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ALLERGAN BATTLES TO KEEP BOTOX-MANUFACTURING PROCESS A TRADE SECRET

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ALLERGAN BATTLES TO KEEP BOTOX-MANUFACTURING PROCESS A TRADE SECRET

 

By: Emily Gaukstern

 

Allergan Plc (“Allergan”) has filed a motion challenging a trade judge’s order to release Allergan’s trade secrets as evidence in a dispute with Botox over its wrinkle treatment. Currently, Allergan’s trade secrets protect the company’s confidential manufacturing process of its popular wrinkle treatment. An U.S. International Trade Commission (ITC) judge told Allergan to give lawyers for Daewoong Pharmaceuticals Co. (“Daeoong”) and Evolus Inc.(“Evolus”) information pertaining to its trade secrets as part of an ongoing legal dispute over processes to make the next generation of Botox.

Patents provide an owner with exclusivity of the claimed invention for approximately 20 years. A patent, however, requires the inventor to fully disclosure the details of their invention to the public in order to obtain the 20 years of protection. Generally patents remain confidential after filing and are not published for the first 1-2 years.  According to the Uniform Trade Secret Act (USTA) a trade secret is defined as “information, including a formula, pattern, compilation, program, device, method, technique or process that derives independent economic value and is the subject of efforts to maintain its secrecy.” Trade secrets provide an inventor, or entity protection as long as they are able to keep the invention away from the public and maintain its secrecy. Although Allergan has obtained patents on Botox, they have stated they have maintained the Botox manufacturing process a trade secret for about 30 years, and instead have pursued patents on the composition of Botox and methods of using Botox.

 

Allergan and Medytox accused a previous Medytox employee, which co-manufactures Botox, in January of stealing trade secrets relating to the complex manufacturing process needed to turn botulinum toxin into a drug. Allergan and Medytox further accuse the former employee of stealing a sample of Medytox’s strain of botulinum toxin. That complaint followed a lawsuit Medytox filed in 2017 against Daewoong on the same claims.

In February, Allergan and Medytox filed trade-secret theft complaints with the ITC asking to block imports of Daewoong’s products. Allergan responded stating there is no need to give Dawwoong the manufacturing process information because the ITC case is not related to the actual process of manufacturing Botox but instead about the next-generation treatment being developed by Medytox.

Not only does Allergan find the information not relevant to the instant case, they have stated, it provides an immense risk to the company’s business as a whole.

“The toxin field is comprised of a small field of experts and they would be unable to unlearn information to which they gained unprecedented access,” Allergan said. “It is highly likely, if not inevitable, that experts granted access to Allergan’s technical information regarding Botox will find themselves working or consulting for Allergan’s competitors down the road.”

 

Medytox and Allergan contend Daewoong had the ability to beat the industry to market with a drug utilizing botulinum toxin because a former Medytox employee provided Daewoong a copy of the bacterial strain that contains a variant of Botox. Daewoong has disputed the claim stating they developed its strain from soil in South Korea, not from Medytox.

Daewoong argues that the processes both Allergan and Medytox claim are protected are not trade secrets. It is alleged that learning how Botox is made would show that the manufacturing steps “are generally known, contained in published materials or self-evidence variations or modifications of that public information,” Daewoong said.

A decision on this ruling is expected in the upcoming months. The case is In the Matter of Certain Botulinum Toxin Products, Complaint No. 337-3359, U.S. International Trade Commission (Washington).

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