Case 1:15-cv-01016-RGA Document 1 Filed 11/04/15 Page 1 of 13 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`C.A. No. __________________
`
`))))))))))))
`
`INDIVIOR INC., INDIVIOR UK LIMITED,
`and MONOSOL RX, LLC,
`
`v.
`
`Plaintiffs,
`
`MYLAN TECHNOLOGIES INC., MYLAN
`PHARMACEUTICALS INC., and MYLAN
`N.V.,
`
`Defendants.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Indivior Inc. (formerly known as Reckitt Benckiser Pharmaceuticals Inc.)
`
`(“Indivior”), Indivior UK Limited (formerly known as RB Pharmaceuticals Limited) (“Indivior
`
`UK”), and MonoSol Rx, LLC (“MonoSol”) (collectively, “Plaintiffs”) file this Complaint against
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`Defendants Mylan Technologies Inc. (“MTI”), Mylan Pharmaceuticals Inc. (“MPI”), and Mylan
`
`N.V. (collectively, “Mylan” or “Defendants”) and allege as follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for patent infringement arising under the Food and Drug Laws
`
`and Patent Laws of the United States, Titles 21 and 35 of the United States Code, respectively,
`
`arising from MTI’s submission of an Abbreviated New Drug Application (“ANDA”) to the Food
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`and Drug Administration (“FDA”) seeking approval to manufacture, use, and sell a generic
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`version of Plaintiffs’ Suboxone® sublingual film prior to the expiration of United States Patent
`
`Nos. 8,475,832 (“the ʼ832 patent”), 8,017,150 (“the ʼ150 patent”), and 8,603,514 (“the ’514
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`patent”) (collectively, “the patents-in-suit”).
`
`Par Pharm., Inc., et al.
`Exhibit 1027
`Page 001
`
`

`

`Case 1:15-cv-01016-RGA Document 1 Filed 11/04/15 Page 2 of 13 PageID #: 2
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`THE PARTIES
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`2.
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`Plaintiff Indivior is a Delaware corporation having a principal place of business at
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`10710 Midlothian Turnpike, Suite 430, Richmond, Virginia.
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`3.
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`Plaintiff Indivior UK is a United Kingdom corporation having a principal place of
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`business at 103-105 Bath Road, Slough, UK.
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`4.
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`Plaintiff MonoSol is a Delaware limited liability corporation having a principal
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`place of business at 30 Technology Drive, Warren, New Jersey.
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`5.
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`On information and belief, MTI is a West Virginia corporation having a principal
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`place of business at 110 Lake Street, Saint Albans, Vermont.
`
`6.
`
`On information and belief, MPI is a corporation organized and existing under the
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`laws of the State of West Virginia and has a principal place of business at 781 Chestnut Ridge
`
`Road, Morgantown, West Virginia. MPI has registered to do business in Delaware. MPI
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`maintains a registered agent in Delaware. MPI may be served with process in Delaware via the
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`Corporation Service Company, 2711 Centerville Road, Suite 400, Wilmington, Delaware.
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`7.
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`On information and belief, Mylan N.V. is a corporation organized and existing
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`under the laws of the Netherlands, having a place of business at Building 4, Trident Place,
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`Mosquito Way, Hatfield, Hertfordshire, AL10 9UL, England.
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`JURISDICTION AND VENUE
`
`8.
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`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
`
`§§ 1331, 1338(a), 2201, and 2202.
`
`9.
`
`On information and belief, Mylan is in the business of, inter alia, developing,
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`manufacturing, obtaining regulatory approval, marketing, selling, and distributing generic copies
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`of branded pharmaceutical products in Delaware and throughout the United States.
`
`2
`
`Par Pharm., Inc., et al.
`Exhibit 1027
`Page 002
`
`

