Free Response to Motion - District Court of Delaware - Delaware


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Case 1:08-cv-00052-GMS-LPS

Document 80

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWAR
FOREST LABORATORIES, INC., et aI.,
Plaintiffs,
v.
)
) ) ) )

C.A. No. 08-52 (GMS)(LPS)

)

DR. REDDY'S LABORATORIES, INC., DR. )

REDDY'S LABORATORIS LIMITED, ) GENPHAR IC., GENPHARM, L.P., )

INTERPHARM HOLDINGS, INC., )
RANBAXY LAB

PHARCETICALS INC., RANBAXY, INC., ) ORA TORIS LIMITED, )
KENDLE INTERNATIONAL INC., SUN INIA)

INTERPHA, INC., MYLAN )

PHARMACEUTICAL INUSTRIS LIMITED)
LTD.), SYNTHON HOLDING B.V., SYNTHON )
B.V., SYNTHON LABORATORIS, INC., and)

(ala SUN PHACEUTICAL INUSTRIS)
SYNTHON PHACEUTICALS, INC. )
)

Defendants.

) )

SYNTHON DEFENDANTS' OPPOSITION TO PLAINTIFFS' MOTION FOR LEAVE TO TAK JURISDICTIONAL DISCOVERY AND TO EXTEND THE TIME TO RESPOND TO SYNTHON'S MOTION TO DISMISS
Of

Counsel:

E. Anthony Figg Elizabeth M. McGeever (# 2057)

Joseph A. Hynds PRICKETT, JONES & ELLIOT, P.A.

Lisa N. Philips 13 10 King Street
ROTHWELL, FIGG, ERNST & MANBECK, P.C. Wilmington, DE 19899

1425 K Street, N.W., Suite 800 Tel: 302-888-6500
Washington, D.C. 20005 Fax: 302-658-0111

Tel: 202-783-6040 emmcgeever(fprickett.com
Fax: 202-783-6031

efigg(frothwell figg.com
i hvndS(frothwwellfigg. com

lphillpS(frothwellfigg.com
Attorneys for Defendants, Synthon Holding B. V, Synthon B. V, Synthon Laboratories, Inc. and Synthon Pharmaceuticals, Inc.

DATED: April 14, 2008

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TABLE OF CONTENTS
Pae:e
TABLE OF AUTHORITIES """"'''''''''''''''''''''''''''''''''''''''' .....................................,.................... ii

INTRODUCTION AND NATURE AND STAGE OF THE PROCEEDINGS .............................l

SUMMARY OF THE ARGUMENT ,..........................................",.""......................................,....4
i.
II.

FACTUAL BACKGROUN..............................................................................................4
ARGUMNT .............,.."....................................................".,.......................................,.....7
A.

PLAINTIFFS HAVE NOT PROVIDED ANY COMPETENT

EVIDENCE TO WARNT LEA VE TO TAK JUSDICTIONAL
DISCOVERY.....................................................,..............................,..,................... 7
1.

The Applicable Legal Standards.............. ........... ...... ........................... ........8

2.

Plaintiffs Have Failed to Support Their Request for Jurisdictional Discovery With Any Basis for Concluding That It Wil Enable Establishing General Them to Meet the Heavy Burden of
Personal Jursdiction.,...,............................., ,...............................................9

B.

BECAUSE JUISDICTIONAL DISCOVERY IS NOT PROPER HERE, PLAINTIFFS SHOULD NOT RECEIVE A LENGTHY EXTENSION OF TIME TO RESPOND TO THE SYNTHON ENTITIES' MOTION
TO DISMISS ,..... ... ........ ....... ....... ,.".", "" .,.... ... ... ............"., ,............................... ..14

CONCLUSION ................................................. ...................,....,............................,.,................... ..15

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TABLE OF AUTHORITIES
Cases
Pae:e

Aladdin Knowledge Sys. Ltd. v. Feitan Techs. Co., No. 05-149, slip. op, at 6 (D. DeL. Feb. 24, 2006) .............................................................10

Boone v. Oy PartekAB, 724 A.2d 1150 (DeL. Super. Ct. 1997)................................................9, 12
Brown v. AST Sports Sci., Inc., No. 02-1682

2002 U.S. Dist. LEXIS 12994 (ED. Pa. July 1,2002)......................................................13
Clark Capital Mgmt. Group, Inc. v. Navigator Invs, LLC,

No. 06-2334, 2006 U.S. Dist. LEXIS 66989 (E.D. Pa, Sept. 19, 2006) ............................11

