<<i think the point is not the response to the suit, which i found quite boilerplate by the way, but the response to the motion for expedited discovery>>
The response to the motion for expedited discovery was filed 1/13 and is copied and pasted below.
DEFENDANTS’ OPPOSITION TO PLAINTIFFS’
MOTION FOR EXPEDITED DISCOVERY
Defendants Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc.
(“Teva USA”) (collectively “Teva”) submit this opposition to plaintiffs’ motion for expedited
discovery. As explained below, plaintiffs have failed to show that expedited discovery is
warranted under any of the factors courts consider in evaluating such requests, and the motion
should be denied.
INTRODUCTION
This litigation is between two manufacturers of generic drugs. Plaintiffs market
enoxaparin, a generic version of Sanofi-Aventis’ branded drug Lovenox®. Plaintiffs are the only
generic manufacturer of enoxaparin on the market, and this litigation is their attempt to protect
their market share in this duopoly by preventing Teva’s anticipated entry into the market with its
own generic enoxaparin drug.
Plaintiffs assert in their Complaint that Teva infringes two patents that are directed to
methods for “analyzing” enoxaparin. Through their motion, plaintiffs seek to avoid the standard
discovery timetable and procedures mandated by Rule 26(d). While their motion acknowledges
Case 1:10-cv-12079-NMG Document 28 Filed 01/13/11 Page 1 of 14
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the factors courts typically consider in evaluating requests for expedited discovery (see Motion at
8 (citing McMann v. Doe, 460 F. Supp. 2d 259, 265 (D. Mass. 2006))), they fail to make a
compelling showing—to the extent they even attempt to do so—under any of those factors.
First, plaintiffs’ motion is filed for improper purposes. McMann, 460 F. Supp. 2d at 265.
Remarkably, plaintiffs acknowledge that they seek expedited discovery “in order to establish that
infringing conduct has occurred.” (Motion at 10.) Of course, plaintiffs should not have even
filed their lawsuit if they lacked a basis for establishing that infringement has occurred. The
other subject of the discovery plaintiffs seek—information indicating when Teva might be
entering the enoxaparin market—is also improper. None of the caselaw cited by plaintiffs
justifies such discovery, which is essentially aimed at the timeliness of plaintiffs’ own lawsuit.
Second, plaintiffs have made no attempt to show that they will suffer irreparable harm
absent the expedited discovery they seek. McMann, 460 F. Supp. 2d at 465. They do not claim,
for example, that witnesses or other evidence are likely to become unavailable, or that
defendants’ assets will be dissipated, or any other hardship that might justify an end-run around
Rule 26. While plaintiffs do claim, feebly, that Teva’s entry into the market may affect their
market share (Motion at 2, 10), they make no effort to explain why such harm could not be
adequately compensated by an award of monetary damages.
Third, plaintiffs have not even attempted to demonstrate a likelihood of success on the
merits. McMann, 460 F. Supp. 2d at 465. Indeed their acknowledgment that they need
discovery to establish the central element of their claims belies any such likelihood of success, as
does the lack of any coherent legal theory of infringement.
Finally, the discovery plaintiffs seek, despite its conclusory characterization as “limited,”
is burdensome and will prejudice Teva.
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BACKGROUND
Teva and Plaintiff Sandoz, Inc. (“Sandoz”) are generic drug manufacturers. In April
2003, Teva USA filed an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and
Drug Administration (“FDA”) seeking approval to market a generic version of Sanofi-Aventis’
Lovenox® (enoxaparin sodium). Based on this filing, Sanofi sued Teva USA for patent
infringement.1 Teva USA counterclaimed that Sanofi’s patent was unenforceable, and following
a bench trial the district court agreed and entered judgment of unenforceability.2 The judgment
cleared the FDA to approve generic applications for enoxaparin, so that pharmaceutical
companies could bring generic enoxaparin to market.
In August 2005, more than two years after Teva USA filed its ANDA and a month after
the district court entered summary judgment (later remanded for bench trial) that Sanofi’s patent
was unenforceable, Sandoz filed its enoxaparin ANDA with the FDA. Following FDA approval
in July 2010, Sandoz started marketing enoxaparin. Sandoz sells the only generic enoxaparin in
the domestic market. The FDA has not yet approved Teva USA’s enoxaparin ANDA, and thus
Teva does not sell generic enoxaparin in the United States.