`

`Case 1:15-cv-01016-RGA Document 1 Filed 11/04/15 Page 3 of 13 PageID #: 3
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`10.
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`This Court has personal jurisdiction over MTI because of, inter alia, MTI’s
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`continuous and systematic contacts with the State of Delaware; its previous submission to the
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`jurisdiction of this judicial district, including, inter alia, by affirmatively invoking this Court’s
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`jurisdiction by filing counterclaims in this District; and its marketing and sales activities in this
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`judicial district, including, but not limited to, the substantial, continuous, and systematic
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`distribution, marketing, and/or sales of generic pharmaceutical products to residents of this
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`judicial district. Further, MTI has registered pursuant to Del. Code. Ann. Tit. 24 § 2540 to
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`distribute generic pharmaceutical products in Delaware and holds current and valid
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`“Distributor/Manufacturer CSR” and “Pharmacy-Wholesale” licenses from the Delaware Board
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`of Pharmacy.
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`11.
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`This Court has personal jurisdiction over MPI at least because MPI has registered
`
`to do business in Delaware and maintains a registered agent in Delaware, and because MPI may
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`be served with process in Delaware via its registered agent, the Corporation Service Company,
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`2711 Centerville Road, Suite 400, Wilmington, DE 19808. Further, MPI has registered pursuant
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`to Del. Code. Ann. Tit. 24 § 2540 to distribute generic pharmaceutical products in Delaware and
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`holds current and valid “Distributor/Manufacturer CSR” and “Pharmacy-Wholesale” licenses
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`from the Delaware Board of Pharmacy. MPI has also availed itself of the protections of this
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`Court as a plaintiff in this District.
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`12.
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`This Court has personal jurisdiction over Mylan N.V. at least under Fed. R. Civ.
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`P. 4(k)(2), and because Mylan N.V., MPI, and MTI operate as an integrated, unitary
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`pharmaceutical business, whereby, on information and belief, Mylan N.V. controls and/or
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`dominates subsidiaries MTI and MPI.
`
`3
`
`Par Pharm., Inc., et al.
`Exhibit 1027
`Page 003
`
`

`

`Case 1:15-cv-01016-RGA Document 1 Filed 11/04/15 Page 4 of 13 PageID #: 4
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`13. Mylan holds itself out and publicly represents itself as a single global entity. For
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`example, Mylan N.V. reports revenue on a consolidated basis that includes its subsidiaries MTI
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`and MPI. Mylan N.V.’s August 6, 2015 Quarterly Report states that Mylan has a consolidated
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`“Generics” segment that conducts business on a global basis. On information and belief, Mylan
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`N.V. issues press releases for its subsidiaries MPI and/or MTI regarding FDA approval of
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`generic drugs, commercialization of generic drugs, and litigations involving the filing of ANDAs
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`or NDAs.
`
`14.
`
`On information and belief, Mylan N.V., MPI, and MTI have an integrated
`
`management structure, including overlapping officers and directors.
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`15.
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`This Court also has personal jurisdiction over each of the Defendants because
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`upon information and belief (1) MPI and MTI have submitted to jurisdiction in this District in
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`patent cases, including Endo Pharms. Inc. v. Mylan Techs. Inc., C.A. No. 11-220-GMS; and (2)
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`Mylan has purposefully availed itself of the privilege of doing business in the State of Delaware
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`by continuously and systematically placing goods into the stream of commerce for distribution
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`throughout the United States including the State of Delaware, and/or by selling, directly or
`
`through its agents, pharmaceutical products in the State of Delaware.
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`16.
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`Upon information and belief, Defendants are agents of each other and/or work in
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`concert with each other with respect to the development, regulatory approval, marketing, sale,
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`and distribution of pharmaceutical products throughout the United States including in Delaware.
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`Such products include the generic buprenorphine hydrochloride and naloxone hydrochloride
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`sublingual film (“Mylan’s generic product”) that is described in ANDA No. 207607.
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`17.
`
`On information and belief, MTI, as the agent of Mylan N.V., and in concert with
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`MPI, sent or caused to be sent a letter dated September 23, 2015 to Plaintiff Indivior and Plaintiff
`
`4
`
`Par Pharm., Inc., et al.
`Exhibit 1027
`Page 004
`
`

