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Supreme Court Finds Naturally Occurring DNA to Be Patent Ineligible

Last summer, the Supreme Court issued its decision in Association for Molecular Pathology v. Myriad Genetics, Inc., which concerned the patent eligibility of the BRCA1 and BRCA2 genes. In Myriad, a unanimous Supreme Court held that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated. The Court also determined, albeit with one caveat, that complementary DNA (cDNA) is patent eligible because it is not naturally occurring.

The Court noted that it is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.” While acknowledging that Myriad “found an important and useful gene,” the Court indicated that “separating that gene from its surrounding genetic material is not an act of invention.” With respect to cDNA, the Court explained that “cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived,” and therefore, “cDNA is not a ‘product of nature’ and is patent eligible.” The Court did provide one caveat for cDNA, noting that “insofar as very short series of DNA may have no intervening introns to remove when creating cDNA,” under such circumstance, “a short strand of cDNA may be indistinguishable from natural DNA.”

Importantly, the opinion concludes by stating that it is important to note what is not implicated by this decision.” In addition to noting that the case did not involve an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes or new applications of knowledge about the BRCA1 and BRCA2 genes, the Court indicated that the case did not concern the patentability of DNA in which the order of the naturally occurring nucleotides had been altered. Instead, the Court indicated that it was “merely hold[ing] that genes and the information they encode are not patent eligible . . . simply because they have been isolated from the surrounding genetic material.”

In March, after months of internal agency discussions, the U.S. Patent and Trademark Office implemented a new examination procedure for assessing patent eligibility in view of the Supreme Court’s Myriad decision (as well as the Court’s 2012 decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which concerned the patent eligibility of a diagnostic method). In outlining the new procedure, the USPTO indicated that “while the [Supreme Court’s] holding in Myriad was limited to nucleic acids, Myriad is a reminder that claims reciting or involving [any] natural product should be examined [under the new procedure].” Thus, the new examination procedure will be used to assess the patent eligibility of “chemicals derived from natural sources (e.g., antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods (e.g., fruits, grains, meats and vegetables); metals and metallic compounds that exist in nature; minerals; natural materials (e.g., rocks, sands, soils); nucleic acids; organisms (e.g., bacteria, plants and multicellular animals); proteins and peptides; and other substances found in or derived from nature.”

Although the USPTO acknowledged in April that the Office had not taken its task lightly when formulating the new examination procedure, and understood the impact the procedure would have on applicants and practitioners, the USPTO did not seek public comment regarding the procedure prior to its implementation. In response to the reaction to the procedure in the patent community – and particularly the reaction by applicants in the biotechnology sector – the USPTO has now begun to solicit feedback regarding possible revisions or updates to the procedure.

 

Donald Zuhn Partner at McDonnell Boehnen Hulbert & Berghoff LLP, Chicago, IL

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