Case 1:14-cv-00422-RGA Document 1 Filed 04/04/14 Page 1 of 16 PageID #: 1
`Case 1:14-cv-00422-RGA Document 1 Filed 04/04/14 Page 1 of 16 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
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`RECKITT BENCKISER
`
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED, and
`
`MONOSOL RX, LLC,
`
`v.
`
`Plaintiffs,
`
`PAR PHARMACEUTICAL, INC, and
`INTELGENX TECHNOLOGIES CORR,
`
`Defendants.
`
`vvvvvvvvvvvv
`
`CA. No.
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`
`COMPLAINT FOR PATENT INFRINGEMENT
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`Plaintiffs Reckitt Benckiser Pharmaceuticals Inc. (“RBP”), RB Pharmaceuticals Limited
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`(“RBP UK”), and MonoSol Rx, LLC (“MonoSol”) (collectively, “Plaintiffs”) file this Complaint
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`against Defendants Par Pharmaceutical, Inc. (“Par”), and IntelGenX Technologies Corp. (“IGX”)
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`and allege as follows:
`
`
`NATURE OF THE ACTION
`
`1.
`
`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,
`
`arising from Defendant Par’s submission of an Abbreviated New Drug Application (“ANDA”) to
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`the Food and Drug Administration (“FDA”) seeking approval to manufacture and sell a generic
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`version of Plaintiff RBP’S Suboxone® sublingual film prior to the expiration of United States
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`Patent Nos. 8,475,832 (“the ’832 patent”) and 8,017,150 (“the ’150 patent”), and 8,603,514 (“the
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`’514 patent”) (collectively, “the patents-in—suit”).
`
`2.
`
`Plaintiffs also seek a declaratory judgment that: (1) some of Defendant Par’s
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`notices of Paragraph IV certification are premature, null and void, and ineffective to trigger the
`
`Par v. MonoSol
`IPR2017-001557
`MONOSOL EX. 2002
`
`

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`ANDA patent litigation process in Case No. 1:13-cv-Ol46l—RGA; and (2) there is no subject
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`matter jurisdiction over Plaintiffs’ claims and Defendants’ counterclaims in Case No. l:l3~cv-
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`01461-RGA because Defendant Par’s premature notices are null and void.
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`THE PARTIES
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`3.
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`Plaintiff RBP 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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`4.
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`Plaintiff RBP 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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`5.
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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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`6.
`
`On information and belief, Defendant Par is a Delaware corporation having a
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`principal place of business at One Ram Ridge Road, Spring Valley, New York 10977.
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`7.
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`On information and belief, Defendant IGX is a Delaware corporation having a
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`principal place of business at 6425 Abrams, Ville St-Laurent (Quebec), Canada.
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`
`JURISDICTION AND VENUE
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`8.
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`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
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`§§ 1331, 1338(a), 2201, and 2202.
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`9.
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`On information and belief, Par is in the business of making and selling generic
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`pharmaceutical products, which it distributes, markets, and/or sells in Delaware and throughout
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`the United States.
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`10.
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`Par has previously submitted to the jurisdiction of the United States District Court
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`for the District of Delaware, for example by bringing the patent infringement suit Par
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`Pharmaceutical Inc. v. Breckenridge Pharmaceutical Inc, CA. No. 13—1 1 l4-SLR.
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`

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`11.
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`This Court has personal jurisdiction over Par because of, inter alia, Par’s
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`incorporation in Delaware, its continuous and systematic contacts with corporate entities within
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`this judicial district, its previous submission to the jurisdiction of this judicial district, and its
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`marketing and sales activities in this judicial district, including, but not limited to, the substantial,
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`continuous, and systematic distribution, marketing, and/or sales of generic pharmaceutical
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`products to residents of this judicial district.
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`12.
`
`On information and belief, IGX is a drug delivery company focused on the
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`development of oral controlled-release products as well as rapidly disintegrating delivery
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`systems.
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`13.
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`IGX, directly or through its affiliates, has previously submitted to the jurisdiction
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`of the United States District Court for the District of Delaware, for example by voluntarily
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`substituting in as defendant in the patent infringement suit Btovaz’l Laboratories International
`
`SRL v. IntelGenx Corp, CA. No. 09-605—LPS.
`
`14.
`
`This Court has personal jurisdiction over IGX because of, inter alia, IGX’s
`
`incorporation in Delaware, its continuous and systematic contacts with corporate entities within
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`this judicial district, and its previous submission to the jurisdiction of this judicial district.
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`15.
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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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`16.
`
`Plaintiff RBP UK is the lawful owner of the ’832 patent, and Plaintiff RBP is an
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`exclusive licensee of the ’832 patent. The ’832 patent, entitled “Sublingual and Buccal Film
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`Compositions,” duly and legally issued on July 2, 2013, naming Garry L. Myers, Samuel D.
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`Hillbert, 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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`

