US ITC bars imports of low-cost Botox amid trade secrets dispute

The US International Trade Commission (ITC) has sided in favour of  AbbVie/Allergan, which argued that a rival should be prevented from importing a low-cost version of its Botox treatment into the US for 21 months, because it had stolen trade secrets.

On Wednesday, 16 December, the ITC handed down its  decision, which held that  Daewoong Pharmaceutical, a subsidiary of  Evolus, had misappropriated trade secrets to make its product,  Jeuveau. This ruling partially upheld and partially reversed the findings of an administrative law judge's finding on July 6.

In February 2019,  Allergan, which was acquired by  AbbVie this year, and the South Korean drugmaker  Medytox, filed a complaint with the ITC claiming Jeuveau was developed using a stolen trade secret.

According to the complaint, they claimed that a former Medytox employee handed over the results of confidential research so its rivals could create a new beauty treatment from  botulinum toxin.

Evolus and  Daewoong countered that the case did not involve a trade secret, and argued it was inappropriate to bring the dispute before the US agency.

But the commission this week agreed with the existence of trade secrets relating to the manufacturing processes owned by Allergan's Medytox, and their misappropriation. However, it rejected the judge’s contention in July that a disputed bacterial strain was also covered by trade secrets.

In doing so, the ITC said it had grounds to reduce the judge’s proposed 10-year ban to 21 months, which will come into force following the completion of a 60-day presidential review period, during which either President Donald Trump or, after January 20, President-elect Joe Biden could theoretically veto the ban.

The commission also issued a cease and desist order, meaning Evolus won’t be able to sell any imported products that it’s already brought into the US. During the presidential review period, Evolus is allowed to sell the product provided it posts a bond equal to $441 for each 100-unit vial.

In a  statement, Evolus welcomed the reduction in the initial proposed ban but also vowed to fight the shorter import ban.

“There’s no immediate impact to the availability of Jeuveau in the US,” a spokeswoman for Evolus said. “We will now focus on overturning the decision by mobilising interested parties close to this matter through the presidential review process.”

She added: “We remain committed to finding a resolution to this legal matter, including reasonable settlement terms with Allergan’s new owner, AbbVie, and Medytox.”