Natural Alternatives Int'l, Inc. v. Creative Compounds, LLC
918 F.3d 1338
Fed. Cir.2019Background
- Natural Alternatives owns patents on dietary supplements and methods using beta‑alanine to increase beta‑alanylhistidine (e.g., carnosine) in muscle, thereby improving anaerobic capacity and regulating intracellular pH.
- Creative Compounds moved for judgment on the pleadings under Rule 12(c), arguing the asserted claims of several patents are patent‑ineligible under 35 U.S.C. § 101. The district court agreed and dismissed.
- On appeal the Federal Circuit reviewed de novo and accepted Natural Alternatives’ proposed claim constructions for purposes of the § 101 analysis at this procedural stage.
- The patents included: (a) Method Claims (administering beta‑alanine to humans to produce physiological effects), (b) Product Claims (dietary supplement compositions with specified beta‑alanine dosages and combinations, e.g., with glycine), and (c) Manufacturing Claims (using beta‑alanine in making human dietary supplements).
- The majority held that, under the plaintiff’s constructions, the claims are treatment and manufacturing applications that do more than claim a natural law or natural product and thus are not directed to ineligible subject matter; it reversed and remanded.
- Judge Reyna concurred in part but dissented in part, arguing the majority relied on an improper claim construction that imported effectiveness and functional limitations into otherwise straightforward claims.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Are the Method Claims (administering beta‑alanine) directed to a patent‑ineligible natural law? | Natural Alternatives: claims are treatment methods altering physiology with specific dosages; not merely observations of natural relationships. | Creative Compounds: claims merely apply the natural law that ingesting beta‑alanine increases tissue carnosine and performance. | Held: Method Claims are patent‑eligible treatment methods under Alice step 1 (not directed to a natural law) and survive at pleading stage. |
| Are the Product Claims (dietary supplement compositions) directed to a natural product/phenomenon? | Natural Alternatives: compositions are isolated/formulated dosages with utility beyond natural beta‑alanine; combinations (e.g., glycine) may be synergistic. | Creative Compounds: claims cover natural substances in ordinary forms and thus are directed to natural products. | Held: Product Claims are not directed to ineligible subject matter at step 1 given alleged formulation/dosage characteristics; factual disputes preclude judgment on pleadings. |
| Are the Manufacturing Claims (use of beta‑alanine in making supplements) directed to a natural law or product? | Natural Alternatives: claim covers manufacturing a non‑natural supplement with properties that increase performance—an application, not a natural law. | Creative Compounds: claim effectively covers putative natural product use and thus is ineligible. | Held: Manufacturing Claims are applications (manufacture of a non‑natural supplement) and not directed to a natural law; eligible at step 1. |
| Should § 101 be resolved on Rule 12(c) without formal claim construction? | Natural Alternatives: district court accepted its proposed constructions for this stage; appellee did not preserve different constructions on appeal. | Creative Compounds: claimed ineligible under either party’s constructions; court may resolve at pleading stage. | Held: Under the plaintiff’s constructions, factual issues remain and § 101 cannot be decided for judgment on the pleadings; remanded. (But dissent urges proper claim construction first.) |
Key Cases Cited
- Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (framework for determining when claims are directed to patent‑ineligible concepts)
- Mayo Collaborative Servs. v. Prometheus Labs., 566 U.S. 66 (holding claims that add only conventional steps to a law of nature are ineligible)
- Vanda Pharm. Inc. v. West‑Ward Pharm. Int’l Ltd., 887 F.3d 1117 (method‑of‑treatment claims that apply a natural relationship can be patent‑eligible)
- Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 576 (distinguishing claims to methods of use from claims to natural products)
- Diamond v. Chakrabarty, 447 U.S. 303 (composition claims that create non‑natural characteristics can be patent‑eligible)
- Funk Bros. Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (combination of natural products without new functionality may be ineligible)
- Rapid Litig. Mgmt. Ltd. v. CellzDirect, 827 F.3d 1042 (subject matter that naturally undergoes a process does not make a claim "directed to" that natural ability)