated DNA segments are ineligible subject matter under § 101. The Court reasoned that Myriad's claims to naturally occurring DNA imparted the same level of inventiveness as the mixed culture of known bacteria strains in Funk Brothers. And although Myriad's discovery of the location of the BRCA genes may be helpful, the Court found that the usefulness of this information did not render the genes eligible for patent protection. Looking to Myriad's patent specification, the Court noted that "[m]any of Myriad's patent descriptions simply detail the 'iterative process' of discovery by which Myriad narrowed the possible locations for the gene sequences that it sought." Slip op. at 14. This effort, while extensive, was not by itself sufficient render the claims patent-eligible.
While the Court recognized that isolating DNA requires severing chemicals bonds, it nevertheless concluded that those types of changes are insufficient to satisfy the patent eligibility requirements of § 101. The Court noted that Myriad's claims are 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. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes." Slip Op. at 14. The Court therefore rejected the idea that merely excising the BRCA DNA from the genome warranted patent protection. The Court suggested that claims drawn to a unique chemical compound, as opposed to claims focusing on the information contained in the genetic sequence, might be patent eligible but would undoubtedly be easy to design around.
Finally, the Court rejected Myriad's argument that it should defer to the USPTO's practice of awarding gene patents. The Court noted that, unlike the scenario in J.E.M. Agricultural Supply, Inc. v. Pioneer Hi-Bred International, Inc., 534 U.S. 124 (2001), where Congress specifically enacted legislation regarding patent protection for plants, Congress has not endorsed the USPTO's practice of awarding gene patents. In addition, the United States argued that isolated DNA is not patent eligible and that the "PTO's practice was not a sufficient reason to hold that isolated DNA is patent-eligible." Id. at 16.
In contrast to its decision regarding isolated genomic DNA, the Court found that cDNA is patent eligible under §101 because it contains only coding sequences, without introns, and thus are not naturally occurring molecules. In removing the introns, "the laboratory technician unquestionably creates something new when cDNA is made." Id. at 17. The Court recognized, however, that very short strands of cDNA whose native counterparts lacked intervening introns may be indistinguishable from natural DNA. In that situation, the cDNA product would fall under the product of nature exception to § 101.
What Is Not Implicated by the Court's Decision
Finally, the Court expressly limited its decision, ostensibly leaving room for other claiming strategies for DNA-based inventions. The Court noted that its decision does not reach the patent eligibility of method claims, stating that "[h]ad Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent." Slip op. at 17. The Court also made clear that this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes, including the unchallenged claims in Myriad's patents. Nor did the Court express any opinion about the application of § 101 to alterations of the genetic code.
Justice Scalia's Concurrence
Justice Scalia concurred with the Court's opinion except for the portions discussing the details of molecular biology, which Justice Scalia was not able to affirm on his "own knowledge or . . . belief." Concurring op. at 1. In sum, Justice Scalia affirmed that "the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA . . . is a synthetic creation not normally present in nature" by relying on the opinions and expert briefs in the record that he studied. Id.
Impact of the Decision
The decision could have an immediate effect on existing patent portfolios of some biotech companies, particularly those in the fields of diagnostics and personalized medicine. It may cause biotech companies to reevaluate their existing patent portfolios, and may presage a shift towards more reliance on trade secret protection for DNA-based inventions. It is, however, a positive development for companies that rely on cDNA for the development and manufacture of novel therapeutic proteins. The decision's long term effect on biotech and medical research remains to be seen.
Please click here to read Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (Supreme Court June 13, 2013) decision.