lyer, Natasha
`
`From:
`Sent:
`To:
`
`Subject:
`
`Attachments:
`
`Cieslak-Tochigi, Aya (acieslaktochigi@mccarter.com>
`Friday, June 17, 2016 4:57 PM
`O'Shaughnessy. William; Arlene Apodaca; Doug Carsten; Kathryn Robinson; Leton,
`Margaret Saldana; Patel, Ravin; Veronica Ascarrunz; William Jackson;
`'lwalsh@thewalshfirm.com'; 'Tricia B. O'Reilly'; MNutter@winston.com:
`kmathas@winston.com; Barbara E. Troyan; 'Joseph Linares': Adam Burrowbridge; Arnell,
`Eric; UTC WSGR; Ugolev, Olga
`United Therapeutics Corp. v. Watson Laboratories, Inc: Civ. A. No. 3:15—cv—05723 —
`Motion for leave to file an amended complaint
`2016 06 15 Decl ISO re First Amended Complaint Against Watson-c.pdf; 2016 06 15
`Notice of Motion re First Amended Complaint Against Watson—cpdf‘, 2016 06 16
`Memo of Law re First Amended Complaint Against Watson_(check font size)-c.pdf;
`Exhibit A — Amended Complaint—cpdf; Proposed Form of Order — Leave to File and
`Amended Complaint-c.pdf
`
`Counsel,
`Please see the attached, which we electronically filed with the Court today.
`Thank you.
`Aya
`
`"fi‘flfijgfi
`
`flflilfféaé‘g‘é‘ilé‘illsflifffi'm
`
`100 Mulberry Street, Four GatewayI Center | Newark, New JerseyI 07102
`T: 973-849-4033
`F: 9?3—29?-3?20
`acieslaktochigi@mccarter.com | www.mccarter.com
`
`BOSTON | HARTFORD | STAMFORD | NEW YORK | NEWARK
`EAST BRUNSWICK | PHILADELPHIA | WILMINGTON | WASHINGTON. DC
`
`This email message from the law firm of McCarter & English, LLP is for the sole use of the intended
`rccipient(s) and may contain confidential and privileged information. Any unauthorized review, use, disclosure
`or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply email and
`destroy all copies of the original message.
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNlTED THERAPEUTICS, IPR201T-01622
`Page 1 of 32
`
`

`

`William J. O’Shaughnessy
`MCCARTER & ENGLISH LLP
`
`Four Gateway Center
`100 Mulberry Street
`Newark, NJ 07102
`
`(978) 639-2094
`woshaughnessy@mccarter.com
`
`OF COUNSEL:
`
`Douglas Carsten
`WILSON SONSINI GOODRICH & ROSATI
`
`12235 El Camino Real
`
`Suite 200
`
`San Diego, CA 92130
`
`William C. Jackson
`
`BOIES, SCHILLER & FLEXNER LLP
`5301 Wisconsin Avenue, NW
`Washington, DC 20015
`
`Attorneys for Pfaintiff
`United Therapeutics Corporation
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF NEW JERSEY
`
`Civil Action No.: 3:15cv-05723-PGS-LHG
`
`DECLARATION OF
`
`WILLIAM J. O’SHAUGHNESSY
`
`)
`
`) ) ) ) ) ) ) ) ) ) )
`
`UNITED THERAPEUTICS CORPORATION
`
`Plaintiff,
`
`V.
`
`WATSON LABORATORIES, INC,
`
`Defendant.
`
`I, William J. O’Shaughnessy, of full age, hereby declare as follows:
`
`1.
`
`I am an attorney at the law firm of McCarter & English LLP for Plaintiff United
`
`Therapeutics Corporation (“Plaintiff”) in the above-captioned matter.
`
`I am familiar with the
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201?-D1622
`Page 2 of 32
`
`

`

`facts of this case and make this Declaration in support of Plaintiff" s Motion for Leave to File an
`
`Amended Complaint.
`
`2.
`
`Attached hereto as Exhibit A is a true and correct copy of Plaintiff’s proposed
`
`First Amended Complaint and Jury Demand.
`
`I declare that the foregoing statements made by me are true.
`
`I am aware that if any of the
`
`foregoing statements made by me are willingly false, 1 may be subject to punishment.
`
`Dated: June 17, 2016
`
`sf William .I. O’Shaughnessy
`William J. O’Shaughnessy
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNiTED THERAPEUTICS, IPR201?-D1622
`Page 3 of 32
`
`

