CENTER FOR DRUG EVALUATION AND
`RESEARCH
`
`
`
`APPLICATION NUMBER:
`
`201023Orig1s000
`
`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
`
`
`
`
`

`

`1.3.5.1 Patent Information
`XRP6258rcabazitaxel - NDA 201023
`
`
`
`PATENT INFORMATION
`
`Pursuant to 21 CFR 314.53(d)(l) the patent information for this original application is being
`submitted concurrently herewith by separate letter addressed to the Central Document Room.
`
`
`
`Linda Gustavson, PhD, RAC
`
`Director. US. Assoc. Therapeutic Axis Head, Oncology
`
`Regulatory Research and Development Portfolio
`
`Corporate Regulatory Affairs
`
`Sanofi-aventis US
`
`
`Version 1.0
`1.0
`Version
`
`Property of the sanofi~aventis group - strictly confidential
`
`Page 1
`
`

`

`This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) with an NDA application,
`amendment, or supplement as required by 21 CFR 314.53 at the address provided in 21 CFR 314.53(d)(4).
`Within thirty (30) days after approval of an NDA or supplement, or within thirty (30) days of issuance of a new patent, a new patent
`
`
`declaration must be submitted pursuant to 21 CFR 314.53(c)(2)(ii) with all of the required information based on the approved NDA or
`supplement. The information submitted in the declaration form submitted upon or after approval will be the
`only information relied
`
`
`upon by FDA for listing a patent in the Orange Book.
`
` For hand-written or typewriter versions (only) of this report: If additional space is required for any narrative answer (i.e., one that
`
`
`does not require a "Yes" or "No" response), please attach an additional page referencing the question number.
`
`
`FDA will not list patent information if you submit an incomplete patent declaration or the patent declaration indicates the
`
`patent is not eligible for listing.
`
`
`For each patent submitted for the pending NDA, amendment, or supplement referenced above, you must submit all the
`information described below. If you are not submitting any patents for this pending NDA, amendment, or supplement,
`complete above section and sections 5 and 6.
`a,“
`
`w,
`
`.
`
`.
`
`~
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`e W
`
`,,
`
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`3?:
`c. Expiration Date of Patent
`
`v
`
`a
`
`
`
`”V ‘-
`
`November 22, 2013
`
`
`
`
`
`
`Form Approved: OMB No. 0910-0513
`
`Department of Health and Human Services
`Expiration Date: 7/31/10
`Food and Drug Administration
`See OMB Statement on Page 3.
`
`
`
`NDA NUMBER
`
`
`
`
`
`PATENT INFORMATION SUBMITTED WITH THE FILING
`
`OF AN NDA, AMENDMENT, OR SUPPLEMENT
`
`For Each Patent That Claims a Drug Substance
`(Active Ingredient), Drug Product (Formulation and Composition)
`and/or Method of Use
`
`NAME OF APPLICANT/NDA HOLDER
`
`sanofi-aventis US. LLC
`
`The following is provided in accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
`TRADE NAME (OR PROPOSED TRADE NAME)
`JEVTANA®
`
`
`
`
`
`
`
`
`
`
`ACTIVE INGREDIENT(S)
`cabazitaxel
`
`
`STRENGTH(S)
`Single dose vials containing 60 mg/ 1.5mL (40 mg/mL)
`
`I O
`
`t
`
`O ‘ V
`
`concentrate for solution for infusion
`
`
`
`
`
`a. United States Patent Number
`
`A
`
`b. Issue Date of Patent
`
`
`
`
`
`August 1, 1995
`5,438,072
`Address (of Patent Owner)
`d. Name of Patent Owner
`174 Avenue de France
`Aventis Pharma SA.
`
` City/State
`
`
`75013 Paris
`
`
`ZIP Code
`FAX Number (if available)
`
`
`FRANCE
`I
`
`
`Telephone Number
` E-Mail Address (if available)
`
`
`
`‘ . -ress o agen or represen a me name m .e.
`e. ‘ameo agen or represen a Ne w o resu-es or main ins
`
`
`
`a place of Busmess Within the United States authorized to
`1041 Route 202/206
`receive notice of patent certification under section 505(b)(3)
`
`and (j)(2)(B) of the Federal Food, Drug, and Cosmetic Act
`_
`
`
`and 21 CFR 314.52 and 314.95 (if patent owner or NDA
`C'tylSta‘e
`applicant/holder does not reside or have a place of
`Bridgewater, New Jersey
`
`
`
`ZIP Code
`FAX Number (if available)
`business within the United States)
`
`
`
`08807
`g
`(908) 231-2840
`
`
`
`
`Charlotte Barney, Esq.
`Telephone Number
`E—Mail Address (if available)
`
`
`
`(908) 231-4551
`charlotte.bamey@sanofi -aventis.com
`
`
`f. st e patent re erence above a patentt at has been sumitted prevuously ort e
`
`
`approved NDA or supplement referenced above?
`'_ Yes
`
`9.
`
`
`
`
`
`
`— Yes
`
`X No
`
`E No
`
`
`
`t e patent re erenoe aoove as oeen SUOOmltte prevnousy or IstIng, ist e expiration
`date a new expiration date?
`
`
`
`1.0
`Version
`
`
`. a ( 2I08)
`Page1
`PSC Graphics (301) 443.1090
`EF
`
`
`
`
`

