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.
Patent-in-Suit:
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.
Acanya®:
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
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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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