High Quality
Open the downloaded document, and select print from the file menu (PDF reader required).
IN
THE UNITED STATES DISTRICT
COURT
FOR THE DISTRICT OF DELAWAREROCHESTER DRUG CO-OPERATIVE, et. ai, )INC., on behalf
of
itself and all others )similarly situated, )
)
Plaintiffs, ))
v.
) Civ. No. 07-142-SLR)BRAINTREE LABORATORIES, ))Defendant. )Jeffrey
S,
Goddess, Esquire
of
Rosenthal, Monhait & Goddess, P.A., Wilmington,Delaware. Counsel
for
Plaintiff.
Of
Counsel: Linda
P.
Nussbaum, Esquire and John
D.
Radice, Esquire
of
Kaplan, Fox & Kilscheimer, LLP, New York,
New
York; David
F.
Sorensen, Esquire and Eric
L.
Cramer, Esquire
of
Berger
&
Montague, P.C.,Philadelphia, Pennsylvania; Bruce
E.
Gerstein, Esquire
of
Garwin, Gerstein & Fisher,LLP, New York, New York; Joseph M. Vanek, Esquire and David
P.
Germaine, Esquire
of
Vakek, Vickers & Masini, Chicago, Illinois; Paul
E.
Slater, Esquire
of
Sperling &Slater, P.C., Chicago, Illinois; John Gregory Odom, Esquire and Stuart
E.
Des Roches,Esquire, Odom
&
Des Roches, LLP, New Orleans, Louisiana; David
P.
Smith, Esquireand W. Ross Foote, Esquire
of
The
Smith Foote Law Firm, LLP, Alexandria, Louisiana;Joshua
P.
Davis, Esquire
of
the Law Offices
of
Joshua
P.
Davis, San Francisco,California; and David Balto, Esquire
of
the Law Offices
of
David Balto, Washington,D.C.Frederick
L.
Cottrell, III, Esquire, Elizabeth Rui He, Esquire and Steven
J.
Fineman,Esquire
of
Richards, Layton
&
Finger, P.A., Wilmington, Delaware. Counsel forPlaintiff.
Of
Counsel: David
B.
Bassett, Esquire and Alexandra McTague, Esquire
of
Wilmer Cutler Pickering Hale and Dorr, LLP, New York, New York; Michelle
D.
Miller,Esquire, Cynthia
D.
Vreeland, Esquire, Peter
A.
Spaeth, Esquire and Mark
A.
Ford,Esquire
of
Wilmer Cutler Pickering Hale and Dorr, LLP, Boston, Massachusetts.Dated: May 18, 2010Wilmington, Delaware
MEMORANDUM OPINION
I
~.
I.
INTRODUCTION
This is
an
antitrust action arising out
of
a patent infringement case filed
on
May
16,2003
by Braintree Laboratories, Inc. ("Braintree" or "defendant"), a pharmaceuticalcompany selling the constipation drug polyethylene glycol 3350 ("PEG")
in
the UnitedStates under the brand name MiraLax®, against a generic drug manufacturer, SchwarzPharma, Inc. ("Schwarz"), seeking to preclude FDA approval for Schwarz's genericPEG drug GlycoLaX®. (Civ. No. 03-477-SLR (hereinafter, "the Braintree/Schwarzlitigation"» The Braintree/Schwarz litigation commenced when Braintree brought suitpursuant to 35 U.S.C.
§
271
(e)(2)(A)1 responsive to Schwarz's filing
of
an
ANDAcontaining a "Paragraph IV" certification
2
claiming that the patent listed by Braintree
in
the FDA's Orange Books as covering MiraLax®, U.S. Patent 5,710,183 ("the '183patent" or the "Halow patent"),
is
invalid
or
not infringed by the manufacture, use, orsale
of
GlycoLax®. That suit triggered the 30-month stay on the FDA's approval
of
Schwarz's ANDA.
See
21
U.S.C.
§
3550)(5)(B)(iii). The Braintree/Schwarz litigationwas voluntarily dismissed by Braintree
on
June
3,
2004. Braintree waived anyremaining portion
of
the 30-month stay, and GlycoLax® entered the market shortly the
1"(2)
It shall be
an
act
of
infringement to submit -(A) an application undersection 5050)
of
the Federal Food, Drug, and Cosmetic Act or described
in
section505(b)(2)
of
such Act for a drug claimed
in
a patent or the use
of
which is claimed
in
apatent[.]"
2See
21
U.S.C.
§
3550)(2)(A)(vij)(IV).
SThe
FDA publishes patent information on approved drug products
in
itspublication entitled "Approved Drug Products with Therapeutic EquivalenceEvaluations," commonly referred to as the "Orange Book," a register that providesnotice
of
patents covering name brand drugs.
FDA issued its approval on July
2,
2004. Plaintiffs filed the instant suit
on
March 12,2007 alleging that the Braintree/Schwarz litigation was a sham litigation designed todelay the FDA's approval
of
GlycoLax® and to improperly maintain monopoly powerwith respect to its pioneer drug. Plaintiffs amended their complaint on October
2,2009.
(0.1.
21)
In
lieu
of
an answer, defendant filed a motion to dismiss pursuant to FederalRule
of
Civil Procedure 12(b)(6).
(0.1.
22) That motion is presently before the court.For the reasons that follow, defendant's motion
is
denied.
II.
BACKGROUNDA. The Parties and their Products
Plaintiffs
in
this action are direct purchasers
of
MiraLax® who allege that theypaid overcharges on their purchases
of
MiraLax® or generic PEG as a result
of
defendant's monopoly prior to July 2004.
(0.1.
21
at
11
1)
Plaintiffs Meijer, Inc. andMeijer Distribution, Inc. (collectively, "Meijer") are corporations organized under the laws
of
the State
of
Michigan, with their principal place
of
business
in
Grand Rapids,Michigan.
('d.
at
11
13) Meijer
is
the assignee
of
the claims
of
the Frank
W.
Kerr Co.which, during the relevant period, purchased MiraLax® directly from defendant.
(/d.)
Plaintiff Rochester Drug Cooperation, Inc. ("ROC")
is
a drug wholesale cooperativelocated
in
Rochester, New York.
(ld.
at
11
14) Plaintiff Louisiana Wholesale DrugCompany, Inc. ("LWO")
is
a Louisiana corporation located
in
Sunset, Louisiana.
(Id.
at
11
15)
Defendant Braintree is a privately held corporation organized and existing underthe laws
of
the Commonwealth
of
Massachusetts and shares its name with its principal
2
Add a Comment