`

`For the patent referenced above, provide the following information on the drug substance, drug product and/or method of
`use that is the subject of the pending NDA, amendment, or supplement.
`
`2.1 Does the patent claim the drug substance that Is the active IngredIent'In the drug product
`described In the pending NDA, amendment or supplement?
`
`2.2 Does the patent claim a drug substance that is a different polymorph of the active
`ingredient described in the pending NDA, amendment, or supplement?
`
`2.4 Specify the polymorphic form(s) claimed by the patent for which you have the test results described in 2.3.
`
`2.5 Does the patent claim only a metabolite of the active ingredient pending in the NDA or supplement?
`(Complete the information in section 4 below if the patent claims a pending method of using the pending
`drug product to administer the metabolite.)
`
`2.6 Does the patent claim only an intermediate?
`
`2.7 If the patent referenced in 2.1 is a product-by-process patent is the product claimedIn the
`patent novel? (An answer is required only if the patent'Is a product-b-y-process patent.)
`
`3.1 Does the patent claIm the drug product, as defined in 21 CFR 314.3, In the pendIng NDA, amendment,
`or supplement?
`
`3.2 Does the patent claim only an intermediate?
`
`3. 3 If the patent referenced'In 3.1 is a product-by—process patent, is the product claimed'In the
`patent novel? (An answer is required only if the patentIs a product--b-yprocess patent.)
`
`
`
`
`
`
`
`
`
`|: No
`
`
`
`2.3 If the answer to question 2.2 is "Yes," do you certify that, as of the date of this declaration, you have test
`data demonstrating that a drug product containing the polymorph will perform the same as the drug product
`described in the NDA? The type of test data required is described at 21 CFR 314.53(b).
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`XYes
`
`
`
`
`ea
`
`-_
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`
`Sponsors must submit the InfonnatIon In section 4 for each method of using the pending drug product for which approval Is being
`sought that is claimed by the patent. For each pending method of use claimed by the patent, provide the following information:
`
`4.1 Does the patent claim one or more methods of use for which approval is being sought in
`the pending NDA, amendment, or supplement?
`
`4.2 Patent Claim Number(s) (as listed in the patent)
`
`Does (Do) the patent claim(s) referenced in 4.2 claim a
`pending method of use for which approval is being sought
`in the pending NDA, amendment, or supplement?
`
`
`
`
`
`
`Use: (Submit indication or method of use information as identified specifically in the proposed labeling.)
`
`4.2a If the answer to 4.2 is
`"Yes," identify with speci-
`ficity the use with refer-
`ence to the proposed
`labeling for the drug
`product.
`
`For this pending NDA, amendment, or supplement, there are no relevant patents that claim the drug substance (active ingredient),
`drug product (formulation or composition) or method(s) of use, for which the applicantIs seeking approval and with respect to which
`a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the
`manufacture, use, or sale of the drug product.
`
`1.0
`Version
`
`
`