Eli Lily & Co. v. Medtronic, Inc., 496 U.S, 661 (1990) .................................................................2
Hansen v. Neumueller GmbH, 163 F.R.D. 471 (D. Del 1995) ............................................8, 10, 11
Mass. Sch. of Law at Andover, Inc. v. ABA, 107 F.3d 1026 (3d Cir, 1997) ....................................8

Merck & Co. v. Barr Labs., Inc., 179 F. Supp. 2d 368 (D. DeL. 2002)......................................9, 11
Neary v. B&L Serv., No. 04-1072,2004 U.S. Dist. LEXIS 9922 (E.D. Pa. May 12,2004) ...........8

Pfizer, Inc. v. Synthon Holding, B. V, 386 F, Supp. 2d 666 (M.D.N.C. 2005) ..............................13

Poe v. Babcocklntl, Inc., 662 F. Supp. 4 (M.D. Pa. 1985) ..........................................................10
Sanofi-Aventis v. Synthon Holding B. V, No. 07-00086, slip. op. at 5 (M,D. N.C. Mar. 20, 2008)............................................................................1 3

Telcordia Techs., Inc. v. Alcatel, s.A., No. 04-874, 2005 U,S, Dist. LEXIS 10194 (D. DeL. May 27, 2005).................................................8, 14

Toys "R" Us, Inc. v. Step Two, s.A., 318 F.3d 446 (3d Cir. 2003)..................................................8
Veliz v. Americorp Builders, Inc., No. 06-4363

2007 U,S, Dist. LEXIS 43560 (D. N.J. June 15,2007) .....................................................14

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Pae:e

Statutes and Rules

28 U . S.C. § 13 91 (c) ..................................................................................................................... ..12

Fed. R. Civ. P, 12(b )(2)............................................,................................,......................................1
Fed, R. Civ. P. 12(b )(3).................................. ..... ....................................................... .................. ....1

Fed. R. Civ. P. 12(b)( 5)....................................................................................................................1

Miscellaneous
http://ww.synthon-usa.com/page.asp?id= 1156...................,.,.....................................................1 0
http://ww .accessdata.fda,gov /scripts/cder/ob/ docs/temptn.cfm................................................. .12

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Defendants, Synthon Holding B.V, ("Synthon Holding"), Synthon B.V, ("Synthon

B.V."), Synthon Laboratories, Inc. ("Synthon Labs"), and Synthon Pharaceuticals, Inc.
("Synthon Pharms") (collectively, the "Synthon Entities"), respectfully submit this memorandum

in opposition to Plaintiffs' motion for leave to take jurisdictional discovery and to extend their

time to respond to the Synthon Entities' motion to dismiss. The Synthon Entities oppose the
motion, because Plaintiffs have not demonstrated any reason to believe that discovery wil reveal

additional facts or information that wil assist the Cour in determining whether any of the
Synthon Entities is subject to this Cour's jurisdiction, Discovery is unecessary and wil impose
substantial expense and burden on the Synthon Entities.

INTRODUCTION AND NATURE AND STAGE OF THE PROCEEDINGS
On January 25, 2008, Forest Laboratories, Inc. ("Forest Labs"), Forest Laboratories

Holdings, Ltd. ("Forest Holdings), Merz Pharma GmbH & Co KGaA ("Merz") and Merz
Pharmaceuticals GmbH ("Merz Phars"), (collectively, "Plaintiffs"), fied an initial complaint
against various defendants alleging infringement of the '703 patent based on defendants' filings

of Abbreviated New Drug Applications ("ANDAs") seeking approval for the manufactue, use
and sale of generic memantine hydrochloride tablets. On February 15, 2008, after receiving

notice that Synthon Labs had also filed an ANDA containing a Paragraph IV Certification with

respect to the '703 patent, Plaintiffs filed an Amended Complaint adding each of the Synthon
Entities as a defendant. On March 12, 2008, the Synthon Entities moved to dismiss this action

for lack of personal jurisdiction pursuant to Fed, R. Civ. P. 12(b )(2), improper venue pursuant to

Fed. R. Civ. P. 12(b)(3) and improper service pursuant to Fed. R. Civ. P. 12(b)(5). Plaintiffs

moved for leave to take jursdictional discovery and to extend their time to respond to the
Synthon Entities' motion to dismiss on March 27,2008.

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The Synthon Entities acknowledge that Plaintiffs' burden of supporting their request for

discovery is not a heavy one, but disagree that Plaintiffs have carried even that burden. Under
the circumstances and facts of

this case, their requests are frvolous.

