`FOR THE EASTERN DISTRICT OF NORTH CAROLINA
`WESTERN DIVISION
`
`Civ. No. 5:l3—cv—76O
`
`RECKITT BENCKISER
`
`PHARMACEUTICALS, INC, RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`V.
`
`Plaintiffs,
`
`BIODELIVERY SCIENCES
`
`INTERNATIONAL, INC,
`
`g/g/\..J\._/\_/\._/\_/*-._M~../N./xg
`
`Defendant.
`
`COMPLAINT
`
`Plaintiffs Reckitt Benckiser Pharmaceuticals, Inc. (“RBP”), RB Pharmaceuticals Limited
`
`(“RBP UK”), and MonoSol Rx, LLC (“MonoSol”) (“collectively, “Plaintiffs”) hereby file this
`
`Complaint against Defendant BioDelivery Sciences International, Inc. (“BDSI”), and allege as
`
`follows:
`
`NATURE OF THE ACTION
`
`1.
`
`This is an action for infringement of United States Patent No. 8,475,832 (“the
`
`’832 patent”), arising under the Food and Drug Laws and Patent Laws of the United States,
`
`Titles 21 and 35 of the United States Code, respectively, and for a declaratory judgment of patent
`
`infringement under 28 U.S.C. §§ 2201 and 2202.
`
`2.
`
`Pursuant to New Drug Application 22-410, the United States Food and Drug
`
`Administration (“FDA”) authorized Plaintiffs to market a pharmaceutical drug product used to
`
`treat opioid dependence that is sold under the name Suboxone®. Suboxone® is a sublingual,
`
`transmucosal film that contains the active ingredients buprenorphine hydrochloride and naloxone
`
`Case 5:l3—cv-00760-80 Document 1 Filed 1029113 Page 1 of 14
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`Page 1
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`BDSI EXHIBIT 1002
`
`Page 1
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`
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`hydrochloride. Plaintiffs have manufactured and continue to manufacture and sell Suboxone®
`
`for the U.S. market.
`
`3.
`
`BDSI has submitted a New Drug Application under 21 U.S.C. § 355(b)(2) (the
`
`“505(b)(2) NDA”)
`
`to the FDA seeking approval
`
`to manufacture and sell a competing
`
`pharmaceutical drug product to Suboxcne® that contains the same active ingredients and is
`
`intended to treat the same medical indications. BDSI intends to market its competing product
`
`under the name Bunavailm.
`
`4.
`
`BDSI’s submission of its application to the FDA constitutes an act of patent
`
`infringement under 35 U.S.C. § 271(e). Furthermore, a real and justiciable controversy exists
`
`between Plaintiffs and BDSI regarding whether Bunavailm infringes the ‘S32 patent. Therefore,
`
`Plaintiffs also seek a declaration that the sale of BDSI’s proposed product will infringe the ’832
`
`patent under 35 U.S.C. § 27l(a)—(c).
`
`THE PARTIES
`
`5.
`
`Plaintiff RBP is a Delaware corporation having a principal place of business at
`
`10710 Midiothian Turnpike, Suite 430, Richmond, Virginia.
`
`6.
`
`Plaintiff RBP UK is a United Kingdom corporation having a principal place of
`
`business at 103-105 Bath Road, Slough, UK.
`
`7.
`
`Plaintiff MonoSol is a Delaware limited liability company having a principal
`
`place of business at 30 Technology Drive, Warren, New Jersey.
`
`8.
`
`Defendant BDSI is a Delaware corporation having a principal place of business at
`
`801 Corporate Center Drive, Suite 210, Raleigh, North Carolina.
`
`Case 5:13—cv—00760—BO Document 1 Filed 10/29/13 Page 2 of 14
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`Page 2
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`Page 2
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`JURISDICTION AND VENUE
`
`9.
`
`This Court has subject matter jurisdiction over this action pursuant to 28 U.S.C.
`
`§§ 1331, l338(a), 2201, and 2202, and 35 U.S.C. § 271.
`
`10.
`
`This Court has personal jurisdiction over BDS1 because BDSI resides in this
`
`judicial district.
`
`1 1.
`
`Venue is proper in this district under 28 U.S.C. §§ 1391 and 1400.