`

`6-1 The undersigned declares that this Is an accurate and complete submission of patent information for the NDA,
`amendment, or supplement pending under section 505 of the Federal Food, Drug, and Cosmetic Act. This time-
`sensitive patent information is submitted pursuant to 21 CFR 314.53. lattest that I am familiar with 21 CFR 314.53 and
`this submission complies with the requirements of the regulation. I verify under penalty of perjury that the foregoing is
`true and correct.
`
`Warning: A willfully and knowingly false statement is a criminal offense under 18 U.S.C. 1001.
`
`6.2 Authorized Signature of NDA Applicant/Holder or Patent Owner (Attorney, Agent, Representative or
`otherAuthorized Official) (We Information below)
`an
`
`Date Signed
`
`Fab, 1?, ZO/O
`
`NOTE: Only an NDA applicant/holder may submit this declaration directly to the FDA. A patent owner who is not the NDA applicant!
`holder is authorized to sign the declaration but may not submit it directly to FDA. 21 CFR 314.53(c)(4) and (d)(4).
`
`Check applicable box and provide information below.
`
`
`
`NDA Applicant/Holder
`
`D NDA Applicant‘s/Holder’s Attorney, Agent (Representative) or other
`Authorized Official
`
`
` Patent Owner
`
`
`
`
`
`E Patent Owner‘s Attorney, Agent (Representative) or Other Authorized
`Official
`
`Name
`
`John D. Conway
`Address
`City/State
`
`Bridgewater, New Jersey
`sanofi-aventis US. Inc.
`1041 Route 202-206
`
`ZIP Code
`Telephone Number
`
`08807
`
`FAX Number (if available)
`(908) 231-2626
`
`(908) 231-5617
`
`E-Mail Address (if available)
`john.conway@sanof1—aventis.com
`
`The public reporting burden for this collection of information has been estimated to average 20 hours per response, including the time for reviewing
`instnictions, surching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send
`comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
`
`Department ofHealth and Human Services
`Food and Dmg Administration
`Office of Chief Information Officer (HFA-710)
`5600 Fishers Lane
`Rockville, MD 20857
`
`An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
`information unless it displays a currently valid OMB control number.
`
`Version
`FORM FDA
`
`
`1.0
`
`
`
`

`

`Department of Health and Human Services
`Food and Drug Administration
`
`Form Approved: OMB No. 0910-0513
`Expiration Date: 7/31/10
`See OMB Statement on Page 3.
`PATENT INFORMATION SUBMITTED WITH THE FILING NDA NUMBER
`OF AN NDA, AMENDMENT, OR SUPPLEMENT
`
`For Each Patent That Claims a Drug Substance
`(Active Ingredient), Drug Product (Formulation and Composition)
`and/or Method of Use
`
`NAME OF APEL'CANT’NDA HOLDER
`san0fi‘aventls US" LLC
`
`The following is provided in accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
`TRADE NAME (OR PROPOSED TRADE NAME)
`JEVTANA®
`
`'
`
`ACTIVE INGREDIENT(S)
`cabazitaxel
`
`STRENGTH(S)
`Single dose vials containing 60 mg/1.5mL (40 mg/mL)
`
`I O
`
`t
`
`O ' V
`
`concentrate for solution for infusion
`
`This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) with an NBA application,
`amendment, or supplement as required by 21 CFR 314.53 at the address provided in 21 CFR 314.53(d)(4).
`Within thirty (30) days after approval of an NBA or supplement, or within thirty (30) days of issuance of a new patent, a new patent
`declaration must be submitted pursuant to 21 CFR 314.53(c)(2)(ii) with all of the required information based on the approved NDA or
`supplement. The information submitted in the declaration form submitted upon or after approval will be the
`only information relied
`upon by FDA for listing a patent in the Orange Book.
`
`For hand-written or typewriter versions (only) of this report: If additional space is required for any narrative answer (i.e., one that
`does not require a "Yes" or "No” response), please attach an additional page referencing the question number.
`
`FDA will not list patent information if you submit an incomplete patent declaration or the patent declaration indicates the
`patent is not eligible for listing.
`
`For each patent submitted for the pending NDA, amendment, or supplement referenced above, you must submit all the
`information described below. If you are not submitting any patents for this pending NDA, amendment, or supplement,
`complete above section and sections 5 and 6.
`x
`1.». m..-
`
`a. United States Patent Number
`
`b. Issue Date of Patent
`
`:
`
`c. Expiration Date of Patent
`
`‘
`
`d. Name of Patent Owner
`Aventis Pharma SA.
`
`Address (of Patent Owner)
`174 Avenue de France
`
`City/State
`75013 Paris
`
`
`ZIP Code
`
`FRANCE
`
`Telephone Number
`E-Mail Address (if available)
`
`J FAX Number (ifavailable)
`
`‘ . oress a agen or represen a me name in .e.
`1041 Route 202/206
`
`
`
`
`AX Number (if available)
`(908) 231-2840
`E-Mail Address (if available)
`charlotte.bamey@sanofi—aventis.com
`
`
`
`e. ‘ameo agen or represen .
`a place of Busmess wrffiln The United States authorized to
`receive notice of patent certification under section 505(b)(3)
`and (j)(2)(B) of the Federal Food, Drug, and Cosmetic Act
`and 21 CFR 314.52 and 314.95 (if patent owner or NDA WW/S‘a‘e
`applicant/holder does not reside or have a place of
`Bridgewater, New Jersey
`business within the United States)
`2|
`ode
`08807
`Telephone Number
`(908) 23 1—4551
`is the patent re erence above a patent that as een suanmitte previously ort e
`approved NDA or supplement referenced above?
`
`Charlotte Barney, Esq.
`
`.
`
`g.
`
`t e patent re erence- a-ove as een su-nmltte prevnousy or Istlng, Ist e expiration
`date a new expiration date?
`
`
`1.0
`Version
`FORM FDA
`('2/08)
`Page 1
`
`PSC Graphics (301) 443.1090
`EF
`
`

