Case 1:13-cv-02003-RGA Document 35 Filed 02/25/14 Page 1 of 11 PageID #: 377
`Case 1:13—cv—O2003—RGA Document 35 Filed 02/25/14 Page 1 of 11 Page|D #: 377
`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`RECKITT BENCKISER
`
`PHARMACEUTICALS, INC., RB
`PHARMACEUTICALS LIMITED, and
`
`MONOSOL RX, LLC,
`
`V.
`
`Plaintiffs,
`
`ALVOGEN PINE BROOK, lNC.,
`
`Defendant.
`
`\/\J\)\%\)%/\J\éL§/§/§/
`
`CA. No. 13—CV-2003 RGA
`
`PLAINTIFFS’ ANSWER TO DEFENDANT
`
`ALVOGEN PINE BROOK, INC.’S COUNTERCLAIMS
`
`Plaintiffs Reckitt Benckiser Pharmaceuticals, Inc. (“RBP”), RB Pharmaceuticals Limited
`
`(“RBP UK”), and MonoSol Rx, LLC (“MonoSol”) (collectively “Plaintiffs”), herein reply to the
`
`numbered paragraphs of the Counterclaims of Defendant Alvogen Pine Brook, Inc. (“Alvogen”)
`
`as alleged in Alvogen’s February 4, 2014 Answer, as follows:
`
`THE PARTIES
`
`1.
`
`Plaintiffs lack sufficient knowledge or information to admit or deny the
`
`allegations in paragraph 1 and, therefore, deny the same.
`
`2.
`
`RBP admits that it is a Delaware corporation having a principal place of business
`
`at 10710 Midlothian Turnpike, Suite 430, Richmond, Virginia.
`
`3.
`
`RBP UK admits that it is a United Kingdom corporation having a principal place
`
`of business at 103-105iBath Road, Slough, UK.
`
`4.
`
`MonoSol admits that it is a Delaware limited liability corporation having a
`
`principal place of business at 30iTechnology Drive, Warren, New Jersey.
`
`

`
`Case 1:13-cv-02003-RGA Document 35 Filed 02/25/14 Page 2 of 11 PageID #: 378
`Case 1:13—cv—O2003—RGA Document 35 Filed 02/25/14 Page 2 of 11 Page|D #: 378
`
`JURISDICTION AND VENUE
`
`5.
`
`Paragraph 5 states a legal conclusion to which no reply is required. To the extent a
`
`reply is required, Plaintiffs admit that this Court has subj ect matter jurisdiction over AlVogen’s
`
`Counterclaims in this action relating to United States Patent Nos. 8,475,832 (“the ’832 patent”),
`
`8,017,150 (“the ’150 patent”), and 8,603,514 (“the ’5 14 patent”) (collectively, “the patents—in-
`
`suit”).
`
`6.
`
`Paragraph 6 states a legal conclusion to which no reply is required. To the extent
`
`a reply is required, RBP admits that this Court has personal jurisdiction over RBP in this action
`
`due to Plaintiffs’ filing of this civil action in this judicial district against Defendant.
`
`7.
`
`Paragraph 7 states a legal conclusion to which no reply is required. To the extent
`
`a reply is required, RBP UK admits that this Court has personal jurisdiction over RBP UK in
`
`this action due to Plaintiffs’ filing of this civil action in this judicial district against Defendant.
`
`8.
`
`Paragraph 8 states a legal conclusion to which no reply is required. To the extent
`
`a reply is required, MonoSol admits that this Court has personal jurisdiction over MonoSol in
`
`this action due to Plaintiffs’ filing of this civil action in this judicial district against Defendant.
`
`9.
`
`Paragraph 9 states a legal conclusion to which no reply is required. To the extent
`
`a reply is required, Plaintiffs admit that venue for this action is proper in this Court.
`
`10.
`
`Paragraph 10 states a legal conclusion to which no reply is required. To the
`
`extent a reply is required, Plaintiffs aver that this action was commenced against Defendant
`
`because Defendant served Plaintiffs with what purport to be notice letters stating that
`
`Defendant’s ANDA No. 205954 contains a certification pursuant to 21 U.S.C. §
`
`355(j)(2)(A)(vii)(lV) (commonly, referred to as a Paragraph IV certification) alleging that the
`
`

