Daewoong Pharmaceutical's Nabota banned in US for 21 months

Daewoong Pharmaceutical's Nabota is sold in the US under trade name Jeuveau (Evolus)

A US trade court ruled Wednesday in favor of Medytox in its 5-year-old legal battle with Daewoong Pharmaceutical over botulinum toxin products.

In its final decision, the US International Trade Commission slapped Daewoong with a 21-month ban on the sale of its botulinum toxin product, Nabota, in the US.

Daewoong’s US partner, Evolus, issued an investors’ notice saying the company “plans to fund a bond to allow for the continued sales and marketing of Jeuveau in the United States,” and that there is no immediate impact on the availability of Jeuveau. Nabota is traded in the US as Jeuveau.

“We will now focus on overturning the decision by mobilizing interested parties close to this matter through the presidential review process,” said David Moatazedi, president and chief executive officer of Evolus.

Settling is an option on the table, according to Moatazedi, who said, “We remain committed to finding a resolution to this legal matter, including reasonable settlement terms with Allergan’s new owner, AbbVie, and Medytox.”

Wednesday’s court decision reduced the 10-year ban suggested in its preliminary ruling in July to 21 months. The USITC upheld the violation of Section 337 of the Tariff Act of 1930 as it relates to certain manufacturing processes, but reversed the finding that a trade secret existed with Medytox’s botulinum toxin strain.

The final determination acknowledges Daewoong’s wrongful procurement of Medytox’s botulinum toxin strain and development process know-how, according to Medytox.

While the ruling was softened due to the strain not being acknowledged as the subject of a trade secret, it has been found that Daewoong indeed misappropriated Medytox’s technology in creating its product, Medytox said.

Meanwhile, Daewoong said Wednesday’s reduced determination was a victory. It has busted Medytox’s claims regarding its toxin, and will do the same for the said technology, Daewoong said.

Daewoong will seek an injunction on the 21-month ban and appeal the case through the Court of Appeals for the Federal Circuit, whereupon Daewoong becomes the plaintiff and the USITC the defendant.

The USITC’s final ruling will be reviewed and confirmed by the US president within the next 60 days. During this period, should Daewoong or Evolus wish to export or sell Jeuveau in the US they must pay a fee of $441 per vial.

In January 2019, Medytox and its US partner Allergan filed a complaint with the USITC against Daewoong and its US partner Evolus for misappropriating Medytox’s proprietary botulinum toxin. Botulinum toxin is the core ingredient in wrinkle smoothening products most commonly referred to as Botox. Botox is a botulinum toxin product sold by Allergan -- there are many BTX products sold under different trade names by various companies.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)

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