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`
`Liza M. Walsh
`Tricia B. O’Reilly
`Joseph L. Linares
`CONNELL FOLEY LLP
`One Newark Center
`1085 Raymond Boulevard, 19th Floor
`Newark, NJ 07102
`(973) 757-1100
`
`Of Counsel:
`Michael K. Nutter (pro hac vice pending)
`Kurt A. Mathas (pro hac vice pending)
`WINSTON & STRAWN LLP
`35 W. Wacker Drive
`Chicago, IL 60601-9703
`(312) 558-5600
`
`Attorneys for Defendant Watson Laboratories, Inc.
`
`
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF NEW JERSEY
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`––––––––––––––––––––––––––––––––––––––– x
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`:
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`UNITED THERAPEUTICS CORPORATION,
`:
`Honorable Peter G. Sheridan
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`:
`
`:
`Civil Action No: 15-cv-5723
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`:
`:
`:
`:
`:
`:
`:
`:
`––––––––––––––––––––––––––––––––––––––– x
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`
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`WATSON LABORATORIES, INC.’S ANSWER
`AND COUNTERCLAIMS TO COMPLAINT
`FOR PATENT INFRINGEMENT
`
`Plaintiff,
`
`v.
`
`
`WATSON LABORATORIES, INC.,
`
`
`Defendant.
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`Defendant Watson Laboratories, Inc. (“Watson”), by and through the undersigned
`
`attorneys, answers the Complaint of United Therapeutics Corporation (“UTC” or “Plaintiff”) as
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`follows.1 This pleading is based upon Watson’s knowledge as to its own activities, and upon
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`information and belief as to the activities of others.
`
`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), and 8,497,393 (the ’393 patent”) (attached as Exhibit C hereto).
`
`ANSWER: Watson admits that the Complaint purports to bring an action for
`
`infringement of the ’212, ’033 and ’393 patents and that the action purports to arise under the
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`patent laws of the United States, 35 U.S.C. §§ 100 et seq. Watson denies that the ’212, ’033 and
`
`’393 patents were legally or properly issued. Watson otherwise denies the remaining allegations
`
`of paragraph 1.
`
`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 (the
`“FDA”) seeking approval, prior to the expiration of the ’212, ’393, and ’033 patents, to
`manufacture, market, and sell a generic copy of UTC’s TYVASO® (treprostinil) Inhalation
`Solution, 0.6 mg/ml that is approved by the FDA for treatment of pulmonary arterial
`hypertension.
`
`ANSWER: Watson admits that this action purports to relate to Watson’s ANDA No.
`
`208172, which seeks to obtain approval for the commercial manufacture, use or sale of a
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`treprostinil inhalation solution, 0.6 mg/ml before the dates of expiration of the ’212, ’033 and
`
`’393 patents. Watson further admits that TYVASO® is indicated for treatment of pulmonary
`
`arterial hypertension. Watson otherwise denies the remaining allegations of paragraph 2.
`
`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.
`
`1 Contemporaneously herewith Watson is filing a motion to dismiss as to Counts 2, 4 and 6.
`Pursuant to Local Civ. R. 12.2, Watson is not required to respond to Counts 2, 4 and 6, if at all,
`until 14 days after the Court’s ruling on its motion to dismiss.
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`UTC is a biotech company focused on the development and commercialization of products
`designed to address the needs of patients with chronic and life-threatening conditions.
`
`ANSWER: Watson admits, on information and belief, that UTC is a corporation
`
`organized and existing under the laws of the State of Delaware, and having a place of business at
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`1040 Spring Street, Silver Spring, Maryland 20910. Watson otherwise denies the remaining
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`allegations of paragraph 3.
`
`4.
`Upon information and belief, Watson is a corporation organized and existing
`under the laws of the State of California and has a principal place of business at Morris
`Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054.
`
`ANSWER: Watson admits that it is a corporation having a place of business at Morris
`
`Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 06054. Watson denies
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`that it is a corporation organized under the laws of the State of California.
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`JURISDICTION AND VENUE
`
`5.
`This Court has jurisdiction over the subject matter of this action pursuant to the
`provisions of 28 U.S.C. §§ 1331, 1338(a), 2201, and 2202.
