Thursday, October 17, 2013

Novartis, Apotex Resolve Suit over Lotrel Patent

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 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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