Federal Circuit Finds Two Life Sciences Patents Not Patent Eligible

September 19, 2019

The U.S. Court of Appeals for the Federal Circuit recently struck down two patents for lack of subject matter eligibility under 35 U.S.C. § 101, including one for a method of treating humans. Under U.S. Supreme Court precedent, natural laws are patent-ineligible subject matter. Patent claims that are “directed to” patent-ineligible concepts, like natural laws, are patentable only if the other claim limitations (either individually or as an ordered combination) “transform” the claim into a patent-eligible concept. In these two recent cases, the Federal Circuit found that the claims were directed to natural laws and that additional claim language did not transform them into patentable subject matter.

Late last month, in INO Therapeutics LLC v. Praxair Distribution Inc., the Federal Circuit held that a method-of-treatment claim excluding at-risk patients from treatment was directed to a patent-ineligible natural phenomenon. The court rested its patent-ineligibility ruling on its finding that the particular “instruction not to act” found in the claim amounted to no more than “leaving the natural processes taking place in the body alone” for the at-risk population, which the court said “risks monopolizing the natural processes themselves.” The court was not convinced, based on the record, that the additional claim limitations “transformed” the claims by an “inventive concept.” The court relied upon the specification, which described the other claim limitations (i.e., the steps of identifying treatment candidates, determining whether patients were in the at-risk population and administering a particular dose of inhaled nitric oxide to patients who were not at risk), as conventional and well-known in the art.

The INO Therapeutics decision was accompanied by Judge Pauline Newman’s dissent with respect to the patent-ineligibility ruling. This follows the recent dissent by Judge Newman and others in the Federal Circuit’s rehearing en banc denial in Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC (a case in which a diagnostic method was found patent-ineligible under Section 101). In a number of concurring and dissenting opinions, several judges called on the Supreme Court and Congress to address the patent eligibility of diagnostic-method patents. It will be interesting to follow any appeals of that case to the Supreme Court.

Earlier in August, in Genetic Veterinary Sciences, Inc. v. Laboklin GMBH & Co. KG, the Federal Circuit found that an in vitro genotyping method directed to the detection of a genetic point mutation in Labrador retrievers was patent-ineligible. The court found that the claims were directed to a natural phenomenon, and therefore were patent-ineligible, because the particular point mutation itself occurred naturally in dogs. The court found that the other steps of the genotyping method did not “transform” the claims because they were conventional and known in the art.