`
`ANSWER: This paragraph contains legal conclusions to which no answer is required.
`
`To the extent an answer is required, Watson does not contest subject matter jurisdiction over
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`Plaintiff’s infringement claims against Watson under 35 U.S.C. § 271(e)(2)(A) (Counts 1, 3 and
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`5) for purposes of this action only. Watson denies that the Court has subject matter jurisdiction
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`over Plaintiff’s infringement claims against Watson under 35 U.S.C. § 271(a), (b), (c), or (g)
`
`(Counts 2, 4 and 6). Watson further admits that the action purports to arise under the
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`Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202. Watson otherwise denies the remaining
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`allegations of paragraph 5.
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`6.
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`Venue is proper in this Court under 28 U.S.C. §§ 1391 and 1400(b).
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`ANSWER: This paragraph contains legal conclusions to which no answer is required.
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`To the extent an answer is required, Watson does not contest that venue is proper in this judicial
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`district for the purposes of this case.
`
`7.
`Upon information and belief, this Court has personal jurisdiction over Watson
`with respect to this Complaint because of, inter alia, its continuous and systematic contacts with
`this judicial district. The notice letter was sent from Watson at Morris Corporate Center III, 400
`Interpace Parkway, Parsippany, New Jersey, NJ 07054. Upon information and belief, Watson
`derives substantial revenue from articles used and consumed in this judicial district and,
`consistent with its practice with respect to other generic products, following any FDA approval
`of Watson’s ANDA, Watson will sell its generic product throughout the United States, including
`in New Jersey. Upon information and belief, Watson is registered to conduct business in the
`State of New Jersey and employs people throughout New Jersey, including at least the following
`locations: Morris Corporate Center III, 400 Interpace Parkway, Parsippany, New Jersey 07054;
`100 Enterprise Drive, Rockaway, New Jersey 07866; and 350 Mt. Kemble Avenue, Morristown,
`New Jersey 07960. In addition, Watson has previously availed itself of this Court as a forum in
`which to bring patent litigation against others.
`
`ANSWER: This paragraph contains legal conclusions to which no answer is required.
`
`To the extent an answer is required, Watson states that it will not contest personal jurisdiction for
`
`purposes of this case. Watson further admits that it has a place of business in Parsippany, New
`
`Jersey. Watson otherwise denies the remaining allegations of paragraph 7.
`
`BACKGROUND
`
`UTC holds an approved New Drug Application (No. 22-387) for TYVASO®
`8.
`(treprostinil) Inhalation Solution, 0.6 mg/ml, which UTC markets and sells under the registered
`trademark TYVASO®.
`
`ANSWER: This paragraph contains legal conclusions to which no answer is required.
`
`To the extent an answer is required, Watson admits, on information and belief, that UTC is the
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`holder of approved New Drug Application No. 22-387 directed to TYVASO® (treprostinil)
`
`Inhalation Solution, 0.6 mg/ml, which is sold under the trade name TYVASO®. Watson
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`otherwise denies the remaining allegations of paragraph 8.
`
`TYVASO® is a pharmaceutical product initially approved by FDA in the United
`9.
`States in July 2009, and is indicated for the treatment of pulmonary arterial hypertension.
`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
`heart, thereby leading to heart failure and death.
`
`ANSWER: Watson admits that TYVASO® was approved by the FDA in the United
`
`States in July 2009 and is indicated for the treatment of pulmonary arterial hypertension. Watson
`
`otherwise denies the remaining allegations of paragraph 9.
`
`TYVASO® is an inhalable product approved for sale in a 0.6 mg/mL
`
`10.
`concentration.
`
`ANSWER: Watson admits TYVASO® is indicated for oral inhalation only and is
`
`approved for sale in a 0.6 mg/mL concentration. Watson otherwise denies the remaining
`
`allegations of paragraph 10.
`
`11.
`The ’212 patent, entitled “Method for treating peripheral vascular disease by
`administering benzindene prostaglandins by inhalation” was duly and legally issued by the
`United States Patent and Trademark Office on February 18, 2003, and is scheduled to expire on
`November 13, 2018. The named inventors are Gilles Cloutier, James Crow, Michael Wade,
`Richard E. Parker, and James E. Loyd.
