Borrowed Science Or Data Piracy?

‘Borrowing’ is really a kind word for ‘stealing.’

By Anthony L. Almada

The low hanging fruit on the nutraceutical technology tree is picked and picked over, with some now rotting on the ground and others continuing to provide some “nourishment.” Case in point: L-carnitine. Long promoted for its “fat burning” ability, it lacks any com­pelling scientific validation in humans. One study appearing in an Asian journal and using less than sensitive and specific techniques to measure body fat found a mild fat reducing ef­fect of a carnitine-containing weight loss program, but no other studies have.

The “C” for carnitine may soon become the “Three C’s” following research published by scientists from the University of Tennessee at Knoxville. They found the com­bination of caffeine, cho­line and carnitine, in greater than human-consumed doses, produced re­ductions in body fat equal to that of exercise. Another “dream away the fat” promise? Not quite, as these studies were done in young male rats. A recent report from the same group attributes this to increased fat burning. What will be exciting to see unfold is the transfer of this technology into the marketplace, whether it truly operates in humans and how this composition technology will be managed and insulated (given the proliferation of fat loss/burner products that use carnitine) in the market.

Insulation against knock-offs and “borrowed science” is a big topic within the natural products industry. A short while ago the phrase “borrowed science” elicited laughter at industry meetings. Now it is the subject of litigation and a new competitive advantage. Before we address that, I’m going to suggest adoption of a new phrase: “data piracy.” Companies don’t “borrow” science from oth­er companies. When was the last time you heard of a CEO coming to the front office of a competitor holding an empty file folder and asking if he could borrow some ginkgo or bilberry science, as if it were a cup of sugar? And like the neighbor who is friendly only when HE needs something, this company exec would never think of “returning” with a folder of his own science to share. Science is stolen and the thank you letters are never sent.

This is an exceptionally dicey subject when we are talking about specific, unimolecular entities that are completely characterized. Science on vitamin C, L-carnitine base, curcumin and creatine (the 4 C’s…) is science on a commodity type ingredient. They lack a proprietary umbrella. The patent around chromium picolinate is different in that it is a patent on the actual molecule, thus the enforcement campaign by its licensees.

Throw in botanicals (and their less than pure extracts) and we have a whole new set of colors on the wall. These polymolecular phytochemical “soups” are complex and essentially unique, with no one product being the same as another unless the extraction method and plant biomass used are identical. Ginkgo from Company X is not the same as ginkgo from Company A, even though they both share the same marker compound profile. If Company X’s product is clinically validated and the data published, can Company A use the same data in its marketing and collateral sales materials?

A recent U.S. district court case brought this point home—hard. Pharmanex’s “Cholestin” red yeast rice extract has been the subject of several published clinical trials. Another company, marketing “Cholestene” red yeast rice, engaged in data piracy with Cholestin’s data. The Utah court ruled in favor of Pharmanex, enjoining the competitor knock-off from referring to Pharmanex’s data. This could be a land­mark case in that it sets the pre­cedent for deterrence of data piracy. Moreover, it lays a strong foundation for a pipeline wherein one’s investment in research on a proprietary product can return back to the source a competitive, differentiating advantage. Visionary, research-driven companies should leverage this decision to the maximum.

NW

Anthony L. Almada is the founder and chief scientific officer of IMAGINutrition and MetaResponse Sciences, two elite nutritional technology companies. He excels in potentiating intellectual property, product development, scientific validation and creating powerful data-driven demand campaigns. Mr. Almada can be reached at 9053 Soquel Drive, Suite 202, Aptos, CA 95003; 831-662-6930; Fax: 831-662-7933; E-mail: [email protected].