On December 2, 2010, plaintiffs filed this suit. They allege infringement of United States
Patent Nos. 7,575,886 (issued Aug. 18, 2009) (the “’886 patent”) and 7,790,466 (issued Sep. 7,
2010) (the “’466 patent”).3 The patents do not cover making or using enoxaparin or any drug
compound, but instead claim only methods of analysis. The ’886 patent, for example, contains a
1 Whereas Sanofi’s patent covered the enoxaparin product, the patents asserted in this action
address methods of “analyzing” enoxaparin.
2 Aventis Pharma S.A. v. Amphastar Pharmaceuticals, Inc., 475 F. Supp. 2d 970 (C.D. Cal.
2007), aff’d, 525 F.3d 1334 (Fed. Cir. 2008).
3 Plaintiffs’ motion asserts that Momenta owns the ’886 and ’466 patents and granted Sandoz an
exclusive license under them. (Motion at 4.)
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total of 69 claims, each claiming “[a] method for analyzing an enoxaparin sample.” The ’466
patent contains 8 claims, which likewise claim “[a] method of analyzing an enoxaparin
preparation.”4 Plaintiffs did not contact Teva prior to filing suit, and made no pre-suit requests
of Teva for information on the methods for analyzing Teva USA’s enoxaparin, which are not
public. See Decl. of Elaine Blais (“Blais Decl.”) ¶ 3.
On December 28, 2010, without any advance notice, plaintiffs filed the pending motion
for expedited discovery. There was no meet and confer regarding plaintiffs’ discovery requests
prior to plaintiffs’ filing of their motion.5 Indeed, Teva never saw the proposed discovery
requests prior to receiving the motion. See Blais Decl. ¶ 11. There has been no Rule 26(f)
conference, and no initial case management conference has been scheduled.
ARGUMENT
Absent agreement or court order, Rule 26(d)(1) prohibits party discovery prior to the
Rule 26(f) conference. While plaintiffs correctly identify the factors that courts in this District
have used to evaluate whether there is good cause to grant expedited discovery (Motion at 8),
they make no effort to show how the factors apply in this case. As set forth in McMann v. Doe,
460 F. Supp. 2d 259, 265 (D. Mass. 2006), those factors are: (1) the purpose for the discovery;
(2) the ability of the discovery to preclude demonstrated irreparable harm; (3) the plaintiffs’
4 Claim 8 differs in reciting “[a] method of processing” rather than “analyzing,” but as plaintiffs
recognize in their Complaint, the term “processing” in this oddly worded claim means analyzing.
See, e.g., Compl. ¶ 20 (“The claims of the ’466 patent are directed to, inter alia, methods of
processing an enoxaparin preparation by determining that one or more defined tetrasaccharide
sequences is present.”) (emphasis added).
5 As a quid pro quo for an extension of time to respond to the Complaint, plaintiffs asked for
Teva USA’s ANDA and Drug Master File, but never: 1) proposed commencing discovery prior
to the Rule 26(f) conference; 2) advised Teva that they intended to bring this motion; or 3)
provided Teva with—or conferred on—the subject discovery requests propounded in the motion.
See Blais Decl. ¶¶ 4-8. After plaintiffs filed their motion, counsel for Teva contacted plaintiffs’
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likelihood of success on the merits; (4) the burden of discovery on the defendants; and (5) the
degree of prematurity.6 See also Wheeler v. HXI, LLC, No. 10-cv-145-JD, 2010 WL 3023518 at
*1 (D.N.H. July 28, 2010) (applying McMann). Those factors each point to denying the motion.
I. THE MOTION SEEKS DISCOVERY FOR AN IMPROPER PURPOSE
The federal rules do not allow a plaintiff to get into court with a deficient complaint and
then demand discovery in hopes of curing those deficiencies. See McCloskey v. Mueller, 446
F.3d 262, 271 (1st Cir. 2006) (“[P]laintiffs should not be permitted to conduct fishing
expeditions in hopes of discovering claims that they do not know they have.”). But that appears
to be precisely the purpose of plaintiffs’ motion. Their motion unabashedly states: “Plaintiffs
seek this focused expedited discovery in order to establish that infringing conduct has occurred,
or will shortly occur[.]” (Motion at 10 (emphasis added).) Plaintiffs have essentially admitted
they are on the proverbial fishing expedition, a discovery venture that courts routinely prohibit.
