throbber
Trademark Trial and Appeal Board Electronic Filing System. http://estta.uspto.gov
`ESTTA907444
`07/05/2018
`
`ESTTA Tracking number:
`
`Filing date:
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`Proceeding.
`
`91219485
`
`Plaintiff
`Ferring B.V.
`
`Defendant
`Allergan, Inc.
`
`Yes
`
`Applicant
`
`Other Party
`
`Have the parties
`held their discov-
`ery conference
`as required under
`Trademark Rules
`2.120(a)(1) and
`(a)(2)?
`
`Motion for Suspension in View of Civil Proceeding With Consent
`
`The parties are engaged in a civil action which may have a bearing on this proceeding. Accordingly, Ferring
`B.V. hereby requests suspension of this proceeding pending a final determination of the civil action. Trade-
`mark Rule 2.117.
`Ferring B.V. has secured the express consent of all other parties to this proceeding for the suspension and
`resetting of dates requested herein.
`Ferring B.V. has provided an email address herewith for itself and for the opposing party so that any order on
`this motion may be issued electronically by the Board.
`
`Certificate of Service
`
`The undersigned hereby certifies that a copy of this paper has been served upon all parties, at their address
`of record by Email on this date.
`Respectfully submitted,
`/s/ James D. Weinberger
`James D. Weinberger
`jweinberger@fzlz.com
`kwilton@seyfarth.com, lgregory@seyfarth.com, MCardona@seyfarth.com, ttabdocket@seyfarth.com
`07/05/2018
`
`

`

`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`
`
`Opposition Nos. 91219485 (parent),
`91219486, 91219487
`
`
`FERRING, B.V.,
`
`
`
`
`
`
`Opposer,
`
`-against-
`
`
`ALLERGAN, INC.,
`
`
`
`
`
`
`Applicant.
`
`
`
`
`
`
`MOTION ON CONSENT TO SUSPEND
`OPPOSITIONS PENDING RESOLUTION OF CIVIL ACTION
`
`Opposer Ferring, B.V. (“Opposer”), with the consent of Applicants Allergan, Inc. and
`
`Serenity Pharmaceuticals, LLC (“Serenity” and together with Allergan, Inc., “Applicants”1),
`
`hereby moves to suspend these consolidated Oppositions pursuant to 37 C.F.R. § 2.117(a),
`
`pending the resolution of a civil action pending in the United States District Court for the
`
`Southern District of New York, captioned Ferring B.V. et al. v. Serenity Pharmaceuticals, LLC
`
`et al., No. 17-CV-9922 (RWS) (S.D.N.Y.) (the “Civil Action”). The Answer, Affirmative
`
`Defenses and Counterclaims to Plaintiffs’ First Amended Complaint for Declaratory Judgment,
`
`filed by Serenity and its co-defendants and counterclaimants in the Civil Action is attached to
`
`this motion as Exhibit A.
`
`The Civil Action involves overlapping parties, the same marks and issues of law or fact
`
`which may have a bearing on these Oppositions. Both Opposer and Applicant Serenity are
`
`parties to the Civil Action. Moreover, the question of whether Serentiy’s NOCTIVA mark (App.
`
`Ser. No. 86247669) is likely to be confused with Opposer’s NOCDURNA mark – the same
`
`
`1 As the Board is aware, Allergan, Inc. has assigned the marks at issue in this proceeding to
`Serenity and a motion to substitute is currently sub judice. See 35 TTABVUE.
`
`{F2670018.2 }
`
`
`
`

