`ESTTA496957
`ESTTA Tracking number:
`09/27/2012
`
`Filing date:
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`Petition for Cancellation
`
`Notice is hereby given that the following party requests to cancel indicated registration.
`Petitioner Information
`
`Name
`Entity
`Address
`
`Medimetriks Pharmaceuticals, Inc.
`Corporation
`Citizenship
`363 Route 46 West
`Fairfield, NJ 07004
`UNITED STATES
`
`Attorney
`information
`
`Marie A. Lavalleye
`Covington & Burling LLP
`1201 Pennsylvania Avenue, N.W.
`Washington, DC 20004
`UNITED STATES
`trademarks@cov.com Phone:202.662.5439
`Registration Subject to Cancellation
`
`Registration No
`Registrant
`
`3772614
`Promesa Distributors, Inc.
`5160 Indiana Avenue, Suite A
`Winston Salem, NC 27106
`UNITED STATES
`Goods/Services Subject to Cancellation
`
`Registration date
`
`Delaware
`
`04/06/2010
`
`Class 003. First Use: 2009/09/25 First Use In Commerce: 2009/09/25
`All goods and services in the class are cancelled, namely: Non-medicated skin care preparations
`which soothe irritations
`
`Grounds for Cancellation
`
`Deceptiveness
`Torres v. Cantine Torresella S.r.l.Fraud
`Abandonment
`The mark is deceptively misdescriptive
`Other
`
`Trademark Act section 2(a)
`808 F.2d 46, 1 USPQ2d 1483 (Fed. Cir. 1986)
`Trademark Act section 14
`Trademark Act section 2(e)(1)
`No Bona Fide Intention to Use the Mark in
`Commerce (Count I); Unlawful Use Renders
`Registration Void Ab Initio (Count II)
`
`Mark Cited by Petitioner as Basis for Cancellation
`
`U.S. Application/
`Registration No.
`Registration Date
`
`NONE
`
`NONE
`
`Application Date
`
`NONE
`
`
`
`Word Mark
`
`Goods/Services
`
`SYNALAR, Serial Number 85740050 and NEO-SYNALAR, Serial
`Number 85740054, both filed September 27, 2012 and not yet
`uploaded in the Patent and Trademark Office's records
`Topical steroid preparation
`
`Attachments
`
`Petition for Cancellation.pdf ( 25 pages )(849345 bytes )
`
`Certificate of Service
`
`The undersigned hereby certifies that a copy of this paper has been served upon all parties, at their address
`record by First Class Mail on this date.
`
`Signature
`Name
`Date
`
`/mariealavalleye/
`Marie A. Lavalleye
`09/27/2012
`
`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE TRADEMARK TRIAL AND APPEAL BOARD
`
`BOX TTAB FEE
`
`In the Matter of:
`
`Reg. No. 3772614
`
`Date of Filing:
`
`August 26, 2008
`
`Mark:
`
`NEO—S|NALAR
`
`Date of Registration:
`
`April 6, 2010
`
`MEDIMETRIKS PHARMACEUTICALS,
`INC.
`
`Petitioner,
`
`v.
`
`PROMESA DISTRIBUTORS, |NC.,
`
`Respondent.
`
`\/\./\/\/\J\./\/\/\/\./\/\y
`
`Cancellation No.:
`
`PETITION FOR CANCELLATION
`
`Petitioner Medimetriks Pharmaceuticals, Inc. (“Petitioner”) believes that it
`
`is being, and absent cancellation will continue to be, damaged by the registration of
`
`Reg. No. 3772614 for the mark NEO—SlNALAR for “non-medicated skin care
`
`preparations which soothe irritations” in Class 3 (the “Mark”), and hereby petitions to
`
`cancel said registration pursuant to Section 14 of the Trademark Act of 1946, 15 U.S.C.
`
`§ 1064 et seq., as amended.
`
`Cancellation is warranted because, among other reasons, Respondent
`
`Promesa Distributors, Inc. (“Respondent”) had no bona fide intention to use the Mark in
`
`DC: 4500790—6
`
`
`
`commerce at the time it filed its registration application and thereafter, and because any
`
`purported use that Respondent may have made of the Mark was not lawful use in
`
`commerce. Respondent allegedly has used the Mark in connection with a skin care
`
`product containing fluocinolone acetonide. As set forth below, products containing
`
`fluocinolone acetonide used to treat skin conditions are “medicated” products that
`
`require FDA approval before such products can be lawfully marketed or sold in the
`
`United States. On information and belief, Respondent has never had FDA approval to
`
`market or sell any fluocinolone acetonide products to soothe skin irritations in the United
`
`States.
