Case 1:13-cv-01674-RGA Document 300 Filed 07/06/15 Page 1 of 20 PageID #: 6700
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 13-1674-RGA
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`RECKITT BENCKISER
`PHARMACEUTICALS, INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
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`Plaintiffs,
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`
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`v.
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`WATSON LABORATORIES, INC. and
`ACTAVIS LABORATORIES UT, INC.,
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`Defendants.
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`DEFENDANTS’ ANSWER AND COUNTERCLAIMS TO
`PLAINTIFFS’ SECOND AMENDED COMPLAINT
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`Defendants Watson Laboratories, Inc. and Actavis Laboratories UT, Inc. (collectively
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`“Defendants”), by and through their undersigned attorneys, answer the second amended complaint
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`of Plaintiffs Reckitt Benckiser Pharmaceuticals, Inc., RB Pharmaceuticals Limited, and MonoSol
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`Rx, LLC (collectively “Plaintiffs”) as follows:
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`AS TO THE NATURE OF THE ACTION
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`1.
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`Defendants admit that Plaintiffs purport to bring this action under the Food and
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`Drug Law and Patent Laws of the United States. Defendants further admit that Watson
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`Laboratories, Inc. (also sometimes referred to as “Watson Laboratories, Inc. (Nevada)” and
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`hereinafter referred to as same) filed ANDA No. 204383 and ANDA No. 207087 with the FDA
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`seeking approval to manufacture and sell a generic version of Suboxone®, a sublingual film
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`containing buprenorphine hydrochloride and naloxone hydrochloride, before the expiration of the
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`patents-in-suit. Except as expressly admitted, Defendants deny the remaining allegations in
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`paragraph 1.
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`Case 1:13-cv-01674-RGA Document 300 Filed 07/06/15 Page 2 of 20 PageID #: 6701
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`AS TO THE PARTIES
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`2.
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`Defendants lack knowledge or information sufficient to form a belief about the truth
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`of the allegations in paragraph 2 and therefore deny them.
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`3.
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`Defendants lack knowledge or information sufficient to form a belief about the truth
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`of the allegations in paragraph 3 and therefore deny them.
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`4.
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`Defendants lack knowledge or information sufficient to form a belief about the truth
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`of the allegations in paragraph 4 and therefore deny them.
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`5.
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`Denied. Further responding, Defendant Watson Laboratories, Inc. (Nevada) is a
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`Nevada corporation having a principal place of business at 311 Bonnie Circle, Corona, California
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`92880.
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`6.
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`Defendants admit that Actavis Laboratories UT, Inc. (formerly known as Watson
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`Laboratories, Inc. or Watson Laboratories, Inc. (Delaware)) is a Delaware corporation having a
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`place of business at 577 Chipeta Way, Salt Lake City, Utah 84108.
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`AS TO JURISDICTION AND VENUE
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`7.
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`Defendant Actavis Laboratories UT, Inc. does not contest that the Court has subject
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`matter jurisdiction over this action. Watson Laboratories, Inc. (Nevada), on the other hand,
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`transferred ownership of ANDA Nos. 204383 and 207087 to Actavis Laboratories UT, Inc.
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`Accordingly, Defendant Watson Laboratories, Inc. (Nevada) contests subject matter jurisdiction
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`because it is no longer the owner of the accused ANDAs.
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`8.
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`Defendants admit that Actavis Laboratories UT, Inc. is a pharmaceutical company
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`engaged in the business of developing and manufacturing generic pharmaceutical products, some
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`of which are ultimately distributed, marketed, and/or sold in Delaware and throughout the United
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`States. Except as expressly admitted, Defendants deny the remaining allegations in paragraph 8.
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`2
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`Case 1:13-cv-01674-RGA Document 300 Filed 07/06/15 Page 3 of 20 PageID #: 6702
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`9.
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`Defendants do not contest this Court’s personal jurisdiction over them for purposes
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`of this action only. Except as expressly admitted, Defendants deny the remaining allegations in
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`paragraph 9.
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`10.
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`Defendants do not contest that venue is proper in this District for purposes of this
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`action only.
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`AS TO THE PATENTS-IN-SUIT
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`11.
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`Defendants admit that the face of the ’832 patent identifies RBP UK as the assignee.
