Botox Rival Seeks Emergency Court Order to Stay on U.S. Market

Bookmark

The makers of a rival to the Botox wrinkle treatment have filed an emergency court request to let them continue selling their product in the U.S. while appealing a trade ruling won by AbbVie’s Allergan that goes into effect on Tuesday.

Daewoong Pharmaceutical Co. and Evolus Inc. filed the request early Saturday, urging the U.S. Court of Appeals for the Federal Circuit to put on hold an import ban lodged against their treatment, Jeuveau. Allergan and its South Korean partner MedyTox Inc. won a ruling that Jeuveau is made using MedyTox’s secret process to turn the deadly botulinum toxin into a cosmetic product.

Daewoong and Evolus argue that the U.S. International Trade Commission, which imposed the 21-month import ban in December, overstepped its authority by ruling that it could punish a company in the U.S. for actions that occurred exclusively in another country.

The order was sent for a 60-day presidential review and, unless President Joe Biden takes the unusual step of overruling it, will take effect on Feb. 16. Daewoong and Evolus have continued to import Jeuveau during the presidential review period, posting a bond to compensate Medytox and Allergan for the sales during that period.

Embroiled in Litigation

Daewoong and MedyTox are embroiled in litigation in South Korea over whether Daewoong stole details of the process. MedyTox has no operations in the U.S. and no product sold in the U.S. Allergan was involved in the case because it has a proposed product being developed with MedyTox, and Botox competes with Jeuveau.

The commission’s job is to protect U.S. markets against “the importation of goods produced in a manner that can be attributed to a violation of U.S. law,” Daewoong and Evolus said. “The statute does not furnish jurisdiction over allegedly wrongful conduct that is wholly foreign.”

Evolus Chief Executive David Moatazedi said in a filing with the Federal Circuit that the loss of its only product posts “an immediate threat of devastation” to the fledgling company. Newport Beach, California-based Evolus, which is scheduled to report earnings on Feb. 25, is expected to report $57 million in 2020 revenue.

In filings with the ITC, Allergan and MedyTox argued the agency has jurisdiction because Daewoong had stolen the secrets in South Korea to make a product “specifically designed to undermine a U.S. domestic industry.”

Botox sales were a key driver in AbbVie’s $63 billion acquisition of Allergan in 2020. Even with a dramatic drop in elective treatments because of the coronavirus pandemic, global revenue for AbbVie’s aesthetics portfolio was $967 million last year.

The petition for an emergency stay was posted in an appeal filed by Allergan and Medytox. They’re challenging the portion of the ITC’s decision that Medytox’s bacterial strain doesn’t qualify as a trade secret. The companies had sought a 10-year import ban on Jeuveau on that issue.

The case is Allergan v. International Trade Commission, 21-1653, U.S. Court of Appeals for the Federal Circuit (Washington). The ITC case is In the Matter of Certain Botulinum Toxin Products, 337-1145, U.S. International Trade Commission (Washington).

©2021 Bloomberg L.P.

BQ Install

Bloomberg Quint

Add BloombergQuint App to Home screen.