`

`William J. O’Shaughnessy
`MCCARTER & ENGLISH LLP
`
`Four Gateway Center
`100 Mulberry Street
`Newark, NJ on 02
`
`(973) 639-2094
`woshaughnessy@mccarter.com
`
`OF COUNSEL:
`
`Douglas Carsten
`WILSON SONSINI GOODRICH & ROSATI
`
`12235 El Camino Real
`
`Suite 200
`
`San Diego, CA 92130
`
`William C. Jackson
`
`BOIES, SCHILLER & FLEXNER LLP
`5301 Wisconsin Avenue, NW
`Washington, DC 20015
`
`Allorneysfor Pfainfifl
`United Iherapeutics Corporation
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF NEW JERSEY
`
`UNITED THERAPEUTICS CORPORATION )
`
`)
`
`) I
`
`) Civil Action No: 3:15-cv-05?23 PGS-LHG
`
`NOTICE OF MOTION
`FOR LEAVE TO FILE
`AN AMENDED COMPLAINT
`
`Motion Date: July 18, 2016
`
`J I
`
`)
`)
`)
`
`) )
`
`Plaintiff,
`
`V.
`
`WATSON LABORATORIES, INC,
`
`Defendant.
`
`T0:
`
`Liza M. Walsh
`
`Tricia B. O’Reilly
`Joseph L, Linares
`Walsh Pizzi O’Reilly Falanga LLP
`One Newark Center, 1085 Raymond Boulevard, 6th Floor
`Newark, NJ 07102
`(973)757-1 100
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-D1622
`Page 4 of 32
`
`

`

`PLEASE TAKE NOTICE that on July 18, 2016, or as soon thereafter as counsel may be
`
`heard, the undersigned attorneys for Plaintiff United Therapeutics Corp. (“Plaintiff”) shall move
`
`before the United States District Court for the District of New Jersey, Clarkson S. Fisher
`
`Building & US. Courthouse, 402 East State Street, Trenton, New Jersey, for an Order granting
`
`Plaintiff" 5 Motion for Leave to File an Amended Complaint.
`
`PLEASE TAKE FURTHER NOTICE that in support of its Motion, Plaintifi" will rely on
`
`its Memorandum of Law and Declaration of William J. O’Shaughnessy (and the exhibit annexed
`
`thereto). A proposed form of Order is also enclosed; and
`
`PLEASE TAKE FURTHER NOTICE counsel for Defendant Watson laboratories Inc.
`
`does not oppose this Motion.
`
`Of Counsel
`
`Douglas Carsten
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real
`Suite 200
`San Diego, CA 92130
`_
`Veronlca S. Ascarrunz
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street, NW
`Suite 500
`
`Washington, DC 20006
`
`William C. Jackson
`
`BOIES, SCHILLER & FLEXNER LLP
`5301 Wisconsin Avenue, NW
`Washington, DC 20015
`
`Respectfully submitted,
`
`stilliam J_ O’Shaughnessy
`William J. O’Shaughnessy
`MCCARTER & ENGLISH LLP
`Four Gateway Center
`100 Mulberry Street
`Newark, NJ 07102
`(973) 639-2094
`woshaughnessy@mccarter. com
`
`Dated: June 17, 2016
`
`Attorneysfbr Plaintiff
`United mempentfcs Corporation
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNtTED THERAPEUTICS, IPR201T-D1622
`Page 5 of 32
`
`

`

`CERTIFICATE OF SERVICE
`
`I certify that on this day I caused to be served by the ECF system copies of the following
`
`documents in support of the within motion: (i) Notice of Motion; (ii) Memorandum of Law; (iii)
`
`Declaration of William J. O’Shaughnessy; and (iv) Proposed form of Order upon the following:
`
`Walsh Pizzi O’Reillyr Falanga LLP
`Liza M. Walsh
`
`Tricia B. O’Reilly
`Joseph L. Linares
`One Newark Center
`
`1085 Raymond Boulevard, 6th Floor
`Newark, NJ 07' 102
`
`(9'13) "157-1100
`
`OF COUNSEL:
`
`WINSTON STRAWN LLP
`
`Michael K. Nutter
`
`Kurt A, Mathas
`
`35 West Wacker Drive
`
`Chicago, Illinois 60601
`Tel: (312) 558-5600
`Fax: (312) 553—5300
`
`Dated: June 1?, 2016
`
`5/ William J. O’Shaughnessy
`William J. O’Shaughnessy
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201?-D1622
`Page 6 of 32
`
`

