Natural Alternatives Int., Inc. v. Creative Compounds, LLC

Docket No. 2018-1295

March 15, 2019

Brief summary: DC finding that NA’s claims related to dietary supplements are not patent eligible under § 101 reversed and remanded.

Summary: Natural Alternatives (NA) appealed DC grant of Creative Compounds’ (CC) motion for judgment on the pleadings that NA’s claims relating to “dietary supplements containing beta-alanine” and “the use of beta-alanine in a dietary supplement to ‘increas[e] the anaerobic working capacity of muscle and other tissue’” are not patent eligible under § 101 (NA’s US 5,965,596; 7,825,084; 7,504,376; 8,993,610; 8,470,865; and RE45,947). The DC decided this case using NA’s “proposed claim constructions” of “the ‘effective’” and “dietary supplement” limitations (e.g., “effective to increase beta-alanylhistidine dipeptide synthesis in the human tissue”, “wherein the amino acid is provided through a dietary supplement”), which the FC panel decided “was proper given the state of litigation” (FN1 notes that Judge Reyna’s dissent incorrectly criticized the FC panel’s decision because “the ‘effective’ limitation ‘is not disclosed in the plain language of the claims and is only present by virtue of the proposed claim construction’” since “nearly all of the claims of four of the patents at issue contain express limitations requiring effectiveness”). Claim 1 of the ‘596 patent and claim 1 of the ‘865 patent were described as representative “Method Claims”. The DC “held both claims to be directed to natural laws” under Alice’s step one (Alice, US 2014) (e.g., “ingesting certain levels of beta-alanine, a natural substance, will…aid in regulating hydronium ion concentration in the tissue”). The FC panel disagreed, finding instead that “[a]dministering certain quantities of beta-alanine to a human subject alters that subject’s natural state…homeostasis is overcome, and the subject’s body will produce greater levels of creating…[resulting] in specific physiological benefits for athletes engaged in certain intensive exercise” and that “[t]he claims not only embody this discovery” but “require that an infringer actually administer the dosage form claims in the manner claimed” (“These are treatment claims and as such they are patent eligible.”) (citing Vanda, FC 2018 (“claims that are directed to particular methods of treatment are patent eligible”; based on results of a test, “a particular dose of iloperidone was selected and internally administered…a new way of using an existing drug”, unlike in Mayo (US 2012)). The FC panel also noted NA’s argument “that the quantities being administered do not” “exist in nature” (“greatly exceeds natural levels”), and FN2 of the FC panel’s opinion notes that under the USPTO’s guidance, “a claim to a practical application of a natural product to treat a particular disease is patent eligible”. Thus, the Method Claims were found to be patent eligible. The FC panel also found “factual impediments” related to Alice’s step two would preclude “resolving the case at this stage”.

Claim 6 of the ‘376 patent and claim 1 of the ‘084 patent were described as representative of the “Product Claims” (e.g., “A human dietary supplement…”, “A composition comprising….”), and the DC held these to be “directed to the natural phenomena of beta-alanine” with or without “glycine”. The FC panel explained that “[a] claim to a manufacture or composition of matter made from a natural product is not directed to a natural product where it has different characteristics and ‘the potential for significant utility’” (citing Diamond, US 1980) and, here, the claimed formulations “can be used in a manner that beta-alanine as it appears in nature cannot.” The FC panel also explained that SCOTUS’s “decision in Funk Brothers” (US, 1948) “does not stand for the proposition that any combination of ineligible subject matter is itself ineligible” and that, here, “sufficient factual allegations” show that “the combination of glycine and beta-alanine could have synergistic effects”. Thus, the Product Claims were found to be patent eligible. The FC panel also wrote that “even if the Product Claims were directed to ineligible subject matter, judgment on the pleadings would be inappropriate under” Alice’s step two since “the specification does not contain language supporting the idea that this limitation was well-understood, routine, and conventional.”

Claim 1 of the ‘610 patent was described as representative of the “Manufacturing Claims” (“Use of beta-alanine in manufacturing a human dietary supplement for oral consumption”), which the DC found to be ineligible for being “directed to ‘the natural phenomenon beta alanine and the natural law that ingesting certain levels of beta-alanine will increase the carnosine concentration in human tissue.” The FC panel disagreed since these claims “are not directed to the natural law or product of nature, but instead are an application of the law and new use of that product” (e.g., “[t]he supplement is not a product and nature and the use of the supplement to achieve a given result is not directed to a law of nature”). Thus, the Manufacturing Claims were found to be patent eligible.

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