PTO- 2306
`
`Approved for use through 11/30/2024. OMB 0651-0061
`
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number
`
`Petition to Make Special
`
`The table below presents the data as entered.
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`Input Field
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`Entered
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`SERIAL NUMBER
`
`MARK SECTION
`
`MARK
`
`LITERAL ELEMENT
`
`STANDARD CHARACTERS
`
`USPTO-GENERATED IMAGE
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`MARK STATEMENT
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`        ATTACHMENT(S)
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`       ORIGINAL PDF FILE
`
`       CONVERTED PDF FILE(S)
`       (7 pages)
`
`       ORIGINAL PDF FILE
`
`       CONVERTED PDF FILE(S)
`       (4 pages)
`
`       ORIGINAL PDF FILE
`
`       CONVERTED PDF FILE(S)
`       (4 pages)
`
`       ORIGINAL PDF FILE
`
`       CONVERTED PDF FILE(S)
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`97689956
`
`https://tmng-al.uspto.gov/resting2/api/img/97689956/large
`
`WAYZAH
`
`YES
`
`YES
`
`The mark consists of standard characters, without claim to any particular font style,
`size or color.
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`97689956_WAYZAH_-_Petition_to_Make_Special_20221157535963.pdf
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`\\TICRS\EXPORT18\IMAGEOUT18\976\899\97689956\xml3\PMS0002.jpg
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`\\TICRS\EXPORT18\IMAGEOUT18\976\899\97689956\xml3\PMS0003.jpg
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`\\TICRS\EXPORT18\IMAGEOUT18\976\899\97689956\xml3\PMS0008.jpg
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`stellas__New_Drug_Application_for_Fezolinetant_-
`_Aug_18_2022_202211575416698.pdf
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`\\TICRS\EXPORT18\IMAGEOUT18\976\899\97689956\xml3\PMS0009.jpg
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`\\TICRS\EXPORT18\IMAGEOUT18\976\899\97689956\xml3\PMS0012.jpg
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`Ex._2_-_Trademarks_Dashboard___USPTO_202211575435545.pdf
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`\\TICRS\EXPORT18\IMAGEOUT18\976\899\97689956\xml3\PMS0014.jpg
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`\\TICRS\EXPORT18\IMAGEOUT18\976\899\97689956\xml3\PMS0016.jpg
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`Ex._3_-_FY_2021_PDUFA_Perf_Report__FINAL__202211575453940.pdf
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`       (93 pages)
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`OWNER SECTION (Current)
`
`NAME
`
`MAILING ADDRESS
`
`CITY
`
`STATE
`
`Astellas US LLC
`
`1 Astellas Way
`
`Northbrook
`
`Illinois
`
`COUNTRY/REGION/JURISDICTION/U.S. TERRITORY
`
`United States
`
`ZIP/POSTAL CODE
`
`EMAIL
`
`OWNER SECTION (Proposed)
`
`NAME
`
`MAILING ADDRESS
`
`CITY
`
`STATE
`
`60062
`
`XXXX
`
`Astellas US LLC
`
`1 Astellas Way
`
`Northbrook
`
`Illinois
`
`COUNTRY/REGION/JURISDICTION/U.S. TERRITORY
`
`United States
`
`ZIP/POSTAL CODE
`
`EMAIL
`
`60062
`
`XXXX
`
`ATTORNEY INFORMATION (current)
`
`NAME
`
`Keith Toms, Esq.
`
`       
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`