`

`William]. O’Shaughnessy
`MCCARTER & ENGLISH LLP
`
`Four Gateway Center
`100 Mulberry Street
`Newark, NJ 07102
`
`(973) 639-2094
`woshaughnessy@mccarter.corn
`
`OF COUNSEL:
`
`Douglas Carsten
`WILSON SONSINI GOODRICH & ROSATI
`
`12235 El Camino Real
`
`Suite 200
`
`San Diego, CA 92130
`
`William C. Jackson
`
`BOIES, SCHILLER & FLEXNER LLP
`5301 Wisconsin Avenue, NW
`Washington, DC 20015
`
`Attorneys for Pfaimiff
`Unifed Therapeutics Corporation
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF NEW JERSEY
`
`UNITED THERAPEUTICS CORPORATION )
`
`Plaintifi‘,
`
`V.
`
`WATSON LABORATORIES, INC,
`
`Defendant.
`
`V‘h—IH—lfi—lfi—lvfi—lvfi—i‘h—IN—f
`
`Civil Action No.: 3: l 5-cv-05723
`
`(PGS-LHG)
`
`PLAINTIFF UNITED THERAPEUTICS’ MEMORANDUM OF LAW IN SUPPORT OF
`ITS MOTION FOR LEAVE TO AMEND ITS COMPLAINT
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201?-01622
`Page 7 of 32
`
`

`

`TABLE OF CONTENTS
`
`INTRODUCTION ......................................................................................................................... 3
`
`STATEMENT OF FACTS ........................................................................................................... 3
`
`LEGAL ARGUMENT.................................................................................................................. 4
`
`CONCLUSION ............................................................................................................................. 6
`
`1
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNlTED THERAPEUTICS, IPR201?-01622
`Page 8 of 32
`
`

`

`TABLE OF AUTHORITIES
`
`CASES
`
`Page(S)
`
`Adams v. (1701;163:0361,
`739 F.2d 858 (3d Cir. 1984) ................................................................................................ 4
`
`Cornell & Co. v. ()ccupationai Safety & Heotth Review Comm ’n,
`573 F.2d 820 {3d Cir. 1928) ................................................................................................ 4
`
`Foman v. Davis,
`
`Hey! & Patterson Int’i, Inc. v. ED. Rich Hons. ofthe V.1., Inc,
`663 F.2d 419 (3d Cir. 1981) ........................................................................................... 4, 5
`
`Howze v. Jones & Laugniin Steei Corp,
`750 F.2d 1208 (3d Cir. 1984) ............................................................................................. 5
`
`Long v. Wilson,
`393 F.3d 390 {3d Cir.2004) 5
`
`Malta v. Rutgers,
`No. 08-2142 (FLW), 2009 WL 689738 (D.N.J. Mar. 11, 2009)
`
`4, 5
`
`Textron Fin. NJ, Inc. v. Herring Land Grp., LLC,
`No. 06-2585 (MLC), 2009 WL 690933 (D.N.J. Mar. 11, 2009) ...................................... 5
`
`United States v. Hougnam,
`364 US. 310 (1960) ............................................................................................................ 4
`
`OTHER AUTHORITIES
`
`Fed. R. Civ. P. 7(a) ........................................................................................................................ 4
`
`Fed. R. Civ. P. 15(a) .................................................................................................................. 3, 4
`
`2
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNiTED THERAPEUTICS, IPR201?-D1622
`Page 9 of 32
`
`

`

`INTRODUCTION
`
`Plaintiff United Therapeutics Corporation (“UTC”) respectfully submits this
`
`Memorandum of Law in Support of Its Motion for Leave to Amend Its Complaint pursuant to
`
`Paragraph 19 of the Scheduling Order and Federal Rule of Civil Procedure 15(a). Paragraph 19
`
`of the Court’s Scheduling Order provides that “[a]ny party may file a motion to amend pleadings
`
`or add parties by August 26, 2016.” [DE 35]. UTC’s proposed First Amended Complaint is
`
`annexed to the Declaration of William J. O’Shaughnessy as Exhibit A. Defendant Watson
`
`Laboratories, Inc. (“Watson”) does not oppose this motion.
`
`STATEMENT OF FACTS
`
`UTC commenced this action for patent infringement against Watson on July 22, 2015.
`
`[DE 1]. In its Complaint, UTC claimed that Watson’s submission of Abbreviated New Drug
`
`Application (“ANDA”) No. 208172 infringed United States Patent Nos. 6,521,212 (“the ’212
`
`patent”), 6,756,033 (“the ’033 patent”), and 8,497,393 (“the ”393 patent”) (collectively, the
`
`“original patents-in-suit”). The claims in the original patents-in-suit cover UTC ’5 TYVASO®
`
`(treprostinil) Inhalation Solution, 0.6 mg/ml and delivery system, an FDA-approved treatment
`
`for pulmonary arterial hypertension. Watson’s ANDA seeks approval to market a generic copy
`
`of the TYVASOEEG product (the “ANDA Product”) before the expiration of the original patents-in-
`
`suit. Watson filed its Answer on September 1, 2015, denying that its manufacturing, marketing,
`
`and sales of its ANDA Product w0u1d infringe UTC’s patents and asserting a counterclaim for a
`
`declaratory judgment of invalidity andfor noninfringement of the original patents in-suit. [DE
`
`10].
`
`After the litigation commenced, UTC learned that the United States Patent and
`
`Trademark Office (“US PTO”) granted two additional patents that cover UTC ’5 TYVASO!“
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNtTED THERAPEUTICS, IPR201T-D1622
`Page 10 of 32
`
`