`

`
`
`marks at issue in the parent Opposition, is at issue in the Civil Action. See Exhibit A,
`
`Counterclaims, ¶¶ 1, 2, 44-54, 90-93. 2 Accordingly, a decision by the federal district court of
`
`whether there is or is not a likelihood of confusion between the marks at issue in the Civil Action
`
`will have a bearing on the issues present in these Oppositions.
`
`
`
`WHEREFORE, in view of the above, Opposer requests the Board grant this motion and
`
`suspend this proceeding final resolution of the Civil Action.
`
`
`Dated: July 5, 2018
`
`New York, New York
`
`
`
`
`
`
`
`
`
`
`
`
`FROSS ZELNICK LEHRMAN & ZISSU, P.C.
`
`
`By: ___________________________________
`
`James D. Weinberger
`4 Times Square, 17th Floor
`New York, New York 10036
`(212) 813-5900
`
`Attorneys for Opposer
`
`
`2 Although Serenity’s NOCUVANT (App. Ser. No. 86247674) and NOCTRISA (App. Ser. No.
`86247672) marks, which are also the subject of these Oppositions, are not at issue in the Civil
`Action, the parties believe that the disposition of the Civil Action will likely have a direct impact
`on their interest in further proceedings before the Board concerning such applications.
`
`{F2670018.2 }
`
`2
`
`

`

`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`{F2670018.2 }
`
`EXHIBIT A
`EXHIBIT A
`
`

`

`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 1 of 45
`
`UNITED STATES DISTRICT COURT
`SOUTHERN DISTRICT OF NEW YORK
`------------------------------------------------------------ x
`)
`FERRING B.V., FERRING INTERNATIONAL
`)
`CENTER S.A., and FERRING
`)
`PHARMACEUTICALS INC.,
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`SERENITY PHARMACEUTICALS, LLC, and
`REPRISE BIOPHARMACEUTICS, LLC,
`
`Defendants.
`------------------------------------------------------------
`
`Plaintiffs,
`
`-v-
`
`------------------------------------------------------------ x
`)
`SERENITY PHARMACEUTICALS, LLC,
`)
`REPRISE BIOPHARMACEUTICS, LLC, and
`)
`AVADEL SPECIALTY PHARMACEUTICALS,
`)
`LLC,
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`Counterclaim-Plaintiffs,
`
`-v-
`
`FERRING B.V., FERRING INTERNATIONAL
`CENTER S.A., and FERRING
`PHARMACEUTICALS INC.,
`
`
`Counterclaim-Defendants.
`------------------------------------------------------------
`
`
`
`
`
`No. 17-cv-9922 (RWS)
`ECF CASE
`
`FILED UNDER SEAL
`
`
`
`
`
`
`
`
`
`
`
`No. 17-cv-9922 (RWS)
`ECF CASE
`
`FILED UNDER SEAL
`
`ANSWER, AFFIRMATIVE DEFENSES, AND COUNTERCLAIMS
`TO PLAINTIFFS’ FIRST AMENDED COMPLAINT
`FOR DECLARATORY JUDGMENT
`
`Defendants Serenity Pharmaceuticals, LLC (“Serenity”) and Reprise Biopharmaceutics,
`
`LLC (“Reprise”) (collectively, “Defendants”), by and through their undersigned counsel, hereby
`
`submit their Answer and Affirmative Defenses to the Amended Complaint for Declaratory
`
`Judgment (D.I. 18) (“FAC”) filed by Ferring Pharmaceuticals Inc., Ferring B.V., and Ferring
`
`

