Case 1:14-cv-00843-RGA Document 1 Filed 06/27/14 Page 1 of 7 PageID #: 1
`Case 1:14—cv—OO843—RGA Document 1 Filed 06/27/14 Page 1 of 7 Page|D #: 1
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`PAR PHARMACEUTICAL, INC,
`
`Plaintiff,
`
`V.
`
`NOVARTIS PHARMACEUTICALS
`
`CORPORATION, NOVARTIS AG,
`
`NOVARTIS PHARMA AG, NOVARTIS
`INTERNATIONAL PIIARMACEUTICAL
`
`. LTD. and LTS LOHMANN THERAPIE—
`
`SYSTEME AG,
`
`Defendants.
`
`C.A. No.
`
`COMPLAINT
`
`Par Pharmaceutical, Inc. (“Par”), for its Complaint against Novartis Pharmaceuticals
`
`Corporation, Novartis AG, Novartis Pharma AG, Novartis International Pharmaceutical Ltd. and
`
`LTS Lohmann Therapie—Systemc AG (collectively, “Defendants”), alleges as follows:
`
`NATURE OF ACTION
`
`1.
`
`Par seeks declaratory judgment of non—infringement and invalidity of U.S. Patent
`
`No. 6,316,023 (“the ’023 patent”) pursuant to the Patent Laws of the United States, 35 U.S.C. §§
`
`100 et seq., the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j)(5)(C)(i), and the
`
`Declaratory Judgment Act, 28 U.S.C. §§ 2201 et Seq.
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`RLF1 l045U329v.l
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`Case 1:14—cv—OO843—RGA Document 1 Filed 06/27/14 Page 1 of 7 Page|D #: 1
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`PAR PHARMACEUTICAL, INC,
`
`Plaintiff,
`
`V.
`
`NOVARTIS PHARMACEUTICALS
`
`CORPORATION, NOVARTIS AG,
`
`NOVARTIS PHARMA AG, NOVARTIS
`INTERNATIONAL PIIARMACEUTICAL
`
`. LTD. and LTS LOHMANN THERAPIE—
`
`SYSTEME AG,
`
`Defendants.
`
`C.A. No.
`
`COMPLAINT
`
`Par Pharmaceutical, Inc. (“Par”), for its Complaint against Novartis Pharmaceuticals
`
`Corporation, Novartis AG, Novartis Pharma AG, Novartis International Pharmaceutical Ltd. and
`
`LTS Lohmann Therapie—Systemc AG (collectively, “Defendants”), alleges as follows:
`
`NATURE OF ACTION
`
`1.
`
`Par seeks declaratory judgment of non—infringement and invalidity of U.S. Patent
`
`No. 6,316,023 (“the ’023 patent”) pursuant to the Patent Laws of the United States, 35 U.S.C. §§
`
`100 et seq., the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j)(5)(C)(i), and the
`
`Declaratory Judgment Act, 28 U.S.C. §§ 2201 et Seq.
`
`RLF1 l045U329v.l
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`
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`Case 1:14-cv-00843-RGA Document 1 Filed 06/27/14 Page 2 of 7 PageID #: 2
`Case 1:14—cv—OO843—RGA Document 1 Filed 06/27/14 Page 2 of 7 Page|D #: 2
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`PARTIES
`
`2.
`
`Par Pharmaceutical, Inc. is a corporation organized and existing under the laws of
`
`the State of Delaware, having a place of business at 300 Tice Boulevard, Woodcliff Lake, New
`
`Jersey 07677.
`
`3.
`
`Upon information and belief, Novartis Pharmaceuticals Corporation is a
`
`corporation organized and existing under the laws of the State of Delaware, having a principal
`
`place of business at 59 Route 10, East Hanover, New Jersey 0793 6.
`
`4.
`
`Upon information and belief, Novartis AG is a corporation organized and existing
`
`under the laws of Switzerland, having an office and place of business at Lichtstrasse 35, CH-
`
`4056 Basel, Switzerland.
`
`5.
`
`Upon information and belief, Novartis Pharma AG is a corporation organized and
`
`existing under the laws of Switzerland, having an office and place of business at Lichtstrasse 35,
`
`CH-4056 Basel, Switzerland.
`
`6.
`
`Upon information and belief, Novartis International Pharmaceutical Ltd. is a
`
`corporation organized and existing under the laws of Bermuda, having an office and place of
`
`business at 131 Front Street, Hamilton HM12, Bermuda.
`
`7.
`
`Upon information and belief, LTS Lohmann Therapie—Systeme AG is a
`
`corporation organized and existing under the laws of Germany, having an office and place of
`
`business at Lohmannstralie 2, D-56626 Andernach, Germany.
`
`JURISDICTION AND VENUE
`
`8.
`
`This Court has subject matter jurisdiction over this action under 28 U.S.C. §§
`
`1331 and 1338(a), and 2201(a); 21 U.S.C. § 355(j)(5)(C)(i)(II); and 35 U.S.C. § 27l(e)(5).
