ChromaDex Milk Vitamin Formulation Patents Aggravated By Section 101 | Kramer Levin Naftalis & Frankel LLP


On September 21, 2021, the U.S. District Court for the District of Delaware allowed Elysium’s summary judgment motion claiming two ChromaDex formulation patents for subject matter ineligible for patent under 35 USC § 101. ChromaDex, Inc. et al. v. Elysium Health, Inc., Civil action n ° 18-1434-CFC-JLH, 2021 WL 4286527, at * 1 (D. Del. 21 Sept. 2021) (ChromaDex). The two ChromaDex patents, U.S. Patent Nos. 8,197,807 and 8,383,086, relate to pharmaceutical compositions and formulations of nicotinamide riboside (NR), a vitamin found in cow’s milk, for oral administration.

The ChromaDex the litigation dates back to September 2018, when ChromaDex filed an action alleging infringement of Elysium’s BASIS® dietary supplement which includes NR. ChromaDex and Elysium both market their products as anti-aging supplements, touted as the “fountain of youth”. Prior to the infringement action, Elysium had licensed the claimed patents, but stopped making payments, resulting in a separate breach of contract action in California.

In 2017, Elysium filed for IPRs challenging the validity of the patents. The Patent Trial and Appeal Board did not institute IPR of the ‘807 patent but instituted the IPR of the’ 086 patent and confirmed one of the disputed claims as valid. ChromaDex claimed both patents in the Delaware litigation, and Elysium filed summary judgment motions of non-infringement, indeterminacy and invalidity under 35 USC § 101. Two weeks before trial, the court in district granted Elysium’s motion for summary judgment under Section 101. Specifically, the court found that the composition and pharmaceutical formulation claims of the two patents were inadmissible under the Supreme Court ruling Alice two-step framework.

Alice The first step

The court ruled that the alleged allegations concerned a natural phenomenon, as NR is a natural vitamin found in cow’s milk. ChromaDex argued that the “right claim” is “whether the compositions of the advanced claims have different characteristics and can be used in a way” not used “in nature”. ChromaDex to 3. The tribunal disagreed, explaining that “the characteristics of the NR isolated in the claimed compositions that ChromaDex identified as being different from the characteristics of the NR in milk – i.e. stability, bioavailability, sufficient purity and therapeutic efficacy – are unimportant for the Alice investigation because none of these features are required by the claims. Username. He ruled that “[n]nothing in the language of the claimed claims or the inherent patent evidence suggests that the claims require these features “and that the features” do not distinguish the NRs isolated in the claimed compositions from the NRs found in milk “. Username. The court compared ChromaDex’s claims to those of Myriad, where the claims of DNA isolated from its natural environment were considered non-patentable subject matter.

Alice Second step

The court concluded that the claimed claims did not contain an inventive concept. It relied on the statement contained in the shared patent specification that compositions containing NR “may be prepared by methods and contain carriers which are well known in the art”. Identifier. at 4 o’clock. ChromaDex argued that the inventive concept was the recognition of the usefulness of NR in “improving health and well-being”. Identifier. at 5. However, the court considered that recognizing the advantage of a natural product was not sufficient to reach the level of an “inventive concept”. The court was also not convinced that the therapeutic application of NR was inventive because “the oral bioavailability of NR is an inherent property of NR and therefore is itself a natural phenomenon”, and stated that the mere application of a natural phenomenon is not inventive. Username. (citing Mayo for the proposition that more than an instruction to “apply” is necessary to “transform a law of a non-patentable nature into a patentable application of such a law”).

The ChromaDex The ruling is notable for its ruling that claims to pharmaceutical compositions and formulations – compositions and formulations that do not occur in nature – are not eligible for patent under Section 101. D ‘ other courts have dismissed Section 101 challenges against natural compound formulations. See, for example, United Cannabis Corp. vs. Pure Hemp Collective Inc., No. 18-CV-1922-WJM-NYW, 2019 WL 1651846, at * 6–7 (D. Colo. April 17, 2019) (The claimed formulations containing cannabinoids for oral or topical administration were not directed against a natural phenomenon because they covered an unnatural delivery method for natural chemicals in unnatural proportions and concentrations); ThermoLife Int’l, LLC v Hi-Tech Pharms., Inc., No. 1: 15-CV-00892-ELR, 2020 WL 9601785, at * 5 (ND Ga. May 29, 2020) (the claimed compositions have “characteristics markedly different from their natural counterparts” because the compositions exhibited properties of better circulation and distribution and improved solubility in water); Ex parte Christopher M. Lockwood, No. APPEAL 2020-005549, 2021 WL 2026317, * 5–6 (PTAB May 20, 2021) (overturning the rejection of Examiner’s Section 101 because even though the specific formulation consisted of “bovine colostrum and protein hydrolyzate whey …[the claims] have different characteristics ”and can be used“ in a way that natural products, as they occur in nature, cannot ”).

Congress To solicited comments on the current state of patent eligibility case law and its effects on investment and innovation, and the United States Patent and Trademark Office is seeking comments from parties stakeholders. The application of the Alice two-part test to pharmaceutical formulations of natural products will be, as was the case in ChromaDex, certainly be part of these discussions.

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