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Natural Alternatives v. Creative Compounds

Representative Claim(s)

‘596 – 1. A method of regulating hydronium ion concentrations in a human tissue comprising:
providing an amount of beta-alanine to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis in the human tissue; and
exposing the tissue to the blood or blood plasma, whereby the concentration of beta-alanylhistidine is increased in the human tissue.

‘865 – 1. A method of increasing anaerobic working capacity in a human subject, the method comprising:
a) providing to the human subject an amount of an amino acid to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis in the tissue, wherein said amino acid is at least one of:
i) beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide;
ii) an ester of beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide; or
iii) an amide of beta-alanine that is not part of a dipeptide, polypeptide or oligopeptide; and
b) exposing the tissue to the blood or blood plasma, whereby the concentration of beta-alanylhistidine is increased in the tissue,
wherein the amino acid is provided through a dietary supplement.

‘376 – 6. [A composition, comprising: glycine; and a) an amino acid selected from the group consisting of a beta-alanine, an ester of a beta-alanine, and an amide of a beta-alanine, or
b) a di-peptide selected from the group consisting of a beta-alanine di-peptide and a beta-alanylhistidine di-peptide, wherein the composition is a dietary supplement or a sports drink] wherein the dietary supplement or sports drink is a supplement for humans.

‘084 – 1. A human dietary supplement, comprising a beta-alanine in a unit dosage of between about 0.4 grams to 16 grams, wherein the supplement pro-vides a unit dosage of beta-alanine.

Posture:

Appeal from decision of the District Court

Exception Categories: Law of Nature, Natural Phenomenon

Law of Nature – ‘596 and ‘865 patents

“Administering certain quantities of beta-alanine to a human subject alters that subject’s natural state. Specifically, homeostasis is overcome, and the subject’s body will produce greater levels of creatine. [Citation omitted.] This, in turn, results in specific physiological benefits for athletes engaged in certain intensive exercise. [Citation omitted.] The claims not only embody this discovery, they require that an infringer actually administer the dosage form claimed in the manner claimed, altering the athlete’s physiology to provide the described benefits. These are treatment claims and as such they are patent eligible.”

“In Mayo, the Court held the claims did not do significantly more than simply describe the natural ‘relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.’ Unlike the claims in Mayo, the Method Claims at issue are treatment claims.”

The court opined on the recited “effective” limitation: “The claims in Vanda further specified the dosages of the compound to be administered. The Method Claims likewise contain a dosage limitation by virtue of the ‘effective’ limitation. As we looked to the specification in Vanda to determine the significance of the dosing ranges, [citation omitted], here, the specification provides a method for calculating dosage based on a subject’s weight, [citation omitted]. This goes far beyond merely stating a law of nature, and instead sets forth a particular method of treatment.”

“Moreover, 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 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. We hold, therefore, that the Method Claims are not directed to ineligible subject matter.”

Natural Phenomenon – ‘376 and ‘084 patents

“Just as the Method Claims are directed to specific methods of treatment that employ a natural law, the Product Claims are directed to specific treatment formulations that incorporate natural products, but they have different characteristics and can be used in a manner that beta-alanine as it appears in nature cannot.”

“In the Product Claims, beta-alanine and glycine are incorporated into particular dosage forms. … In each case, the natural products have been isolated and then incorporated into a dosage form with particular characteristics. At this stage in the litigation, 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.”

The court distinguished Funk Brothers: “[T]he record indicates that the claimed combination of glycine and beta-alanine could have synergistic effects allowing for outcomes that the individual components could not have.”

Significantly More: Not Decided

Judge Reyna dissented in part

Disagreeing with the majority’s stance on claim construction, Judge Reyna would have found the claims patent ineligible. Judge Reyna, concurred however, in the decision to remand for further proceedings, “which I take to mean could include a formal claim construction and a potential revisit of the § 101 issue.”