The U.S. Patent and Trademark Office (USPTO) recently released a guidance memorandum1 to its examiners on a new procedure for assessing whether a patent claim contains subject matter eligible for patenting. The guidance was established in view of the U.S. Supreme Court's decision in Association for Molecular Pathology v. Myriad Genetics, Inc.2,3 Importantly, the USPTO now requires that apparent products of nature, such as proteins, nucleic acids, organisms, or minerals, be "significantly different" than something that is naturally occurring to be eligible for patenting.
In the United States, subject matter eligible for patenting is described in 35 U.S.C. § 101 and includes "any new and useful process, machine, manufacture, or composition of matter."4 Courts have created judicial exceptions to these categories, including laws of nature, physical phenomena, and natural products.5 The scope of these exceptions is defined in part by the Supreme Court case Diamond v. Chakrabarty, which held that a bacterium comprising four plasmids added by scientists was patent eligible because it had "markedly different characteristics from any found in nature."6 In Myriad, the Supreme Court relied on Chakrabarty in holding that merely isolating naturally occurring DNA (i.e., breaking bonds) does not render such DNA patent eligible.7
While Myriad's holding was limited to isolated, naturally occurring DNA, the USPTO will now apply the "marked difference" standard used in Myriad and Chakrabarty to evaluate the patent eligibility of other potential natural products.8 According to the guidance, a "marked difference" must be a "significant difference," and an examiner that identifies a claim with an apparent natural product will ask whether the claim as a whole recites something significantly different than a naturally occurring object. This question applies to claims that recite not only nucleic acids, but also other subject matter that could be considered a natural product, such as proteins, organisms, and minerals. The claim will be analyzed using a factor-based analysis balancing test,9 and the guidance provides an exemplary list of six factors10 that weigh toward eligibility and six factors11 that weigh against eligibility. A weighing of the totality of the relevant factors will be used to assess eligibility. The guidance also provides hypothetical examples in which the "significantly different" standard is applied.
Going forward, the exemplary list of factors for the factor-based analysis and the exemplary hypotheticals in the guidance should be consulted as a guide for drafting patent-eligible claims reciting subject matter that could be considered a natural product. Further developments in the case law in this area also should be considered. Whether courts extend the Myriad holding to subject matter beyond isolated, naturally occurring DNA remains to be determined.