KSM-66 Manufacturer Sues Sensoril Maker for False Claims

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Los Angeles, CA – Ixoreal Biomed Inc., the manufacturer of KSM-66 ashwagandha extract, has expanded a suit against Sensoril producer Natreon and its distributor NutraGenesis, claiming false patent marking, defamation, product disparagement and tortious interference.

The new claims this week are on top of an earlier countersuit Ixoreal Biomed filed with the U.S. District Court for the District of New Jersey alleging false and deceptive advertising and unfair competition, following a lawsuit filed by Natreon against Ixoreal Biomed in 2016. Natreon’s suit claimed, among other things, that samples of KSM-66 contained milk allergens without stating it on the label, prompting Ixoreal Biomed to countersue.

When it comes to the allegations of milk allergens, Ixoreal denies the claim. KSM-66 comes in two versions, says KSM-66 CEO Kartikeya Baldwa, one that is pre-treated with milk consistent with traditional Ayurvedic practice and another version that is milk-free for vegan customers. “We not only communicate to every customer about the two variants when they contact us to buy KSM-66, we also provide them an appropriate allergen statement (based on the variant they use),” said Baldwa in response to these allegations in a previous article. “That we are trying to conceal the milk allergens, as the lawsuit seems to suggest, is flatly incorrect.”

In Natreon’s original lawsuit, claiming deceptive advertising and unfair competition, the suit alleged that Ixoreal manufactured an inferior product, but by marketing it as a superior product and selling it for a cheaper price than competitors, unfairly undercut other ashwagandha ingredients such as Sensoril. However, in their counterclaim alleging false and deceptive advertising and unfair competition, Ixoreal challenged Natreon’s integrity, citing documents from the Government of India showing Sensoril’s cost basis is about $25/kg but is sold in the U.S. at a 500% markup of about $150/kg.

“Natreon and Nutragenesis have been claiming for years that Sensoril comes from a patent-protected process, perhaps to get customers to pay so much,” Baldwa said in the prepared statement. However, the firm alleges that this patent is marketed deceptively.

“The single claim of this patent recites a process of making an extract composition using an ‘aqueousalcoholic’ solvent, and also involves treating its extract with chemicals such as chloroform,” states the counterclaim. “Yet Natreon and NutraGenesis also market Sensoril as being prepared by a ‘totally aqueous’, i.e. entirely with water, extraction process. If Sensoril is prepared by a ‘totally aqueous’ extraction process, then Natreon’s and NutraGenesis’s statements that Sensoril is manufactured by a process protected by this patent, or any of their other patents, are literally false.”

KSM-66’s lawsuit also alleges that Natreon and NutraGenesis falsely represent that Natreon is the only company with the right to make an extract from ashwagandha roots and leaves. “In reality, the Natreon Patents do not give it the exclusive right to make an ashwagandha extract using roots and leaves,” states the countersuit. “The claims in the Natreon Patents are directed to specific extract compositions and methods of making the extract compositions; the claims do not cover every process of making an ashwagandha extract using roots and leaves.”

Because of this root and leaf composition, KSM-66’s lawsuit also alleges that claims made by Natreon and NutraGenesis are unsupported, including that “Sensoril can assist in ‘effective weight management,’ can reduce the activity of a particular liver enzyme in order to boost energy levels; suppresses food cravings, speeds workout recovery time; stimulates anabolic muscle development’ increases metabolism; promotes the natural synthesis of performance enhancing hormones.”

“While studies using the ashwagandha root-only products have shown some of these effects, these studies cannot be used to justify similar claims for Sensoril because Sensoril is a phytochemically different root-and-leaf combination,” explains the countersuit.

For that matter, says Baldwa, Ixoreal’s suit also presents evidence against the claim by Natreon that Sensoril is patent protected under U.S. patent No. 6,153,198, “based on inconsistencies between the patent and Sensoril’s specification documents.”

Ixoreal also challenges Natreon’s claim that Sensoril is protected by European Patent EP 1569669 A2. “In reality, this application was withdrawn in 2012 and the European Patent was never issued,” alleges Baldwa in his statement. “False patent markings may mean [Sensoril customers] will have to recall or re-label every product that cites coverage by U.S. patent 6,713,092 B1 or U.S. patent 6,153,198 or European patent EP 1569669 A2.”

Ixoreal was relatively quiet about its countersuit, until now. “We are strictly against using lawsuits as a tactic. We prefer instead to compete based on what our customers value, which is by offering high quality products with excellent pricing and high transparency,” states Baldwa in a press release. “We took the high road and did not issue any counter press statements, because we respect the litigation process and chose to work quietly and diligently through the court system.”

However, Baldwa said the company chose to come forward at this time because of tactics by Natreon. Ixoreal alleges that Natreon continued to send email blasts and subpoenas to its customers, without waiting for the discovery responses from the parties and that the company tried to use industry press to cause confusion and issued a press release twice after serving its lawsuit.

When asked for a response by WholeFoods, Natreon CEO and Chairman Sanni Raju said the primary claims in its ashwagandha patents “are for composition, independent of the process… As long as the composition remains the same while using water as the solvent, we are covered by the primary claim. When people apply for patents, they do not have time to cover all the possible process parameters.

“Sensoril has been made with an aqueous process for several years now. There is no truth in the allegation that Sensoril is being made by an organic solvent extraction process,” he added.

Related Story: KSM-66 Secures Medicine Hunter for Ashwagandha Campaign

UPDATED 9/21/2017 9:42 AM

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