`
`ANSWER: Watson admits that, on its face, the ’212 patent is entitled “Method for
`
`treating peripheral vascular disease by administering benzindene prostaglandins by inhalation,”
`
`bears a issuance date of February 18, 2003, and is scheduled to expire on November 13, 2018.
`
`Watson further admits that, on its face, the named inventors of the ’212 patent are listed as Gilles
`
`Cloutier, James Crow, Michael Wade, Richard E. Parker, and James E. Loyd. Watson denies
`
`that the ’212 patent was legally or properly issued.
`
`12.
`UTC is the lawful owner of the ’212 patent by assignment of all right, title and
`interest in and to the ’212 patent, including the right to bring infringement suits thereon.
`
`ANSWER: This paragraph contains legal conclusions to which no answer is required.
`
`To the extent an answer is required, Watson admits that, per the face of the patent, UTC is
`
`identified as the assignee of the ’212 patent. Watson otherwise denies the remaining allegations
`
`of paragraph 12.
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`13.
`The ’393 patent, entitled “Process to Prepare Treprostinil, the Active Ingredient in
`Remodulin®,” was duly and legally issued by the United States Patent and Trademark Office on
`July 30, 2014, and is scheduled to expire December 15, 2028. The named inventors are Hitesh
`Batra, Sudersan M. Tuladhar, Raju Penmasta, and David A. Walsh.
`
`ANSWER: Watson admits that, on its face, the ’393 patent is entitled “Process to
`
`Prepare Treprostinil, the Active Ingredient in Remodulin®,” bears a issuance date of July 30,
`
`2014, and is scheduled to expire on December 15, 2028. Watson further admits that, on its face,
`
`the named inventors of the ’393 patent are listed as Hitesh Batra, Sudersan M. Tuladhar, Raju
`
`Penmasta, and David A. Walsh. Watson denies that the ’393 patent was legally or properly
`
`issued.
`
`14.
`UTC is the lawful owner of the ’393 patent by assignment of all right, title and
`interest in and to the ’393 patent, including the right to bring infringement suits thereon.
`
`ANSWER: This paragraph contains legal conclusions to which no answer is required.
`
`To the extent an answer is required, Watson admits that, per the face of the patent, UTC is
`
`identified as the assignee of the ’393 patent. Watson otherwise denies the remaining allegations
`
`of paragraph 14.
`
`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, and is scheduled to expire on November 13, 2018. The named inventors are Gilles
`Cloutier, James Crow, Michael Wade, Richard E. Parker, and James E. Loyd.
`
`ANSWER: Watson admits that, on its face, the ’033 patent is entitled “Method for
`
`delivering benzindene prostaglandins by inhalation,” bears a issuance date of June 29, 2004, and
`
`is scheduled to expire on November 13, 2018. Watson further admits that, on its face, the named
`
`inventors of the ’033 patent are listed as Gilles Cloutier, James Crow, Michael Wade, Richard E.
`
`Parker, and James E. Loyd. Watson denies that the ’033 patent was legally or properly issued.
`
`16.
`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.
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`ANSWER: This paragraph contains legal conclusions to which no answer is required.
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`To the extent an answer is required, Watson admits that, per the face of the patent, UTC is
`
`identified as the assignee of the ’033 patent. Watson otherwise denies the remaining allegations
`
`of paragraph 16.
`
`TYVASO® and its FDA approved manufacture and uses are covered by one or
`17.
`more claims of the ’212 patent, the ’033 patent, and the ’393 patent, which have been listed in
`connection with TYVASO® in the FDA’s Approved Drug Products with Therapeutic
`Equivalents publication (also known as the “Orange Book”).
`
`ANSWER: This paragraph contains legal conclusions to which no answer is required.
`
`To the extent an answer is required, Watson admits that the ’212, ’033 and ’393 patents are listed
`
`in the Orange Book in connection with TYVASO®. Watson otherwise denies the remaining
`
`allegations of paragraph 17.
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`ACTS [ALLEGEDLY] GIVING RISE TO THIS ACTION
`
`18. 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 TYVASO® (treprostinil) Inhalation Solution, 0.6 mg/mL (“Watson’s ANDA
`Product”) prior to the expiration of the ’212,’033, and ’393 patents.
