In Natural Alternatives International, Inc. v. Creative Compounds, LLC, [2018-1295](March 15, 2019), the Federal Circuit reversed and remanded judgment on the pleadings that the asserted claims of U.S. Patent Nos. 5,965,596, 7,825,084, 7,504,376, 8,993,610, 8,470,865, and RE45,947
relating to dietary supplements containing beta-alanine, are not patent eligible.
The district purported accepted Natural Alternatives’ proposed claim constructions, in finding that the subject matter ineligible. However, the Federal Circuit found that the proposed claim constructions, we hold that the complaint’s factual allegations, together with all reasonable inferences, plausibly establish the eligibility of the representative claims. While the Method Claims have similarities to the claims found ineligible in Mayo, as they utilize an underlying natural law, this is not sufficient to establish that they are directed to that law. Under Natural Alternatives’ constructions, the Method Claims require specific steps be taken in order to bring about a change in a subject, altering the subject’s natural state.
The Federal Circuit said that like the claims in Vanda, the Method Claims contain specific elements that clearly establish they are doing more than simply reciting a natural law. Like the Vanda claims, which specify a patient population to be treated, the Method Claims specify particular results to be obtained by practicing the method. The Federal Circuit also noted that while beta-alanine may exist in nature, Natural Alternatives has argued that the quantities being administered do not, and that the claimed consumption greatly exceeds natural levels.
The Federal Circuit concluded that the Method Claims at issue are treatment claims. They cover using a natural product in unnatural quantities to alter a patient’s natural state, to treat a patient with specific dosages outlined in the patents. The Federal Circuit held that the Method Claims are not directed to ineligible subject matter.
The Federal Circuit further noted that at step two, factual impediments exist to resolving the case at this stage.
As to the product claims, the Federal Circuit noted that although beta-alanine is a natural product, the Product Claims are not directed to beta-alanine. The Federal Circuit said that a claim to a manufacture or composition of matter made from a natural product is not directed to the natural product where it has different characteristics and “the potential for significant utility.” At this stage in the litigation, the Federal Circuit found that it has been sufficiently alleged that these characteristics provide significant utility, as the claimed dosage forms can be used to increase athletic performance in a way that naturally occurring beta-alanine cannot. Accordingly, neither claim is directed to ineligible subject matter.