Niki Ip Services - CHROMADEX, INC. v. ELYSIUM HEALTH

ChromaDex’s patent fell under § 101 because they claimed an “isolated” natural compound without functional differentiation. Conceding that milk inherently contains the same ingredients and lacks dosage limitations doomed their chances—even though their NAD⁺-boosting formulation was scientifically distinct. A powerful case study in claim drafting failure and missed scientific strategy.

Why ChromaDex Lost Under § 101: A Case Study in Missed Scientific and Legal Strategy

1. Background: The Patent at Issue ChromaDex, Inc. owned U.S. Patent No. 8,197,807, which claimed dietary compositions containing nicotinamide riboside (NR) and tryptophan. The formulation was intended to boost NAD+ levels in humans—a key mechanism for improving mitochondrial health, longevity, and metabolic function. The patent was asserted against Elysium Health, a competitor in the nutraceutical space.

2. The Court’s Reasoning: Isolation Is Not Invention The Federal Circuit affirmed the district court’s holding that ChromaDex’s claims were not patent-eligible under 35 U.S.C. § 101. Relying on Mayo, Myriad, and Funk Brothers, the court held that the claimed compositions were directed to natural products: NR and tryptophan, both of which are found in cow’s milk.

Crucially, the court emphasized that "isolated NR" was not markedly different from the naturally occurring NR in milk. The mere act of isolating a compound already present in nature—even if not in free form—was insufficient for patent eligibility.

3. What Went Wrong: Legal and Strategic Missteps

Overbroad Claim Construction: ChromaDex conceded that milk contains both NR and tryptophan. Worse, they accepted a broad definition of "isolated NR" that did not require a specific purity or functional outcome. This allowed the court to equate the claimed formulation with what exists in nature.
Failure to Argue Functional Distinction: ChromaDex did not convincingly argue that their composition had "markedly different characteristics" than milk. In particular, they failed to demonstrate that milk does not meaningfully raise NAD+ levels in vivo, whereas their formulation does.
Lack of Specific Utility in the Claims: While the patent discussed the NAD+-boosting properties of NR, the claims lacked specific language linking the composition to improved bioavailability, dosing, or biological outcomes.

4. The Scientific Counterpoint: Milk Is Not Functionally Equivalent

ChromaDex missed a powerful argument rooted in nutritional biochemistry:

Milk contains NR in trace amounts: Roughly 5 µmol/L, or ~1.28 mg/L. To achieve a common clinical dose of 250 mg NR, one would need to drink nearly 196 liters of milk. This argument alone could have distinguished the claims vs the natural counterparts as established by Creative Compounds v. Natural Alternatives.

No clinical evidence that milk raises NAD+: While milk contains NR and tryptophan, there is no published data showing that consuming milk leads to a measurable increase in NAD+ levels in humans. In contrast, multiple human trials confirm that isolated NR supplements significantly raise NAD+. It is also logical to assume and argue that a large amount of the population with declining NAD+ levels already drink milk.
Bound vs. Free Form: Tryptophan in milk is largely protein-bound and released only after digestion. The claimed composition presumably uses free-form tryptophan for immediate NAD+ biosynthesis support—a critical distinction that was never pressed.

5. Takeaways for Practitioners: Draft Smarter § 101 Claims

Include Functional Limitations: Claim formulations with specific purity thresholds, dosage ranges, or measurable biological effects (e.g., "at least 5-fold increase in NAD+ levels").
Avoid Overbroad Concessions: Never equate your claimed invention to its loosely similar natural counterpart in litigation or prosecution.
Leverage Clinical Data: If the natural form does not deliver the claimed outcome (e.g., NAD+ increase), make that distinction explicit in both the claims and specification.
Use Method of Treatment Claims: These remain more resilient to § 101 challenges when properly tied to specific dosing and outcomes.

In both patent prosecution and litigation, patentees are strongly advised to seek guidance from consultants who are deeply familiar with both the relevant scientific field and the patent law framework. Interdisciplinary strategy is often the difference between success and invalidation.

Conclusion

“ChromaDex’s position was not just weak—it was plainly foreclosed by precedent and unsupported by science. This case qualifies as exceptional under § 285 because Plaintiffs insisted on asserting ineligible claims after the law had made their futility clear.”

— U.S. District Court, D. Del., March 25, 2024

The ChromaDex case serves as a cautionary tale: under today’s § 101 jurisprudence, merely isolating a compound is not enough. If a natural product is claimed, the inventor must show that the claimed composition does something nature does not. Here, better claim drafting and scientific argumentation could have preserved patent rights in a commercially important domain. Let this serve as a lesson for anyone working at the intersection of natural compounds and patent law: distinguish not just by structure, but by function and outcome.

In the aftermath of Merck v. Gilead, and now with the $9.15 million in legal fees awarded in ChromaDex v. Elysium, this case offers another stark reminder: rushed, careless, incomplete, scientifically baseless, or unclean patent prosecution can transform a patent from a strategic asset into a costly legal liability.

Furthermore, cases like the present and Finnavations LLC v. Payoneer, Inc. , Genentech, Inc. v. Eli Lilly & Co. serve as powerful reminders that a plaintiff’s duty to reevaluate the merit of their claims does not end with the filing of a lawsuit. As the legal landscape evolves—particularly in areas such as patent eligibility and enablement—litigants must continuously assess whether their claims remain viable in light of new case law. Ignoring such developments not only risks sanctions but may also give rise to broader reputational and strategic consequences.

Links:

ChromaDex, Inc. v. Elysium Health, Inc. — Federal Circuit Opinion

The full, precedential opinion is available on the Federal Circuit’s website. It affirms invalidity under § 101:

https://www.cafc.uscourts.gov/opinions-orders/22-1116.OPINION.2-13-2023_2079642.pdf

Trammell et al. (2016) — Milk NAD⁺ Precursor Study

This peer-reviewed study quantifies NR and other NAD⁺ precursors in cow’s milk (milk samples contained 7.3 ± 1.5 μmol nicotinamide/L and 4.3 ± 2.6 μmol NR/L )

https://pmc.ncbi.nlm.nih.gov/articles/PMC6879052

Association for Molecular Pathology v. Myriad Genetics, Inc. (2013)

Supreme Court ruling that isolated natural DNA is not patent-eligible

https://supreme.justia.com/cases/federal/us/569/576/?utm_source=chatgpt.com

USPTO 2019 Revised Patent Subject Matter Eligibility Guidance

Official guidance explaining how functional or structural differences from nature can support § 101 eligibility:

https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf

9.15 million dollars of legal fees awarded to Elysium Health
https://www.dlapiper.com/en/insights/publications/synthesis/2024/significant-award-of-fees-and-costs-result-from-101-litigation-position

Page updated

Google Sites

Report abuse

ChromaDex, Inc. v. Elysium Health, Inc. — Federal Circuit Opinion

Trammell et al. (2016) — Milk NAD⁺ Precursor Study

Association for Molecular Pathology v. Myriad Genetics, Inc. (2013)

USPTO 2019 Revised Patent Subject Matter Eligibility Guidance

Trammell et al. (2016) — Milk NAD⁺ Precursor Study