Background
ChromaDex, Inc. and the Trustees of Dartmouth College sued Elysium Health, Inc. for infringing patent claims covering dietary-supplement compositions containing isolated nicotinamide riboside, or NR, and other ingredients. The claims required formulations for oral administration that increase NAD+ biosynthesis. The district court held the asserted claims patent-ineligible under 35 U.S.C. § 101 as directed to a product of nature, and the Federal Circuit affirmed that judgment in 2023.
After prevailing on eligibility, Elysium sought attorney fees under 35 U.S.C. § 285. The district court deemed the case exceptional because it viewed Association for Molecular Pathology v. Myriad Genetics, Inc. as dispositive and concluded that ChromaDex had essentially ignored that decision. It awarded Elysium $9,151,133, including fees incurred before claim construction. ChromaDex appealed the fee award.
The Court’s Holding
The Federal Circuit reversed. It held that the district court legally erred by treating Myriad as the beginning and end of the eligibility analysis. Myriad established that isolating a naturally occurring molecule, without more, was insufficient, but ChromaDex did not rely solely on NR’s isolation. It also argued that its compositions had markedly different characteristics and significant utility because isolated NR could increase NAD+ biosynthesis in a way naturally occurring NR could not.
Although those arguments ultimately failed, evaluating them required analysis beyond Myriad, including comparison with Natural Alternatives International, Inc. v. Creative Compounds, LLC, the quantity and bioavailability of NR required by the claims, NR’s relationship to increased NAD+ biosynthesis, and milk’s ability to increase NAD+ through tryptophan. ChromaDex’s position therefore was not so exceptionally meritless or unreasonable that the case stood out under § 285. The court declined to remand because neither the district court’s analysis nor the existing record and Elysium’s arguments could support exceptionality.
Key Takeaways
- Losing a patent-eligibility argument does not by itself make a case exceptional under 35 U.S.C. § 285.
- Myriad foreclosed reliance on isolation alone, but it did not eliminate the need to evaluate claimed functional characteristics and significant utility.
- The Federal Circuit reversed the entire $9.1 million fee award without remanding for further exceptionality proceedings.
Why It Matters
The nonprecedential decision reinforces that § 285 focuses on the substantive strength and reasonableness of a litigating position, not merely whether that position ultimately succeeds. A district court abuses its discretion when an exceptional-case determination rests on an overly broad reading of controlling eligibility precedent.
For patent litigants, the ruling also distinguishes an unsuccessful but meaningfully developed eligibility theory from an exceptionally meritless one. Arguments based on functional differences and significant utility may be reasonable enough to avoid fee shifting even when the claims are ultimately invalidated as products of nature.