Court Issues Positive Outcome for Cadence in Ofirmev Patent Litigation

Case Filed: Aug 18, 2011

Case Closed: Nov 22, 2013

Court: Delaware District Court

Judge: Leonard P. Stark

Case Summary:

Cadence and SCR Pharmatop, a French company sued Exela, a generic drug manufacturer alleging that their abbreviated new drug application for generic injectable acetaminophen had infringed on their patent rights. Perrigo Company and Paddock Laboratories were the other defendants in the suit. Cadence sublicenses the patents from SCR Pharmatop’s exclusive licensee, Bristol-Myers Squibb Co. The patents are currently assigned* to SCR Pharmatop (source: MaxVal’s Assignment Database).

Cadence said defendants have submitted abbreviated new drug applications no. 202605 (Paddock and Perrigo) and 203092 (Exela) with the U.S. Food and Drug Administration, seeking approval to manufacture and sell a generic versions of Cadence’s product Ofirmev, which is covered by the patents-in-suit.  According to the complaint, if allowed to pursue their generic versions, defendants would infringe the following U.S. patents that protect the branded pain reliever:

•        US6028222 titled ‘Stable liquid paracetamol compositions, and method for preparing same,’ issued on Feb 22, 2000 and expires+ by Aug 05, 2016
•      US6992218 titled ‘Method for obtaining aqueous formulations of oxidation-sensitive active principles,’ issued on Jan 31, 2006 and expires+ by Jun 06, 2020

Cadence is the current holder± of the New Drug Application (NDA) no. 022450 for Ofirmev, (source: Patent Marker) with active ingredient as acetaminophen that is approved by FDA on November 02, 2010.  Ofirmev is used to treat pain and to reduce fever and is sometimes given with opioid pain medication to treat moderate to severe pain.

The case is now concluded and final judgment has been rendered in favor of Cadence. In late 2012, Paddock and Perrigo were dismissed (with prejudice) from the case as a result of parties agreeing to settle the dispute. Exela continued litigation and recently, the Court rejected Exela's claim that the patents are invalid and found that Exela's ANDA for a generic version of the product infringes both the patents.  FDA is ordered that any approval of ANDA No. 203092 should not be earlier than the expiration of the '222 and ‘218 patents.

See 1:11-cv-00733 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.

* Expected expiration date using Patent Term Estimator, use our free tool or download our free Android app on Google Play Store. 

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* MaxVal offers Patent Assignment Alert service where subscribers receive email alerts when assignments relating to target applications, patents or entities of interest are recorded. 

+ 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.

± Patent Marker provides an online environment where patentees can virtually mark products and search products for patent-related information.