`
`Case 1:13-cv-02003-RGA Document 35 Filed 02/25/14 Page 3 of 11 PageID #: 379
`Case 1:13—cv—O2003—RGA Document 35 Filed 02/25/14 Page 3 of 11 Page|D #: 379
`
`’832, ’l50 and ’5 14 patents are invalid, unenforceable, and/or will not be infringed by the
`
`commercial manufacture, use, or sale of the generic product proposed in the ANDA. Plaintiffs
`
`take no position at this time as to whether those notice letters were timely, proper or otherwise
`
`effective to trigger the 45 day period to file suit pursuant to 21 U.S.C. § 355(j)(5)(B)(iii) and
`
`fully reserve their rights in that regard.
`
`BACKGROUND
`
`ll. MonoSol lacks sufficient knowledge or information to admit or deny the
`
`allegations in paragraph 11 and, therefore, denies the same. RBP and RBP UK admit that RBP is
`
`the holder of New Drug Application (“NDA”) No. 22-410 for Suboxone® (buprenorphine
`
`hydrochloride and naloxone hydrochloride) sublingual film. RBP and RBP UK admit that, 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.
`
`12.
`
`Plaintiffs state that, to the extent the allegations contained in paragraph 12
`
`characterize legal requirements and a Food and Drug Administration (“FDA”) publication, the
`
`requirements and publication speak for themselves. Plaintiffs deny the allegations in paragraph
`
`12, except that they admit that the FDA publishes Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (a.k.a., the “Orange Book”).
`
`13.
`
`Plaintiffs state that to the extent the allegations in paragraph 13 characterize the
`
`’832 patent, the patent speaks for itself. Plaintiffs deny the allegations in paragraph 13, except
`
`that they admit that the ’832 patent, entitled “Sublingual and Buccal Film Compositions,” was
`
`duly and legally issued on July 2, 2013.
`
`

`
`Case 1:13-cv-02003-RGA Document 35 Filed 02/25/14 Page 4 of 11 PageID #: 380
`Case 1:13—cv—O2003—RGA Document 35 Filed 02/25/14 Page 4 of 11 Page|D #: 380
`
`14.
`
`hAonoSolkwkssuffidentknoudedgeornnbnnafiontoadnfitordenythe
`
`allegations in paragraph 14 and, therefore, denies the same. RBP and RBP UK state that to the
`
`extent the allegations in paragraph 14 characterize Plaintiffs’ First Amended Complaint dated
`
`January 24, 2014 (“the First Amended Complaint”), the pleading speaks for itself. RBP and
`
`RBP UK deny the allegations of paragraph 14, except that they admit that RBP UK is the lawful
`
`owner of the ’832 patent, and that RBP is an exclusive licensee of the ‘832 patent.
`
`15.
`
`Plaintiffs state that to the extent the allegations in paragraph 15 characterize the
`
`’150 patent, the patent speaks for itself. Plaintiffs deny the allegations of paragraph 15, except
`
`that they admit that the ’ 150 patent, entitled “Polyethylene Oxide-Based Films and Drug
`
`Delivery Systems Made Therefrom,” was duly and legally issued on September 13, 2011.
`
`16.
`
`RBP and RBP UK lack sufficient knowledge or information to admit or deny the
`
`allegations in paragraph 16 and, therefore, deny the same. MonoSol states that to the extent the
`
`allegations in paragraph 16 characterize the First Amended Complaint, the pleading speaks for
`
`itself. MonoSol denies the allegations in paragraph 16, except that it admits that it is the lawful
`
`owner of the ’514 patent.
`
`17.
`
`Plaintiffs state that to the extent the allegations in paragraph 17 characterize the
`
`First Amended Complaint, the pleading speaks for itself. Plaintiffs deny the allegations in
`
`paragraph 17, except that they admit that RBP is an exclusive licensee of the ’5 14 patent.
`
`18.
`
`Plaintiffs state that to the extent the allegations in paragraph 18 characterize the
`
`’5 14 patent, the patent speaks for itself. Plaintiffs deny the allegations in paragraph 18, except
`
`that they admit that the ’5 14 patent, entitled “Uniform Films for Rapid Dissolve Dosage Forms
`
`Incorporating Taste-Masking Compositions,” was duly and legally issued on December 10,
`
`2013.
`
`