`

`product and thereby implicate Watson’s ANDA Product. Specifically, UTC learned on May 17,
`
`2016 that the USPTO issued US. Patent No. 9,339,507 (“the ’50? patent”) and that subsequently
`
`the FDA listed the ’50? patent in the FDA’s Approved Drug Products with Therapeutic
`
`Equivalents publication (also known as the “Orange Book”). Thereafter, UTC learned on June 7,
`
`2016 that the USPTO had issued an additional patent, U.S. Patent No. 9,358,240 (“the ’240
`
`patent”), and that subsequently the FDA listed the ’240 patent in the Orange Book.l Similar to
`
`the original patents-in—suit, Watson’s submission of ANDA No. 20817? is an act of infringement
`
`with respect to UTC’s “507 patent and ’240 patent.
`
`LEGAL ARGUMENT
`
`When reviewing a motion to amend a party’s pleading, “[t]he Court should freely give
`
`leave when justice so requires.” Fed. R. Civ. P. 15(a); see also Fed. R. Civ. P. 7(a) (defining
`
`“pleading” to include a complaint). Leave to amend is granted liberally. Heyl (Q Patterson lnt’l,
`
`Inc. v. F. D. Riel? Hons. of V. 1., Inc, 663 F.2d 419, 425 (3d Cir. 1981); see also Malta v.
`
`Rutgers, No. 08-2142 (FLW), 2009 WL 68973 8, at *2 (D.N.J. Mar, 1 1, 2009) (“Courts have a
`
`liberal tendency in granting leave to amend .
`
`. .”) (citing United States v. Honglram, 364 US.
`
`310, 317 (1960)). A court’s discretion to deny leave to amend is limited. See Heyl & Patterson,
`
`663 F.2d at 425; see also Adams v. Gould Inc, 739 F.2d 858, 864 (3d Cir. 1984) (“This liberal
`
`amendment philosophy [of the federal rules] limits the district court’s discretion to deny leave to
`
`amend”). Undue prejudice to the non-movin g party is “the touchstone for the denial of leave to
`
`amend.” Heylr & Patterson, 663 F.2d at 425 (quoting Cornell & (To. v. Occupational Safety &
`
`Health Review (‘omm ’n, 573 F.2d 820, 823 (3d Cir. I9'l8)). “To establish prejudice, the non-
`
`moving party must make a showing that allowing the amended pleading would (1) require the
`
`1http:llwww.accessdata.fda.govlscriptslcderlobldocslpatexclnew.cfm?AppI_No=022387r'&Produc
`t_No=001&tablel=OB_Rx.
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNlTED THERAPEUTICS, |PR201?-D1622
`Page 11 of 32
`
`

`

`nonmoving party to expend significant additional resources to conduct discovery and prepare for
`
`trial, (2) significantly delay the resolution of the dispute, or (3) prevent a party from bringing a
`
`timely action in another jurisdiction.” iexiron Fin. N.J., Inc. v. Herring Land Gnu, LLC, No.
`
`06-2585 (MLC), 2009 WL 690933, at *4 (D.N.J. Mar. 1 1, 2009) (citing Long v. Wilson, 393
`
`F.3d 390, 400 (3d Cir. 2004)).
`
`In the absence of “undue prejudice,” denial of leave to amend “must be grounded in bad
`
`faith or dilatory motives, truly undue or unexplained delay, repeated failure to cure deficiency by
`
`amendments previously allowed or futility of amendment.” Hey! & Patterson, 663 F.2d at 425
`
`(citing Foman v. Davis, 371 U.S. 178, 182 (1962)); see aiso Mnha, 2009 WL 689738, at *2
`
`(holding that, without such grounds, “the leave sought should, as the rules require[], be freely
`
`given”) (citation omitted). Although UTC is promptly moving to amend after the new patents
`
`were listed in the Orange Book, delay alone would not have justified denying its motion to
`
`amend. Unless delay becomes “undue,” placing an unwarranted burden on the court, or
`
`“prejudicial,” placing an unfair burden on the opposing party, denial of a motion to amend is
`
`inappropriate. Mirna, 2009 WL 689738, at *2 (citing Foman, 371 US. at 182.); see aisa Hawse
`
`v. Jones & Langhiin Steel Corp, 750 F.2d 1208, 1212 (3d Cir. 1984) (“Delay alone .
`
`.
`
`. is an
`
`insufficient ground upon which to deny a motion to amend”) (citation omitted).
`
`UTC’s two new patents cover its TYVASO® inhalable treprostinil product as well as the
`
`Watson ANDA Product at issue in this case. Accordingly, the ongoing discovery in this case
`
`will be directly relevant to the ’50? patent and the ’240 patent. Amending the pleadings at this
`
`stage, where the parties still have the opportunity to conduct fact and expert discovery on the
`
`TYVASC‘i0 system, will allow the parties to argue, and the Court to consider, validity and
`
`infringement in the context of all the relevant technology and asserted claims. Such an approach
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNtTED THERAPEUTICS, IPR2017-01622
`Page 12 of 32
`
`

