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ViiV Healthcare UK Ltd., v. Lupin Ltd., C.A. No. 11-576-RGA (consol.) (D. Del. Dec. 17, 2013)

ViiV Healthcare UK Ltd., v. Lupin Ltd., C.A. No. 11-576-RGA (consol.) (D. Del. Dec. 17, 2013)

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02/10/2014

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE VIIV HEALTHCARE
U
LTD. AND VIIV -HEALTHCARE CO., Plaintiffs, v. LUPIN LTD. AND LUPIN PHARMACEUTICALS, INC., TEV A PHARMACEUTICALS, INC., Defendants. C.A. 11-576-RGA CONSOLIDATED)
TRI L OPINION
Brian
E
Farnan, Esq., Wilmington, Delaware;
F
Christopher Mizzo, Esq., Washington, D.C.; Gregg
F
LoCascio, Esq., Washington, D.C.; Charles A. Fernandez, Esq., Washington, D.C.; Tiffany
P
Cunningham, Esq., Chicago Illinois; Craig
T
Murray, Esq., Washington, D.C.; Attorneys for Plaintiffs ViiV Healthcare
U
Limited and ViiV Healthcare Co. John C. Phillips, Jr., Esq., Wilmington, Delaware; Deanne M. Mazzochi, Esq., Chicago, Illinois.; Paul J. Molino, Esq., Chicago, Illinois; Neil A. Benchell, Esq., Chicago, Illinois; Rachel P. Waldron, Chicago, Illinois; Matthew
T
Lord, Esq., Chicago, Illinois; Attorneys for Defendants Lupin Ltd. and Lupin Pharmaceuticals, Inc. Richard
L
Horwitz, Esq., Wilmington, Delaware; Ira J. Levy, Esq., New York, New York; Annemarie Hassett, Esq., New York, New York; Gregory
T
Sandidge, Esq., New York, New York; Attorneys for Defendant Teva Pharmaceuticals USA, Inc. December
Jl2
13
Wilmington, Delaware
1
 
Plaintiffs ViiV Healthcare
UK
Ltd. and ViiV Healthcare Co. (collectively ViiV ) assert U.S. Patent No. 6,417,191
(''the'
191
Patent ) against Defendants Teva Pharmaceuticals, Inc. ( Teva ), Lupin Ltd., and Lupin Pharmaceuticals, Inc. (collectively Lupin ). The '191 Patent (JX
1
is titled Synergistic Combinations ofZidovudine, 1592U89 and 3TC.
1
(D.I.178, Ex. 1
7 .
The patent issued on July 9, 2002, and expires on March 28, 2016.
( d.~~
7, 9). The named inventors are David Walter Barry and Martha Heider St. Clair.
Id.
8.
The patent claims recite formulations and methods
of
treating HIV infection, using (a) the ''triple combination
of
abacavir, zidovudine, and 3TC; or (b) the double combination
of
abacavir and 3TC. (JX 1 cols. 12-16). ViiV holds NDA No. 21-205 for Trizivir, an oral tablet dosage form, which the FDA approved in November 2000 as an HIV drug. (D.I. 178, Ex. 1 13-15). Trizivircontains the triple combination ofabacavir, 3TC, and AZT. ViiV also holds NDA No. 21-652 for an oral tablet dosage form for Epzicom, which the FDA approved in August 2004 as an HIV drug.
( d.
20). Epzicom contains the double combination
of
abacavir and 3TC. The
FDA's
Orange Book lists ViiV's '191 Patent in connection with both products.
( d.~~
16, 23). ViiV's case against Teva and Lupin arises out the Defendants' ANDA filings with the FDA. Teva seeks FDA approval to market a generic version ofEpzicom, while Lupin seeks FDA approval for a generic version ofTrizivir.
( d.
17). Defendants assert that the '191 Patent is invalid as obvious. Lupin individually asserts that the '191 Patent is invalid due to lack
of
enablement and utility, and also asserts that its proposed generic product does not infringe the '191 Patent. The Court held a four and a
half
day
1
Zidovudine is also referred to
as
AZT.
1592089
is
also referred to as abacavir or ABC. 3TC
is
also referred to
as
lamivudine. The terms are used interchangeably throughout the opinion.
2
 
bench trial on June 24, 25, 26, 27, and 28.
2
Defendants failed to prove any
of
their invalidity defenses
by
clear and convincing evidence, while ViiV failed to prove that Lupin's generic drug product infringes the asserted claims
of
the '191 Patent.
I
INFRING M NT
ViiV asserts that Lupin's generic product would infringe claims 4, 26, 27, 29, 30, 34, 36, 38, 39, and 47
of the
191
Patent. Claim 47 is a formulation claim, while the remaining claims recite methods
of
treatment. All claims encompass abacavir and 3TC, while certain claims add AZT as the third drug in the combination. There is no dispute that Lupin's ANDA product will contain AZT and 3TC. The infringement dispute hinges on the abacavir limitation, and whether Lupin's ANDA product's use ofabacavir sulfate puts the product outside the scope
ofthe
asserted claims. Lupin argues that it does not infringe any
of
the claims because (1) the asserted claims
do
not encompass the sulfate form
of
abacavir; (2) the method claims are only directed to treating the opportunistic conditions associated with HIV rather than the HIV infection itself; and (3) there is no evidence that Lupin would induce and contribute to the infringement
of
the method claims. ViiV disagrees, arguing that (1) abacavir is contained
by
the abacavir sulfate in Lupin's generic product; (2) the method claims are aimed at the treatment
ofthe
underlying HIV infection; and (3) Lupin clearly intends to infringe the method claims
by
inducing and contributing to use
by
clinicians and patients
of
the claimed combinations. (A) FINDINGS
OFF
ACT
1
Independent claim 45 recites the chemical compounds
of
AZT, 3TC, and pure abacavir, also referred to as abacavir free base. '191 Patent, claim 45.
2
Claim 46 depends from claim 45, reciting the formulation
of
claim 45 in a unit dosage form. '191 Patent, claim 46.
2
{Transcripts available at D.L 192, 193, 194, 195, and 196).
3

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