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`17.
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`Plaintiff MonoSol is the lawful owner of the ’ 150 patent, and Plaintiff RBP is an
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`exclusive licensee of the ’150 patent. The ’150 patent, entitled “Polyethylene Oxide-Based
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`Films and Drug Delivery Systems Made Therefrom,” duly and legally issued on September 13,
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`2011, naming Robert K. Yang, Richard C. Fuisz, Garry L. Myers, and Joseph M. Fuisz as
`
`inventors. A true copy of the ’150 patent is attached hereto as Exhibit B.
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`18.
`
`Plaintiff MonoSol is the lawful owner of the ’5 l4 patent, and Plaintiff RBP is an
`
`exclusive licensee of the ’5 l4 patent. The ”514 patent, entitled “Uniform Films for Rapid
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`Dissolve Dosage Form Incorporating Taste-Masking Compositions,” duly and legally issued on
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`December 10, 2013, naming Robert K. Yang, Richard C. Fuisz, Garry L. Myers, and Joseph M.
`
`Fuisz as inventors. A true copy of the ’5 14 patent is attached hereto as Exhibit C.
`
`
`SUBOXONE® SUBLINGUAL FILM
`
`19.
`
`Plaintiff RBP 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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`20.
`
`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 maintenance treatment of opioid
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`dependence. Plaintiff RBP has sold Suboxone® sublingual film under NDA No. 22-410 since its
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`approval.
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`21.
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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.
`
`
`THE DRUG APPROVAL PROCES§
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`22.
`
`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.
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`

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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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`23.
`
`Under 21 U.S.C. § 355(b)(l), 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
`
`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 its Approved Drug Products with
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`Therapeutic Equivalence Evaluations, commonly known as the “Orange Book.”
`
`24.
`
`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
`
`extensive testing required for a new drug application. Under 21 U.S.C. § 35 50), ANDAs can
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`rely 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.
`
`25.
`
`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
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`

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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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`26.
`
`Under 21 U.S.C. § 3550)(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 (“Paragraph III” certifications); or (iv) that the “patent is
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`invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the
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`application is submitted” (“Paragraph IV certifications”).
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`27.
`
`Paragraph IV certifications can allow generic manufacturers to obtain FDA
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`approval long before expiration of the patents listed in the Orange Book.
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`28.
`
`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
`
`U.S.C. § 3550)(2)(B).
`
`29.
`
`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
`
`injunction or stay of the FDA approval, beginning on the date of receipt of the notice. See 21
`
`U.S.C. § 3556)(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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`

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`30.
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`The date of receipt of the notice of Paragraph IV certification by the patent owner
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`affects important rights and remedies of the patent owner, including the deadline for filing an
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`infringement action and the start and end dates of the 30-month injunction. By providing a
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`premature notice of Paragraph IV certification to the NDA holder or patent owner, the ANDA
`
`applicant attempts to trigger the 30-month injunction earlier and to reach the market sooner than
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`it would otherwise be permitted. In addition, there is a significant risk for the patent owner to
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`miss the 45 —day deadline for filing an infringement action, and consequently the opportunity for
`
`a 30-month injunction, if the patent owner mistakenly relies on a premature and ineffective
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`notice of Paragraph IV certification.
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`31.
`
`The ANDA applicant may not send the notice of Paragraph IV certification to the
`
`patent owner before the FDA “informs the applicant that the application has been filed.” 21
`
`U.S.C. § 3550)(2)(B)(ii)(l); SB Pharmco Puerlo Rico, Inc. v. Mut. Pharm. C0., Inc., 552 F.
`
`Supp. 2d 500, 508 (ED. Pa. 2008); Orsuka Pharm. Co. v. Par Pharm, Ina, Docket No. 13-1979
`
`(D. Del. March 10, 2014) (Andrews, J.).
`
`32.
`
`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
`
`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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`DEFENDANTS’ ANDA AND PREMATURE
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`NOTICES OF PARAGRAPH IV CERTIFICATION
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`33.
`
`Plaintiffs received a letter from Defendant Par dated July 8, 2013 (the “July 2013
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`Notice Letter”), stating that ANDA No. 20-5854 contains a certification pursuant to 21 U.S.C. §
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`3550)(2)(A)(vii)(IV) (a “Paragraph IV certification”) alleging that the ”832 and ’ 150 patents are
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`

