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09-943

09-943

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IN THE UNITED STATES DISTRICT COURT
FOR
THE DISTRICT OF DELAW
ARE
Pfizer Inc., et al.,Plaintiffs,
v.
Civ. No. 09-943-LPSDr. Reddy's Laboratories Ltd.,
et
al.,Defendants.RudolfE. Hutz, Esquire, Jeffrey B. Bove, Esquire, Mary W. Bourke, Esquire, Daniel
C. 
Mulveny, Esquire, Dana
K.
Severance, Esquire, and Daniel M. Attaway, Esquire,
of
CONNOLLY BOVE LODGE
&
HUTZ LLP, Wilmington, Delaware. 
Of
Counsel: William E. McShane, Esquire,
of
CONNOLLY BOVE LODGE
&
HUTZ LLP, Washington, DC. Attorneys for Plaintiffs Pfizer Inc., Pfizer Ireland Pharmaceuticals, Warner-Lambert Company, and Warner-Lambert Company LLC. John W. Shaw, Esquire, Karen L. Pascale, Esquire, and James
L.
Higgins, Esquire,
of
YOUNG CONA WAY STARGATT
&
TAYLOR, LLP, Wilmington, Delaware. Louis H. Weinstein, Esquire,
of
BUDD LARNER, P.C., Short Hills,
New
Jersey. Attorneys for Defendants, Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. 
MEMORANDUM OPINION 
February 28,2011Wilmington, Delaware
 
r , ~ ? 
0i: 
Stark, District Judge:
This action was filed by plaintiffs Pfizer Inc., Pfizer Ireland Phannaceuticals, andWarner-Lambert Company LLC, formerly Warner-Lambert Company (collectively, "Pfizer"),
on
December
8,2009,
alleging infringement
of
U.S. Patent No. 5,969,156 and its ReexaminationCertificate (collectively,
"the'
156 patent,"
or
"patent-in-suit,,).l (D.I.
1)
The Court conducted a
Markman
hearing
on
the disputed claim terms
on
February
2,2011.
See
Transcript
of
February
2,2011 Markman
hearing (D.I. 115) (hereinafter
"Tr
."). The Court
now
provides constructions
of
the disputed claim terms
of
the'
156 patent.
BACKGROUND
On October 19, 1999, the United States Patent and Trademark Office (the "PTO") issued
the'
156 patent, entitled "Crystalline [R-(R* ,R *)]-2-(
4 - F l u o r o p h e n y l ) - ~ , o - D i h y d r o x y - 5 - ( 1 -
Methylethyl)-3-Phenyl-4-[(Phenylamino )Carbonyl]-IH-Pyrrole-I-Heptanoic Acid HemicalciumSalt (Atorvastatin)." (D.I. 1 tjI2)
On
September
26,2006,
the PTO issued an
Ex
ParteReexamination Certificate for
the'
156 patent.
(ld.)
Pfizer holds approved
New
DrugApplication ("NDA") No. 02-0702 for atorvastatin calcium ("atorvastatin") formulations,including 10 mg, 20 mg,
40
mg, and 80
mg
dosage strengths, which it sells under the brand nameLipitor® -a drug that lowers cholesterol, specifically "bad"
or
low-density lipoprotein (LDL)cholesterol in the blood
of
patients.
(ld.
~
10; D.I. 97
at
2) While the expiration date for
the'
156patent is July
8,
2016, the pediatric exclusivity period associated with
the'
156 patent will expireon January 18,2017. (D.I. 1
~ t j I 4 0 , 
42)ITo the extent not otherwise noted, the
'156
patent and file history are located in therecord at D.I.
91
and D.I. 92.1
 
Defendants Dr.
Reddy's
Laboratories, Ltd. and Dr.
Reddy's
Laboratories, Inc.(collectively, "DRL") filed with the United States Food and Drug Administration ("FDA")
an
Abbreviated
New
Drug Application ("ANDA") No. 91-650, seeking
FDA
approval to marketgeneric atorvastatin tablets in 10 mg, 20 mg, and 40 mg dosage strengths, prior to the expiration
of
the
'156
patent.
(ld.
~ ~
12,43)
In response, Pfizer sued DRL for infringement
of
the
'156
patent.For purposes
of
construction, the parties have
now
placed the following three categories
of
disputed2claim terms before the Court:
1. 
the
"Form"
terms, i.e.,
a. 
"Form
I atorvastatin/' appearing in claims
1-27,45,47,52-55,61-99,
11012, and 115;b. 
"Form
II atorvastatin," appearing in claims 28-35, 56-57, 100-05, 113, and116;
c. 
"Form
IV atorvastatin," appearing
in
claims 36-44, 46, 48-51, 58-60, 10609, 114, and 117;2. "hydrate," appearing in all claims; and3. the "having" terms, i.e.,a. "[h]aving
an
X-ray powder diffraction containing," appearing in claims
5,28-31,36-40,45-69,
100-10, and 113-17;b. "[h]aving a chemical shift difference," appearing in claims 6,
32,41,
and
2The
parties initially also presented a dispute relating to the term "crystalline," whichappears in all claims, disagreeing as to the plain and ordinary meaning
of
the term.
(See
D.I. 89;D.L 96
at
2, 12-13; D.I. 97
at
18; D.I.
101
at 5; D.I. 103 at 16)
At
the Markman hearing, Pfizerstated that either party's proposed construction for this term would
be
acceptable.
(See
Tr. at
3) Hence, the Court will adopt
DRL's
construction and construe the term "crystalline" as used inall
of
the claims to mean
"a
solid form having a long range periodic ordered structure extendingin three dimensions."2

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