Case 1:13-cv-01674-RGA Document 304 Filed 07/23/15 Page 1 of 11 PageID #: 6723
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`CA. No. 13-1674-RGA
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`RECKITT BENCKISER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`v.
`
`Plaintiffs,
`
`WATSON LABORATORIES, INC., and
`ACTAVIS LABORATORIES UT, INC.,
`
`Defendants.
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`PLAINTIFFS’ ANSWER TO DEFENDANTS’ COUNTERCLAIMS
`
`Plaintiffs Reckitt Benckiser Pharmaceuticals Inc. (“RBP”), RB Pharmaceuticals Limited
`
`(“RBP UK”), and MonoSol Rx, LLC (“MonoSol”) (collectively, “Plaintiffs”) herein reply to the
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`numbered paragraphs of the Counterclaims of Defendants Watson Laboratories, Inc. (“Watson”)
`
`and Actavis Laboratories UT (“Actavis”) (collectively, “Defendants”), as alleged in Defendants’
`
`July 6, 2015 Answer and Counterclaims to Plaintiffs’ Second Amended Complaint, 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.
`
`Plaintiffs lack sufficient knowledge or information to admit or deny the
`
`allegations in paragraph 2 and, therefore, deny the same.
`
`3.
`
`RBP admits that it is a Delaware corporation having a principal place of business
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`at 10710 Midlothian Turnpike, Suite 430, Richmond, Virginia.
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`4.
`
`RBP UK admits that it is a United Kingdom corporation having a principal place
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`of business at 103-105 Bath Road, Slough, UK.
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`CA. No. 13-1674-RGA
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`RECKITT BENCKISER
`PHARMACEUTICALS INC., RB
`PHARMACEUTICALS LIMITED, and
`MONOSOL RX, LLC,
`
`v.
`
`Plaintiffs,
`
`WATSON LABORATORIES, INC., and
`ACTAVIS LABORATORIES UT, INC.,
`
`Defendants.
`
`PLAINTIFFS’ ANSWER TO DEFENDANTS’ 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 Defendants Watson Laboratories, Inc. (“Watson”)
`
`and Actavis Laboratories UT (“Actavis”) (collectively, “Defendants”), as alleged in Defendants’
`
`July 6, 2015 Answer and Counterclaims to Plaintiffs’ Second Amended Complaint, 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.
`
`Plaintiffs lack sufficient knowledge or information to admit or deny the
`
`allegations in paragraph 2 and, therefore, deny the same.
`
`3.
`
`RBP admits that it is a Delaware corporation having a principal place of business
`
`at 10710 Midlothian Turnpike, Suite 430, Richmond, Virginia.
`
`4.
`
`RBP UK admits that it is a United Kingdom corporation having a principal place
`
`of business at 103-105 Bath Road, Slough, UK.
`
`
`
`Case 1:13-cv-01674-RGA Document 304 Filed 07/23/15 Page 2 of 11 PageID #: 6724
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`5.
`
`MonoSol admits that it is a Delaware limited liability corporation having a
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`principal place of business at 30 Technology Drive, Warren, New Jersey.
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`JURISDICTION AND VENUE
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`6.
`
`Paragraph 6 states a legal conclusion to which no reply is required. To the extent
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`a reply is required, Plaintiffs admit that this Court has subject matter jurisdiction over
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`Defendants’ counterclaims in this action relating to U.S. Patent Nos. 8,475,832 (“the ’832
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`patent”), 8,017,150 (“the ’150 patent”), and 8,603,514 (“the ’514 patent”) (collectively, “the
`
`patents-in-suit”).
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`7.
`
`Paragraph 7 states a legal conclusion to which no reply is required. To the extent
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`a reply is required, RBP admits that this Court has personal jurisdiction over RBP in this action
`
`due to Plaintiffs’ filing of a civil action in this judicial district against Defendants.
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`8.
`
`Paragraph 8 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 a civil action in this judicial district against Defendants.
`
`9.
`
`Paragraph 9 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 a civil action in this judicial district against Defendants.
`
`10.