`

`Case 1:15-cv-01016-RGA Document 1 Filed 11/04/15 Page 5 of 13 PageID #: 5
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`Monosol, corporations organized under the laws of the State of Delaware, stating that MTI had
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`submitted ANDA No. 207607 seeking approval to commercially manufacture, use, import, offer
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`for sale and sell Mylan’s generic product (the “Notification Letter”). Mylan purposefully
`
`directed its activities to Plaintiff Indivior and Plaintiff Monosol, both Delaware corporations.
`
`18.
`
`On information and belief, if ANDA No. 207607 is approved, the generic product
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`will, among other things, be marketed and distributed by Mylan, directly and/or through its
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`agents, in Delaware, and/or prescribed by physicians practicing and dispensed by pharmacies
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`located within Delaware.
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`19.
`
`On information and belief, Mylan intends its generic product to be distributed and
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`sold in the United States, including in Delaware.
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`20.
`
`Venue is proper in this District under 28 U.S.C. §§ 1391 and 1400.
`
`THE PATENTS-IN-SUIT
`
`21.
`
`Plaintiff Indivior UK is the lawful owner of the ʼ832 patent, and Plaintiff Indivior
`
`is an exclusive licensee of the ’832 patent. The ʼ832 patent, entitled “Sublingual and Buccal Film
`
`Compositions,” was duly and legally issued on July 2, 2013, naming Garry L. Myers, Samuel D.
`
`Hilbert, Bill J. Boone, B. Arlie Bogue, Pradeep Sanghvi, and Madhusudan Hariharan as
`
`inventors. A true copy of the ’832 patent is attached hereto as Exhibit A.
`
`22.
`
`Plaintiff MonoSol is the lawful owner of the ʼ150 patent, and Plaintiff Indivior is
`
`an exclusive licensee of the ʼ150 patent. The ʼ150 patent, entitled “Polyethylene Oxide-Based
`
`Films and Drug Delivery Systems Made Therefrom,” was duly and legally issued on September
`
`13, 2011, naming Robert K. Yang, Richard C. Fuisz, Garry L. Myers, and Joseph M. Fuisz as
`
`inventors. A true copy of the ʼ150 patent is attached hereto as Exhibit B.
`
`23.
`
`Plaintiff MonoSol is the lawful owner of the ʼ514 patent, and Plaintiff Indivior is
`
`an exclusive licensee of the ʼ514 patent. The ʼ514 patent, entitled “Uniform Films for Rapid
`
`5
`
`Par Pharm., Inc., et al.
`Exhibit 1027
`Page 005
`
`

`

`Case 1:15-cv-01016-RGA Document 1 Filed 11/04/15 Page 6 of 13 PageID #: 6
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`Dissolve Dosage Form Incorporating Taste-Masking Compositions,” was duly and legally issued
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`on December 10, 2013, naming Robert K. Yang, Richard C. Fuisz, Garry L. Myers, and Joseph
`
`M. Fuisz as inventors. A true copy of the ʼ514 patent is attached hereto as Exhibit C.
`
`SUBOXONE® SUBLINGUAL FILM
`
`24.
`
`Plaintiff Indivior is the holder of New Drug Application (“NDA”) No. 22-410 for
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`Suboxone® (buprenorphine hydrochloride and naloxone hydrochloride) sublingual film.
`
`25.
`
`On August 30, 2010, the FDA approved NDA No. 22-410 for the manufacture,
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`marketing, and sale of Suboxone® sublingual film for the treatment of opioid dependence.
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`Plaintiff Indivior has sold Suboxone® sublingual film under NDA No. 22-410 since its approval.
`
`26.
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`The patents-in-suit are listed in the FDA’s Approved Drug Products with
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`Therapeutic Equivalence Evaluations (the “Orange Book”) as covering Suboxone® sublingual
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`film.
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`THE DRUG APPROVAL PROCESS
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`27.
`
`In 1984, Congress enacted the Drug Price Competition and Patent Term
`
`Restoration Act, commonly known as the “Hatch-Waxman Act” and codified at 21 U.S.C. § 355.
`
`The Hatch-Waxman Act was intended to balance two important public policy goals. First,
`
`Congress wanted to ensure that innovator drug manufacturers would have meaningful patent
`
`protection and a period of marketing exclusivity to enable them to recoup their investments in
`
`the development of valuable new drugs. Second, Congress sought to ensure that, once the patent
`
`protection and marketing exclusivity for these drugs expire, consumers would benefit from the
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`availability of lower priced generic versions of approved drugs.
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`28.
`
`Under 21 U.S.C. § 355(b)(1), the innovator drug manufacturer and NDA
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`applicant is required to submit extensive testing and safety information concerning the drug. In
`
`6
`
`Par Pharm., Inc., et al.
`Exhibit 1027
`Page 006
`
`