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`invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale of the
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`generic product proposed in the ANDA.
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`34.
`
`The July 2013 Notice Letter further states that Defendant Par submitted ANDA
`
`No. 20—5854 to the FDA under 21 U.S.C. § 3550), seeking approval to engage in the commercial
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`manufacture, use, and/or sale of buprenorphine hydrochloride and naloxone hydrochloride
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`sublingual film (“Defendants’ generic product”) before expiration of the patents-in-suit.
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`35.
`
`On information and belief, ANDA No. 20—5854 refers to and relies on Plaintiff
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`RBP’s NDA for Suboxone® sublingual film and purports to contain data showing
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`bioequivalence of Defendants’ generic product with Suboxone® sublingual film.
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`36.
`
`On information and belief, ANDA No. 20—5854 was prepared and submitted with
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`the active cooperation, participation, and assistance of, and at least in part for the benefit of,
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`Defendant IGX. On information and belief, if ANDA No. 20-5 854 is approved, IGX will
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`actively participate in manufacturing, marketing, and/or selling Defendants’ generic product.
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`37.
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`On information and belief, IGX designed Defendants’ generic product that is the
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`subject of Defendant Par’s ANDA No. 20-5854.
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`38.
`
`On information and belief, Defendants’ generic product that is the subject of
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`Defendant Par’s ANDA No. 20—5 854 includes IGX’s VersaFilmTM drug delivery technology.
`
`39.
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`IGX filed statements with the SEC in 2013 asserting that IGX’S “US. based co-
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`development and commercialization partner” submitted an ANDA to the FDA for approval of a
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`generic formulation of Plaintiff RBP’S Suboxone® sublingual film, indicated for maintenance
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`treatment of opioid dependence.
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`40.
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`Plaintiffs filed suit against Defendants in this judicial district on August 20, 2013
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`(Case No. 1 :13-cv—0146l -RGA), within 45 days of receiving the July 2013 Notice Letter.
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`

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`41.
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`Plaintiffs received another letter from Defendant Par dated February 3, 2014 (“the
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`’5 14 Notice Letter”), stating that ANDA No. 20—5 854 contains a Paragraph IV certification
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`pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV), alleging that the ’5 l4 patent is invalid and/or will
`
`not be infringed by the manufacture, use, or sale of the generic product proposed in the ANDA.
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`42.
`
`Plaintiffs amended their complaint in Case No. 1:13-cv-01461—RGA on February
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`18, 2014, within 45 days of receiving the ’5 14 Notice Letter, to further assert the infringement of
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`the ’514 Patent under 35 U.S.C. § 271(c)(2).
`
`43.
`
`Plaintiffs received yet another letter from Defendant Par dated March 25, 2014
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`(the “March 2014 Notice Letter”), repeating that ANDA No. 20—5854 contains a Paragraph IV
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`certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) alleging that the ”832, ’150, and ”514
`
`patents are invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale
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`of the generic product proposed in the ANDA.
`
`44.
`
`The March 2014 Notice Letter further states that Defendant Par submitted ANDA
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`No. 20-5854 to the FDA under 21 U.S.C. § 35 5 (j), seeking approval to engage in the commercial
`
`manufacture, use, and/or sale of Defendants’ generic product, i.e. buprenorphine hydrochloride
`
`and naloxone hydrochloride sublingual film, before expiration of the patents-in—suit.
`
`45.
`
`Unlike the earlier notices of Paragraph IV certifications (which include the July
`
`2013 Notice Letter and the ’5 14 Notice Letter), the March 2014 Notice Letter represents that the
`
`FDA “has received [ANDA No. 20-5854] for substantive review.”
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`46.
`
`On information and belief, Defendant Par’s earlier notices of Paragraph IV
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`certifications, which predate the March 2014 Notice Letter, were sent before receiving the
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`FDA’s acknowledgment letter stating that ANDA No. 20-5854 is sufficiently complete to permit
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`a substantive review.
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`