`

`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 2 of 45
`
`International Center S.A. (collectively, “Ferring” or “Plaintiffs”) on June 30, 2017 in C.A. No. 17-
`
`cv-479-GMS (D. Del.), which case was transferred to this Judicial District as the above-captioned
`
`action on December 20, 2017. Defendants submit their Answer and Affirmative Defenses to the
`
`FAC in accordance with the numbered paragraphs thereof, as follows. To the extent the
`
`unnumbered headings of the FAC contain allegations supporting Plaintiffs’ claims, they are
`
`denied. Defendants further deny all allegations of the FAC that are not expressly admitted below.
`
`Further, Defendants and Avadel Specialty Pharmaceuticals, LLC (“Avadel”) (collectively
`
`with Defendants, “Counterclaimants”), by and through their undersigned counsel, hereby submit
`
`their Counterclaims to the FAC.
`
`THE PARTIES
`
`Admitted, on information and belief.
`
`Admitted, on information and belief.
`
`Admitted, on information and belief.
`
`Admitted, on information and belief.
`
`Admitted.
`
`Admitted that Serenity develops products that address urinary conditions, and that
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`the U.S. Food and Drug Administration (“FDA”) approved NDA No. 201656 (“Serenity’s NDA”)
`
`for NOCTIVA (desmopressin acetate) nasal spray for the treatment of nocturia. Except as expressly
`
`admitted herein, Defendants deny the allegations of Paragraph 6 of the FAC.
`
`7.
`
`8.
`
`Admitted.
`
`Admitted that Dr. Seymour Fein (“Fein”) and Dr. Ronald V. Nardi (“Nardi”) are
`
`equity participants and principals of Reprise. Except as expressly admitted herein, Defendants
`
`deny the allegations of Paragraph 8 of the FAC.
`
`- 2 -
`
`

`

`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 3 of 45
`
`9.
`
`Defendants lack knowledge or information sufficient to form a belief as to the truth
`
`of the allegations of Paragraph 9 of the FAC and, therefore, deny them.
`
`PERSONAL JURISDICTION AND VENUE
`
`10.
`
`Paragraph 10 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 10
`
`of the FAC.
`
`Personal Jurisdiction over Serenity
`
`11.
`
`Paragraph 11 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 11
`
`of the FAC.
`
`Personal Jurisdiction over Allergan
`
`12.
`
`Paragraph 12 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants lack knowledge or information
`
`sufficient to form a belief as to the truth of the allegations of Paragraph 12 of the FAC and,
`
`therefore, deny them.
`
`13.
`
`Paragraph 13 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants lack knowledge or information
`
`sufficient to form a belief as to the truth of the allegations of Paragraph 13 of the FAC and,
`
`therefore, deny them.
`
`Personal Jurisdiction over Reprise
`
`14.
`
`Defendants state that whether Serenity Pharmaceuticals Corp. is “the predecessor
`
`of Defendant Serenity” is a legal conclusion to which no response is required. Admitted that Fein
`
`is the inventor of, inter alia, United States Patent No. 7,405,203 (the “’203 patent”); 7,579,321
`
`(the “’321 patent”); and 7,799,761 (the “’761 patent”) (collectively, the “Patents in Suit”), that
`
`- 3 -
`
`

`

`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 4 of 45
`
`Serenity Pharmaceuticals Corp. was formed under the laws of Delaware on December 13, 2006,
`
`and that Reprise was formed under the laws of New York on January 2, 2007. Except as expressly
`
`admitted herein, Defendants deny the allegations of Paragraph 14 of the FAC and expressly note
`
`that this case was transferred from the District of Delaware to this Judicial District on December
`
`20, 2017.
`
`15.
`
`16.
`
`17.
`
`Admitted.
`
`Denied.
`
`Defendants state that whether Serenity is “the successor-in-interest to Serenity
`
`Pharmaceuticals Corp.” is a legal conclusion to which no response is required. Admitted that
`
`Serenity was formed under the laws of Delaware in November 2009, and that Serenity is an
`
`exclusive licensee of the Patents in Suit. Except as expressly admitted herein, Defendants deny
`
`the allegations of Paragraph 17 of the FAC and expressly note that this case was transferred from
`
`the District of Delaware to this Judicial District on December 20, 2017.
`
`18.
`
`Admitted that Serenity and Reprise entered into an agreement with Allergan Sales,
`
`LLC and Allergan, Inc. (collectively, “Allergan”) on March 31, 2010 (the “Three-Way
`
`Agreement) and that a copy of what purports to be a redacted version of the Three-Way Agreement
`
`was attached to the FAC as Exhibit A. To the extent that Paragraph 18 of the FAC purports to
`
`quote from, summarize, describe, or make allegations concerning the Three-Way Agreement,
`
`Defendants state that such documents speak for themselves, and further that such quotes,
`
`summaries, descriptions, and allegations are incomplete and, therefore, inaccurate, and
`
`accordingly Defendants deny Plaintiffs’ characterizations of such documents and their contents.
`
`Except as expressly admitted herein, Defendants deny the allegations of Paragraph 18 of the FAC.
`
`19.
`
`Admitted.
`
`- 4 -
`
`

