(USITC)
Daewoong Pharmaceuticals and Medytox on Tuesday gave contrasting interpretations of the US International Trade Commission‘s announcement to review parts of the final initial determination.
The USITC decided Monday to review parts of the FID, accepting respondent Daewoong’s notice of a “new factual development” regarding the trade secret misappropriation allegation levied by complainant Medytox.
Since 2016, Medytox and Daewoong have been engaged in legal disputes over the latter’s alleged theft of the trade secret of its botulinum toxin strain.
The USITC, as per section 337 of the Tariff Act of 1930, bars entry of foreign products that threaten to destroy or substantially injure a domestic industry in the US. In July, the commission had sided with Medytox, imposing a 10-year sales ban of Daewoong’s BTX product Jeuveau in the US.
A strong argument working in the favor of Medytox had been that its US partner Allergan since 2013 had been heavily invested in the development of Medytox’s liquid BTX Innotox in the US. These efforts were undermined by Daewoong and its partner US firm Evolus, whose products use a misappropriated BTX strain from Medytox, the complainants argued.
Daewoong contests that Medytox’s Hall A-hyper BTX strain cannot be a trade secret, as it was readily available to unspecified firms in earlier days of the BTX development.
In the FID review, USITC will seek to hear the differences between the Medytox strain and other Hall A-hyper strains; the availability of Hall A-hyper strains in the marketplace since Dr. Hall discovered it in the 1920s and the US Army developed it in the 1940s; and whether the federal legal standard determines this as a misappropriation of a trade secret sufficient to establish an “unfair method of competition.”
Daewoong on Tuesday interpreted this development as the suit “going back to the beginning,” while Medytox referred to it as a customary check.
Along with the decision to review parts of the FID, the USITC advised Medytox and Allergan to submit their proposals of remedial orders in case the USITC determines Daewoong is indeed in the wrong.
This submission, to be considered by the commission, will suggest an amount of the bond that should be imposed on Daewoong’s Jeuveau during the 60 days of presidential review that will follow the FID announcement on Nov. 6.
By Lim Jeong-yeo (kaylalim@heraldcorp.com)