Case 1:14-cv-01451-RGA Document 1 Filed 12/02/14 Page 1 of 10 PageID #: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`CA. No.
`
`)
`)
`)
`
`))
`
`)
`)
`
`))
`
`)
`
`RECKITT BENCKISER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`v.
`TEVA PHARMACEUTICALS USA, INC.,
`
`Plaintiffs,
`
`Defendant.
`
`COMPLAINT FOR PATENT INFRINGEMENT
`
`Plaintiffs Reckitt Benckiser Pharmaceuticals Inc. (“RBP”), RB Pharmaceuticals Limited
`
`(“RBP UK”), and MonoSol Rx, LLC (“MonoSol”) (collectively, “Plaintiffs”) file this Complaint
`
`against Defendant Teva Pharmaceuticals USA, Inc. (“Teva” or “Defendant”) 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 Defendant’s submission of an Abbreviated New Drug Application (“ANDA”) to the
`
`Food and Drug Administration (“FDA”) seeking approval to manufacture and sell a generic
`
`version of Plaintiff RBP's Suboxone® sublingual film prior to the expiration of United States
`
`Patent Nos. 8,475,832 (“the ‘832 patent”), 8,017,150 (“the ‘150 patent”), and 8,603,514 (“the
`
`‘514 patent”) (collectively, “the patents-in-suit”).
`
`THE PARTIES
`
`2.
`
`Plaintiff RBP is a Delaware corporation having a principal place of business at
`
`10710 Midlothian Turnpike, Suite 430, Richmond, Virginia.
`
`1
`
`MONOSOL RX EXHIBIT 2005 page 0001
`
`

`
`Case 1:14-cv-01451-RGA Document 1 Filed 12/02/14 Page 2 of 10 PageID #: 2
`
`3.
`
`Plaintiff RBP UK is a United Kingdom corporation having a principal place of
`
`business at 103-105 Bath Road, Slough, UK.
`
`4.
`
`Plaintiff MonoSol is a Delaware limited liability corporation having a principal
`
`place of business at 30 Technology Drive, Warren, New Jersey.
`
`5.
`
`On information and belief, Defendant Teva is a Delaware corporation having a
`
`principal place of business at 1090 Horsham Road, North Wales, Pennsylvania, 19454.
`
`JURISDICTION AND VENUE
`
`6.
`
`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
`
`§§ 1331 and 1338(a).
`
`7.
`
`On information and belief, Defendant is in the business of, inter alia, developing,
`
`manufacturing, obtaining regulatory approval, marketing, selling, and distributing generic copies
`
`of branded pharmaceutical products in Delaware and throughout the United States.
`
`8.
`
`This Court has personal jurisdiction over Teva because of, inter alia, Teva’s
`
`incorporation in Delaware, its continuous and systematic contacts with corporate entities within
`
`this judicial district, its previous submission to the jurisdiction of this judicial district, and its
`
`marketing and sales activities in this judicial district, including, but not limited to, the substantial,
`
`continuous, and systematic distribution, marketing, and/or sales of generic pharmaceutical
`
`products to residents of this judicial district.
`
`9.
`
`Venue is proper in this district under 28 U.S.C. §§ 1391 and 1400.
`
`THE PATENTS-IN-SUIT
`
`10.
`
`Plaintiff RBP UK is the lawful owner of the ‘832 patent, and Plaintiff RBP is an
`
`exclusive licensee of the ‘832 patent. The ‘832 patent, entitled “Sublingual and Buccal Film
`
`Compositions,” duly and legally issued on July 2, 2013, naming Garry L. Myers, Samuel D.
`
`2
`
`MONOSOL RX EXHIBIT 2005 page 0002
`
`

`
`Case 1:14-cv-01451-RGA Document 1 Filed 12/02/14 Page 3 of 10 PageID #: 3
`
`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.
`
`11.
`
`Plaintiff MonoSol is the lawful owner of the ‘150 patent, and Plaintiff RBP is an
`
`exclusive licensee of the ‘150 patent. The ‘150 patent, entitled “Polyethylene Oxide-Based Films
`
`and Drug Delivery Systems Made Therefrom,” 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 ‘150 patent is attached hereto as Exhibit B.
`
`12.
`
`Plaintiff MonoSol is the lawful owner of the ‘514 patent, and Plaintiff RBP is an
`
`exclusive licensee of the ‘514 patent. The ‘514 patent, entitled “Uniform Films for Rapid
`
`Dissolve Dosage Form Incorporating Taste-Masking Compositions,” duly and legally issued 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 '514 patent is attached hereto as Exhibit C.
`
`SUBOXONE® SUBLINGUAL FILM
`
`13.
`
`Plaintiff RBP is the holder of New Drug Application (“NDA”) No. 22-410 for
`
`Suboxone® (buprenorphine hydrochloride and naloxone hydrochloride) sublingual film.
`
`14.
`
`On August 30, 2010, the FDA approved NDA No. 22-410 for the manufacture,
`
`marketing, and sale of Suboxone® sublingual film for the maintenance treatment of opioid
`
`dependence. Plaintiff RBP has sold Suboxone® sublingual film under NDA No. 22-410 since its
`
`approval.
`
`15.
`
`The patents-in-suit are listed in the FDA’s Approved Drug Products with
`
`Therapeutic Equivalence Evaluations (the “Orange Book”) as covering Suboxone® sublingual
`
`film.
`
`3
`
`MONOSOL RX EXHIBIT 2005 page 0003
`
`