`

`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 5 of 45
`
`20.
`
`Admitted that Serenity issued a press release on March 6, 2017, and that a copy of
`
`what purports to be Serenity’s March 6, 2017 press release was attached to the FAC as Exhibit B.
`
`To the extent that Paragraph 20 of the FAC purports to quote from, summarize, describe, or make
`
`allegations concerning Serenity’s March 6, 2017 press release, the Defendants state that such
`
`documents speak for themselves, and further that such quotes, summaries, descriptions, and
`
`allegations are incomplete and, therefore, inaccurate, and accordingly Defendants deny Plaintiffs’
`
`characterizations of the document and its contents. Except as expressly admitted herein,
`
`Defendants deny the allegations of Paragraph 20 of the FAC.
`
`21.
`
`22.
`
`23.
`
`24.
`
`Admitted.
`
`Denied.
`
`Admitted.
`
`Paragraph 24 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent a response is required, admitted that Fein is an equity participant and
`
`principal of Reprise, and that Fein is an equity participant and Chief Medical Officer of Serenity.
`
`Except as expressly admitted herein, Defendants deny the allegations of Paragraph 24 of the FAC.
`
`25.
`
`Paragraph 25 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 25
`
`of the FAC.
`
`26.
`
`Paragraph 26 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 26
`
`of the FAC.
`
`- 5 -
`
`

`

`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 6 of 45
`
`27.
`
`Paragraph 27 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 27
`
`of the FAC.
`
`28.
`
`Paragraph 28 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 28
`
`of the FAC.
`
`29.
`
`Paragraph 29 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 29
`
`of the FAC.
`
`30.
`
`Paragraph 30 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent a response is required, admitted that Defendants’ undersigned counsel
`
`represent, inter alia, Serenity, Reprise, and Fein in Ferring B.V. et al. v. Allergan, Inc. et al., C.A.
`
`No. 12-cv-2650-RWS (S.D.N.Y.) (the “2012 Action”). Except as expressly admitted herein,
`
`Defendants deny the allegations of Paragraph 30 of the FAC.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`- 6 -
`
`

`

`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 7 of 45
`
`32.
`
`Paragraph 32 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 32
`
`of the FAC.
`
`33.
`
`Paragraph 33 of the FAC sets forth legal conclusions to which no response is
`
`required. Admitted that Fein is an equity participant and principal of Reprise, and that Fein is an
`
`equity participant and Chief Medical Officer of Serenity. Except as expressly admitted herein,
`
`Defendants deny the allegations of Paragraph 33 of the FAC.
`
`34.
`
`Paragraph 34 of the FAC sets forth legal conclusions to which no response is
`
`required. Admitted that Reprise licensed rights to the Patents in Suit to Serenity. Except as
`
`expressly admitted herein, Defendants deny the allegations of Paragraph 34 of the FAC.
`
`35.
`
`Paragraph 35 of the FAC sets forth legal conclusions to which no response is
`
`required. Admitted that Fein has intellectual property rights to, inter alia, his inventions embodied
`
`in the Patents in Suit, that Fein transferred certain intellectual property rights to Reprise, and that
`
`Reprise has entered into patent assignments and/or licenses with Serenity and Allergan. Except as
`
`expressly admitted herein, Defendants deny the allegations of Paragraph 35 of the FAC.
`
`36.
`
`Paragraph 36 of the FAC sets forth legal conclusions to which no response is
`
`required. Admitted that Fein has intellectual property rights to, inter alia, his inventions embodied
`
`in the Patents in Suit. Except as expressly admitted herein, Defendants deny the allegations of
`
`Paragraph 36 of the FAC.
`
`37.
`
`Paragraph 37 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 37
`
`of the FAC.
`
`- 7 -
`
`

