Natural Alternatives - Claim Construction Defeats A 101 Challenge On The Pleadings

March 26, 2019 – Article

        The Federal Circuit on March 19 in Natural Alternatives Intl. v Creative Compounds LLC. reversed a district court’s opinion finding Natural’s patent claims to be patent ineligible. The district court’s decision arose out of a motion for judgment on the pleadings filed by Creative. The Federal Circuit’s decision relied heavily upon Natural’s claim construction submitted as part of its opposition. For the purposes of the motion Natural’s claim construction was accepted by the district court and Creative. Six patents were involved in the litigation and all six shared a common parent, the six patents are: U.S. Patent Nos. 5,965,596, 7,825,084, 7,504,376, 8,993,610, 8,470,865, and RE45,947. The ‘596 patent claim 1 reads:

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. [Emphasis by Court]

Claim 1 of the ‘865 patent reads:

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. [Emphasis by Court]

         The italicized claim limitations were the subject of the claim construction. Natural’s proposed construction of the “effective” limitation was “elevates beta-alanine above natural levels to cause an increase in the synthesis of beta-alanyl-histidine dipeptide in the tissue.” The “dietary supplement” was defined as “an addition to the human diet, which is not a natural or conventional food, which effectively increases athletic performance when administered to the human over a period of time.” 

        The Federal Circuit disagreed that the ‘596 patent claim 1 was directed to a natural law as found by the district court. The Federal Circuit found that the claim as interpreted required that an infringer actually administers the dosage form claimed to alter the person’s physiology to provide the described benefits as defined in the claim construction. As such the Federal Circuit found that the ‘596 claim 1 was a method of treatment claim relying on its Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., 887 F.3d 1117, 1134–36 (Fed. Cir. 2018) decision. The Court noted that the claim required specific steps be taken to bring about a change in the person’s natural state. As such, the Court found the claim to be different from those in Mayo.

        The ‘865 patent claim 1, which also had the “effective” limitation to be patent eligible for the same reasons as ‘596 claim 1 plus its recitation of three specific forms of beta alanine recited in the claim and the “dietary supplement” limitation as defined in the claim construction. Creative argued that “inventors admitted in the ’865 patent, and all of the patents-on-appeal, that placing a natural substance into a dietary supplement for administration to a human, in order to increase the function of tissues is a conventional, well-known activity.” The Court disagreed noting that the language cited to support this argument simply acknowledged that natural food supplements are designed to compensate for reduced levels of natural nutrients in the modern human an animal diet. Under the claim construction the amount used was to provide a dose well in excess of the normal beta-alanine levels.

        While significant questions exist as to whether Natural’s proffered claim construction is correct, the case shows that a carefully crafted claim construction may avoid a dismissal on the pleadings. At this stage of the proceeding a dispute as to the claim construction would have precluded a dismissal and required the court to proceed to the claim construction stage. By asserting a claim construction which passed the Mayo and Vanda tests Natural is able to continue to pursue its infringement claims.