`
`Paragraph 10 states legal conclusions 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.
`
`11.
`
`Plaintiffs admit an actual and justiciable controversy exists between the parties
`
`with respect to the patents-in-suit.
`
`BACKGROUND
`
`12.
`
`Plaintiffs admit the allegations in paragraph 12.
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`2
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`
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`Case 1:13-cv-01674-RGA Document 304 Filed 07/23/15 Page 3 of 11 PageID #: 6725
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`13.
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`Plaintiffs state that, to the extent the allegations contained in paragraph 13
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`characterize legal requirements and a Food and Drug Administration (“FDA”) publication, the
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`requirements and publication speak for themselves. Plaintiffs deny the allegations in paragraph
`
`13, except that they admit that the FDA publishes Approved Drug Products with Therapeutic
`
`Equivalence Evaluations (a.k.a., the “Orange Book”).
`
`2011.
`
`2013.
`
`14.
`
`15.
`
`16.
`
`17.
`
`18.
`
`19.
`
`20.
`
`21.
`
`22.
`
`Plaintiffs admit that the ’832 patent duly and legally issued on July 2, 2013.
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`Plaintiffs admit that RBP UK is the lawful owner of the ’832 patent.
`
`Plaintiffs admit that the ’150 patent duly and legally issued on September 13,
`
`Plaintiffs admit that MonoSol is the lawful owner of the ’150 patent.
`
`Plaintiffs admit that RBP is the exclusive licensee of the ’150 patent.
`
`Plaintiffs admit that the ’514 patent duly and legally issued on December 10,
`
`Plaintiffs admit that MonoSol is the lawful owner of the ’514 patent.
`
`Plaintiffs admit that RBP is the exclusive licensee of the ’514 patent.
`
`Plaintiffs deny the allegations in paragraph 22, except that they admit that the
`
`’832 patent, the ’150 patent, and the ’514 patent are listed in the Orange Book as covering
`
`Suboxone® sublingual film.
`
`23.
`
`Plaintiffs lack sufficient knowledge or information to admit or deny paragraph 23
`
`and, therefore, deny the same.
`
`24.
`
`Plaintiffs deny the allegations in paragraph 24, except that they admit that
`
`Defendant’s ANDA No. 20-4383 includes certifications pursuant to 21 U.S.C.
`
`§ 355(j)(2)(A)(vii)(IV) alleging that the ’832 patent, the ’150 patent, and the ’514 patent are
`
`3
`
`
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`Case 1:13-cv-01674-RGA Document 304 Filed 07/23/15 Page 4 of 11 PageID #: 6726
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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.
`
`25.
`
`Plaintiffs lack sufficient knowledge or information to admit or deny paragraph 25
`
`and, therefore, deny the same.
`
`26.
`
`Plaintiffs deny the allegations in paragraph 26, except that they admit that
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`Defendant’s ANDA No. 20-7087 includes certifications pursuant to 21 U.S.C. §
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`355(j)(2)(A)(vii)(IV) alleging that the ’832 patent, the ’150 patent, and the ’514 patent are
`
`invalid, unenforceable, and/or will not be infringed by the manufacture, use, or sale of the
`
`generic product proposed in the ANDA.
`
`27.
`
`Plaintiffs admit the allegations in paragraph 27 except state they lack sufficient
`
`knowledge or information to admit or deny as to the current incorporation status of the Watson
`
`Laboratories, Inc. entity.
`
`28.
`
`Plaintiffs admit the allegations in paragraph 28 except state they lack sufficient
`
`knowledge or information to admit or deny as to the current incorporation status of the Watson
`
`Laboratories, Inc. entity.
`
`29.
`
`Plaintiffs lack sufficient knowledge or information to admit or deny paragraph 29
`
`and, therefore, deny the same.
`
`30.
`
`Plaintiffs admit the allegations in paragraph 30 except state they lack sufficient
`
`knowledge or information to admit or deny as to the current incorporation status of the Watson
`
`Laboratories, Inc. entity.
`
`COUNT I
`(Dismissal of Watson Laboratories, Inc. (Nevada))
`
`31.
