Before the formal commencement of the invalidation trial on the U.S. patent related to botulinum toxin filed against Medytox by HUGEL, the trial was terminated.
According to industry sources on Aug. 29, the U.S. Patent Trial and Appeal Board (PTAB) rejected the initiation of the review, which HUGEL had instigated, claiming that Medytox’s U.S. patent regarding the separation method of botulinum toxin was invalid. Consequently, Medytox’s related patent will continue to be valid. If a procedure for a U.S. patent invalidation trial is not initiated, it concludes immediately.
At the time of the review filing, HUGEL claimed that Medytox’s patent in question was a generic manufacturing technique lacking innovation. They argued that patenting such a method could obstruct market entry for later companies and potentially hinder industrial advancement.
In response, Medytox argued to the PTAB that their patent should be recognized. The PTAB accepted Medytox’s argument after it was proven that the botulinum toxin complex is separated more efficiently within the isoelectric point (pI) range and below the hydrogen ion concentration (pH).
On another front, HUGEL and Medytox are currently involved in a lawsuit related to botulinum toxin at the US International Trade Commission (ITC). Last March, Medytox filed a complaint with the ITC against HUGEL, suspecting them of appropriating strains and manufacturing processes.