Daewoong Pharmaceutical on Friday accused the US’ International Trade Commission’s decision to put a 10-year sales ban on its botulinum toxin product of “lacking evidence” and being “biased and distorted.” Daewoong said it has filed a detailed complaint to the USITC for its “significant errors.”

Daewoong has been enwrapped in legal battles in Korea and in the US against Medytox for nearly five years over an alleged theft of trade secrets by a former researcher of the latter’s botulinum toxin strain.

On July 7, news broke that the USITC’s initial determination advised a 10-year sales ban on Daewoong Pharmaceutical’s Jeuveau for posing a threat to the US’ domestic economy.

Daewoong has since submitted a statement to the USITC explaining why Jeuveau must continue to be sold in the US.

In its latest claim, Daewoong cited parts of the USITC’s initial determination as proof that its decision lacked grounds. The document had been released to the public without certain confidential parts since Thursday.

Daewoong specifically pointed to the phrase, “In any event, while it is clear that Dr. BK Lee had access to Medytox’s strain, no evidence was presented to show when and how a specific quantity of Medytox’s strain went missing,” as indication that the commission made an unreasonable decision against Daewoong. Dr. BK Lee is the former Medytox employee accused of stealing Medytox’ BTX and unlawfully passing it on to industry competitor Daewoong.

It also highlighted the phrase, “While evidence has been presented to explain complainant’s (Medytox’s) suspicion and belief in his involvement in the misappropriation, it has not been established that Dr. BK Lee took the strain from Medytox and, for consideration or otherwise, gave it to Daewoong.”

Daewoong argued that the ITC’s administrative law judge made an “unfair and biased decision that is distanced from the actual truth by standing only in favor of Allergan in the name of ‘protecting the US industry’.”

Allergan is the US partner of Medytox.

Daewoong also claimed that for an accurate decision, the USITC must conduct a proper spore formation test that includes verification of any coidentity of Medytox’s BTX strain and the gene analysis of Allergan’s strain, both of which are denied by the partnering firms.

Daewoong further claimed that US consumers of BTX products pay five times the price of their peers in other countries, a pricing disparity driven by Allergan’s Botox.

Daewoong went on to accuse Allergan of being a disloyal partner to Medytox. Allergan, Daewoong claimed, had purposefully bought Medytox’s BTX product to stall the latter’s US market entry while giving empty promises of helming the project.

Daewoong's Jeuveau launched in the US in February 2019 through its US partner Evolus. Medytox's BTX product is yet to enter the US.

The USITC’s final determination on the Daewoong-Medytox spat is scheduled for Nov. 6.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)