`
`Plaintiffs repeat the responses contained in paragraphs 1-30 of their Answer as if
`
`fully set forth herein.
`
`4
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`Case 1:13-cv-01674-RGA Document 304 Filed 07/23/15 Page 5 of 11 PageID #: 6727
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`32.
`
`Plaintiffs lack sufficient knowledge or information to admit or deny paragraph 32
`
`and, therefore, deny the same.
`
`33.
`
`Paragraph 33 states legal conclusions to which no reply is required. To the extent
`
`that a reply is required, Plaintiffs deny the allegations of Paragraph 33.
`
`COUNT II
`(Declaratory Judgment of Non-infringement of the ’832 Patent)
`
`34.
`
`Plaintiffs repeat the responses contained in paragraphs 1-33 of their Answer as if
`
`fully set forth herein.
`
`35.
`
`36.
`
`Plaintiffs deny the allegations of paragraph 35.
`
`Plaintiffs admit an actual and justiciable controversy exists between the parties
`
`with respect to the ’832 patent.
`
`37.
`
`Plaintiffs deny the allegations of paragraph 37.
`
`COUNT III
`(Declaratory Judgment of Non-infringement of the ’150 Patent)
`
`38.
`
`Plaintiffs repeat the responses contained in paragraphs 1-37 of their Answer as if
`
`fully set forth herein.
`
`39.
`
`40.
`
`Plaintiffs deny the allegations of paragraph 39.
`
`Plaintiffs admit an actual and justiciable controversy exists between the parties
`
`with respect to the ’150 patent.
`
`41.
`
`Plaintiffs deny the allegations of paragraph 41.
`
`COUNT IV
`(Declaratory Judgment of Non-infringement of the ’514 Patent)
`
`42.
`
`Plaintiffs repeat the responses contained in paragraphs 1-41 of their Answer as if
`
`fully set forth herein.
`
`43.
`
`Plaintiffs deny the allegations of paragraph 43.
`
`5
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`
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`Case 1:13-cv-01674-RGA Document 304 Filed 07/23/15 Page 6 of 11 PageID #: 6728
`
`44.
`
`Plaintiffs admit an actual and justiciable controversy exists between the parties
`
`with respect to the ’514 patent.
`
`45.
`
`Plaintiffs deny the allegations of paragraph 45.
`
`COUNT V
`(Declaratory Judgment of Invalidity of the ’832 Patent)
`Plaintiffs repeat the responses contained in paragraphs 1-45 of their Answer as if
`
`46.
`
`fully set forth herein.
`
`47.
`
`48.
`
`Plaintiffs deny the allegations of paragraph 47.
`
`Plaintiffs admit an actual and justiciable controversy exists between the parties
`
`with respect to infringement of the ’832 patent. Plaintiffs deny all other allegations of paragraph
`
`48.
`
`49.
`
`Plaintiffs deny the allegations of paragraph 49.
`
`COUNT VI
`(Declaratory Judgment of Invalidity of the ’150 Patent)
`
`50.
`
`Plaintiffs repeat the responses contained in paragraphs 1-49 of their Answer as if
`
`fully set forth herein.
`
`51.
`
`52.
`
`Plaintiffs deny the allegations of paragraph 51.
`
`Plaintiffs admit an actual and justiciable controversy exists between the parties
`
`with respect to infringement of the ’150 patent. Plaintiffs deny all other allegations of paragraph
`
`52.
`
`53.
`
`Plaintiffs deny the allegations of paragraph 53.
`
`COUNT VII
`(Declaratory Judgment of Invalidity of the ’514 Patent)
`
`54.
`
`Plaintiffs repeat the responses contained in paragraphs 1-53 of their Answer as if
`
`fully set forth herein.
`
`6
`
`
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`Case 1:13-cv-01674-RGA Document 304 Filed 07/23/15 Page 7 of 11 PageID #: 6729
`
`55.
`
`56.
`
`Plaintiffs deny the allegations of paragraph 55.
`
`Plaintiffs admit an actual and justiciable controversy exists between the parties
`
`with respect to infringement of the ’514 patent. Plaintiffs deny all other allegations of paragraph
`
`56.