`

`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 8 of 45
`
`38.
`
`The allegations in Paragraph 38 of the FAC purport to quote from, summarize,
`
`describe, or make allegations concerning the Three-Way Agreement. Defendants state that such
`
`documents speak for themselves, and further that such quotes, summaries, descriptions, and
`
`allegations are incomplete and, therefore, inaccurate, and accordingly Defendants deny Plaintiffs’
`
`characterizations of such documents and their contents. Except as expressly admitted herein,
`
`Defendants deny the allegations of Paragraph 38 of the FAC.
`
`39.
`
`Paragraph 39 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 39
`
`of the FAC.
`
`40.
`
`Paragraph 40 of the FAC sets forth legal conclusions to which no response is
`
`required. Further, the allegations in Paragraph 40 of the FAC purport to quote from, summarize,
`
`describe, or make allegations concerning the Three-Way Agreement. Defendants state that such
`
`documents speak for themselves, and further that such quotes, summaries, descriptions, and
`
`allegations are incomplete and, therefore, inaccurate, and accordingly Defendants deny Plaintiffs’
`
`characterizations of such documents and their contents. Except as expressly admitted herein,
`
`Defendants deny the allegations of Paragraph 40 of the FAC.
`
`41.
`
`Admitted that Reprise has been a party to assignments involving the Patents in Suit.
`
`Except as expressly admitted herein, Defendants deny the allegations of Paragraph 41 of the FAC.
`
`42.
`
`43.
`
`Denied.
`
`Admitted that Reprise has entered into certain agreements with Serenity and
`
`Allergan. Except as expressly admitted herein, Defendants deny the allegations of Paragraph 43
`
`of the FAC.
`
`- 8 -
`
`

`

`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 9 of 45
`
`44.
`
`Paragraph 44 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 44
`
`of the FAC.
`
`45.
`
`Paragraph 45 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 45
`
`of the FAC.
`
`46.
`
`The allegations in Paragraph 46 of the FAC purport to quote from, summarize,
`
`describe, or make allegations concerning certain assignments between Fein and Reprise.
`
`Defendants state that such documents speak for themselves, and further that such quotes,
`
`summaries, descriptions, and allegations are incomplete and, therefore, inaccurate, and
`
`accordingly Defendants deny Plaintiffs’ characterizations of such documents and their contents.
`
`Except as expressly admitted herein, Defendants deny the allegations of Paragraph 46 of the FAC.
`
`47.
`
`Paragraph 47 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 47
`
`of the FAC.
`
`48.
`
`Paragraph 48 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 48
`
`of the FAC.
`
`49.
`
`Paragraph 49 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 49
`
`of the FAC.
`
`- 9 -
`
`

`

`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 10 of 45
`
`50.
`
`Paragraph 50 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 50
`
`of the FAC.
`
`51.
`
`Paragraph 51 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 51
`
`of the FAC.
`
`52.
`
`Paragraph 52 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 52
`
`of the FAC.
`
`53.
`
`Paragraph 53 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 53
`
`of the FAC.
`
`THE PATENTS IN SUIT
`
`54.
`
`Defendants admit that a copy of what purports to be the ’203 patent was attached
`
`to the FAC as Exhibit C. Defendants admit the remaining allegations of Paragraph 54 of the FAC.
`
`55.
`
`Defendants admit that a copy of what purports to be the ’321 patent was attached
`
`to the FAC as Exhibit D. Defendants admit the remaining allegations of Paragraph 55 of the FAC.
`
`56.
`
`Defendants admit that a copy of what purports to be the ’761 patent was attached
`
`to the FAC as Exhibit E. Defendants admit the remaining allegations of Paragraph 56 of the FAC.
`
`57.
`
`The allegations in Paragraph 57 of the FAC purport to quote from, summarize,
`
`describe, or make allegations concerning certain patent applications. Defendants state that such
`
`documents speak for themselves, and further that such quotes, summaries, descriptions, and
`
`allegations are incomplete and, therefore, inaccurate, and accordingly Defendants deny the
`
`allegations in Paragraph 57 of the FAC.
`
`- 10 -
`
`

