Commission Issues Exclusion Order in Botox Trade Secret Case

In July we reported that the presiding Administrative Law Judge recommended issuing an exclusion order blocking the importation of Jeuveau® (prabotulinumtoxinA-xvfs), Evolus’s follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection).  Since that time, the parties have submitted lengthy Petitions for Review and answered questions raised by the Commissioners.  Now, the Commission has ruled.

On December 16, the Commission issued its confidential opinion, which was accompanied by a three-page public notice of final determination.  The confidential opinion will not be available in public form for another few weeks, but the public notice outlines the Commission’s most pertinent holdings.  Namely, the Commission issued both a limited exclusion order prohibiting Jeuveau® imports and a cease and desist order prohibiting Jeuveau® sales from existing U.S. inventories.  As in all ITC Investigations, there is a 60-day Presidential review of the Commission’s orders.  During this 60-day period, the Commission has set a bond of  $441 per 100U vial of imported and/or sold Jeuveau.

While the Commission has put these remedial orders in place, the public notice confirms that the Commission’s findings overturn the ALJs recommendations in certain respects.  For example, the ALJ determined that Medytox’s bacterial strain was a protected trade secret itself, but the Commission reversed on this point.  The Commission’s reasoning is still unknown.  The Commission did, however, adopt the ALJ’s determination that there was a misappropriation of manufacturing processes.  It is that misappropriation that serves as the basis for the remedial orders.  Perhaps related to the Commission’s condensed misappropriation findings, the Commission’s exclusion order is set to be in place for only twenty-one months.  This exclusion order period is eight years shorter than the ALJ’s recommended ten-year exclusion period.

Stay tuned to Big Molecule Watch for further developments on this case, including a summary of the Commission’s public opinion that will be released in coming weeks once the parties’ proposed redactions are applied.