McCloskey, 446 F.3d at 271. As explained below in Part III.A, moreover, plaintiffs’
infringement allegations appear to be based on speculation.
Plaintiffs’ other stated purpose for seeking expedited discovery – “to determine whether a
motion for a preliminary injunction should be filed,” (Motion at 1) – is also improper. Plaintiffs
do not cite, and Teva has not found, any First Circuit authority that approves expedited discovery
for the purpose of finding a basis for a preliminary injunction motion. On the contrary, a
“motion for expedited discovery is not reasonably timed where, as here, plaintiff has not yet filed
a temporary restraining order or a motion for preliminary injunction, setting out in detail the
areas in which discovery is necessary in advance of a determination of preliminary injunctive
counsel to discuss a mutual exchange of discovery of reasonable scope and on a reasonable
schedule. As of the filing of this opposition, no agreement has yet been reached.
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relief.” Dimension Data N. Am., Inc. v. NetStar-1, Inc., 226 F.R.D. 528, 531-32 (E.D.N.C. 2005);
see also In re Fannie Mae Derivative Litig., 227 F.R.D. 142, 143 (D.D.C. 2005) (rejecting
expedited discovery motion “to make a record upon which to base a motion for preliminary
injunction” as “a thinly veiled attempt to circumvent the normal litigation process”). Plaintiffs’
reliance on the New Hampshire District Court’s decision in Wheeler is not to the contrary, as the
court in that case granted only the requested discovery that was “reasonabl[y] and narrowly
tailored” to issues in a pending preliminary injunction hearing. See Wheeler, 2010 WL 3023518,
*2.7
While plaintiffs cite one case from the Northern District of New York for the proposition
that a preliminary injunction motion is not a prerequisite for seeking expedited discovery
(Motion at 8), the weight of authority is to the contrary. See Dimension Data, 226 F.R.D. at 531-
32; see also Wheeler, 2010 WL 3023518 at *1-2; El Pollo Loco, S.A. De C.V. v. El Pollo Loco,
Inc., 344 F. Supp.2d 986, 991 (S.D. Tex. 2004) (“[T]he possibility that Plaintiff might seek
injunctive relief in the future” does not justify expedited discovery.); In re Fannie Mae
Derivative Litig., 227 F.R.D. at 143.8 In sum, the purposes of the discovery plaintiffs seek are
improper. Accordingly, by any standard of “good cause,” plaintiffs’ motion fails.
6 The requested discovery is wholly premature given that Teva has not responded to the
Complaint and parties have not held a Rule 26(f) conference.
7 The Wheeler court flatly denied the request for discovery that related generally to “evidence in
support of [movant’s] defense against [opponent’s] PI motion,” agreeing with Defendant “that
the request is not narrowly tailored or sufficiently specific, and risks converting the expedited
discovery process into a fishing expedition.” Wheeler, 2010 WL 3023518, *2. The discovery
requested in this motion casts an even broader net than the discovery rejected in Wheeler.
8 Plaintiffs’ other cases concern expedited discovery where a preliminary injunction motion had
already been filed, and give no support to the proposition that expedited discovery is permissible
absent a pending preliminary injunction. See, e.g., Wachovia Securities, L.L.C. v. Stanton, 571
F. Supp. 2d 1014, 1050 (N.D. Iowa 2008) (granting expedited discovery subject to pending
motion for preliminary injunction after first denying a motion for temporary restraining order);
In re Websecure, Inc. Sec. Litig., No. 97-cv-10662 GAO, 1997 WL 770414, *1 (D. Mass. Nov.
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II. PLAINTIFFS DO NOT IDENTIFY AND DO NOT PROVIDE
ANY EVIDENTIARY BASIS FOR CLAIMING IRREPARABLE HARM
Plaintiffs do not identify, or provide any evidence of, irreparable harm they will suffer
absent the expedited discovery. They make no evidentiary showing or argument, for example,
that absent immediate discovery witnesses may become unavailable or that evidence may be lost
or destroyed. See, e.g., Monsanto Co. v. Woods, 250 F.R.D. 411, 413 (E.D. Mo. 2008).