`
`RLFI i0450329v.l
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`9.
`
`This Court has personal jurisdiction over Defendants based on, inter alia,
`
`Defendants’ filing of related lawsuits in this jurisdiction, in Novartis Pkarms. Corp. er al. v. Par
`
`Pkarm., Inc., Case Nos. 11—1077-RGA and 13—l467—RGA (D. Del.).
`
`10.
`
`Venue is proper in this judicial district under 28 U.S.C. §§ l39l(b)-(d), l400(b),
`
`and Defendants’ choice of forum.
`
`FACTUAL BACKGROUND
`
`11.
`
`U.S. Patent No. 6,316,023 (“the ‘O23 patent”) entitled “TTS containing an
`
`antioxidant,” issued on November 13, 2001. A copy of the ‘O23 patent is attached hereto as
`
`Exhibit A.
`
`12.
`
`On information and belief, Novartis AG and LTS Lohmann Therapie-Systeme
`
`AG are the assignees of the ’023 patent.
`
`13.
`
`On information and belief, Novartis Pharmaceuticals Corporation is the holder of
`
`New Drug Application No. 022083 (“NDA 022083”) for rivastigmine transdermal extended.
`
`release film, 4.6 mg/24 hr, 9.5 mg/24 hr and 13.3 mg/24 hr, marketed under the brand name
`
`Exe1on® Patch. In connection with NDA 022083, Novartis Pharmaceuticals Corporation caused
`
`the US. Food and Drug Administration (“FDA”) to list U.S. Patent No. 6,335,031 (“the ‘O31
`
`patent”) and the ’023 patent in the Approved Drug Products with Therapeutic Equivalence
`
`Evaluations (“Orange Book”).
`
`14.
`
`Par submitted to the FDA an Abbreviated New Drug Application (“ANDA”)
`
`requesting regulatory approval to engage in the commercial manufacture, use, or sale of
`
`rivastigmine transdermal extended release film, 13.3 mg/24 hr (“Par’s Rivastigmine Product”)
`
`before the expiration of the Orange Book patents listed for Exe1on® Patch. Par made
`
`certifications pursuant to 21 U.S.C. § 35 5(j)(2)(A)(vii)(lV) (“Paragraph IV Certifications”) that
`
`RLFI 104503 29v.l
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`
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`the ’03l and ‘O23 patents listed in the Orange Book for Exelon® Patch are invaiid,
`
`unenforceable, and/or will not be infringed by the commercial manufacture, use, or sale of Par’s
`
`Rivastigmine Product.
`
`15.
`
`Par has made substantial preparations for the commercial manufacture, use, and
`
`sale of Par’s Rivastigrnine Product.
`
`16.
`
`Defendants have previously asserted the ’031 patent against Pat in connection
`
`with Par’s filing of ANDA No. 202339 for its 13.3 mg/24 hr dosage strength rivastigrnine
`
`transdermal product. Novartis Pharms. Corp, er al. v. Par Pharm., Inc., Case No. 13-1467-
`
`RGA (D. Del).
`
`17.
`
`Defendants have previously asserted the ’031 and ’O23 patents against Par in
`
`connection with Par’s filing of ANDA No. 202339 for its 4.6 mg/24 hr and 9.5 rng/24 hr dosage
`
`strength rivastigrnine transdermal products. Novarris Pharms. Corp, er al. v. Par Pharm, Inc,
`
`Case No. ll—l077—RGA (D. Del.).
`
`18.
`
`Defendants have also asserted the ’03l and ’023 patents against another ANDA
`
`filer, Watson Laboratories, lnc., Actavis Pharma, Inc. (f/k/a Watson Pharma, lnc.), and Actavis,
`
`Inc. (f/k/a Watson Pharmaceuticals, Inc.) (collectively, “ActaVis”), in connection with Actavis’
`
`ANDA seeking approval to market a rivastigmine transdermal product, in Novartis Pharms.
`
`Corp, et al. v. Watson Labs, Inc, et 5211., Case Nos. ll-l l l2—RGA (D. Del.) and 13-371-RGA
`
`(D. Del.).
`
`19.
`
`Defendants have further asserted the ’03l and ’023 patents against additional
`
`ANDA filers, in connection with ANDAS seeking approval to market rivastigrnine transdermal
`
`products, in Novartis Pharms. Corp. et al. v. Alva-gen Pine Brook Inc, et 511., Case No. 13-52-
`
`RLF1 l045G329V.l
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`Case 1:14—cv—OO843—RGA Document 1 Filed 06/27/14 Page 5 of 7 Page|D #: 5
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`RGA (D. Del.), and Novarris Pharms. Corp. er al. V. Noven Pharm. Inc, Case Nos.l3—527 and
`
`14~l l l~RGA (D. Del).
`
`20.
