`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. __________________
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`))))))))))
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`INDIVIOR INC., INDIVIOR UK LIMITED,
`and MONOSOL RX, LLC,
`
`v.
`
`SANDOZ INC.
`
`Plaintiffs,
`
`Defendant.
`
`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Indivior Inc. (formerly known as Reckitt Benckiser Pharmaceuticals Inc.)
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`(“Indivior”), Indivior UK Limited (formerly known as RB Pharmaceuticals Limited) (“Indivior
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`UK”), and MonoSol Rx, LLC (“MonoSol”) (collectively, “Plaintiffs”) file this Complaint against
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`Defendant Sandoz Inc. (“Sandoz”) and allege as follows:
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`NATURE OF THE ACTION
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`1.
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`This is an action for patent infringement arising under the Food and Drug Laws
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`and Patent Laws of the United States, Titles 21 and 35 of the United States Code, respectively,
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`arising from Sandoz’s submission of an Abbreviated New Drug Application (“ANDA”) to the
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`Food 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
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`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”).
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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, Defendant Sandoz is a Colorado corporation having a
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`principal place of business at 100 College Road West, Princeton, New Jersey. On information
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`and belief, Sandoz has registered pursuant to Del. Code. Ann. Tit. 24 § 2540 to distribute generic
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`pharmaceutical products in Delaware and holds current and valid “Distributor/Manufacturer
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`CSR” and “Pharmacy-Wholesale” licenses from the Delaware Board of Pharmacy.
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`JURISDICTION AND VENUE
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`6.
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`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
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`§§ 1331 and 1338(a).
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`7.
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`On information and belief, Sandoz 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. Such
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`products include the generic buprenorphine hydrochloride and naloxone hydrochloride
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`sublingual film (“Sandoz’s generic product”) that is described in ANDA No. 205477.
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`8.
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`This Court has personal jurisdiction over Sandoz because of, inter alia, Sandoz’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, Sandoz has registered pursuant to Del. Code. Ann. Tit. 24 § 2540 to
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`2
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`Case 1:15-cv-01051-RGA Document 1 Filed 11/13/15 Page 3 of 11 PageID #: 3
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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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`9.
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`This Court also has personal jurisdiction over Sandoz because, upon information
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`and belief, Sandoz has submitted to jurisdiction in this District in patent cases, including, for
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`example, Cephalon Inc. v. Sandoz Inc. et al., 15-cv-00178-GMS; Forest Laboratories, LLC et al.
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`v. Apotex Corp. et al., 15-cv-00018-GMS; Sanofi et al. v. Sandoz Inc., 14-cv-01434-RGA; Teva
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`Pharms. USA, Inc. et al. v. Sandoz Inc., 14-cv-01171-GMS; Merck Sharp & Dohme Corp. v.
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`Sandoz Inc., 14-cv-00916-RGA; Allos Therapeutics, Inc. et al. v. Teva Pharms. USA, Inc. et al.,
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`14-cv-00778-RGA; and ALZA Corp. et al. v. Sandoz Inc., 14-cv-00744-RGA. This Court also
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`has personal jurisdiction over Sandoz because, upon information and belief, Sandoz has
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`affirmatively availed itself of this Court’s jurisdiction as a plaintiff, including, for example, in
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`Sandoz Inc. v. Pfizer, Inc. et al., 10-cv-00104-LPS.
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`10.
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`This Court also has personal jurisdiction over Sandoz because Sandoz has
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`purposefully availed itself of the privilege of doing business in the State of Delaware by
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`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
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`through its agents, pharmaceutical products in the State of Delaware.
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`11.
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`On information and belief, Sandoz sent or caused to be sent a letter dated October
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`1, 2015 to Plaintiff Indivior and Plaintiff MonoSol, corporations organized under the laws of the
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`State of Delaware, stating that Sandoz had submitted ANDA No. 205477 seeking approval to
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`commercially manufacture, use, import, offer for sale and sell Sandoz’s generic product (the
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`3
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`
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`Case 1:15-cv-01051-RGA Document 1 Filed 11/13/15 Page 4 of 11 PageID #: 4
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`“Notification Letter”). Sandoz purposefully directed its activities to Plaintiff Indivior and
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`Plaintiff Monosol, both Delaware corporations.
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`12.
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`On information and belief, if ANDA No. 205477 is approved, the generic product
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`will, among other things, be marketed and distributed by Sandoz, 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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`13.
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`On information and belief, Sandoz intends its generic product to be distributed
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`and sold in the United States, including in Delaware.
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`14.
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`Venue is proper in this District under 28 U.S.C. §§ 1391 and 1400.
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`THE PATENTS-IN-SUIT
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`15.
