On January 13, the U.S. International Trade Commission (“ITC”) issued the long-awaited public version of its final opinion in the Matter of Botulinum Products (Inv. No. 337-TA-1145), otherwise known as the “Botox case.” As previewed in the ITC’s earlier notice of decision, the ITC’s final opinion affirmed the Administrative Law Judge’s issuance of a 21-month ban on imports and sale of Respondents’ lower-cost alternative to Botox for misappropriation of trade secret manufacturing processes and reversed the finding that Complainant Medytox’s specific strain of botulinum toxin bacteria is a protectable trade secret.
As we previously reported, South Korean company Daewoong Pharmaceutical and its U.S.-based licensee Evolus had been facing a potential 10-year ban of the import and sale of its product, Juveau; however, because the ITC reversed the ALJ’s finding and instead held that the bacterial strain at issue was not a protectable trade secret, the Respondents could not be liable for trade secret misappropriation of the bacterial strain itself. The ITC thus reduced the length of the ban from 10 years to 21 months, accounting for the ITC’s finding that Respondents were liable for theft of trade secrets related to Medytox’s manufacturing process.
Notably, the ITC also affirmed the ALJ’s finding that the ITC had jurisdiction over the investigation even though neither Medytox nor Allergan had begun to sell their lower-cost alternatives to Botox in the U.S., and even though Allergan’s Botox product does not use the bacterial strain at issue in the investigation or the manufacturing trade secrets that led to the 21-month ban.
The ITC’s decision will become final upon the conclusion of the 60-day presidential review period in mid-February.
A fulsome analysis concerning the ITC’s ruling, including a deep-dive on the standing and jurisdictional questions raised, is forthcoming in a separate publication to be linked here.