Free Letter - District Court of Delaware - Delaware

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Date: December 31, 1969
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State: Delaware
Category: District Court of Delaware
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Case 1:05-cv-00854-JJF Document 18-2 Filed O1/27/2006 Page 1 of 2
Slip Copy Page 1
Slip Copy, 2005 WL 3664014 (D.N.J.)
(Cite as: 2005 WL 3664014 (D.N.J.))
Only the Westlaw citation is currently available. that the 937 patent is invalid or would not be
infringed by Teva's application. Id On February 22,
NOT FOR PUBLICATION 2005, as required by the Hatch-Waxman Act, Teva
sent Novartis a notice letter, entitled "Detailed
United States District Court, Statement", explaining why Teva's proposed generic
D. New Jersey. version of Nova1tis' tablets will not infringe upon any
NOVARTIS PHARMACEUTICALS valid or enforceable claim of Novartis' patents. Id at
CORPORATION, Novartis Pharma AG, and 1] 15.
International Pharmaceutical Ltd., Plaintiffs, On April 8, 2005, after receipt of Teva's Notice
v. letter, Novartis filed a complaint against Teva for
TEVA PHARMACEUTICALS USA, INC., infringement on the 937 patent on ground that the
Defendant. notice letter was deficient Novartis alleges that Teva's
No. Civ.A.05-CV-1887 (DM. manufacture of famciclovir would constitute direct
infringement on one or more of the method claims of
Dec. 30, 2005. the 937 patent. Comp. at 1] 18. Teva filed an answer
James Michael Altieri, Stacy P. Rappaport, Drinker to the Complaint on June 3, 2005, asserting
Biddle & Reath LLP, Florham Park, NJ, for counterclaims for invalidity, non-infringement and
Plaintiffs. unenforceability of the 937 patent. Simultaneously,
Teva filed the instant motion to strike.
Michael E. Patunas, Lite Depalma Greenberg &
Rivas, LLC, Newark, NJ, for Defendant. In its moving papers, Teva requests that this Court
strike Novartis' allegations in its Complaint that (1)
OPINION Teva failed to "provide the required detailed
statement and legal basis in its notice letter" as
QAVANAUGH, j_ required by 21 U.S.C. § 355(`l)l2llBl(ii) of the Drug
Price Competition and Patent Restoration Act of
*1 This matter comes before the Court upon I984 ("tho Huteh‘WaXmah Act") (Complaint ‘ll 20,
Defendant Teva Pharmaceuticals usA, rnere (Teva) Pravor for Roiiof 11 B) arid (2) that this is ah
ntetren to strike prarntrrre Novartis pnarntaeentreare "orrooptiorrai oaso" orrtitiirrs Novartis to attorriovs foos
cetpbtatrbn, Novartis Pharma Ao, and Novartis rirrdor of tho patoht statuto-
rntetnanenar pnarmaeentreai Ltdne (··ee11eetrve1y (€orrrpiairrt'll 21, Prayor for Roiiof 'll F)- Tho oorrrt
Novartis") claims related to Teva's detailed statement Wu] exarhthe eaeh of Tova's requests as to striko ih
and request for exceptional case status. For the turh-
reasons set forth below, Teva's motion is denied.
BA CKG RO UND Detailed Statement
The instant case is a patent infringement action
arising under the Hatch-Waxman Act, which governs TeVa argues that the Federal Crreutrs ruuhg th
tho approval of generic drugs by rho U_S_ Food and Minnesota Mining and Manu;. C0. v. Barr Labs.,
Drug Administration ("FDA"). Novartis is the owner (H-tM" ) bars
of United States patent Ne. 5, 246, 937 (··tne 937 Novartis from pirrsoirrg a oarrso of aotiorr hasod irporr
Patent").Complaintat1] 9. Pursuant to the Hatch- a dotioiorrt rrotioo iottar, and that this Court is
Waxman Act, Teva filed an abbreviated new drug thoroforo proohriod from oorrsidorirrg Novartis'
application (··ANDA··) soaking FDA approval to allegations of a deficient notice letter. As such, Teva
commercially manufacture famciclovir tablets. Id at is roqrrostirrg tho Court striko paragraph 20 or
tl 11. Teva's ANDA apprreatren rnernded a Novartis Complaint arid paragraph B of tho pravor
certification made pursuant to 21 U.S.C. § for roiiof
355] `l ll 2 lg A llvii ll IV l, (the "Paragraph IV
cenrneatrbno with respect to Navanre 937 patent, *2 hr rosporrsa, Novartis statas that it is hot asking
[al atv l3_ "l*ova·s paragraph IV Certification Srarorl the court to enforce the Notice Letter statute or
© 2006 Thomson/West. No Claim to Orig. U.S. Govt. Works.