Plaintiffs made generalized, unsupported jurisdictional allegations in their Amended
Complaint against the Synthon Entities. The only act of infringement that they allege is that
Synthon Labs' fiing of its ANDA constituted infingement under 35 U.S.C. § 271(e)(2)(A)-a

type of infingement that the Supreme Cour has characterized as "artificiaL." Eli Lily & Co. v.
Medtronic, Inc., 496 U.S. 661, 676 (1990). Plaintiffs do not and cannot allege that the Synthon
Entities have engaged in any commercial activities involving the patented product in Delaware

or anywhere else. Thus, Plaintiffs did not allege that the Synthon Entities have engaged in any

conduct in this District that gave rise to the cause of action upon which their Amended
Complaint is based.

Accordingly, at the time the Amended Complaint was fied, Plaintiffs knew or should
have known that if personal jurisdiction over the Synthon Entities existed at all, it would have to

be based on principles of general jurisdiction, not specific jurisdiction. Plaintiffs also knew or
should have known that the Delaware standards for establishing general jurisdiction are rigorous

- requiring a showing that the defendant has continuous and systematic contacts with the State.
Yet, despite these requirements, Plaintiffs alleged personal jurisdiction without any evidence that

any of the Synthon Entities has an office or other physical presence here, has any employees

here, sends sales or other representatives into ths state, maintains any ban accounts here, is

listed in local telephone directories or has engaged in any other continuous and systematic
contacts that could subject it to general jurisdiction.

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Now that Plaintiffs' jurisdictional allegations have been challenged, they apparently have

scoured the public records in the futile hope of finding evidence of signficant contacts between

the Synthon Entities and this foru. What they have found, beyond the trivial, sporadic contacts

that the Synthon Entities themselves identified in their motion papers, is that for a brief time
several years ago, a Synthon company was incorporated in Delaware but shortly thereafter was
dissolved and that Synthon Phars at one time had a distribution agreement with a company that

allegedly was, but no longer is, incorporated in Delaware, for a product that Synthon Pharms
divested well before this case was initiated. These past contacts are irrelevant to the question of

whether any of the Synthon Entities were engaged in continuous and systematic contacts with
this District at the time the Amended Complaint was fied.

Plaintiffs try to justify their request for discovery on grounds that they should be able to

investigate whether the Synthon Entities' declarants were untruthfl or provided incomplete
information.

But Plaintiffs have offered nothing beyond irrelevant past contacts with this

District and unsupported speculation to show that three months of discovery wil lead to any
information beyond what already is known,

Plaintiffs' request for discovery is, therefore,

frivolous, These issues are addressed in greater detail below in Section II.A.

With respect to Plaintiffs' request for an extension of time, the Synthon Entities do not,

of course, object to a reasonable extension of the time for responding to their motion, if the
Plaintiffs require it. What the Synthon Entities did find objectionable was a 90-day extension
during which Plaintiffs would demand expensive and unecessary discovery from domestic and
foreign corporations and witnesses. i As set forth below in Section II.B., because Plaintiffs have

i Plaintiffs imply that the Synthon entities were unresponsive to their requests for an extension of

time. What they

overlook is that their requests came in close proximity to the Easter holiday when decision makers were unavailable

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not demonstrated a need for discovery, their request for a 90-day extension also is unwarranted.

The Synthon Entities request that this Cour set a date ten (10) days after entry of its ruling on
the present motion as the due date for Plaintiffs' opposition to the outstanding motion to dismiss.

SUMMARY OF THE ARGUMENT
(1)

Plaintiffs have not provided any competent evidence that would warant a period
the "facts" that they present are either irrelevant,

of jurisdictional discovery in this case. Each of

as having had occured long before this action was commenced, or they are based on speculation
that, after a full examination of the actual facts, is easily set aside as unsupported and inaccurate.
The contacts with this foru that the Synthon Entities have acknowledged and described in their

motion to dismiss and supporting declarations are not sufficient to establish general jursdiction
over any of the domestic or foreign Synthon Entities.
Consequently, there is no basis for

asserting either an alter-ego or agency theory of jursdiction over the foreign Synthon Entities.
(2)

Because Plaintiffs have not demonstrated the need for jurisdictional discovery,
time also is unwaranted.

their request for a lengthy extension of

I. FACTUAL BACKGROUND2

On February 15, 2008, after receiving Synthon Labs' Paragraph iv notification against
u.s. Patent No, 5,061,703 (the "'703 Patent"), Plaintiffs amended their existing Complaint to

add the Synthon Entities as additional defendants.

