ChromaDex bolsters IP protection around pTeroPure with memory, sun damage patents

By Hank Schultz contact

- Last updated on GMT

Related tags: Ceo frank jaksch, Food and drug administration, Chromadex

ChromaDex uses images of blueberries in its marketing for pTeroPure, but the ingredient itself is a synthesized, bioidentical version of pterostilbene.
ChromaDex uses images of blueberries in its marketing for pTeroPure, but the ingredient itself is a synthesized, bioidentical version of pterostilbene.
ChromaDex has bolstered the IP protection around pTeroPure, one of its branded ingredients, with the announcement of two patents relating to pterostilbene, which are the second and third patents granted to the company on the ingredient.

“It provides considerable value to use in protecting our investment in the branded ingredient by having a patent portfolio underlying it.  It prevents other companies coming in with some hack material.  We have made considerable investments in filing patents but also in conducting clinical studies,”​ Chromadex CEO Frank Jaksch told NutraIngredients-USA.

Memory, skin damage

One of the patents,  #8,809,400 B2​ (referred to as the '400 patent) is titled "Method to Ameliorate Oxidative Stress and Improve Working Memory Via Pterostilbene Administration,” and relates to a method of using pterostilbene to forestall, prevent and reverse the effects of neuronal and behavioral aging and the development of neurodegenerative diseases. Specifically, pterostilbene is shown in research studies to be effective in reversing motor deficits and working memory of subjects. The patent application was initially filed in August 2011 by the U. S. Department of Agriculture (USDA). Subsequently, ChromaDex was granted an exclusive worldwide license to all rights of the pterostilbene patent from the University of Mississippi and the Agricultural Research Service (ARS), which is USDA's principal intramural scientific research agency. The term of the license is up to and including the expiration of various pterostilbene patents and pending patents held by the licensors.

Agnes Rimando, PhD is one of the co-inventors of the patent.  Rimando first began working with pterostilbene (first isolated from red sandalwood) as a graduate student at the University of Illinois-Chicago in the 1990s and continued her work at the USDA-ARS Natural Products Utilization Research Unit, housed in the University of Mississippi Thad Cochran Research Center. Dr. Rimando's pterostilbene studies led to the discovery of its presence in blueberries, as well as the finding that the ingredient activates a protein involved in fatty acid metabolism.

The other patent,  #8,841,350 B2​ (referred to as the '350 patent), relates to a method of administering an effective amount of pterostilbene to a subject in order to suppress or prevent the progression of a precancerous disease (associated with photodamage to the skin) to non-melanoma skin cancer by inducing UDP-glucuronosyltransferase (UGT) activity. UGT is an enzyme responsible for the process of glucuronidation, which changes unwanted compounds into a more water-soluble version to allow for easier elimination from the body. It is known that UGTs prevent melanoma invasiveness by eliminating toxic compounds and are lost during melanoma progression.

The University of California Irvine (UCI) and ChromaDex jointly filed this pterostilbene patent application in May 2012 and, subsequently, ChromaDex was granted an exclusive worldwide license to all rights in the patent.

Relating patents to claims

Jaksch said ChromaDex is well aware that these patents tread on dangerous ground when it comes to making claims on the effects of a dietary supplement.  This is especially true for the 350 patent, which would probably be of no use at all in marketing a supplement.  A compliant claim along the lines of supporting normal short term function could probably be crated around the 400 patent.  But Jaksch said ChromaDex has wider ambitions for pTeroPure.

“We want to make sure we are protecting a potential use,”​ Jaksch said. “You can file an IND (Investigational New Drug application) on almost anything, but you have to do it in the right way.”

Jaksch pointed to the example of Star Scientific (now doing business as Rock Creek Pharmaceutical) as an example of what can go wrong if a company doesn’t plan its supplement-to-pharmaceutical strategy in the right way.  Rock Creek eventually had to take its ingredient anatabine citrate off the supplement market and pursue a drug-only strategy after FDA determined that it had filed an IND without having first had the ingredient legally on the market as a supplement ingredient.  The regulations state that a supplement ingredient can subsequently be developed as a pharmaceutical agent, but not the other way around.

ChromaDex launched a dietary supplement line called BluScience that featured pTeroPure.  The company sold that business to Canadian firm NeutriSci International, but retains rights to the ingredient itself.

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