[서울=뉴스핌] Reporter Park Da-young = The US International Trade Commission (ITC) lawsuit against Daewoong Pharmaceutical and Medytox has been settled. Medytox agreed with Allergan (now Abbey) and Daewoong Pharmaceutical’s U.S. partner Evolus.
Ebolus will sell the botulinum toxin’Nabota’ in the U.S., but will pay a settlement money and royalties between Medytox and Aller. Medytox withdrew its ITC lawsuit and its California lawsuit against Ebolus.
The problem is that the embers are still there. Daewoong Pharmaceutical, the party, is missing from this agreement. Daewoong Pharmaceutical said that it would continue with Meditox and domestic civil and criminal trials, expressing the position that it did not know that the agreement was going on.
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◆ Three-way agreement between Medytox, Allergan, and Ebolus
Medytox announced on the 19th that it has signed a three-party agreement to resolve all intellectual property lawsuits including Allergan, Ebolus and ITC lawsuits.
Medytox and Allergan filed a lawsuit against the U.S. International Trade Commission (ITC) in 2019 against Daewoong Pharmaceutical and Ebolus for “theft of botulinum strains and parts of the manufacturing process.”
In December of last year, the ITC accepted the claim that it had stolen a part of the manufacturing process and issued an order to ban the import and sale of Daewoong Pharmaceutical’s botulinum toxin’Nabota’ (US product name bulletin) in the US for 21 months.
With the agreement of the three companies this time, Medytox decided to withdraw the ITC lawsuit. The US California lawsuit against Evolus is also withdrawn.
With the withdrawal of ITC litigation, Ebolus has the right to sell and distribute Nabota in the United States. Instead, the settlement between Medytox and Aller and royalties will be paid for sales generated from Nabota sales. It also decided to issue common stocks to Medytox.
◆ Daewoong Pharmaceutical “I do not agree in advance of the agreement…to eliminate US business risks”
Daewoong Pharmaceutical fell out of this agreement. Daewoong Pharm analyzed that the three companies agreed to continue selling Nabota in the US, thereby eliminating business risks.
Daewoong Pharmaceutical released a press release on the 20th and said, “I am not a party to this agreement and I have never agreed in advance.”
Daewoong Pharmaceutical said, “With this agreement, business risks in the US have been completely resolved and the basis for Nabota sales resumption has been laid.”
However, they expressed regret that the ITC lawsuit was withdrawn due to a three-party agreement. Daewoong Pharmaceutical has appealed to the US Federal Circuit Court of Appeals (CAFC) in objection to the ITC’s 21-month ban on import and sale of Nabota.
Daewoong Pharmaceutical said, “Because we are confident that we will win the appeals trial, there was no reason to agree,” and said, “We regret that the opportunity to correct errors in ITC decisions according to this agreement has disappeared.”
◆ Domestic civil and criminal cases continued… Daewoong Pharmaceutical requests FDA to investigate Innotox
The court battle between Medytox and Daewoong Pharmaceutical at ITC was ended with this agreement, but the two companies are still fighting over the source of the botulinum toxin strain.
A Meditox official said, “This agreement has no effect on the legal rights and status of Medytox and Daewoong in Korea and other countries, investigations or litigation proceedings,” implying that the domestic lawsuit will continue.
A representative from Daewoong Pharmaceutical said, “We are able to focus only on domestic civil and criminal lawsuits,” he said.
In addition, when Medytox’s liquid botulinum toxin formulation’Innotox’ was revoked in Korea due to forgery of safety test data, Daewoong Pharmaceutical requested an investigation on Innotox from the US Food and Drug Administration (FDA).