`
`ANSWER: Watson admits that it sent Plaintiff a Notice Letter dated June 12, 2015,
`
`notifying Plaintiff that ANDA No. 208172 was filed with the FDA in order to obtain approval to
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`engage in the commercial manufacture, use or sale of Watson’s ANDA Product before the dates
`
`of expiration of the ’212, ’033 and ’393 patents. Watson otherwise denies the remaining
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`allegations of paragraph 18.
`
`19. Watson’s Notice Letter included a statement pursuant to 21 U.S.C. §
`355(j)(2)(vii)(IV) purporting to recite Watson’s “factual and legal basis” for its opinion that the
`’212, ’033, and ’393 patents are not valid, are unenforceable, and/or would not be infringed by
`the commercial manufacture, use, or sale of Watson’s ANDA Product. Yet that statement did 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 ’212 patent and claims 1-3
`and 5 of the ’033 patent were invalid. The statement also did not include anything beyond
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`conclusory statements regarding alleged non-infringement. Watson provided no explanation as to
`the alleged unenforceability.
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`ANSWER: Watson admits that it sent Plaintiff a Notice Letter dated June 12, 2015,
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`which included factual and legal bases for its paragraph IV certification that the claims of the
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`’212, ’033 and ’393 patents are invalid, unenforceable, and/or will not be infringed Watson’s
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`ANDA Product. Watson otherwise denies the remaining allegations of paragraph 19.
`
`20.
`Upon information and belief, Watson submitted ANDA No. 208172 with the
`FDA seeking approval to commercially manufacture, market, use, and sell generic copies of
`TYVASO® (treprostinil) Inhalation Solution, 0.6 mg/mL (“Watson’s ANDA Product”) prior to
`the expiration of the ’212, ’033, and ’393 patents.
`
`ANSWER: Watson admits that it filed ANDA No. 208172 with the FDA in order to
`
`obtain approval to engage in the commercial manufacture, use or sale of Watson’s ANDA
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`Product before the dates of expiration of the ’212, ’033 and ’393 patents. Watson otherwise
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`denies the remaining allegations of paragraph 20.
`
`21.
`UTC is commencing this action before the expiration of forty-five days from the
`date UTC received Watson’s Notice Letter.
`
`ANSWER: This paragraph contains legal conclusions to which no answer is required.
`
`To the extent an answer is required, Watson lacks sufficient information to form a belief as to the
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`truth of the allegations of paragraph 21 and, therefore, denies the same.
`
`22.
`Upon information and belief, Watson’s ANDA Product contains the same active
`compound as UTC’s approved TYVASO® product.
`
`ANSWER: Watson admits that Watson’s ANDA Product contains treprostinil, the
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`same active ingredient as TYVASO®.
`
`23.
`Upon information and belief, Watson’s ANDA No. 208172 seeks approval from
`the FDA to market Watson’s ANDA Product for the same indication as UTC’s approved
`TYVASO® product.
`
`ANSWER: Watson admits that its ANDA seeks approval for the same indication as
`
`TYVASO®.
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`24.
`Upon information and belief, Watson represented to the FDA in ANDA No.
`208172 that Watson’s ANDA Product is bioequivalent to UTC’s approved TYVASO® product.
`
`ANSWER: Watson admits
`
`that ANDA No. 208172 contains
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`the
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`required
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`bioavailability and/or bioequivalence data and/or bioequivalence waiver. Watson denies the
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`remaining allegations of paragraph 24.
`
`25.
`Upon information and belief, Watson intends to commercially manufacture, sell,
`offer for sale, and/or import Watson’s ANDA Product upon, or in anticipation of, FDA approval.
`
`ANSWER: Watson admits that it submitted ANDA No. 208172 under 21 U.S.C. §
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`355(j) to obtain approval for the commercial manufacture, use, and sale of Watson’s ANDA
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`Product in the United States. Watson denies the remaining allegations of paragraph 25.
`
`26.
`According to Watson’s Notice Letter, Watson’s ANDA No. 208172 contained a
`“Paragraph IV” certification pursuant to 21 U.S.C. § 355(j)(2)(vii)(IV) stating that in Watson’s
`opinion the ’212, ’033, and ’393 patents are invalid, unenforceable, and/or would not be
`infringed by the manufacture, use or sale of Watson’s ANDA Product.