`
`Case 1:13-cv-02003-RGA Document 35 Filed 02/25/14 Page 5 of 11 PageID #: 381
`Case 1:13—cv—O2003—RGA Document 35 Filed 02/25/14 Page 5 of 11 Page|D #: 381
`
`19.
`
`RBP and RBP UK lack sufficient knowledge or information to admit or deny the
`
`allegations in paragraph 19 and, therefore, deny the same. MonoSol states that to the extent the
`
`allegations in paragraph 19 characterize the First Amended Complaint, the pleading speaks for
`
`itself. MonoSol denies paragraph 19 of the complaint, except that it admits that it is the lawful
`
`owner of the ’5 14 patent.
`
`20.
`
`Plaintiffs state that to the extent the allegations in paragraph 20 characterize the
`
`First Amended Complaint, the pleading speaks for itself. Plaintiffs deny paragraph 20 of the
`
`complaint, except that they admit that RBP is an exclusive licensee of the ’514 patent.
`
`21.
`
`Plaintiffs deny the allegations in paragraph 21, except that they admit that the
`
`patents-in-suit are listed in the Orange Book as covering Suboxone® sublingual film.
`
`22.
`
`Plaintiffs state that to the extent the allegations in paragraph 22 characterize
`
`Abbreviated New Drug Application (“ANDA”) No. 205954, the ANDA speaks for itself.
`
`Plaintiffs lack sufficient knowledge or information to admit or deny the allegations in paragraph
`
`22 and, therefore, deny the same, except that they admit that, on information and belief, Alvogen
`
`submitted ANDA No. 205954 to the FDA seeking approval to manufacture, use, and sell a
`
`generic Version of Plaintiff RBP’s Suboxone® sublingual film prior to the expiration of the
`
`patents-in-suit.
`
`23.
`
`Plaintiffs state that to the extent the allegations in paragraph 23 characterize
`
`ANDA No. 205954, the ANDA speaks for itself. Plaintiffs lack sufficient knowledge or
`
`information to admit or deny the allegations in paragraph 23 and, therefore, deny the same,
`
`except that they admit that they received letters from Alvogen collectively indicating that ANDA
`
`No. 205954 contains a certification pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) (a “Paragraph
`
`IV certification”) alleging that the patents-in-suit are invalid, unenforceable, and/or will not be
`
`

`
`Case 1:13-cv-02003-RGA Document 35 Filed 02/25/14 Page 6 of 11 PageID #: 382
`Case 1:13—cv—O2003—RGA Document 35 Filed 02/25/14 Page 6 of 11 Page|D #: 382
`
`infringed by the commercial manufacture, use, or sale of the generic product proposed in the
`
`ANDA.
`
`24.
`
`Plaintiffs state that to the extent the allegations in paragraph_24 characterize the
`
`First Amended Complaint, the pleading speaks for itself. Plaintiffs deny the allegations in
`
`paragraph 24, except that they admit that, on January 24, 2014, they filed the First Amended Complaint.
`
`COUNT I
`
`(N0n-Infringement of the ’832 Patent)
`
`25.
`
`Plaintiffs repeat the responses contained in paragraphs 1-24 of their Answer as if
`
`fully set forth herein.
`
`26.
`
`27.
`
`Plaintiffs deny the allegations in paragraph 26.
`
`Paragraph 27 states a legal conclusion to which no response is required. To the
`
`extent a reply is required, Plaintiffs repeat the response contained in paragraph 10 of their Answer
`
`as if fully set forth herein.
`
`28.
`
`Plaintiffs deny the allegations in paragraph 28.
`
`COUNT II
`
`(Non-Infringement of the ’150 Patent)
`
`29.
`
`Plaintiffs repeat the responses contained in paragraphs 1-28 of their Answer as if
`
`fully set forth herein.
`
`30.
`
`Plaintiffs deny the allegations in paragraph 30.
`
`31.
`
`Paragraph 31 states a legal conclusion to which no response is required. To the
`
`extent a reply is required, Plaintiffs repeat the response contained in paragraph 10 of their Answer
`
`as if fully set forth herein.
`
`

