Case 3:15-cv-05723-PGS-LHG Document 46-1 Filed 06I17116 Page 1 of 8 PageID: 362
`
`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
`
`Attorneysfw Plaintiff
`United Therapenncs Corporation
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`UNITED THERAPEUTICS CORPORATION )
`
`Plaintifl‘,
`
`V.
`
`WATSON LABORATORIES, INC,
`
`Defendant.
`
`vvvvvvwvvwv
`
`Civil Action No: 3: 1 S-cv-05723
`
`(PGS-LHG)
`
`PLAINTIFF UNITED THERAPEUTICS’ MEMORANDUM OF LAW IN SUPPORT OF
`
`ITS MOTION FOR LEAVE TO AMEND ITS COMPLAINT
`
`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR201?-01622
`Page 1 of 31
`
`

`

`Case 3:15-cv-05723-PGS-LHG Document 46-1 Filed OfiflelEi Page 2 of 8 PagelD: 363
`
`TABLE OF CONTENTS
`
`INTRODUCTION ......................................................................................................................... 3
`
`STATEMENT OF FACTS ........................................................................................................... 3
`
`LEGAL ARGUMENT .................................................................................................................. 4
`
`CONCLUSION ............................................................................................................................. 6
`
`1
`
`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNiTED THERAPEUTICS, IPR201T-D1622
`Page 2 of 31
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`

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`Case 3:15-cv-05723-PGS-LHG Document 46-1 Filed 06i17i16 Page 3 of 8 PagelD: 364
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Page(8)
`
`Adams v. (ionic! Inc,
`739 F.2d 858 (3d Cir. 1984) ................................................................................................ 4
`
`(“orneii (Er Co. v. Occiipaiionai Safety & Heaiih Review Comm 'n,
`5?3 F.2d l820 (3d Cir.1978) 4
`
`Fenian v. Davis,
`3?1 US. 178 (1962) ............................................................................................................ 5
`
`Hey! & Patterson int'i, Inc. v. iii). Rich Hans. afine Vi, Inc,
`663 F.2d 419 (3d Cir. 1981) ........................................................................................... 4, 5
`
`Howze v. Jones & Langhiin Sreez' Corp,
`750 F.2d 1208 (3d Cir. 1984)
`
`5
`
`Long v. Wilson,
`393 F.3d 390 (3d Cir. 2004) ............................................................................................... 5
`
`Muha v. Rutgers,
`No. 08-2142 (FLW), 2009 WL 689738 (DNJ, 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.
`
`1 1, 2009) ...................................... 5
`
`United States v. Haagham,
`364 US. 310 (1960) ............................................................................................................ 4
`
`OTHER AUTHORITIES
`
`Fed. R. Civ. P. 2(a)
`
`Fed. R. Civ. P. 15(3)
`
`4
`
`3, 4
`
`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR2017-D1622
`Page 3 of 31
`
`

`

`Case 3:15-cv-05723-PGS-LHG Document 46-1 Filed 06!17116 Page 4 of 8 PagelD: 365
`
`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 8,49?,393 (“the ”393 patent”) (collectively, the
`
`“original patcnts-in-suit”). The claims in the original patcnts-in-suit cover UTC’s 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 TYVASO® 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 AN DA Product would infringe UTC’s patents and asserting a counterclaim for a
`
`declaratory judgment of invalidity andfor noninfringcmcnt of the original patents in-suit. [DE
`
`10].
`
`After the litigation commenced, UTC learned that the United States Patent and
`
`Trademark Office (“USPTO”) granted two additional patents that cover UTC’s T‘YVASO“J
`
`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNiTED THERAPEUTICS, IPR201?-D1622
`Page 4 of 31
`
`

