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IP Alert: Federal Circuit Finds Claims Containing Natural Product Are Not Directed to a Judicial Exception

March 20, 2019

On March 15, in Natural Alternatives Int’l., Inc. v. Creative Compounds, LLC, the Federal Circuit rejected a “law of nature” challenge to claims to a dietary supplement containing a naturally occurring amino acid and a method for treatment of a patient using the dietary supplement.

Because the claims specified “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 court determined that—at least under the initial claim construction applied by the district court—the claims were not drawn to a patent-ineligible law of nature. The court further held that claims to a method of manufacture of the supplement likewise were not directed toward a law of nature.

Natural Alternatives owns patents directed to a dietary supplement containing beta-alanine and methods for its use and manufacture. Beta-alanine is a naturally occurring amino acid that assists with alleviating muscle contraction. When Natural Alternatives sued Creative Compounds, Creative Compounds moved for immediate judgment of invalidity under Rule 12(c), asserting that the claims were directed to a natural law and therefore not patent-eligible under section 101 of the Patent Act.

Accepting Natural Alternatives’s claim construction, the district court applied the two-part Alice/Mayo test: Laws of nature, natural phenomena, and abstract ideas are not patent-eligible (step one) unless “additional elements ‘transform the nature of the claim’ into a patent-eligible application, i.e., whether there is an ‘inventive concept’” (step two). After considering this test, the district court granted Creative Compound’s 12(c) motion, concluding without discovery or trial that the claims to the supplement, the patient treatment method, and the method of manufacture were all directed to natural laws and therefore patent-ineligible.

On appeal, the Federal Circuit reversed and held that when Natural Alternatives’s proposed claim constructions were applied with the factual allegations of the complaint and all reasonable inferences, the patent eligibility of the supplement and treatment method claims was plausibly established. For this reason, the court determined that it was improper for the district court to have summarily held the claims invalid under section 101.

The asserted treatment method claims were directed to a method of regulating hydronium ion concentrations in human tissue and increasing anabolic working capacity in a human, respectively, “by providing an amount of beta-alanine to blood or blood plasma effective to increase beta-alanylhistidine dipeptide synthesis” in human tissue. The Federal Circuit held that on the record before it these claimed methods were “directed to patent eligible new ways of using an existing product, beta-alanine,” which is permitted as a “new and useful process” under section 101. Further, the Federal Circuit found that even though the active ingredient “occurs in nature and is consumed as part of a human diet,” the claims did more, in fact, than utilize a natural law. They required specific steps, such as specifying a compound to be administered to accomplish the claimed result, and contained a dosage limitation, which did not exist in nature and exceeded natural levels. Thus, on the record before it, the Federal Circuit held that the method claims covered “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.”

Turning to the asserted product claims, these were “directed to specific treatment formulations that incorporate natural products, but . . . have different characteristics and can be used in a manner that beta-alanine as it appears in nature cannot.” One patent claimed a combination of glycine and beta-alanine with a synergistic effect that the individual amino acids did not have. Also, the question whether the “dietary supplement” in the claims was well-understood, routine, and conventional was still a fact at issue.

With respect to the manufacturing claims, the Federal Circuit held that the representative claim of the ’610 patent, which claims the manufacture of a dietary supplement with beta-alanine, was also not directed to natural law or product of nature but to “the manufacture of a human dietary supplement with certain characteristics.” While the court remanded the eligibility question for the claims to the supplement and the treatment method, it appears that the court reversed altogether the patent-ineligibility holding for the method of manufacture claims, stating “[w]e do not see, therefore, how a claim to the manufacture of a non-natural supplement would be directed to the law of nature or natural product.”

The judgment, however, was not unanimous. Judge Reyna concurred with the majority to remand, but dissented on the reason for doing so. Specifically, Judge Reyna stated that the majority opinion “relies on a construction that improperly imports limitations into the claims and is contradicted by the written description.” In addressing claim 1 of the ’084 patent (one of the product claims), Judge Reyna held that the claim is a “natural substance . . . applied by wholly conventional and natural means.” Further, he concluded that Natural Alternatives’s proposed construction of “dietary supplement” was contrary to its plain meaning. However, Judge Reyna surmised that a proper claim construction will take place on remand and pondered whether “the time has come for [the Federal Circuit] to reconsider whether a Rule 12(c) motion based on § 101 should be decided before claim construction.”

A takeaway from this decision is that a claim that specifies quantities or specific treatment may allow a product, method, or manufacture that utilizes a natural product to overcome a patent-eligibility challenge. The decision also provides guidance on how district courts and litigants should address Rule 12(c) and other similar challenges to patent eligibility.

For more information on this case, please contact Fitch Even attorney Margaret A. Herrmann, author of this alert.

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