`
`THE PATENT-IN-SUIT
`
`12.
`
`Plaintiff RBP UK is the lawful owner of the ’832 patent. The ’832 patent, entitled
`
`“Sublingual and Buccal Film Compositions,” was duly and legally issued on July 2, 2013, to
`
`Garry L. Myers, Samuel D. Hilbert, Bill J. Boone, B. Arlie Bogue, Pradeep Sanghvi, and
`
`Madhusudan Hariharan as inventors. The named inventors assigned their rights to MonoSol,
`
`who subsequently assigned its rights in the ‘832 patent to Reckitt Benckiser Healthcare (UK)
`
`Limited, which then assigned its rights to RBP UK. MonoSol manufactures Suboxone® for the
`
`US market. A true copy of the ‘S32 patent is attached hereto as Exhibit A.
`
`PLAINTIFFS’ SUBOXONE® PRODUCTS
`
`13.
`
`Plaintiff RBP is the owner of New Drug Application (“NDA”) No. 22-410 for
`
`Suboxone® (buprenorphine hydrochloride and naioxone 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 since its approval.
`
`15.
`
`RBP also owns NDA No. 20-733 for Suboxone® sublingual tablet. Suboxone®
`
`sublingual
`
`tablet contains
`
`the same active ingredients
`
`as Suboxone® sublingual
`
`film
`
`(buprenorphine hydrochloride and naloxone hydrochloride).
`
`Case 5:13-cv—O0760-BO Document 1 Filed 10/29/13 Page 3 of 14
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`Page 3
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`Page 3
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`BDSI’s ATTEMPT TO CIRCUMVENT THE HATCH—WAXMAN ACT
`
`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 drug manufacturers would have meaningfiil 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. § 3S5(b)(l), the NDA applicant is required to submit extensive
`
`testing and safety information concerning the drug (“505(b)(l) applications”).
`
`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.
`
`Both the NDA for the Suboxone® sublingual
`
`film and the NDA for the
`
`Suboxone® sublingual tablet are 505(b)(l) applications. The ‘S32 patent is listed in the FDA’s
`
`Orange Book as covering Suboxone® sublingual film. There are no unexpired patents listed on
`
`the Orange Book for Suboxone® sublingual tablet.
`
`19.
`
`The I-latch—Waxman Act amended the FD&C Act to provide for applications filed
`
`under 21 U.S.C. § 355(b)(2) (“505(b)(2) applications”), which allow applicants to obtain FDA
`
`approval for other versions of previously—approved drugs without having to repeat the extensive
`
`Case 5:13—cv—0O7’60—BO Document 1 Filed 10/29/13 Page 4 of 14
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`Page 4
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`Page 4
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`
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`testing required for a new drug application. Section 505(b)(2) applications can rely, in part, on
`
`FDA’s previous findings of safety and effi cacy for an approved drug product.
`
`20.
`
`if a 505(b)(2) applicant relies on previous FDA findings of safety and efficacy for
`
`a previously—approved drug product, the SOS(b)(2) applicant must identify the drug application
`
`which formed the basis for FDA approval (“Reference Listed Drug” or “RLD”).
`
`21.
`
`Under 21 U.S.C. § 355(b)(2)(A), the 505(b)(2) applicant must make 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 infonnation has not been filed (“Paragraph
`
`1” certifications); (ii) that the patent has expired (“Paragraph 11” certifications); (iii) that the
`
`patent will expire on a specific date (“Paragraph Ill” 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).
`
`22.
`
`If a 505(b)(2) applicant makes a Paragraph IV certification, the Hatch-Waxman
`
`Act, 21 U.S.C. § 355(b)(3), requires the 505(b)(2) applicant to give notice to the patent owner of
`
`the factual and legal basis for the applicant's opinion that the patent is invalid or will not be
`
`infringed.
`
`23.
`
`If the 505(b)(2) application includes a Paragraph IV certification,
`
`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 FDA
`
`approval, beginning on the date of receipt of the notice. See 21 U.S.C. § 355(c)(3)(C). 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.
`
`Case 5:13—cv—OO760-BO Document 1 Filed 10/2913 Page 5 of 14
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`Page 5
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`Page 5
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`24.