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`Defendants further admit that the ’832 patent states on its face that it issued on July 2, 2013.
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`Defendants also admit that the ’832 patent is entitled “Sublingual and Buccal Film Compositions.”
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`Defendants further admit that the face of the ’832 patent identifies Garry L. Myers, Samuel D.
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`Hilbert, Bill J. Boone, B. Arlie Bogue, Pradeep Sanghvi, and Madhusudan Hariharan as inventors.
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`Defendants also admit that Exhibit A to the second amended complaint appears to be a copy of the
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`’832 patent. Defendants aver that the allegation the ’832 patent was duly and legally issued states
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`a legal conclusion to which no response is required, but if a response is required Defendants deny
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`the same. Defendants lack knowledge or information sufficient to form a belief about the truth of
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`the remaining allegations in paragraph 11 and therefore deny them.
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`12.
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`Defendants admit that the face of the ’150 patent identifies MonoSol as the
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`assignee. Defendants further admit that the ’150 patent states on its face that it issued on
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`September 13, 2011. Defendants admit that the ’150 patent is entitled “Polyethylene Oxide-Based
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`Films and Drug Delivery Systems Made Therefrom.” Defendants further admit that the face of
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`the ’150 patent identifies Robert K. Yang, Richard C. Fuisz, Garry L. Myers, and Joseph M. Fuisz
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`as inventors. Defendants further admit that Exhibit B to the second amended complaint appears
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`to be a copy of the ’150 patent. Defendants aver that the allegation the ’150 patent was duly and
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`legally issued states a legal conclusion to which no response is required, but if a response is
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`3
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`Case 1:13-cv-01674-RGA Document 300 Filed 07/06/15 Page 4 of 20 PageID #: 6703
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`required, Defendants deny the same. Defendants lack knowledge or information sufficient to form
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`a belief about the truth of the remaining allegations of paragraph 12 and therefore deny them.
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`13.
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`Defendants admit that the face of the ’514 patent identifies MonoSol as the
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`assignee. Defendants further admit that the ’514 patent states on its face that it issued on December
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`10, 2013. Defendants also admit that the ’514 patent is entitled “Uniform Films for Rapid Dissolve
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`Dosage Form Incorporating Taste-Masking Compositions.” Defendants further admit that the face
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`of the ’514 patent identifies Robert K. Yang, Richard C. Fuisz, Garry L. Myers, and Joseph M.
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`Fuisz as inventors. Defendants further admit that Exhibit C to the second amended complaint
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`appears to be a copy of the ’514 patent. Defendants aver that the allegation the ’514 patent was
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`duly and legally issued states a legal conclusion to which no response is required, but if a response
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`is required, Defendants deny the same. Defendants lack knowledge or information sufficient to
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`form a belief about the truth of the remaining allegations of paragraph 13 and therefore deny them.
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`AS TO SUBOXONE® SUBLINGUAL FILM
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`14.
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`Defendants admit that the Approved Drug Products with Therapeutic Equivalence
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`Evaluations (the “Orange Book”) entry for NDA No. 22-410 for Suboxone® (buprenorphine
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`hydrochloride and naloxone hydrochloride) sublingual film identifies Plaintiff Reckitt Benckiser
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`as the applicant. Defendants lack knowledge or information sufficient to form a belief about the
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`truth of the remaining allegations in paragraph 14 and therefore deny them.
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`15.
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`Defendants admit that the Orange Book entry for NDA No. 22-410 identifies the
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`FDA approval date as August 30, 2010. Defendants further admit that the labeling for Suboxone®
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`sublingual film indicates the product is “indicated for maintenance treatment of opioid
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`dependence” when used as part of a complete treatment plan to include counseling and
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`psychosocial support. Defendants lack knowledge or information sufficient to form a belief about
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`the truth of the remaining allegations in paragraph 15 and therefore deny them.
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`4
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`Case 1:13-cv-01674-RGA Document 300 Filed 07/06/15 Page 5 of 20 PageID #: 6704
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`16.
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`Defendants admit that the patents-in-suit are listed in the Orange Book with respect
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`to Suboxone® sublingual film. Defendants aver that Plaintiff RBP caused the patents-in-suit to
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`be listed in the Orange Book relative to Suboxone® sublingual film by filing a declaration with
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`the FDA, and that the FDA published this patent information for Suboxone® sublingual film as a
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`purely ministerial act. Except as specifically admitted, Defendants deny the remaining allegations
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`in paragraph 16.