`ATTORNEY BAR MEMBERSHIP NUMBER
`
`YEAR OF ADMISSION
`
`U.S. STATE/ COMMONWEALTH/ TERRITORY
`
`XXX
`
`XXXX
`
`XX
`
`FIRM NAME
`
`STREET
`
`CITY
`
`STATE
`
`POSTAL CODE
`
`COUNTRY/REGION/JURISDICTION/U.S. TERRITORY
`
`PHONE
`
`EMAIL
`
`DOCKET/REFERENCE NUMBER
`
`ATTORNEY INFORMATION (proposed)
`
`McCarter & English, LLP
`
`265 Franklin Street
`
`Boston
`
`Massachusetts
`
`02110-3113
`
`United States
`
`617-449-6500
`
`ktoms@mccarter.com
`
`127206-10200
`
`NAME
`
`Keith Toms, Esq.
`
`ATTORNEY BAR MEMBERSHIP NUMBER
`
`YEAR OF ADMISSION
`
`U.S. STATE/ COMMONWEALTH/ TERRITORY
`
`XXX
`
`XXXX
`
`XX
`
`FIRM NAME
`
`STREET
`
`CITY
`
`STATE
`
`POSTAL CODE
`
`COUNTRY/REGION/JURISDICTION/U.S. TERRITORY
`
`PHONE
`
`EMAIL
`
`DOCKET/REFERENCE NUMBER
`
`CORRESPONDENCE INFORMATION (current)
`
`McCarter & English, LLP
`
`265 Franklin Street
`
`Boston
`
`Massachusetts
`
`02110-3113
`
`United States
`
`617-449-6500
`
`ktoms@mccarter.com
`
`127206-10200
`
`NAME
`
`Keith Toms, Esq.
`
`PRIMARY EMAIL ADDRESS FOR CORRESPONDENCE
`
`ktoms@mccarter.com
`
`SECONDARY EMAIL ADDRESS(ES) (COURTESY COPIES)
`
`bostontrademarks@mccarter.com; mandrews@mccarter.com
`
`DOCKET/REFERENCE NUMBER
`
`127206-10200
`
`CORRESPONDENCE INFORMATION (proposed)
`
`NAME
`
`Keith Toms, Esq.
`
`PRIMARY EMAIL ADDRESS FOR CORRESPONDENCE
`
`ktoms@mccarter.com
`
`SECONDARY EMAIL ADDRESS(ES) (COURTESY COPIES)
`
`bostontrademarks@mccarter.com; mandrews@mccarter.com
`
`DOCKET/REFERENCE NUMBER
`
`127206-10200
`
`PAYMENT SECTION
`
`NUMBER OF CLASSES
`
`1
`
`

`

`PETITION TO DIRECTOR FEE
`
`TOTAL FEES DUE
`
`SIGNATURE SECTION
`
`       ORIGINAL PDF FILE
`
`       CONVERTED PDF FILE(S)
`       (1 page)
`
`SIGNATORY'S NAME
`
`SIGNATORY'S POSITION
`
`SIGNATORY'S PHONE NUMBER
`
`SIGNATURE METHOD
`
`SUBMISSION SIGNATURE
`
`SIGNATORY'S NAME
`
`SIGNATORY'S POSITION
`
`SIGNATORY'S PHONE NUMBER
`
`DATE SIGNED
`
`250
`
`250
`
`Signed_Declaration_-_Petition_to_Make_Special_202211575532377.pdf
`
`\\TICRS\EXPORT18\IMAGEOUT18\976\899\97689956\xml3\PMS0110.jpg
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`Christopher Bolinger
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`Sr. Director, IP Development & Commercial, Trademarks
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`000-000-0000
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`Handwritten
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`/Keith Toms/
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`Keith Toms
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`Attorney of record, MA Bar Member
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`617-449-6500
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`12/05/2022
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`ROLE OF AUTHORIZED SIGNATORY
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`Authorized U.S.-Licensed Attorney
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`SIGNATURE METHOD
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`Sent to third party for signature
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`FILING INFORMATION SECTION
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`SUBMIT DATE
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`TEAS STAMP
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`Mon Dec 05 21:05:35 EST 2022
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`USPTO/PMS-XX.XXX.X.XX-202
`21205210535000056-9768995
`6-20221205195330551859-DA
`-05352309-202212051953305
`51859
`
`PTO- 2306
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`Approved for use through 11/30/2024. OMB 0651-0061
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number
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`To the Commissioner for Trademarks:
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`Petition to Make Special
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`The following is submitted for application serial number: 97689956
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`FORM FILE NAME(S):
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`Original PDF file:
`97689956_WAYZAH_-_Petition_to_Make_Special_20221157535963.pdf
`Converted PDF file(s) (7 pages)
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`Original PDF file:
`stellas__New_Drug_Application_for_Fezolinetant_-_Aug_18_2022_202211575416698.pdf
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`Original PDF file:
`Ex._2_-_Trademarks_Dashboard___USPTO_202211575435545.pdf
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`Original PDF file:
`Ex._3_-_FY_2021_PDUFA_Perf_Report__FINAL__202211575453940.pdf
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`The owner proposes to amend the following:
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`