`
`On July 31, 2013, Defendant BDSI submitted a 505(b)(2) NDA to the FDA,
`
`seeking approval to engage in the commercial manufacture and/or sale of Bunavailm. See
`
`BDSl’s August 1, 2013 press release, attached as Exhibit B. BDSI has not made a certification
`
`under 21 U.S.C. § 355(b)(2)(A)(iv) as to the ’832 patent or any other patent.
`
`25.
`
`Although the most similar alternative to Defendant BDSl’s Bunavailm film
`
`product is Suboxone® sublingual film (NDA No. 22-410), BDSl’s 505(b)(2) application uses
`
`Suboxone® sublingual tablet (NDA No. 20-733) as the reference drug.
`
`26.
`
`On information and belief, BDSl's Bunavailw product, like Suboxone® film and
`
`unlike SuboXone® tablet,
`
`is a mucoadhesive, erodible, high surface area to weight ratio
`
`polymeric dosage form, that is orally delivered and applied to a mucosal surface. Additionally,
`
`the excipient profile and associated functionality are distinct from those of the Suboxone® tablet.
`
`See MonoSol’s FDA Citizen Petition dated August 12, 2013, attached as Exhibit C. According
`
`to BDSI, Bunavailm uses BDSl’s BioErodible MucoAdhesive (“BEMA”) drug delivery
`
`technology.
`
`27.
`
`Further, while BDSI has not yet announced the strength of the Bunavailm
`
`product, BDSI has enrolled patients into a clinical trial with the following strengths: 3.5/0.6 mg
`
`and 5.25/0.9 mg (buprenorphine/naloxone). The strengths of BDSl’s buprenorphine/naloxone
`
`product in the clinical
`
`trial are “most similar” to the 4 mg/l mg (buprenorphinefnaloxone)
`
`strength of the Suboxone® film product. See BDSI, Clinical Trial, An Open Label Study to
`
`Assess the Safety and Tolerability of BEMA® Buprenorphine NX In Opioid Dependent
`
`Subjects, attached as Exhibit D.
`
`28.
`
`BDSl’s decision to use Suboxone® tablet as the reference drug instead of
`
`Suboxone® film was a blatant attempt to avoid providing RBP with a notice of Paragraph IV
`
`Case 5:13—cv—O0760-BO Document 1 Filed 10129113 Page 6 of 14
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`Page 6
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`Page 6
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`
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`certification to the ’832 patent, thereby preventing RBP from filing an infringement action within
`
`45 days of receiving the notice of Paragraph IV certification and obtaining a 30-month injunction
`
`against BDSI, as permitted under 21 U.S.C. § 355(c)(3)(C).
`
`29.
`
`In a Citizen’s Petition dated December 2, 2011, Docket No. FDA-201 l—P—0869,
`
`Plaintiffs requested that
`
`the FDA “[r]efuse the submission of any 505(b)(2) NDA for a
`
`buprenorphine/naloxone drug product consisting of a polymer film for application to the oral
`
`mucosal membranes unless such 50S(b)(2) NDA references NDA No. # 22-410 (Suboxone®),
`
`which is the NDA for the sublingual film formulation of this product, and makes the appropriate
`
`certifications with respect to all patents listed for NDA #22--410.”
`
`30.
`
`After BDSI submitted its 505(b)(2) application, a different FDA regulation
`
`applied; and on August 12, 2013, the Plaintiffs re-filed the Citizen’s Petition which was assigned
`
`docket number FDA-20 l 3—P—0995.
`
`31.
`
`On September 18, 2013, the FDA responded to both Citizen’s Petitions, granting
`
`them in part and denying them in part (attached as Exhibit E).
`
`lmportantly, the FDA did not
`
`reject BDSl’s 505(b)(2) application and found that “[i]n the absence of a pharmaceutically
`
`equivalent product, a 505(b)(2) applicant is not required to select a listed drug that is the ‘most
`
`similar’ (in [petitioner’s] view) to the proposed product as long as reliance on the listed drug is
`
`scientifically justified.”
`
`32.
`
`BunavailTM will compete directly with Suboxone® sublingual film.