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`AS TO ACTAVIS’ ANDAS
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`17.
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`Defendants admit that Watson Laboratories, Inc. (Nevada) sent Plaintiffs a notice
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`letter dated August 27, 2013, stating that ANDA No. 204383 contains a Paragraph IV certification,
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`and explaining the reasons that the claims of the ’832 and ’150 patents are invalid, unenforceable,
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`and/or will not be infringed by the manufacture, use, or sale of the proposed ANDA products.
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`Defendants lack knowledge and information sufficient to form a belief as to the truth of the
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`remaining allegations in paragraph 17 and therefore deny them.
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`18.
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`Defendants admit that Watson Laboratories, Inc. (Nevada) submitted ANDA No.
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`204383 to the FDA under 21 U.S.C. § 355(j), seeking approval to engage in commercial
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`manufacture, use, and/or sale of the proposed ANDA products before expiration of the patents-in-
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`suit. Defendants further admit that ANDA No. 204383 identifies Plaintiff RBP’s NDA for
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`Suboxone® sublingual film as the Reference Listed Drug, and that ANDA No. 204383 contains
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`data demonstrating that the proposed ANDA products meet FDA requirements for bioequivalence
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`with respect to Suboxone® sublingual film. Defendants lack knowledge and information
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`sufficient to form a belief as to the truth of the remaining allegations in paragraph 18 and therefore
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`deny them.
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`19.
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`Defendants lack knowledge or information sufficient to form a belief as to the truth
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`of the allegations in paragraph 19 and therefore deny them.
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`5
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`Case 1:13-cv-01674-RGA Document 300 Filed 07/06/15 Page 6 of 20 PageID #: 6705
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`20.
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`Defendants admit that Watson Laboratories, Inc. (Nevada) sent Plaintiffs a notice
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`letter dated February 4, 2014, stating that ANDA No. 204383 contains a Paragraph IV certification,
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`and explaining the reasons that the claims of the ’514 patent are invalid, unenforceable, and/or will
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`not be infringed by the manufacture, use, or sale of the proposed ANDA products. Defendants
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`lack knowledge and information sufficient to form a belief as to the truth of the remaining
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`allegations in paragraph 20 and therefore deny them.
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`21.
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`Defendants admit that Watson Laboratories, Inc. (Nevada) submitted ANDA No.
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`204383 to the FDA under 21 U.S.C. § 355(j), seeking approval to engage in commercial
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`manufacture, use, and/or sale of the proposed ANDA products before expiration of the ’514 patent.
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`Defendants further admit that ANDA No. 204383 identifies Plaintiff RBP’s NDA for Suboxone®
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`sublingual film as the Reference Listed Drug, and that ANDA No. 204383 contains data
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`demonstrating that the proposed ANDA products meet FDA requirements for bioequivalence with
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`respect to Suboxone® sublingual film. Defendants lack knowledge and information sufficient to
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`form a belief as to the truth of the remaining allegations in paragraph 21 and therefore deny them.
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`22.
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`Defendants lack knowledge or information sufficient to form a belief as to the truth
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`of the allegations in paragraph 22 and therefore deny them.
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`23.
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`Defendants admit that Actavis Laboratories UT, Inc. sent Plaintiffs a notice letter
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`dated April 22, 2015, stating that ANDA No. 207087 contains a Paragraph IV certification, and
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`explaining the reasons that claims of the ’832, ’150, and ’514 patents are invalid, unenforceable,
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`and/or will not be infringed by the manufacture, use, or sale of the proposed ANDA products.
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`Defendants lack knowledge and information sufficient to form a belief as to the truth of the
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`remaining allegations in paragraph 23 and therefore deny them.
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`6
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`Case 1:13-cv-01674-RGA Document 300 Filed 07/06/15 Page 7 of 20 PageID #: 6706
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`24.
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`Defendants admit that Watson Laboratories, Inc. (Nevada) submitted ANDA No.