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`47.
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`Recent authority from this judicial district demonstrates that Defendant Par’s I
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`earlier notices of Paragraph IV certifications, which predate the March 2014 Notice Letter, are
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`premature and ineffective to trigger the 45-day period for filing an infringement action and the
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`30-month injunction on FDA approval of Defendants’ ANDA No. 20-5854. See Otsuka Pharm.
`
`Co. v. Par Pharm, Ina, Docket No. 13-1979 (D. Del. March 10, 2014) (Andrews, J.).
`
`48.
`
`Plaintiffs commenced this action within 45 days of receiving the March 2014
`
`Notice Letter, to preserve their right to a 30—month stay under 21 U.S.C. 355(j)(5)(B)(iii).
`
`9211111.!
`(Declaratory Judgment)
`
`49.
`
`Plaintiffs reallege paragraphs 1-48 above as if fully set forth herein.
`
`50.
`
`On information and belief, Defendant Par’s earlier notices of Paragraph IV
`
`certifications, which predate the March 2014 Notice Letter, were sent before receiving the
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`FDA’s letter stating that ANDA No. 20-5854 is sufficiently complete to permit a substantive
`
`review.
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`51.
`
`Defendant Par’s earlier notices of Paragraph IV certifications, which predate the
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`March 2014 Notice Letter, are premature, null and void, and ineffective to trigger the 45-day
`
`period for filing an infringement action and the 30-month injunction on FDA approval of ANDA
`
`No. 20-5 854.
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`52.
`
`A11 actual, substantial, and justiciable controversy exists between Defendants and
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`Plaintiffs regarding whether Defendant Par’s earlier notices of Paragraph IV certifications, which
`
`predate the March 2014 Notice Letter, are premature, null, void, and ineffective to trigger the
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`ANDA litigation process in Case No. 1:13—cv—Ol461-RGA.
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`53.
`
`The controversy concerning the validity and effectiveness of Defendant Par’s
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`earlier notices of Paragraph IV certifications, which predate the March 2014 Notice Letter, will
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`10
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`

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`cause Plaintiffs to suffer substantial prejudice and irreparable harm, unless the controversy and
`
`its surrounding uncertainty are resolved by the Court. Defendant Par attempts to trigger the 30-
`
`month injunction earlier and to reach the market sooner than it would otherwise be permitted. In
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`addition, there is a significant risk for Plaintiffs to miss the 45-day deadline for filing an
`
`infringement action, and consequently the opportunity for a 30-month injunction, if they
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`mistakenly rely on Defendant Par’s premature and ineffective notices of Paragraph IV
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`certification.
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`54.
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`Plaintiffs are entitled to a declaration that: (1) Defendant Par’s earlier notices of
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`Paragraph IV certifications, which predate the March 2014 Notice Letter, are premature, null and
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`void, and ineffective to trigger the ANDA patent litigation process in Case No. 1:13-cv-0146l-
`
`RGA; (2) Defendant Par’s earlier notices of Paragraph IV certifications, which predate the
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`March 2014-Notice Letter, did not trigger the 45-day period for filing an infringement action and
`
`the 30—month injunction on FDA approval of Defendants’ ANDA No. 20-5 854; and (3) there is
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`no subject matter jurisdiction over Plaintiffs’ claims and Defendants’ counterclaims in Case No.
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`1:13-cv-0146l—RGA because Defendant Par’s earlier notices of Paragraph IV certifications,
`
`which predate the March 2014 Notice Letter, are null and void.
`
`(Infringement 0f the ’832 Patent Under 35 U.S.C. § 271(c)(2))
`
`COUNT II
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`55.
`
`Plaintiffs reallege paragraphs 1-54 above as if fully set forth herein.
`
`56.
`
`On information and belief, Defendants’ generic product is covered by one or more
`
`claims of the ’832 patent.
`
`57.
`
`By filing ANDA No. 20-5854 under 21 U.S.C. § 3550) for the purposes of
`
`obtaining approval to engage in the commercial manufacture, use, sale and/or importation of
`
`11
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`

