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Evolus Lobbies Trump to Avoid U.S. Ban on its Botox Alternative

Bloomberg logoBloomberg 11/18/2020 Susan Decker
a close up of a hand: Dr. Keith A. Marcus injects Allergan Inc. Botox into a patient's forehead at the offices of Marcus Facial Plastic Surgery in Redondo Beach, California, U.S., on Tuesday, April 22, 2014. © Bloomberg Dr. Keith A. Marcus injects Allergan Inc. Botox into a patient's forehead at the offices of Marcus Facial Plastic Surgery in Redondo Beach, California, U.S., on Tuesday, April 22, 2014.

(Bloomberg) -- A California beauty company and its South Korean partner are lobbying the Trump administration to ensure their rival to the Botox wrinkle treatment doesn’t get frozen out of the U.S. market.

Evolus Inc. and its partner Daewoong Pharmaceutical Co. have been reaching out over the past two months to President Donald Trump and his administration to overrule a possible U.S. import ban on their treatment, called Jeuveau, which is manufactured in South Korea.

The U.S. International Trade Commission is scheduled to announce Thursday if it will follow a trade judge’s recommendation for a 10-year ban on Jeuveau imports amid claims that trade secrets were stolen from Botox-makers Medytox Inc. and AbbVie Inc.’s Allergan.

Evolus has said an import ban of its Jeuveau -- its only product -- would be “catastrophic” to the company. That’s why a company official personally briefed Trump on the case and the company has lobbied agencies, including the U.S. Trade Representative and Department of Justice’s Competition Policy and Advocacy Section, according to lawyers for the companies.

“They haven’t shut the door on this,” said Daewoong lawyer Daniel Zaheer of Kobre & Kim in San Francisco. “The fact that you see so many different parts of the administration engage with this issue tells you about the importance of it.”

Read More: Evolus Botox Rival Loses First Round Over AbbVie’s Allergan

Daewoong and Medytox, both South Korean companies, are embroiled in a heated legal battle in South Korea. Evolus and Daewoong argue, in part, that the dispute belongs in that country and shouldn’t be decided in the U.S.

“The stakes are very high,” Zaheer said. “This is an unusual case that could have serious effects on competition and innovation and the relationship between courts and administrative agencies in our country and the courts in their country.”

The process to turn deadly botulinum toxin into the wrinkle treatment Botox, which also is used to treat chronic migraines and urinary incontinence, has been a closely kept secret by Allergan. That secret has allowed Allergan to maintain its dominance since it was first approved for sale in 1989.

The trade secret in this case is for a next-generation drug developed with Medytox for a liquid-type version called MT10109L that’s seen as easier to use than Botox but isn’t available in the U.S. Allergan signed an agreement with Medytox in 2013, though a product hasn’t been approved by regulators, and Evolus has argued that Allergan doesn’t belong in this case.

AbbVie officials had no comment on the lobbying. Officials with the White House, USTR and the Justice Department didn’t immediately comment.

Related: Botox Battle Rages With Upstart Evolus Backed by Dermatologists

If the commission issues an import ban, there’s a 60-day presidential review period to consider whether it should be overruled on public policy grounds. That decision is usually relegated to the trade representative, though Zaheer said Trump has been briefed on the case.

It’s not unusual for companies to try to get government officials on their side, but it’s rarely successful, said Smith Brittingham of the law firm Finnegan Henderson, who specializes in ITC cases but isn’t involved in this one.

The last time a company that lost at the ITC won reversal of an import ban was in 2013, when the Obama administration vetoed one on Apple Inc. iPhones, because government agencies were debating the ITC’s authority in cases involving standard-essential technology. That was the first time since the Reagan administration, which rejected a ban on gray-market batteries while Congress was considering legislation on the issue.

“You have to sell the government on the idea that the commission decision is going to be some outlier and cause confusion as to what government policy really should be,” Brittingham said. “It’s a bit of a Hail Mary, but if you’re desperate, there’s no harm in pursuing it.”

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