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:
- 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?:
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:
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:
- 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 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:
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?
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