Hugel Files Patent Invalidity Trial Against Medytox at US Patent Trial and Appeal Board

Patent Invalidity Trial on Botulinum Toxin Strain
"General Manufacturing Technology Lacking Inventiveness"
"May Hinder Entry of Follow-up Companies and Industry Development"

The dispute between Hugel and Medytox over the Botulinum Toxin (BTX) strain has escalated into the patent domain.

According to industry sources on the 3rd, Hugel filed a petition for patent invalidation against Medytox's BTX strain-related patent at the United States Patent Trial and Appeal Board (PTAB) on the 21st of last month. The petition claims that the patent for the "method of isolating botulinum toxin from a botulinum toxin-containing solution," registered by Medytox in the US in May last year, is invalid.

A Hugel representative explained the background of filing the patent invalidation petition, stating, "The patent in question is a general manufacturing technique lacking inventiveness," and added, "If this is registered as a patent, it could hinder not only the market entry of subsequent companies but also the development of the industry." They also noted, "This is the first time Hugel has filed a patent invalidation petition."

This is not the first time Medytox has been involved in a BTX strain-related patent trial in the US. Previously, Swiss pharmaceutical company Galderma and US BTX company Revance Therapeutics also filed patent invalidation petitions against Medytox. Among these, the PTAB upheld the lawsuit filed by Galderma in July 2021, invalidating Medytox's patent for the "long-lasting effect of a new botulinum toxin formulation." However, the invalidation petition filed by Revance Therapeutics was dismissed in January of this year.

BTX is a highly toxic substance extracted from the botulinum bacterium. When an extremely small amount of BTX is injected under the skin, it causes a slight paralysis effect on muscles, which is utilized for cosmetic or medical purposes to smooth wrinkles. The American pharmaceutical company Allergan was the first to commercialize this ingredient and named the BTX preparation "Botox," a trademark that has become widely used as is.

Meanwhile, Medytox and Hugel are also engaged in litigation at the United States International Trade Commission (ITC). Medytox filed a complaint against Hugel at the ITC in March last year, suspecting that Hugel had stolen its strain. Previously, Medytox also filed a lawsuit against Daewoong Pharmaceutical at the ITC in 2019 and won. When the ITC issued a 21-month import ban ruling, Daewoong Pharmaceutical's local partner Evolus paid Medytox a settlement of $35 million, ending the lawsuit.

Medytox's Meditoxin (left) and Hugel's Botulex (right). [Image provided by each company]