`

`For the patent referenced above, provide the following information on the drug substance, drug product and/or method of
`use that is the subject of the pending NDA, amendment, or supplement.
`
`2.1 Does the patent claim the drug substance that is the active ingredient in the drug product
`described in the pending NDA, amendment, or supplement?
`
`2.2 Does the patent claim a drug substance that is a different polymorph of the active
`ingredient described in the pending NDA, amendment, or supplement?
`
`2.4 Specify the polymorphic form(s) claimed by the patent for which you have the test results described in 2.3.
`
`2.3 If the answer to question 2.2 is "Yes," do you certify that. as of the date of this declaration, you have test
`data demonstrating that a drug product containing the polymorph will perform the same as the drug product
`described in the NDA? The type of test data required is described at 21 CFR 314.53(b).
`
`
`
`2.5 Does the patent claim only a metabolite of the active ingredient pending in the NDA or supplement?
`(Complete the information in section 4 below if the patent claims a pending method of using the pending
`drug product to administer the metabolite.)
`
`2.6 Does the patent claim only an intermediate?
`
`2.7 If the patent referenced in 2.1 is a product—by-process patent, is the product claimed in the
`patent novel? (An answer is required only if the patent is a product-by-process patent.)
`
`
`
`3.1 Does the patent claim the drug product. as
`or supplement?
`
`3.2 Does the patent claim only an intermediate?
`
`3.3 If the patent referenced in 3.1 is a product-by-process patent, is the product claimed in the
`patent novel? (An answer is required only if the patent is a product-by-process patent.)
`
`.
`
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`
`Sponsors must submrt the information in section 4 for each method of usmg the pending drug product for which approval :5 being
`sought that is claimed by the patent. For each pending method of use claimed by the patent, provide the following information:
`
`4.1 Does the patent claim one or more methods of use for which approval is being sought in
`the pending NDA, amendment, or supplement?
`
`4.2 Patent Claim Number(s) (as listed in the patent)
`
`Does (Do) the patent claim(s) referenced in 4.2 claim a
`pending method of use for which approval is being sought
`in the pending NDA, amendment. or supplement?
`
`
`
`Use: (Submit indication or method of use information as identified specifically in the proposed labeling.)
`
`4.2a If the answer to 4.2 is
`"Yes." identify with speci-
`ficity the use with refer-
`ence to the proposed
`labeling for the drug
`product.
`
`J,
`
`._
`
`.
`
`ms
`
`.3“:
`
`_ ms
`
`.
`
`a
`
`s
`
`For this pending NDA, amendment, or supplement, there are no relevant patents that claim the drug substance (active ingredient),
`drug product (formulation or composition) or method(s) of use, for which the applicant is seeking approval and with respect to which
`a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the
`manufacture, use, or sale of the drug product.
`
`1.0
`Version
`
`
`

