Case Filed: Mar 21, 2012
Case Closed: Apr 29, 2014
Court: Delaware District Court
Judge: Richard G. Andrews
Case Summary:
Novartis, based in Basel,
Switzerland sued generic-drug maker Actavis of Zug, Switzerland, alleging infringement
of two U.S. patents, which Novartis listed as covering the iron-control drug, Exjade.
The lawsuit concerned Actavis filing an
ANDA seeking approval to market a generic version of Exjade, deferasirox in
tablet form.
The patents at issue were: US6465504
and US6596750 both reading ‘Substituted 3, 5-diphenyl-1,2,4-triazoles and their
use as pharmaceutical metal chelators’. The patents were issued on Oct 15, 2002
and July 22, 2003, respectively. The patents are set to expire[i]
by Jun 25, 2016 and are currently assigned[ii]
to Novartis (source: MaxVal’s Assignment
Database).
The complaint alleged that
Actavis Group acted collaboratively in the preparation and submission of ANDA
No. 203560. By filing ANDA, Actavis has represented that its generics have the
same active ingredient and are bioequivalent to Exjade®. In the notice letter,
Actavis had told Novartis its patents “are invalid, unenforceable.”
Novartis is the current holder[iii]
of New Drug Application (NDA) No. 21-882, which the FDA granted approval for
marketing and sale of 125 mg, 250 mg and 500 mg strength deferasirox tablets,
oral suspension (source: Patent
Marker.) Novartis markets deferasirox tablets in the United States under the
trade name Exjade®. It is used to treat patients with chronic anemia disorders
who get blood transfusions that result in an excess of iron, which may cause
damage to the heart, liver and other organs.
According to the complaint, the composition,
formulation, dosing and method of administration for Exjade® are covered by
certain claims of the ’504 and’750 patents.
Stipulation and order of dismissal
was filed by Novartis in which it stated that both the parties stipulate and
agree to dismiss all the claims and counterclaims, defenses, motions and
petitions asserted in this action without prejudice and each party shall bear
its own costs and attorneys' fees. Accordingly, Court granted the stipulation,
thereby ending the dispute.
See 1:12-cv-00366
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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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