`

`Case 3:15-cv-05723-PGS-LHG Document 46-1 Filed 06l17l16 Page 5 of 8 PagelD: 366
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`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 ’507 patent”) and that subsequently
`
`the FDA listed the ’507 patent in the FDA’s Approved Drug Products with Therapeutic
`
`Equivalents publication (also known as the “Orange Book”). Thereafier, UTC learned on June 7,
`
`2016 that the USPTO had issued an additional patent, US. Patent No. 9,358,240 (“the ’240
`
`patent”), and that subsequently the FDA listed the ’240 patent in the Orange Book.1 Similar to
`
`the original patents-in-suit, Watson’s submission of ANDA No. 208172 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 & Patterson [nr’l,
`
`Inc. v. F. D. Rich Hons. ofV. l., Inc, 663 F.2d 419, 425 (3d Cir. 1981); see also Mano v.
`
`Rutgers, No. 08-2142 (FLW), 2009 WL 689738, at *2 (D.N.J. Mar. 11, 2009) (“Courts have a
`
`liberal tendency in granting leave to amend .
`
`. .”) (citing UnlredStates v. Hongham, 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-moving party is “the touchstone for the denial of leave to
`
`amend.” Heyl & Patterson, 663 F.2d at 425 (quoting Cornell & Co. v. Occupational Safety &
`
`Health Review Comm ’n, 573 F.2d 820, 823 (3d Cir. 1978)). “To establish prejudice, the non-
`
`moving party must make a showing that allowing the amended pleading would (1) require the
`
`
`lhttp:llwww.accessdata.fda.gow’scriptslcderlobldocslpatexclncw.cfrri'?731ppl_l\lo=022387&Produc
`t_No=001&table1=OB_Rx.
`
`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNlTED THERAPEUTICS, |PR2017-01622
`Page 5 of 31
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`

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`Case 3:15-cv-05723-PGS-LHG Document 46-1 Filed 06!17i16 Page 6 of 8 PagelD: 367
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`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.” Textron Fin. N.J., Inc. v. Herring Land (fro, LLC, No.
`
`06-2585 (MLC), 2009 WL 690933, at *4 (D,N.J. Mar.
`
`1 l, 2009) (citing Long v. Wiison, 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 Fenian v. Davis, 311 US. 178, 182 (1962)); see also Mirna, 2009 WL 689238, 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 Fomnn, 371 US. at 182.); see aiso Howze
`
`v. Jones (Er Laughiin 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 trcprostinil product as well as the
`
`Watson AN DA 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
`
`T‘r’VASO® 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. 2009
`WATSON LABORATORIES V. UNlTED THERAPEUTICS, IPR2017-D1622
`Page 6 of 31
`
`

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`Case 3:15-cv-05723-PGS-LHG Document 46-1 Filed 06,117,116 Page 7 of 8 PagelD: 368
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`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, 201?, 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 dispositivc 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. 2009
`WATSON LABORATORIES V. UNlTED THERAPEUTICS, IPR201?-D1622
`Page 7 of 31
`
`

`

`Case 3:15-cv-05723-PGS-LHG Document 46-1 Filed 06i17l16 Page 8 of 8 PagelD: 369
`
`Respectfully submitted,
`
`Of Counsei
`Douglas Carsten
`WILSON SONSINI GOODRICH & ROSATI
`
`
`siWilliam .1. O’Shaughnessx
`William J . O’Shaughnessy
`McCARTER & ENGLISH LLP
`
`12235 El Camino Real
`Suite 200
`San Diego, CA 92130
`
`Four Gateway Center
`100 Mulberry Street
`Newark, NJ 02102
`(973) 639-2094
`
`Veronica S. Asearrunz
`WILSON SONSINI GOODRICH & ROSATI
`
`woshaughnessy@meearter.eom
`
`1700 K Street, NW
`Suite 500
`
`Washington, DC 20006
`
`William C. Jackson
`
`BOIES, SCHILLER & FLEXNER LLP
`5301 Wisconsin Avenue, NW
`Washington, DC 20015
`
`Dated: June 1?, 2016
`
`Atromeysfor Plainiifi
`United Therapeutics Corporation
`
`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNiTED THERAPEUTICS, |PR201?-D1622
`Page 8 of 31
`
`

`

`Case 3:15-ev-05723-PGS-LHG Document 46 Filed 06717716 Page 1 of 3 PagelD: 359
`
`William J. O’Shaughnessy
`MeCARTER & ENGLISH LLP
`
`Four Gateway Center
`100 Mulberry Street
`Newark, NJ 07102
`(973) 639-2094
`
`woshaughnessy@meearter.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
`
`A itorneys for 1")".t1rim‘ifir
`United Therapeutics Corporation
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`UNITED THERAPEUTICS CORPORATION)
`)
`
`) )
`
`) Civil Action No: 3:15-ev-05723 PGS—LHG
`
`Plaintiff,
`
`v.
`
`NOTICE OF MOTION
`FOR LEAVE TO FILE
`AN AMENDED COMPLAINT
`
`Motion Date: July 18, 2016
`
`) )
`
`)
`)
`)
`
`) )
`
`WATSON LABORATORIES, INC .,
`
`Defendant.
`
`TO:
`
`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) 757-1100
`
`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNiTED THERAPEUTICS, IPR2017-D1622
`Page 9 of 31
`
`

