Background
Natural Alternatives International (NAI) owns a portfolio of patents covering the use of beta-alanine—an amino acid found naturally in the body and in some foods—as a dietary supplement for athletes and others seeking to improve physical performance. Beta-alanine is a precursor to carnosine, a dipeptide in muscle tissue that buffers acid buildup during intense exercise. NAI’s patents claimed methods and products involving administering beta-alanine in dosages far above what would be consumed through ordinary diet, increasing muscle carnosine concentrations beyond naturally occurring baseline levels.
Creative Compounds, a competitor in the supplement market, challenged several of NAI’s patents in the U.S. District Court for the Southern District of California, arguing that the claims were directed to a natural phenomenon—specifically, the naturally occurring relationship between beta-alanine and carnosine levels in muscle tissue—and were therefore ineligible for patent protection under 35 U.S.C. § 101 following Mayo Collaborative Services v. Prometheus Laboratories. The district court agreed and invalidated the claims. NAI appealed.
The Court’s Holding
The Federal Circuit reversed, holding that NAI’s method and product claims were patent eligible. Writing for a unanimous panel, Judge Moore explained that although beta-alanine is a naturally occurring compound, NAI’s claims did not merely describe the compound’s existence in nature or claim the natural metabolic relationship between beta-alanine and carnosine. Instead, they claimed a specific application: administering beta-alanine to a human in quantities that do not naturally occur through ordinary diet, for the specific purpose of altering the body’s natural state by dramatically increasing muscle carnosine concentration beyond baseline levels to achieve a desired physiological effect.
The court emphasized that the relevant inquiry is not whether the active ingredient is a naturally occurring molecule, but whether the claimed use treats the naturally occurring molecule as something different from what it is in nature. When the claims require administering a compound in non-naturally-occurring quantities that alter the patient’s physiology in a manner that the natural substance cannot accomplish on its own, the claims are directed to an application of the natural compound—not to the compound’s natural properties itself. That constitutes patent-eligible subject matter.
Key Takeaways
- A patent claiming use of a naturally occurring compound can be eligible under § 101 when it requires administering that compound in non-naturally-occurring quantities to alter the patient’s physiological state in ways that nature does not accomplish.
- The mere fact that an active ingredient exists in nature does not render all patent claims covering its use ineligible; the focus is on whether the claim is directed to the natural phenomenon itself or to a specific human-directed application.
- Method of treatment claims in the nutraceutical and dietary supplement space can be patent eligible, provided they require specific dosing protocols designed to achieve defined physiological outcomes rather than merely observing natural phenomena.
- This decision, alongside Endo v. Teva (also decided in March 2019), reinforced a distinction between diagnostic method claims (which tend to be invalid under Mayo) and treatment/product claims (which can be valid when they go beyond observing natural laws).
Why It Matters
The dietary supplement and nutraceutical industry had largely assumed, after Mayo, that patents on natural compounds were unenforceable—after all, if the Federal Circuit routinely strikes down diagnostic tests for finding correlations between natural molecules and diseases, how could supplement companies claim rights over natural amino acids? This decision drew a clearer line: the problem is not the use of natural compounds, but claiming the natural phenomenon underlying their activity. Treatment and product claims that harness natural compounds in ways that go beyond their naturally occurring function can still be protected.
For innovators in the supplement, nutraceutical, and natural product pharmaceutical space, Natural Alternatives v. Creative Compounds provided an important roadmap: structure claims to require non-naturally-occurring dosing regimens, defined physiological endpoints, or specific treatment protocols—rather than simply observing that a natural compound produces a natural effect. Competitors and generic manufacturers, on the other hand, should recognize that claims carefully drafted around treatment applications of natural compounds may be much harder to invalidate under § 101 than purely observational claims.