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`Defendants’ generic product prior to the expiration of the ’832 patent, Par has committed an act
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`of infringement of the ’832 patent under 35 U.S.C. § 271(e)(2).
`
`58.
`
`On information and belief, IGX was actively involved in the preparation and are
`
`actively involved in the prosecution before the FDA of ANDA No. 20-5854.
`
`59.
`
`IGX’S active assistance and involvement with the submission of ANDA No. 20-
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`5854 is an act of infringement of the ’832 patent under 35 U.S.C. § 271(c)(2).
`
`60.
`
`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(c)(4), including,
`
`inter alia, an order of this Court that the FDA set the effective date of approval for ANDA No.
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`20—5 854 to be a date which is not any earlier than the expiration date of the ’832 patent,
`
`including any extensions of that date.
`
`29.12.15.111;
`(Infringement of the ’150 Patent Under 35 U.S.C. § 271(c)(2))
`
`61.
`
`Plaintiffs reallege paragraphs 1-60 above as if fully set forth herein.
`
`62.
`
`On information and belief, Defendants” generic product is covered by one or more
`
`claims of the ’150 patent.
`
`63.
`
`By filing ANDA No. 20—5854 under 21 U.S.C. § 3550) for the purposes of
`
`obtaining approval to engage in the commercial manufacture, use, sale and/or importation of
`
`Defendants’ generic product prior to the expiration of the ’ 150 patent, Par has committed an act
`
`of infringement of the ’150 patent under 35 U.S.C. § 271(e)(2).
`
`64.
`
`On information and belief, IGX was actively involved in the preparation and are
`
`actively involved in the prosecution before the FDA of ANDA No. 20—5854.
`
`65.
`
`IGX’s active assistance and involvement with the submission of ANDA No. 20-
`
`5854 is an act of infringement of the ’150 patent under 35 U.S.C. § 271(c)(2).
`
`12
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`66.
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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.
`
`20—5854 to be a date which is not any earlier than the expiration date of the ’150 patent,
`
`including any extensions of that date.
`
`(Infringement of the ’514 Patent Under 35 U.S.C. § 271(c)(2))
`
`COUNT IV
`
`67.
`
`Plaintiffs reallege paragraphs 1-66 above as if fully set forth herein.
`
`68.
`
`On information and belief, Defendants’ generic product is covered by one or more
`
`claims of the ’5 l4 patent.
`
`69.
`
`ANDA No. 20-5854 under 21 U.S.C. § 3550) seeks to obtain approval to engage
`
`in the commercial manufacture, use, sale and/or importation of Defendants’ generic product prior
`
`to the expiration of the ’5 l4 patent. Therefore, Par’s maintenance of this filing constitutes an act
`
`of infringement of the ’5 14 patent under 35 U.S.C. § 271(c)(2).
`
`70.
`
`On information and belief, IGX was actively involved in the preparation and are
`
`actively involved in the prosecution before the FDA of ANDA No. 20-5854.
`
`71.
`
`IGX’s active assistance and involvement with the submission of ANDA No. 20-
`
`5854 is an act of infringement of the ’514 patent under 35 U.S.C. § 271(c)(2).
`
`72.
`
`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 271(c)(4), including,
`
`inter alia, an order of this Court that the FDA set the effective date of approval for ANDA No.
`
`20-5 854 to be a date which is not any earlier than the expiration date of the ’5 14 patent,
`
`including any extensions of that date.
`
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request that this Court:
`
`13
`
`

