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USITC postpones final ruling on Medytox, Daewoong’s BTX trade secret suitBy Lim Jeong-yeo
Published : Nov. 20, 2020 - 14:29
The ITC did not elaborate on the reason for the postponement, but the agency‘s website indicates that the whole organization is teleworking since March this year due to COVID-19, suggesting that the pandemic may have interfered with its regular workflow.
This is the second time the ITC has postponed making the final decision on the suit. Originally, it was scheduled to close the case on Nov. 6 but delayed that to Nov. 19, and now to Dec. 16.
Similarly, Korean energy companies LG Chem and SK Innovation’s final USITC ruling on alleged technology theft had also been postponed from Oct. 5 to Oct. 27 and finally to Dec. 10.
What‘s at stake in the suit is a 10-year sales ban on Daewoong’s BTX product Jeuveau in the US.
Medytox officially filed a complaint with the ITC in January last year, accusing Daewoong of stealing its strains and technical documents on manufacturing processes. The ITC made a preliminary ruling in favor of Medytox in July.
Because the July ruling by the ITC was only preliminary, Daewoong’s US partner Evolus is still able to market Jeuveau until a final ruling is made and the US president confirms the decision.
Since the ban was proposed in July by the ITC, Daewoong‘s US partner Evolus is still able to market Jeuveau until the final ruling is made and the US’ president confirms the decision.
Jeuveau, also known as Nabota outside of the US, gained sales approval from the US Food and Drug Administration in February, 2019.
It is facing headwinds, however, due to the ITC suit filed in January by Meydtox and its US partner Allergan, claiming that Daewoong‘s product is based on a stolen trade secret and is damaging the US economy.
Daewoong is adamant that Medytox’s claims to ownership of its BTX strain are unfounded. It appealed the case in September. Daewoong interprets the delayed final ruling as a favorable sign.
BTX, or botulinum toxin, is popularly referred to as Botox, after the name of US company Allergan’s product.
The toxins are most widely used to numb muscles in the forehead, near the eyes and jawlines, to achieve an aesthetic enhancement by reducing wrinkles.
BTX is also used as a medical treatment for more serious indications, such as muscle spasticity and persistent headache, in different amounts of distillation.
In Korea, the main players in the BTX market are Medytox, Daewoong and Hugel.
Each company claims they secured the first bacteria for their toxin from a different source. Medytox says it got its strain from the US laboratory where the Hall A Hyper strain was available in the past.
Daewoong says it got its strain from the Korean soil, and Hugel says its strain came from a rusted tin that once contained preserved food.
Medytox‘s product was the first Korean BTX product to be approved. It is called Meditoxin here and variably Neuronox, Siax, Botulift, Cunox and Acebloc in countries it is exported to.
Daewoong’s is called Nabota in Korea and Jeuveau in the US, where it had gained the commercial approval from the FDA in Feburary 2019.
In January 2019, Medytox had filed a suit against Daewoong at the USITC, claiming the latter had stolen its trade secret BTX through a researcher who had moved between the two companies.
Medytox filed the suit in partnership with its US partner Allergan, to whom it had licensed-out its liquid-form BTX called Innotox in 2013.
Disappointingly for Medytox, Innotox is yet to enter the US market after seven years.
Daewoong‘s faster tapping of the US market is a blow to the company.
The USITC’s ruling is bound to affect similar domestic suits between the two companies, and will affect the long-term business of both.
By Lim Jeong-yeo (firstname.lastname@example.org)
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