TIBOTEC INC. et al v. LUPIN LIMITED et al

Filing 334

OPINION/ORDER denying 229 Motion for Leave to File to Amend Non-Infringement Contentions. Signed by Magistrate Judge Steven C. Mannion on 5/9/13. (DD, )

UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW JERSEY
NOT FOR PUBLICATION
JANSSEN PRODUCTS, L.P. et al.,
Civil Action No.
Plaintiffs,
10-5954-WHW-SCM
OPINION AND ORDER DENYING
TEVA’S MOTION FOR LEAVE TO
AMEND NON-INFRINGEMENT
CONTENTIONS

v.
LUPIN LIMITED, et al.,
Defendants.

[D.E. 229]

I.

INTRODUCTION

This matter comes before the Court on the motion of Defendant
Teva Pharmaceuticals USA, Inc. (“Teva”) to amend its noninfringement contentions.

(See Docket Entry (“D.E.”) 229,

Teva’s Motion to Amend).

Plaintiff United States of America

(the “Government”) opposes the motion.
Government’s Opposition).

(See D.E. 232, the

Plaintiffs Janssen Products, L.P.,

Janssen R&D Ireland, and G.D. Searle, LLC (collectively,
“Janssen”) neither consent to nor oppose Teva’s motion.
D.E. 231, Janssen’s Response).

(See

The Court has considered all of

the submissions of the parties pursuant to Fed. R. Civ. P. 78
and, for the reasons set forth below, Teva’s motion is DENIED.

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II.

BACKGROUND AND PROCEDURAL HISTORY

On March 16, 2011, Janssen filed its initial complaint
[D.E. 1] against Teva, asserting infringement of its U.S. Patent
No. 5,843, 946 (the “‘946 patent”) and U.S. Patent No. 7,700,645
(the “‘645 patent”).

(See D.E. 1, Complaint).

Janssen then

filed an amended complaint in the now consolidated Civil Action
No. 11-1509 on March 24, 2011, adding U.S. Patent No. 6,248,775
(the “‘775 patent”).

(See D.E. 6, Civil Action No. 11-1509).

Pursuant to the Court’s scheduling orders, Teva served its
preliminary non-infringement contentions for the ‘946, ‘645, and
‘775 patents on Janssen on November 18, 2011.
Teva’s Brief in Support, at *4).

(See D.E. 229-1,

Since Teva served its

preliminary contentions, Janssen asserted two more patents
against Teva, U.S. Patent Nos. RE42,889 (the “‘889 patent”) and
RE43,596 (the “‘596 patent”), in Civil Action Nos. 12-3569 and
12-5358.

Id. at *4-5.

Janssen filed its complaint asserting

infringement of the ‘889 patent on June 13, 2012, and its
complaint asserting infringement of the ‘596 patent August 24,
2012.

Since then, both of the aforementioned actions have been

consolidated with the instant action by the Court.

Id.

Teva served its non-infringement contentions for the ‘889
patent on August 7, 2012. (See D.E. 229-1, Teva’s Brief in
Support of Motion).

Pursuant to the Court’s scheduling orders,
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Teva served its preliminary non-infringement contentions for the
‘946, ‘645, and ‘775 patents on Janssen on November 18, 2011.
Id. at *6.

Teva served its non-infringement contentions for the

‘889 patent on August 7, 2012.

Id. at *5.

On October 5, 2012,

the Court consolidated the ‘596 patent case was with this
action, and entered a schedule for contentions and claim
construction disclosures in accordance with the Local Patent
Rules. Id.
Janssen has asserted claims 24 and 25 of the ‘889 patent,
and claims 7-12 of the ‘946 patent against Teva.

Teva alleges

that the asserted claims of the ‘889 patent are similar to the
asserted claims of the ‘946 patent, noting that claim 25 of the
‘889 patent and claim 7 of the ‘946 patent would both “cover a
pharmaceutical composition comprising (i) darunavir and (ii) a
pharmaceutically acceptable carrier.”

(See D.E. 229-1,

Plaintiff’s Brief in Support of Motion to Amend, at *6).

In its

non-infringement contentions for the ‘889 patent, Teva averred
that its products do not infringe the asserted claims of the
‘889 patent because “Teva USA’s ANDA products do not contain
darunavir, but rather contain a solvate that is substantially
different from darunavir.”

(See D.E. 229-1, Teva’s Brief in

Support of Motion, at *6).

Teva now alleges that, while

preparing its non-infringement contentions for the ‘889 patent,

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it recognized a similar defense also applied to the asserted
claims of the ‘946 patent.

Id.

