The legal dispute between Medytox and Daewoong Pharmaceutical over the source of the latter’s botulinum toxin (BTX) strain for several years is nearing the end, as a U.S. administrative court started a hearing.
The U.S. International Trade Commission (ITC) began a hearing on Medytox’s suit against Daewoong on Tuesday, industry sources said. Medytox claims that Daewoong stole its BTX strain. The hearing will continue through Friday.
During the hearing, both sides verbally stated their claims before the judge based on the evidence and expert reports submitted so far. The hearing is the final process before the judge announces the verdict. The two will have an opportunity to rebut claims in writing about issues raised during the trial.
In the earlier process of evidence discovery by the ITC, Daewoong and Medytox conducted appraisals by experts on the DNA sequencing of their wrinkle-erasing BTX products, Nabota and Meditoxin, respectively. The ITC has reportedly received five appraisal reports, including those by investigators, each designated by Daewoong and Medytox.
However, their analysis results showed contradicting outcomes, making it impossible for the two to reach a shared conclusion.
Paul Keim, a professor at Northern Arizona University, speaking on behalf of Medytox, said a single-nucleotide polymorphism (SNP) analysis showed that Daewoong’s BTX strain originated from the strain of Medytox.
In contrast, Professor David Sherman of the University of Michigan, on Daewoong’s side, said the two companies’ BTX strains do not share the same source, citing a direct comparison of whole-genome sequencing (WGS).
The two BTX makers also had split opinions over spore formation. In a local spore formation test for a civil lawsuit in Korea, Daewoong argued that its strain formed spores. This even supports Medytox’s claim that its strain is the only one not to form spores under any conditions, thus different from Daewoong’s strain, Daewoong said.
However, Medytox said Dr. Andrew Pickett, who developed a BTX product for a French drugmaker, tested Meditoxin under the same conditions as Daewoong’s test and found that Medytox’s strain also formed spores.
In rebuttal, Daewoong’s investigator Brenda Wilson pointed out that Medytox’s test had various errors, questioning the validity of the test. Even if there was no error, the two strains showed the same results in only eight combinations under 18 test conditions, including heat treatment, anaerobic, aerobic, and incubation period, she said. Therefore, the two strains have different spore-forming properties, she argued.
Both Daewoong and Medytox are confident about winning the suit, respectively.
No matter who wins, an ITC ruling is likely to hit the losing side hard. The ITC is scheduled to make a preliminary ruling on June 5, and confirm the verdict on Oct. 6.
The two-stage ruling is for a case where the U.S. President Donald Trump may veto the preliminary decision for policy reasons.
However, it has been rare in history where the U.S. chief executive vetoed an ITC determination, and a ruling in June will be considered virtually final.