What Does the Jeuveau Ruling Mean for Evolus?

Posted By Mike Meyer, Friday, December 18, 2020


By Patrick O'Brien, JD, Legal Coordinator, American Med Spa Association

On Wednesday, the U.S. International Trade Commission (ITC) upheld a ruling that stated Evolus Inc. (and its partner, Daewoong Pharmaceutical Co.) manufactured its Botox competitor Jeuveau with a process that was stolen from the Medytox Inc., the South Korean partner of Allergan, the creator and manufacturer of Botox. As a result, the ITC ordered a halt to the importation of Jeuveau for a period of 21 months.

This sounds bad for Evolus, but it is not as severe a punishment as it could have been. The judge in the previous case had recommended a 10-year import ban on Jeuveau, so 21 months, while not great, is also not the worst-case scenario. But what caused them to face this ban in the first place, and what does it mean for your supply of Jeuveau? Let's have a look.

As you probably know, Jeuveau was released in early 2019 as a competitor to Botox Cosmetic from Allergan (now a part of AbbVie Inc.). The launch party even made the New York Times. However, Allergan believed Evolus had developed Jeuveau with the help of trade secrets stolen by a former employee. So, Allergan took Evolus and Daewoong Pharmaceuticals to the ITC.

The ITC is a federal agency that administers federal trade laws, and it remedies against unfair trade practices. It isn't a court of law, but it does conduct administrative hearings for matters it is investigating. After investigation, reviewing the evidence and holding the hearing, the administrative law judge (ALJ) issues their decision, called an initial determination, that is then either approved, modified or reversed by the commissioners of the ITC.

In this case, the ALJ issued a determination in July finding that a violation had occurred and suggesting a ban on the importation of Jeuveau for 10 years. On Wednesday, the commissioners approved that finding but reduced the ban to the 21 months. The ban takes effect in 60 days. During this time, the president of the United States can overturn the order or do nothing and let it become final. Both President Donald Trump and President-elect Joe Biden will have the chance to overturn the ruling, as the 60-day window straddles the inauguration.

In addition to prohibiting importation of Jeuveau, the ITC also issued a cease-and-desist order prohibiting the sale of Jeuveau that is already here. Evolus is able to sell its product on hand during the 60-day period if it posts a $441 bond for each 100-unit vial. Evolus has indicated it plans to do this. What about the Jeuveau you already have in your office? That is unaffected by these orders, so you can continue to use it as normal. You just won't be able to buy more after the order is finalized (unless the president overturns it).

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