Plaintiffs Motion for Leave to Take

because of

vacation schedules. Under the circumstances, the Synthon Entities' counsel responded promptly to

Plaintiffs' request. 2 The facts relating to the jurisdictional issues are set forth in full in the Synthon Entities' memorandum in support
ofthe motion to dismiss (D.I. 48); however, the most pertinent of recitation of

those facts wil be set forth herein. For a detailed

the facts relating to each part and the facts relating to the ANDA at issue here, the Synthon Entities respectfully refer the Court to that memorandum.

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Jurisdictional Discovery and to Extend Their Time to Respond to Synthon's Motion to Dismiss
("Opening Brief'), p. 4 (D.l. 60); Amended Complaint, (D.l. 31) ~ 90.

Synthon Holding is a Dutch company, with its principal place of business in the
Netherlands. Amended Complaint, ~ 16. Synthon Holding was not involved in the development

of Synthon Labs' generic memantine hydrochloride product or the preparation and fiing of the
ANDA, which is the subject of

the present litigation. D.l. 48, at Exhibit A, ~ 7.

Synthon B.V. is also a Dutch company, with its principal place of business in the
Netherlands. Amended Complaint, ~ 17. Synthon B.V, was involved in both the development of

the generic memantine hydrochloride product and the preparation and assembly of the ANDA
that is the subject of

this litigation. D.l. 48, at Exhbit A, ~~ 11-12.

Synthon Labs is a Virginia corporation, with its principal place of business in
Gainesvile, Virginia. Amended Complaint, ~ 18. Synthon Labs submitted ANDA No. 90-047
seeking approval from the FDA for the manufactue, use and sale of generic memantine

hydrochloride tablets, which ANDA is the subject of this litigation, and once that ANDA is

approved, will be the sole ANDA holder, D.L 48, at Exhbit B, ~ 1 l. No aspect of the
development of the ANDA product, the preparation of the ANDA or its fiing occured in this
District. D.l. 48, at Exhbit B, ~~ 5-11. Synthon Labs does not sell any products in this District,
nor elsewhere in the United States. Id., ~ 4.

Synthon Phars is a North Carolina corporation with its principal place of business in

North Carolina. Amended Complaint, ~ 19. Synthon Pharms had very minor involvement with
the product at issue. It paricipated in, inter alia, initial consultation with the FDA regarding the

studies required to establish bioequivalence to NamendaiI and provided, in an advisory role,

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review and comment to the ANDA. D.I. 48, at Exhbit C, ~~ 7-8. All of

those activities occurred

in North Carolina, outside of this District. Id., ~ 9.

On February 20, 2008, Plaintiffs served the Amended Complaint on the Delaware
Secretary of State, purortedly pursuant to the Delaware Long Ar Statute, 10 DeL. C. §
3104(d). The next day, Plaintiffs sent, via registered mail, copies of

the Summons and Amended

Complaint to each ofthe Synthon Entities. Synthon Labs received the letter with attachments on
February 26, 2008. Declaration of

Mailng (as to Synthon Laboratories, Inc.), D.l. 43, at Exhibit

B. Synthon Pharms received the letter with attachments on February 27, 2008. Declaration of
Mailing (as to Synthon Pharmaceuticals, Inc.), D,l. 45, at Exhbit B.

According to the

Declaration of

Mailing (as to Synthon Holding B.V. and Synthon B.V.) fied on March 31,2008,

each of the foreign defendants, Synthon B,V. and Synthon Holding, received the letter with
attachments on March 6, 2008.3

Declaration of Mailng (as to Synthon Holding B.V. and

Synthon B.V.), D.l. 63, at Exhbits C and D.