`
`ANSWER: Watson admits its Notice Letter indicated that its ANDA included
`
`paragraph IV certifications as to the ’212, ’033 and ’393 patents. Watson admits that the letter
`
`disclosed that the claims of the ’212, ’033 and ’393 patents are invalid, unenforceable, and/or
`
`would not be infringed by the activities described in Watson’s ANDA. Watson denies the
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`remaining allegations of paragraph 26.
`
`27.
`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. §§
`355(j)(2)(B)(iv)(II) and 21 C.F.R. § 314.95(c)(6).
`
`ANSWER: Watson admits that 21 U.S.C. §§ 355(j)(2)(B)(iv)(II) and 21 C.F.R. §
`
`314.95(c)(6) were in effect as of the date of its Notice Letter. Watson denies the remaining
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`allegations of paragraph 27.
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`28.
`Upon information and belief, the acts of infringement by Watson have been
`intentional and willful.
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`ANSWER: This paragraph contains legal conclusions to which no answer is required.
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`To the extent that an answer is required, Watson denies the allegations of paragraph 28.
`
`29.
`In Watson’s Notice Letter, Watson offered confidential access to portions of the
`Watson ANDA on terms and conditions set forth in paragraph VII of the Watson Notice Letter
`(“Watson Offer”). Watson requested that UTC accept the Watson Offer before receiving access
`to any portion of the Watson ANDA. The Watson Offer contained sweeping, unreasonable
`restrictions that differ materially from restrictions found under protective orders, such as those
`protective orders in pending, related cases in the United States District Court for the District of
`New Jersey. For example, the Watson Offer required that UTC’s outside counsel “do not engage,
`formally or informally, in any patent prosecution for United Therapeutics or any FDA
`counseling, litigation or other work before or involving the FDA.”
`
`ANSWER: Watson admits that its Notice Letter offered to UTC confidential access to
`
`certain information from its ANDA No. 208172 for the sole and exclusive purpose of
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`determining whether an infringement action referred to in § 355(j)(5)(B)(iii) can be brought.
`
`Watson further admits that, in its Notice Letter, it proposed, as a term and restriction on its offer
`
`of confidential access, that UTC’s outside counsel “not engage, formally or informally, in any
`
`patent prosecution for United Therapeutics or any FDA counseling, litigation or other work
`
`before or involving the FDA.” Watson denies the remaining allegations of paragraph 29.
`
`30.
`Under 21 U.S.C. § 355(j)(5)(C)(i)(III), an “offer of confidential access shall
`contain such restrictions . . . on the use and disposition of any information accessed, as would
`apply had a protective order been entered for the purpose of protecting trade secrets and other
`confidential business information.”
`
`ANSWER: This paragraph contains legal conclusions to which no answer is required.
`
`To the extent that an answer is required, Watson admits that paragraph 30 purports to recite an
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`incomplete portion of 21 U.S.C. § 355(j)(5)(C)(i)(III). Watson denies the remaining allegations
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`of paragraph 30, including any implication that Watson’s offer of confidential access did not
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`contain the restrictions allowed under 21 U.S.C. § 355(j)(5)(C)(i)(III).
`
`31.
`UTC attempted to negotiate with Watson to obtain relevant information from the
`Watson ANDA under restrictions “as would apply had a protective order been issued.” Those
`negotiations were unsuccessful. For example, Watson continued to insist that attorneys
`representing UTC and in-house counsel and the staff of such counsel agree not to be engaged in
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`the drafting of submissions related to compositions, treatment methods, or formulations
`containing treprostinil to the FDA or any FDA counseling related to such matters, though such a
`restrictions has not been present in any prior protective order relating to any other UTC
`treprostinil-containing product, such as REMODULIN® (treprostinil) Injection. See United
`Therapeutics Corp. v. Sandoz, Inc., 3:12-cv-01617-PGS-LHG, Protective Order, Docket No. 32
`(D.N.J. Sept. 12, 2012); United Therapeutics Corp. v. Teva Pharmaceuticals USA, Inc., 3:14-cv-
`05498-PGS-LHG, Protective Order, Docket No. 24, Discovery Confidentiality Order (D.N.J.
