The Intellectual Property around Nicotinamide Riboside (NR), a form of vitamin B3, has been hotly contested for several years.
At the center of the disputes are US Patents 8,197,807 (the ‘807 patent) and 8,383,086 (the ‘086 patent) held by the Trustees of Dartmouth College and licensed to ChromaDex. Both entities have vigorously defended the validity of the patents as interest in the potential health benefits of NR have grown.
Thorne, which markets products formulated with nicotinamide riboside hydrogen malate (a different salt form to the nicotinamide riboside chloride form marketed by ChromaDex as Niagen), had challenged both patents, requesting an inter partes review (IPR). The PTAB instituted Thorne’s requested IPR of the ’086 patent on June 10, 2021, and the IPR of the ‘807 patent on August 12, 2021.
The decision on the ‘086 patent was issued earlier this year, with PTAB ruling in favor of Thorne that a key claim in the patent was in fact unpatentable. This decision has since been appealed by Dartmouth.
On August 10, 2022, PTAB ruled in favor of Dartmouth on the ‘807 patent.
Paul Jacobson, CEO of Thorne, told NutraIngredients-USA, that Thorne has yet to decide if it will appeal the decision in the ‘807 dispute.
“There’s just over three years left on this patent’s life,” he added, noting that the patent is anticipated to expire in April 2026.
There is also a lawsuit in the US District Court for the Southern District of New York involving ChromaDex and Dartmouth (Plaintiffs) and Thorne Research (Defendant), which alleges Thorne infringed on the ‘807 and ‘086 patents. The case had been stayed pending the decision of the IPR.
Commenting on the most recent PTAB decision, Rob Fried, the CEO of ChromaDex, said: “We continue to strongly advocate for nicotinamide riboside chloride (NR) and its benefits for healthy aging, cellular health, and overall wellness. We are pleased with the PTAB’s decision upholding the validity of the ‘807 patent for NR.
“ChromaDex is a leader in the industry, having received New Dietary Ingredient (NDI) status for our product Niagen from the U.S. Food and Drug Administration (FDA) as well as a Generally Recognized as Safe (GRAS) No Objection Letter for Nicotinamide Riboside Chloride (NR) in 2015.
“While it is important that we protect our intellectual property, we are always open to business relationships with entities that represent the science accurately and honor their obligations.”
All eyes on the Delaware appeal
Regular readers of NutraIngredients-USA will remember that a judge in US District Court for the District of Delaware ruled last year that both ‘807 and ‘086 patents were invalid in a case between ChromaDex and New York-based Elysium Health because nicotinamide riboside is a naturally-occurring vitamin, and therefore patent ineligible (Alice Corp. Pty. v. CLS Bank Int 'l, 573 U.S. 208, 216 (2014)).
ChromaDex filed a notice of appeal on November 2, 2021, with both companies filing briefs earlier this year. Oral argument has not yet been scheduled.
One legal source suggested that the recent PTAB ruling in Dartmouth’s and ChromaDex’s favor for the ‘807 patent only comes into play if the Elysium ruling is reversed, and the patents are found to be valid again. Should the appeal be unsuccessful, the patents would be invalid.