Pure Encapsulations, LLC v. Lean Living, Inc. et al. (19-cv-10113) and Tsalevich et al. (19-cv-10120).

  • January 18, 2019

Purdue accuses Collegium of patent infringement relating to Collegium’s New Drug Application (“NDA”) for the manufacture and sale of Xtampza ER oxycodone extended release capsules. Purdue asserts that Collegium’s sale of this drug would infringe their U.S. 10,407,434 patent. The ‘434 patent is listed in the FDA’s Orange Book as covering OxyContin. Collegium submitted an NDA for its own oxycodone-based product. Purdue asserts that Collegium’s filing of the NDA constitutes infringement of the ‘434 patent under 35 U.S.C. § 271(e), and that the actual manufacture and sale of the product infringes under § 271(a), (b), (c), and (g). Purdue says this litigation is related to previously-filed actions involving earlier Purdue patents on extended release oxycodone, and notes that Collegium has agreed to consolidate this case with the previous lead case for pretrial purposes.

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