ChromaDex Milk Vitamin Formulation Patents Soured by Section 101

Kramer Levin Naftalis & Frankel LLP

On Sept. 21, 2021, the U.S. District Court for the District of Delaware granted Elysium’s motion for summary judgment that two ChromaDex formulation patents were directed to patent-ineligible subject matter under 35 U.S.C. § 101. ChromaDex, Inc. et al. v. Elysium Health, Inc., Civil Action No. 18-1434-CFC-JLH, 2021 WL 4286527, at *1 (D. Del. Sep. 21, 2021) (ChromaDex). The two ChromaDex patents, U.S. Patent Nos. 8,197,807 and 8,383,086, concerned compositions and pharmaceutical formulations of nicotinamide riboside (NR), a vitamin present in cow’s milk, for oral administration.

The ChromaDex litigation goes back to September 2018, when ChromaDex filed an action alleging infringement by Elysium’s dietary supplement BASIS® that includes NR. Both ChromaDex and Elysium market their products as anti-aging supplements, touted as the “Fountain of Youth.” Prior to the infringement action, Elysium had licensed the asserted patents but stopped making payments, leading to a separate breach of contract action in California.

In 2017, Elysium filed IPR petitions challenging the validity of the patents. The Patent Trial and Appeal Board did not institute IPR of the ’807 patent but instituted IPR of the ’086 patent and upheld one of the challenged claims as valid. ChromaDex asserted both patents in the Delaware litigation, and Elysium filed motions for summary judgment of non-infringement, indefiniteness and invalidity under 35 U.S.C. § 101. Two weeks before trial, the district court granted Elysium’s motion for summary judgment under Section 101. Specifically, the court found the composition and pharmaceutical formulation claims of both patents patent ineligible under the Supreme Court’s Alice two-step framework.

Alice Step One

The court held the asserted claims are directed to a natural phenomenon because NR is a naturally occurring vitamin present in cow milk. ChromaDex argued the “correct inquiry” is “whether compositions of the Asserted Claims have different characteristics and can be used in a manner” not used “in nature.” ChromaDex at *3. The court disagreed, explaining that “the characteristics of the isolated NR in the claimed compositions that ChromaDex has identified as being different from the characteristics of NR in milk—i.e., stability, bioavailability, sufficient purity, and therapeutic efficacy—are immaterial to the Alice inquiry because none of these characteristics are required by the claims.” Id. It held that “[n]othing in the language of the asserted claims or the patent’s intrinsic evidence suggests that the claims require these characteristics” and that the characteristics “do not distinguish isolated NR in the claimed compositions from NR found in milk.” Id. The court analogized the ChromaDex claims to those in Myriad, where claims to DNA isolated from its natural setting were held to be patent ineligible subject matter.

Alice Step Two

The court found the asserted claims did not contain an inventive concept. It relied on the statement in the patents’ shared specification that compositions containing NR “can be prepared by methods and contain carriers which are well-known in the art.” Id. at *4. ChromaDex argued the inventive concept was the recognition of the utility of NR for “enhancing health and well-being.” Id. at *5. However, the court found recognizing the benefit of a natural product is not sufficient to rise to the level of an “inventive concept.” The court also was not convinced that therapeutic application of NR was inventive because “NR’s oral bioavailability is an inherent property of NR and thus is itself a natural phenomenon,” and stated that mere application of a natural phenomenon is not inventive. Id. (citing Mayo for the proposition that more than an instruction to “apply it” is necessary to “transform an unpatentable law of nature into a patent-eligible application of such a law”).

The ChromaDex decision is notable for its holding that claims directed to compositions and pharmaceutical formulations — compositions and formulations that do not exist in nature — are not patent eligible under Section 101. Other courts have rejected Section 101 challenges to formulations of natural compounds. See e.g., United Cannabis Corp. v. Pure Hemp Collective Inc., No. 18-CV-1922-WJM-NYW, 2019 WL 1651846, at *6–7 (D. Colo. Apr. 17, 2019) (claimed formulations containing cannabinoids for oral or topical administration were not directed to a natural phenomenon because they covered a non-naturally occurring delivery method for naturally occurring chemicals in non-naturally occurring proportions and concentrations); ThermoLife Int’l, LLC v. Hi-Tech Pharms., Inc., No. 1:15-CV-00892-ELR, 2020 WL 9601785, at *5 (N.D. Ga. May 29, 2020) (claimed compositions have “markedly different characteristics from their naturally occurring counterparts” because the compositions exhibited properties of better circulation and distribution and improved water solubility); Ex parte Christopher M. Lockwood, No. APPEAL 2020-005549, 2021 WL 2026317, *5–6 (P.T.A.B. May 20, 2021) (overturning Examiner’s Section 101 rejection because even though the specific formulation consisted of “bovine colostrum and whey-protein hydrolysate…[the claims] have different characteristics” and can be used “in a manner that the natural products, as they appear in nature, cannot”).

Congress has sought input on the current state of patent-eligibility jurisprudence and its effect on investment and innovation, and the U.S. Patent and Trademark Office is in the process of collecting comments from stakeholders. The application of the Alice two-part test to pharmaceutical formulations of natural products will, as was the case in ChromaDex, certainly be part of these discussions.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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