ChromaDex – A Man-Made Dietary Supplement can also be a Naturally-Occurring Product

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The United States Court of Appeals for the Federal Circuit recently affirmed a trial court’s decision that a claimed dietary supplement is patent-ineligible subject matter under 35 U.S.C. §101 because the supplement includes isolated nicotinamide riboside, which is a naturally-occurring vitamin present in cow’s milk. The ChromaDex decision is an important reminder that extra care is required when claiming inventions with strong similarities to any naturally-occurring materials.

In ChromaDex, Inc., Trustees of Dartmouth College (“ChromaDex”) v. Elysium Health, Inc.,[1]the United States Court of Appeals for the Federal Circuit (CAFC) affirmed a district court’s decision finding a claimed dietary supplement to be patent-ineligible subject matter under 35 U.S.C. §101. The claimed dietary supplement includes isolated nicotinamide riboside, which is a naturally-occurring vitamin present in cow’s milk. The court found the claims to be too close to the corresponding natural product and thus ineligible subject matter. The ChromaDex decision is an important reminder that patent applicants should be especially careful when claiming inventions with strong similarities to any naturally-occurring products. 

From cutting-edge medicines to the latest health food, innovative products often rely on components and products found in nature to provide their distinguished features. In seeking patent protection of such products, some patent applicants find themselves in an unfortunate situation where their patents are rendered invalid by claiming too closely to a naturally-occurring counterpart. In ChromaDex,the district court found that a claimed dietary supplement directed to isolated nicotinamide riboside (NR) was a naturally-occurring vitamin and therefore ineligible. Does this holding mean that no dietary supplements are eligible for patenting? 

35 U.S.C. § 101 of the U.S. patent statute defines four statutory categories of inventions: (1) processes, (2) machines, (3) articles of manufacture, and (4) compositions of matter. In Alice Corp. Pty. Ltd. v. CLS Bank Int’l, the U.S. Supreme Court articulated several judicially recognized exceptions to patenting (i.e., “judicial exceptions”). Judicial exceptions are particular subject matter recited in a claim that are considered to be exceptions to the four statutory categories of inventions. Examples of judicial exceptions include abstract ideas, laws of nature, and natural phenomena.  For a naturally-occurring product, the Supreme Court previously established in Diamond v. Chakrabarty that a claimed product having markedly different characteristics over its naturally-occurring counterpart does not fall within any judicial exceptions. In other words, the dietary supplement at issue in ChromaDex would be patent eligible if the supplement had markedly different characteristics from cow’s milk or its components.

The “markedly different characteristics analysis” compares the claim limitations of the claimed product to its naturally-occurring counterpart in its natural state. Examples of markedly different characteristics include differences in structures, chemical properties, and functions. Under this analysis, an artificially-created product which does not differ from its natural counterpart functionally, physically, or structurally would be considered to be directed to a judicial exception. 

When preparing a patent application, several important considerations should be taken into account for avoiding future eligibility issues when the claimed product has similarities to a naturally-occurring product. First, a patent applicant should analyze the initial claims to determine if any claimed feature might fall within a judicial exception.  As an illustrative example, the United States Patent and Trademark Office (PTO) provides an Example 1 for Nature-Based Products, which has an exemplary claim directed to a firework.[2] While the claimed firework is shown to contain several naturally-occurring products (e.g., calcium chloride and gunpowder, which is a composition of potassium nitrate, charcoal and sulfur), the PTO concludes that the “claim is focused on the assembly of components that together form the firework” and thus, it is not necessary to apply the markedly different characteristics analysis.  For patent applicants, there is no question that a firework is not a naturally-occurring product.  However, a claimed composition containing calcium chloride, i.e., a naturally-occurring product, could run afoul of patent eligibility outside the context of a firework or other man-made manufacture. 

In addition, patent applicants may want to consider explicitly identifying limitations that provide markedly different characteristics for a claimed product. In particular, these identified  limitations may be described in the specification as being distinct from a naturally-occurring product.  Also, dependent claims can also be used to clarify any claim term necessary to render a claimed product markedly different from the similar naturally-occurring product. For instance, a structurally and chemically indistinguishable natural-occurring component in a composition could nonetheless be considered as eligible if the component provides a different function than the naturally-occurring component. This different function may provide a new benefit or advantage to a user not found in the naturally-occurring product.  Likewise, the different function may also exist with respect to other claimed components, such as to improve structural stability of a claimed combination.  Conversely, a claimed component could be considered eligible if an individual component is shown to have a structurally different feature, even if the function of the individual component is identical to that of the naturally-occurring counterpart.  

In identifying markedly different characteristics, it should be noted that the analysis is conducted specifically on the characteristics of the claimed product. In other words, a mixture containing a naturally-occurring product A and non-naturally-occurring product B may be analyzed for markedly different characteristics only based on product A. If product A is found to fall within the judicial exception, the mixture would also be considered ineligible unless product B provides additional features to the mixture that add significantly more than product A. 

For some patent applications, it may be also helpful to identify unexpected changes in the characteristics of a composition based on including a particular naturally-occurring component. For example, patent applicants may show that specific advantageous effects can only be obtained by including certain limitations to the composition, such as a specific content range of the component within the composition.

Returning to ChromaDex, the patent owner argued that the isolation of nicotinamide riboside (NR) allows for significantly more nicotinamide adenine dinucleotide (NAD+) biosynthesis than is found in milk, and that the large quantity of NR itself can alone increase NAD+ biosynthesis. However, the CAFC explained that the asserted claims do not have characteristics markedly different from milk because the claims do not require any minimum quantity of isolated NR nor do these claims attribute the claimed increase in NAD+ biosynthesis to the isolated NR. ChromaDex suggests that if the quantity of NR were included in the claims, and that specific effects of increase NAD+ biosynthesis were attributed to specific quantity of NR in the composition, the outcome of the markedly different characteristic analysis may have been different. 

Moreover, patent applicants may consider including an embodiment with a man-made product in the claims or the specification. This man-made product could provide a feature that is “significantly more” than any naturally-occurring product alone.  This man-made product may prove useful in situations where identification of markedly different characteristics is found to be difficult.  For example, a composition that includes a naturally-occurring product and an artificial preservative may be considered eligible if the preservative is shown as providing a food preservation effect. The food preservation effect could be considered significantly more than the naturally-occurring product alone.  

Finally, the patent applicant may consider drafting process claims rather than only claiming a particular manufacture or composition that contains a naturally-occurring product.  For example, the patent owner in ChromaDex also owned U.S. Patent No. 11,524,022, which included claims directed to a method for delivering at least one NR compound to an infant mammal subject. Some examples of method claims may include methods of use, such as in a specific medical treatment, or particular methods of manufacturing a product with the naturally-occurring product. While method claims can also be held ineligible by being directed to a natural law, method claims may be more easily directed to practical applications that can overcome potential eligibility issues. 

In conclusion, a care should be taken in preparing a patent application for an invention directed to a product that includes any components found directly in nature. With proper planning, claim rejections based on such judicial exception pitfalls can be avoided accordingly.