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.