Teva sent its proposed amended

non-infringement contentions for the ‘946 patent to Janssen on
October 10, 2012, and now seeks leave to amend its contentions
to add this defense.

Id.

With regard to the ‘506 patent, the Government asserted
claims 1, 2, and 5-9 of the ‘506 patent against Teva on March
15, 2011.

(See D.E. 229-1, Teva’s Brief in Support, at *6).

Teva served its non-infringement contentions for the ‘506 patent
on the Government on November 18, 2011.

Id.

Claim 1 of the

‘506 patent and the rest of the asserted claims all contain the
limitation:
(ii) administering to the HIV-infected mammal an
effective amount of a compound of the formula:

wherein X is oxygen, R5 is isobutyl, and Ar is
substituted phenyl.
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Id. at 7.
Teva argues that the Government has asserted that the genus
of compounds depicted in claim 1 of the ‘506 patent includes
darunavir, and therefore the Government has asserted that each
of the asserted claims of the ‘506 patent includes the
limitation of “administering” darunavir.

Id.

Teva asserts that

it recognized during the exchange of claim construction
disclosure that the Government may also dispute the construction
of the term “administering,” and Teva amended its list of terms
requiring construction in the Joint Claim Construction and
Prehearing Statement filed on May 22, 2012 to include this term.
Id.

Teva proposes that “administering should be construed

according to its “plain and ordinary meaning, which is to
provide externally for the purpose of delivering into the body,”
whereas the Government proposes that this term should be
construed to mean “managing or supervising the execution or use
of the claimed compound(s) of the ‘506 patent.”

Id.

Teva contends that under its proposed construction,
administration of the ANDA products would not infringe the
asserted claims of the ‘506 patent because the ANDA products do
not contain darunavir, and Teva now seeks leave to amend its
contentions to add this defense.

Id. at 7-8.

Janssen has filed

a response stating that, while it does not consent to Teva’s
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proposed amended non-infringement contentions, it does not
oppose the amendment either.
Response).

(See D.E. 231, Janssen’s

The Government opposes Teva’s proposed amendment and

has accordingly filed opposition.

(See D.E. 232, the

Government’s Opposition).
III. ARGUMENTS
A. Teva’s Argument
Teva contends that the Court should grant it leave to amend
its non-infringement contentions, arguing that there is good
cause, Teva has been sufficiently diligent in seeking leave to
amend, and that the proposed amendments would not cause
significant prejudice or delay.
in Support of Motion).

(See D.E. 229-1, Teva’s Brief

Teva asserts that it only recognized

that its darunavir hydrate non-infringement defense applies to
the ‘946 patent while preparing a nearly identical defense for
its contentions on the more recently asserted ‘889 patent.

Teva

further asserts that it recognized the non-infringement defense
in its proposed amended contentions for the ‘506 patent during
the exchange of claim construction disclosures, and that Teva
and the Government addressed the claim construction issue
related to Teva’s proposed amended ‘506 patent contentions in
their respective opening and responsive claim construction
briefs.

Accordingly, Teva argues that the substance of the non6

infringement issues in its proposed amendments to its ‘946 and
‘506 patent contentions is already in this case, and that
Janssen and the Government could “readily amend their
infringement contentions to address Teva’s amended contentions”
without significant prejudice or delay.
Teva argues that it was diligent in seeking the instant
motion to amend, noting that courts have “granted leave to amend
contentions under circumstances similar to this case.”

(See

D.E. 229-1, Teva’s Brief in Support of Motion, at *8).

Teva

cites to International Development, LLC v. Richmond, 2010 WL
3946714, at *4 (D.N.J. Oct. 4, 2010), a case where the patentee,
while briefing another issue, recognized that it had omitted
several of its products that it asserted were covered by the
patents at issue from its infringement contentions.

Teva argues

that the instant matter is analogous to International
Development because Teva only recognized its darunavir hydrate
argument while preparing a nearly identical defense for its
contentions regarding the ‘889 patent.

Thus, Teva argues that

it should be granted leave to amend its ‘946 and ‘506 patent
non-infringement contentions because it “has been sufficiently
diligent in seeking leave to amend […].”
Teva’s Brief in Support of Motion, at *9).

(See D.E. 229-1,

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B. The Government’s Argument
The Government opposes Teva’s motion, arguing that Teva has
not made the requisite showing of good cause, that Teva’s motion
is untimely, and that granting the proposed amendments would
cause undue prejudice.