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`207087 to the FDA under 21 U.S.C. § 355(j), seeking approval to engage in commercial
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`manufacture, use, and/or sale of the proposed ANDA products before expiration of the ’832, ’150,
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`and ’514 patents. Defendants further admit that ANDA No. 207087 identifies Plaintiff RBP’s
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`NDA for Suboxone® sublingual film as the Reference Listed Drug, and that ANDA No. 207087
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`contains data demonstrating that the proposed ANDA products meet FDA requirements for
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`bioequivalence with respect to Suboxone® sublingual film. Defendants lack knowledge and
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`information sufficient to form a belief as to the truth of the remaining allegations in paragraph 24
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`and therefore deny them.
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`25.
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`Defendants lack knowledge or information sufficient to form a belief as to the truth
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`of the allegations in paragraph 25 and therefore deny them.
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`
`COUNT I
`(Infringement of the ‘832 Patent Under 35 U.S.C. § 271(e)(2))
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`26.
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`Defendants repeat and incorporate by reference their answers to paragraphs 1-25 of
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`the second amended complaint as if fully set forth here.
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`27.
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`Denied.
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`28.
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`Defendants admit that the filing of ANDA No. 204383 and ANDA No. 207087 are
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`technical acts of infringement under 35 U.S.C. § 271(e)(2) that give rise to subject matter
`
`jurisdiction. Defendants deny that the proposed ANDA products infringe any valid claim of the
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`‘832 patent.
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`29.
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`Denied.
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`7
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`Case 1:13-cv-01674-RGA Document 300 Filed 07/06/15 Page 8 of 20 PageID #: 6707
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`
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`COUNT II
`(Infringement of the ‘150 Patent Under 35 U.S.C. § 271(e)(2))
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`30.
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`Defendants repeat and incorporate by reference their responses to paragraphs 1-29
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`of the second amended complaint as if fully set forth here.
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`31.
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`Denied.
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`32.
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`Defendants admit that the filing of ANDA No. 204383 and ANDA No. 207087 are
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`technical acts of infringement under 35 U.S.C. § 271(e)(2), that give rise to subject matter
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`jurisdiction. Defendants deny that the proposed ANDA products infringe any valid claim of the
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`‘150 patent.
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`33.
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`Denied.
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`COUNT III
`(Infringement of the ’514 Patent Under 35 U.S.C. § 271(e)(2))
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`34.
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`Defendants repeat and incorporate by reference their responses to paragraphs 1-33
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`of the second amended complaint as if fully set forth here.
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`35.
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`Denied.
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`36.
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`Defendants admit that the filing of ANDA No. 204383 and ANDA No. 207087 are
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`technical acts of infringement under 35 U.S.C. § 271(e)(2), that give rise to subject matter
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`jurisdiction. Defendants deny that the proposed ANDA products infringe any valid claim of the
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`‘514 patent.
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`37.
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`Denied.
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`8
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`Case 1:13-cv-01674-RGA Document 300 Filed 07/06/15 Page 9 of 20 PageID #: 6708
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`AS TO PLAINTIFFS’ PRAYER FOR RELIEF
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`The remainder of the second amended complaint recites a prayer for relief to which no
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`response is required. To the extent a response is required, Defendants deny that Plaintiffs are
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`entitled to any remedy or relief, including those requested.
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`AFFIRMATIVE DEFENSES
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`Without any admission as to the burden of proof, burden of persuasion, or the truth of any
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`allegation in the second amended complaint, Defendants state the following affirmative defenses:
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`First Affirmative Defense
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`The claims of the patents-in-suit are invalid for failure to comply with the statutory
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`provisions of Title 35 of the United States Code, including without limitation, one or more of
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`sections 101, 102, 103, 111, 112, 116, 135, 256, and 287, and/or the doctrine of obviousness-type
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`double patenting.
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`Second Affirmative Defense
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`The manufacture, use, sale, offer for sale, or importation of the proposed ANDA products
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`will not infringe, directly or indirectly, any valid and/or enforceable claim of the patents-in-suit.
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`Third Affirmative Defense
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`The filing of ANDA No. 204383 has not infringed, and will not infringe, directly or
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`indirectly, any valid and/or enforceable claim of the patents-in-suit.
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`Fourth Affirmative Defense
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`The filing of ANDA No. 207087 has not infringed, and will not infringe, directly or
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`indirectly, any valid and/or enforceable claim of the patents-in-suit.
