Galderma Laboratories filed a lawsuit in the Northern District of Texas against Watson Pharmaceuticals. Watson submitted an ANDA (abbreviated new drug application) no. 204067 seeking approval to engage in the commercial manufacture of generic Adapalene and Benzoyl Peroxide Gel, which according to Galderma infringes the claims of three of its patents. The patents involved in this suit were:
US8071644 - Combinations of adapalene and benzoyl peroxide for treating acne lesions and issued on Dec 06, 011.
US8080537 - Combinations of adapalene and benzoyl peroxide for treating acne lesions and issued on Dec 20, 2011
US8129362 - Combination/association of adapalene and benzoyl peroxide for treating acne lesions and issued on Mar 06, 2012
The patents expire[i] by Jul 13, 2026 and are currently assigned[ii] to Galderma (source: MaxVal’s Assignment Database). Galderma currently holds[iii] the NDA (new drug abbreviation) no. 022320 for Epiduo® gel to treat acne (source: MaxVal’s Patent Marker) approved by FDA in Dec, 2008.
Par Pharmaceuticals substituted Watson during the prosecution. The case is now closed as the parties have filed for stipulated dismissal and the Court ordered dismissal upon the request. However, no further information is available on the terms of settlement.
Case Filed: Jul 27, 2012
Case Closed: May 21, 2013
Judge: Ed Kinkeade
Court: Texas Northern District Court
See 3:12-cv-02563 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.
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[ii] MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded.
[iii] Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.