The U.S. Patent Trial and Appeal Board (PTAB) issued an order on Aug. 22 denying Hugel’s petition against Medytox to invalidate the latter’s U.S. patent on botulinum toxin (BTX).

This resurfaces the complaint filed by Hugel with the PTAB on Feb. 21, claiming that Medytox's patent (U.S. patent number: 11331598) on "Method of Isolating Botulinum Toxin from Botulinum Toxin-containing Solution," registered in the U.S. in May last year was invalid.

When filing the complaint in February, Hugel said that the patent in question was a generic manufacturing technology that lacked innovativeness and that patenting it would prevent other companies from entering the market and hinder industrial development.

Medytox argued to the PTAB that the patent should be upheld, and the PTAB agreed, finding that Medytox's patent claims demonstrated that the BTX complex is more efficiently separated in a pH range below the isoelectric point.

After the PTAB heard arguments from both sides, the PTAB issued an order denying the institution on Aug. 22, 2023. The order stated that Hugel had failed to properly demonstrate evidence to challenge the invalidation of the patent.

As a result, Medytox's related patents remain valid. However, Hugel has the right to appeal the PTAB's decision to the Federal Circuit but it is not clear if Hugel will appeal the decision.

"The dismissal of this invalidity appeal does not affect our entry into the U.S. and Hugel will continue to contribute to the advancement of botulinum toxin technology in the industry," said a Hugel spokesperson. However, she did not comment on whether Hugel would appeal the decision.

Separately, Medytox filed a complaint against Hugel with the U.S. International Trade Commission (ITC), alleging misappropriation of its strain and manufacturing process in March last year.