Case 1:05-cv-00854-JJF Document 18-2 Filed O1/27/2006 Page 2 of 2
Slip Copy Page 2
Slip Copy, 2005 WL 3664014 (D.N.J.)
(Cite as: 2005 WL 3664014 (D.N.J.))
declare the Notice Letter insufficient under the stands for the proposition that an ANDA filing,
statute, causes of action prohibited under 3M Rather, without more, does not constitute willful
Novartis avers that the purpose of its allegation of an infringement, it is possible that Novartis may be able
incomplete or fiawed Notice Letter is to support its to show activity in addition to the ANDA filing to
claim of willful infringementl litigation misconduct, support the issue of wilfulness. As such, under
appropriate under the Federal Circuit's holding in Yamanouchi, Novartis is entitled to proceed with
Yamanouchi Pharmaceutical Co., Ltd. v. Danbury litigation under the current state of the pleadings. If
Pharmacol, Inc., 231 F.3d 1339, 1342 after discovery the evidence is such that Novartis'
lFed.Cir.2000). Furthermore, Novartis asserts that it claim cannot be supported, Novartis may consider
has not identified any action it wishes the court to voluntarily withdrawing its claim or Teva may renew
take with regard to the Notice Letter, nor any remedy its application.
it may be entitled to as a result of any lack of
compliance with the notice statute. *3 In light of the above, Teva‘s request to strike
portions of the Complaint relating to Novartis'
In light of the fact that Novartis' allegations request for exceptional case status must be denied.
regarding the Notice Letter are in the Complaint to
support Novartis' request for exceptional case status, CONCLUSION
the Court does not find it necessary strike Novartis' Based on the foregoing, Teva‘s motion to strike
allegations regarding the insufficiency of the Notice Novartis' claims related to Teva‘s detailed statement
Letter. and request for exceptional case status is denied. An
appropriate Order accompanies this Opinion.
Exceptional Case Status
Slip Copy, 2005 WL 3664014 (D.N.J.)
Tevat requests that the Court strike those portions of
the Complaint that concern Novartis' claim for END OF DOCUMENT
exceptional case status, on the grounds that the filing
of an ANDA cannot support the finding of willful
infringement for purposes of awarding attorneys fees
under QUSC. § 285. Teva relies on Glaxo Groug
Limited v. Agotex, Inc., 376 F.3d 1339
{Fed.Cir.2004), where the Federal Circuit found that
the evidence presented by Glaxo, which consisted
mainly of an ANDA filing, did not support a claim
for willful infringement for purposes of awarding
attorneys fees.
Under 35 U.S.C. § 285, "the [C]ourt in exceptional
circumstances may award reasonable attorneys fees
to the prevailing party." Furthermore, 35 U.S.C. §
271{e)(4l specifically states that when infringement
is based on the filing of an ANDA, "a court may
award attorneys fees under Section 285." In
Yamanouchi, the Federal Circuit held that a patentee
in a ANDA case can recover attorney fees for willful
infringementl litigation misconduct under the
appropriate circumstances. 231 F.3d 1339, 1342.
Yamanouchi involved a similar pattern of facts as
those alleged here: the filing of an ANDA, the
Paragraph IV certification, the Notice Letter, and
litigation misconduct, and the Federal Circuit found
exceptional case status warranted.
Novartis argues that Teva‘s reliance upon Glaxo is
incorrect, and that Yamanouchi controls. This Court
agrees. Although Teva is correct in stating that Glaxo
© 2006 Thomson/West. No Claim to Orig. U.S. Govt. Works.