`

`will require Watson, as well as UTC and the Court, to expend significantly less resources than
`
`conducing separate discovery and preparing for an additional trial if the Motion to Amend is
`
`denied and UTC is required to file a separate action addressing the ’507 patent and ’240 patent.
`
`Because trial is not set to commence until September 12, 2017, amending the Complaint at this
`
`stage will not significantly delay resolution of the dispute. Finally, since UTC promptly raised
`
`the additional patents with Watson and the Court, and the USPTO only issued the ’50? patent
`
`and the ’240 patent less than four weeks ago, UTC has not delayed in amending its Complaint
`
`and clearly has not acted in bad faith or with dilatory motives.
`
`In view of the express language in the Scheduling Order setting a schedule for a motion
`
`such as this, the First Amended Complaint will not cause any undue prejudice to Watson.
`
`Pursuant to Paragraph 19, the Scheduling Order specifically contemplated amendments to the
`
`pleadings before August 26, 2016. Trial is not set to commence for nearly fourteen more months
`
`and the deadline for filing dispositive motions is April 21, 201?, £26., more than ten months from
`
`today. Fact discovery is to remain open until November 30, 2016 and expert discovery is to
`
`remain open until March 31, 2017. As discussed, the amendment UTC seeks will not cause any
`
`undue duplication or delay as it relates to discovery whereas filing a new action, conducting
`
`separate discovery and conducting a separate trial would unnecessarily expend additional judicial
`
`resources and the resources of the parties-
`
`CONCLUSION
`
`For the foregoing reasons, UTC respectfully requests that the Court grant its motion for
`
`leave to file the proposed First Amended Complaint attached as Exhibit A to the Declaration of
`
`William J. O’Shaughnessy.
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNlTED THERAPEUTICS, IPR201?-D1622
`Page 13 of 32
`
`

`

`Respectfully submitted,
`
`Qf'CounseI'
`Douglas Carsten
`WILSON SONS [NI GOODRICH & ROSATI
`
`stilliam J. O’Shaughnessy
`William J. O’Shaughnessy
`McCARTER & ENGLISH LLP
`
`Four Gateway Center
`100 Mulberry Street
`Newark, NJ 07102
`
`(913) 639-2094
`woshaughnessy@mccarter,com
`
`12235 El Camino Real
`Suite 200
`San Diego, CA 92130
`
`Veronica S. Ascarrunz
`WILSON SONSINI GOODRICH & ROSATI
`
`1700 K Street, NW
`Suite 500
`
`Washington, DC 20006
`
`William C. Jackson
`
`BOTES, SCHILLER & FLEXNER LLP
`
`5301 Wisconsin Avenue, NW
`
`Washington, DC 20015
`
`Dated: June 17, 2016
`
`Afforneysfor Plaimfff
`United Therapemics Corporarfon
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNlTED THERAPEUTICS, |PR201?-D1622
`Page 14 of 32
`
`

`

`EXHIBIT A
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR201?-01622
`Page 15 of 32
`
`

`

`William J. O‘Shaughnessy
`MCCARTER & ENGLISH LLP
`
`Four Gateway Center
`100 Mulberry Street
`Newark, NJ 07102
`
`(973) 639-2094
`woshaughnessy@mccarter_com
`
`OF COUNSEL:
`
`Douglas Carsten
`WILSON SONSINI GOODRICH & ROSATI
`
`12235 El Camino Real
`Suite 200
`
`San Diego, CA 92130
`
`William C. Jackson
`
`BOIES, SCHILLER & FLEXNER LLP
`
`5301 Wisconsin Avenue, NW
`
`Washington, DC 20015
`
`Attorneys for Piat'nri'ff
`United Ihempeutios Corporation
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF NEW JERSEY
`
`Civil Action No.: 3:150V-05723-PGS-LHG
`
`)
`
`) ) ) ) i
`
`) ) )
`
`UNITED THERAPEUTICS CORPORATION
`
`Plaintiff,
`
`V.
`
`WATSON LABORATORIES, INC,
`
`Defendant.
`
`FIRST AMENDED COMPLAINT AND JURY DEMAND
`
`Plaintiff United Therapeutics Corporation (“UTC”), by its undersigned attorneys, for its
`
`First Amended Complaint against Watson Laboratories, Inc. (“Watson”), alleges as follows:
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNtTED THERAPEUTICS, IPR201T-D1622
`Page 16 of 32
`
`