`

`Current: Astellas US LLC, having an address of
`      1 Astellas Way
`      Northbrook, Illinois 60062
`      United States
`      Email Address: XXXX
`
`Proposed: Astellas US LLC, having an address of
`      1 Astellas Way
`      Northbrook, Illinois 60062
`      United States
`      Email Address: XXXX
`The owner's/holder's current attorney information: Keith Toms, Esq.. Keith Toms, Esq. of McCarter & English, LLP, is a member of the XX bar,
`admitted to the bar in XXXX, bar membership no. XXX, is located at
`
`      265 Franklin Street
`      Boston, Massachusetts 02110-3113
`      United States
`The docket/reference number is 127206-10200.
`
`The phone number is 617-449-6500.
`
`The email address is ktoms@mccarter.com
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`The owner's/holder's proposed attorney information: Keith Toms, Esq.. Keith Toms, Esq. of McCarter & English, LLP, is a member of the XX
`bar, admitted to the bar in XXXX, bar membership no. XXX, is located at
`
`      265 Franklin Street
`      Boston, Massachusetts 02110-3113
`      United States
`The docket/reference number is 127206-10200.
`
`The phone number is 617-449-6500.
`
`The email address is ktoms@mccarter.com
`
`Correspondence Information (current):
`      Keith Toms, Esq.
`      PRIMARY EMAIL FOR CORRESPONDENCE: ktoms@mccarter.com
`      SECONDARY EMAIL ADDRESS(ES) (COURTESY COPIES): bostontrademarks@mccarter.com; mandrews@mccarter.com
`
`The docket/reference number is 127206-10200.
`
`Correspondence Information (proposed):
`      Keith Toms, Esq.
`      PRIMARY EMAIL FOR CORRESPONDENCE: ktoms@mccarter.com
`      SECONDARY EMAIL ADDRESS(ES) (COURTESY COPIES): bostontrademarks@mccarter.com; mandrews@mccarter.com
`
`The docket/reference number is 127206-10200.
`
`Requirement for Email and Electronic Filing: I understand that a valid email address must be maintained by the applicant owner/holder and
`the applicant owner's/holder's attorney, if appointed, and that all official trademark correspondence must be submitted via the Trademark
`Electronic Application System (TEAS).
`
`FEE(S)
`Fee(s) in the amount of $250 is being submitted.
`
`SIGNATURE(S)
`Declaration Signature
`Original PDF file:
`Signed_Declaration_-_Petition_to_Make_Special_202211575532377.pdf
`Converted PDF file(s) (1 page)
`
`

`

`Signature File1
`Signatory's Name: Christopher Bolinger
`Signatory's Position: Sr. Director, IP Development & Commercial, Trademarks
`Signatory's Phone Number: 000-000-0000
`Signature method: Handwritten
`
`Submission Signature
`Signature: /Keith Toms/     Date: 12/05/2022
`Signatory's Name: Keith Toms
`Signatory's Position: Attorney of record, MA Bar Member
`Signatory's Phone Number: 617-449-6500
`Signature method: Sent to third party for signature
`
`The signatory has confirmed that he/she is a U.S.-licensed attorney who is an active member in good standing of the bar of the highest court of a
`U.S. state (including the District of Columbia and any U.S. Commonwealth or territory); and he/she is currently the petitioner's attorney or an
`associate thereof; and to the best of his/her knowledge, if prior to his/her appointment another U.S.-licensed attorney not currently associated
`with his/her company/firm previously represented the petitioner in this matter: the petitioner has revoked their power of attorney by a signed
`revocation or substitute power of attorney with the USPTO; the USPTO has granted that attorney's withdrawal; the petitioner has filed a power of
`attorney appointing him/her in this matter; or the petitioner's appointed U.S.-licensed attorney has filed a power of attorney appointing him/her as
`an associate attorney in this matter.
`
`Mailing Address:    Keith Toms, Esq.
`   McCarter & English, LLP
`
`      265 Franklin Street
`
`   Boston, Massachusetts 02110-3113
`Mailing Address:    Keith Toms, Esq.
`   McCarter & English, LLP
`
`      265 Franklin Street
`
`   Boston, Massachusetts 02110-3113
`
`PAYMENT: 05352309
`PAYMENT DATE: 12/05/2022
`
`Serial Number: 97689956
`Internet Transmission Date: Mon Dec 05 21:05:35 EST 2022
`TEAS Stamp: USPTO/PMS-XX.XXX.X.XX-202212052105350000
`56-97689956-20221205195330551859-DA-0535
`2309-20221205195330551859
`
`        
`        
` 
`

