Federal Circuit Weighs In On Patent Eligibility Of Isolated Vitamin

22 February 2023 PharmaPatents Blog
Author(s): Courtenay C. Brinckerhoff

It has been a while since the Federal Circuit weighed in on the patent eligibility of so-called “natural product” claims. While the finding of non-eligibility in ChromaDex, Inc. v. Elysium Health, Inc. is not surprising, it is interesting that the court chose to distinguish Natural Alternatives instead of characterizing that decision as being based on a unique procedural posture.


The Patent At Issue

The patent at issue in ChromaDex was U.S. Patent No. 8,197,807, which ChromaDex (as licensee) and the Trustees of Dartmouth College (as patent owner) had asserted against Elysium Health. As summarized in the Federal Circuit decision, the ’807 patent is directed to “dietary supplements containing isolated nicotinamide riboside (“NR”)” which is “a form of vitamin B3 naturally present—in non-isolated form—in cow’s milk and other products.” As also explained in the opinion, “Animal cells convert ingested NR into the coenzyme nicotinamide adenine dinucleotide, or NAD+,” deficiencies of which “can cause diseases in both animals and humans.”

The court considered claim 1 as representative:

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 increased NAD+ biosynthesis upon oral administration.

The District Court Proceedings

The district court construed “isolated”  NR to mean NR “that is separated or substantially free from at least some other components associated with the source of [NR],” and granted Elysium’s motion for summary judgment of invalidity under 35 USC § 101.

The Federal Circuit Decision

The Federal Circuit decision was authored by Judge Prost and joined by Judges Chen and Stoll.

The opinion starts by comparing the subject matter of the claims to naturally occurring milk, and finds that “[t]he claims are very broad and read on milk.” According to the opinion, the parties did not dispute that milk contains NR and also “tryptophan and lactose, a sugar.” According to the opinion, the parties also did not dispute that “the tryptophan in milk treats NAD+ deficiencies.” In reaching its decision, the court found that “milk is formulated for oral administration;” thus, the only difference between milk and the claimed composition was the claims’ recitation of “isolated” NR. 

Applying the Supreme Court decisions in Myriad and Chakrabarty, the court cited Myriad for the proposition that “the act of isolating the NR compared to how NR naturally exists in milk is not sufficient, on its own, to confer patent eligibility.” According to the opinion, Chakrabarty defines the relevant eligibility inquiry as follows:

[T]o be patentable, the claimed composition must “ha[ve] markedly different characteristics and have the potential for significant utility.”

Since milk exhibits the same function as the claimed compositions of increasing NAD+ biosynthesis upon oral administration, the court concluded, “The claimed compositions do not exhibit markedly different characteristics from natural milk and are, therefore, invalid for claiming a patent-ineligible product of nature.”

Distinguishing Natural Alternatives

The opinion distinguishes Natural Alternatives, where, “claims directed to dietary supplements containing beta-alanine” were upheld against an eligibility challenge at the motion to dismiss stage. The opinion characterizes the decision in Natural Alternatives as being based on a conclusion that “the patents there claimed ‘specific treatment formulations that incorporate[d] natural products’ and that those formulations ‘ha[d] different characteristics and c[ould] be used in a manner that beta-alanine as it appears in nature cannot.’” In particular, the “‘natural products ha[d] been isolated and then incorporated into a dosage form’” at a specific dose (“between about 0.4 grams to 16 grams”) that “‘effectively increased athletic performance.’” According to the ChromaDex opinion, “Those markedly different characteristics distinguished the claimed supplements from natural beta-alanine and preserved the claims’ validity.”

Turning back to the claims at issue in ChromaDex, the court noted that they “do not require any minimum quantity of isolated NR,” and do not “attribute the claimed increase in NAD+ biosynthesis to the isolated NR.” The court also noted that other points of distinction raised by the patentees were not reflected in the claims, such as the amount of NR present in the composition and its bioavailability. The bottom line boiled down to this principle:

Because the claims are broad enough to encompass a product of nature, it is invalid under § 101.

Following The Alice/Mayo Steps

The opinion also considered eligibility under “the Alice/Mayo two-step framework”:

[A]t step one we conclude the asserted claims are directed to a product of nature for the reasons stated above, and at step two the claims lack an inventive step because they are directed to nothing more than compositions that increase NAD+ biosynthesis, which is the very natural principle that renders the claims patent-ineligible.

In a line that gets to the frustrating heart of the current state of U.S. patent eligibility for “natural products,” the court explained that “recognizing the utility of NR is nothing more than recognizing a natural phenomenon, which is not inventive.”

Should The Patent Attorneys Have Known Better?

Assessing these claims today, the outcome is not surprising, but I disagree with the statement in this PatentlyO article that “the patent drafter should have been aware of Chakrabarty (1980)” and drafted the patent differently. That assertion ignores the sea change in U.S. patent eligibility jurisprudence wrought by Myriad and its progeny, the fact that prior to Myriad using the term “isolated” was sufficient to distinguish product claims from otherwise corresponding products of nature, and the fact that two out of three Federal Circuit judges held that Myriad’s “isolated” DNA claims were eligible for patenting under §101. It took the Supreme Court 33 years to interpret Chakrabarty as setting forth a “markedly different characteristics test” for eligibility under § 101 and to apply that test in a manner that invalidated “isolated” DNA claims. I would not blame the patent attorneys for failing to foresee a decision that cast doubt on the validity of thousands of patents that had been granted pursuant to longstanding examination practices and the understanding that any claim language reflecting the “hand of man” (such as “isolated”) was sufficient to satisfy the patent eligibility requirement of § 101. But that’s just my not unbiased opinion.
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