Just after March 12, 2008, the day the Synthon Entities' filed their motion to dismiss,
Plaintiffs requested that the Synthon Entities agree to a period of jursdictional discovery and a

corresponding extension of time to oppose the motion, Opening Brief, p. 11, Plaintiffs made

3 Shortly before the due date for the Synthon Entities' time to answer or otherwise respond to the Amended time. Apparently anticipating the problems with the Complaint, they sought Plaintiffs' agreement to an extension of jurisdictional allegations in their Amended Complaint, Plaintiffs stated that they would not agree to an extension unless the Synthon Entities agreed not to contest personal jurisdiction. The Synthon Entities refused to agree to them would submit to jurisdiction in the United States District Court for those conditions, but did offer that each of Virginia ("EDV A"). Plaintiffs' refusal to agree to an extension led to the fiing ofD.1. 46. In the Eastern District of the Synthon Entities' agreement to submit to jurisdiction in the EDV A, Plaintiffs, on March 20, 2008, fied a spite of the '703 Patent against the Synthon Entities in the United States District Court second suit alleging infringement of North Carolina. See EDNC, Civil Action No. 08-00150. Shortly before fiing the North for the Eastern District of Plaintiffs' counsel contacted Synthon Labs' President to inquire whether the Carolina action, a representative of
company held a license to do business in New Jersey. This motion, coupled with the fiing of

their protective suit in

the EDNC and the inquiry regarding contacts with New Jersey, reflect Plaintiffs' obvious resistance to litigating this case in the EDV A's well known "rocket docket." A speedy resolution would result in an earlier introduction of generic competition to Plaintiffs' lucrative Namendail product.

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these requests on March 14 (by telephone), March 19 and March 25 (both via e-mail). Id. at
Exhibits D-F, During that period of time, at least two of

the Synthon Entities' attorneys were out

of the offce, Upon their retu, and in response to Plaintiffs' request less than three hours

earlier, the Synthon Entities responded on March 25, 2008.

Opening Brief, at Exhbit D.

Plaintiffs then fied, on March 27, 2008, the present motion for leave to take jurisdictional
discovery and to extend their time to respond to the Synthon Entities' motion to dismiss. This
opposition is timely filed.

II. ARGUMENT
A.

PLAINTIFFS HAVE NOT PROVIDED ANY COMPETENT EVIDENCE TO WARRNT LEAVE TO TAKE JURISDICTIONAL DISCOVERy4

Although the required showing for jursdictional discovery does not present a large
hurdle, Plaintiffs do not offer any evidence that justifies the discovery that they seek. The only

alleged new facts that Plaintiffs offer are irrelevant contacts with this District that ended long
before the Amended Complaint was fied.s The remainder of the offered evidence was set forth in the Synthon Entities' memorandum in support of their motion to dismiss and the supporting
declarations and is of a character and quantity that cours in this District and others have
previously held to be insufficient to establish general personal jursdiction. For at least these

reasons, and the reasons set forth in detail below, Plaintiffs' motion for leave to take

jurisdictional discovery should be denied,

4 Plaintiffs allege solely that this court has general jurisdiction over the Synthon Entities. See Amended
Complaint, irir 16-19,22,34-37.
all of Plaintiffs' claims for infringement of the '703 patent are addressed in this District," it is axiomatic that, for such to occur, this Court must have personal 5 Although Plaintiffs state that ''judicial economy would be promoted if jurisdiction over each of

the named Defendants. Opening Brief, pp. 4-5 n.1.

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1.

The Applicable Legal Standards
"Although the plaintiff bears the burden of demonstrating facts that support personal

jurisdiction, cours are to assist the plaintiff by allowing jurisdictional discovery uness the

plaintiffs claim is 'clearly frivolous.''' Telcordia Techs., Inc. v. Alcatel, SA., No. 04-874,2005
u.s. Dist. LEXIS 10194, at *28 (D. DeL. May 27, 2005) (citing Toys "R" Us, Inc. v. Step Two,
SA., 318 F.3d 446,456 (3d Cir. 2003)). "On the other hand, a cour canot permit discovery as

a matter of course simply because a plaintiff has named a paricular par as a defendant. The

cour must be satisfied that there is some indication that this paricular defendant is amenable to
suit in this foru," Hansen v. Neumueller GmbH, 163 F.R.D. 471, 475 (D, Del 1995) (emphasis
added). Whether or not to provide the plaintiff an opportty to take jurisdictional discovery is

within the cour's discretion. Mass. Sch. of Law at Andover, Inc. v. ABA, 107 F.3d 1026, 1042
(3d Cir. 1997).

"Where a defendant has submitted an affidavit attesting to a lack of jurisdictional

contacts and plaintiff, who has the burden of establishing jursdictional facts, has countered the

affidavits with mere speculation, his request for an opportty to conduct discovery on the
matter must be denied." Neary v. B&L Serv., No. 04-1072,2004 U.S. Dist. LEXIS 9922, at *3

(E.D. Pa. May 12,2004) (citation omitted). Importantly, with respect to the foreign defendants,

Synthon B.V. and Synthon Holding, "the United States Supreme Court has held that cours
should exercise special vigilance to protect foreign litigants from the danger that unecessary, or

unduly burdensome, discovery may place them in a disadvantageous position," Telcordia
Techs., Inc., 2005 U.S, Dist. LEXIS 10194, at *28 (internal quotations and citation omitted).