`

`Case 3:15-cv-05723-PGS-LHG Document 48 Filed 06(171'16 Page 2 of 3 PageID: 360
`
`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 movc
`
`before the United States District Court for the District of New Jersey, Clarkson S. Fisher
`
`Building & U.S. Courthouse, 402 East State Street, Trenton, New Jersey, for an Order granting
`
`Plaintiff‘s Motion for Leave to File an Amended Complaint.
`
`PLEASE TAKE FURTHER NOTICE that in support ofits Motion, Plaintiffwill 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.
`
`0f (bonsai
`
`Douglas Carsten
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real
`Suite 200
`San DICEO, CA 92130
`_
`Veromca S. Ascarrunz
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street, NW
`Suite 500
`
`Washington, DC 20006
`
`William C. Jackson
`
`BOIES, SCHILLER & FLEXNER LLP
`530] Wisconsin Avenue, NW
`
`Washington, DC 20015
`
`Respectfully submitted,
`
`siWilliam J_ O’Shaughnessy
`William J. O’Shaughnessy
`MCCARTER & ENGLISH LLP
`Four Gateway Center
`100 Mulberry Street
`Newark, NJ 07102
`(973) 639-2094
`woshaughnessy@mccarter.eom
`
`Dated: June 1?, 2016
`
`Attorneysfiw Piaimifi‘
`United Therapeutics (.Torpomiion
`
`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-D1622
`Page 10 of 31
`
`

`

`Case 3:15-cv-05723-PGS-LHG Document 46 Filed 06117116 Page 3 of 3 PagelD: 361
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`CERTIFICATE OF SERVICE
`
`I certify that on this day 1 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’Reilly Falanga LLP
`Liza M. Walsh
`
`Tricia B. O’Reilly
`Joseph L. Linares
`Onc Newark Center
`
`1085 Raymond Boulevard, 6th Floor
`Newark, NJ 07102
`(973) 757-1100
`
`OF COUNSEL:
`
`WINSTON STRAWN LLP
`Michael K. Nutter
`Kurt A. Mathas
`35 West Wacker Drive
`
`Chicago, Illinois 60601
`Tel: (312) 558-5600
`Fax: (312) 558-5?00
`
`Dated: June 17", 2016
`
`
`3/ William J. O’Shaughnessy
`William J. O’Shaughnessy
`
`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201?-D1622
`Page 11 of 31
`
`

`

`Case 3:15-CV-05723-PGS-LHG Document 46-2 Filed 06f17f16 Page 1 of 2 PagelD: 370
`
`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 fl)?” Plaintiff
`United Therapeutics (.Torpomiion
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`Civil Action No.: 3:15cv-05723-PGS-LI-IG
`
`DECLARATION OF
`WILLIAM J. O’SHAUGHNESSY
`
`)
`
`) l ) ) ) ) ) ) ) ) )
`
`UNITED THERAPEUTICS CORPORATION
`
`Plaintiff,
`
`V.
`
`WATSON LABORATORIES, INC,
`
`Defendant.
`
`I, William J. O’Shaughncssy, 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. 2009
`WATSON LABORATORIES V. UNiTED THERAPEUTICS, IPR201?-D1622
`Page 12 of 31
`
`

`

`Case 3:15-cv-05723-PGS-LHG Document 46-2 Filed 06/17flfi Page 2 of 2 PagelD: 371
`
`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, I may be subject to punishment.
`
`Dated: June 17, 2016
`
`sf William J. O’Shaughnessy
`William J. O’Shaughnessy
`
`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201?-D1622
`Page 13 of 31
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`