The motion at best makes vague allusions to monetary losses that plaintiffs might suffer
when Teva USA launches its generic enoxaparin. Plaintiffs argue that “[t]he commencement of
sales by Teva will have an irreparable impact on the market for Plaintiffs’ generic enoxaparin
product.” (Motion at 2 (emphasis added); see also Motion at 10.) While not explained, the
“irreparable impact” appears to refer to the prospect that Teva USA’s entry will make the generic
enoxaparin market competitive. Plaintiffs’ speculations, however, relate to calculable and
compensable injury, and do not demonstrate or identify any irreparable harm that will be
suffered without the discovery.
It is hornbook law that irreparable harm does not exist where money damages are
calculable and defendants have the ability to pay them. See Eli Lilly & Co. v. Am. Cyanamid
Co., 82 F.3d 1568, 1578 (Fed. Cir. 1996); In re Websecure, Inc. Sec. Litig., No. 97-cv-10662-
GAO, 1997 WL 770414, *1 (D. Mass. Nov. 26, 1997) (“Normally, a court would not find a
likelihood of irreparable injury where only money is at stake and where plaintiff has a
satisfactory remedy at law to recover the money at issue.”) (quotations omitted). Teva USA’s
entry in the enoxaparin market will add a third manufacturer. While Teva USA will presumably
26, 1997) (granting expedited discovery subject to pending preliminary injunction motion and a
likelihood of irreparable harm in view of defendant’s dissipating assets); Benham Jewelry Corp.
v. Aron Basha Corp., No. 97-cv-3841 RWS, 1997 WL 639037 *1, 50 (S.D.N.Y. Oct. 14, 1997)
(permitting expedited discovery following grant of preliminary injunction).
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take some market share from plaintiffs upon entry, that loss to plaintiffs is ascertainable. Indeed,
economists are well-versed in calculating such damages.9 Any harm, in short, is not irreparable,
and plaintiffs have made no argument that these principles are not applicable here. See Eli Lilly,
82 F.3d at 1578.10
III. PLAINTIFFS HAVE NO LIKELIHOOD OF SUCCESS ON THE MERITS
Plaintiffs have made no attempt to demonstrate likelihood of success on the merits.
Indeed, both the Complaint and motion, read together, suggest that plaintiffs’ infringement
theories, both factually and legally, are at most speculative and at worst fatally flawed.
A. Teva Does Not Infringe
Notably, plaintiffs’ motion contradicts statements made in the Complaint regarding their
infringement allegations. Whereas, the Complaint alleges infringement based on Teva’s offering
generic enoxaparin for sale in the United States (¶¶ 32, 37), the motion admits that Teva has not
sold, and has no FDA approval to sell, generic enoxaparin in the United States. (Motion at 1, 2,
6-7.) Whereas, the Complaint alleges infringement based on using the claimed methods in the
United States (¶¶ 32, 37, 43, 48), the motion concedes that Teva’s accused “use” takes place
9 Courts have repeatedly found that Teva has the ability to pay any such damages, so that there is
no issue of a prospective inability to recover damages absent preliminary injunction. See, e.g.,
Altana Pharma AG v. Teva Pharmaceuticals USA, Inc., 532 F. Supp. 2d 666, 682-84 (D.N.J.
2007), aff’d 566 F.3d 999 (Fed. Cir. 2009); Novartis Pharms. Corp. v. Teva Pharms. USA, Inc.,
No. 05-cv-1887-DMC, 2007 WL 2669338, *14 (D.N.J. Sept. 6, 2007), aff’d 280 Fed. Appx. 996
(Fed. Cir. 2008).
10 There is, moreover, no presumption of irreparable harm. Although the Federal Circuit
previously held that a judgment of patent infringement created a presumption of irreparable harm
supporting injunctive relief, the Supreme Court squarely rejected that holding in eBay Inc. v.