Based on these authorities and Plaintiffs' failure to demonstrate "some indication" that the
Synthon Entities are subject to personal jurisdiction in this foru, their motion should be denied.

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2.

Plaintiffs Have Failed to Support Their Request for Jurisdictional Discovery With

Any Basis for Concluding That It Wil Enable Them to Meet the Heavy Burden of Establishing General Personal Jurisdiction
Plaintiffs refer to activities that the Synthon Entities acknowledged and explained in their

own motion papers. Under controllng legal authority, such activities cannot support general
jurisdiction. Specifically, Plaintiffs state that "at least two of Synthon's pharaceutical products

are sold in Delaware," citing sales of the products, amlodipine besylate and zolpidem tarrate,

through a retail distribution channel into Delaware. Opening Brief, p. 7; at Exhbit A. The
Synthon Entities acknowledged that Synthon Pharms sells those products to a pharmaceutical

products distributor (not located within the State of Delaware). That distributor then sells to its
own customers, leading to small quantities of those products' finding their way into Delaware.
D.l. 48, p, 11; at Exhbit C, ~~ 4-5. Additionally, the Synthon Entities acknowledged that

Synthon Phars holds a Drug Wholesalers License within the State of Delaware. Id. Those
facts are insufficient to establish general personal jurisdiction over Synthon Phars. There is no

evidence or even contention that Synthon Pharms sells products directly into the State of
Delaware. At most, it places its products into commerce by sellng to a pharmaceutical product
distributor which then may re-sell to its own customers. Under the applicable law, "the general

jurisdiction provision of the (Delaware Long Arm J statute does not anticipate that placing a

product into the stream of commerce would give rise to jursdiction." Merck & Co. v. Barr
Labs., Inc., 179 F. Supp. 2d 368, 373-74 (D. DeL. 2002) (citing Boone v. Oy PartekAB, 724 A.2d

1150, 1156 (Del. Super. Ct. 1997)), Such an analysis is only relevant when the product placed
into the stream of commerce is the actual product that causes the injury -- a situation not present

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here.6 In fact, the case on which Plaintiffs principally rely in that section of their brief is

distinguishable on precisely this point. Aladdin Knowledge Sys. Ltd. v. Feitan Techs. Co., No.

05-149, slip. op. at 6 (D. DeL. Feb. 24, 2006), attached hereto as Exhbit A. The basis for
permitting jurisdictional discovery in the Aladdin Knowledge case was that the distributor had

"the authority to distribute the accused products anywhere in the United States, including
Delaware," Id. (emphasis added). In this case, Synthon's accused memantine hydrochloride

products have not been approved by the FDA and may not be sold anywhere in the United States.

Plaintiffs also argue that, in view of the two products that Synthon Pharms does sell, they
"should be given leave to take jurisdictional discovery concernng all pharaceutical products

that Synthon may distribute, sell or offer for sale in Delaware." Opening Brief, p. 7; at Exhbit
A. However, a careful review of

the public record would have revealed that Synthon Pharms is

the only Synthon Entity that sells any products in the United States, and it sells only the two

products that were identified in Plaintiffs' motion papers.

See htt://ww.synthon-

usa.com/page.asp?id=1156 ("The Synthon product range in the USA includes two products.").

Thus, Plaintiffs' request is based on unsupported speculation that there actually are other
products that the Synthon Entities sell in this District - speculation that is inconsistent with

Synthon Phars' publicly available website, Hansen, 163 F,R.D. at 476 (because defendant
provided two affidavits that supported defendant's "unequivocal denial of contact with the State

of Delaware" and there was "a complete absence of jursdictional facts by the plaintiff'
discovery was denied.), See also, Poe v. Babcock Intl, Inc., 662 F. Supp, 4, 7 (M.D, Pa. 1985).

6 Moreover, "(w)hen a manufacturer passes title to goods to a third par outside of

Delaware it is not deemed to

have performed an act in this State." Boone, 724 A.2d at 1156 (citation omitted).

