Three patent disputes between pharma companies for filing abbreviated new drug application were resolved on Tuesday. One among them is the Celgene Corporation vs. Intellipharmaceutics.
Case Filed: June 29, 2012
Case Closed: May 21, 2013
Judge: Susan D. Wigenton
Court: New Jersey District Court
Case Summary:
Celgene
and Novartis filed a complaint against Intellipharmaceutics for filing
(ANDA) no. 78-992 with the U.S Food and Drug Administration (FDA)
seeking approval to manufacture a generic version of Novartis’ Focalin XR® drug that allegedly infringes the patents:
Patent Number
Current Assignee[i] |
Issued Date
|
Expiration Date[ii]
|
Title
|
|
|
Nov 17, 1998
|
Dec 04, 2015
|
Delivery of multiple doses
of medications |
|
| Oct 21, 2003 | Dec 04, 2015 |
Delivery of multiple doses
of medications |
|
|
Jun 01, 1999
|
Dec 04, 2015
|
Method of treating
attention deficit disorders with d-threo methylphenidate |
|
|
Mar 12, 2002
|
Dec 04, 2015
|
Phenidate drug formulations
having diminished abuse potential |
|
|
Mar 04, 2003
|
Dec 04, 2015
|
Phenidate drug formulations
having diminished abuse potential |
|
|
Oct 07, 2008
|
Jun 10, 2023
|
Delivery of multiple doses
of medications |
Novartis currently holds[iii] an FDA approved New Drug Application(NDA) no. 021802 for extended release capsules that are sold under thetrade name Focalin XR® (source: Maxval’s Patent Marker). It is used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) inpatients above 6 years.
The
suit is now concluded. It appears that the parties have reached an
agreement. Followed by the agreement, the court ordered a stay for 60
days in order to permit review of the settlements. It is also ordered
that all claims, counterclaims to be dismissed without prejudice. The
charges are imposed on any parties. The terms of the settlements were
undisclosed.
See 2:12-cv-04039 for more details. To get alerts on cases filed/closed, subscribe to our Litigation Alerts.
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[i] MaxVal offers
Patent Assignment Alert service where subscribers receive email alerts
when assignments relating to target applications, patents or entities of
interest are recorded.
[ii] 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.
[iii] Patent
Marker provides an online environment where patentees can virtually
mark products and search products for patent-related information.
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