`
`Therefore, any marketing or sale by Respondent of a product containing
`
`fluocinolone acetonide for use in soothing skin irritations is, and was, illegal and
`
`Respondent cannot rely on any such use to secure or maintain the NEO—SlNALAR
`
`registration. Moreover, because Respondent’s NEO-SINALAR product is a
`
`“medicated,” any use of the Mark in connection with such product would not constitute
`
`use of the Mark for a “non-medicated” skin care product, as claimed in Reg. No.
`
`3772614.
`
`As specific grounds for this petition, Petitioner alleges:
`
`1. Petitioner is a Delaware corporation doing business at 363 Route 46
`
`West, Fairfield, NJ 07004-2402. Petitioner is engaged in the development, licensing
`
`and commercialization of innovative prescription and nonprescription skincare brands
`
`in the dermatology and podiatry markets.
`
`
`
`2. On information and belief, Respondent is a North Carolina
`
`corporation with a last known address of 5160 Indiana Avenue, Suite A, Winston
`
`Salem, NC 27106.
`
`3. Respondent owns a Principal Register registration, Reg. No.
`
`3772614, for the mark NEO—SlNALAR for “non—medicated skin care preparations
`
`which soothe irritations” in Class 3. The registration was issued by the United States
`
`Patent and Trademark Office (“USPTO”) on April 6, 2010.
`
`4. Petitioner is the owner of the New Drug Application (NDA) 12-787,
`
`which was approved by the Food and Drug Administration (FDA) on February 15,
`
`1963 and gives Petitioner the right to market and sell a 0.01% or 0.025% fluocinolone
`
`acetonide prescription cream under the brand name SYNALAR for use in relieving
`
`the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses
`
`(i.e., to soothe skin irritations). Petitioner is also the owner of other FDA-approved
`
`NDAs -— namely, NDA 13-960 for a SYNALAR 0.025% fluocinolone acetonide topical
`
`ointment, NDA 15-296 for a SYNALAR 0.01 % fluocinolone acetonide topical solution
`
`and NDA 16-161 for a SYNALAR-HP 0.2% fluocinolone acetonide topical cream -— as
`
`well as a FDA-approved Abbreviated New Drug Application (ANDA) 60-700 for a
`
`NEO-SYNALAR combination 0.025% fluocinolone acetonide and 3.5 mg neomycin
`
`topical cream.
`
`(Collectively, NDA 12-787, NDA 13-960, NDA 15-296, NDA 16-161
`
`and ANDA 60-700 hereinafter sometimes referred to as the “SYNALAR Drug
`
`Approvals”)
`
`5. Petitioner acquired the rights to the SYNALAR Drug Approvals and
`
`to U.S. Reg. No. 0714627 for the mark SYNALAR for a “topical steroid hormone
`
`3
`
`
`
`preparation” in Class 5 from Medicis Pharmaceutical Corporation (“Medicis”) on July
`
`7, 2011.
`
`6. On information and belief, Medicis had acquired the rights to the
`
`SYNALAR Drug Approvals and to U.S. Reg. No. 0714627 (SYNALAR), as well as to
`
`a second trademark registration, U.S. Reg. No. 1171932, for the mark NEO-
`
`SYNALAR for “topical steroid hormone preparations” in Class 5 (cancelled in 2002),
`
`from Syntex (U.S.A.) Inc. on February 24, 1997.
`
`7. On information and belief, Syntex (U.S.A.) Inc. had acquired the
`
`rights to the SYNALAR Drugs Approvals and to U.S. Reg. No. 0714627 (SYNALAR)
`
`from Syntex S.A. on February 3, 1967.
`
`8. For many decades, following the FDA’s issuance of the SYNALAR
`
`Drug Approvals, Petitioner’s predecessors in interest to the SYNALAR Drug
`
`Approvals marketed fluocinolone acetonide products in the United States under the
`
`brand names SYNALAR, SYNALAR HP and NEO-SYNALAR. As a result of such
`
`extensive use of these brand names by Petitioner’s predecessors in interest, the
`
`marks SYNALAR, SYNALAR-HP and NEO-SYNALAR have become closely
`
`associated with the FDA-approved fluocinolone acetonide products marketed and
`
`sold by Petitioner's predecessors in interest in accordance with such SYNALAR Drug
`
`Approvals.