`

`Mark:
`Application No.:
`Application Date:
`Owner:
`
`WAYZAH
`97/689,956
`November 23, 2022
`Astellas US LLC
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`PETITION TO MAKE SPECIAL
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`Petitioner Astellas US LLC (“Astellas”) respectfully requests that its U.S. Application
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`Serial No. 97/689,956 for WAYZAH be madethe subject of a special action pursuant to 37
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`C.F.R.
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`§ 2.146 and be examined without delay.'
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`In particular, Astellas requests this
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`extraordinary remedy to avoid the demonstrable loss of substantial rights that may arise if it is
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`unable to coordinate the timing of the present application with the timeline for the approval of
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`proposedproprietary names to the Food and Drug Administration (“FDA”).
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`Astellas recognizes that petitions to make special must meet an extraordinary bar and
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`believes, as discussed below,
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`that the circumstances surrounding its application warrant the
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`granting of this Petition. The Declaration of Christopher Bolinger, Sr. Director, IP Development
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`& Commercial, Trademarks, verifying this petition attests that Astellas believes it will suffer a
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`loss of substantial rights if the Petition to Make Special is not granted.
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`
`
`' Through separatefilings, Astellas is requesting that ten additional applications be made
`special so that it may adapt its FDA submissioninimize its loss of substantial rights if the
`proprietary namecurrently underreview is not accepted, Astellas will noso that it can present
`diverse options to the FDA and respond promptly to Agency guidance, and thus respectfully
`seeks to have examination expedited for this slate of marks so it can exclude any with associated
`registrability issues.
`37 C.F.R. § 2.146 does not place any numeric limits on the numberof applications that
`can be made special, and Astellas believes that it has good cause for each of the applications to
`be madespecial given the challenging FDA review of the fezolinetant. The slate of marks
`includes both a diversity of marks (in case the FDAidentifies a fundamental obstacle) and
`spelling variations, in case the FDA’s concerns can be mitigated by modifying a mark. Given
`the late stage of the FDA review process, Astellas believes that having this diversity of name
`candidates is essential to minimizing the risk of a substantial loss of rights.
`Should the USPTO, however, determine only to grant a subset of the petitions, Astellas
`respectfully requests that the applications for VEYJAH (SN 97689948), FEIZDU (SN
`97689924), CEVMIHO (SN 97657239), and FEZKAYO (SN 97689932) be prioritized.
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`MEI 43516459v.1
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`

