Friday, June 13, 2014

Valeant, Dow, Actavis Settle Patent Challenge over Antibiotic Acanya®

Case Filed: Oct 24, 2013

Case Closed: Jun 09, 2014

Judge: Stanley R. Chesler

Court: New Jersey District Court

Case Summary:
Dow Pharmaceutical Sciences, Inc. (Dow) and Valeant Pharmaceuticals North America LLC (Valeant) together filed a patent infringement suit against Actavis, Inc. (formerly Watson Pharmaceuticals, Inc.) and Andrx Corporation (Andrx), a wholly owned subsidiary of Actavis for filing abbreviated new drug application (ANDA) seeking FDA approval to market generic clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5%, for topical use gel.

The patent in question was US8288434 entitled ‘Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent,’ issued on Oct 16, 2012 and set to expire[i] by Jun 03, 2029. Goldman Sachs Lending Partners is the current assignee[ii] of the ‘434 patent (source: MaxVal’s Assignment Database).

The ’434 patent claims formulations of benzoyl peroxide and clindamycin and methods of treating acne with such formulations.

As in Complaint:
The complaint was filed soon after the ‘434 patent was granted and after FDA’s approval of the drug.  Plaintiffs alleged that defendants have infringed the ’434 patent by submitting ANDA to the FDA, seeking approval for the commercial marketing of generic clindamycin phosphate and benzoyl peroxide gel before the expiration date of the ’434 patent. Counterclaims were filed by defendants for declaratory judgment of non-infringement and invalidity of one or more claims of the ‘434 patent.

NDA Holder:
Dow is the current holder[iii] of new drug application (NDA) no. 050819 for Acanya, which the FDA approved on Oct 23, 2008 (source: Patent Marker) and the ’434 patent is listed in the FDA’s approved drug products.

According to Valeant, Acanya is the only FDA-approved fixed combination antibiotic and benzoyl peroxide (BPO) medication for once-daily treatment of both non-inflammatory and inflammatory lesions of acne. Acanya was developed by Arcutis, now a part of Coria Laboratories, a division of Valeant Pharmaceuticals. The formulation is protected by two U.S. patents and has pending patent applications. For the 12 months ending July 2013, Acanya had total U.S. sales of approximately $62 million and approximately $121 million ending Feb 2014, according to IMS Health data.

District Court Judgment:
A stipulated consent judgment was released by the court stating that unlicensed manufacture and sale of Acanya generics would infringe the ‘434 patent.  The parties are enjoined from marketing Acanya generics until the expiration of the patent or unless expressly licensed by the plaintiffs. Each party will bear their own costs and fees.

Settlement Agreement by the parties:
Under the terms of the agreement, Valeant will grant Actavis a license to market its generic Acanya beginning July 2018 or earlier under certain circumstances. Other details of the settlement were not disclosed.

See 2:13-cv-06401 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

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[i] Expected expiration date. Patent Term Estimator is a free web-based tool that automatically calculates patent terms and expiration dates for U.S. utility patents.
[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.

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