Federal Circuit Finds Method of Treatment Claims Patent-Eligible in Natural Alternatives

In Natural Alternatives Int’l, Inc. v. Creative Compounds, LLC, No. 2018-1295, 2019 U.S. App. LEXIS 7647 (Fed. Cir. Mar 15, 20190, the U.S. Court of Appeals for the Federal Circuit found claims to administering a dosage of beta-alanine to a human subject patent-eligible. The claims specifically required that the substance be administered in an amount effective to increase beta-alanylhistidine dipeptide synthesis in the patient’s tissue. The lower court had granted a motion for judgment on the pleadings, stating that the claims were directed to the natural law that ingesting certain levels of beta-alanine, a natural substance, will increase the carnosine concentration in human tissue and, thereby, increase the anaerobic working capacity in a human.

The CAFC stated that these claims were patent-eligible primarily because they were treatment claims. It emphasized that § 101 expressly provides for patenting new uses of known compositions of matter and materials, which is what it said the claims did. The Court distinguished the Supreme Court’s Mayo decision as being directed only to diagnosis, without any action taken as a result of the detection of a natural correlation. It also characterized certain elements of the claims, such as particular forms of beta-alanine to be administered and requiring that the dosage be “effective” to achieve a required result, as being “specific” in a way that ensured they were more than a simple recitation of the natural law. The Court highlighted that the quantities required for administration to achieve that “effective” threshold greatly exceeded the natural levels of beta-alanine in the normal human diet. Finally, the majority stated that the specification raised a factual question whether the required dosage was unconventional, which prevented ruling on subject-matter eligibility in a motion for judgment on the pleadings. Regarding the product and method of making claims, the Court held that they likewise were patent-eligible because they altered natural products in a manner that changed their characteristics for use in a manner that naturally occurring beta-alanine cannot function. Notably, this reasoning was based on an acceptance of the patentee’s claim constructions, which was required at the motion for judgment on the pleadings stage.

Judge Reyna dissented, arguing that requiring an unaltered, naturally occurring substance to be present or administered in a specified dosage did not transform that naturally occurring substance into patent-eligible subject matter. He also complained that the claim construction employed by the majority improperly imported effectiveness limitations from the specification into the claims based on the words “dietary supplement” in the preambles of the claims. He agreed with the majority, however, that this appeal was predestined for remand because the lower court made a dispositive ruling early in the case without claim construction.

This case highlights the difficulties with developments in subject-matter eligibility that biotech innovators face. When your innovation is identifying a substance that, when provided in a treatment-effective amount not found in nature, is used to affect the human body, you have a much better chance of being categorized as a patent-eligible method of treatment. Claims are more likely to be characterized as a law of nature, product of nature, or abstract idea when the substance occurs or is ingested naturally in the claimed amounts or when the innovation is primarily in the discovery of a new marker enabling early diagnosis and prevention using standard treatments.

The information you obtain at this site is not, nor is it intended to be, legal advice. You should consult an attorney for advice regarding your individual situation.