Endo Pharmaceuticals Inc. et al v. Teva Pharmaceuticals USA, Inc. et al

Filing 77

OPINION: Dechert may participate in the inter parties review proceedings instituted by Amneal subject to two restrictions. First, Dechert may not amend, draft, or consult with Endo or Mayer Brown regarding the amendment of patent claims. Second, Dech ert may not share with Mayer Brown any information designated confidential under the Amneal protective order or any related protective order or share any information about defendants' ANDA products. (Signed by Judge Thomas P. Griesa on 8/13/2014) (ama)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
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:
ENDO PHARMACEUTICALS INC.,
:
:
Plaintiff,
:
:
– against –
:
:
ACTAVIS INC. and ACTAVIS SOUTH
:
ATLANTIC LLC,
:
:
Defendants.
:
---------------------------------------------x
:
ENDO PHARMACEUTICALS INC.,
:
:
Plaintiff,
:
:
– against –
:
:
ROXANE LABORATORIES, INC.,
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:
Defendant.
:
:
:
---------------------------------------------x
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ENDO PHARMACEUTICALS INC. and
:
GRÜNENTHAL GMBH,
:
:
Plaintiffs,
:
:
– against –
:
:
:
TEVA PHARMACEUTICALS USA, INC.,
:
and BARR LABORATORIES, INC.,
:
:
Defendants.
:
:
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12 Civ. 8985 (TPG)

13 Civ. 3288 (TPG)

12 Civ. 8060 (TPG)

(captions continued on
next page)

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:
ENDO PHARMACEUTICALS INC. and
:
GRÜNENTHAL GMBH,
:
:
Plaintiffs,
:
:
– against –
:
:
IMPAX LABORATORIES, INC. and
:
:
THORX LABORATORIES, INC.,
:
Defendants.
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:
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:
ENDO PHARMACEUTICALS INC. and
:
GRÜNENTHAL GMBH,
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:
Plaintiffs,
:
:
– against –
:
:
SANDOZ INC.,
:
:
Defendant.
:
:
:
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ENDO PHARMACEUTICALS INC. and
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GRÜNENTHAL GMBH,
:
:
Plaintiffs,
:
:
– against –
:
:
AMNEAL PHARMACEUTICALS, LLC et
:
al.,
:
Defendants.
:
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2

12 Civ. 8317 (TPG)

12 Civ. 8318 (TPG)

12 Civ. 8115 (TPG)

(captions continued on
next page)

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:
ENDO PHARMACEUTICALS INC. and
:
GRÜNENTHAL GMBH,
:
:
Plaintiffs,
:
:
– against –
:
:
PAR PHARMACEUTICAL COMPANIES,
:
INC. and PAR PHARMACEUTICAL, INC.,
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:
Defendants.
:
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:
ENDO PHARMACEUTICALS INC.,
:
:
Plaintiff,
:
:
– against –
:
:
PAR PHARMACEUTICAL COMPANIES,
:
INC. and PAR PHARMACEUTICAL, INC.,
:
:
Defendants.
:
:
:
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ENDO PHARMACEUTICALS INC.,
:
:
Plaintiff,
:
:
– against –
:
:
RANBAXY LABORATORIES LTD.,
:
RANBAXY INC., and RANBAXY
:
PHARMACEUTICALS INC.,
:
:
Defendants.
:
--------------------------------------------x
3

12 Civ. 9261 (TPG)

13 Civ. 3284 (TPG)

13 Civ. 4343 (TPG)

(captions continued on
next page)

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:
ENDO PHARMACEUTICALS INC. and
:
GRÜNENTHAL GMBH,
:
:
Plaintiffs,
:
:
– against –
:
:
:
IMPAX LABORATORIES, INC.,
:
:
Defendant.
:
:
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:
ENDO PHARMACEUTICALS INC. and
:
GRÜNENTHAL GMBH,
:
:
Plaintiffs,
:
:
– against –
:
:
:
ACTAVIS INC. et al.,
:
:
Defendants.
:
:
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13 Civ. 0435 (TPG)

13 Civ. 0436 (TPG)

OPINION
These cases concern plaintiff Endo Pharmaceuticals Inc.’s (“Endo”)
allegations that defendants infringed its patents on OPANA® ER, an opiod
painkiller.

