Background
ChromaDex, Inc. sells dietary supplements containing isolated nicotinamide riboside (NR), a form of vitamin B3 that occurs naturally in cow’s milk and other food sources. ChromaDex held U.S. Patent No. 8,197,807, which claimed compositions comprising isolated NR. Elysium Health, Inc. — a competing supplement company — sold products containing NR and challenged ChromaDex’s patent on multiple grounds, including patent eligibility under 35 U.S.C. § 101.
The district court granted summary judgment to Elysium, holding that the ‘807 patent claims were directed to a natural phenomenon — specifically, the naturally occurring NR molecule — and that isolating it from milk did not add an inventive concept sufficient to make the claims patent-eligible. ChromaDex appealed, arguing that its isolated NR compositions were meaningfully different from NR as it exists in nature.
The Court’s Holding
The Federal Circuit unanimously affirmed. Applying the Alice/Mayo two-step framework, the court held at step one that the claims were directed to a natural phenomenon. The court observed that the ‘807 patent’s claims would literally read on cow’s milk, with the only distinction being that the NR in milk is not “isolated.” The court rejected ChromaDex’s argument that isolated NR is structurally different from NR in milk in any meaningful way — both are the same molecule; one simply has been separated from other components in a natural mixture.
At step two, the court found no inventive concept. ChromaDex argued that its patent described advantageous properties of isolated NR — such as improved bioavailability and the ability to use it in targeted dosages. But the court emphasized that those advantages were not captured in the actual claim language. The patent claims did not include any limitations directed to those benefits, and courts evaluate what is actually claimed, not unclaimed advantages described in the specification. The isolation process itself — separating NR from its natural matrix — did not constitute a meaningful inventive step beyond the natural phenomenon.
Key Takeaways
- A patent claim directed to a naturally occurring compound does not escape § 101 simply because it requires the compound to be “isolated” — the isolated form must be structurally or functionally distinct from the natural form in a meaningful way.
- Patent claims are assessed on their actual language, not on advantages described in the specification; beneficial properties not reflected in the claims cannot supply the inventive concept at Alice step two.
- Claims that effectively read on a natural product (such as milk) with only a processing step (isolation) as a distinction are vulnerable to § 101 invalidity even in the life sciences and supplement industries.
- Companies seeking to patent naturally derived compounds should ensure that the claims capture the specific, non-obvious structural or functional features that make their product inventive — not just the act of isolation or purification.
Why It Matters
ChromaDex v. Elysium Health is an important data point in the ongoing challenge of patenting naturally derived compounds in the dietary supplement and nutraceutical space. The Federal Circuit’s decision makes clear that isolating a compound from its natural source — a standard step in producing any purified supplement — does not by itself create patent-eligible subject matter. This ruling aligns with the court’s broader natural phenomenon doctrine and the Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics, which held that isolated DNA sequences found in nature are not patent-eligible.
For supplement makers, pharmaceutical companies, and biotech firms, the decision highlights the importance of claiming specific, non-obvious formulations, dosage forms, delivery mechanisms, or combinations — not just isolated forms of naturally occurring molecules. Companies that have built patent protection around isolated natural compounds should audit their portfolios in light of this ruling, particularly if their claims do not include structural or functional limitations that distinguish the claimed product from the natural source.