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`9
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`Case 1:13-cv-01674-RGA Document 300 Filed 07/06/15 Page 10 of 20 PageID #: 6709
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`Fifth Affirmative Defense
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`The second amended complaint fails to state a claim upon which relief may be granted.
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`Sixth Affirmative Defense
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`Defendants’ actions in defending this case do not give rise to an exceptional case under 35
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`U.S.C. § 285.
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`Seventh Affirmative Defense
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`Defendants have not willfully infringed any claims of the patents-in-suit.
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`Eighth Affirmative Defense
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`The relief requested in the second amended complaint is barred by the doctrines of estoppel
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`and/or waiver.
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`Ninth Affirmative Defense
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`Any additional defenses or counterclaims that discovery may reveal.
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`WHEREFORE, Defendants request that the second amended complaint be dismissed with
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`prejudice and that Defendants be awarded the costs of this action, their attorneys’ fees, and all
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`other relief this Court deems just and proper.
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`COUNTERCLAIMS
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`For its counterclaims against Plaintiffs/Counterclaim-Defendants Reckitt Benckiser
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`Pharmaceuticals,
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`Inc., RB Pharmaceuticals Limited,
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`and MonoSol Rx, LLC,
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`Defendant/Counterclaim-Plaintiffs Watson Laboratories, Inc. (Nevada) and Actavis Laboratories
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`UT, Inc. allege as follows:
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`10
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`Case 1:13-cv-01674-RGA Document 300 Filed 07/06/15 Page 11 of 20 PageID #: 6710
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`
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`THE PARTIES
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`1.
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`Watson Laboratories, Inc. (Nevada) is a Nevada corporation having a place of
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`business at 311 Bonnie Circle, Corona, California, 92880.
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`2.
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`Actavis Laboratories UT, Inc., formerly known as Watson Laboratories, Inc. or
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`Watson Laboratories, Inc. (Delaware), is a Delaware corporation having a place of business at 577
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`Chipeta Way, Salt Lake City, Utah 84108.
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`3.
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`On information and belief, as stated in Plaintiffs’ second amended complaint
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`against Counterclaim-Plaintiffs, RBP is a Delaware corporation having a principal place of
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`business at 10710 Midlothian Turnpike, Suite 430, Richmond, Virginia.
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`4.
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`On information and belief, as stated in Plaintiffs’ second amended complaint
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`against Counterclaim-Plaintiffs, RBP UK is a United Kingdom corporation having a principal
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`place of business at 103-105 Bath Road, Slough, UK.
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`5.
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`On information and belief, as stated in Plaintiffs’ second amended complaint
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`against Counterclaim-Plaintiffs, MonoSol is a Delaware limited liability corporation having a
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`principal place of business at 30 Technology Drive, Warren, New Jersey.
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`JURISDICTION AND VENUE
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`6.
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`These counterclaims arise under the Patent Act, 35 U.S.C. §§ 1 et seq., and the
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`Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202. To the extent the Court has subject matter
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`jurisdiction over Counterclaim-Defendants’ claims against Counterclaim-Plaintiffs, this Court has
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`subject matter jurisdiction over these counterclaims under 28 U.S.C. §§ 2201 and 2202 and 35
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`U.S.C. §§ 1331 and 1338(a).
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`7.
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`This Court has personal jurisdiction over RBP because, among other reasons, it
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`subjected itself to the jurisdiction of this Court by filing the second amended complaint against
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`Counterclaim-Plaintiffs here.
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`11
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`Case 1:13-cv-01674-RGA Document 300 Filed 07/06/15 Page 12 of 20 PageID #: 6711
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`8.
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`This Court has personal jurisdiction over RBP UK because, among other reasons,
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`it subjected itself to the jurisdiction of this Court by filing the second amended complaint against
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`Counterclaim-Plaintiffs here.
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`9.
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`This Court has personal jurisdiction over MonoSol because, among other reasons,
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`it subjected itself to the jurisdiction of this Court by filing the second amended complaint against
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`Counterclaim-Plaintiffs here.
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`10.
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`To the extent this venue is appropriate for Counterclaim-Defendants’ claims
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`against Counterclaim-Plaintiffs, venue is also appropriate in this Court for the following
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`counterclaims. Venue is also proper in this judicial district under 28 U.S.C. § 1391(b) and (c).
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`11.
