Sterne Kessler Director Sounds Warning Over “Scary” Food Supplement Threat

Sterne Kessler Director Paul Ainsworth spoke with Managing IP on the recent settlement for client IntraBio in the company’s patent dispute against Tesseract Medical Research. Ainsworth discussed why medical claims by dietary supplement companies, such as Tesseract, can threaten IP rights.

The case focused on IntraBio’s drug Aqneursa containing the active ingredient N-acetyl-L-leucine (NALL) used to treat neurological disorders that affect cognition, fine motor skills, and speech. Tesseract had its own dietary supplement containing NALL marketed for neurological support and therapeutic benefits, which Ainsworth said, “never received any kind of approval” from the U.S. Food and Drug Administration (FDA).

The lawsuit was settled on August 1^st, with Tesseract agreeing to suspend any marketing and sales of their product until IntraBio’s patents expire.

Ainsworth explained, “They were out there marketing it as something you could use in the place of a drug that cost my client millions of dollars to get FDA approval for.” He added, “Once we established what they were doing and what they were marketing, it was a straight infringement analysis to show that they were promoting their product for uses that we have extensive patent protection for.”

Ainsworth detailed the danger of marketing a dietary supplement in this way, “The risk here for the company is that its product treats certain rare diseases, and it’s expensive to bring to the market. The idea that something can circumvent all the exclusivity protections we have and be marketed as a dietary supplement is scary.”

“I think this is a good example of how IP can help any company protect its investments against what is ultimately unfair competition by third parties,” Ainsworth concluded.