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As discussed in the Synthon Entities' memorandum in support of

their motion to dismiss,

the fact that Synthon Phars holds a Drug Wholesalers License in the State of Delaware is also

not a contact that reaches the threshold required to establish general jurisdiction. D.l. 48, p. 15;

Merck & Co., Inc., 179 F. Supp. 2d at 373, In fact, in the Merck case, defendant Barr held a

Drug Wholesalers License, had an account manager assigned to the State of Delaware who
visited the State about thee times a year, had a contract with a Delaware entity, and even

maintained a wholly-owned subsidiar in the State, and the cour stil did not permit the exercise
of general jurisdiction over it. Synthon Pharms' Drug Wholesalers License, in and of itself, does
not establish that there is "some indication" that jurisdiction is proper here. Hansen, 163 F .RD.

at 475. See also, Clark Capital Mgmt. Group, Inc. v. Navigator Invs, LLC, No. 06-2334,2006

U.S. Dist. LEXIS 66989, at *20-21 (E.D. Pa. Sept. 19, 2006) (finding that jurisdictional

discovery was not warranted because, even if the facts presented by plaintiff were true, those
"facts" would not establish

jurisdiction over the defendant).

Next, Plaintiffs rely on a report of a contract between Synthon Pharms and Ventiv Health,

Inc. in an effort to demonstrate a jurisdictional contact with Delaware. The existence of that
contract was publicly disclosed in February 2004. Opening Brief, p. 8; at Exhbit B, Plaintiffs
assert that this "connection" with a company "which was incorporated in Delaware during the
relevant period," supports a fuher investigation of "the sales and marketing activities that may

have occured in Delaware preceding, during and as a result of' the agreement or with "any other

Delaware company." Id. Plaintiffs relegate to a footnote the most relevant facts concernng this

allegation; namely, that "Ventiv was incorporated in Delaware from January 2000 until
December 2006," Id. at n. 3. The Synthon Entities do not know what Plaintiffs mean by their

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reference to the "relevant period," but a contact with Delaware that ended two years before the
Amended Complaint was fied has no relevance to the existence vel non of personal jurisdiction,
This is so because a finding of general jurisdiction requires that a corporation engage in sufficient activities in this State to establish a 'general presence.' . . . However, once established, this general presence is not everlasting. To the contrary, when a defendant only has general jursdictional contacts with a state they may withdraw from that state for jurisdictional puroses.
Boone, 724 A.2d at 1156 (citations omitted). See also, 28 U.S.C. § 1391(c) (proper venue is
determined "at the time the action is commenced."). This contact with Delaware is irrelevant for

the additional reason that, as publicly available information confrms, the product which was the
subject of

the Ventiv agreement is no longer a Synthon Phars product, and was not at the time
See http://ww. accessdata. fda.

the Amended Complaint was filed.
temptn.cfm (showing that IDS Pharms is now the holder of

gov / scripts/ cder/ o b/ docs/

the approval for the PexevaiI product

that was the subject of

the Ventiv agreement).

Demonstrating their desperation to find some contacts between the Synthon Entities and

this foru, Plaintiffs also rely on the fact that a Synthon company was, for a period of
"approximately six months," incorporated in Delaware, Opening Brief, at p. 9; at Exhibit C.
Coupled with this assertion (relying on the attached incorporation papers but curiously never
including the dissolution papers), Plaintiffs state that they "should be given leave to take

jurisdictional discovery on the activities that may have occurred in Delaware preceding
dissolution (because such "facts") can hardly be considered 'clearly frivolous.'" Opening Brief,

p. 9 (citation omitted). Plaintiffs protest too much, and, in fact, their argument is frvolous. The

dissolution to which Plaintiffs refer, by their own admission, occured in roughly April 2004 nearly four years before the action against the Synthon Entities was commenced. The fact that a
Synthon company was once incorporated in Delaware but was dissolved years before this action

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was commenced has no bearing whatsoever on the jurisdictional issues on which the Plaintiffs
wish to take discovery, 28 U.S.C. § 1391(c); Boone, 724 A.2d at 1156 (citations omitted).

Plaintiffs finally argue that "jurisdictional discovery over Synthon B.V. and Synthon
Holding B.V. is also warranted." Opening Brief, at p. 9, Plaintiffs argue, without support, that,
"(b)ased upon Plaintiffs' understanding of Synthon's corporate structure, Plaintiffs believe that
Synthon B.V. and Synthon Holding B.V. are controllng the Synthon entities in the United
States." Id. Whatever Plaintiffs' subjective beliefs may be, the Synthon Entities have fully
explained the Synthon Entities' corporate structue, as well as each of the Synthon Entities'

involvement (or lack thereof) in the activities relating to this litigation, D.l. 48, at pp. 5-8; 13-14;

at Exhbits A-C. Plaintiffs respond to those facts with unsupported speculation.7 Moreover,
irrespective of the relationships between the domestic Synthon Entities and Synthon B.V. or
Synthon Holding, Plaintiffs canot establish personal jursdiction in this District through an alter
ego theory, because it cannot show that any of

the Synthon Entities has suffcient contacts with

Delaware to constitute the continuous, regular and systematic contacts that are required for
general personal jurisdiction.