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`There is an actual and justiciable controversy between the parties as to the
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`infringement, validity, and enforceability of United States Patent Nos. 8,475,832 (“the ’832
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`patent”), 8,017,150 (“the ’150 patent”), and 8,603,514 (“the ’514 patent”).
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`BACKGROUND
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`12.
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`Upon information and belief, as stated in the second amended complaint against
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`Counterclaim-Plaintiffs, RBP holds approved NDA No. 22410 for Suboxone® (buprenorphine
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`hydrochloride and naloxone hydrochloride) sublingual film.
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`13.
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`NDA holders are required to disclose to the FDA the patent numbers of patents
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`claiming the drug or the method of using such drug for which the NDA is submitted. FDA lists
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`these patents in the FDA publication entitled Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (the “Orange Book”).
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`14.
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`The ’832 patent, entitled “Sublingual and Buccal Film Compositions,” states on its
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`face that it issued on July 2, 2013.
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`12
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`Case 1:13-cv-01674-RGA Document 300 Filed 07/06/15 Page 13 of 20 PageID #: 6712
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`15.
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`Upon information and belief, as stated in the second amended complaint against
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`Counterclaim-Plaintiffs, RBP UK claims to be the assignee of the ’832 patent.
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`16.
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`The ’150 patent, entitled “Polyethylene Oxide-Based Films and Drug Delivery
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`Systems Made Therefrom,” states on its face that it issued on September 13, 2011.
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`17.
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`Upon information and belief, as stated in the second amended complaint against
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`Counterclaim-Plaintiffs, MonoSol claims to be the assignee of the ’150 patent.
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`18.
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`Upon information and belief, as stated in the second amended complaint against
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`Counterclaim-Plaintiffs, RBP claims to be an exclusive licensee to the ’150 patent.
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`19.
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`The ’514 patent, entitled “Uniform Films for Rapid Dissolve Dosage Form
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`Incorporating Taste-Marking Compositions,” states on its face that it issued on December 10,
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`2013.
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`20.
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`Upon information and belief, as stated in the second amended complaint against
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`Counterclaim-Plaintiffs, MonoSol claims to be the assignee of the ’514 patent.
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`21.
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`Upon information and belief, as stated in the second amended complaint against
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`Counterclaim-Plaintiffs, RBP claims to be an exclusive licensee to the ’514 patent.
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`22.
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`Upon information and belief, Counterclaim-Defendants, including MonoSol and
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`RBP, caused the ’832, ’150, and ’514 patents to be listed in the Orange Book as patents that
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`purportedly claim Suboxone® sublingual film and/or claim a method of using Suboxone®
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`sublingual film.
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`23.
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`Counterclaim-Plaintiff Watson Laboratories, Inc. (Nevada) submitted ANDA No.
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`204383 to obtain FDA approval to engage in the commercial manufacture, use, and sale of
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`buprenorphine hydrochloride and naloxone hydrochloride sublingual films (“proposed ANDA
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`products”) before the expiration of the ’832, ’150, and ’514 patents.
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`13
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`Case 1:13-cv-01674-RGA Document 300 Filed 07/06/15 Page 14 of 20 PageID #: 6713
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`24.
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`ANDA No. 204383 contains “Paragraph IV” certifications under 21 U.S.C. §
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`505(j)(2)(A)(vii)(IV) indicating that the claims of the ’832, ’150, and ’514 patents are invalid,
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`unenforceable, and/or will not be infringed by the commercial manufacture, use, or sale of the
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`proposed ANDA products.
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`25.
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`Counterclaim-Plaintiff Watson Laboratories, Inc. (Nevada) submitted ANDA No.
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`207087 to obtain FDA approval to engage in the commercial manufacture, use, and sale of the
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`proposed ANDA products described therein before the expiration of the ’832, ’150, and ’514
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`patents.
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`26.
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`ANDA No. 207087 contains Paragraph IV certifications indicating that the claims
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`of the ’832, ’150, and ’514 patents are invalid, unenforceable, and/or will not be infringed by the
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`commercial manufacture, use, or sale of the proposed ANDA products.
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`27.
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`On October 8, 2013, Counterclaim-Defendants filed a complaint against Watson
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`Laboratories, Inc. (Nevada) alleging infringement of the ’832 and ’150 patents.
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`28.
