US ITC’s’Botox Dispute’ verdict revealed…”Kyunju is not a trade secret”

Daewoong Pharmaceutical “Controversy over ITC strains.. Denial of trade secrets for strains”
Medytox “Fixed suspicion of stealing manufacturing process technology… criminality”
Medytox-Daewoong Pharmaceutical CI. ImageㅣCompany

In the News Reporter Nam Gung-gyeongㅣThe full text of the US International Trade Commission (ITC)’s final judgment on the lawsuit for infringement of trade secrets of botulinum strains by Meditox and Daewoong Pharmaceuticals has been released.

The two companies are having a conflict over the source of the botulinum strain, the raw material of the so-called botulinum toxin formulation, called’Botox’. Medytox and Daewoong Pharmaceuticals have botulinum toxin formulations’Meditoxin’ and’Nabota’, respectively.

According to Daewoong Pharmaceutical and Medytox on the 14th, the ITC Committee considered Daewoong Pharmaceutical’s use of Medytox’s manufacturing process technology as a basis for violating the Customs Act and disposing of it, but said that the strain of Medytox itself does not qualify as a trade secret.

Prior to this, on December 16 (local time) of last year, the ITC Committee said, “Daewoong Pharmaceutical’s botulinum toxin formulation’Nabota’ (U.S. product name bulletin) violates Article 337 of the Customs Act and orders a ban on imports into the United States for 21 months. “However, the strain of Medytox is not recognized as a trade secret.”

Both companies acknowledge that the strain was not recognized as a trade secret, and that a ruling was issued due to a violation of manufacturing process technology. In particular, Daewoong Pharmaceutical emphasizes that the ITC strain debate has ended with this full disclosure.

Daewoong Pharmaceutical’s position is that the ITC judged that the Medytox strain was not a trade secret, dismissing all claims of Medytox related to the strain. The plan is to appeal the alleged violation of manufacturing process technology.

A representative of Daewoong Pharmaceutical said, “There is sufficient evidence that we independently developed the process technology for the botulinum strain.” “Meditox’s process is only a general-purpose technology that has been unveiled decades ago, and is different from us in many ways.”

“Now, the Federal Court of Appeals proves that the ITC’s decision regarding the infringement of process technology is an obvious misjudgment, and all errors are corrected.

Medytox expressed regret that the strain was not recognized as a trade secret, but meant that the criminal activity was revealed. A Medytox official said, “The gene analysis revealed that Daewoong Pharmaceutical’s strain was derived from Medytox, but the strain was not recognized as a trade secret, so it was not subject to ITC regulation.”

The official added, “It was clearly revealed that the manufacturing process technology was stolen as a trade secret, and an import ban was imposed.”

However, Daewoong Pharmaceutical is refuting this. An official of Daewoong Pharmaceutical said, “Based on the results of genetic analysis in Meditox, we claim that we have stolen the strain, but many experts point out that there are limitations and errors in the analysis method.” “ITC also acknowledged that the analysis was limited, so the strain was stolen. There is no evidence that it did.”

Medytox plans to request Daewoong Pharmaceutical to ban the use of the manufacturing process and return the rights to the strain based on this ITC ruling. It has said that it will also claim compensation and disposal of products that have already been produced or in circulation.

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