Monday, May 5, 2014

Actavis, Novartis Resolve Patent Dispute over Iron-Control Drug Patents

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 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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