Posts Tagged: "allergan"

ITC’s Botox Ruling Could Have Public Interest Implications

Korean company Daewoong and its U.S. counterpart Evolus recently found themselves in a dispute with U.S.-Irish company Allergan and its counterpart Medytox over misappropriation of both a bacterial strain and the manufacturing process to make cosmetic injection products from that strain. Daewoong recently received Food and Drug Administration (FDA) approval to market an injection in the United States that competes with Botox, owned by Allergan-Medytox. In order to prevent this entrance into the market, Allergan-Medytox filed a complaint with the International Trade Commission (ITC) to block imports of the new product under Section 337. The only relationship between Allergan and Medytox is an anticompetitive market allocation agreement. Daewoong’s new product posed a threat to the profitability of Allergan’s agreement with Medytox and therefore became the subject of a dispute before the ITC. Importantly, the manufacture of the products occurs in Korea and the injectables are then imported into the United States.

ITC Issues Limited Exclusion Order on Botox Products, Partially Reverses Trade Secret Finding

In September, the International Trade Commission (ITC) decided to review an initial final determination (FID) in the Matter of “Certain Botulinum Toxin Products, Processes for Manufacturing or Relating to Same and Certain Products Containing Same,” Investigation No. 337-TA-1145, a complaint filed by Allergan against Botox products made by Daewoong and its partner, Evolus, a “performance beauty company”. On Wednesday, the ITC issued a Final Determination in the case, finding that the sale and importation of the products into the United States violated Section 337 of the U.S. Tariff Act. The Commission issued a Limited Exclusion Order (LEO) prohibiting importation of the products by Daewoong and Evolus for a period of 21 months, as well as a cease and desist order against Evolus preventing the Company from selling, marketing, or promoting the products in the United States for a period of 21 months. However, the Commission reversed the FID’s finding that a trade secret exists with respect to Medytox’s bacterial strain.

ITC Decision to Review Final Initial Determination in Botox Case Could Have Big Implications for Trade Secrets

Last week, the United States International Trade Commission (ITC) issued a notice in the Matter of “Certain Botulinum Toxin Products, Processes for Manufacturing or Relating to Same and Certain Products Containing Same,” Investigation No. 337-TA-1145, stating that the ITC has “determined to review in part a final initial determination (FID) of the presiding administrative law judge (ALJ) finding a violation of section 337 of the Tariff Act of 1930.”Last year, Allergan, the U.S. manufacturer of Botox, and Medytox, the Korean manufacturer of a similar product, filed a joint complaint against Daewoong, a Korean drug maker, under Section 337 of the Tariff Act of 1930, alleging that Daewoong had stolen Medytox’s botox strain trade secret in Korea and introduced it to the U.S. market. The FID was issued on July 6, 2020, wherein the ALJ found that certain products sold by the Korean drug maker Daewoong and its partner Evolus, Inc. violated section 337 through their importation and sale in the United States of a botulinum neurotoxin product “by reason of the misappropriation of trade secrets.”

Patent Filings Roundup: Robot Vacuum Wars, PTAB Filings Dip, Pharma Litigation Abounds

This week’s District Court filings were robust, with a dip in Patent Trial and Appeal Board (PTAB) filings–a big chunk of which were related to a dispute over robot vacuum cleaners. A few new (or renewed) assertion campaigns, a few small inter-company disputes, and a number of pharmaceutical disputes led the charge. I say Robot, you say vacuum:  Call it the great robot vacuum wars of 2020: industry leader iRobot sued SharkNinja for infringement of three patents (as well as false advertising)—seeking a preliminary injunction of a competing product right before the lucrative holiday season.  iRobot contended that SharkNinja had “brazenly ripped off” their Roomba robotic vacuum cleaners with their much less expensive IQ Robot competitor product.  That bid failed, and the case continued; now SharkNinja has filed multiple IPRs seeking to invalidate the asserted patents.

Drug Patents and the High Cost of Healthcare: Case of Over-Advocacy for Under-Patentability

The price-tag for non-innovative drug patents, such as these second-wave Restasis patents, is substantial. Indeed, one cannot help but question Allergan’s true motivations for attempting to evade PTAB scrutiny of these patents by reliance on Tribal Immunity based on its deal with the St. Regis Mohawk Tribe. The PTAB, unlike the examiner corps, does have the ability to consider rebuttal expert testimony, and is thus not-so handicapped in its capacity to vet drug patents of questionable validity, with aplomb.