MercExchange L.L.C., 547 U.S. 388 (2006). See, e.g., Acoustic Processing Tech., Inc. v. KDH
Electronic Sys., Inc., 697 F. Supp. 2d 146, 156-57 (D. Me. 2010) (“Although eBay dealt with
permanent injunctions, its holding applies equally to preliminary injunctions because, according
to the Federal Circuit, the ‘standard for a preliminary injunction is essentially the same as for a
permanent injunction with the exception that the plaintiff must show a likelihood of success on
the merits rather than actual success.’”) (quoting Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341,
1364 (Fed. Cir. 2008)).
Case 1:10-cv-12079-NMG Document 28 Filed 01/13/11 Page 8 of 14
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“outside the United States.” (Motion at 6 n.3.) 11 Whereas, the motion characterizes the
Complaint as asserting infringement under 35 U.S.C. § 271(g) for “importing into the United
States” a product “made” by the claimed methods (Motion at 6 n.3), the Complaint does not even
allege “importing” as an element for any count. (¶¶ 32, 37 43, 48).
All in all, plaintiffs’ infringement allegations are wholly speculative. In contending that
the prospect of an allegedly imminent generic launch provides some basis for expedited
discovery on infringement, plaintiffs simply assume that the only way to commercially
manufacture enoxaparin requires using the methods claimed in plaintiffs’ patents. (E.g., ¶¶ 16,
29-30.) Plaintiffs are alleging, in essence, that because Teva has stated that it expects FDA
approval, it therefore must be infringing plaintiffs’ patents. But this is speculation, and the broad
discovery plaintiffs seek, and the reason they claim to seek it, make clear that plaintiffs are on
the proverbial “fishing expedition.”
B. Plaintiffs Have Not Advanced A Coherent Legal Theory of Infringement
Plaintiffs’ contend that Teva infringes the ’886 and ’466 patents by manufacturing
generic enoxaparin “using” the claimed methods, “and offering those products for sale in the
United States.” (¶¶ 32, 37.) But as noted above, even if Teva were using the claimed methods –
and it is not – that “use” takes place overseas, and thus cannot itself be the basis of an
infringement allegation under 35 U.S.C. § 271(a).12 The ’886 and ’466 patents claim methods of
analysis, not products. Thus, under Section 271(a) the “patented invention” is the claimed
11 Teva’s press release, cited by plaintiffs (Motion at 6 n.3), provides that Teva’s enoxaparin is
manufactured and tested overseas, and that Teva has non infringement defenses. See Blais Decl.
¶ 12, Ex. A. The press release does not, as plaintiffs suggest, provide that Teva makes infringing
use of an asserted claim overseas.
12 Section 271(a) provides, in relevant part: “[W]hoever without authority makes, uses, offers to
sell, or sells any patented invention, within the United States, or imports into the United States
Case 1:10-cv-12079-NMG Document 28 Filed 01/13/11 Page 9 of 14
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methods of “analyzing” enoxaparin, not Teva’s enoxaparin product. As explained above Sanofi
held the patent on enoxaparin, and the court held that patent unenforceable in the earlier
litigation. Section 271(a) only applies to using the claimed methods in the United States, and
plaintiffs acknowledge there is no domestic use.
Plaintiffs’ motion further contends that “while Teva’s manufacturing activities to date
have taken place outside the United States,” Teva still infringes the ’886 and ’466 patents under
Section 271(g).13 (Motion at 6 n.3.) This theory of infringement is equally flawed. Under
Section 271(g), a product “made by a process patented in the United States” means “a physical
article that was ‘manufactured’ and [ ] production of information is not covered.” Bayer AG v.
Housey Pharms., Inc., 340 F.3d 1367, 1376 (Fed. Cir. 2003). The patented process “must be
used directly in the manufacture of the product, and not merely as a predicate process to identify
the product to be manufactured.” Id. at 1378. “[P]rocesses of identification and generation of
data are not steps in the manufacture of a final drug product.” Id. at 1377 (citation omitted).
Here, the ’886 and ’466 patent claims are drawn to “methods of analysis” that result in
information, i.e., “generation of data.” By their own terms the claimed processes are not relevant
to manufacturing contemplated by Section 271(g).14
In short, plaintiffs’ infringement case has serious flaws and is not likely to succeed.
any patented invention during the term of the patent therefor, infringes the patent. 35 U.S.C. §
271(a) (emphasis added).
