South Korean drugmaker Daewoong Pharmaceutical Co. received much lighter-than-expected 21-month sanction on sales of its botulinum products in the United States from the International Trade Commission (ITC) last month because although it was found to have copied the manufacturing process of a botulinum toxin strain of its rival Medytox Inc., the strain itself does not qualify as a “trade secret.”
“The genetic evidence establishes by more than a preponderance of the evidence that Daewoong derived its strain from Medytox,” the ITC said in its entire 74-page opinion released on Wednesday elaborating on the grounds for its December ruling.
“Complainants [however] failed to satisfy their burden to establish that the Medytox strain or its genetic makeup quality as a trade secret.”
The U.S. trade panel on Dec. 16 ordered a 21-month ban on imports of Daewoong Pharmaceutical’s botulinum products into the U.S. – down from the initial 10-year ban proposed by the preliminary panel that said Daewoong Pharmaceutical misappropriated trade secrets that belong to Medytox.
Daewoong Pharmaceutical and Medytox are both manufacturers of botulinum toxin or botox products that are widely used to treat wrinkles.
In 2019, Medytox filed a complaint with the ITC, saying that Daewoong Pharmaceutical stole trade secrets of the manufacturing process and introduced its botox product in the U.S.
Daewoong Pharmaceutical see the latest release has put to an end the long dispute between the two companies over botulinum strain origin.
Daewoong Pharmaceutical still plans to make an appeal with the federal appellate court over the decision that it infringed manufacturing processing technology.
An unnamed official from Daewoong Pharmaceutical said that it has sufficient evidence that it independently developed processing technology of botulinum strain and that Medytox manufacturing process is a generally-used technology from several decades ago and is different from its own.
Medytox expressed regret that the botulinum strain was not taken as trade secret, but still focused on how illegal activity was involved.
The Korea Centers for Disease Control, meanwhile, plans to inspect all local botulinum toxin manufacturers in Korea amid growing controversy over safety and origin of botulinum strain.
By Kim Si-gyun and Lee Eun-joo
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