`
`COUNT I
`
`No Bona Fide Intention To Use The Mark In Commerce
`
`9. Petitioner repeats and incorporates by reference the allegations set
`
`forth in paragraphs 1 through 8.
`
`
`
`10. Respondent filed its intent-to—use application on August 26, 2008,
`
`seeking registration of the mark NEO-SINALAR for a “skin soothing preparation” in
`
`Class 5 (medicated goods).
`
`In its application, Respondent claimed under oath that it
`
`had “a bona fide intention to use...the mark in commerce on or in connection with the
`
`identified goods” in Class 5 (medicated goods).
`
`11.0n June 4, 2009, in response to an Office Action dated December 8,
`
`2008, in which the USPTO objected to the description “skin soothing preparation” as
`
`indefinite because the description could cover goods classified in either Class 3 (non-
`
`medicated goods) or Class 5 (medicated goods), Respondent amended its goods
`
`description to “non—medicated skin care preparations which soothe irritations” in
`
`Class 3.
`
`12.As a result of such amendment, Respondent's claims regarding its
`
`bona fide intention to use the mark NEO-SINALAR in its application were then
`
`asserted with respect to the new amended description of goods, namely, “non-
`
`medicated skin care preparations which soothe irritations” in Class 3.
`
`13. On information and belief, the preparation(s) that Respondent
`
`intended to offer under the NEO—SlNALAR mark and which it intended to identify in its
`
`original application and in its amended application were fluocinolone acetonide
`
`products for use in the treatment of skin irritations, as evidenced by the specimen that
`
`Respondent submitted to secure Reg. No. 3772614.
`
`14. F luocinolone acetonide products for use in connection with the
`
`treatment of skin conditions are “medicated” products regulated by the FDA.
`
`
`
`A.
`
`No Bona Fide Intention to Use The Mark For Medicated
`Products.
`
`15. Because fluocinolone acetonide products for use in the treatment of
`
`skin conditions are regulated products, manufacturers and sellers of such
`
`fluocinolone acetonide products must obtain FDA approval before they can lawfully
`
`market and/or sell such products in commerce in the United States.
`
`16. On information and belief, Respondent has never had any legal right
`
`under applicable FDA law to market and/or sell any fluocinolone acetonide product to
`
`treat skin conditions in commerce in the United States and has never obtained FDA
`
`approval to market and/or sell any such products in commerce in the United States.
`
`17. Because Respondent intended to rely on use of the NEO-SINALAR
`
`mark in connection with a “medicated” product that it could not legally market or sell
`
`in the United States, Respondent could not have had a bona fide intention to use the
`
`NEO—S|NALAR mark legally in commerce with respect to a “medicated” product, as
`
`claimed in its original application at the time it filed that application on August 26,
`
`2008 or at any time thereafter.
`
`18. Respondent therefore never had a bona fide intent to use the NEO-
`
`SINALAR mark in commerce as required by the relevant provisions of the Lanham
`
`Act, 15 U.S.C. § 1051(b)-(d) in connection with a “medicated” product as claimed in
`
`its original application.
`
`B.
`
`No Bona Fide Intention to Use The Mark For Non—Medicated
`Products.
`
`19.Although Respondent’s registration for the NEO—S|NALAR mark,
`
`Reg. No. 3772614, covers a “non—medicated” skin care product, Respondent secured
`
`6
`
`
`
`the registration by submitting a specimen showing use of the Mark in connection with
`
`a “medicated” product, which, upon information and belief, Respondent has never
`
`had a legal right to market or sell in the United States.
`
`20. Because the specimen was of a “medicated” product, by definition
`
`Respondent had no bona fide intention to use the NEO-SINALAR mark in commerce
`
`in connection with a “non—medicated” product, as claimed in its amended application,
`
`amended on June 4, 2009.
`
`21 . Respondent therefore had no bona fide intent to use the NEO-
`
`SINALAR mark in commerce in connection with a “non—medicated" product at the
`
`time it filed its intent to use application, at the time it amended its application, or at
`
`any time thereafter.
`
`22. For the foregoing reasons, Reg. No. 3772614 should be cancelled.
`
`COUNT ll
`
`Unlawful Use Renders Registration Void Ab lnitio
`
`23. Petitioner repeats and incorporates by reference the allegations set
`
`forth in paragraphs 1 through 22.