13 Section 271(g) provides in relevant part: “Whoever without authority imports into the United
States or offers to sell, sells, or uses within the United States a product which is made by a
process patented in the United States shall be liable as an infringer, if the importation, offer to
sell, sale, or use of the product occurs during the term of such process patent.” 35 U.S.C. §
271(g) (emphasis added).
14 Although plaintiffs also allege that Teva induces infringement under 35 U.S.C. § 271(b), (¶¶
32-33), there can be no inducement absent direct infringement. See Joy Techs., Inc. v. Flakt,
Inc., 6 F.3d 770, 774 (Fed. Cir. 1993). Because there is no direct infringement, there can be no
infringement under 35 U.S.C. § 271(b).
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IV. THE REQUESTED DISCOVERY IS BURDENSOME AND PREJUDICIAL
In determining whether plaintiffs have good cause for seeking expedited discovery, the
court should consider the scope of the requested discovery. See In re Websecure, Inc. Sec. Litig.,
1997 WL 770414 (granting motion for expedited discovery where it was “particularized.”);
Philadelphia Newspapers, Inc. v. Gannett Satellite Info. Network, Inc., 1998 WL 404820 (E.D.
Pa. July 15, 1998) (denying motion for expedited discovery where discovery requests were
overly broad and not narrowly tailored to the specific issues to be addressed at the preliminary
injunction hearing). Here, plaintiffs seek on an expedited basis the entirety of Teva’s
Abbreviated New Drug Application and all amendments thereto, the entire Drug Master File and
all amendments thereto, all communications with FDA regarding those documents and all
manufacturing records for enoxaparin produced by or for Teva since August 18, 2009.
Although plaintiffs characterize this discovery as “limited,” the broad scope of their
document requests belie that characterization.15 Plaintiffs’ requests largely encompass
documents describing events that not only pre-date the current action but describe actions that
occurred only before issuance of either of the asserted patents. Such actions simply cannot be
relevant to an infringement analysis. Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352,
1359-60 (Fed. Cir. 2007) (holding infringement under Section 271(g) is not possible “when
[certain] steps of the claimed process are performed before the issuance of the patent.”).
Moreover, to the extent the discovery requests address conduct which has already occurred, it
would have little, if any, bearing on irreparable injuries that may occur pendente lite and thus
cannot be relevant to establishing the need for a preliminary injunction. Qwest Commun. Intl.,
Inc. v. Worldquest Networks, Inc., 213 F.R.D. 418, 420-21 (D. Col. 2003).
15 Teva reserves the right to object to plaintiffs’ discovery requests on other grounds, including
the right to object to plaintiffs’ demand for a shortened period to respond to the requests.
Case 1:10-cv-12079-NMG Document 28 Filed 01/13/11 Page 11 of 14
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The requested discovery, in short, is burdensome and prejudicial to Teva under McMann,
and compels denial of plaintiffs’ motion.
V. CONCLUSION
There is no good cause to allow expedited discovery. No factor under the McMann
analysis supports departing from the Rule 26(d) moratorium on pre-conference discovery. The
motion is a thinly veiled attempt to circumvent the normal litigation process and should be
denied.
* * *
REQUEST FOR ORAL ARGUMENT
Pursuant to Local Rule 7.1(d), Teva requests oral argument on plaintiffs’ motion for
expedited discovery.
Dated: January 13, 2011 Respectfully submitted,
GOODWIN PROCTER LLP
By: /s/ James C. Rehnquist
James C. Rehnquist (BBO # 552602)
Elaine Herrmann Blais (BBO #656142)
Adam R. Wichman (BBO #678324)
Robert Frederickson III (BBO #670111)
GOODWIN PROCTER LLP
Exchange Place
53 State Street
Boston, MA 02109
Tel.: (617) 570-1000
Fax: (617) 523-1231
jrehnquist@goodwinprocter.com
eblais@goodwinprocter.com
awichman@goodwinprocter.com
rfrederickson@goodwinprocter.com
David M. Hashmall (pro hac vice)
GOODWIN PROCTER LLP
The New York Times Building
620 Eighth Avenue
New York, NY 10018
Tel.: (212) 813-8800
Fax: (212) 355-3333
dhashmall@goodwinprocter.com
Attorneys for Defendants
TEVA PHARMACEUTICAL INDUSTRIES LTD.
and TEVA PHARMACEUTICALS USA, INC.