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:
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.
*
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.