`

`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 11 of 45
`
`58.
`
`The allegations in Paragraph 58 of the FAC purport to quote from, summarize,
`
`describe, or make allegations concerning certain patent applications and publications. Defendants
`
`state that such documents speak for themselves, and further that such quotes, summaries,
`
`descriptions, and allegations are incomplete and, therefore, inaccurate, and accordingly
`
`Defendants deny the allegations in Paragraph 58 of the FAC.
`
`59.
`
`The allegations in Paragraph 59 of the FAC purport to quote from, summarize,
`
`describe, or make allegations concerning certain patents and patent applications. Defendants state
`
`that such documents speak for themselves, and further that such quotes, summaries, descriptions,
`
`and allegations are incomplete and, therefore, inaccurate, and accordingly Defendants deny the
`
`allegations in Paragraph 59 of the FAC.
`
`60.
`
`61.
`
`62.
`
`Admitted.
`
`Denied.
`
`The allegations in Paragraph 62 of the FAC purport to quote from, summarize,
`
`describe, or make allegations concerning certain patents and patent applications. Defendants state
`
`that such documents speak for themselves, and further that such quotes, summaries, descriptions,
`
`and allegations are incomplete and, therefore, inaccurate, and accordingly Defendants deny the
`
`allegations in Paragraph 62 of the FAC.
`
`63.
`
`Admitted that the ’203 patent claims priority to PCT/US03/14463 (“PCT ’463”),
`
`and that PCT ’463 claims priority to Great Britain Patent Application No. 0210397.6 (“GB ’397”).
`
`Defendants deny the remaining allegations of Paragraph 63 of the FAC.
`
`64.
`
`65.
`
`Admitted.
`
`To the extent that Paragraph 65 of the FAC purports to summarize or describe the
`
`’203 patent and its claims, Defendants state that such patent and claims speak for themselves, and
`
`- 11 -
`
`