`
`In its 2012
`
`annual report, attached as Exhibit F, BDSI stated that:
`
`Currently, we remain on track to file the NDA for BUNAVAILTM with the
`U.S. Food and Drug Administration (FDA) in mid—summer 2013, putting
`BDSI
`in the position to introduce the next branded transmucosal
`buprenorphine/naloxone film into the marketplace for opioid dependence.
`This filing will
`include data from our positive pivotal bioequivalence
`study completed in the second half of 2012, as well as data from the
`
`Case 5:l3—cv-OO760—BO Document 1 Filed 10/29/13 Page 7 of 14
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`Page 7
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`Page 7
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`
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`“Suboxone conversion” safety study which completed in early 2013. In
`the
`latter, we were able to demonstrate
`favorable tolerability of
`BUNAVAILTM in opioid dependent
`subjects when switched from
`Suboxone. We believe that BUNAVAILW will offer an alternative
`treatment option with advantages over Suboxone, a product that generated
`sales in excess of $1.5 billion in 2012, according to Wolters Kluwer. As
`we stated earlier this year, we are evaluating strategic options for the
`commercialization of BUNAVAILTM,
`including partnerships as well as
`leading the commercialization on our own. We plan to finalize this
`strategy and decision in the second half of 2013.
`
`33.
`
`In a press release dated August 9, 2013, attached as Exhibit G, BDSI stated that
`
`“[i]f approved, BUNAVAIL will be the first buccal film dosage form containing buprenorphine
`
`for the treatment of opioid dependence that will compete with the market leader Suboxone .
`
`.
`
`. .”
`
`34.
`
`On October 9, 2013, BDSI issued another press release, attached as Exhibit 1-1,
`
`announcing that its NDA for Bunavailm “has been accepted for filing by the [FDA]” and that
`
`“the review of the BUNAVAIL NDA is expected to be completed by early June 2014.”
`
`35.
`
`Plaintiffs have been deprived of relief available under the Hatch—Waxman Act,
`
`including a stay by the FDA of any approval of BDSl’s 505(b)(2) NDA until “the expiration of
`
`the thirty—month period beginning on the date of the receipt of the notice provided under
`
`subsection (b)(3) of this section or such shorter or longer period as the court may order.”
`
`21 U.S.C. § 35S(c)(3)(C).
`
`BDSI’s REPEATED PATTERN OF INFRINGEMENT, FILING ADVERSARY
`PROCEEDINGS AGAINST MONOSOUS PATENTS, AND DELAY
`
`36.
`
`In an action pending in the United States District Court for the District of New
`
`Jersey, Docket No. 3:lO—cv-O5695—FLW—DEA (“the New Jersey Action”), Plaintiff MonoSol
`
`asserted patent infringement claims against BDSI in connection with the Onsolism film product.
`
`Plaintiff MonoSol asserted infringement of U.S. Patent No. 7,425,292 (“the ‘292 patent”) as well
`
`as US. Patents Nos. 7,357,891 (“the ‘S91 patent”) and 7,824,588 (“the ’588 patent”).
`
`Case 5:13-cv-00760-130 Document 1 Filed 1029/13 Page 8 of 14
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`Page 8
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`Page 8
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`37.
`
`The OnsolisTM film product,
`
`like Bunavailm also, according to BDSI, uses
`
`BDSI’s BEMA film technology.
`
`38.
`
`The ‘Z92 and ’89l patents were subject to ex parte reexamination proceedings
`
`before the United States Patent and Trademark Office (“USPTO”),
`
`initiated by BDSI
`
`in
`
`Application Serial No. 90/012,097 and Application Serial No. 90/012,098, respectively. The
`
`’588 patent is also subject to an inter PQYIES reexamination proceeding before the USPTO,
`
`Application Serial No. 95/001,753, requested by BDSI.
`
`39.
`
`BDSI moved to stay the proceedings in the New Jersey Action pending resolution
`
`by the USPTO of the inter parres reexamination of the ‘S88 patent and the ex parre
`
`reexaminations of the ’292 and ’89l patents. The motion to stay was granted on March 7, 2012.
`
`40.