`
`24.To secure Reg. No. 3772614, Respondent submitted a Statement of
`
`Use with a specimen showing use of the mark NEO-SINALAR in connection with
`
`0.01% fluocinolone acetonide cream product.
`
`25. Because the marketing and sale of fluocinolone acetonide cream
`
`products for the treatment of skin conditions are subject to FDA approval and, upon
`
`information and belief, Respondent has never had FDA approval to market or sell
`
`such a product, any use by Respondent ofthe NEO—S|NALAR mark in connection
`
`7
`
`
`
`with any such unauthorized products is unlawful and renders Reg. No. 3772614 void
`
`ab initio.
`
`26. Respondent filed its Statement of Use on January 27, 2010.
`
`In its
`
`Statement of Use, Respondent claimed under oath that the NEO-SINALAR mark “is
`
`in use in commerce” on or in connection with “non-medicated skin care preparations
`
`which soothe irritations” in Class 3. (emphasis added)
`
`27. In its Statement of Use, Respondent also claimed under oath that
`
`the NEO—SlNALAR mark “was first used by the applicant....at least as early as
`
`09/25/2009, and first used in commerce at least as early as 09/25/2009, and is now in
`
`use in such commerce.” (emphasis added)
`
`28. Respondent submitted with its Statement of Use, a specimen which
`
`Respondent characterized as a “Label" and which Respondent claimed under oath
`
`“show[s] the mark as used in commerce” on or in connection with a non-medicated
`
`skin care preparation which soothes irritations in Class 3. A copy of the specimen of
`
`use that Respondent submitted with its Statement of Use is attached hereto as
`
`Exhibit A. (emphasis added)
`
`29.The specimen of use submitted by Respondent in support of its
`
`Statement of Use displays the mark NEO—S|NALAR as well as a slightly different
`
`mark NEO-SYNALAR (in which the second term is spelled with the letter “y” instead
`
`of an “i”) and describes the product identified under the mark as a 0.01% fluocinolone
`
`acetonide cream product.
`
`30. Products that contain the active ingredient fluocinolone acetonide for
`
`use to treat skin conditions are new drugs that require FDA approval.
`
`8
`
`
`
`31 .Therefore, no product containing fluocinolone acetonide can be
`
`marketed or sold in the United States unless such product is the subject of an
`
`abbreviated new drug application (ANDA) or a new drug application (NDA), approved
`
`by the FDA, and unless the manufacturer or seller of such product has rights under a
`
`FDA—approved NDA or ANDA for such a product.
`
`32. Petitioner has not, and, on information and belief, none of its
`
`predecessors in interest in any of the SYNALAR Drug Approvals has ever, granted
`
`Respondent any rights under any of the SYNALAR Drugs Approvals to market and
`
`sell any fluocinolone acetonide product under a SYNALAR mark or under any other
`
`mark, including the mark NEO-SINALAR.
`
`33.0n information and belief, Respondent does not own any NDA or
`
`ANDA, or otherwise hold rights in any third party-owned NDA or ANDA, granting
`
`Respondent the right to market or sell any fluocinolone acetonide product in the
`
`United States under a NEO-SINALAR mark or any other mark.
`
`34. The 32nd edition of the FDA’s Approved Drug Products with
`
`Therapeutic Equivalence Evaluations publication (2012) (the “Orange Book”) contains
`
`no listing for a NEO—SlNALAR 0.01% fluocinolone acetonide product in the name of
`
`Respondent (or any other party) as an approved drug product.
`
`35. Nor is a NEO—SlNALAR 0.01% fluocinolone acetonide product listed
`
`in the Orange Book’s list of discontinued drug products in the name of Respondent or
`
`any other party.
`
`
`
`36.Therefore, to the extent that Respondent has marketed or sold a
`
`0.01% fluocinolone acetonide cream product in the United States under the mark
`
`NEO-SINALAR or any other mark, it has done so without FDA approval.
`
`37. Respondent’s marketing and sale of a 0.01% fluocinolone acetonide
`
`cream product in the United States without FDA approval violates Section 355(a) of
`
`the Federal Food, Drug and Cosmetic Act, which prohibits introduction into interstate
`
`commerce of any unapproved new drug. Any use by Respondent of a mark in
`
`connection with such unauthorized products, therefore, is unlawful.
