Natural Alternatives International, Inc. v. Creative Compounds, LLC.: Dietary Supplement Containing A Natural Product Incorporated into a Dosage Form is Patent Eligible

| Agnes Juang, Ph.D.

In Natural Alternatives International, Inc. v. Creative Compounds, LLC., Appeal No. 2018-1295, a divided panel of the Federal Circuit reversed and remanded a decision by the District Court for the Southern District of California that granted a judgment on the pleading holding the asserted claims invalid as not patent eligibile.

Natural Alternatives International, Inc., a California-headquartered manufacturer of nutritional supplements, asserted claims of several of its patents, directed to (1) methods of “regulating hydronium ion concentrations in a human tissue” and “increasing anaerobic working capacity in a human subject” by providing an amount of beta-alanine “effective to increase beta-alanyl histidine dipeptide synthesis” in the human tissue (“the Method Claims”), (2) human dietary supplements comprising beta-alanine (“the Product Claims”), and (3) uses of beta-alanine in manufacturing a human dietary supplement (“the Manufacturing Claims”). The District Court held that, even under Natural Alternatives’ own proposed constructions, such claims were directed to natural laws or products of nature and, thus, were not eligible for patent protection under 35 U.S.C. §101.

In an opinion authored by Judge Moore and joined by Judge Wallach, the Federal Circuit held that, the factual allegations in the Complaint, with all reasonable inferences drawn in favor of the patentee, were sufficient to plausibly establish eligibility.

The Federal Circuit concluded that the Method Claims were directed to “new ways of using an existing product” and were patent-eligible as methods of treatment. The Federal Circuit also noted that Natural Alternatives proposed to construe the claim phrase “effective to increase” to mean “elevat[ing] beta-alanine above natural levels to cause an increase in the synthesis of beta-alanyl-histidine dipeptide in the tissue.” Under this claim construction, the Method Claims would require administering a specific dosage form of beta-alanine in a specific manner to alter a human subject’s condition from the natural homeostatic processes to achieve a specific physiological benefit.

The Federal Circuit also concluded that the Product Claims were directed to “specific treatment formulations that incorporate” naturally-occurring amino acid ingredients “into a dosage form with particular characteristics” and that the Manufacturing Claims were “directed to the manufacture of a human dietary supplement with certain characteristics.” The Federal Circuit explained that, at the pleading stage, Natural Alternatives’ assertions that “the claimed dosage forms can be used to increase athletic performance in a way that naturally occurring beta-aniline cannot” sufficed to support the requisite “different characteristics.”

Moreover, all three types of claims recite the term “dietary supplement.” Natural Alternatives proposed to construe the claims phrase “dietary supplement” to mean “an addition to the human diet, which is not a natural or conventional food.” The Federal Circuit also concluded that, on this record and given the procedural posture of this appeal, the “dietary supplement” claim limitation could not be considered routine and conventional. Thus, the Federal Circuit concluded that the asserted claims pass muster under the Mayo/Alice framework.

Judge Reyna dissented, and questioned both the panel majority’s reliance on the patentee’s claim construction position in assessing patent eligibility under 35 U.S.C. § 101 and whether a district court should decide patent eligibility issues before resolving the relevant, underlying claim construction issues.