`
`By listing the ’031 and “O23 patents in the Orange Book, and previously suing Par
`
`and other ANDA filers for alleged infringement of the ’03l and “O23 patents, Defendants’
`
`actions inject uncertainty into the pursuit of regulatory approval and subsequent
`
`commercialization of Par’s Rivastigmine Product.
`
`21.
`
`In response to Par’s ANDA filing and Paragraph IV certifications against the "031
`
`and ’023 patents, Defendants filed an infringement action selectively asserting only the ’03l
`
`patent, thus gaining the exclusionary benefit of an automatic 30-month stay of approval of Par’s
`
`ANDA while jeopardizing only the “O31 patent in litigation.
`
`22.
`
`Defendants did not assert the ’023 patent against Par for its 13.3 mg/24 hr dosage
`
`strength rivastigmine product within the statutory 45-day period following Defendants’ receipt of
`
`Par’s Notice Letter.
`
`23.
`
`35 U.S.C. § 271(c)(5) provides that the Court shall have subject matter
`
`jurisdiction under 28 U.S.C. § 2201 for a declaratory judgment claim that an Orange Book-listed
`
`patent that is not asserted during the statutory 45-day period is invalid and/or not infringed.
`
`24.
`
`Should Par prevail in the previously-filed litigation in which only the ’03l patent
`
`was asserted by Defendants, Par would still be faced with the threat of iitigation from Defendants
`
`over the ’023 patent, relating to Par’s Rivastigmine Product.
`
`25.
`
`A judgment that Par’s Rivastigtnine Product will not infringe the ’023 patent
`
`and/or that the patent is invalid will remove any independent barriers to competition that may
`
`exist by virtue of Defendants’ maintenance of the listing of the patents in the Orange Book in
`
`connection with NDA 022083 for Exelon® Patch.
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`R_LFl i0450329v.l
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`26.
`
`Upon information and belief, the first-filer for a 13.3 rng/24 hr rivastigmine
`
`transderrnal system, generic to Exelon® Patch, has not forfeited its l80—day exclusivity under 21
`
`U.S.C. § 355(j)(5)(D).
`
`27.
`
`Defendants’ actions have resuited in a substantial controversy regarding the ’023
`
`patent between Par and Defendants of sufficient immediacy and reality to warrant the issuance of
`
`a declaratory judgment that the ’(}23 patent is invalid and not infringed.
`
`COUNT ONE
`
`Deciaratory Judgment Regarding U.S. Patent No. 6,316,023
`
`28.
`
`The claims of the ’023 patent are invalid for failure to satisfy the requirements of
`
`Title 35 of the United States Code § 112.
`
`29.
`
`The filing of Par’s ANDA on Par’s Rivastigmine Product did not infringe any
`
`valid claim of the ’O23 patent.
`
`30.
`
`The commercial manufacture, use, offer for sale, sale, or importation of Par’s
`
`Rivastigmine Product would not infringe any valid claim of the ‘O23 patent.
`
`31.
`
`An actual and justiciable controversy exists between the parties with respect to the
`
`’023 patent, and Par is entitled to a declaratory judgment that the ’023 patent is invalid and not
`
`infringed by Par.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Par respectfully requests that this Court enter judgment in its favor and
`
`against Defendants and grant the following relief:
`
`A.
`
`B.
`
`Declare that the claims of the ‘O23 patent are invalid;
`
`Declare that the filing of Par’s ANDA on Par’s Rivastigrnine Product did not
`
`infringe any claim of the ’023 patent;
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`RLF1 lO450329v.l
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`
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`Case 1:14-cv-00843-RGA Document 1 Filed 06/27/14 Page 7 of 7 PageID #: 7
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`C.
`
`Declare that the manufacture, use, offer for sale, sale, marketing, distribution, or
`
`importation of Par’s Rivastigmine Product would not infringe any valid claim of the ’023 patent;
`
`D.
`
`Award Par its costs and reasonable attorney fees to the extent permitted by law;
`
`and
`
`E.
`
`Award Par such other and further relief as the Court deerns just and proper.
`
`Of Counsel:
`
`/s/ Steven J. Finemcm
`
`Steven J. Fineman (#4025)
`Katharine C. Lester (#5629)
`RICHARDS LAYTON & FINGER, PA
`
`One Rodney Square
`920 North King Street
`Wilmington, DE 19801
`(302) 651-7700
`Fineman@rlf.corn
`Lester@rlf.com
`
`Attomeysfor Plaimzfi”Par Pharmaceutical,
`Inc.
`
`Daniel G. Brown
`LATHAM & WATKINS LLP
`
`885 Third Avenue
`New York, NY 10022
`(212) 906-1200
`
`Roger J. Chin
`LATHAM & WATKINS LLP
`505 Montgomery Street
`Suite 2000
`San Francisco, CA 9411]
`
`(415) 906-1200
`
`Jennifer Koh
`
`LATHAM & WATKINS LLP
`
`12670 High Bluff Drive
`San Diego, CA 92130
`(858) 523-5400
`
`Dated: June 27, 2014
`
`RLF1 10450329v.1
`
`7
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