In a much-anticipated decision, the Supreme Court today issued its opinion in Association for Molecular Pathology v. Myriad Genetics, Inc. Justice Thomas authored the opinion and was joined by Chief Justice Roberts and Justices Kennedy, Ginsberg, Breyer, Alito, Sotomayor and Kagan. Justice Scalia filed a brief opinion concurring in part and concurring in the judgment. The Court held that a DNA segment in a naturally occurring setting (e.g., genomic DNA) does not become patent eligible under 35 U.S.C. § 101 merely by virtue of being “isolated.” On the other hand, DNA copied from a naturally occurring mature messenger RNA from which the introns have been removed (cDNA) is patent eligible. The case has far-reaching implications and leaves unanswered a number of important issues for the biotechnology industry.
The Federal Circuit had reversed a holding by Southern District of New York Judge Sweet that Myriad’s claims to isolated DNA were not patent eligible because they covered products of nature. On remand from the Supreme Court to reconsider in light of the Mayo v. Prometheus Supreme Court decision, the Federal Circuit again found that Myriad’s claims to isolated DNA sequences were patent eligible. Judge Lourie, writing for the majority, held that the act of isolation created a new product sufficiently different, both structurally and functionally, from that which existed in the genome and that the isolated DNA was no longer a natural product. As a consequence, the Federal Circuit majority deemed isolated DNA patent eligible. Judge Moore concurred in part but did not rely solely on Judge Lourie’s “structural difference” standard. She also relied on the USPTO’s long-standing practice of granting such claims and on the consequent reliance interests of patent holders. Judge Bryson disagreed with Judge Lourie’s structural difference rationale, concluding that any chemical structural changes at the ends of the isolated DNA were merely ancillary to the breaking of the covalent bonds that occurred during isolation. All three Federal Circuit panel judges agreed that claims relating to cDNA met the patent eligibility requirements of §101 because such DNA’s, lacking introns, could not be isolated from nature and had to be created in the lab. Myriad’s other claims to diagnostic and screening methods were not before the Supreme Court and are not discussed here.
The Supreme Court Decision
As an initial matter, the justices rejected (in a footnote) Myriad’s arguments regarding lack of standing. Later in the opinion, the Court also rejected any deference to the USPTO on the issue before the Court, noting, among other things, that the United States had argued before the Federal Circuit and the Supreme Court that isolated DNA (but not cDNA) was patent ineligible under §101. With respect to reliance interests of patent holders, the Court provided a footnote suggesting those interests were “better directed to Congress.”
Going to the merits, the Court began by characterizing Myriad’s principal contribution as “uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within chromosomes 17 and 13.” The Court acknowledged the extensive effort required to accomplish this but held that effort “insufficient to satisfy the demands of §101.” In addition, the fact that isolation severs chemical bonds did not save the claims. In a comment that may have implications for claim drafting, Justice Thomas stated 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. Instead, the claims understandably focus on the genetic information in the BRCA1 and BRCA2 genes.” The Court then went on to distinguish cDNA, stating that it “does not present the same obstacles to patentability as naturally occurring, isolated DNA segments.” The Court reasoned that “creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring” and as such was patent eligible. In a corollary to this holding, however, Justice Thomas raised a cautionary note about “very short series of DNA [that] may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.”
Finally, the Supreme Court opinion set out several items specifically not addressed by the opinion. First, the decision does not relate to method claims, and innovative methods to manipulate genes may be patentable. Similarly, as the first party with knowledge of the BRCA1 and BRCA2 sequences, “Myriad was in an excellent position to claim applications of that knowledge.” In addition, the opinion did not address “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.” Summarizing, Justice Thomas stated, “We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.”
The Supreme Court’s decision of course has important implications for any entity holding patents with claims directed to isolated genomic DNA. Depending on business models, patent holders may want to consider requesting reissue of issued patents claiming “isolated DNA,” particularly if those claims encompass genomic DNA and there are no backup claims limited to cDNA. Beyond this, the Supreme Court opinion raises questions about patenting of cDNA from any sources in which the polypeptide-coding sequences are not interrupted by introns (e.g., many bacterial and plant species). The opinion also raises questions about the patenting of primers and probes if the sequences of such molecules can be found embedded in the corresponding natural sequences. Claim drafters should be thinking carefully about including as much chemical structure in the claims as possible. It is clear that any claimed DNA with altered sequence or with other chemical structures not found in nature, such as detectable markers, likely will pass the patent eligibility hurdle. The extent to which this Supreme Court decision implicates other “naturally occurring” chemicals, such as antibodies, hormones, therapeutic RNA, and other biological molecules, remains to be determined. But again, to the degree such molecules can be claimed with modifications not found in nature, the claims likely will be found patent eligible.
For more information, view the full decision