`

`Case 1:14-cv-00422-RGA Document 1 Filed 04/04/14 Page 14 of 16 PageID #: 14
`Case 1:14-cv-00422-RGA Document 1 Filed 04/04/14 Page 14 of 16 PageID #: 14
`
`A.
`
`Preliminarily and permanently enjoin Par to withdraw its earlier notices of
`
`Paragraph IV certifications, which predate the March 2014 Notice Letter;
`
`B.
`
`Enter a declaratory judgment that: (1) Defendant Par’s earlier notices of
`
`Paragraph IV certifications, which predate the March 2014 Notice Letter, are premature, null and
`
`void, and ineffective to trigger the ANDA patent litigation process in Case No. 1:13-cv-01461-
`
`RGA; (2) Defendant Par’s earlier notices of Paragraph IV certifications, which predate the
`
`March 2014 Notice Letter, did not trigger the 45—day period for filing an infringement action and
`
`the 30—month injunction on FDA approval of Defendants’ ANDA No. 20-5854; and (3) there is
`
`no subject matter jurisdiction over Plaintiffs’ claims and Defendants’ counterclaims in Case No.
`
`1:13-cv—01461-RGA because Defendant Par’s earlier notices of Paragraph IV certifications,
`
`which predate the March 2014 Notice Letter, are null and void;
`
`C.
`
`Enter a judgment that Defendants have infringed each of the patents-in-suit under
`
`35 U.S.C. § 271(c)(2) by submitting and maintaining ANDA No. 20-5854;
`
`D.
`
`Enter preliminary and permanent injunctions, restraining and enjoining
`
`Defendants, their 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;
`
`E.
`
`Enter an order that the effective date of any approval of ANDA No. 20-5854 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;
`
`14
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`

`

`Case 1:14-cv-00422-RGA Document 1 Filed 04/04/14 Page 15 of 16 PageID #: 15
`Case 1:14-cv-00422-RGA Document 1 Filed 04/04/14 Page 15 of 16 PageID #: 15
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`F.
`
`Enter 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;
`
`G.
`
`Enter a judgment granting Plaintiffs compensatory damages in an amount to be
`
`determined at trial including both pre-j udgment and post-judgment interest if Defendants
`
`commercially manufacture, use, offer to sell, or sell in the United States, or import into the
`
`United States, Defendants’ generic product before the expiration of each patent—in-suit that
`
`Defendants are found to infringe, including any extensions; and
`
`H.
`
`Order any and all other relief as the Court deems just and proper.
`
`Dated: April 4, 2014
`
`Respectfully submitted,
`
`WOMBLE CARLYLE SANDRIDGE &
`
`RICE, LLP
`
`_/s/Mar 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
`
`Attorneys for Plaintififv
`
`Of Counsel:
`
`Daniel A. Ladow
`
`James M. Bollinger
`Timothy P. Heaton
`TROUTMAN SANDERS LLP
`
`405 Lexington Avenue
`New York, NY 10174
`
`15
`
`

`

`Case 1:14-cv-00422-RGA Document 1 Filed 04/04/14 Page 16 of 16 PageID #: 16
`Case 1:14-cv-00422-RGA Document 1 Filed 04/04/14 Page 16 of 16 PageID #: 16
`
`(212) 704—6000
`(212) 704—5 929 (Fax)
`daniel.1adow@troutmansanders.com
`james.bo11inger@troutmansanders.com
`timothy.heaton@troutmansanders.com
`
`Troy S. Kieckley
`Puja R. Patel
`TROUTMAN SANDERS LLP
`
`600 Peachtree Street, NE
`Suite 5200
`
`Atlanta, GA 30308
`(404) 885—3000
`(404) 885—3900
`troy.kleckley@troutmansanders.com
`puj a.pate1@troutmansanders.com
`
`Attorneys for Plaintififs
`Reckitt Benckiser Pharmaceuticals Inc.
`and RB Pharmaceuticals Limited
`
`Of Counsel:
`
`James F. Hibey
`Timothy C. Bickham
`STEPTOE & JOHNSON LLP
`
`13 3 0 Connecticut Avenue, NW
`
`Washington DC 20036
`(202) 429-3000
`(202) 429-3902 (Fax)
`jhibey@steptoe.com
`tbickham@steptoe.com
`
`Attorneys for Plaintifl
`MonoSol Rx, LLC
`
`31213852
`
`16
`
`