`
`38. In addition, the label submitted by Respondent with its Statement of
`
`Use, attached hereto as Exhibit A, which Respondent claimed under oath “show[s]
`
`the mark as used in commerce,” upon information and belief, fails to comply with
`
`significant FDA labeling requirements, thus rendering the drug allegedly sold by
`
`Respondent under the NEO—S|NALAR mark to be misbranded and its sale in
`
`commerce to be unlawful under 21 U.S.C. § 331(a).
`
`39.Accordingly, Respondent cannot now, and, upon information and
`
`belief, could not at the time of its filing of its Statement of Use, rely on its use of the
`
`NEO-SINALAR mark in connection with the marketing or sale of a 0.01 % fluocinolone
`
`acetonide cream product to claim lawful use of the NEO—S|NALAR mark in
`
`commerce.
`
`40. Reg. No. 3772614 therefore should be cancelled as void ab initio on
`
`the ground that Respondent has failed to demonstrate lawful use of the NEC-
`
`SINALAR mark in commerce as required to secure such registration.
`
`10
`
`
`
`COUNT Ill
`
`Fraud
`
`41. Petitioner repeats and incorporates by reference the allegations set
`
`forth in paragraphs 1 through 40.
`
`42.0n information and belief, Respondent submitted its original
`
`application, its amended application, and its Statement of Use, knowing that its
`
`claims of “bona fide intent” and “use in commerce” contained therein were false and
`
`misleading, in order to deceive the USPTO into accepting its application and granting
`
`Reg. No. 3772614.
`
`43.0n information and belief, at the time Respondent filed its original
`
`application on August 26, 2008, the claims made by Respondent therein, under oath,
`
`and referred to in paragraphs 10 and 12 above, were false and misleading, and were
`
`known by Respondent to be false and misleading at such time.
`
`44.0n information and belief, at the time Respondent amended its
`
`goods description in its application on June 4, 2009, the claims made by Respondent
`
`therein, under oath, and referred to in paragraphs 10 and 12 above, were false and
`
`misleading, and were known by Respondent to be false and misleading at such time.
`
`45.0n information and belief, at the time Respondent filed its
`
`application on August 26, 2008, seeking registration of the NEO-SINALAR mark for
`
`“skin soothing preparations” in Class 5 (the medicated goods class), Respondent had
`
`no bona fide intention to lawfully use the NEO-SINALAR mark on a medicated
`
`product, because at no time prior to such filing or thereafter, upon information and
`
`belief, did Respondent seek FDA—approval, or hold any rights under any FDA-
`
`11
`
`
`
`approved NDA or ANDA, to market and/or sell a 0.01 % fluocinolone acetonide
`
`product for the treatment of skin conditions in the United States under the NEO-
`
`SINALAR mark or any other mark.
`
`46.0n information and belief, at the time Respondent amended its
`
`goods description on June 4, 2009 seeking registration of the mark for a non-
`
`medicated product in Class 3, Respondent had no bona fide intention to use the
`
`NEO—SlNALAR mark on a non-medicated product, as evidenced by the fact that
`
`Respondent submitted a specimen with its Statement of Use that shows use of the
`
`Mark on or in connection with a medicated product (i.e., a 0.01% fluocinolone
`
`acetonide product), which requires FDA approval to be lawfully marketed and sold in
`
`the United States.
`
`47. On information and belief, at the time Respondent filed its Statement
`
`of Use on January 27, 2010, the claims asserted by Respondent therein, under oath,
`
`and referred to in paragraphs 26-28 above, were false and/or misleading, and were
`
`known by Respondent to be false and/or misleading at such time.
`
`48.0n information and belief, at the time that Respondent submitted its
`
`Statement of Use on January 27, 2010, Respondent had no Iavvful right to market or
`
`sell a 0.01% fluocinolone acetonide product for use in the treatment of skin conditions
`
`in the United States under the mark NEO—SlNALAR or any other mark.
`
`49. Nor, on information and belief, did Respondent have a lawful right to
`
`market or sell such a product on the date that Respondent claimed under oath in its
`
`Statement of Use that it first used the NEO—SlNALAR mark in commerce (i.e., on
`
`September 25, 2009).
`
`12
`
`
`
`50.0n information and belief, at the time that Respondent submitted its
`
`Statement of Use, Respondent knew (i) that FDA approval was required to lawfully
`
`market and/or sell a 0.01% fluocinolone acetonide product for use in the treatment of
`
`skin conditions in the United States under the mark NEO-SINALAR or any other mark
`
`and (ii) that it did not have FDA approval, and therefore, had no legal right, to market
`
`and/or sell a 0.01 % fluocinolone acetonide product for use in the treatment of skin
`
`conditions in the United States under the mark NEO-SINALAR or any other mark.