`

`Case 1:15-cv-01016-RGA Document 1 Filed 11/04/15 Page 7 of 13 PageID #: 7
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`addition, the NDA applicant must submit information on “any patent which claims the drug for
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`which the applicant submitted the application or which claims a method of using such drug and
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`with respect to which a claim of patent infringement could reasonably be asserted.” Once the
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`NDA is approved, the FDA lists this patent information in the Orange Book.
`
`29.
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`In contrast, the Hatch-Waxman Act allows ANDA applicants to obtain FDA
`
`approval for generic versions of previously-approved drugs without having to repeat the
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`extensive testing required for a new drug application. Under 21 U.S.C. § 355(j), ANDAs can rely
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`on FDA’s previous findings of safety and efficacy for an approved drug product, if they
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`demonstrate, among other things, that the generic drug is bioequivalent to the previously-
`
`approved drug.
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`30. When a generic manufacturer submits an ANDA, the FDA conducts a preliminary
`
`review of the application to ensure it is sufficiently complete to permit a substantive review. See
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`21 C.F.R. § 314.101(b)(1). “Receipt of an [ANDA] means that FDA has made a threshold
`
`determination that the abbreviated application is sufficiently complete to permit a substantive
`
`review.” Id.
`
`31.
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`Under 21 U.S.C. § 355(j)(2)(A)(vii), the ANDA must also include one of the
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`following four certifications with respect to each of the patents listed in the Orange Book for the
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`previously-approved drug product: (i) that the patent information has not been filed (“Paragraph
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`I” certifications); (ii) that the patent has expired (“Paragraph II” certifications); (iii) that the
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`patent will expire on a specific date, and the generic will stay off the market until that date
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`(“Paragraph III” certifications); or (iv) that the “patent is invalid or will not be infringed by the
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`manufacture, use, or sale of the new drug for which the application is submitted” (“Paragraph
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`IV” certifications).
`
`7
`
`Par Pharm., Inc., et al.
`Exhibit 1027
`Page 007
`
`

`

`Case 1:15-cv-01016-RGA Document 1 Filed 11/04/15 Page 8 of 13 PageID #: 8
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`32.
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`If the ANDA includes a Paragraph IV certification, the Hatch-Waxman Act
`
`requires the ANDA applicant to give notice (“notice of Paragraph IV certification”) to the patent
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`owner of the factual and legal basis for the applicant’s opinion that patents listed in the Orange
`
`Book are invalid or will not be infringed, “not later than 20 days after the date of the postmark on
`
`the notice with which the [FDA] informs the applicant that the application has been filed.” 21
`
`U.S.C. § 355(j)(2)(B).
`
`33.
`
`The patent owner can file an infringement action within 45 days of receiving the
`
`notice of Paragraph IV certification. Such a filing by the patent owner triggers a 30-month
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`injunction or stay of the FDA approval, beginning on the date of receipt of the notice. See 21
`
`U.S.C. § 355(j)(5)(B)(iii). This 30-month period is intended to allow time for judicial resolution
`
`on the merits of any patent infringement, validity, and/or enforceability claims, before the
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`competitor is allowed entry into the market.
`
`34.
`
`Federal regulations also govern the timing of the notice of Paragraph IV
`
`certification by directing the generic manufacturer to send such notice “when it receives from
`
`FDA an acknowledgment letter stating that its [ANDA] is sufficiently complete to permit a
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`substantive review.” 21 C.F.R. § 314.95(b).
`
`MYLAN’S PARAGRAPH IV NOTICE
`
`35.
`
`Plaintiffs received the Notification Letter from Mylan dated September 23, 2015,
`
`stating that ANDA No. 207607 contains Paragraph IV certifications alleging that the ʼ832, ʼ150,
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`and ’514 patents are invalid, unenforceable, and/or will not be infringed by the manufacture, use,
`
`or sale of the generic product proposed in the ANDA.
`
`36.
`
`The Notification Letter further states that Mylan submitted ANDA No. 207607 to
`
`the FDA under 21 U.S.C. § 355(j), seeking approval to engage in commercial manufacture, use,
`
`8
`
`Par Pharm., Inc., et al.
`Exhibit 1027
`Page 008
`
`