The Government argues that Teva was not

diligent in seeking to amend its non-infringement contentions,
noting that Teva sent its Paragraph IV certification notice to
plaintiffs on January 31, 2011, with which Teva included a
document entitled “Teva Pharmaceuticals USA, Inc.’s Detailed
Statement Of The Factual and Legal Bases For Its Opinion That
U.S. Patent Nos….7,470,506…Are Invalid, Unenforceable, Or Not
Infringed By The Manufacture, Use Or Sale Of Its Darunavir
Hydrate Tablets…”
Opposition, at *8).

(See D.E. 232, Government’s Brief in
The Government notes that in that document

Teva spent “three single-spaced pages” outlining the factual and
legal bases for its assertion that Claims 1-9 of the ‘506 patent
would not be infringed by Teva’s proposed generic product.
at *8-9.

Id.

The Government notes that “although the very title of

the document describes Teva’s products as ‘Darunavir Hydrate
Tablets,’ Teva did not in any way suggest that the use of
darunavir hydrate was a basis to assert non-infringement as to
the ‘506 patent.”

Id. at *9.

Accordingly, the Government

argues that Teva’s claim that it was diligent in seeking the

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instant request to include the darunavir hydrate argument to its
non-infringement contentions is not credible, as the Paragraph
IV certification notice that Teva served in January 2011
explicitly describes Teva’s products as “Darunavir Hydrate
Tablets.”

Id. at *10.

Additionally, the Government contends

that even if Teva’s darunavir hydrate argument was credible, it
would still not explain Teva’s delay in seeking the instant
amendment.

Id.

C. Janssen’s Response
While Janssen does not oppose Teva’s motion, Janssen does
assert that Teva’s new non-infringement position is “baseless”
and “outlandish.”
at *3-5).

(See D.E. 231, Janssen’s Brief in Response,

Janssen alleges that Teva’s assertion that its

products do not contain darunavir is factually incorrect, and
that the fact that Teva uses a hydrate form of darunavir has no
bearing on whether Teva’s ANDA product infringes the asserted
claims of the ‘889 or ‘946 patents.

Id. at *4.

However,

Janssen notes that this consolidated action is still at its
“early stages” and that discovery is ongoing, and therefore
Janssen neither consents nor objects to Teva’s amendment.
at *5-7.

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Id.

IV.

DISCUSSION

Pursuant to Local Patent Rule 3.7, leave to amend noninfringement contentions may be granted “by order of the Court
upon a timely application and showing of good cause.”

The Local

Patent Rules are “designed to require parties to crystallize
their theories of the case early in the litigation and to adhere
to those theories once they have been disclosed.”

TFH

Publications, Inc. v. Doskocil Manufacturing, Co., Inc., 705
F.Supp.2d 361, 365-66 (D.N.J. 2010) (citing Atmel Corp. v. Info.
Storage Devices, Inc., 1998 WL 775115, at *2 (N.D.Cal. Nov. 5,
1998)).

In contrast to the liberal standard for amending

pleadings, “the philosophy behind amending claim charts is
decidedly conservative, and designed to prevent the ‘shifting
sands’ approach to claim construction.”

Id. (quoting Atmel

Corp., 1998 WL 775115, at *2); see also King Pharmaceuticals,
Inc. v. Sandoz, Inc., 2010 WL 2015258, at *4 (D.N.J. May 20,
2010).

In the District of New Jersey, the Local Patent Rules

emphasize the “ultra early disclosure of infringement and
invalidity contentions for patent cases arising under the HatchWaxman Act.”

Sanofi-Aventis v. Barr Labs., Inc., 598 F.Supp.2d

632, 637 (D.N.J. 2009) (emphasis in original).
It should be noted, however, that Rule 3.7 “is not a
straightjacket into which litigants are locked from the moment
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their contentions are served.”

Comcast Cable Communs. Corp. v.

Finisar Corp., 2007 WL 716131, at *2 (N.D.Cal. March 2, 2007).
Instead, “a modest degree of flexibility [exists], at least near
the outset” of litigation.

Id.

Accordingly, it is important to

recognize that while the Local Patent Rules strive to encourage
parties to establish their contentions early on, “preliminary
infringement contentions are still preliminary.”

TFH

Publications, Inc., 705 F.Supp.2d at 366 (quoting General
Atomics v. Axis-Shield ASA, 2006 WL 2329464, at *2 (N.D.Cal.
Aug. 9, 2006)).
With regard to the “good cause” requirement of Rule 3.7,
the Federal Circuit has stated that parties must “proceed with
diligence in amending when new information comes to light in the
course of discovery.”

O2 Micro Int’l Ltd. v. Monolithic Power

Sys., Inc., 467 F.3d 1355, 1366-68 (Fed. Cir. 2006).