`
`51.Nevertheless, on information and belief, Respondent submitted its
`
`Statement of Use knowing that the claims contained therein, and referred to in
`
`paragraphs 26-28, were false and/or misleading.
`
`52.0n information and belief, Respondent submitted its application, its
`
`amended application, and its Statement of Use with the intent to deceive the USPTO
`
`and to fraudulently secure a registration for the mark NEO—SlNALAR.
`
`53. In reliance on Respondent's sworn statements in its original
`
`application and in its amended application with respect to its alleged bona fide intent
`
`and in its Statement of Use with respect to its alleged use of the mark NEO-SINALAR
`
`in commerce, the USPTO granted registration of Respondent’s NEO-SINALAR mark.
`
`54. Because the registration was procured through fraud, Reg. No.
`
`3772614 should be cancelled.
`
`COUNT IV
`
`NEO-SINALAR Mark is Deceptive Under Section 2(a)
`
`55. Petitioner repeats and incorporates by reference the allegations set
`
`forth in paragraphs 1 through 54.
`
`13
`
`
`
`56.The NEO-SINALAR mark is deceptive as to the origin, approval,
`
`affiliation, character, quality, function, composition and/or use of the goods covered
`
`by Reg. No. 3772614 and should have been denied registration pursuant to Section
`
`2(a) of the Trademark Act of 1946, as amended, 15 U.S.C. § 1052(a).
`
`57. Respondent’s registered NEO-SINALAR mark consists of the prefix
`
`NEO, which can mean “new” or serve as an abbreviation for “neomycin,” and the
`
`term SINALAR, which is substantially similar to, and phonetically identical to, the
`
`SYNALAR brand name approved by the FDA under NDA 12-787 and NDA 15-296,
`
`both for a SYNALAR 0.01 % fluocinolone acetonide product for use in the treatment of
`
`skin conditions, as to which Petitioner owns the FDA drug approval rights.
`
`58. Respondent’s registered NEO-SINALAR mark is substantially similar
`
`to, and phonetically identical to, the NEO—SYNALAR brand name approved by the
`
`FDA under ANDA 60—700 for a combination 0.025% fluocinolone acetonide and 3.5
`
`mg neomycin topical cream product as to which Petitioner owns the FDA drug
`
`approval rights.
`
`59. On information and belief, Respondent selected the NEO-SINALAR
`
`mark in order to benefit from the goodwill associated with the SYNALAR brand
`
`names for the products that are the subject of Petitioner’s SYNALAR Drug Approvals
`
`—— SYNALAR, SYNALAR-HP and NEO—SYNALAR.
`
`60. On information and belief, Respondent did so with the intent to
`
`deceive, mislead and confuse consumers by causing them to believe, erroneously,
`
`that Respondent’s NEO-SINALAR product (i) is the non—prescription or over—the—
`
`counter form of the FDA-approved SYNALAR 0.01% fluocinolone acetonide
`
`14
`
`
`
`prescription cream product and/or the FDA-approved NEO—SYNALAR neomycin and
`
`fluocinolone acetonide combination product, as to which Petitioner owns the
`
`SYNALAR Drug Approvals, and/or (ii) is a “new” or “improved” version of Petitioner’s
`
`FDA-approved SYNALAR 0.01% fluocinolone acetonide prescription product, since
`
`NEO can mean “new”, and/or (iii) originates from, has been approved by, or is
`
`somehow affiliated with or connected to, Petitioner, and/or (iv) has the same or
`
`comparable characteristics, benefits, quality, function, composition and/or use as the
`
`SYNALAR and SYNALAR-HP 0.01% and 0.025% fluocinolone acetonide prescription
`
`products and/or the NEO—SYNALAR neomycin and fluocinolone acetonide
`
`combination product, as to which Petitioner owns the SYNALAR Drug Approvals,
`
`and/or (v) contains neomycin sulfate, when, on information and belief, it does not,
`
`and/or (vi) is marketed and/or sold under Petitioner’s SYNALAR Drug Approvals,
`
`and/or (vii) has been approved by the FDA.
