June 14, 2013

Myriad Gene Patentability Ruled on by Supreme Court

DNApurple.jpgYesterday, the U.S. Supreme Court held that "a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring." The Court's ruling decided the question: "Are human genes patentable?" We have been blogging on this issue for some time now, see for example here, our blog on the oral arguments at the Supreme Court with links to some previous blogs.

Myriad concerns the "discover[y of] the precise location and sequence of what are known as the BRCA1 and BRCA2 genes." Specifically, Myriad discovered that "[m]utations in these genes can dramatically increase an individual's risk of developing breast and ovarian cancer." Myriad subsequently obtained a patent including such claims as "[a]n isolated DNA coding for a BRCA1 polypeptide" that included a specific amino acid sequence. The isolated DNA existed in nature before Myriad found them, the Court noted, and Myriad's principle contribution involved determining the precise location and genetic sequence of these polypeptides. The Court said that finding the location of the genes does not make the genes themselves patentable, nor does the extensive effort involved in discovering them. Additionally, the Court found that isolating certain DNA from the human genome by severing chemical bonds would be not enough to render the matter patent eligible, because the "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." As a result, the Court held the claims invalid since "genes and the information they encode are not patent eligible under [35 U.S.C.] § 101 simply because they have been isolated from the surrounding genetic material."

Another issue was whether the cDNA sequence claimed in the patent (as opposed to the full DNA sequence) would be patent-eligible. Here, the Court said that "cDNA cannot be isolated from nature, but instead must be created in the laboratory." The Court noted that "cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments." So, even though "cDNA retains the naturally occurring exons of DNA, [] it is distinct from the DNA from which it was derived." For this reason, the Court concluded, "cDNA is not a 'product of nature' and is patent eligible under § 101, except insofar as . . . a short strand of cDNA may be indistinguishable from natural DNA."

The Court indicated "what is not implicated by this decision," specifically that "an innovative method of manipulating genes" and "new applications of knowledge about the BRCA1 and BRCA2 genes" could be patentable. In addition, the Court noted that it did not consider "the patentability of DNA in which the order of the naturally occurring nucleotides has been altered."

The biotechnology industry and venture capital community are concerned about the impact of the Supreme Court's Myriad decision on the biotechnology industry. For instance, Jim Greenwood, President of the Biotechnology Industry Organization said in an article by Paul Handley in The Denver Post: "'The Supreme Court's decision today represents a troubling departure from decades of judicial and Patent and Trademark Office precedent . . . .' Companies 'have long relied on patents on preparations of DNA molecules and other biological chemicals in order to bring innovative, socially beneficial products to the marketplace' . . . the United States is 'now the only developed country to take such a restrictive view of patent eligibility.'" Mr. Handley's article also quotes Kelly Stone, Vice President of the National Venture Capital Association, as stating: "'This is a real disappointment for the advancement of medical innovation. . . . Venture capitalists need[] certainty, and that certainty is what patents provide.'"

As for Myriad, they stated that they would continue with their main business, which is selling their tests for the rare BRCA1 and BRCA2 genes that can point to the likelihood of cancer. Myriad may encounter additional competition, however, following the Court's decision.