`
`Case 1:13-cv-02003-RGA Document 35 Filed 02/25/14 Page 7 of 11 PageID #: 383
`Case 1:13—cv—O2003—RGA Document 35 Filed 02/25/14 Page 7 of 11 Page|D #: 383
`
`32.
`
`Plaintiffs deny the allegations in paragraph 32.
`
`COUNT III
`
`(Non-Infringement of the ’514 Patent)
`
`33.
`
`Plaintiffs repeat the responses contained in paragraphs 1-32 of their Answer as if
`
`fully set forth herein.
`
`34.
`
`Plaintiffs deny the allegations in paragraph 34.
`
`35.
`
`Paragraph 35 states a legal conclusion to which no response is required. To the
`
`extent a reply is required, Plaintiffs repeat the response contained in paragraph 10 of their Answer
`
`as if fully set forth herein.
`
`36.
`
`Plaintiffs deny the allegations of paragraph 36.
`
`COUNT IV
`
`(Invalidity of the ’832 Patent)
`
`37.
`
`Plaintiffs repeat the responses contained in paragraphs 1-36 of their Answer as if
`
`fully set forth herein.
`
`I
`
`38.
`
`Plaintiffs deny the allegations in paragraph 38.
`
`39.
`
`Paragraph 39 states a legal conclusion to which no response is required. To the
`
`extent a reply is required, Plaintiffs repeat the response contained in paragraph 10 of their Answer
`
`as if fully set forth herein.
`
`40.
`
`Plaintiffs deny the allegations in paragraph 40.
`
`COUNT V
`
`(Invalidity of the ’150 Patent)
`
`41.
`
`Plaintiffs repeat the responses contained in paragraphs 1-40 of their Answer as if
`
`fully set forth herein.
`
`

`
`Case 1:13-cv-02003-RGA Document 35 Filed 02/25/14 Page 8 of 11 PageID #: 384
`Case 1:13—cv—O2003—RGA Document 35 Filed 02/25/14 Page 8 of 11 Page|D #: 384
`
`42.
`
`43.
`
`Plaintiffs deny the allegations in paragraph 42.
`
`Paragraph 43 states a legal conclusion to which no response is required. To the
`
`extent a reply is required, Plaintiffs repeat the response contained in paragraph 10 of their Answer
`
`as if fully set forth herein.
`
`44.
`
`Plaintiffs deny the allegations in paragraph 44.
`
`COUNT VI
`
`(Invalidity of the ’514 Patent)
`
`45.
`
`Plaintiffs repeat the responses contained in paragraphs 1-44 of their Answer as if
`
`fully set forth herein.
`
`46.
`
`47.
`
`Plaintiffs deny the allegations in paragraph 46.
`
`Paragraph 47 contains a legal conclusion to which no response is required. To the
`
`extent a reply is required, Plaintiffs repeat the response contained in paragraph 10 of their Answer
`
`as if fully set forth herein.
`
`48.
`
`Plaintiffs deny the allegations in paragraph 48.
`
`PRAYER FOR RELIEF
`
`The “WHEREFORE” paragraph following paragraph 48 of the Counterclairns and the
`
`seven lettered paragraphs a—g that follow it purport to state AlVogen’s prayer for relief, to which
`
`no response is required. To the extent that a response is required, Plaintiffs deny the allegations
`
`set forth in the “WHEREFORE” paragraph following paragraph 48 of the Counterclairns and the
`
`seven lettered paragraphs a-g that follow it and deny that Alvogen is entitled to any of the relief
`
`described therein, or to any relief whatsoever.
`
`Plaintiffs deny any and all allegations of the Counterclaims not expressly admitted
`
`herein.
`
`