`
`57.
`
`Plaintiffs deny the allegations of paragraph 57.
`
`PRAYER FOR RELIEF
`
`The “WHEREFORE” paragraph following paragraph 57 of the Counterclaims and the
`
`nine lettered paragraphs that follow it purport to state Defendants’ 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 57 of the Counterclaims and the
`
`nine lettered paragraphs that follow it and deny that Defendants are 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.
`
`WHEREFORE, Plaintiffs respectfully request the following relief:
`
`(a)
`
`An order dismissing Defendants’ Counterclaims with prejudice, and a judgment
`
`that Defendants are not entitled to the relief sought, or to any other relief on their Counterclaims;
`
`(b)
`
`An order granting each and every Prayer for Relief sought by Plaintiffs in their
`
`Second Amended Complaint;
`
`(c)
`
`(d)
`
`An award of costs and expenses of Plaintiffs in defending the Counterclaims; and
`
`Such other and further relief as the Court deems just and proper.
`
`7
`
`
`
`Case 1:13-cv-01674-RGA Document 304 Filed 07/23/15 Page 8 of 11 PageID #: 6730
`
`Respectfully submitted,
`
`WOMBLE CARLYLE SANDRIDGE & RICE, LLP
`
`/s/ Mary W. Bourke
`Mary W. Bourke (#2356)
`Dana K. Severance (#4869)
`Daniel M. Attaway (#5130)
`222 Delaware Avenue, Suite 1501
`Wilmington, DE 19801
`(302) 252-4320
`(302) 252-4330 (Fax)
`mbourke@wcsr.com
`dseverance@wcsr.com
`dattaway@wcsr.com
`
`Counsel for Plaintiffs
`
`Dated: July 23, 2015.
`
`OF COUNSEL:
`
`Daniel A. Ladow
`James M. Bollinger
`Timothy P. Heaton
`J. Magnus Essunger
`TROUTMAN SANDERS LLP
`875 Third Avenue
`New York, NY 10022
`(212) 704-6000
`(212) 704-6288 (Fax)
`daniel.ladow@troutmansanders.com
`james.bollinger@troutmansanders.com
`timothy.heaton@troutmansanders.com
`magnus.essunger@troutmansanders.com
`
`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
`
`Robert E. Browne, Jr.
`TROUTMAN SANDERS LLP
`55 West Monroe Street, Suite 300
`Chicago, IL 60603
`(312) 759-1923
`(773) 877-3739 (Fax)
`robert.browne@troutmansanders.com
`
`Charanjit Brahma
`TROUTMAN SANDERS LLP
`401 9th Street, N.W., Suite 1000
`Washington, DC 20004
`(202) 274-2816
`(202) 274-2994 (Fax)
`charanjit.brahma@troutmansanders.com
`
`8
`
`
`
`Case 1:13-cv-01674-RGA Document 304 Filed 07/23/15 Page 9 of 11 PageID #: 6731
`
`Attorneys for Plaintiffs Reckitt Benckiser
`Pharmaceuticals Inc. and RB Pharmaceuticals
`Limited
`
`James F. Hibey
`Timothy C. Bickham
`Rachel M. Hofstatter
`STEPTOE & JOHNSON LLP
`1330 Connecticut Avenue, NW
`Washington DC 20036
`(202) 429-3000
`(202) 429-3902 (Fax)
`jhibey@steptoe.com
`tbickham@steptoe.com
`rhofstatter@steptoe.com
`
`David L. Hecht
`Cassandra A. Adams
`STEPTOE & JOHNSON LLP
`1114 Avenue of the Americas
`New York, NY 10036
`(212) 506-3905
`(212) 506-3950 (Fax)
`dhecht@steptoe.com
`cadams@steptoe.com
`
`Attorneys for Plaintiff MonoSol Rx, LLC
`
`9