`

`Case 3:15-ev-05723-PGS-LHG Document 46-4 Filed 06l17l16 Page 1 of 1 PagelD: 389
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF NEW JERSEY
`
`UNITED THERAPEUTICS CORPORATION )
`
`Plaintiff,
`
`v.
`
`WATSON LABORATORIES, INC,
`
`Defendant.
`
`wvwvvvvwvwv
`
`Civil Action No: 3:15-CV-05723 PGS-LHG
`
`[PROPOSED] ORDER
`
`This matter having been opened to the Court by McCarter & English LLP, attorneys for
`
`Plaintiff United Therapeutics Corporation (“Plaintiff”),
`
`for leave to file a First Amended
`
`Complaint and the Court having considered any opposition thereto, and for good cause shown;
`
`IT IS on this _ day of
`
`, 2016,
`
`ORDERED that Plaintiff’s Motion for Leave to File an Amended Complaint is hereby
`
`GRANTED; and it is further
`
`ORDERED that, within 14 days from the date hereof, Plaintiff shall file its First
`
`Amended Complaint and Jury Demand in the form attached as Exhibit A to the Declaration of
`
`William J. O’Shaughnessy, dated June 17, 2016.
`
`
`
`Hon. Lois H. Goodman
`
`United States Magistrate Judge
`
`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNlTED THERAPEUTICS, IPR201?-D1622
`Page 14 of 31
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`

`

`Case 3:15-cv-05723-PGS-LHG Document 46-3 Filed 06117I16 Page 1 of 17 PageID: 372
`
`EXHIBIT A
`
`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01622
`Page 15 of 31
`
`

`

`Case 3:15-CV-05723-PGS-LHG Document 46-3 Filed 06117116 Page 2 of 17 PagelD: 373
`
`William J. O’Shaughnessy
`McCARTER & ENGLISH LLP
`
`Four Gateway Center
`100 Mulberry Street
`Newark, NJ 0?]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
`
`A Homeys for Plaintifi"
`United Therapeutics Corporation
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`UNITED THERAPEUTICS CORPORATION)
`
`Plaintiff,
`
`v.
`
`WATSON LABORATORIES, INC .,
`
`Defendant.
`
`vvvvvvvvx—r
`
`Civil Action No.: 3:15ev-05723—PGS-LI-IG
`
`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. 2009
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201?-D1622
`Page 16 of 31
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`