`
`Case 1:14-cv-01451-RGA Document 1 Filed 12/02/14 Page 4 of 10 PageID #: 4
`
`THE DRUG APPROVAL PROCESS
`
`16.
`
`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
`
`availability of lower priced generic versions of approved drugs.
`
`17.
`
`Under 21 U.S.C. § 355(b)(1), the innovator drug manufacturer and NDA
`
`applicant is required to submit extensive testing and safety information concerning the drug. In
`
`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
`
`with respect to which a claim of patent infringement could reasonably be asserted.” Once the
`
`NDA is approved, the FDA lists this patent information in its Approved Drug Products with
`
`Therapeutic Equivalence Evaluations, commonly known as the “Orange Book.”
`
`18.
`
`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. § 355(j), ANDAs can
`
`rely on FDA’s previous findings of safety and efficacy for an approved drug product, if they
`
`demonstrate, among other things, that the generic drug is bioequivalent to the previously-
`
`approved drug.
`
`4
`
`MONOSOL RX EXHIBIT 2005 page 0004
`
`

`
`Case 1:14-cv-01451-RGA Document 1 Filed 12/02/14 Page 5 of 10 PageID #: 5
`
`19. 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
`
`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.
`
`20.
`
`Under 21 U.S.C. § 355(j)(2)(A)(vii), the ANDA must also include one of the
`
`following four certifications with respect to each of the patents listed in the Orange Book for the
`
`previously-approved drug product: (i) that the patent information has not been filed (“Paragraph
`
`I” certifications); (ii) that the patent has expired (“Paragraph II” certifications); (iii) that the
`
`patent will expire on a specific date (“Paragraph III” certifications); or (iv) that the “patent is
`
`invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the
`
`application is submitted” (“Paragraph IV” certifications).
`
`21.
`
`Paragraph IV certifications can allow generic manufacturers to obtain FDA
`
`approval long before expiration of the patents listed in the Orange Book.
`
`22.
`
`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
`
`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).
`
`23.
`
`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
`
`injunction or stay of the FDA approval, beginning on the date of receipt of the notice. See 21
`
`5
`
`MONOSOL RX EXHIBIT 2005 page 0005
`
`

`
`Case 1:14-cv-01451-RGA Document 1 Filed 12/02/14 Page 6 of 10 PageID #: 6
`
`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
`
`competitor is allowed entry into the market.
`
`24.
`
`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
`
`substantive review.” 21 C.F.R. § 314.95(b).
`
`DEFENDANT’S ANDA
`
`25.
`
`Plaintiffs received a letter from Defendant dated October 17, 2014 (the
`
`“Notification Letter”), stating that ANDA No. 205806 contains a certification pursuant to 21
`
`U.S.C. § 355(j)(2)(B)(vii)(IV) (a “Paragraph IV certification”) alleging that the ‘832, ‘150 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.
`
`26.
`
`The Notification Letter further states that Defendant submitted ANDA No.
`
`205806 to the FDA under 21 U.S.C. § 355(j), seeking approval to engage in the commercial
`
`manufacture, use, and/or sale of buprenorphine hydrochloride and naloxone hydrochloride
`
`sublingual film (“Defendant's generic product”) before expiration of the patents-in-suit. On
`
`information and belief, ANDA No. 205806 refers to and relies on Plaintiff RBP’s NDA for
`
`Suboxone® sublingual film and purports to contain data showing bioequivalence of Defendant’s
`
`generic product with Suboxone® sublingual film.
`
`27.
`
`Plaintiffs commenced this action within 45 days of receiving the Notification
`
`Letter.
`
`6
`
`MONOSOL RX EXHIBIT 2005 page 0006
`
`