`
`Case 1:13-cv-02003-RGA Document 35 Filed 02/25/14 Page 9 of 11 PageID #: 385
`Case 1:13—cv—O2003—RGA Document 35 Filed 02/25/14 Page 9 of 11 Page|D #: 385
`
`WHEREFORE, Plaintiffs respectfully request the following relief:
`
`(a)
`
`An order dismissing Alvogen’s Counterclaims with prejudice, and a judgment
`
`that Alvogen is not entitled to the relief sought, or to any other relief on its Counterclaims;
`
`(b)
`
`An order granting each and every Prayer for Relief sought by Plaintiffs in their
`
`First Amended Complaint; and
`
`(c)
`
`An award of costs and expenses of Plaintiffs in defending the Counterclaims.
`
`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.co1n
`dseverance@wcsr.com
`
`Attorneys for Plaintiffs
`
`Dated: February 25, 2014
`
`Of Counsel:
`
`Daniel A. Ladow
`James M. Bollinger
`Timothy P. Heaton
`TROUTMAN SANDERS LLP
`405 Lexington Avenue
`New York, NY 10174
`(212) 704-6000
`(212) 704-6288 (Fax)
`Daniel . ladow@trout1nansanders.co1n
`James.bollinger@troutmansanders.com
`Timothy.heaton@troutmansanders.co1n
`
`Troy S. Kleckley
`TROUTMAN SANDERS LLP
`
`600 Peachtree Street, NE
`Suite 5200
`
`Atlanta, GA 30308
`
`(404) 885-3000
`(404) 885-3900 (Fax)
`Troy.klecklev@troutmansanders.com
`
`Attorneys for PlaintzflReckil’l Berzckiser
`Pharmaceuticals, Inc. & RB Pharmaceuticals Limited
`
`

`
`Case 1:13-cv-02003-RGA Document 35 Filed 02/25/14 Page 10 of 11 PageID #: 386
`Case 1:13—cv—O2003—RGA Document 35 Filed 02/25/14 Page 10 of 11 Page|D #: 386
`
`James F. Hibey
`Timothy C. Bickham
`Houda Morad
`
`Stephanie L. Sconewald
`STEPTOE & JOHNSON LLP
`
`1330 Connecticut Avenue, NW
`
`Washington DC 20036
`(202) 429-3000
`(202) 429-3902 (Fax)
`jhibey@steptoe.com
`tbickham@steptoe.co1n
`hmorad@steptoe.com
`sschonew@steptoe.co1n
`
`Attorneys for Plaz'ntzflMon0S0l Rx, LLC
`
`10
`
`

`
`Case 1:13-cv-02003-RGA Document 35 Filed 02/25/14 Page 11 of 11 PageID #: 387
`Case 1:13—cv—O2003—RGA Document 35 Filed 02/25/14 Page 11 of 11 Page|D #: 387
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on February 25, 2014, I caused the foregoing to be electronically
`
`filed with the Clerk of the Court using CM/ECF which will send electronic notification of such
`
`filing to all registered participants.
`
`Additionally, I hereby certify that true and correct copies of the foregoing were caused to
`
`be served on February 25, 2014, upon the following individuals via electronic mail:
`
`Steven H. Sklar
`
`Gregory C. Bays
`LEYDIG, VOIT & MAYER, LTD.
`Two Prudential Plaza
`
`180 N. Stetson Avenue, Suite 4900
`Chicago, IL 60601
`(312) 616-5600
`(3 12) 616-5700 (Fax)
`ssklar@leydig.com
`gbays@leydig.com
`
`‘
`
`3
`
`if
`
`Karen E. Keller
`
`Jeffrey T. Castellano
`David M. Fry
`SHAW KELLER LLP
`
`300 Delaware Avenue, Suite 1120
`Wilmington, DE 19801
`(302) 298-0700
`l<l<eller@shawkeller.com
`jcastellano@shawl<eller.com
`dfry@shawke1ler.com
`
`Attorneys for Defendants Alvogen Pine Brook,
`Inc.
`
`Attorneys for Defendants Alvogen Pine Brook,
`Inc.
`
`WOMBLE CARLYLE SANDRIDGE & RICE, LLP
`
`/s/ Mary W Bourke
`Mary W. Bourke (#2356)
`222 Delaware Avenue, Suite 1501
`
`Wilmington, DE 19801
`Telephone (3 02) 252-4320
`mbourl<e@wcs1'.com
`
`31946346
`
`11