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`Plaintiff Indivior UK is the lawful owner of the ʼ832 patent, and Plaintiff Indivior
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`is an exclusive licensee of the ’832 patent. The ʼ832 patent, entitled “Sublingual and Buccal Film
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`Compositions,” was duly and legally issued on July 2, 2013, naming Garry L. Myers, Samuel D.
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`Hilbert, Bill J. Boone, B. Arlie Bogue, Pradeep Sanghvi, and Madhusudan Hariharan as
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`inventors. A true copy of the ’832 patent is attached hereto as Exhibit A.
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`16.
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`Plaintiff MonoSol is the lawful owner of the ʼ150 patent, and Plaintiff Indivior is
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`an exclusive licensee of the ʼ150 patent. The ʼ150 patent, entitled “Polyethylene Oxide-Based
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`Films and Drug Delivery Systems Made Therefrom,” was duly and legally issued on September
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`13, 2011, naming Robert K. Yang, Richard C. Fuisz, Garry L. Myers, and Joseph M. Fuisz as
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`inventors. A true copy of the ʼ150 patent is attached hereto as Exhibit B.
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`17.
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`Plaintiff MonoSol is the lawful owner of the ʼ514 patent, and Plaintiff Indivior is
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`an exclusive licensee of the ʼ514 patent. The ʼ514 patent, entitled “Uniform Films for Rapid
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`Dissolve Dosage Form Incorporating Taste-Masking Compositions,” was duly and legally issued
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`4
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`on December 10, 2013, naming Robert K. Yang, Richard C. Fuisz, Garry L. Myers, and Joseph
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`M. Fuisz as inventors. A true copy of the ʼ514 patent is attached hereto as Exhibit C.
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`SUBOXONE® SUBLINGUAL FILM
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`18.
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`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.
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`19.
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`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.
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`20.
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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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`21.
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`In 1984, Congress enacted the Drug Price Competition and Patent Term
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`Restoration Act, commonly known as the “Hatch-Waxman Act” and codified at 21 U.S.C. § 355.
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`The Hatch-Waxman Act was intended to balance two important public policy goals. First,
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`Congress wanted to ensure that innovator drug manufacturers would have meaningful patent
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`protection and a period of marketing exclusivity to enable them to recoup their investments in
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`the development of valuable new drugs. Second, Congress sought to ensure that, once the patent
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`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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`22.
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`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
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`addition, the NDA applicant must submit information on “any patent which claims the drug for
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`5
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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.
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`23.
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`In contrast, the Hatch-Waxman Act allows ANDA applicants to obtain FDA
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`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-
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`approved drug.
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`24. When a generic manufacturer submits an ANDA, the FDA conducts a preliminary
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`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
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`determination that the abbreviated application is sufficiently complete to permit a substantive
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`review.” Id.
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`25.
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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).
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`6
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`26.
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`If the ANDA includes a Paragraph IV certification, the Hatch-Waxman Act
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`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
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`Book are invalid or will not be infringed, “not later than 20 days after the date of the postmark on
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`the notice with which the [FDA] informs the applicant that the application has been filed.” 21
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`U.S.C. § 355(j)(2)(B).
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`27.
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`The patent owner can file an infringement action within 45 days of receiving the
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`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
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`U.S.C. § 355(j)(5)(B)(iii). This 30-month period is intended to allow time for judicial resolution
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`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.
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`28.
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`Federal regulations also govern the timing of the notice of Paragraph IV
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`certification by directing the generic manufacturer to send such notice “when it receives from
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`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).
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`SANDOZ’S PARAGRAPH IV NOTICE
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`29.
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`Plaintiffs received the Notification Letter from Sandoz dated October 1, 2015
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`stating that ANDA No. 205477 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,
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`or sale of the generic product proposed in the ANDA.
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`30.
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`The Notification Letter further states that Sandoz submitted ANDA No. 205477 to
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`the FDA under 21 U.S.C. § 355(j), seeking approval to engage in commercial manufacture, use,
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`7
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`Case 1:15-cv-01051-RGA Document 1 Filed 11/13/15 Page 8 of 11 PageID #: 8
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`and/or sale of Sandoz’s generic product before expiration of the patents-in-suit. On information
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`and belief, ANDA No. 205477 refers to and relies on Plaintiff Indivior’s NDA for Suboxone®
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`sublingual film and purports to contain data showing bioequivalence of Sandoz’s generic product
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`with Suboxone® sublingual film.
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`31.
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`Plaintiffs commenced this action within 45 days of receiving the Notification
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`Letter.
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`32.
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`33.
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`COUNT I
`(Infringement of the ʼ832 Patent Under 35 U.S.C. § 271(e)(2))
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`Plaintiffs reallege paragraphs 1–31 above as if fully set forth herein.
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`On information and belief, Sandoz’s generic product is covered by one or more
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`claims of the ʼ832 patent.
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`34.
