March 3, 2023
co-authored by Sara Pistilli, PharmD. and Richard D. Kelly
In Chromadex, Inc., Dartmouth College, v. Elysium Health, Inc., on February 13, 2023, the Federal Circuit affirmed a summary judgement for the asserted claims of US 8,197,807 (the ’807 patent) being directed to unpatentable subject matter under 35 U.S.C. § 101. The invalidity of the claim in question related to the “product of nature” and “law of nature” exceptions to patentability.
The claim in contention recited:
1. 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.
The original filing of the ’807 patent battled novelty and obviousness objections ending in three allowable claims out of a total of 33 claims presented during prosecution. Claims 2 and 3 respectively further recited, “[t]he nicotinamide riboside [NR] is isolated from a natural or synthetic source” and “[t]he formulation comprises a tablet, troche, capsule, elixir, suspension, syrup, wafer, chewing gum, or food.”
The district court focused its analysis of the alleged infringement on the term, “isolated [NR],” which it interpreted as, “[NR] that is separated or substantially free from at least some other components associated with the source of [NR].” The court furthered that “compositions comprising isolated [NR], a naturally occurring vitamin present in cow milk” were directed towards a natural phenomenon. ChromaDex, the licensee of the ’807 Patent, argued (unsuccessfully) that isolated NR differed from naturally occurring nicotinamide riboside (NR) in stability, bioavailability, purity, and therapeutic efficacy, thus making the claims eligible patent subject matter. The district court concluded that the claims were patent ineligible because the claims applied a patent ineligible law of nature.
The Federal Circuit affirmed that the claims directed towards a bioavailable oral form of NR were patent ineligible because the bioavailable oral form of NR is a naturally occurring product. This decision hinged on a comparison of the claimed invention and natural cow’s milk. Both parties agreed that:
1. Milk is a naturally occurring product and is patent ineligible;
2. Milk contains tryptophan and lactose, a sugar; and
3. Tryptophan in milk treats NAD+ deficiencies.
Therefore, the only difference between at least one embodiment within the scope of the claims in question and natural cow’s milk was that the claims were directed towards “isolated” NR.
In view of Myriad (Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013)), the Federal Circuit found the act of isolating NR alone insufficient to make the claims in question patent eligible subject matter, because isolating NR does not make it different from its natural counterpart in structure or function. ChromaDex, the licensee of the ’807 Patent, argued that the claimed “isolated” NR composition was advantageous over natural cow’s milk because the isolated NR increased NAD+ biosynthesis. ChromaDex, the licensee of the ’807 Patent, furthered that “NR in milk does not enhance NAD+ biosynthesis” but rather tryptophan was the source of enhanced NAD+ biosynthesis. The Federal Circuit found this argument unpersuasive, as the claims did not require NR specifically to raise NAD+ biosynthesis. Because an increase in NAD+ biosynthesis was the only therapeutic effect claimed, milk’s ability to increase NAD+ biosynthesis was sufficient to satisfy the claimed effect, despite it accomplishing the claimed effect through a different mechanism.
Next, ChromaDex, the licensee of the ’807 Patent, argued the isolated NR composition patent eligible because it was markedly different from milk. It stated the isolation of NR provided NR in higher concentrations than was found in milk. It furthered the isolated NR was different from its natural counterpart because it was bioavailable due to the lack of NR bound lactalbumin whey protein, present in milk. The Federal Circuit compared this case to Natural Alternatives (Nat. Alts. Int'l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019)), where an isolated natural product was incorporated into an oral dosage form. The Federal Circuit’s decision in Natural Alternatives stated claims directed towards specific treatment formulations that incorporated natural products could be patent eligible if the formulations had different claimed characteristics and could be used in a manner the natural counterpart could not. Based on this decision, the Federal Circuit stated that the increased bioavailability did not distinguish the claimed composition from milk, as the claims did not require the composition to be bioavailable or to be separated from lactalbumin whey protein. Additionally, the Federal Circuit stated the higher concentrations of NR, when in the isolated form, leading to the increase in NAD+ biosynthesis also did not distinguish the claimed composition from milk because the claims did not require a specific amount or concentration to achieve the claimed therapeutic effect. Thus, the Federal Circuit found that the isolated NR composition lacked any markedly different characteristic from its natural counterpart to make it patent eligible.
This case is a reminder that the isolation of a natural product, without specifically claiming a feature that distinguishes the isolated product from its natural counterpart, is insufficient for subject matter eligibility in the US. Claiming natural products in a patent eligible manner requires that the claim recites a markedly different characteristic from the product of nature in its natural state. Markedly different characteristics can be pharmaceutical functions or activities, chemical properties, functional characteristics, or the like.
In the present case, the Applicants did not sufficiently claim the composition’s characteristics that differentiated it from its natural counterpart. If the Applicants had recited a specific concentration/quantity of isolated NR needed to increase NAD+ biosynthesis, a bioavailability requirement, a need for NR to be separated from lactalbumin whey protein, or a required mechanism for NAD+ biosynthesis—the Federal Circuit likely would have considered the claimed composition as patent eligible subject matter. Although these differences were stated in the ‘807 Patent’s specification, it is the claims that must be directed towards patent eligible subject matter. Applicants attempting to patent a composition that includes a natural product should therefor make sure to include language in the claims that is directed towards a specific characteristic the claimed composition possesses that the naturally occurring counterpart does not.