`

`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 12 of 45
`
`further that such summary or description is incomplete and, therefore, inaccurate and denied. To
`
`the extent that Paragraph 65 purports to delineate or characterize the scope of one or more patent
`
`claims, such delineations and characterizations state a conclusion of law, to which no response is
`
`required. Defendants deny the remaining allegations in Paragraph 65.
`
`66.
`
`67.
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`Admitted.
`
`Admitted that the ’321 patent claims priority to PCT ’463, and that PCT ’463 claims
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`priority to GB ’397. Defendants deny the remaining allegations of Paragraph 67 of the FAC.
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`68.
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`69.
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`Admitted.
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`To the extent that Paragraph 69 of the FAC purports to summarize or describe the
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`’321 patent and its claims, Defendants state that such patent and claims speak for themselves, and
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`further that such summary or description is incomplete and, therefore, inaccurate and denied. To
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`the extent that Paragraph 69 purports to delineate or characterize the scope of one or more patent
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`claims, such delineations and characterizations state a conclusion of law, to which no response is
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`required. Defendants deny the remaining allegations in Paragraph 69.
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`70.
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`71.
`
`Admitted.
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`Admitted that the ’761 patent claims priority to GB ’397. Defendants deny the
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`remaining allegations of Paragraph 63 of the FAC.
`
`72.
`
`73.
`
`Admitted.
`
`To the extent that Paragraph 73 of the FAC purports to summarize or describe the
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`’761 patent and its claims, Defendants state that such patent and claims speak for themselves, and
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`further that such summary or description is incomplete and, therefore, inaccurate and denied. To
`
`the extent that Paragraph 73 purports to delineate or characterize the scope of one or more patent
`
`- 12 -
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`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 13 of 45
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`claims, such delineations and characterizations state a conclusion of law, to which no response is
`
`required. Defendants deny the remaining allegations in Paragraph 73.
`
`FACTUAL BACKGROUND
`
`Nocturia and Treatment with Desmopressin
`
`74.
`
`75.
`
`76.
`
`Admitted, on information and belief.
`
`Admitted, on information and belief.
`
`Admitted.
`
`Serenity’s NOCTIVA (desmopressin) Product
`
`77.
`
`Admitted that a copy of what purports to be the March 3, 2017 letter from Hylton
`
`V. Joffe to Serenity was attached to the FAC as Exhibit F. Defendants admit the remaining
`
`allegations of Paragraph 77 of the FAC.
`
`78.
`
`Admitted that the FDA granted final approval for Serenity’s NDA on March 3,
`
`2017. Except as expressly admitted herein, Defendants deny the allegations of Paragraph 78 of
`
`the FAC.
`
`79.
`
`Admitted.
`
`Ferring’s Long History with Desmopressin
`
`80.
`
`Defendants lack knowledge or information sufficient to form a belief as to the truth
`
`of the allegations of Paragraph 80 of the FAC and, therefore, deny them.
`
`81.
`
`Defendants lack knowledge or information sufficient to form a belief as to the truth
`
`of the allegations of Paragraph 81 of the FAC and, therefore, deny them.
`
`82.
`
`Defendants lack knowledge or information sufficient to form a belief as to the truth
`
`of the allegations of Paragraph 82 of the FAC and, therefore, deny them.
`
`83.
`
`Defendants lack knowledge or information sufficient to form a belief as to the truth
`
`of the allegations of Paragraph 83 of the FAC and, therefore, deny them.
`
`- 13 -
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`

`

`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 14 of 45
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`84.
`
`Defendants lack knowledge or information sufficient to form a belief as to the truth
`
`of the allegations of Paragraph 84 of the FAC and, therefore, deny them.
`
`Ferring’s NOCDURNA
`
`85.
`
`Defendants lack knowledge or information sufficient to form a belief as to the truth
`
`of the allegations of Paragraph 82 of the FAC and, therefore, deny them.
`
`86.
`
`87.
`
`Admitted, on information and belief.
`
`Admitted that Serenity’s NDA was reviewed by the Division of Bone,
`
`Reproductive and Urologic Products (“DBRUP”), and that the review of NDA No. 022517
`
`(“Ferring’s NDA”) was originally assigned to the Division of Metabolism and Endocrinology
`
`Products (“DMEP”) of the FDA. Defendants lack knowledge or information sufficient to form a
`
`belief as to the truth of the remaining allegations of Paragraph 87 of the FAC and, therefore, deny
`
`them.
`
`88.
`
`Admitted that Ferring submitted a Citizen Petition to the FDA on November 22,
`
`2016 (“Ferring’s Citizen Petition”) and that a copy of what purports to be Ferring’s Citizen Petition
`
`was attached to the FAC as Exhibit G. The allegations in Paragraph 88 of the FAC purport to
`
`quote from, summarize, describe, or make allegations concerning Ferring’s Citizen Petition.
`
`Defendants state that such documents speak for themselves, and further that such quotes,
`
`summaries, descriptions, and allegations are incomplete and, therefore, inaccurate, and
`
`accordingly Defendants deny Plaintiffs’ characterizations of such documents and their contents.
`
`Except as expressly admitted herein, Defendants deny the allegations of Paragraph 88 of the FAC.
`
`89.
`
`Admitted that the FDA approved Serenity’s NDA and denied Ferring’s Citizen
`
`Petition on March 3, 2017, and that a copy of what purports to be the FDA’s March 3, 2017 denial
`
`of Ferring’s Citizen Petition (the “Janet Woodcock Letter”) was attached to the FAC as Exhibit H.
`
`- 14 -
`
`