`Nov. 25, 2014); United Therapeutics Corp. v. Sandoz, Inc., 3:14-cv-05499-PGS-LHG, Stipulated
`Protective Order and Cross Use Agreement (D.N.J. Jan. 15, 2015.). UTC objected to this
`provision of Watson’s OCA as unreasonable and in violation of 21 U.S.C. 355(j)(5)(C)(i)(III).
`
`ANSWER: Watson admits that it negotiated with UTC with respect to the terms and
`
`restrictions on its offer of confidential access. Watson denies the remaining allegations of
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`paragraph 31.
`
`32.
`UTC is not aware of any other means of obtaining information regarding
`Watson’s ANDA Product within the 45-day statutory period. Without such information, UTC
`will use the judicial process and the aid of discovery to obtain, under appropriate judicial
`safeguards, such information as is required to confirm its allegations of infringement and to
`present to the Court evidence that Watson’s ANDA Product fall within the scope of one or more
`claims of the ’212 patent, the ’393 patent, and the ’033 patent.
`
`ANSWER: This paragraph contains legal conclusions to which no answer is required.
`
`Watson admits that UTC filed this action, which includes allegations of infringement. Watson
`
`denies the remaining allegations of paragraph 32.
`
`COUNT 1: INFRINGEMENT OF THE ’212 PATENT UNDER 35 U.S.C. § 271(e)
`
`herein.
`
`33.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`
`ANSWER: Watson repeats and incorporates by reference the answers to paragraphs 1-
`
`32 as if fully set forth herein.
`
`34.
`Upon information and belief, Watson’s ANDA Product or an intermediate in its
`manufacture is covered by one or more claims of the ’212 patent.
`
`ANSWER: This paragraph contains legal conclusions to which no answer is required.
`
`To the extent an answer is required, Watson denies the allegations of paragraph 34.
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`35. Watson had knowledge of the ’212 patent when it submitted ANDA No. 208172.
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`ANSWER: Watson admits that it had knowledge of the ’212 patent when it submitted
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`ANDA No. 208172. Watson otherwise denies the remaining allegations of paragraph 35.
`
`36. Watson’s submission of ANDA No. 208172 for the purpose of obtaining approval
`to engage in the commercial manufacture, use, sale, and/or offer for sale of Watson’s ANDA
`Product was an act of infringement of the ’212 patent under 35 U.S.C. § 271(e)(2).
`
`ANSWER: This paragraph contains legal conclusions to which no answer is required.
`
`To the extent an answer is required, Watson admits that it filed ANDA No. 208172 seeking
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`approval to engage in the commercial manufacture, use, sale and/or offer for sale of Watson’s
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`ANDA Product. Watson otherwise denies the remaining allegations of paragraph 36, including
`
`any implication that Watson’s ANDA Product infringes any valid and enforceable claim of the
`
`’212 patent.
`
`37.
`Upon information and belief, the commercial manufacture, use, offer for sale, sale
`and/or importation of Watson’s ANDA Product would infringe one or more claims of the ’212
`patent.
`
`
`ANSWER: This paragraph contains legal conclusions to which no answer is required.
`
`To the extent an answer is required, Watson denies the allegations of paragraph 37.
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`38.
`Upon information and belief, Watson was and is aware of the existence of the
`’212 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.
`
`ANSWER: This paragraph contains legal conclusions to which no answer is required.
`
`To the extent an answer is required, Watson denies the allegations of paragraph 38.
`
`39.
`UTC will be substantially and irreparably damaged and harmed if Watson’s
`infringement of the ’212 patent is not enjoined by this Court. UTC does not have an adequate
`remedy at law.
`
`ANSWER: This paragraph contains legal conclusions to which no answer is required.
`
`To the extent an answer is required, Watson denies the allegations of paragraph 39.
`
`40.
`Upon information and belief, the acts of infringement by Watson have been
`intentional and willful.
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`ANSWER: This paragraph contains legal conclusions to which no answer is required.
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`To the extent an answer is required, Watson denies the allegations of paragraph 40.
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`COUNT 2: INFRINGEMENT OF THE ’212 PATENT
`UNDER 35 U.S.C. §§ 271(a)-(c) AND (g)
`
`herein.
