The U.S. International Trade Commission (ITC) is to give a preliminary ruling on Monday, local time, on a dispute between Medytox and Daewoong Pharmaceutical over the source of botulinum toxin (BTX) strains.
The initial schedule for the preliminary ruling was on June 5. Still, the ITC delayed it by one month after accepting Daewoong’s additional data. The postponed preliminary ruling pushed back the date of the final verdict from Oct. 6-Nov. 6.
|The U.S. International Trade Commission (ITC) will soon announce the winner of a dispute between Medytox and Daewoong Pharmaceutical over the ownership of botulinum toxin strains. At right is Meditoxin, the BTX agent of Medytox, and at left is Daewoong’s Nabota.|
A ruling in July is expected to be virtually final because it has been unprecedented that the U.S. president vetoed an ITC decision.
The two companies’ battle over the BTX strain ownership began in November 2016 when Medytox claimed that Daewoong stole its BTX strain. Medytox released Korea’s first BTX, Meditoxin, in 2006. Daewoong’s anti-wrinkle product Nabota arrived in the local market in 2014.
Going one step further, Medytox filed a suit with a U.S. court against Daewoong in June 2017. Medytox claimed that its former employee stole its BTX strain and documents containing the BTX manufacturing process and gave them to Daewoong. In October 2017, Medytox also filed a suit with a local court.
An imminent ITC ruling is expected to bring a significant impact on not only domestic but U.S. BTX market, worth 2 trillion won ($1.64 billion), drawing keen attention of the pharmaceutical industry.
No matter who wins, an ITC decision is likely to hit the other side hard. It can also affect the export of Korean BTX products to the U.S. market, observers said.
Medytox is already in a crisis because the Korean drug regulator recently decided to revoke the license of three Meditoxin products due to the use of unauthorized ingredients and fabrication of related documents. If the company loses the suit to Daewoong in the U.S., it will be fatal to its brand and corporate credibility.
If Daewoong loses, the company will face a significant challenge in promoting Nabota (brand name in the U.S.: Jeuveau) in the U.S. Daewoong has put more effort into Jeuveau in the U.S. than in Korea.
Daewoong obtained the FDA nod for Jeuveau in February 2019 and rolled out the product in May. According to Evolus, the partner firm of Daewoong, Jeuveau sold 40 billion won in eight months after the market release.
Medytox licensed out Innotox, a liquid BTX agent, to Allergan in 2013, and the company is waiting for FDA approval.