`
`61. Respondent’s use and continued registration of the mark NEO-
`
`SINALAR for a 0.01% fluocinolone acetonide product or any “non—medicated
`
`preparations for soothing irritations” likely will lead consumers to believe mistakenly,
`
`and to purchase Respondent’s NEO—S|NALAR product in the mistaken belief, that
`
`Respondent’s NEO-SINALAR product (i) is the non-prescription or over—the—counter
`
`form of the FDA-approved SYNALAR 0.01% fluocinolone acetonide prescription
`
`cream product and/or the FDA-approved NEO—SYNALAR neomycin and fluocinolone
`
`acetonide combination product, as to which Petitioner owns the SYNALAR Drug
`
`Approvals, and/or (ii) is a “new” or “improved” version of Petitioner’s FDA-approved
`
`SYNALAR 0.01% fluocinolone acetonide prescription product, since NEO can mean
`
`15
`
`
`
`“new”, and/or (iii) originates from, has been approved by, or is somehow affiliated
`
`with or connected to, Petitioner, and/or (iv) has the same or comparable
`
`characteristics, benefits, quality, function, composition and/or use as the SYNALAR
`
`and SYNALAR-HP 0.01% and 0.025% fluocinolone acetonide prescription products
`
`and/or the NEO—SYNALAR neomycin and fluocinolone acetonide combination
`
`product, as to which Petitioner owns the SYNALAR Drug Approvals, and/or (v)
`
`contains neomycin sulfate, when, on information and belief, it does not, and/or (vi) is
`
`marketed and/or sold under Petitioner’s SYNALAR Drug Approvals, and/or (vii) has
`
`been approved by the FDA.
`
`62. For the foregoing reasons, Reg. No. 3772614 should be cancelled.
`
`COUNT V
`
`NEO-SINALAR Mark is Deceptively Misdescriptive Under Section 2(e)(1)
`
`63. Petitioner repeats and incorporates by reference the allegations set
`
`forth in paragraphs 1 through 62.
`
`64. The NEO-SINALAR mark is deceptively misdescriptive as to the
`
`origin, approval, affiliation, character, quality, function, composition and/or use of the
`
`goods covered by Reg. No. 3772614 and should have been denied registration
`
`pursuant to Section 2(e)(1) of the Trademark Act of 1946, as amended, 15 U.S.C. §
`
`1052(e)(1).
`
`65. Respondent’s registered NEO—SlNALAR mark consists of the prefix
`
`NEO which can mean “new” or serve as an abbreviation for “neomycin,” and the term
`
`SINALAR, which is substantially similar to, and phonetically identical to, the
`
`SYNALAR brand name approved by the FDA under NDA 12-787 and NDA 15-296,
`
`16
`
`
`
`both for a SYNALAR 0.01% fluocinolone acetonide product for use in the treatment of
`
`skin conditions, as to which Petitioner owns the FDA drug approval rights.
`
`66. Respondent’s registered NEO-SINALAR mark is substantially similar
`
`to, and phonetically identical to, the NEO—SYNALAR brand name approved by the
`
`FDA under ANDA 60-700 for a combination 0.025% fluocinolone acetonide and 3.5
`
`mg neomycin topical cream product, as to which Petitioner owns the FDA drug
`
`approval rights.
`
`67.0n information and belief, Respondent selected the NEO—S|NALAR
`
`mark in order to benefit from the goodwill associated with the SYNALAR brand
`
`names for the products that are the subject of Petitioner’s SYNALAR Drug Approvals
`
`— SYNALAR, SYNALAR—HP, and NEO—SYNALAR.
`
`68.0n information and belief, Respondent did so with the intent to
`
`deceive, mislead and confuse consumers by causing them to believe, erroneously,
`
`that Respondent’s NEO—S|NALAR product (i) is the non-prescription or over—the—
`
`counter form of the FDA—approved SYNALAR 0.01% fluocinolone acetonide
`
`prescription product and/or the FDA—approved NEO—SYNALAR neomycin and
`
`fluocinolone acetonide combination product, as to which Petitioner owns the
`
`SYNALAR Drug Approvals, and/or (ii) is a “new” or “improved” version of Petitioner’s
`
`FDA—approved SYNALAR 0.01% fluocinolone acetonide prescription product, since
`
`NEO can mean “new”, and/or (iii) originates from, has been approved by, or is
`
`somehow affiliated with or connected to, Petitioner, and/or (iv) has the same or
`
`comparable characteristics, benefits, quality, function, composition and/or use as the
`
`SYNALAR and SYNALAR-HP 0.01% and 0.025% fluocinolone acetonide prescription
`
`17
`
`
`
`products and/or the NEO-SYNALAR neomycin and fluocinolone acetonide
`
`combination product, as to which Petitioner owns the SYNALAR Drug Approvals,
`
`and/or (v) contains neomycin sulfate, when, on information and belief, it does not,
`
`and/or (vi) is marketed and/or sold under Petitioner’s SYNALAR Drug Approvals,
`
`and/or (vii) has been approved by the FDA.
