Thursday, November 7, 2013

Court Dismisses Cumberland, Sagent Suit over Acetadote Generic

Case Filed: Jun 26, 2012

Case Closed: Nov 01, 2013

Court: Delaware District Court

Judge: Leonard P. Stark

Case Summary:
Sagent Agila and Sagent Pharmaceuticals resolved suits brought in by Cumberland accusing the generic manufacturers of infringing its patent relating to treating acetaminophen-induced hepatotoxicity. Judge granted the motion filed by the defendants, Sagent Agila and Sagent Pharmaceuticals and dismissed the complaint. thereby ending the litigation over defendants’ abbreviated new drug application for a generic version of Acetadote® infringing the ‘356 patent covering the medication. The memorandum order stated “the Court agrees with Sagent that "there is no reasonable view of the facts pled in Cumberland's Complaint that would support a claim for relief,..".

The patent entitled ‘Acetylcysteine composition and uses therefor’ was legally issued to Leo Pavliv on Apr 03, 2012 and expires[i] by Aug 24, 2025.  Bank of America is the current assignee[ii] of the ‘356 patent (source: MaxVal’s Assignment Database). Cumberland Pharmaceuticals is the owner of the patent, as said in the complaint.

Cumberland filed complaint to protect its patent after defendants submitted an ANDA no. 091684 to the U.S. Food and Drug Administration (FDA) for acetylcysteine injection, 200mg/ml (a generic version of Acetadote) by which it alleged that defendants had committed an act of infringement. Cumberland sought the court to declare a permanent enjoinment of defendants from marketing and selling its generic version of Acetadote, as well as a court order that any approval of defendants’ ANDA would not be effective until after expiration of the ‘356 patent.

Cumberland currently holds the new drug application (NDA) No. 021539 with formulation of N-acetylcysteine (“acetylcysteine”) which is sold under the trademark Acetadote®. It is used as an antidote for acetaminophen overdose to prevent life-threatening liver damage.
See case 1:12-cv-00825 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.

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