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`STATEMENT OF FACTS
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`In August 2022, Astellas’ New Drug Application (“NDA”) for a drug generically named
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`fezolinetant was accepted by the U.S. Food and Drug Administration (“FDA”) for Priority
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`Review. The fezolinetant drug product is a first-in-class nonhormonal treatment option for
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`moderate to severe vasomotor symptoms (VMS)associated with menopause. Per the guidelines
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`specified in the Prescription Drug User Fee Act (“PDUFA”), FDA priority review of Astellas’
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`NDAs will be complete by February 22, 2022 (the “PDUFA Action Date”).
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`See Ex. 1,
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`Fezolinetant Press Release.
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`In early 2020, long before the submission of its NDA, Astellas had begun the process of
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`securing trademark protection and regulatory approval
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`for a proprietary brand name for
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`fezolinetant.
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`Its diligence culminated in selecting a primary mark, which was submitted to the
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`FDA in February 2021. Unfortunately,
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`in August 2021 the FDA’s review determined that
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`Astellas’ first-choice proprietary name did not satisfy all the rigorous requirements for FDA
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`approval due a conflict with another undisclosed product under FDAreview.
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`Astellas then submitted a second mark VEOZA (U.S. Serial No. 97/070,486)
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`in
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`December 2021. While Astellas was supposed to receive preliminary feedback on this
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`proprietary name by June 2022, the FDA did not complete its review until September 2022,
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`where the VEOZA mark was found unacceptable due to an orthographic handwriting conflict
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`with a prior drug product.
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`The FDArefusal of the backup mark has necessitated efforts by Astellas to develop and
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`seek protection for new proprietary namesthat will satisfy the rigorous requirements of both the
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`FDA and the USPTO. After consultation with the FDA, Astellas determined that its previously
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`filed back-up applications, that had already been prosecuted at the USPTO, would notbe suitable.
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`MEI 43516459v.1
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`

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`Instead, Astellas developed a new mark that it has instead submitted for FDA approval
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`in
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`October 2022.
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`Review of this FDA submission is pending, with a decision expected in January 2023.
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`Given the nature of the FDA review, however, there remains a significant risk that the name
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`under current consideration will not be approved, which leads little time before the PDUFA
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`Action Date to submit an alternative. The application for the WAYZAH markis part of a slate
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`of backup marks specifically developed to maximize the speed of FDA review and approval in
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`advance of the PDUFA Action Date or as soon thereafter as possible.
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`Due to the FDA’s rejection of its first and second choice proprietary names,
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`the
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`uncertainty regarding its current pending candidate name, Astellas now faces a significant issue
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`of timing that could lead to a demonstrable possibility of a substantial loss of rights. Should the
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`current name under consideration not be accepted, Astellas will need to work closely with the
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`FDA and move quickly to submit a name to the FDA for hope of approval in advance of the
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`February 2023 PDUFA Action Date. Under standard USPTO examination timelines, however,
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`the earliest Astellas can expect the present application to be examined would be August 2023.
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`See Ex. 2 (indicating average first action in 8.2 months). As such, Astellas would not have time
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`to submit an alternative name for FDA approvalif, for example, the Examining Attorney finds
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`the proposed proprietary nameto be unregisterable.
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`Failure to have a proprietary namethat is both registerable at the USPTO and acceptable
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`to the FDA by the PDUFAAction Date would lead to a demonstrable loss of substantive rights
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`for Astellas under any scenario.
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`If the lack of a proprietary name were to delay launch, then
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`Astellas is losing part of its substantial rights to limited market exclusivity and data exclusivity,
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`which are granted to Astellas pursuant to the patent statute and the Hatch-Waxmanact. See 21
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`MEI 43516459v.1
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`

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`C.F.R.
`
`§ 314.108 (providing right
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`to 5 years exclusivity for new molecular entities like
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`fezolinetant). A delayed launch would also deprive patients of a beneficial drug treatment.
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`Alternatively, if Astellas accepts an FDA-approved proprietary name that ultimately cannot be
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`registered at the USPTO,then Astellas would be losing the substantive rights associated with a
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`federally registered trademark.
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`Finally, proceeding to market with its new drug under the
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`generic name fezolinetant would also lead to a loss of substantial rights, namely the ability to use
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`a trademark to capture the goodwill generated by a successful product launch of an exciting new
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`drug.
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`The circumstances giving rise to Astellas’ present
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`issue are rare and will not be
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`encountered by a substantial number of other companies, as new drugs are one of the few
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`products or services that require regulatory approval of trademarks before their use.
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`Indeed,
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`even in the pharmaceutical industry, only a small number of drug products received Priority
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`Review status. See Ex. 3 at 5, FDA FY2021 Performance Report to Congress (noting five-year
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`average of fifty six Original Priority NDA and BLAfilings per year for new molecular entities
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`(“NMEs”) and non-NMEproducts). While Astellas is not aware ofstatistics, presumably only a
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`small subset thereof encounters similar challenges in selecting a proprietary name.
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`I.
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`THE APPLICATION FOR WAYZAH SHOULD BE EXAMINED ON AN
`EXPEDITED BASIS
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`Astellas respectfully requests that its application be examined out of order to avoid a
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`demonstrable loss of substantive rights that could arise if it cannot appropriately coordinate the
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`timing of USPTO and FDA review procedures. See TMEP § 1710.01 (an application may be
`
`made special on the finding of “a demonstrable possibility of the loss of a substantial right.”).
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`First, given the situation outlined above, there is a demonstrable risk that Astellas will
`
`suffer a loss of substantive rights if the present application is not examined in time to submit an
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`MEI 43516459v.1
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`