`
`69. Respondent’s use and continued registration of the mark NEO-
`
`SINALAR for a 0.01% fluocinolone acetonide product or any “non—medicated
`
`preparations for soothing irritations” likely will lead consumers to believe, mistakenly,
`
`and to purchase Respondent’s NEO-SINALAR product in the mistaken belief, that
`
`Respondent’s NEO-SINALAR product (i) is the non-prescription or over-the-counter
`
`form of the FDA—approved SYNALAR 0.01% fluocinolone acetonide prescription
`
`product and/or the FDA—approved NEO-SYNALAR neomycin and fluocinolone
`
`acetonide combination product, as to which Petitioner owns the SYNALAR Drug
`
`Approvals, and/or (ii) is a “new” or “improved” version of Petitioner’s FDA—approved
`
`SYNALAR 0.01% fluocinolone acetonide prescription product, since NEO can mean
`
`“new”, and/or (iii) originates from, has been approved by, or is somehow affiliated
`
`with or connected to, Petitioner, and/or (iv) has the same or comparable
`
`characteristics, benefits, quality, function, composition and/or use as the SYNALAR
`
`and SYNALAR-HP 0.01% and 0.025% fluocinolone acetonide prescription products
`
`and/or the NEO-SYNALAR neomycin and fluocinolone acetonide combination
`
`product, as to which Petitioner owns the SYNALAR Drug Approvals, and/or (v)
`
`contains neomycin sulfate, when, on information and belief, it does not, and/or (vi) is
`
`18
`
`
`
`marketed and/or sold under Petitioner’s SYNALAR Drug Approvals, and/or (vii) has
`
`been approved by the FDA.
`
`70.For the foregoing reasons, Reg. No. 3772614 should be cancelled.
`
`COUNT VI
`
`Abandonment
`
`(No Use)
`
`71. Petitioner repeats and incorporates by reference the allegations set
`
`forth in paragraphs 1 through 70.
`
`72. On information and belief, Respondent is not currently using the
`
`mark NEO—SlNALAR in commerce in connection with any “non-medicated skin care
`
`preparations which soothe irritations” and has never used the mark NEO—SlNALAR in
`
`commerce in connection with any such products, and such nonuse does not
`
`constitute excusable nonuse.
`
`73. Reg. No. 3772614, therefore, should be cancelled, because
`
`Respondent has abandoned its alleged rights in the NEO—SlNALAR mark, including
`
`its alleged right to Reg. No. 3772614.
`
`COUNT VII
`
`Abandonment
`
`(No Use Because Cannot Rely on Illegal Use)
`
`74. Petitioner repeats and incorporates by reference the allegations set
`
`forth in paragraphs 1 through 73.
`
`75.0n information and belief, Respondent is not currently making lawful
`
`use of the NEO—SlNALAR mark in commerce, has never made lawful use of the
`
`19
`
`
`
`NEO—SINALAR mark in commerce, and has not taken any steps to make lawful use
`
`of the NEO—SINALAR mark in commerce.
`
`76. Reg. No. 3772614, therefore, should be cancelled because
`
`Respondent has abandoned its alleged rights in the NEO—SINALAR mark, including
`
`its alleged right to Reg. No. 3772614.
`
`77.To the extent that Respondent currently sells any skin care
`
`preparations in the United States, Respondent competes with Petitioner for sales of
`
`skin care preparations in the United States.
`
`78.As a competitor of Respondent for the sale of skin care preparations
`
`in the United States, and as the exclusive owners of the SYNALAR Drug Approvals,
`
`which gives Petitioner the exclusive right to market and sell fluocinolone acetonide
`
`products in the United States under the brand names SYNALAR, SYNALAR—HP and
`
`NEO—SYNALAR, Petitioner believes that it is being, and absent cancellation will
`
`continue to be, damaged by the registration of Reg. No. 3772614.
`
`79. For all the reasons set forth above, Petitioner respectfully requests
`
`that the Board cancel Reg. No. 3772614.
`
`20
`
`
`
`WHEREFORE, Petitioner prays that this Petition for Cancellation be
`
`granted and tha
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