`

`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement arising under the patent laws of the
`
`United States, Title 35, United States Code, Sections 100 et seq, involving United States Patent
`
`Nos. 6,521,212 (“the ’212 patent”) (attached as Exhibit A hereto), 6,756,033 (“the ’033 patent")
`
`(attached as Exhibit B hereto), 8,497 ,3 93 (“the ’393 patent”) (attached as Exhibit C hereto),
`
`9,339,507 (“the ’50? patent”) (attached as Exhibit D hereto), and 9,358,240 (“the ’240 patent”)
`
`(attached as Exhibit E hereto).
`
`2.
`
`This action arises out of Watson’s submission of Abbreviated New Drug
`
`Application (“ANDA”) No. 208172 to the United States Food and Drug Administration (“FDA”)
`
`seeking approval, prior to the expiration of the ’212, ’393, ’033,
`
`’507, and ”240 patents, to
`
`manufacture, market, and sell a generic copy of UTC’s TYVASO® (treprostinil) Inhalation
`
`Solution, 0.6 mg/ml that is approved by FDA for treatment of pulmonary arterial hypertension.
`
`THE PARTIES
`
`3.
`
`UTC is a corporation organized and existing under the laws of the State of
`
`Delaware, and having a place of business at 1040 Spring Street, Silver Spring, Maryland 20910.
`
`UTC is a biotechnology company focused on the development and commercialization of
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`products designed to address the needs of patients with chronic and life-threatening conditions.
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`4.
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`Upon information and belief, Watson is a corporation organized and existing
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`under the laws of the State of California and has a principal place of business at Morris
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`Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054.
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`JURISDICTION AND VENUE
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`5.
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`This Court has jurisdiction over the subject matter of this action pursuant to the
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`provisions of28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNtTED THERAPEUTICS, IPR201?-01622
`Page 17 of 32
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`6.
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`7.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
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`Upon information and belief, this Court has personal jurisdiction over Watson
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`with respect to this Complaint because, inter alia, of its continuous and systematic contacts with
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`this judicial district. The notice letter was sent from Watson at Morris Corporate Center III, 400
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`Interpace Parkway, Parsippany, New Jersey, NJ 07054. Upon information and belief, Watson
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`derives substantial revenue from articles used and consumed in this judicial district, and
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`consistent with its practice with respect to other generic products, following any FDA approval
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`of Watson‘s ANDA, Watson will sell its generic product throughout the United States, including
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`in New Jersey. Upon information and belief, Watson is registered to conduct business in the
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`State of New Jersey and employs people throughout New Jersey, including at least the following
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`locations: Morris Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054;
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`100 Enterprise Drive, Rockaway, New Jersey 07866; and 350 Mt. Kemble Avenue, Morristown,
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`New Jersey W960. In addition, Watson has previously availed itself of this Court as a forum in
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`which to bring patent litigation again st others.
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`BACKGROUND
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`8.
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`UTC holds an approved New Drug Application (No. 22—387) for TYVASO®
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`(treprostinil) Inhalation Solution, 0.6 mgfml, which UTC markets and sells under the registered
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`trademark TYVASO®.
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`9.
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`TYVASO® is a pharmaceutical product initially approved by FDA in the United
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`States in July 2009, and is indicated for the treatment of pulmonary arterial hypertension.
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`Pulmonary arterial hypertension is a rare disease affecting the pulmonary vasculature and results
`
`in high pressure in the pulmonary arteries, which increases strain on the right ventricle of the