`
`The inter partes reexamination of the ‘588 patent is still pending before the
`
`USPTO, but the ex parte reexarninations of the ’292 and ’89l patents have been resolved. The
`
`USPTO issued reexamination certificates for both the ’292 and ’89l patents on July 3, 2012 and
`
`August 21, 2012, respectively. Having failed to invalidate the ’292 and ’89l patents through the
`
`ex pane reexaminations, on June 12, 2013, BDSI filed petitions to institute inter parres review of
`
`the ’292 and ’89l patents with the USPTO, Case No. IPR20l3—0O3l5 and Case No. IPR2Gl3—
`
`00316, respectively. The petitions are still pending before the USPTO.
`
`41.
`
`Accordingly,
`
`there is a real, substantial, and continuing justiciable case or
`
`controversy between Plaintiffs and Defendant BDSI regarding whether Defendant’s commercial
`
`manufacture, use, sale, offer for sale, or importation into the United States of Bunavailm
`
`according to BDSl’s 505(b)(2) NDA, will infringe one or more claims of the patent—in—suit.
`
`Plaintiffs are entitled to a declaration that the making, using, sale, offer for sale, and importation
`
`Case 5:13—cv—0O?60—BO Document 1 Filed 10f29/13 Page 9 of 14
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`Page 9
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`Page 9
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`
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`into the United States of Bunavailm according to BDSI’s 505(b)(2) NDA would infringe one or
`
`more claims of the patent—in—suit.
`
`(Declaratory Judgment as to U.S. Patent No. 8,475,832)
`
`COUNT I
`
`Plaintiffs reallege paragraphs 1-41 above as if fully set forth herein.
`
`On information and belief BDS1’s Bunavailm product is covered by one or more
`
`42.
`
`43.
`
`claims of the ’832 patent.
`
`44.
`
`On information and belief, unless enjoined by this Court, BDSI intends to engage
`
`in the commercial manufacture, use, sale, or offer for sale within the United States or importation
`
`into the United States of Bunavailm, upon approval of its pending 505(b)(2) application.
`
`45.
`
`Pursuant to 35 U.S.C. § 2'/'l(a)—{c), Defendant BDSl’s commercial manufacture,
`
`use, sale, offer for sale, or importation into the United States, of Bunavailm will
`
`infringe,
`
`contribute to the infringement of and/or induce the infringement of one or more claims of the
`
`‘832 patent.
`
`46.
`
`On information and belief, by seeking approval to distribute BDSl’s Bunavailm,
`
`BDSI intends to cause others -— specifically, for example, medical professionals and patients -— to
`
`perform acts that BDSI knows will infringe one or more claims of the ‘S32 patent.
`
`47'.
`
`On information and belief, BDSI knows (a)
`
`that
`
`its Bunavailm product
`
`is
`
`especially made or adapted for use in infringing one or more claims of the ‘E332 patent and (b)
`
`that the Bunavailm product is not suitable for any substantial noninfringing use.
`
`48.
`
`The acts of infringement by BDSI set forth above will cause Plaintiffs irreparable
`
`harm for which they have no adequate remedy at
`
`law, and those acts will continue unless
`
`enjoined by this Court.
`
`10
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`Page 10
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`Page 10
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`49.
`
`There is a real, substantial, and continuing justiciable case and controversy
`
`between Plaintiffs and Defendant BDSI regarding whether Defendant BDSI’s commercial
`
`manufacture and/or sale of Bunavailm will infringe one or more claims of the ’832 patent.
`
`Plaintiffs are entitled to a declaration that such activities would infringe one or more claims of
`
`the ’832 patent.
`
`COUNT II
`
`(Infringement of U.S. Patent No. 8,475,832)
`
`50.
`
`51.
`
`Plaintiffs reallege paragraphs 1-49 above as if fully set forth herein.
`
`The submission of BDSI’s 505(b)(2) NDA is an act of infringement by BDSI of
`
`one or more claims of the ’832 patent under 35 U.S.C. § 27l(e)(2)(A), which provides that:
`
`It shall be an act of infringement to submit—
`
`(A)
`
`an application under section 5050) of the Federal Food,
`Drug, and Cosmetic Act or described in section 505(b)(2)
`of such Act for a drug claimed in a patent or the use of
`which is claimed in a patent,
`
`the purpose of such submission is to obtain approval under such
`Act to engage in the commercial manufacture, use, or sale of a
`drug, veterinary biological product, or biological product claimed
`in a patent or the use of which is claimed in a patent before the
`expiration of such patent.