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`alternative name to the FDA should trademark registration not be available.
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`Indeed, as shown
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`above, Astellas would be put in the unenviable situation of choosing between (1) losing a portion
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`of its substantial right to time-limited market exclusivity with a delayed launch, (2) foregoing the
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`substantial rights granted by federal trademark protection, or (3) foregoing the substantial rights
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`inherent in using a trademark altogether. Expedited review of Astellas’ trademark application
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`would materially improve its chances of securing a brand name acceptable both to the USPTO
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`and FDA by the PDUFA Action Date or as quickly thereafter as possible, thereby avoiding this
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`harm.”
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`Moreover, the present issue has arisen despite Astellas’ diligence in taking all reasonable
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`steps available in selecting a proprietary name for fezolinetant. Astellas not only started the
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`proprietary nameselection process in early 2020, but it had also prosecuted its first and second
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`choice trademarks to USPTO Allowancewell in advance of the PDUFA Action Date. Given the
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`FDAreview timelines, the fact that the FDA will only review one markat a time, and the FDA’s
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`delay in reviewing Astellas’ second choice mark, there is nothing further that Astellas could have
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`done to avoid the present situation.
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`Astellas does not believe the present situation would apply equally to a large number of
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`applicants, and thus there is no reason to deny the reasonablerelief that Astellas is seeking. First,
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`new drugs are one of the very few types of products that require regulatory approval of brand
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`names before their use, so this rules out applicants operating in virtually all other industries.
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`Even among pharmaceutical applicants, Astellas’ present timing challenges are the result of an
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`exceedingly rare combination of (1) the six-month time frame of FDA Priority review of an
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`NDA,and (2) the FDA’s rejection of Astellas’ primary name, the delayed rejection of its backup
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`> Even if the USPTOis not able to act on the Petition by the deadline to submit an alternative mark to the FDA,
`expedited review of this application will still alleviate the harm to Astellas by minimizing any delay in market entry.
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`MEI 43516459v.1
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`5
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`

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`name and guidance on name modifications, and the FDA review timeline for additional
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`submissions. Given the small number of NDAsto be granted Priority Review each year, few
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`applicants are likely to encounter the challenges that Astellas has encountered.
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`The TMEPrecognizes that a requirement for government approval of a brand name may
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`commonly warrant special examination. See TEMP § 1710.01 (“Commonly accepted types of
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`evidence for granting Petition to Make Special .
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`.
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`. or copies of government regulations showing
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`that a trademark registration is required to secure government approval
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`for the goods or
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`services.”). While trademark registration is not formally required for FDA approval, Astellas has
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`amply demonstrated that the absence of a USPTO registerable and FDA approved proprietary
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`name by the PDUFA Action Date will cause significant, demonstrable harm that can be
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`alleviated with expedited examination. Moreover, rare is the case where a difficult FDA
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`examination necessitates late-game adjustments to a company’s trademarkfilings, despite years
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`ofdiligence andits best efforts to the contrary.
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`Further, granting this Petition to Make Special will also create appropriate incentives for
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`companies navigating the complexities of FDA and USPTO review of drug brand names.