On May 4, 2016, the United States Patent and Trademark Office (USPTO) issued new guidance on how examiners should formulate rejections under 35 U.S.C. § 101, subject matter eligibility. The USPTO included several examples of patentable subject matter relating to life sciences. Specifically, the USPTO provided 20 exemplary claims as being directed to eligible subject matter under §101, including:

  • 6 claims directed to different vaccines, for example, live attenuated, inactivated, etc. (Natural Product)
  • 6 claims directed to the diagnosis and/or treatment of a disease (Law of Nature)
  • 4 claims directed to dietary sweetener compositions (Natural Product)
  • 4 claims directed to methods for screening for gene alterations (Abstract Idea)

Taken together, the USPTO guidelines establish that for a nature-based product to be patentable under § 101, when compared to the naturally occurring counterpart, the claimed product must be different in structure, form, function, activity or chemical/physical property. See, Examples 28 and 30 in the Subject Matter Eligibility Examples provided by the USPTO. In other words, vaccines comprising a live attenuated virus or inactivated virus are patentable under § 101 when the claimed virus "has markedly different characteristics than the counterpart." In the examples provided, this requirement is met when the claimed virus has a different structural characteristic. Notably, while a structural difference is enough to render the claim patentable under § 101, the structural difference can also result in a functional change, which would further support patentability.

Claims directed to a law of nature are patentable under § 101 when they include a limitation that is not well-understood, routine, or conventional. Example 29 in the USPTO guidelines concerns diagnosis and method of treatment claims. Mayo Collaborative Svcs. v. Prometheus Labs., 132 S. Ct. 1289, 1297 (2012) is cited in the guidelines as illustrating that "recited steps of administering a drug to a patient and determining the resultant level of 6-thioguanine in the patient 'are not themselves natural laws.'" Consequently, a method claim having two steps, (1) obtaining a sample, and (2) detecting the presence of a biomarker using its antibody, is not directed to an exception, and consequently is eligible for patentability under § 101. In contrast, when a third step of diagnosing a disease based on the presence of the biomarker is included, the claim now "describes a correlation or relationship between the presence of [the biomarker]… and the presence of [the disease]," and is directed to a judicial exception, specifically a law of nature and/or abstract idea. Taking this into consideration, it appears that one way of protecting a biomarker might be to focus the claims on detection, not diagnosis.

In this same example, the USPTO also cites Mayo v. Prometheus as evidence that a treatment claim having an administration step does not recite any recognized judicial exception. Thus, an otherwise ineligible diagnostic method claim becomes eligible under § 101 by adding a specific administering step to the claim: "[t]he totality of these steps … integrate the exception into the diagnostic and treatment process, and amount to more than merely diagnosing a patient … and instructing a doctor to generically 'treat it.'" As such, method of treatment claims may survive eligibility scrutiny by the USPTO, and should be considered as another potential avenue for protecting inventive aspects of a diagnostic method.

In an ever changing area of patent law, the latest USPTO guidelines may serve as a practical road map for patent examiners and applicants. However, this is not a permanent fix to the issues surrounding patentability under 35 U.S.C. § 101 because the newly issued guidelines are not law, and therefore are not binding on the Courts who will ultimately decide the outcome of patents that issue under these guidelines. Practitioners nevertheless should take heed.