`
`On February 18, 2014, Counterclaim-Defendants filed an amended complaint
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`against Watson Laboratories, Inc. (Nevada) alleging infringement of the ’832, ’150, and ’514
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`patents.
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`29. Watson Laboratories, Inc. (Nevada) subsequently transferred ownership of ANDA
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`Nos. 204383 and 207087 to Actavis Laboratories UT, Inc.
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`30.
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`On June 4, 2015, Counterclaim-Defendants filed their second amended complaint
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`against Counterclaim-Plaintiffs Watson Laboratories, Inc. (Nevada) and Actavis Laboratories UT,
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`Inc. alleging infringement of the ’832, ’150, and ’514 patents.
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`COUNT I
`(Dismissal of Watson Laboratories, Inc. (Nevada))
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`31.
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`Counterclaim-Plaintiffs repeat and re-allege the allegations in paragraphs 1-30
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`above as if fully set forth here.
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`32. Watson Laboratories, Inc. (Nevada) is no longer a party-in-interest with respect to
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`ANDA Nos. 204383 and 207087.
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`33. Watson Laboratories, Inc. (Nevada) is entitled to dismissal as a named defendant
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`in Counterclaim-Defendants’ second amended complaint for lack of subject matter jurisdiction.
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`COUNT II
`(Declaratory Judgment of Noninfringement of the ‘832 Patent)
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`34.
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`Counterclaim-Plaintiffs repeat and re-allege the allegations in paragraphs 1-33
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`above as if fully set forth here.
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`35.
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`The manufacture, use, sale, offer for sale and/or importation of the proposed ANDA
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`products will not infringe, directly or indirectly, any valid or enforceable claim of the ’832 patent.
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`36.
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`There is an actual and justiciable controversy between the parties concerning
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`whether the manufacture, use, offering for sale or importation of the proposed ANDA products
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`will infringe the ’832 patent.
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`37.
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`Counterclaim-Plaintiffs are entitled to a judicial declaration that they have not
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`infringed and do not infringe—literally or under the doctrine of equivalents, directly or indirectly,
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`by inducement or contribution—any valid claim of the ’832 patent.
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`COUNT III
`(Declaratory Judgment of Noninfringement of the ‘150 Patent)
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`38.
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`Counterclaim-Plaintiffs repeat and re-allege the allegations in paragraphs 1-37
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`above as if fully set forth here.
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`39.
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`The manufacture, use, sale, offer for sale and/or importation of the proposed ANDA
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`products will not infringe, directly or indirectly, any valid or enforceable claim of the ’150 patent.
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`40.
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`There is an actual and justiciable controversy between the parties concerning
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`whether the manufacture, use, offering for sale or importation of the proposed ANDA products
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`will infringe the ’150 patent.
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`41.
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`Counterclaim-Plaintiffs are entitled to a judicial declaration that they have not
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`infringed and do not infringe—literally or under the doctrine of equivalents, directly or indirectly,
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`by inducement or contribution—any valid claim of the ’150 patent.
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`COUNT IV
`(Declaratory Judgment of Non-Infringement of the ‘514 Patent)
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`42.
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`Counterclaim-Plaintiffs repeat and re-allege the allegations in paragraphs 1-41
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`above as if fully set forth here.
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`43.
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`The manufacture, use, sale, offer for sale and/or importation of the proposed ANDA
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`products will not infringe, directly or indirectly, any valid or enforceable claim of the ’514 patent.
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`44.
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`There is an actual and justiciable controversy between the parties concerning
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`whether the manufacture, use, offering for sale or importation of the proposed ANDA products
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`will infringe the ’514 patent.
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`45.
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`Counterclaim-Plaintiffs are entitled to a judicial declaration that they have not
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`infringed and do not infringe—literally or under the doctrine of equivalents, directly or indirectly,
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`by inducement or contribution—any valid claim of the ’514 patent.
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`COUNT V
`(Declaratory Judgment of Invalidity of the ‘832 Patent)
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`46.
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`Counterclaim-Plaintiffs repeat and re-allege the allegations in paragraphs 1-45
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`above as if fully set forth here.
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`47.
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`On information and belief, the asserted claims of the ’832 patent are invalid for
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`failure to comply with the statutory prerequisites of Title 35 of the United States Code, including
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`without limitation, one or more of sections 101, 102, 103, 111, 112, 116, 132, 135, 256 and 287,
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`and/or the doctrine of obviousness-type double patenting.
