Case Filed: May 05, 2013
Case Closed: May 08, 2014
Court: Virginia Eastern District
Court
Judge: Arenda L. Wright Allen
Case Summary:
G.D. Searle and Pfizer jointly
filed a suit alleging patent infringement of U.S RES44048 by defendants Lupin,
Teva, Mylan, Watson and Apotex. The lawsuit concerned filing of abbreviated new
drug applications (ANDAs) with the U.S Food and Drug Administration (FDA) seeking
approvals to market generic versions of Pfizer's Celebrex® drug product to
treat rheumatoid arthritis and osteoarthritis, prior to expiration of the '048
patent and related period of exclusivity.
Patent-in-suit:
The patent involved in this suit
is: RE44048 entitled ‘4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-YL]benzenesulfonamide
for the treatment of inflammation or an inflammation-associated disorder,’ duly
issued to G.D. Searle on May 05, 2013 and expired[i]
on Nov 30, 2013. The patent describes a class of pyrazolyl benzenesulfonamide
compounds, compositions and methods for treating inflammation and
inflammation-associated disorders.
As in complaint:
Pfizer filed this suit on the day
the patent office issued the '048 patent and has a pediatric exclusivity that
expires by Dec 02, 2015. Defendants intend to market generic versions of
Pfizer's Celebrex® drug product beginning on or about May 30, 2014, which is
prior to the expiration of the '048 patent. One or more claims of the '048
patent cover use of the pyrazolyl benzenesulfonamide compounds disclosed to
treat each of the indications in Pfizer's Celebrex® label.
Defendants’ notice letters referring
to the ANDAs (nos. 202240, 76-898, 78-857, 200562 and 204197) stated the claims
1-17 of the patent-in-suit as invalid, unenforceable and/or will not be
infringed by the commercial manufacture of their ANDA products.
The complaint stated that the act
of infringement will cause plaintiffs to suffer irreparable harm (even in case
of later judicial determination) and sought preliminary injunction to prevent
irreparable and irreversible harm.
ANDA holder:
G.D. Searle currently holds[ii]
an approved new drug application, no. 20-998, for celecoxib capsules, 50, 100,
200and 400mg dosage strengths, which it sells under the registered name
Celebrex® (source: Patent
Marker). As stated in Pfizer's FDA approved label for Celebrex®, the drug
is indicated for the treatment of osteoarthritis, rheumatoid arthritis,
juvenile rheumatoid arthritis, ankylosing spondylitis, acute pain and primary
dysmenorrhea.
Final Judgment:
The Court found that the '048
patent is invalid for obviousness-type double patenting. Accordingly, the Court
granted in part the Joint Motion for Summary Judgment filed by defendants and
denied plaintiffs' Motion for Summary Judgment. In line with court’s opinion
and order, final judgment was entered in favor of defendants.
Appeal:
The case has now been appealed by
G.D. Searle and Pfizer on May 09 challenging court’s decision favoring Lupin,
Teva, Mylan, Watson and Apotex.
See 2:13-cv-00121
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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]
Patent Marker provides an online environment
where patentees can virtually mark products and search products for patent-related
information.