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| Medytox CEO Jung Hyun-ho, left, and Hugel CEO Sohn Ji-hoon |
By Baek Byung-yeul
Another patent war among domestic botulinum toxin (BTX or Botox) makers has broken out after Medytox accused its local competitor, Hugel, of stealing its BTX strains, filing a lawsuit with the United States International Trade Commission (USITC), according to company officials, Tuesday.
On April 1, Medytox said it sued Hugel, its partner, Croma-Pharma GmbH, and their joint venture, Hugel America, claiming they produced BTX products by stealing its BTX strains and manufacturing know-how. This suit comes about three years after the company filed another lawsuit with the USITC against Daewoong Pharmaceutical in 2019.
It remains to be seen whether Medytox's second attempt to take the lead in the BTX market will also succeed. In the legal fight against Daewoong, the USITC ordered a 21-month import ban in December 2020 on Daewoong's products into the United States. Daewoong agreed to pay royalties to Medytox to settle the dispute shortly after.
"In the complaint, we stated that Hugel had developed and produced botulinum toxin by stealing trade secrets and manufacturing processes from us. We also mentioned that the ITC should initiate an investigation into Hugel's illegal activities and issue an order to ban imports of its botulinum toxin products into the U.S. market," a Medytox spokesman said.
Asked how Medytox has determined that Hugel stole its technology, the spokesman said, "We have disclosed the information to the ITC and cannot disclose it for confidentiality reasons unless the ITC discloses it."
BTX is injected into the skin to treat wrinkles. Often shortened to "Botox," it is a neurotoxic protein. Toxins extracted from strains of the Clostridium botulinum bacterium are purified and used for treatments. The controversy between BTX makers here has been over the origins of strains in commercial use. Medytox is the first Korean company to succeed in mass-producing BTX strains. Hugel has the largest market share in the domestic botulinum toxin market, followed by Medytox.
In response, Hugel said that Medytox's lawsuit is intended to prevent the company from entering the U.S. market, adding that Medytox is making a false claim and it will counter with legal action.
"Medytox's claim that Hugel stole trade secrets and manufacturing processes for BTX strains is false. There are no facts or circumstances to support Medytox's claims," a Hugel spokeswoman said. "Nevertheless, we feel badly for their behavior of disparaging and slandering the achievements of Hugel employees for a long time by making such indiscriminate false claims."
Hugel is currently waiting for an approval of its BTX product from the U.S. Food and Drug Administration (FDA). The official added that Hugel is on course to launch the product in the U.S. in the second half of this year once FDA approval is received.
The USITC will have to decide whether to conduct an investigation into Hugel due to the complaint filed by Medytox.
"We expect the USITC to make a decision in about a month whether to investigate as Medytox argues. No matter what decision they make, we will respond strongly to Medytox," a Hugel official added.
Medytox has been claiming that Daewoong, Hugel and other companies stole its BTX strains because the origins of their own BTX strains are not clear. Daewoong said it found its own BTX strain in a barn in Gyeonggi Province, while Hugel said its strain came from an expired can of beans.
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