`
`52.
`
`Plaintiffs are entitled to the relief provided by 35 U.S.C. § 2'/'l(e)(4), including,
`
`im/‘er cilia, an Order of this Court that the FDA set the effective date of approval for BDSI’s
`
`505(b)(2) NDA to be a date which is not any earlier than the expiration date of the ’832 patent,
`
`including any extensions of that date.
`
`11
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`Case 5:l3~cv—OO760—BO Document 1 Filed 10/29/13 Page 11 of 14
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`Page 11
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`Page 11
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`
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`PRAYER FOR RELIEF
`
`WHEREFORE, Plaintiffs respectfully request that this Court enter:
`
`A.
`
`A declaratory judgment that the commercial manufacture, use, offer to sell, or
`
`sale within the United States, or importation into the United States, of BDSI’s Bunavailm would
`
`infringe the ’832 patent under 35 U.S.C. § 2"/'l(a)—(c);
`
`B.
`
`A judgment
`
`that BDSI has infringed the ’832 patent by submitting BDSI’s
`
`505(b)(2) NDA under 35 U.S.C. § 271(c)(2);
`
`C.
`
`Preliminary and permanent
`
`injunctions,
`
`restraining and enjoining BDSI,
`
`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 contributing to and/or inducing the use of methods,
`
`claimed in the ’832 patent;
`
`D.
`
`An Order that the effective date of any approval of BDS1’s 505(b)(2) NDA be a
`
`date that is not earlier than the expiration of the ’832 patent, including any extensions thereof and
`
`any later expiration of exclusivity associated with the patent;
`
`E.
`
`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;
`
`F.
`
`A judgment granting Plaintiffs compensatory damages in an amount
`
`to be
`
`determined at trial including both pre—judgment and post—judgment interest, if Defendant BDSI
`
`commercially manufactures, uses, offers to sell, or sells in the United States, or imports into the
`
`United States BDSI’s Bunavailm before the expiration of the ‘S32 patent,
`
`including any
`
`extensions; and
`
`G.
`
`Any and all other relief as the Court deems just and proper.
`
`12
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`Case 5:l3—cv-00760-80 Document 1 Filed 10/29/13 Page 12 of 14
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`Page 12
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`Dated: October 29, 2013
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`Respectfully submitted,
`
`/51’ Michael E. Ray
`
`Michael E. Ray (N.C. State Bar 8480)
`WOMBLE, CARLYLE, SANDRIDGE & RICE LLP
`One West Fourth Street
`
`Winston—Salem, NC 27101
`Phone: 1-336-721-3648
`Fax: 1-336-733-8312
`
`E-mail: mray@wcsr.com
`
`Attorneys for Plaintzfls
`
`OfCounsel :
`
`TROUTMAN SANDERS LLP
`Daniel A. Ladow
`
`James M. Bollinger
`TROUTMAN SANDERS LLP
`
`405 Lexington Avenue
`New York, NY 10174
`(212) 704-6000
`(212) 704-5929 (Fax)
`Claniel.1adow@troutn1ansanders.com
`james.bo1linger@troutmansanders.com
`
`Troy S. Kleckley
`Aaron Rugh
`TROUTMAN SANDERS LLP
`
`600 Peachtree Street, NE
`Suite 5200
`
`Atlanta, GA 30308
`(404) 885-3000
`(404) 885-3900 (Fax)
`troy.k1eck1ey@troutmansanders.com
`aaron.rugh@troutn1ansanders.com
`
`Attorneys for Plafnryjfv
`Reckirt Benckiser Pharmaceuticals, Inc.
`and RB Pharmaceuticals Limited
`
`Case 5:l3—cv—00760-BO Document 1 Filed 10/2913 Page 13 of 14
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`Page 13
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`Page 13
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`Of Counsel.‘
`
`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.corn
`
`Attorneys for Plainrijj’
`Mon0S01 Rx, LLC
`
`14
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`Case 5:13-cv-OO760—BO Document 1 Filed 10/2913 Page 14 of 14
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