On March 15, 2019, the Court of Appeals for the Federal Circuit (CAFC) heard an appeal in the matter of Natural Alternatives International, Inc. v. Creative Compounds, LLC regarding the subject matter eligibility of dietary supplements. At issue in the case were six patents related to the CarnoSyn® beta-alanine athletic performance supplement.
In reversing the lower court’s ruling, the CAFC found that each of the six patents contained patent eligible subject matter under 35 U.S.C. § 101. In fact, the court found that the patents directed at the beta-alanine product, method of manufacturing the beta-alanine product, and method of using the beta-alanine product for treatment (i.e., improving athletic performance), were are all subject matter eligible, and therefore patentable.
With regards to the patents on the beta-alanine product, the Court noted that, “A claim to a manufacture or composition of matter made from a natural product is not directed to the natural product where it has different characteristics and ‘the potential for significant utility.’” In the present case, the court found that the combination of a specific form of beta-alanine and glycine, and that the specific dosages of beta-alanine may increase athletic performance in a way that naturally occurring beta-alanine may not.
With respect to the patents on the method of administering beta-alanine, the Court likened the claims to those at issue in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd, noting that, “Claims that are directed to particular methods of treatment are patent eligible[i].” Here, the claims in the method patents are directed to administering beta-alanine to a human subject in order to overcome homeostasis and increase creatine production, resulting in physiological benefits to the subject. The Court, in no unclear terms noted, “These are treatment claims, and as such they are patent eligible.[ii]”
Finally, with regards to the manufacturing claims, the Court also found that subject matter eligibility under 35 U.S.C. § 101 was met by the fact that the claims were “[D]irected to the manufacture of a human dietary supplement with certain characteristics,[iii]” and that, “The supplement is not a product of nature and the use of the supplement to achieve a given result is not directed to a law of nature.[iv]”
It is clear from the Court’s analysis that it is important to take certain precautions when drafting the specification and claims of patents directed to these dietary supplements and related products. Here, the Court appeared to rely heavily on interpretations pulled from the specification of the patents at issue in order determine the claims were subject matter eligible. For instance, the court looked to the specification of the patents to find the significance of dosing ranges, how they were calculated based on bodyweight, and how those dosing ranges were required to effectively increase athletic performance. Applicants would be wise not to submit skimpy disclosures with a bare minimum of detail, as it could mean the difference between validity and invalidity of a patent.
Ultimately, the Court’s findings in the matter provide welcome guidance on the ever-challenging issue of subject matter eligibility under U.S.C. § 101. The ruling gives clarity on the ability of sports nutrition companies to secure the lucrative rights in their proprietary performance enhancing dietary supplements; the dietary supplement market being valued at $152 billion (USD) as of 2018, and expected to grow to $220 billion (USD) by 2022[v].