In order to protect confidential information exchanged by the

parties during the course of this litigation, the parties signed protective orders.
These orders restrict the type of work Endo’s litigation counsel—Dechert LLP—
may engage in before the U.S. Patent and Trademark Office (“PTO”).
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Specifically, the orders prohibit Dechert from engaging in what is known as
“patent prosecution” or “claim amendment” before the PTO.
Recently,

defendants

Amneal

Pharmaceuticals,

LLC

and

Amneal

Pharmaceuticals of New York, LLC (collectively, “Amneal”) filed an action before
the PTO that involves many of the same issues. Endo retained Mayer Brown
LLP to serve as its primary counsel in that action. Endo now asks the court to
rule that the protective orders do not bar the Dechert attorneys who represent
Endo before this court from collaborating with attorneys from Mayer Brown
about claims and defenses that are at issue in both proceedings.
For the following reasons, Dechert may participate in the PTO
proceeding, subject to two restrictions: (1) Dechert may not amend, draft, or
consult with Endo or Mayer Brown regarding the amendment of its patent
claims and (2) Dechert may not share with Mayer Brown any information
designated confidential under any of the protective orders in the related cases
or any information about defendants’ Abbreviated New Drug Application
(“ANDA”) products.
Statement of Facts
In 2012, Endo brought a patent-infringement action against Amneal for
attempting to market a generic pharmaceutical product that allegedly infringes
Endo’s OPANA® ER patents.

Between 2012 and 2013, Endo filed similar

actions against Actavis, Inc., Actavis South Atlantic LLC, and Watson
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Pharmaceuticals, Inc.; Roxane Laboratories, Inc.; Teva Pharmaceuticals USA,
Inc. and Barr Laboratories, Inc.; Impax Laboratories, Inc. and Thorx
Laboratories, Inc.; Sandoz, Inc.; Par Pharmaceutical Companies, Inc. and Par
Pharmaceuticals, Inc.; and Ranbaxy Laboratories Ltd., Ranbaxy Inc., and
Ranbaxy Pharmaceuticals, Inc. (collectively, the “related defendants”).

Endo

retained Dechert LLP to serve as its litigation counsel in all of these actions.
In connection with those actions, Endo entered into a series of protective
orders. Given that Endo’s litigation with Amneal involves many of the same
patents and issues as Endo’s litigation against the related defendants,
Amneal’s protective order and the protective orders entered into in the related
cases are relevant to the court’s analysis.
Amneal’s protective order states that Dechert may not become “involved
in prosecution of patent applications” and limits the use of confidential
information learned during the litigation. See Amneal Protective Order, No. 12cv-8115 (Doc. No. 47). Endo and Impax, a related defendant, entered into a
more comprehensive protective order. Impax’s protective order bars Dechert
from becoming “involved in prosecution of patent applications . . . or in any
drafting or amendment of claims or claim language in any patent office
proceeding relating to oxymorphone. . .” (Related Defs. Br., Ex. A at 9).
Since that time, defendant Amneal filed a petition for inter partes review
before the PTO’s Patent Trial and Appeal Board. Congress created inter partes
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review in order to provide a “trial proceeding . . . to review the patentability of
one or more claims in a patent only on a ground that could be raised under [35
U.S.C.] §§ 102 or 103, and only on the basis of prior art consisting of patents
or

printed

publications.”

See

USPTO.gov,

http://www.uspto.gov/aia_implementation /bpai.jsp (last visited Jul. 29,
2014). The inter partes review petition related to these cases asks the PTO to
rule on the validity of three of the patents at issue in these actions: U.S. Patent
No. 8,309,122, U.S. Patent No. 8,329,216, and U.S. Patent No. 7,851,482.
As mentioned above, Endo hired Mayer Brown LLP to serve as its
primary counsel before the PTO.

Endo now asks the court to state for the

record that Dechert—the law firm representing Endo before this court—may
participate in the inter partes review proceedings subject to certain limitations.
Amneal and the related defendants oppose that request. Defendants are
concerned that if Dechert is permitted to participate in the inter partes review
proceedings, Endo could amend its claims against defendants based on
confidential information Dechert learned during the course of this litigation.
As a result, Amneal argues that (1) the protective orders set forth a patent
prosecution bar that applies to the PTO proceedings and (2) the court should
not grant Dechert an exemption from that prosecution bar.

The related

defendants argue that Dechert should not be permitted to participate “so long
as Endo has the right to amend or draft claims.” (Rel. Defs. Br. at 2).

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Significantly, Dechert has made a series of representations to the court
and to defendants regarding how it will ensure the protective orders are not
violated. In addition to upholding the provisions of the protective orders that
govern the use of confidential information, Dechert has stated that it will not
“consult with or advise Endo or [Mayer Brown] regarding any amendment or
proposed amendments to any claims of the patents-in-suit.” (Endo Br. at 8).
Discussion
A. The Protective Orders Do Not Bar Dechert’s Proposed Participation
in the Inter Partes Review Proceedings
1. Amneal’s Protective Order
Amneal’s protective order, which states that Dechert may not become
“involved in prosecution of patent applications,” does not bar Dechert from
participating in the inter partes review proceedings.

