ITC Favors Medytox over Daewoong in Botulinum Toxin Strain Dispute in Final Ruling

SEOUL, Dec. 17 (Korea Bizwire) — A U.S. trade panel has upheld its preliminary ruling by siding with South Korean drugmaker Medytox Inc. in a trade dispute, saying its local rival Daewoong Pharmaceutical Co. copied the manufacturing process of a botulinum toxin strain, industry officials here said Thursday.

In a final decision, the U.S. International Trade Commission (ITC) ordered a 21-month ban on imports of Daewoong Pharmaceutical’s botulinum products into the United States.

The ruling, however, reduces an initial 10-year ban proposed by the preliminary panel that ruled that Daewoong Pharmaceutical misappropriated trade secrets belonging to Medytox.

The import ban is expected to take affect following the completion of a 60-day presidential review period, in which the U.S. president could veto it, which is rarely done, according to the industry officials.

The ruling is expected to reshape the U.S. botulinum toxin market and affect various lawsuits between the two firms in both countries that have been ongoing for the past five years.

In January 2019, Medytox — along with development partner Allergan plc — filed a complaint with the ITC, alleging that Daewoong Pharmaceutical stole trade secrets related to turning the deadly botulinum toxin into a wrinkle treatment and introduced the product to the U.S. market.

Medytox also claimed that its former employee had handed over trade secrets on the complex manufacturing process that is needed to turn botulinum toxin into a drug product.

Daewoong Pharmaceutical has refuted the argument, saying its botulinum toxin product has its own indigenous strain and that Medytox is trying to block U.S. imports of its rival product.

Medytox has its own botulinum toxin product called Meditoxin, which won South Korea’s first license in 2006 and has maintained the No. 2 position in the country.

It is effective in treating various muscle spasms, overactive muscle diseases and facial wrinkles.

Daewoong then released its botulinum toxin named Nabota in the country in 2014. The product also won sales approval from the U.S. Food and Drug Administration (FDA) in February 2019.

Daewoong Pharmaceutical’s global partner Evolus Inc. is in charge of the sale of Nabota in the United States, which is marketed under the name, Jeuveau.

Medytox welcomed the ruling, saying it was proven that Daewoong Pharmaceutical stole the manufacturing process and a botulinum strain to develop its product.

Daewoong Pharmaceutical, meanwhile, said the ruling only partially supported Medytox’s claims as its botulinum strain is not a trade secret. The company also claimed it will appeal to a higher court.

The ITC only announced a brief notice of its final decision, with the full text of the ruling to be available to the public in a couple of weeks.

(Yonhap)