On July 7th (US time), a bio pharmaceutical company Medytox (CEO HyunHo Jung) announced that the United States International Trade Commission (ITC) in Washington, D.C. issued on July 6th (US time) an initial determination against Daewoong Pharmaceutical (Daewoong) in the case about misappropriation of botulinum strain and manufacturing process, finding that Daewoong botulinum neurotoxin Nabota (Jeuveau in US) is a result of unfair competition in violation of Section 337 of the Tariff Act and it should be excluded from the United States market for 10 years.

This ITC administrative law judge’s (ALJ) ruling proved that Daewoong’s claim that its botulinum strain was found in the soil of Yongin, Gyeonggi-do Province in Korea was obviously a lie, and it revealed that Medytox’s botulinum strain and manufacturing processes were misappropriated to develop Nabota (DWP-450). Daewoong developed its botulinum neurotoxin product by misappropriating Medytox’s strain and is currently selling such product in domestic and various foreign markets under the names of Nabota, Jeuveau and Nuceiva.

In January last year, Medytox and Allergan (currently AbbVie) filed a complaint with the ITC, claiming that Daewoong misappropriated Medytox’s botulinum strain and parts of its manufacturing processes. Daewoong and Evolus (co-defendant) fully participated in the investigation, along with Medytox and Allergan and the Staff of the International Trade Commission’s Office of Unfair Import Investigations. The ITC’s investigation lasted more than a year. Following extensive discovery and submission of expert evidence, an evidentiary hearing was held in Washington, D.C. February 4-7, 2020. This initial determination is subject to potential review by the full International Trade Commission, with a final decision expected in November 2020, and will be finally affirmed after the presidential review.

The ALJ’s initial determination established the followings:

1. Medytox’s strain and manufacturing process are protectable trade secrets,
2. Medytox and Allergan each have a protectable commercial interest in the trade secrets,
3. Daewoong misappropriated Medytox’s trade secrets.

A Medytox official stated, "By this ruling, it became clear that Daewoong Pharmaceutical had stolen the strain and manufacturing processes of Medytox” and “This ruling is significant because it objectively proved the Daewoong Pharmaceutical has been falsely informed regulatory authorities and customers in various countries around the world about the source of its strain and manufacturing processes over the years.” He also emphasized that “because the ITC’s initial rulings, which confirmed misappropriation of trade secrets, are not normally reversed, this ruling is likely to be a final decision.”

Medytox intends to vigorously pursue our case regarding the misappropriation of botulinum strain and manufacturing processes against Daewoong in Korea, which has been strengthened by the ITC judge’s findings

A Medytox official stated, “We are confident that the Korean court as well as the prosecution office will reach the same conclusion as the ITC ruling that ‘Daewoong misappropriated Medytox’s trade secrets,” and “Medytox will also promptly proceed with the ongoing lawsuits through various evidence and expert reports submitted to the US ITC.”