`

`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 15 of 45
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`The allegations in Paragraph 89 of the FAC purport to quote from, summarize, describe, or make
`
`allegations concerning the Janet Woodcock Letter. Defendants state that such documents speak
`
`for themselves, and further that such quotes, summaries, descriptions, and allegations are
`
`incomplete and,
`
`therefore,
`
`inaccurate, and accordingly Defendants deny Plaintiffs’
`
`characterizations of such documents and their contents. Except as expressly admitted herein,
`
`Defendants deny the allegations of Paragraph 89 of the FAC.
`
`90.
`
`The allegations in Paragraph 90 of the FAC purport to quote from, summarize,
`
`describe, or make allegations concerning the Janet Woodcock Letter. Defendants state that such
`
`documents speak for themselves, and further that such quotes, summaries, descriptions, and
`
`allegations are incomplete and, therefore, inaccurate, and accordingly Defendants deny Plaintiffs’
`
`characterizations of such documents and their contents. Defendants lack knowledge or
`
`information sufficient to form a belief as to the truth of the remaining allegations of Paragraph 90
`
`of the FAC and, therefore, deny them.
`
`91.
`
`The allegations in Paragraph 91 of the FAC purport to quote from, summarize,
`
`describe, or make allegations concerning the Janet Woodcock Letter. Defendants state that such
`
`documents speak for themselves, and further that such quotes, summaries, descriptions, and
`
`allegations are incomplete and, therefore, inaccurate, and accordingly Defendants deny Plaintiffs’
`
`characterizations of such documents and their contents. Defendants lack knowledge or
`
`information sufficient to form a belief as to the truth of the remaining allegations of Paragraph 91
`
`of the FAC and, therefore, deny them.
`
`
`
`
`
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`- 15 -
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`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 16 of 45
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`SUBJECT MATTER JURISDICTION
`
`99.
`
`Paragraph 99 of the FAC sets forth legal conclusions to which no response is
`
`required. To the extent any response is required, Defendants deny the allegations of Paragraph 99
`
`of the FAC.
`
`The Extensive Litigation History between the Parties
`
`- 16 -
`
`

`

`Case 1:17-cv-09922-RWS Document 101 Filed 06/28/18 Page 17 of 45
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`100. Admitted that at least one of Defendants is a party to the litigations addressed in
`
`subsections (i) to (iii) of Paragraph 100 of the FAC. Except as expressly admitted herein,
`
`Defendants deny the allegations of Paragraph 100 of the FAC.
`
`101. The allegations Paragraph 101 of the FAC concerning Defendants’ “course of
`
`conduct” and “belie[f] that NOCDURNA is covered by the claims of the Patents in Suit” sets forth
`
`legal conclusions to which no response is required. Admitted that the U.S. Patent and Trademark
`
`Office (“PTO”) duly issued U.S. Patent Application No. 13/378,778 (the “’778 Application”) as
`
`U.S. Patent No. 9,539,302 (the “’302 patent”), that the ’302 patent lists Dr. Fein as the sole
`
`inventor, and that a copy of what purports to be the July 5, 2016 Response to Office Action from
`
`the prosecution of the ’778 Application was attached to the FAC as Exhibit J. To the extent that
`
`Paragraph 101 of the FAC purports to quote from, summarize, describe, or make allegations
`
`concerning Exhibit J, Defendants state that such documents speak for themselves, and further that
`
`such quotes, summaries, descriptions, and allegations are incomplete and, therefore, inaccurate,
`
`and accordingly Defendants deny Plaintiffs’ characterizations of such document and their contents.
`
`Except as expressly admitted herein, Defendants deny the allegations of Paragraph 101 of the FAC.
`
`102. Admitted that a copy of what purports to be a letter dated October 7, 2016 from
`
`Allergan and Reprise to the EPO was attached to the FAC as Exhibit K, that a copy of what

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