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`
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`Case 1:13-cv-01674-RGA Document 304 Filed 07/23/15 Page 10 of 11 PageID #: 6732
`
`CERTIFICATE OF SERVICE
`
`I hereby certify that on the 23rd day of July, 2015 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 the following counsel of record via electronic mail:
`Daniel G. Brown
`Emily C. Melvin
`Jennifer R. Saionz
`Brenda L. Danek
`LATHAM & WATKINS LLP
`LATHAM & WATKINS LLP
`885 Third Avenue
`330 North Wabash Avenue, Suite 2800
`New York, NY 10022
`Chicago, IL 60611
`(212) 906-1200
`(312) 876-7700
`(212) 751-4864 (Fax)
`(312) 993-9767 (Fax)
`Daniel.brown@lw.com
`Emily.melvin@lw.com
`Jennifer.saionz@lw.com
`Brenda.danek@lw.com
`
`James K. Lynch
`LATHAM & WATKINS LLP
`505 Montgomery Street, Suite 2000
`San Francisco, CA 94111-6536
`(415) 391-0600
`(415) 395-8095 (Fax)
`Jim.lynch@lw.com
`
`Jennifer Koh
`B. Thomas Watson
`LATHAM & WATKINS LLP
`12670 High Bluff Drive
`San Diego, CA 92130
`(858) 523-5400
`(858) 523-5450 (Fax)
`Jennifer.koh@lw.com
`Thomas.watson@lw.com
`
`Steven J. Fineman
`Katharine C. Lester
`RICHARDS LAYTON & FINGER, P.A.
`One Rodney Square
`920 N. King Street
`Wilmington, DE 19801
`(302) 651-7700
`(302) 651-7701 (Fax)
`fineman@rlf.com
`lester@rlf.com
`
`Michelle R. Ma
`Terrance Kearney
`LATHAM & WATKINS LLP
`140 Scott Drive
`Menlo park, CA 94025
`(650) 328-4600
`(650) 463-2600 (Fax)
`Michelle.ma@lw.com
`Terry.kearney@lw.com
`
`Attorneys for Defendants Par Pharmaceutical, Inc.
`and IntelGenX Technologies Corp.
`
`10
`
`
`
`Case 1:13-cv-01674-RGA Document 304 Filed 07/23/15 Page 11 of 11 PageID #: 6733
`
`Michael K. Nutter
`Mr. Sharick Naqi
`Tyler G. Johannes
`George C. Lombardi
`Jason C. Hamilton
`WINSTON & STRAWN, LLP
`35 W. Wacker Drive
`Chicago, IL 60601
`(312) 558-5600
`(312) 558-5700 (Fax)
`mnutter@winston.com
`snaqi@winston.com
`tjohannes@winston.com
`glombardi@winston.com
`jhamilton@winston.com
`
`David P. Dalke
`Ashlea Raymond Pflug
`Stephen R. Smerek
`WINSTON & STRAWN, LLP
`333 S. Grand Avenue, Suite 3800
`Los Angeles, CA 90071
`(231) 615-1700
`(231) 615-1750 (Fax)
`ddalke@winston.com
`araymond@winston.com
`ssmerek@winston.com
`
`Melinda K. Lackey
`WINSTON & STRAWN, LLP
`1111 Louisiana Street, 25th Floor
`Houston, TX 7702-5242
`(713) 651-2600
`(713) 651-2700 (Fax)
`mlackey@winston.com
`
`Megan C. Haney
`John C. Phillips, Jr.
`David A. Bilson
`PHILLIPS, GOLDMAN & SPENCE, P.A.
`1200 N. Broom Street
`Wilmington, DE 19806
`(302) 655-4200
`(302) 655-4210 (Fax)
`mch@pgslaw.com
`jcp@pgslaw.com
`dab@psglaw.com
`
`Attorneys for Defendant Watson Laboratories, Inc.
`
`/s/ Mary W. Bourke
`Mary W. Bourke (#2356)
`WOMBLE CARLYLE SANDRIDGE & RICE, LLP
`222 Delaware Avenue, Suite 1501
`Wilmington, DE 19801
`(302) 252-4320
`(302) 252-4330 (Fax)
`dattaway@wcsr.com
`
`34554869
`
`11
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