Free Stipulation - District Court of Delaware - Delaware

Case 1 :O7—cv-00360-JJF Document 28 Filed O3/10/2008 Page 1 of 3
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
PFIZER, INC., ) .
PFIZER IRELAND PI-IARMACEUTICALS,)
WARNER-LAMBERT COMPANY, )
WARNER-LAMBERT COMPANY, LLC )
and ‘ )
WARN ER~LAMBERT EXPORT LTD., ) ‘
)
Plaintiffs, ‘ ) Civil Action No. 07-3 60-J J F
v. . )
)
TEVA PHARMACEUTICALS USA, INC., )
J
Defendant. )
STIPULATION T
Defendant Teva Pharmaceuticals USA, Inc. ("Teva") and plaintiffs Pfizer, Inc., Pfizer
Ireland Pharmaceuticals, Warner-Lambert Company, Warner—Lambert Company, LLC and
Warner¥Lambert Export Ltd. (collectively referred to as "Pfizer”), hereby stipulate and agree as
follows: I
1. A person of ordinary skill in the art, before July 2l, 1988 (more than one year
p before the effective filing date of U.S. Patent 5,273,995, could have resolved a racemic mixture
· of the enantiomers of trans-5~(4—fluorophenyl)—2-( l -methylethyl)~N,4~diphenyl— l —[2-
1 (tetrahydro—4—hydroxy-6-oxo-2H—pyran—2—yl)ethyl]— lH-pyrrole-3 —carboxa.mide into its
individual enantiomers without undue experimentation.
2. A person of ordinary skill in the art, before July 2l, 1988 (more than one year
before the effective filing date of U.S. Patent 5,273,995), could have resolved a racemic mixture
of the enantiomers of (R*, R*)—2-(4—fluorophenyl)—[3, 5—dihydroxy-5—(l—methylethyl)—3 -phenyl-4-
[(phenylamino)—carbonyl]— lH—pyrrole~l—heptanoic acid into its individual enantiomers without -
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undue experimentation.
3. . A person of ordinary skill in the art, before July 21, 1988 (more than one year
before the effective filing date of U.S. Patent 5,273,995 ), could have opened the lactone ring in
the compound (2R-trans)—5—(4~fluorophenyl)-2-(1—methylethyl)—N,4-diphenyl-1-[2—(tetrahydro-4-
hydroxy-6—oxo—2H-pyran-2—yl)ethyl]-1H~pyrrole~3 —carboxamide to form the compound [R-(R*
,R*)]—2-(4-fluorophenyl)-[3, 5—dihydroxy—5-(1—methylethyl)-3-phen yl~4-[(phenylamino)-
carbonyl]- 1H-pyrrole—1—heptanoic acid without undue experimentation.
3 4. The prior art to U.S. Patent 5,273,995 taught that the R-trans enantiomer (lactone
form) or the [R—(R* ,R*)] enantiomer (opened acid or salt form) of other statins was active as an
inhibitor of HMG-CoA reductase. V
5. Pfizer agrees that as of May 30, 1986 (the filing date of U.S. Patent 4,681,893),
Bruce Roth expected that one of the component isomers of a racemic mixture of the enantiomers
of trans-5 —(4—fluorophenyl)—2~( 1 —methylethyl) -N,4—diphenyl- 1 — [2—(tetrahydro—4-hydroxy-6-oxo-
2H—pyran-2—yl)ethyl]~ 1H—py1role-3 —carboxamide --either the R~trans or the S~trans -— would have
more activity than the other and that the more active isomer _in the mixture would function in the
racemate and provide activity. I
6. Pfizer agrees that based on what was known from prior art statins, as of May 30,
1986 (the filing date of U.S. Patent 4,681,893), Bruce Roth had an expectation that the R-trans
enantiomer would be the more active isomer, but that at best the R-trans enantiomer would be
two times more active than the racemic mixture.
7. Pfizer agrees that Bruce Roth will not be identified in response to lnterrogatory
No. 3 of Teva’s First Set of Interrogatories.
8. Teva agrees not to depose Bruce Roth duringthe period of fact discovery in the
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Case 1 :O7—cv-00360-JJF Document 28 Filed O3/10/2008 Page 3 of 3
above-identified litigation.
9. Both parties agree to identify any witnesses that they plan to bring at trial, who
have not previously been deposed, at least 40 days prior to the pre-trial conference, and that the
opposing party shall be given the opportunity to depose said witnesses prior to the pre-trial
conference. ’
Pfizer and Teva reserve the right to offer evidence relating to the foregoing stipulations.
Dated: March 10, 2008 _
/s/ Jejjrey B. Bove /s/ Richard D. Kirk 1
Rudolf E. Hutz (#484) Richard D. Kirk (#922)
Jeffrey B. Bove (#998) Ashley B. Stitzer (#3891) ·
Mary W. Bourke (#2356) BAYARD, P.A.
‘ CONNOLLY BOVE LODGE & I-IUTZ LLP 222 Delaware Avenue, Suite 900
The Nemours Building Wilmington, DE 19899-5130
1007 North Orange Street (302) 655-5000
P.O. Box 2207 V . .
Wilmington,_DE 19899-2207 Attorneys for Defendant
(302) 658-9141 TEVA PHARMACEUTICALS USA, INC
Attorneys for Plaintiffs OF COUNSEL:
. David M. Haslnnall
Frederick H. Rein
Emily L. Rapalino
Joseph B. Crystal .
GOODWIN PROCTER LLP
599 Lexington Avenue
New York, NY 10022
(212)813—8800
ITIS SO ORDERED this day of , 2008.
United States District Judge
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