`

`Case 1:15-cv-01016-RGA Document 1 Filed 11/04/15 Page 9 of 13 PageID #: 9
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`and/or sale of Mylan’s generic product before expiration of the patents-in-suit. On information
`
`and belief, ANDA No. 207607 refers to and relies on Plaintiff Indivior’s NDA for Suboxone®
`
`sublingual film and purports to contain data showing bioequivalence of Mylan’s generic product
`
`with Suboxone® sublingual film.
`
`37.
`
`Plaintiffs commenced this action within 45 days of receiving the Notification
`
`Letter.
`
`38.
`
`39.
`
`COUNT I
`(Infringement of the ʼ832 Patent Under 35 U.S.C. § 271(e)(2))
`
`Plaintiffs reallege paragraphs 1–37 above as if fully set forth herein.
`
`On information and belief, Mylan’s generic product is covered by one or more
`
`claims of the ʼ832 patent.
`
`40.
`
`By filing ANDA No. 207607 under 21 U.S.C. § 355(j) for the purposes of
`
`obtaining approval to engage in the commercial manufacture, use, and/or sale of Mylan’s generic
`
`product prior to the expiration of the ʼ832 patent, Mylan has committed an act of infringement of
`
`the ʼ832 patent under 35 U.S.C. § 271(e)(2).
`
`41.
`
`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(e)(4), including,
`
`inter alia, an order of this Court that the FDA set the effective date of approval for ANDA No.
`
`207607 to be a date which is not any earlier than the expiration date of the ʼ832 patent, including
`
`any extensions of that date.
`
`COUNT II
`(Infringement of the ʼ150 Patent Under 35 U.S.C. § 271(e)(2))
`
`Plaintiffs reallege paragraphs 1–41 above as if fully set forth herein.
`
`On information and belief, Mylan’s generic product is covered by one or more
`
`42.
`
`43.
`
`claims of the ʼ150 patent.
`
`9
`
`Par Pharm., Inc., et al.
`Exhibit 1027
`Page 009
`
`

`

`Case 1:15-cv-01016-RGA Document 1 Filed 11/04/15 Page 10 of 13 PageID #: 10
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`44.
`
`By filing ANDA No. 207607 under 21 U.S.C. § 355(j) for the purposes of
`
`obtaining approval to engage in the commercial manufacture, use, and/or sale of Mylan’s generic
`
`product prior to the expiration of the ʼ150 patent, Mylan has committed an act of infringement of
`
`the ʼ150 patent under 35 U.S.C. § 271(e)(2).
`
`45.
`
`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(e)(4), including,
`
`inter alia, an order of this Court that the FDA set the effective date of approval for ANDA No.
`
`207607 to be a date which is not any earlier than the expiration date of the ʼ150 patent, including
`
`any extensions of that date.
`
`COUNT III
`(Infringement of the ʼ514 Patent Under 35 U.S.C. § 271(e)(2))
`
`Plaintiffs reallege paragraphs 1–45 above as if fully set forth herein.
`
`On information and belief, Mylan’s generic product is covered by one or more
`
`46.
`
`47.
`
`claims of the ʼ514 patent.
`
`48.
`
`By filing ANDA No. 207607 under 21 U.S.C. § 355(j) for the purposes of
`
`obtaining approval to engage in the commercial manufacture, use, and/or sale of Mylan’s generic
`
`product prior to the expiration of the ʼ514 patent, Mylan has committed an act of infringement of
`
`the ʼ514 patent under 35 U.S.C. § 271(e)(2).
`
`49.
`
`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(e)(4), including,
`
`inter alia, an order of this Court that the FDA set the effective date of approval for ANDA No.
`
`207607 to be a date which is not any earlier than the expiration date of the ʼ514 patent, including
`
`any extensions of that date.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request that this Court enter:
`
`10
`
`Par Pharm., Inc., et al.
`Exhibit 1027
`Page 010
`
`

