[이코노믹리뷰=황진중 기자] Daewoong Pharmaceutical (069620) said on the 15th, “Meditox is subtly and maliciously distorting the ruling of the US International Trade Commission (ITC) and making false claims. By making a final judgment, Medytox’s claims regarding the strain were dismissed. Daewoong Pharmaceutical will correct all errors by proving that the ITC’s decision on process technology infringement is a clear misjudgment through an appeal to the US Federal Appeals Court scheduled for this week.”
An official of Daewoong Pharmaceutical said, “Meditox is misleading that the fact that Daewoong’s strain was derived from Medytox was revealed through genetic analysis, which is a solid evidence in the press release.” In addition, on page 33 of the judgment, it was concluded that Daewoong had not been able to clarify that he had committed fraudulent acts.”
According to the explanation, on page 33 of the ITC judgment,’However, because the committee determined that the Medytox strain did not meet the requirements as a protectable trade secret, the applicants did a fraudulent act of stealing trade secrets from Daewoong for the strain of Medytox. Could not be identified.’
A representative from Daewoong Pharmaceutical said, “Many experts believe that the origin of the strain cannot be determined with the evidence of DNA analysis performed in the preliminary determination.” “The genealogy analysis is only based on the relative genetic distance, and whether the mutation in a specific strain is the only one? “Since there is no way to confirm it, genetic analysis alone cannot prove whether the strains are directly derived.”
A representative from Daewoong Pharmaceutical said, “Prof. Bart Weimer UC Davis, a representative authority in the field of microbial genomes, also pointed out that the result of the genetic test of Dr. Paul Keim, which ITC presented as the basis for the preliminary decision, was a’logic elixir’. “He pointed out the limitations of’SNP’ (single nucleotide polymorphism) analysis, and said that the microbial forensics method is still in its infancy, so it is important to pay attention to the limitations of this method.”
A representative from Daewoong Pharmaceutical also said, “The WGS·SNP analysis method has limitations in revealing the origins between different strains, and it cannot be said to have a scientific meaning unless it is combined with a trait that does not form spores. “In fact, there are many cases in which strains with similar base sequences were found on different continents.”
A representative from Daewoong Pharmaceutical said, “ITC’s SNP analysis is insufficient analysis that even the Allergan strain was not included in the strain to be compared. It is not possible to know whether the six SNPs are shared only between the Medytox strain and the Daewoong strain. Even Paul Keim admitted. “Even the anthrax case that Dr. Keim claimed to have revealed, the US National Research Center (NRC) has concluded that it is impossible to prove the relationship between the strains, even though more than 1000 samples were obtained directly from around the world. . Furthermore, in this ITC, we did a direct comparison between only two strains, not 1000.”
An official of Daewoong Pharmaceutical said, “Daewoong Pharmaceutical’s botulinum bacteria exist in nature and cannot be artificially synthesized. It is natural that Dr. Hall found Hall A strains in soil. He emphasized that the plaintiff’s claim that it is not possible is only a typical sub-acquisition claim.”
According to the description, botulinum strains are widespread in the environment, including soil, rivers and seawater. In Korea, many cases of botulism, which are botulinum bacteria poisoning, have been reported, so it is known that the possibility of botulinum strains present in domestic soil is sufficient.
As a result of the botulinum distribution survey conducted by the Ministry of Agriculture, Forestry and Livestock Quarantine, the botulinum toxin gene was identified in 13% of 209 temporary specimens in 32 ranches in 11 cities, counties, and 6% of 301 environmental samples such as soil. In 2007, the National Institutes of Health found a type A botulinum strain in soil and registered it with the World Gene Bank (GenBank). Before and after Daewoong Pharmaceutical secured the strain, botulism occurred in Tancheon area near Yongin, Gyeonggi-do.
An official of Daewoong Pharmaceutical said, “Daewoong Pharmaceutical’s strains proved to form spores through strain spore test in domestic civil lawsuits and ITC lawsuits.” “It is a naturally occurring strain and is essentially different from the Hall A hyper strain claimed by Medytox. It proved that it is” he emphasized.
An official from Daewoong Pharmaceutical said, “Meditox is making false claims by viciously distorting the interpretation of the judgment or by cunningly citing errors.” In the press release, “Meditox claimed that Daewoong Pharmaceutical’s criminal acts were revealed and convicted. It is completely false.”
A representative from Daewoong Pharmaceutical said, “ITC is an administrative agency that judges whether or not imports are banned, and has no authority to convict or innocence”. “The’conviction’ asserted by Meditox is that we do not understand the nature of ITC litigation. I am proving it.”
A representative from Daewoong Pharmaceutical also admitted, “Moreover, even though ITC conducted extensive evidence disclosure procedures, no evidence could be found, and the most basic facts could not be revealed as no analysis of other strains was performed in genetic analysis.” “The final decision also simply cites the preliminary decision, and there is no additional analysis and review at all.”
Daewoong Pharmaceutical dismissed the claim that the final decision and the conclusion of a domestic civil lawsuit would be the same is just a leap. A representative from Daewoong Pharmaceutical said, “ITC made a biased judgment that would never have been judged by a Korean court solely for the monopolization of the US market between Aller and allergan without evidence.” “Many prominent US lawyers and professors have also made the judgment of ITC. I have pointed out that it is wrong. The false claims made by Medytox in the ITC litigation process and the evidence for counterfeiting will be evident in federal circuit court appeals and domestic trials. We will sue for this separately.”
“Rather, in this final decision, it became clear that the trade secret of the strain, which is the core of the Medytox claim, was completely denied, and that the strain could no longer be controversial.” It was confirmed that it was a false claim.”
A representative from Daewoong Pharmaceutical said, “Meditox has obtained false product licenses by manipulating test data so far, making medicines with unlicensed undiluted solutions, producing and distributing unsterilized products in contaminated workplaces, and taking private interests through smuggling. As a pharmaceutical company that requires ethics, it has been clearly revealed several times that it has committed unimaginable cheating. “Even so, Medytox is consistent with excuses, but it does not show any improvement in problems or genuine apology to victims. have. Even now, Medytox will have to sincerely apologize to the people for various corruptions and illegal acts committed by them, and will have to fully fulfill its responsibilities.”
An official of Daewoong Pharmaceutical said, “Daewoong Pharmaceutical has already disclosed a public question to the media on January 29 to clarify the truth about Medytox’s contradictory position, and Medytox has not been able to respond to this.” “If Medytox’s false claims continue, Daewoong Pharmaceutical will respond more decisively and punish them so that people can no longer be deceived and use safe products.”