Milk Vitamin Patents Surprisingly Soured By Section 101

Published: 2022-01-19 03:13:05 ET CDXC

On Sept. 21, 2021, the U.S. District Court for the District of Delaware granted summary judgment that two formulation patents were directed to patent-ineligible subject matter.1 The two ChromaDex patents concern compositions and pharmaceutical formulations of nicotinamide riboside, or NR, a vitamin present in cow's milk, for oral administration.

The ChromaDex Inc. v. Elysium Health Inc. decision was particularly surprising since the compositions and formulations at issue do not exist in nature and the U.S. Court of Appeals for the Federal Circuit and district courts have generally upheld patent claims to formulations of natural compounds under Title 35 of the U.S. Code, Section 101.

Both ChromaDex patents also survived challenges in inter partes review proceedings. The Patent Trial and Appeal Board denied institution of IPR for one of the patents, and it upheld a challenged claim in the other patent as valid.2 3

The ChromaDex litigation goes back to September 2018, when ChromaDex filed an action alleging that Elysium's dietary supplement Basis infringed its patents. Both ChromaDex and Elysium market their products as anti-aging supplements, and NR has been touted as the "Fountain of Youth."4 5 6

Since the discovery of the potential anti-aging benefits of NR, ChromaDex's dietary supplement generated much enthusiasm and has been featured in publications such as Forbes, GQ, Entrepreneur and Shape. NR has been the subject of numerous studies to investigate its health benefits, including for the treatment of neurological disorders, cancer and even COVID-19. 7 8

Elysium had taken a license to the two formulation patents but stopped making payments, which prompted ChromaDex to file a breach of contract action.9 ChromaDex later sued Elysium for patent infringement. Elysium filed motions for summary judgment on several issues, including noninfringement, indefiniteness and invalidity under Section 101.

Two weeks before trial, the district court granted Elysium's motion for summary judgment under Section 101. It found the asserted claims to be patent-ineligible under the U.S. Supreme Court's 2014 two-step framework in Alice Corp. v. CLS Bank International.10

ChromaDex Analysis of Alice Step One

The district court held the asserted claims are directed to a natural phenomenon because NR is a naturally occurring vitamin present in cow's milk.11

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."12

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" are not required by the claims.13 It found that "[n]othing in the language of the asserted claims or the patent's intrinsic evidence suggests that the claims require these characteristics" and the characteristics "do not distinguish isolated NR in the claimed compositions from NR found in milk" in any event.14

The court analogized the ChromaDex formulation claims to those in Association for Molecular Pathology v. Myriad Genetics Inc., where claims to DNA isolated from its natural setting were held to be patentineligible.

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Footnotes

1. ChromaDex, Inc. et al., v. Elysium Health, Inc., No. CV 18-1434-CFC-JLH, 2021 WL 4286527 (D. Del. Sep. 21, 2021) ("ChromaDex").

2. Elysium Health Inc. v. Trustees of Dartmouth College, No. IPR2017-01795, Paper No. 39 (P.T.A.B. Jan. 16, 2019), aff'd, 196 Fed. App'x 745 (Fed. Cir. 2020).

3. Elysium Health Inc. v. Trustees of Dartmouth College, No. IPR2017-01796, Paper No. 9 (P.T.A.B. Jan. 18, 2018).

4. https://time.com/5159879/is-an-anti-aging-pill-on-the-horizon/.

5. https://www.truniagen.com/.

6. https://www.elysiumhealth.com/products/basis/?gclid=EAIaIQobChMI5M7RuczI9AIVq_7jBx2mkwnD EAAYASAAEgJAzfD_BwE.

7. https://www.medrxiv.org/content/10.1101/2020.10.02.20202614v1.

8. https://www.aboutnad.com/scientific-analysis (studies relating to NR curated by ChromaDex Corp.)

9. ChromaDex, Inc. v. Elysium Health, Inc., Case No. 8:16-cv-02277-CJC (DFMx), Dkt. No. 570, Jury Form at 2-11 (C.D. Cal. Sept. 27, 2021). In September 2021, a jury found in favor of ChromaDex on certain claims, and in favor of Elysium on counterclaims.

10. ChromaDex at *5.

11. Id. at *4.

12. Id.at *3.

13. Id.

14. Id.

Originally published by Law.com

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Ms Irena Royzman Kramer Levin Naftalis & Frankel LLP 1177 Avenue Of The Americas New York NY 10036 UNITED STATES Tel: 2127159100 Fax: 2127158000 E-mail: [email protected] URL: www.kramerlevin.com