`

`Case 1:15-cv-01016-RGA Document 1 Filed 11/04/15 Page 11 of 13 PageID #: 11
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`A.
`
`A judgment that Mylan has infringed each of the patents-in-suit under 35 U.S.C.
`
`§ 271(e)(2) by submitting and maintaining ANDA No. 207607;
`
`B.
`
`Preliminary and permanent injunctions, restraining and enjoining Mylan, its
`
`officers, agents, attorneys, affiliates, divisions, successors and employees, and those acting in
`
`privity or concert with them, from engaging in, causing, or inducing the commercial
`
`manufacture, use, offer to sell, or sale within the United States, or importation into the United
`
`States, of drugs and formulations, or from inducing and/or encouraging the use of methods,
`
`claimed in the patents-in-suit;
`
`C.
`
`An order that the effective date of any approval of ANDA No. 207607 be a date
`
`that is not earlier than the expiration of the last to expire of the patents-in-suit, including any
`
`extensions thereof and any later expiration of exclusivity associated with those patents;
`
`D.
`
`A judgment and order finding that this is an exceptional case within the meaning
`
`of 35 U.S.C. § 285 and awarding to Plaintiffs their reasonable attorneys’ fees;
`
`E.
`
`A judgment granting Plaintiffs compensatory damages in an amount to be
`
`determined at trial including both pre-judgment and post-judgment interest if Mylan
`
`commercially manufactures, uses, offers to sell, or sells in the United States, or imports into the
`
`United States, Mylan’s generic product before the expiration of each patent-in-suit that Mylan is
`
`found to infringe, including any extensions; and
`
`F.
`
`Any and all other relief as the Court deems just and proper.
`
`11
`
`Par Pharm., Inc., et al.
`Exhibit 1027
`Page 011
`
`

`

`Case 1:15-cv-01016-RGA Document 1 Filed 11/04/15 Page 12 of 13 PageID #: 12
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`Dated: November 4, 2015
`
`Respectfully submitted,
`
`OF COUNSEL:
`
`WOMBLE CARLYLE SANDRIDGE & RICE, LLP
`
`/s/ Mary W. Bourke
`Mary W. Bourke (#2356)
`Dana K. Severance (#4869)
`222 Delaware Avenue, Suite 1501
`Wilmington, DE 19801
`(302) 252-4320
`(302) 252-4330 (Fax)
`mbourke@wcsr.com
`dseverance@wcsr.com
`
`Counsel for Plaintiffs
`
`Daniel A. Ladow
`James M. Bollinger
`Timothy P. Heaton
`J. Magnus Essunger
`TROUTMAN SANDERS LLP
`875 Third Avenue
`New York, NY 10022
`(212) 704-6000
`(212) 704-6288 (Fax)
`daniel.ladow@troutmansanders.com
`james.bollinger@troutmansanders.com
`timothy.heaton@troutmansanders.com
`magnus.essunger@troutmansanders.com
`
`Jeffrey B. Elikan
`Jeffrey H. Lerner
`Erica N. Andersen
`COVINGTON & BURLING LLP
`One CityCenter
`850 10th St. NW
`Washington, DC 20001
`(202) 662-6000
`(202) 662-6291 (Fax)
`jelikan@cov.com
`jlerner@cov.com
`eandersen@cov.com
`
`Counsel for Plaintiffs Indivior Inc. & Indivior UK
`Limited
`
`James F. Hibey
`Timothy C. Bickham
`STEPTOE & JOHNSON LLP
`1330 Connecticut Avenue, NW
`Washington, DC 20036
`(202) 429-3000
`(202) 429-3902 (Fax)
`jhibey@steptoe.com
`tbickham@steptoe.com
`
`12
`
`Par Pharm., Inc., et al.
`Exhibit 1027
`Page 012
`
`

`

`Case 1:15-cv-01016-RGA Document 1 Filed 11/04/15 Page 13 of 13 PageID #: 13
`
`Cassandra A. Adams
`STEPTOE & JOHNSON LLP
`1114 Avenue of the Americas
`New York, NY 10039
`(212) 506-3900
`(212) 506-3950 (Fax)
`cadams@steptoe.com
`
`Counsel for Plaintiff MonoSol Rx, LLC
`
`13
`
`Par Pharm., Inc., et al.
`Exhibit 1027
`Page 013
`
`