`

`Case 3:15-cv-05723-PGS-LHG Document 46-3 Filed 06117116 Page 3 of 17 PagelD: 374
`
`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 ’2 l 2 patent”) (attached as Exhibit A hereto), 6,256,033 (“the ’033 patent”)
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`(attached as Exhibit B hereto), 8,49?,393 (“the ’393 patent”) (attached as Exhibit C hereto),
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`9,339,507 (“the ’50? patent”) (attached as Exhibit D hereto), and 9,3 58,240 (“the ’240 patent”)
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`(attached as Exhibit E hereto).
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`2.
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`This action arises out of Watson’s submission ofAbbreviated New Drug
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`Application (“ANDA”) No. 208172 to the United States Food and Drug Administration (“FDA”)
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`seeking approval, prior to the expiration of the ’212, ’393, ”033, ”507, and “240 patents, to
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`manufacture, market, and sell a generic copy of UTC‘s TYVASO® (trcprostinil) Inhalation
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`Solution, 0.6 mgfml that is approved by FDA for treatment of pulmonary arterial hypertension.
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`THE PARTIES
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`3.
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`UTC is a corporation organized and existing under the laws of the State of
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`Delaware, and having a place of business at 1040 Spring Street, Silver Spring, Maryland 20910.
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`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 Mon‘is
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`Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054.
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`W
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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 01°28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
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`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNiTED THERAPEUTICS, |PR201?-D1622
`Page 17 of 31
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`Case 3:15-cv-05723-PGS-LHG Document 46-3 Filed 06f17l16 Page 4 of 17 PageID: 375
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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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`thisjudicial 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 ofNew Jersey and employs people throughout New Jersey, including at least the following
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`locations: Morris Corporate Center III, 400 Interpacc 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 07960. In addition, Watson has previously availed itself of this Court as a forum in
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`which to bring patent litigation against 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 TYVASOGO
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`(trcprostinil) Inhalation Solution, 0.6 mg/ml, 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
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`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. 2009
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-D1622
`Page 18 of 31
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`Case 3:15-cv-05723-PGS-LHG Document 46-3 Filed 06l17!16 Page 5 of 17 PagelD: 376
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`10.
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`TYVASO'E is an inhalable product approved for sale in a 0.6 mg/mL
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`concentration.
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`I 1.
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`The ’212 patent, entitled “Method for treating peripheral vascular disease by
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`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 C loutier, James Crow, Michael Wade, Richard E. Parker, and James E. Loyd.
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`12.
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`UTC is the lawful owner of the ’2 l 2 patent by assignment of all right, title, and
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`interest in and to the ’21 2 patent, ineludin g the right to bring infringement suits thereon.
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`13.
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`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 Hitcsh Batra, Sudcrsan M. Tuladhar, Raju Penmasta,
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`and David A. Walsh.
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`14.
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`UTC is the lawful owner of the ’393 patent by assignment of all right, title, and
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`interest in and to the ’3 93 patent, including the right to bring infringement suits thereon.
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`15.
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`The ’033 patent, entitled “Method for delivering benzindene prostaglandins by
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`inhalation,” was duly and legally issued by the United States Patent and Trademark Office on
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`Jum: 29, 2004. The named inventors are Gilles Cloutier, James Crow, Michael Wade, Richard E.
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`Parker, and James E. Loyd.
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`16.
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`UTC is the lawful owner ofthe ’033 patent by assignment of all right, title, and
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`interest in and to the ’033 patent, including the right to bring infringement suits thereon.
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`17.
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`The ’50? patent, entitled “Treprostinil administration by inhalation,” was duly and
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`legally issued by the United States Patent and Trademark Office on May 17, 2016. The named
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`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR2017-D1622
`Page 19 of 31
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`Case 3:15-cv-05723-PGS-LHG Document 46-3 Filed 06117t16 Page 6 of 17 PagelD: 377
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`inventors are Horst Olschewski, Robert Roscingo, Lewis Rubin, Thomas Sehmehl, Werner
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`Seeger, Carl Sterritt, and Robert Voswinckcl.
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`18.
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`UTC is the lawful owner of the ’507 patent by assignment of all right, title, and
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`interest in and to the ’50? patent, including the right to bring infringement suits thereon.
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`19.
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`The ’240 patent, entitled “Treprostinil administration by inhalation,” was duly and
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`legally issued by the United States Patent and Trademark Office on June 7, 2016. The named
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`inventors are Horst Olschewski, Robert Roscingo, Lewis Rubin, Thomas Sehmehl, Werner
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`Seeger, Carl Sterritt, and Robert Voswinckel.
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`20.
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`UTC is the lawful owner of the ’240 patent by assignment of all right, title, and
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`interest in the ‘240 patent, including the right to bring infringement suits thereon.
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`21.
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`TYVASOE and its FDA approved manufacture and uses are covered by one or
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`more claims of the ’212, ’033, ’393, ’507, and ’240 patents, which have all been listed in
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`connection with TYVASO'E‘ in the FDA’s Approved Drug Products with Therapeutic
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`Equivalents publication (also known as the “Orange Book").
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`ACTS GIVING RISE TO THIS ACTION
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`22_
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`Watson notified UTC by letter dated June 12, 2015, which was delivered to UTC
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`on or about, Saturday, June 13, 2015 (“Watson’s Notice Letter”), that it had filed ANDA No.
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`208172 with the FDA seeking approval to commercially manufacture, market, use, and sell