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`heart, thereby leading to heart failure and death.
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`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNtTED THERAPEUTICS, IPR201?-D1622
`Page 18 of 32
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`10,
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`TYVASO'E is an inhalable product approved for sale in a 0.6 mgme
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`concentration.
`
`1 1.
`
`The ’2 l 2 patent, entitled “Method for treating peripheral vascular disease by
`
`administering benzindene prostaglandins by inhalation” was duly and legally issued by the
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`United States Patent and Trademark Office on February 18, 2003, The named inventors are
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`Gilles Cloutier, James Crow, Michael Wade, Richard B. Parker, and James E. Loyd.
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`12.
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`UTC is the lawfill owner ofthe ”212 patent by assignment of all right, title, and
`
`interest in and to the ’2 12 patent, including the right to bring infringement suits thereon.
`
`13.
`
`The “393 patent, entitled “Process to Prepare Treprostinil, the Active Ingredient in
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`Remodulin®,” was duly and legally issued by the United States Patent and Trademark Office on
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`July 30, 2014. The named inventors are Hitesh Batra, Sudersan M. Tuladhar, Raju Penmasta,
`
`and David A. Walsh.
`
`14.
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`UTC is the lawfitl owner ofthe ”393 patent by assignment of all right, title, and
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`interest in and to the ”393 patent, including the right to bring infringement suits thereon.
`
`15,
`
`The ’033 patent, entitled “Method for delivering benzindene prostaglandins by
`
`inhalation," was duly and legally issued by the United States Patent and Trademark Office on
`
`June 29, 2004. The named inventors are Gilles Cloutier, James Crow, Michael Wade, Richard B.
`
`Parker, and James E. Loyd.
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`16,
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`UTC is the lawful owner of the ’033 patent by assignment of all right, title, and
`
`interest in and to the ’033 patent, including the right to bring infringement suits thereon.
`
`17,
`
`The ‘507 patent, entitled “Treprostinil administration by inhalation," was duly and
`
`legally issued by the United States Patent and Trademark Office on May 17’, 2016. The named
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNlTED THERAPEUTICS, IPR201?-D1622
`Page 19 of 32
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`inventors are Horst Olschewski, Robert Roscingo, Lewis Rubin, Thomas Schmehl, Werner
`
`Seeger, Carl Sterritt, and Robert Voswinckel.
`
`18.
`
`UTC is the lawful owner of the ’50? patent by assignment of all right, title, and
`
`interest in and to the ’507 patent, including the right to bring infringement suits thereon.
`
`19.
`
`The ’240 patent, entitled “Treprostinil administration by inhalation,” was duly and
`
`legally issued by the United States Patent and Trademark Office on June 7, 2016. The named
`
`inventors are Horst Olschewski, Robert Roscingo, Lewis Rubin, Thomas Schrnehl, Werner
`
`Seeger, Carl Sterritt, and Robert Voswinckel.
`
`20.
`
`UTC is the lawful owner of the ’240 patent by assignment of all right, title, and
`
`interest in the ‘240 patent, including the right to bring infringement suits thereon.
`
`21.
`
`TYVASO® and its FDA approved manufacture and uses are covered by one or
`
`more claims ofthe ’2 12, ’033, ’393, ’507, and ’240 patents, which have all been listed in
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`connection with TYVASO® in the FDA’s Approved Dmg Product‘s with Therapeutic
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`Equivaiems publication (also known as the “Orange Book”).
`
`ACTS GIVING RISE TO THIS ACTION
`
`22.
`
`Watson notified UTC by letter dated June 12, 2015, which was delivered to UTC
`
`on or about, Saturday, June 13, 2015 (“Watson’s Notice Letter”), that it had filed ANDA No.
`
`208172 with the FDA seeking approval to commercially manufacture, market, use, and sell
`
`generic copies of TYVASOQ” (treprostinil) Inhalation Solution, 0.6 mgme (“Watson’s ANDA
`
`Products”) prior to the expiration of the ’212, ’033, and ’393 patents.
`
`23.
`
`Watson’s Notice Letter included a statement pursuant to 21 U.S.C. §
`
`3550)(2)(vii)(1V) purporting to recite Watson’s “factual and legal basis” for its opinion that the
`
`’2 12, ”033, and ”393 patents are not valid, are unenforceable, andx’or would not be infringed by
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNtTED THERAPEUTICS, IPR201?-D1622
`Page 20 of 32
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`the commercial manufacture, use, or sale of Watson’s ANDA Products. Yet that statement did
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`not include any explanation as to why claims 1-5 and 9-12 of the ’212 patent, claims 4 and 6-10
