Hugel’s Botulax botulinum toxin product
Hugel’s Botulax botulinum toxin product

The U.S. International Trade Commission (ITC) has rejected a summary judgment application by Hugel, which had asserted that there was no dispute in its ongoing legal battle with Medytox over the source of a botulinum toxin strain.

According to industry sources on Feb. 1, the ITC’s decision to deny Hugel’s application came on Jan. 30 (local time), though the specifics remain confidential.

Medytox and Hugel have been embroiled in litigation since March 2022 over the origins of the botulinum toxin strain needed for the production of their respective formulations. The lawsuit has involved DNA testing of the botulinum toxin strain, along with the submission and approval of evidence and witnesses.

Hugel had applied for a summary judgment to the ITC in December 2023, following consultations with Medytox, who opposed the application. Hugel argued for summary judgment on the grounds that Medytox experts failed to prove that Hugel’s strain originated from Medytox. Hugel criticized Medytox for inappropriately focusing on whether its strain was derived from a canned source.

Additionally, Hugel claimed that Medytox lacked non-genetic evidence to support allegations of strain theft and modification, highlighting a lack of evidence in Medytox’s claims regarding the theft and modification of the strain.

Despite Hugel’s request for a summary trial, the ITC investigative staff recommended that the application be denied, leading to the administrative judge’s dismissal of the summary judgment request.

A preliminary decision in this lawsuit is expected on June 10, with Medytox and Hugel set to go through pre-hearing conferences, evidence hearings, and the submission of final lists of evidence. According to the ITC, a final decision is anticipated by Oct. 10.

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