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`generic copies of TYVASO® (treprostinil) Inhalation Solution, 0.6 mg/mL (“Watson’s ANDA
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`Products”) prior to the expiration of the ’2 12, ’033, and ’393 patents.
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`23.
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`Watson’s Notice Letter included a statement pursuant to 21 U.S.C. §
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`355(i)(2)(vii)(IV) purporting to recite Watson’s “factual and legal basis” for its opinion that the
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`’2 12, ’033, and ’393 patents are not valid, are unenforceable, andtor would not be infringed by
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`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201t-D1622
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`Case 3:15-cv-05723-PGS-LHG Document 46-3 Filed 06!17!16 Page 7 of 17 PagelD: 378
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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 ’2 12 patent, claims 4 and 6-10
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`of the ’033 patent, and any claim of the ’3 93 patent were invalid. The statement also did not
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`include anything beyond conclusory statements as to why claims 6-8 of the ’212 patent and
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`claims 1-3 and 5 of the ’033 patent were invalid. The statement also did not include anything
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`beyond conclusory statements regarding alleged non-infringement. Watson provided no
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`explanation as to the alleged unenforceability.
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`24.
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`Upon information and belief, Watson submitted ANDA No. 208172 with FDA
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`seeking approval to commercially manufacture, market, use, and sell generic copies of
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`TYVASO® (treprostinil) Inhalation Solution, 0.6 mgme (“Watson‘s ANDA Products”) prior to
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`the expiration ofthc ’212, ’033, ’393,’50?, and ’240 patents.
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`25.
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`UTC commenced this action before the expiration of forty-five days from the date
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`UTC received Watson’s Notice Letter.
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`26.
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`Upon information and belief, Watson’s ANDA Products contains the same active
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`compound as UTC's approved TYVASO® product.
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`2?
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`Upon information and belief, Watson’s ANDA No. 208172 seeks approval from
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`the FDA to market Watson’s ANDA Products for the same indication as UTC’s approved
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`TWASO® product.
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`28.
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`Upon information and belief, Watson represented to FDA in AN DA No. 208172
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`that Watson’s ANDA Products is bioequivalent to UTC’s approved TYVASO® product.
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`29.
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`Upon information and belief, Watson intends to commercially manufacture, sell,
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`offer for sale, andfor import Watson’s AN DA Products upon, or in anticipation of, FDA
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`approval.
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`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR2017-D1622
`Page 21 of 31
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`Case 3:15-cv-05723-PGS-LHG Document 46-3 Filed 06!17!16 Page 8 of 17 PagelD: 379
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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 1V” certification pursuant to 21 U.S.C. § 3550)(2)(Vii)(lV) stating that in Watson’s
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`opinion the ’212, ’033, and ’393 patents are invalid, unenforceable, andfor would not be
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`infringed by the manufacture, use or sale of Watson ’5 ANDA Products.
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`31.
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`Upon information and belief, as of the date of Watson’s Notice Letter, Watson
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`was aware of the statutory provisions and regulations set forth in 21 U.S.C. §§
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`3556)(2)(B)(iv)(ll) and 21 C.F.R. § 314.95(c)(6).
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`32.
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`Upon information and belief, the acts of infringement by Watson have been
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`intentional and willful.
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`COUNT 1 INFRINGEMENT OF THE ’212 PATENT UNDER 35 U.S.C.
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`271 e
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`33.
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`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
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`herein.
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`34.
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`Upon information and belief, Watson’s ANDA Products or an intermediate in its
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`manufacture is covered by one or more claims of the ”212 patent.
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`35.
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`Watson had knowledge of the “212 patent when it submitted ANDA No. 208170.
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`36.
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`Watson’s submission of AN DA No. 208172 for the purpose of obtaining approval
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`to engage in the commercial manufacture, use, sale, andfor offer for sale of Watson‘s ANDA
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`Products was an act of infringement of the ’212 patent under 35 U.S.C. § 271(e)(2).
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`37.
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`Upon information and belief, the commercial manufacture, use, offer for sale, sale
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`andfor importation of Watson’s ANDA Products would infringe one or more claims of the ’212
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`patent.
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`UNITED THERAPEUTICS, EX. 2009
`WATSON LABORATORIES V. UNiTED THERAPEUTICS, IPR201?-D1622
`Page 22 of 31
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`Case 3:15-cv-05723-PGS-LHG Document 46-3 Filed 06f17!16 Page 9 of 17 PagelD: 380
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`38.
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`Upon information and belief, Watson was and is aware of the existence of the
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`’2 l 2 patent and acted without a reasonable basis for believing that it would not be liable for
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`infringement of the ’212 patent, thus rendering this case “exceptional” under 35 U.S.C. § 285.
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`39.
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`UTC will be substantially and irreparably damaged and harmed if Watson’s
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`infringement of the ’212 patent is not enjoined by this Court. UTC does not have an adequate
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`remedy at law.
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`40.
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`Upon information and belief, the acts of infringement by Watson have been
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`intentional and willful.
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`
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`COUNT 2: INFRINGEMENT OF THE ’393 PATENT UNDER 35 U.S.C. 271 e
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`41.
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`UTC repeats and rcallegcs each of the foregoing paragraphs as if fully set forth
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`herein.
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`42.
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`Upon information and belief, Watson’s ANDA Products or an intermediate in its
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`manufacture is cov