As the PTO’s Patent Trial

and Appeal Board recently held in Google Inc. v. Jongerius Panoramic Techs.,
LLC, an inter partes review proceeding is “neither a patent examination nor a
patent reexamination.

Rather, it is a trial, adjudicatory in nature and

constitutes litigation.” Case IPR2013-00191, Paper No. 50, at 4. (P.T.A.B. Feb.
13, 2014). Amneal’s attempts to distinguish Google are unpersuasive.
2. The Related Defendants’ Protective Orders
The related defendants’ protective orders—including Impax’s order which
bars

Dechert

from

becoming

“involved

in

prosecution

of

patent

applications . . . or in any drafting or amendment of claims or claim language
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in any patent office proceeding relating to oxymorphone. . .”—do not bar
Dechert from participating in the inter partes review proceedings as long as
Dechert is not involved in claim amendment. Dechert and Endo have assured
the court and defendants that Dechert will not participate in claim amendment
proceedings or discussions with either Endo or Mayer Brown. Thus, in light of
these, the related defendants’ protective orders pose no issue here.
However, even if the protective orders did bar Dechert from participating
in the inter partes review proceedings, the court would make an exception
based on the facts of these cases.
B. The Deutsche Bank Factors Favor an Exemption to the Prosecution
Bar
In re Deutsche Bank Trust Co. Americas, the Federal Circuit set forth
factors that the district court must consider when evaluating a party’s request
for an exemption from a patent prosecution bar:
. . . the party seeking an exemption from a patent prosecution bar must
show on a counsel-by-counsel basis: (1) that counsel's representation of
the client in matters before the PTO does not and is not likely to
implicate competitive decisionmaking related to the subject matter of the
litigation so as to give rise to a risk of inadvertent use of confidential
information learned in litigation. . . and (2) that the potential injury to
the moving party. . .outweighs the potential injury to the opposing
party. . . .
605 F.3d 1373, 1381 (Fed. Cir. 2010).

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Here, Dechert’s participation is limited to the issues before this court—
questions of obviousness and prior art. Those issues need not implicate
competitive decisionmaking or claim amendment.
Additionally, Dechert’s coordination with Mayer Brown in defending
against the invalidity challenges presents minimal risk of the inadvertent
disclosure of confidential information. Although Amneal expresses concern
that Dechert might “implicitly transmit to Mayer Brown” recommendations
regarding claim amendment or inadvertently disclose Amneal’s confidential
information, there is no factual basis for believing Dechert would commit these
violations. Furthermore, Amneal’s primary concern is that Dechert will amend
claims. This opinion explicitly prohibits Dechert from participating in claim
amendment or any discussions related to it. Thus the potential injury to
Amneal is minimal.
In contrast, the potential injury to Endo, if Dechert is barred from
participating, is high. Endo would be at a significant disadvantage if Dechert is
not permitted to assist in the defense of Endo’s patents against the same prior
art raised in this litigation. Defendants concede that the prior art references
raised by Amneal in its inter partes review filings are the same ones presented
in this litigation. Dechert has developed extensive knowledge and expertise
regarding those challenges. Although Mayer Brown has represented Endo in
patent prosecution before the PTO, Mayer Brown does not have experience

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representing Endo in the patent litigation involving OPANA® ER. (Endo Br. at
8).
Of interest are the concerns expressed by other district courts about a
policy that would “encourage defendants to file for reexamination while
excluding plaintiff’s counsel from participating in the reexamination, thereby
forcing a plaintiff to defend a patent in two separate venues with two teams of
attorneys.” Mirror Worlds, LLC v. Apple, Inc., No. 08-cv-88, 2009 WL 2461808,
at *2 (E.D. Tex. Aug. 11, 2009). Forcing Mayer Brown to prepare from scratch
the defense that Dechert has already prepared would be a waste of time and
resources.
Additionally, the PTO’s decision and choices made before it may have
direct consequences in the district court. Xerox Corp. v. Google, Inc., 270
F.R.D. 182, 185 (D. Del. 2010). Thus, Endo has a “legitimate interest in
formulating a coherent and consistent litigation strategy.” Id.
Conclusion
Dechert may participate in the inter parties review proceedings instituted
by Amneal subject to two restrictions. First, Dechert may not amend, draft, or
consult with Endo or Mayer Brown regarding the amendment of patent claims.
Second, Dechert may not share with Mayer Brown any information designated
confidential under the Amneal protective order or any related protective order
or share any information about defendants’ ANDA products.
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Dated: New York, New York
August 13, 2014

Thomas P. Griesa
U.S. District Judge

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