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`By filing ANDA No. 205477 under 21 U.S.C. § 355(j) for the purposes of
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`obtaining approval to engage in the commercial manufacture, use, and/or sale of Sandoz’s
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`generic product prior to the expiration of the ʼ832 patent, Sandoz has committed an act of
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`infringement of the ʼ832 patent under 35 U.S.C. § 271(e)(2).
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`35.
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`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(e)(4), including,
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`inter alia, an order of this Court that the FDA set the effective date of approval for ANDA No.
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`205477 to be a date which is not any earlier than the expiration date of the ʼ832 patent, including
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`any extensions of that date.
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`COUNT II
`(Infringement of the ʼ150 Patent Under 35 U.S.C. § 271(e)(2))
`
`Plaintiffs reallege paragraphs 1–31 above as if fully set forth herein.
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`On information and belief, Sandoz’s generic product is covered by one or more
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`36.
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`37.
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`claims of the ʼ150 patent.
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`8
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`Case 1:15-cv-01051-RGA Document 1 Filed 11/13/15 Page 9 of 11 PageID #: 9
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`38.
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`By filing ANDA No. 205477 under 21 U.S.C. § 355(j) for the purposes of
`
`obtaining approval to engage in the commercial manufacture, use, and/or sale of Sandoz’s
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`generic product prior to the expiration of the ʼ150 patent, Sandoz has committed an act of
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`infringement of the ʼ150 patent under 35 U.S.C. § 271(e)(2).
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`39.
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`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(e)(4), including,
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`inter alia, an order of this Court that the FDA set the effective date of approval for ANDA No.
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`205477 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 1–31 above as if fully set forth herein.
`
`On information and belief, Sandoz’s generic product is covered by one or more
`
`40.
`
`41.
`
`claims of the ʼ514 patent.
`
`42.
`
`By filing ANDA No. 205477 under 21 U.S.C. § 355(j) for the purposes of
`
`obtaining approval to engage in the commercial manufacture, use, and/or sale of Sandoz’s
`
`generic product prior to the expiration of the ʼ514 patent, Sandoz has committed an act of
`
`infringement of the ʼ514 patent under 35 U.S.C. § 271(e)(2).
`
`43.
`
`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.
`
`205477 to be a date which is not any earlier than the expiration date of the ʼ514 patent, including
`
`any extensions of that date.
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`9
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`Case 1:15-cv-01051-RGA Document 1 Filed 11/13/15 Page 10 of 11 PageID #: 10
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`PRAYER FOR RELIEF
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`WHEREFORE, Plaintiffs respectfully request that this Court enter:
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`A.
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`A judgment that Sandoz has infringed each of the patents-in-suit by submitting
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`and maintaining ANDA No. 205477;
`
`B.
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`Preliminary and permanent injunctions, restraining and enjoining Sandoz, its
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`officers, agents, attorneys, affiliates, divisions, successors and employees, and those acting in
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`privity or concert with them, from engaging in, causing, or inducing the commercial
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`manufacture, use, offer to sell, or sale within the United States, or importation into the United
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`States, of drugs and formulations, or from inducing and/or encouraging the use of methods,
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`claimed in the patents-in-suit;
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`C.
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`An order that the effective date of any approval of ANDA No. 205477 be a date
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`that is not earlier than the expiration of the last to expire of the patents-in-suit, including any
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`extensions thereof and any later expiration of exclusivity associated with those patents;
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`D.
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`A judgment and order finding that this is an exceptional case within the meaning
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`of 35 U.S.C. § 285 and awarding to Plaintiffs their reasonable attorneys’ fees;
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`E.
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`A judgment granting Plaintiffs compensatory damages in an amount to be
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`determined at trial including both pre-judgment and post-judgment interest if Sandoz
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`commercially manufactures, uses, offers to sell, or sells in the United States, or imports into the
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`United States, Sandoz’s generic product before the expiration of each patent-in-suit that Sandoz
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`is found to infringe, including any extensions; and
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`F.
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`Any and all other relief as the Court deems just and proper.
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`10
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`Case 1:15-cv-01051-RGA Document 1 Filed 11/13/15 Page 11 of 11 PageID #: 11
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`Dated: November 13, 2015
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`Respectfully submitted,
`
`WOMBLE CARLYLE SANDRIDGE & RICE, LLP
`
`/s/Mary W. Bourke
`Mary W. Bourke (#2356)
`Dana K. Severance (#4869)
`Daniel M. Attaway (#5130)
`222 Delaware Avenue, Suite 1501
`Wilmington, DE 19801
`(302) 252-4320
`(302) 252-4330 (Fax)
`mbourke@wcsr.com
`dseverance@wcsr.com
`dattaway@wcsr.com
`
`Counsel for Plaintiffs Indivior Inc.,
`Indivior UK Limited, & MonoSol Rx, LLC
`
`OF COUNSEL:
`
`Daniel A. Ladow
`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
`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
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`11