`
`Case 1:14-cv-01451-RGA Document 1 Filed 12/02/14 Page 7 of 10 PageID #: 7
`
`COUNT I
`(Infringement of the ‘832 Patent Under 35 U.S.C. § 271(e)(2))
`
`Plaintiffs reallege paragraphs 1-27 above as if fully set forth herein.
`
`On information and belief, Defendant’s generic product is covered by one or more
`
`28.
`
`29.
`
`claims of the ‘832 patent.
`
`30.
`
`By filing ANDA No. 205806 under 21 U.S.C. § 355(j) for the purposes of
`
`obtaining approval to engage in the commercial manufacture, use, sale and/or importation of
`
`Defendant’s generic product prior to the expiration of the ‘832 patent, Defendant has committed
`
`an act of infringement of the ‘832 patent under 35 U.S.C. § 271(e)(2).
`
`31.
`
`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.
`
`205806 to be a date which is not any earlier than the expiration date of the ‘832 patent, including
`
`any extensions of that date.
`
`COUNT II
`(Infringement of the ‘150 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, Defendant's generic product is covered by one or more
`
`32.
`
`33.
`
`claims of the ‘150 patent.
`
`34.
`
`By filing ANDA No. 205806 under 21 U.S.C. § 355(j) for the purposes of
`
`obtaining approval to engage in the commercial manufacture, use, sale and/or importation of
`
`Defendant’s generic product prior to the expiration of the ‘150 patent, Defendant has committed
`
`an act of infringement of the ‘150 patent under 35 U.S.C. § 271(e)(2).
`
`35.
`
`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.
`
`7
`
`MONOSOL RX EXHIBIT 2005 page 0007
`
`

`
`Case 1:14-cv-01451-RGA Document 1 Filed 12/02/14 Page 8 of 10 PageID #: 8
`
`205806 to be a date which is not any earlier than the expiration date of the ‘150 patent, including
`
`any extensions of that date.
`
`COUNT III
`(Infringement of the ‘514 Patent Under 35 U.S.C. § 271(e)(2))
`
`Plaintiffs reallege paragraphs 1-35 above as if fully set forth herein.
`
`On information and belief, Defendants’ generic product is covered by one or more
`
`36.
`
`37.
`
`claims of the ‘514 patent.
`
`38.
`
`ANDA No. 205806 under 21 U.S.C. § 355(j) 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 ‘514 patent. Therefore, Defendants’ maintenance of this filing constitutes
`
`an act of infringement of the ‘514 patent under 35 U.S.C. § 271(e)(2).
`
`39.
`
`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.
`
`205806 to be a date which is not any earlier than the expiration date of the ‘514 patent, including
`
`any extensions of that date.
`
`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request that this Court enter:
`
`A.
`
`A judgment that Defendant has infringed each of the patents-in-suit under 35
`
`U.S.C. § 271(e)(2) by submitting and maintaining ANDA No. 205806;
`
`B.
`
`Preliminary and permanent injunctions, restraining and enjoining Defendant, its
`
`officers, agents, attorneys, affiliates, divisions, successors and employees, and those acting in
`
`privity or concert with it, 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
`
`8
`
`MONOSOL RX EXHIBIT 2005 page 0008
`
`

`
`Case 1:14-cv-01451-RGA Document 1 Filed 12/02/14 Page 9 of 10 PageID #: 9
`
`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. 205806 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 Defendant
`
`commercially manufactures, uses, offers to sell, or sells in the United States, or imports into the
`
`United States, Defendant’s generic product before the expiration of each patent-in-suit that
`
`Defendant is found to infringe, including any extensions; and
`
`F.
`
`Any and all other relief as the Court deems just and proper.
`
`Dated: December 2, 2014.
`
`Of Counsel:
`
`Daniel A. Ladow
`James M. Bollinger
`Timothy P. Heaton
`J. Magnus Essunger
`TROUTMAN SANDERS LLP
`405 Lexington Avenue
`New York, NY 10174
`(212) 704-6000
`(212) 704-6288 (Fax)
`daniel.ladow@troutmansanders.com
`james.bollinger@troutmansanders.com
`timothy.heaton@troutmansanders.com
`magnus.essunger@troutmansanders.com
`
`Respectfully submitted,
`
`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
`
`Attorneys for Plaintiffs
`
`9
`
`MONOSOL RX EXHIBIT 2005 page 0009
`
`

`
`Case 1:14-cv-01451-RGA Document 1 Filed 12/02/14 Page 10 of 10 PageID #: 10
`
`Troy S. Kleckley
`Puja R. Patel
`TROUTMAN SANDERS LLP
`600 Peachtree Street, NE
`Suite 5200
`Atlanta, GA 30308
`(404) 885-3000
`(404) 885-3900 (Fax)
`troy.kleckley@troutmansanders.com
`puja.patel@troutmansanders.com
`
`Attorneys for Plaintiff Reckitt Benckiser
`Pharmaceuticals Inc. & RB Pharmaceuticals Ltd.
`
`James F. Hibey
`Timothy C. Bickham
`Houda Morad
`Stephanie L. Schonewald
`STEPTOE & JOHNSON LLP
`1330 Connecticut Avenue, NW
`Washington DC 20036
`(202) 429-3000
`(202) 429-3902 (Fax)
`jhibey@steptoe.com
`tbickham@steptoe.com
`hmorad@steptoe.com
`sschonew@steptoe.com
`
`Attorneys for Plaintiff MonoSol Rx, LLC
`
`33296671
`
`10
`
`MONOSOL RX EXHIBIT 2005 page 0010