The U.S. District Court for the Southern District of California invalidated several dietary supplement product and method patents as being directed to ineligible subject matter, even though they claimed products providing a certain dose or combination of ingredients, or methods using the products. The decisions were rendered in the context of a motion to dismiss filed by defendant HBS International Corp. in Natural Alternatives International, Inc. v. Allmax Nutrition, Inc., and underscore the growing threat of current patent eligibility jurisprudence to pharmaceutical and biotechnology patents.

The Patents At Issue

The patents at issue were U.S. Patent No. 5,965,596, U.S. Patent No. 7,504,376, U.S. Patent No. 7,825,084, and U.S. Patent No. RE 45,947. The Court focused on claim 1 of the ’084 patent, claim 1 of the ’596 patent, claim 34 of the ’947 patent, and claim 6 of the ’376 patent as representative. The court applied the Alice/Mayo two-step analysis, and determined that each claim was ineligible under 35 USC § 101.

Unit Dosage Forms Of Natural Products Are Ineligible

Claim 1 of the ’084 patent recites:

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 provides a unit dosage of beta-alanine.

Alice Step 1: The claim is directed to a natural phenomenon.

The court’s finding on this step is not surprising, but its explanation was interesting in how it drew a distinction between the claimed invention as a whole and what the claim is “directed to”:

Step one of the § 101 inquiry does not simply look to whether the overall claimed invention is itself a natural phenomenon. Rather, step one of the inquiry requires a court to look at what the claim is specifically directed to and whether what it is directed to is a natural phenomenon, law of nature, or abstract idea. For example, a computer is a physical machine and is not itself an abstract idea. Nevertheless, in Alice, the Supreme Court found that the claims at issue were directed to an abstract idea – specifically, “the concept of intermediated settlement” – even though all of the claims were implemented using a computer.  See 134 S. Ct. at 2352-53, 2355; see also id. at 2358 (“The fact that a computer ‘necessarily exist[s] in the physical, rather than purely conceptual, realm,’ is beside the point.”).  Similarly, here, claim 1 is directed to the natural phenomenon beta-alanine even though the claim is implemented using a “human dietary supplement.”

Alice Step 2: There is no additional inventive concept to support eligibility.

The court’s finding on this step also was not surprising, but could be far-reaching. The court determined that “the inventive concept” was “placing a specific dosage of beta-alanine into a human dietary supplement,” and noted that placing specific dosages of natural substances into dietary supplements was conventional.

Combinations Of Natural Products Are Ineligible

Claim 34 of the ’947 patent recites:

34. A human dietary supplement for increasing human muscle tissue strength comprising a mixture of creatine, a carbohydrate and free amino acid beta-alanine that is not part of a dipeptide, polypeptide or an oligopeptide, wherein the human dietary supplement does not contain a free amino acid L-histidine, wherein the free amino acid beta-alanine is in an amount that is from 0.4 g to 16.0 g per daily dose, wherein the amount increases the muscle tissue strength in the human, and wherein the human dietary supplement is formulated for one or more doses per day for at least 14 days.

Alice Step 1: The claim is directed to a natural phenomenon.

The court’s analysis for this step did not distinguish between the individual components potentially found in nature from the combination recited in the claim. Instead, the court simply concluded that this claim is directed to “the natural phenomenon of beta-alanine, creatine, and carbohydrates.”

Alice Step 2: The claim is ineligible by analogy to Funk Brothers

The court’s analysis on this step was based on the Supreme Court decision in Funk Brothers, where a combination product of naturally-occurring bacteria was held invalid even though “the combination provided certain advantages.”

The court treated—and disposed of—claim 6 of the ‘376 patent in a similar manner.

Methods Using Natural Products Are Ineligible?

Claim 1 of the ’596 patent 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.

Alice Step 1: The claim is directed to a law of nature

The court’s finding on this step is concerning. The court determined that this method claim is directed to a law of nature, which it described as “the principle that ingesting beta-alanine, a natural substance, will increase carnosine concentration in tissue and, thereby, aid in regulating the hydronium ion concentration in the tissue.”

Alice Step 2: There is no additional inventive concept to support eligibility.

The court’s finding on this step also is concerning:

The Court agrees with Defendants that the language in claim 1 does nothing more than simply state the law of nature and add the words apply it to human tissue.  Specifically, the language in claim 1 simply acknowledges the natural law that providing beta-alanine to human tissue will increase the carnosine concentration in the tissue and aid in regulating hydronium ion concentration, and then merely instructs to do so.  This is insufficient to render the claim patent-eligible.

The court rejected the patentee’s arguments that the method claim satisfied § 101 “because the claimed method increases the carnosine content in the tissue through a non-natural process.” The court reasoned:

There is nothing in the claim language requiring that the carnosine concentration achieved by the method be at unnatural levels. Moreover, there is nothing in the claim language requiring that the beta-alanine used in the method come from non-natural sources, and, thus, the claim appears to encompass natural methods of exposing beta-alanine to human tissue and, thereby, increasing the carnosine content in the tissue.

Without undertaking a claim construction, how can the court determine that the claim “appears” to encompass “natural methods”? 

The court also cited Myriad, Genetic Technologies, and Ariosa for the proposition that the usefulness of the method was irrelevant to the issue of eligibility.

What Now?

My first thought on reading this decision was, “Will they appeal?”

My second thought was, “Do I want them to?”

Without delving deeper into the record, it’s hard to know if the product claims present a compelling enough case to be a sure win on appeal. And, while any method of treatment claims should satisfy § 101, can we risk an affirmance of a decision holding otherwise because (for example) the treatment at issue was claimed at a physiological level?