The party

seeking to amend bears the burden of establishing diligence.
Id. at 1366; Jazz Pharms., Inc. v. Roxane Labs., Inc., 2013 U.S.
Dist. LEXIS 28374, at *7 (D.N.J. Feb. 28, 2013) (citing West v.
Jewelry Innovations, Inc., 2008 U.S. Dist. LEXIS 84928, at *1
(N.D.Cal. Oct. 8, 2008)).

Moreover, a party must not only prove

that it was diligent in seeking leave to amend, but also prove
that it was diligent in discovering the basis for the proposed
amendment. Id.

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The Court, in its discretion, concludes that Teva did not
act diligently in seeking leave to amend its non-infringement
contentions, and therefore Teva has failed to make a showing of
good cause pursuant to L. Pat. R. 3.7.

Specifically, the Court

finds that Teva has not sufficiently explained its delay in
seeking to amend its non-infringement contentions to add the
darunavir hydrate argument.

As the Government notes, it is

apparent that Teva recognized that its products contained
darunavir hydrate at the time it served its Paragraph IV
certification on January 31, 2012.

While there is no rule that

limits an ANDA filer in litigation to the defenses in its notice
letter, the Court cannot ignore that Teva, by its own admission,
first recognized its darunavir hydrate argument in early April
of 2012, nearly six months before filing the instant motion.
Teva cites TFH Publications, Inc. in support of the instant
motion.

705 F.Supp.2d 361.

However, the Court notes that the

plaintiff in TFH moved to amend its infringement contentions
within two months of filing their initial contentions.
363.

Id. at

In the instant matter, Teva has waited nearly one year

since filing its initial contentions, and nearly six months
since the time Teva alleges to have become aware of its
darunavir hydrate argument.

Moreover, the Court notes that TFH

did not arise under the Hatch-Waxman Act and therefore did not

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require the “ultra early disclosure of infringement and
invalidity contentions” mandated by this Court’s Local Patent
Rules.

See Sanofi-Aventis, 598 F.Supp.2d at 637.

In determining whether Teva’s delay in seeking the
amendment is undue the Court must consider Teva’s reasons for
not seeking leave to amend sooner.

See King Pharmaceuticals,

Inc. v. Sandoz, Inc., 2010 WL 2015258, at *4 (May 20, 2010).
Here, Teva has not articulated any explanation for its delay in
seeking leave to amend its non-infringement contentions, instead
providing the conclusory assertion that “Teva has been
sufficiently diligent in seeking leave to amend its noninfringement contentions.”
at *4).

(See D.E. 242, Teva’s Reply Brief,

Teva’s bare assertion of diligence does not satisfy the

good cause requirement of Local Patent Rule 3.7.
Next, the Court will briefly address the issue of
prejudice.

In the context of Local Patent Rule 3.7, in

determining whether good cause exists, the court “considers
first whether the moving party was diligent in amending its
contentions and then whether the non-moving party would suffer
prejudice if the motion to amend were granted.”

Acer, Inc. v.

Tech, Prob. Ltd., 2010 WL 3618687, at *3 (N.D.Cal. Sept. 10,
2010) (citing O2 Micro, 467, F.3d at 1355).

However, the court

may only consider prejudice to the non-moving party if the
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moving party is able to demonstrate diligence.

Jazz Pharms.,

Inc. v. Roxane Labs., Inc., 2013 U.S. Dist. LEXIS 28374, at *13
(citing CBS Interactive, Inc. v. Etilize, Inc., 257 F.R.D. 195,
201 (N.D.Cal. 2009); see also Apple v. Samsung, 2012 U.S. Dist.
LEXIS 83115, at *13 (N.D.Cal. Mar. 27, 2012).

Here, Teva has

failed to make a showing of diligence and therefore the Court
need not consider prejudice to the moving party.

See

Astrazeneca AB v. Dr. Reddy’s Laboraties, Inc., 2013 WL 1145359,
at *4 (D.N.J. Mar. 18, 2013) (denying motion to amend in nonHatch-Waxman case where moving party delayed seven months in
seeking amendment); see also Apple v. Samsung, 2012 U.S. Dist.
LEXIS 83115, at *13.

Accordingly, the Court finds that Teva has

failed to show good cause and the motion to amend must be
denied.#

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V.

CONCLUSION AND ORDER
The Court has considered the papers submitted pursuant to

Fed. R. Civ. P. 78 and, for the reasons set forth above,
IT IS on this 9th day of May, 2013,
ORDERED that Defendant Teva’s Motion for Leave to Amend
Non-Infringement Contentions is DENIED.

5/9/2013 4:15:00 PM

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