The U.S. ITC Commissioners, ‘Decided to review certain portions of the initial determination from some of Daewoong’s objections’…’the review is merely a routine and regular practice’

  • The ITC Commissioners’ decision to review the initial determination (ID), ‘It is merely a routine and regular procedure,’ ‘There are rarely any occurrences where the ID is overturned by such review.’
  • Medytox’s official stated that “the ID’s findings were based on scientific facts and evidence. We remain confident that the ITC will uphold the ID’s findings in the final determination on November.”

Bio pharmaceutical company, Medytox (CEO Hyun Ho Jung) stated on the 22nd (U.S. time) that the U.S. ITC in Washington, D.C. “decided to review certain portions of the challenged parts by Daewoong in the ID, which earlier confirmed the Daewoong’s misappropriation, as a routine practice.”

If even one member of the ITC Commissioners, which consists of five members, decides to accept a party’s objection, it is a routine and regular procedure to conduct review.

The ITC investigation was instituted on February 2019 based on a complaint filed by Medytox and Allergan (now part of Abbvie) against Daewoong Pharmaceutical and Evolus. Through more than a year of extensive discovery, submission of expert evidence, and a five day evidentiary hearing, the ITC administrative law judge found this July that Daewoong misappropriated Medytox’s strain and trade secrets, ruling the ban on the import of Nabota into the U.S. for 10 years.

Going forward, the ITC Commission will review legal remedies against Daewoong and Evolus in violation of section 337 of the Tariff Act along with reviewing certain portions of the challenged parts of the ID. Specifically, the Commission will review the judge’s recommendation that Nabota and Jeuveau be excluded from the US market for 10 years, the amount of bond to be posted for importation and sale of Nabota and Jeuveau during the period of time when the ITC’s remedial order is subject to final review by the President of the United States, and whether there is a compelling U.S. public interest that should outweigh the need for the remedial order. The ITC will render its final decision on November 6 (U.S. time), and, after two months when the decision is approved by the President, the decision will be finally confirmed.

A Medytox official stated that "the ITC's review of some parts of the ID is just a routine and regular practice that generally occurs during the ITC investigations, and such review rarely changes the outcome of the ID" and "we are confident that the ITC will ultimately adopt the ID, as the judge made the right decision based on the scientific facts and evidence."

A Medytox official further stated, "setting aside Korean toxin companies, not even the four companies that successfully commercialized the botulinum toxin type A strain worldwide have directly discovered the botulinum strain" and added "in the current situation where as many as twenty Korean companies claim to have discovered botulinum strains themselves, Medytox will not submit to any pressure or coercion and will continue to make efforts to reveal the truth in order to play a role in establishing a Korean bio industry where only companies that properly and legitimately develop their own technology will prosper.”