Because No One is Immune to the Law
March 13, 2023 - Healthcare, Litigation, Intellectual Property, United States

Don’t Cry Over Spilled Milk: Federal Circuit Finds Milk Vitamin Patent Invalid

Abstract Biotech image

In ChromaDex Inc. v. Elysium Health Inc.,[1] the Federal Circuit found U.S. Patent No. 8,197,807 (the “’807 patent”), which is directed to a dietary supplement comprising an isolated vitamin, invalid for lack of subject matter eligibility under 35 U.S.C. § 101. ChromaDex, a dietary supplement company and licensee of the ’807 patent brought a patent infringement suit against Elysium. The district court initially found the ’807 patent invalid under 35 U.S.C. § 101 as directed to a natural product. The Federal Circuit affirmed the district court’s decision, concluding that the dietary supplement in the asserted claims was not markedly different from naturally occurring milk.

The ’807 patent relates to nutritional supplements containing isolated nicotinamide riboside (NR), a form of naturally occurring vitamin B3 present in non-isolated form in cow’s milk and other products. Claim 1 of the ’807 patent recites:

A composition comprising isolated nicotinamide riboside in combination with one or more of tryptophan, nicotinic acid, or nicotinamide, wherein said combination is in admixture with a carrier comprising a sugar, starch, cellulose, powdered tragacanth, malt, gelatin, talc, cocoa butter, suppository wax, oil, glycol, polyol, ester, agar, buffering agent, alginic acid, isotonic saline, Ringer's solution, ethyl alcohol, polyester, polycarbonate, or polyanhydride, wherein said composition is formulated for oral administration and increases NAD+ biosynthesis upon oral administration.

Elysium argued that the claimed composition reads on naturally occurring milk, which comprises NR, tryptophan, and the sugar lactose, and that the only difference between the two is that the claims recite that the NR is “isolated.” ChromaDex responded that the claimed NR composition is different from the naturally occurring form because it contains a stable isolated form of NR, which is bioavailable, sufficiently pure, and at a higher concentration than the NR found in naturally occurring milk. According to ChromaDex, NR is found only in trace amounts in naturally occurring milk and is primarily bound to whey protein.

The Federal Circuit rejected ChromaDex’s arguments and sided with Elysium. Specifically, the court found that naturally occurring milk inherently increases NAD+ biosynthesis via tryptophan, regardless of the trace amounts of NR, and that the claims did not recite that the isolated NR must be bioavailable. In view of the decision in Myriad,[2] simply isolating the NR was found to be insufficient for patent eligibility; the claimed composition was not markedly different from naturally occurring milk. The court also distinguished its previous decision in Natural Alternatives,[3] where it found claims to specific formulations including natural products were patent-eligible because the natural products were incorporated into a dosage form with a particular characteristic. In contrast, the claims in ChromaDex did not require any minimum quantity of NR and they did not connect the recited increase in NAD+ biosynthesis to the isolated NR.

This case demonstrates the continued relevance of subject matter eligibility to pharmaceutical and food supplement claims. The decision reaffirms Myriad by asserting that the mere recitation of “isolated” is not sufficient to confer subject matter eligibility and highlights key considerations for drafting claims. For example, patent applicants should provide description of any advantages and improved properties of a formulation over its natural counterpart in the specification and draft claims that provide a connection between the modifications to the natural product and the improved function. Applicant should also consider composition or formulation claims that recite specific thresholds or amounts outside those found in nature to reduce the impact of subject-matter eligibility issues.

[1] ChromaDex, Inc. v.Elysium Health, Inc., No. 2022-1116 (Fed. Cir. Feb. 13, 2023).

[2] Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (Jun. 13, 2013)

[3] Natural Alternatives International, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. Mar. 15, 2019).