Patent Eligibility is Confirmed Based on Claims Directed to Methods of Treatment

by Joshua B. Goldberg (Nath, Goldberg & Meyer – U.S.A.)

The US Court of Appeals for the Federal Circuit (“CAFC”) again confirmed medical treatment claims are patent eligible subject matter in Natural Alternatives International, Inc. v. Creative Compounds LLC. In Natural Alternatives, the CAFC affirmed the validity of Natural Alternatives’ patent covering various forms of the naturally-occurring compound beta-alanine and its use as a muscle-building supplement. In its decision, the CAFC specifically stated “These are treatment claims and as such they are patent eligible.”

Natural Alternatives sued Creative for infringing six of its patents covering various forms of the naturally-occurring compound beta-alanine and its use as a muscle-building supplement. The case was dismissed by the District Court on the basis of lack of subject matter eligibility as being directed to an unpatentable product and law of nature. Specifically, the District Court found that the claims were directed toward a product of nature (beta-alanine) and a law of nature (that taking beta-alanine in sufficient quantities builds muscle).

Exemplary claim 1 of one of the patents at issue, U.S. Patent No. 5,965,596, recites:

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.

On appeal, the CAFC agreed with Natural Alternatives that the asserted method claims did indeed recite patent eligible subject matter. Initially, the majority opinion accepted Natural Alternatives’ proposed claim construction for certain critical claim requirements, such as “effective”, “dietary supplement”, and “increasing anaerobic working capacity”. The Court proceeded to explain that practitioners shouldn’t take the law-of-nature prohibition too far since “[w]e live in the natural world, and all inventions are constrained by the laws of nature.”

The core holding of this decision is that “These are treatment claims and as such they are patent eligible.” In explaining this statement, the CAFC discussed the difference between method of treatment claims that are eligible under Vanda and method claims that are ineligible under Mayo. Specifically, the CAFC indicated that as was “explained in Vanda … claims that are directed to particular methods of treatment are patent eligible” in that they “required a doctor to affirmatively administer a drug to alter a patient’s condition from their natural state.” In contrast, according to the CAFC, the claims held ineligible in Mayo required only the observation of a natural law. In Mayo, the discovery underlying the claims was seen as that when blood levels were above a certain level harmful effects were more likely and when they were below another level the drug’s beneficial effect were lost. “Nothing in the claim required any application of that discovery.” Accordingly, the CAFC viewed the Mayo claim as not a true method of treatment claim.

The majority opinion emphasized that the Supreme Court itself distinguished the Mayo claims from method of treatment claims:

This was expressly recognized in Mayo, which distinguished the Mayo claim from “a typical patent on a new drug or a new way of using an existing drug,” because the Mayo claim did not “confine [its] reach to particular applications” of the natural laws relied upon.

In contrast, Natural Alternatives’ method claims in this case, while similarly relying on the relationship between the administration of beta-alanine and beta-alanylhistidine dipeptide synthesis, require specific steps to bring about a change in a subject, thereby altering the subject’s natural state. Accordingly, since the method of treatment claims involved using a natural product in unnatural quantities to alter a patient’s natural state, these claims were viewed as not “directed to” ineligible subject matter.

Thus, it seems clear on its face that method of treatment claims are per se patent eligible.