In other words, because there is no basis for permitting

jurisdictional discovery of either Synthon Pharms or Synthon Labs, as neither maintains the
required continuous and systematic contacts in this District, there is no jurisdictional "hook" to
pull in Synthon Holding or Synthon B.V. based on either an agency or alter-ego theory. SanofiAventis, No. 07-00086, slip. op. at 5 n. 5; Brown v. AST Sports Sci, Inc., No, 02-1682,2002 U.S.

Dist. LEXIS 12294, at *34 n. 9 (E.D. Pa. July 1,2002).
7 Plaintiffs refer to Pfizer Inc. v. Synthon Holding, B. v., 386 F. Supp. 2d 666, 677 (M.D.N.C. 2005); however, that the ANDA at issue in the Pfizer case, there case is inapposite. The same Judge who determined that, for purposes of was dominance and control among the parties, determined that such was not the case in a litigation involving a different ANDA (which surrounding facts more closely resemble those found in the case at bar). Compare, SanofiAventis v. Synthon Holding B. v., No. 07-00086, slip. op. at 5, 10 (M.D. N.C. Mar. 20, 2008), attached hereto as
Exhibit B.

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Plaintiffs cannot establish the need for expensive and protracted discovery through bare

allegations that there is personal jursdiction over the Synthon Entities in this Cour "by virte of,

inter alia, (their) systematic and continuous contacts with Delaware." Amended Complaint, ~~
34-37, Such an allegation is "emblematic of

the clearly frivolous standard." Veliz v. Americorp

Builders, Inc., No. 06-4363, 2007 U.S. Dist. LEXIS 43560, at * 12 (D. N.J. June 15, 2007)
(unpublished).

None of the "facts" Plaintiffs included in their Opening Brief, nor the allegations of their
Amended Complaint, require that, in the face of the detailed affidavits presented in support of

the Synthon Entities' motion to dismiss, jurisdictional discovery be permitted. Where, as here,

"the lack of personal jursdiction is clear. . . fuher discovery serves no purose and should be
denied." Telcordia Techs., Inc., 2005 U,S. Dist. LEXIS 10194, at *30 (citation omitted).

B.

BECAUSE JURISDICTIONAL DISCOVERY IS NOT PROPER HERE, PLAINTIFFS SHOULD NOT RECEIV A LENGTHY EXTENSION OF TIME TO RESPOND TO THE SYNTHON ENTITITES' MOTION TO DISMISS

Because Plaintiffs' request for leave to take jurisdictional discovery should be denied,
their corresponding request for an extension of time of ninety days within which to conduct such

discovery should also be denied as moot. The Synthon Entities would agree to a reasonable

extension of time for the Plaintiffs to respond to their outstanding motion to dismiss, The
Synthon Entities respectfully suggest that a reasonable extension period would be ten (10) days,
calculated from the date that this motion is decided.

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CONCLUSION
For the reasons set forth above, the Synthon Entities respectfully request that Plaintiffs'

motion for leave to take jurisdictional discovery and to extend their time to respond to the
Synthon Entities' motion to dismiss be denied,

Dated: April 14, 2008

~ ì1M.'McGeever(# 2057) M1L ~ Elizabeth
PRICKETT, JONES & ELLIOT, P.A. 1310 King Street Wilmington, DE 19899 Telephone: (302) 888-6500 Facsimile: (302) 658-8111 emmcgeever(fprickett.com
Attorney for Defendants Synthon Holding B. V,
Synthon B. V,

Synthon Laboratories, Inc. and Synthon Pharmaceuticals, Inc.
Of

Counsel:

E. Anthony Figg Joseph A. Hynds Lisa N. Phillps ROTHWELL, FIGG, ERNST & MANBECK, P.C. 1425 K Street, N.W. Suite 800 Washington, D.C. 20005 Telephone: (202) 783-6040 Facsimile: (202) 783-6031 efigg(frothwellfigg.com
i hvndS(frothwellfigg. com

lphillps~rothwellfigg.com

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