Case Filed: Jan 07, 2011
Case Closed: May 28, 2014
Court: Delaware District Court
Judge: Gregory M. Sleet
Case Summary:
Pfizer filed a patent
infringement lawsuit against Novel Laboratories for filing abbreviated new drug
application (ANDA) with FDA seeking approval to market a generic version of
Pfizer’s pharmaceutical product Lyrica, prior to expiry of U.S. patents covering
the drug and its use.
Patents-in-Suit:
The patents involved in this suit
are:
- US6197819 entitled ‘Gamma amino butyric acid analogs and optical isomers,’ issued on Mar 06, 2001 and expires* by Mar 06, 2018
- US5563175 entitled ‘GABA and L-glutamic acid analogs for antiseizure treatment,’ issued on Oct 10, 1996 and expired* on Oct 03, 2013
- RE41920 entitled ‘Isobutylgaba and its derivatives for the treatment of pain,’ issued on Nov 09, 2010 and expires* by Jul 16, 2017
The ‘819 and ‘920 patents are
currently+
assigned to Northwestern University and Warner-Lambert (source: MaxVal’s Assignment
Database.)
The patents relate to compounds
that are analogs of glutamic acid and gamma-aminobutyric acid (GABA). The
analogs are useful as antiseizure therapy for central nervous system disorders
such as epilepsy, Huntington's chorea, cerebral ischemia, Parkinson's disease,
tardive dyskinesia and spasticity.
As in Complaint:
Pfizer and Northwestern received
a notice letter stating that Novel had submitted ANDA no. 202269 and the
patents-in-suit are invalid, unenforceable, or will not be infringed by the
commercial manufacture of the Novel’s ANDA product.
Novel’s Counterclaim:
Novel asserted counterclaims,
including declaratory judgment of non-infringement and invalidity of the '819,
'175 and '920 patents and for a declaration of unenforceability of the '819 and
'920 patents’ term extensions.
Lyrica NDA:
Pfizer currently± holds approved new drug application
(NDA) no. 22-488 approved by FDA for a
pregabalin oral solution containing 20mg/mL of pregabalin (source: Patent Marker). The
patents-in-suit are listed in the FDA publication “Approved Drug Products with
Therapeutic Equivalence Evaluations,” with respect to Lyrica.
District Court Proceedings:
On July 2012, the court concluded
that the asserted claims of the '819, '175 and '920 patents are not invalid and
the '819 and '920 patents’ term extensions are not invalid and defendants'
proposed products infringe claims 1 and 4 of the '819 patent. Accordingly
judgment was entered in favor of Pfizer. The judgment was appealed (2012-1576) and
the federal court affirmed that claim 2 of the '819 patent is infringed and not
invalid and affirmed the judgment of the district court. In Mar 2013, district court
entered a stipulated order staying the action pending final disposition of
appeal.
The stay is now removed and Novel
is enjoined from commercially manufacturing of their proposed ANDA product, prior
to Dec 30, 20I8. The claims and counterclaims are dismissed with no costs
imposed on parties.
See 1:11-cv-00027
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*
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.
+
MaxVal offers Patent Assignment Alert service
where subscribers receive email alerts when assignments relating to target
applications, patents or entities of interest are recorded.
± Patent
Marker provides an online environment where patentees can virtually mark
products and search products for patent-related information.