Case Filed: Sep 06, 2012
Case Closed: Oct 10, 2013
Court: New Jersey District Court
Judge: Jose L. Linares
Case Summary:
Apotex resolved a suit brought in
by Novartis accusing the generic manufacturer for infringing its patent related
to treating cardiovascular disease. Judge granted the stipulation filed by the
parties and dismissed the case without prejudice, ending the litigation that
alleged Apotex’s abbreviated new drug application for a generic version of Lotrel
infringed the ‘802 patent covering the medication.
Novartis filed a complaint to
protect its ‘802 patent after Apotex submitted an ANDA no. 91431 to the U.S.
Food and Drug Administration (FDA) for amlodipine and benazepril hydrochloride
combination capsules (generic version of Lotrel), in 2.5 mg/10 mg, 5 mg/10 mg,
5 mg/20 mg, 5 mg/40 mg, 10 mg/20 mg, and 10 mg/40 mg dosage strengths. With its
suit, Novartis sought the court to declare a permanent enjoinment of Apotex
from marketing and selling its generic version of Lotrel, as well as a court
order that any approval of Apotex's ANDA would not be effective until after
expiration of the ‘802 patent.
The patent in suit US6162802
entitled ‘Synergistic combination therapy using benazepril and amlodipine for
the treatment of cardiovascular disorders and compositions therefor’, was
legally issued to Joseph Papa and Marc M. J. Henis on Dec 19, 2000 and expires[i]
by Dec 19, 2017. The patent is currently assigned[ii]
to Novartis (source: MaxVal’s Assignment
Database).
As pointed out in complaint, the
’802 patent is directed to compositions consisting of specified amounts of
benazepril and amlodipine as well as a method of treating hypertension in humans,
consisting of administering a daily dose of specified amounts of benazepril and
amlodipine.
Novartis’s Lotrel is used to
treat high blood pressure (hypertension). It works by relaxing blood vessels,
causing them to widen. Lowering high blood pressure helps prevent strokes,
heart attacks and kidney problems. Novartis currently holds[iii]
the new drug application no. 020364 for amlodipine and benazepril hydrochloride
combination capsules in various dosage strengths, which it sells under the
brand name Lotrel® (source: MaxVal’s Patent Marker) and
approved by FDA
on Mar 3, 1995.
See case 2:12-cv-05574 for more details. To get alerts on cases
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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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