`
`of the ’033 patent, and any claim of the ’393 patent were invalid. The statement also did not
`
`include anything beyond conclusory statements as to why claims 6-8 of the ’2 12 patent and
`
`claims 1-3 and 5 of the ’033 patent were invalid. The statement also did not include anything
`
`beyond conclusory statements regarding alleged non-infringement. Watson provided no
`
`explanation as to the alleged unenforceability.
`
`24,
`
`Upon information and belief, Watson submitted ANDA No. 208172 with FDA
`
`seeking approval to commercially manufacture, market, use, and sell generic copies of
`
`TYVASO® (treprostinil) Inhalation Solution, 0.6 mgme (“Watson’s AN DA Products”) prior to
`
`the expiration of the ’2 12, ’033, 393,507, and ’240 patents.
`
`25.
`
`UTC commenced this action before the expiration of forty-five days from the date
`
`UTC received Watson’s Notice Letter.
`
`26,
`
`Upon information and belief, Watson’s ANDA Products contains the same active
`
`compound as UTC’S approved TYVASO® product.
`
`27".
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`Upon information and belief, Watson’s ANDA No. 208172 seeks approval from
`
`the FDA to market Watson’s AN DA Products for the same indication as UTC ’5 approved
`
`TYVASO® product.
`
`28,
`
`Upon information and belief, Watson represented to FDA in ANDA No. 208172
`
`that Watson’s ANDA Products is bioequivalent to UTC’s approved TYVASO® product.
`
`29,
`
`Upon information and belief, Watson intends to commercially manufacture, sell,
`
`offer for sale, andx’or import Watson’s ANDA Products upon, or in anticipation of, FDA
`
`approval.
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNtTED THERAPEUTICS, IPR201?-D1622
`Page 21 of 32
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`30.
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`According to Watson’s Notice Letter, Watson’s ANDA No. 208172 contained a
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`“Paragraph IV” certification pursuant to 21 U.S.C. § 35 5(j )(2)(vii)(IV) stating that in Watson’s
`
`opinion the ’212, ’033, and ’393 patents are invalid, unenforceable, andx'or would not be
`
`infiinged by the manufacture, use or sale of Watson’s ANDA Products.
`
`31.
`
`Upon information and belief, as of the date of Watson’s Notice Letter, Watson
`
`was aware of the statutory provisions and regulations set forth in 21 U.S.C. §§
`
`3550)(2)(B)(iv)(ll) and 21 C.F.R. § 314.95(c)(6).
`
`32,
`
`Upon information and belief, the acts of infringement by Watson have been
`
`intentional and willful.
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`COUNT 1 INFRINGEMENT OF THE ’212 PATENT UNDER 35 U.S.C. § 2711c!
`
`33.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`34,
`
`Upon information and belief, Watson’s AN DA Products or an intermediate in its
`
`manufacture is covered by one or more claims of the ’212 patent.
`
`35, Watson had knowledge of the ’2 l 2 patent when it submitted ANDA No. 208172,
`
`36. Watson’s submission of ANDA No. 208172 for the purpose of obtaining approval
`
`to engage in the commercial manufacture, use, sale, andfor offer for sale of Watson’s ANDA
`
`Products was an act ofinfringement of the ’2 12 patent under 35 U.S.C. § 271(c)(2).
`
`37,
`
`Upon information and belief, the commercial manufacture, use, offer for sale, sale
`
`andx’or importation of Watson’s ANDA Products w0uld infringe one or more claims of the ’212
`
`patent.
`
`UNITED THERAPEUTICS, EX. 2010
`WATSON LABORATORIES V. UNlTED THERAPEUTICS, IPR201?-D1622
`Page 22 of 32
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`38.
`
`Upon information and belief, Watson was and is aware of the existence of the
`
`’2 12 patent and acted without a reasonable basis for believing that it would not be liable for
`
`infringement of the ’212 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
`
`39.
`
`UTC will be substantially and irreparably damaged and harmed if Watson’s
`
`infringement of the ’2 12 patent is not enjoined by this Court. UTC does not have an adequate
`
`remedy at law.
`
`40.
`
`Upon information and belief, the acts of infringement by Watson have been
`
`intentional and willful.
`
`
`
`COUNT 2: INFRINGEMENT OF THE ’393 PATENT UNDER 35 U.S.C. 271 e
`
`41 .
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`herein.
`
`42.
`
`Upon information and belief, Watson’s ANDA Products or an intermediate in its
`
`manufacture is covered by one or more claims of the ’393 patent.
`
`43. Watson had knowledge of the ’393 patent when it submitted ANDA No. 208172.
`
`44. Watson’s submission of ANDA No. 208172 for the purpose of obtaining approval
`
`to engage in the commercial manufacture, use, sale, andfor offer for sale of Watson’s ANDA
`
`Products was an act ofinfringement of the ’393 patent under 35 U.S.C. § 27" l (e)(2).
`
`45.
`
`Upon information and belief, the commercial manufacture, use, offer for sale, sale
`
`andr’or importation of Watson’s ANDA Products w0uld infringe one or more claims of the ’3 93
`
`patent.
`
`46.
`
`Upon information and belief, Watson was and is aware of the existence of the
`
`”393 patent and acted without a reasonable basis for believing that it would not be liable for
`
`infringement of the ”393 patent, thus rendering this case “exceptional” under 35 U.S.C. §