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`48.
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`There is an actual and justiciable controversy between the parties concerning
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`whether the ’832 patent claims are valid.
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`49.
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`Counterclaim-Plaintiffs are entitled to a judicial declaration that the asserted claims
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`of the ’832 patent are invalid.
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`COUNT VI
`(Declaratory Judgment of the Invalidity of the ‘150 Patent)
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`50.
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`Counterclaim-Plaintiffs repeat and re-allege the allegations in paragraphs 1-49
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`above as if fully set forth here.
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`51.
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`On information and belief, the asserted claims of the ’150 patent are invalid for
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`failure to comply with the statutory prerequisites of Title 35 of the United States Code, including
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`without limitation, one or more of sections 101, 102, 103, 111, 112, 116, 132, 135, 256 and 287,
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`and/or the doctrine of obviousness-type double patenting.
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`52.
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`There is an actual and justiciable controversy between the parties concerning
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`whether the ’150 patent claims are valid.
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`53.
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`Counterclaim-Plaintiffs are entitled to a judicial declaration that the asserted claims
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`of the ’150 patent are invalid.
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`COUNT VII
`(Declaratory Judgment of the Invalidity of the ‘514 Patent)
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`54.
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`Counterclaim-Plaintiffs repeat and re-allege the allegations in paragraphs 1-53
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`above as if fully set forth here.
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`55.
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`On information and belief, the asserted claims of the ’514 patent are invalid for
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`failure to comply with the statutory prerequisites of Title 35 of the United States Code, including
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`without limitation, one or more of sections 101, 102, 103, 111, 112, 116, 132, 135, 256 and 287,
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`and/or the doctrine of obviousness-type double patenting.
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`56.
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`There is an actual and justiciable controversy between the parties concerning
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`whether the ’514 patent claims are valid.
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`57.
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`Counterclaim-Plaintiffs are entitled to a judicial declaration that the asserted claims
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`of the ’514 patent are invalid.
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`PRAYER FOR RELIEF
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`WHEREFORE, Counterclaim-Plaintiffs pray that the Court enter judgment in their favor
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`and against Counterclaim-Defendants as follows:
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`a.
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`Dismissing Defendant/Counterclaim-Plaintiff Watson Laboratories, Inc.
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`(Nevada) as a named defendant in the second amended complaint;
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`b.
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`Dismissing the second amended complaint with prejudice and denying each
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`request for relief made by Plaintiffs/Counterclaim-Defendants;
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`c.
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`Declaring that the filing of ANDA No. 204383 has not infringed, does not
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`infringe, and would not infringe any valid and enforceable claims of the ’832, ’150, and/or ’514
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`patents;
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`d.
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`Declaring that the filing of ANDA No. 207087 has not infringed, does not
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`infringe, and would not infringe any valid and enforceable claims of the ’832, ’150, and/or ’514
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`patents;
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`e.
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`Declaring that the manufacture, use, sale, offer for sale, and/or importation
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`in the United States of the proposed ANDA products that are the subject of ANDA Nos. 204383
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`and/or 207087 does not, and will not, infringe any valid and enforceable claim of the ’832, ’150
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`and/or ’514 patents;
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`f.
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`Declaring that the asserted claims of the ’832, ’150 and/or ’514 patents are
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`invalid;
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`g.
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`h.
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`U.S.C. § 285; and
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`Awarding Counterclaim-Plaintiffs their costs and expenses in this action;
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`Awarding Counterclaim-Plaintiffs their attorneys’ fees pursuant to 35
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`i.
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`Awarding other and further relief as this Court deems just and proper.
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`Dated: July 6, 2015
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`Respectfully Submitted,
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` __/s/ John C. Phillips, Jr.___________
`John C. Phillips, Jr. (#110)
`Megan C. Haney (#5016)
`PHILLIPS, GOLDMAN & SPENCE, P.A.
`1200 North Broom Street
`Wilmington, DE 19806
`(302) 655-4200 (telephone)
`(302) 655-4210 (facsimile)
`jcp@pgslaw.com
`mch@pgslaw.com
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`Attorneys for Defendants
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`Case 1:13-cv-01674-RGA Docum