Medytox Files ITC Complaint Against Hugel to Block Import of Botox Follow-On

On March 30, 2022, Medytox filed a complaint with the ITC requesting that the ITC block imports of Hugel’s follow-on biologic Letybo® (LetibotulinumtoxinA) product.  The complaint alleges that Hugel expects to obtain approval and launch its product in the U.S. in 2022.  The complaint alleges that “Hugel misappropriated Medytox’s trade secrets by stealing its proprietary strain of C. botulinum and related highly confidential manufacturing documents,” to develop Hugel’s product.

This ITC case follows Medytox’s prior ITC case against Evolus, which we have previously reported on.  In that case, Medytox alleged that Evolus misappropriated its trade secrets in relation to the development of Evolus’s follow-on biologic, Jeuveau®.  In December 2021, the ITC issued both a limited exclusion order prohibiting imports of Evolus’s Jeuveau® and a cease and desist order prohibiting Jeuveau® sales from existing U.S. inventories.  After the ITC’s final determination, the parties announced that they had entered a settlement agreement whereby Evolus agreed to pay milestone and royalty payments to AbbVie and Medytox.  Furthermore, AbbVie and Medytox agreed to “release all claims against Evolus related to the alleged misappropriation of Medytox’s trade secrets and grant a license to Evolus to continue to commercialize Jeuveau® in the United States.”

Stay tuned to Big Molecule Watch for further developments on this new ITC case.