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`41.
`
`UTC repeats and realleges each of the foregoing paragraphs as if fully set forth
`
`
`ANSWER: Watson repeats and incorporates by reference the answers to paragraphs 1-
`
`40 as if fully set forth herein.
`
`42.
`Upon information and belief, upon FDA approval Watson will manufacture,
`market, sell, offer to sell, import, and distribute Watson’s ANDA Products which will result in
`infringement of one or more claims of the ’212 patent.
`
`ANSWER: No response is required at this time because the allegations of this paragraph
`
`are subject to Watson’s motion to dismiss. To the extent an answer is required, Watson denies
`
`the allegations of paragraph 42.
`
`43. Watson’s ANDA and Watson’s intention to engage in the commercial
`manufacture, use, offer for sale, sale, or importation of Watson’s ANDA Product upon receiving
`FDA approval prior to the expiration of the ’212 patent creates an actual and justiciable
`controversy with respect to infringement of the ’212 patent.
`
`ANSWER: No response is required at this time because the allegations of this paragraph
`
`are subject to Watson’s motion to dismiss. To the extent an answer is required, Watson denies
`
`the allegations of paragraph 43.
`
`44.
`Upon information and belief, upon FDA approval of Watson’s ANDA, Watson’s
`commercial manufacture, use, sale offer for sale and/or importation into the United States of
`Watson’s ANDA Product will directly infringe one or more claims of the ’212 patent, and will
`indirectly infringe by actively inducing infringement by others, under 35 U.S.C. § 271(a), 35
`U.S.C. § 271(b), 35 U.S.C. § 271(c) and/or 35 U.S.C. § 271(g).
`
`ANSWER: No response is required at this time because the allegations of this paragraph
`
`are subject to Watson’s motion to dismiss. To the extent an answer is required, Watson denies
`
`the allegations of paragraph 44.
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`45.
`Upon information and belief, Watson’s ANDA Product or an intermediate in its
`manufacture as described in and/or directed by Watson’s proposed labeling, ANDA, applicable
`DMF, and/or other corporate documents for Watson’s ANDA Product would infringe one or
`more claims of the ’212 patent.
`
`ANSWER: No response is required at this time because the allegations of this paragraph
`
`are subject to Watson’s motion to dismiss. To the extent an answer is required, Watson denies
`
`the allegations of paragraph 45.
`
`46.
`Upon information and belief, Watson will induce others to infringe one or more
`claims of the ’212 patent under 35 U.S.C. § 271(b) by, among other things, actively and
`knowingly aiding and abetting others to infringe, including, but not limited to the manufacturer
`of Watson’s ANDA Product, or its Active Pharmaceutical Ingredient (“API”), or other
`subsequent purchasers, distributors, or users thereof, which product or its manufacture
`constitutes direct infringement of one or more claims of the ’212 patent. Upon information and
`belief, Watson’s aiding and abetting includes Watson’s engagement of, contracting of, and/or
`encouragement of others to engage in the manufacture, use, sale, or importation of infringing
`products pursuant to Watson’s ANDA.
`
`ANSWER: No response is required at this time because the allegations of this paragraph
`
`are subject to Watson’s motion to dismiss. To the extent an answer is required, Watson denies
`
`the allegations of paragraph 46.
`
`47.
`Upon information and belief, Watson will also contributorily infringe one or more
`claims of the ’212 patent under 35 U.S.C. § 271(c) in that Watson will make, use, sell, offer to
`sell, and/or import its ANDA Product and/or the API thereof, which Watson knows has no
`substantial non-infringing uses. Upon
`information and belief, subsequent purchasers,
`distributors, or users thereof will also directly infringe one or more claims of the ’212 patent.
`
`ANSWER: No response is required at this time because the allegations of this paragraph
`
`are subject to Watson’s motion to dismiss. To the extent an answer is required, Watson denies
`
`the allegations of paragraph 47.
`
`48.
`Upon information and belief, Watson will also infringe one or more claims of the
`’212 patent under 35 U.S.C. § 271(g) by importing, selling, offering to sell or using Watson’s
`ANDA Product or the API or an intermediate thereof which is neither materially changed by
`subsequent process nor a trivial or non-essential component of another product.
`
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