`

` 3 Patent Owner
`
`
`
`E Patent Owner’s Attorney, Agent (Representative) or Other Authon'zed
`' Official
`Name
`
`
`
`J».
`
`6.1 The undersigned declares that this is an accurate and complete submission ofpatent information for the NDA,
`amendment, or supplement pending under section 505 of the Federal Food, Drug, and Cosmetic Act. This time-
`sensitive patent information is submitted pursuant to 21 CFR 314.53. Iattest that I am familiar with 21 CFR 314.53 and
`this submission complies with the requirements of the regulation. I verify under penalty of perjury that the foregoing is
`true and correct.
`
`Warning: A willfully and knowingly false statement is a criminal offense under 18 us. C. 1001.
`
`6.2 Authorized Signature of NDA Applicant/Holder or Patent Owner (Attorney, Agent, Representative or
`
`Date Signed
`
`otherAuthorized Official (Prov/armation below)
`’
`)6
`.
`_
`
`i
`
`Fal. My 50/0
`
`‘
`NOTE: On! an NDA applicant/holder may su mit this declaration directly to the FDA. A patent owner who is not the NDA applicantl
`holder is authorized to sign the declaration but may not submit it directly to FDA. 21 CFR 314.53(c)(4) and (d)(4).
`
`Check applicable box and provide information below.
`
`
`j NDA Applicant's/Holders Attorney, Agent (Representative) or other
`j NDA Applicant/Holder
`Authorized Official
`
`
`information unless it displays a currently valid OMB control number.
`
`John D. Conway
`
`
`Address
`
`City/State
`
`Bridgewater, New Jersey
`sanofi-aventis US. Inc.
`1041 Route 202-206
`
`
`ZIP Code
`
`08807
`
`FAX Number (if available)
`(908) 231-2626
`
`Telephone Number
`
`(908) 231-5617
`
`E-Mail Address (if available)
`john.conway@sanofl-aventis.com
`
`The public reporting burden for this collection of information has been estimated to average 20 hours per response, including the time for reviewing
`instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send
`comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
`
`Department of Health and Human Services
`Food and Drug Administration
`Office of Chief Information Officer (HFA-710)
`5600 Fishers Lane
`Rockville, MD 20857
`
`An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
`
`1.0
`
`Version
`
`
`
`
`

`

`F°”“ Appmvedi OMB N°- 0910'0513
`Department of Health and Human Services
`Expiration Date: 7/31/10
`.
`.
`.
`See OMB Statement on Page 3.
`Food and Drug Administration
`PATENT INFORMATION SUBMITTED WITH THE FILING NDANUMBER
`OF AN NDA, AMENDMENT, OR SUPPLEMENT
`
`For Each Patent That Claims a Drug Substance
`(Active Ingredient), Drug Product (Formulation and Composition)
`and/or Method of Use
`
`NAME OF APPL'CANT/NDA HOLDER
`samfi'aventis US“ LLC
`
`The following is provided in accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
`TRADE NAME (OR PROPOSED TRADE NAME)
`JEVTANA®
`
`ACTIVE lNGREDlENT(S)
`
`cabazitaxel
`
`STRENGTH(S)
`
`Single dose vials containing 60 mg/l .5mL (40 mg/mL)
`
`I O
`
`‘
`
`O ' V
`
`concentrate for solution for infusion
`
`This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) with an NDA application,
`amendment, or supplement as required by 21 CFR 314.53 at the address provided in 21 CFR 314.53(d)(4).
`Within thirty (30) days after approval of an NDA or supplement, or within thirty (30) days of issuance of a new patent, a new patent
`declaration must be submitted pursuant to 21 CFR 314.53(c)(2)(ii) with all of the required information based on the approved NDA or
`supplement. The information submitted in the declaration form submitted upon or after approval will be the
`only information relied
`upon by FDA for listing a patent in the Orange Book.
`
`For hand-written or typewriter versions (only) of this report: If additional space is required for any narrative answer (i.e., one that
`does not require a "Yes" or "No" response), please attach an additional page referencing the question number.
`
`FDA will not list patent information if you submit an Incomplete patent declaration or the patent declaration indicates the
`patent is not eligible for listing.
`
`For each patent submitted for the pending NDA, amendment, or supplement referenced above, you must submit all the
`information described below. If you are not submitting any patents for this pending NDA, amendment, or supplement,
`complete above section and sections 5 and 6.
`
`Address (of Patent Owner)
`174 Avenue de France
`
`City/State
`
`75013 Paris
`
`ZIP Code
`FRANCE
`Telephone Number
`
`FAX Number (if available)
`
`d. Name of Patent Owner
`Aventis Pharma S.A.
`
`e. ‘ame o agen or represen a Ne w o resnes or main ains
`a place of Busmess Within the United States authorized to
`receive notice of patent certification under section 505(b)(3)
`and (j)(2)(B) of the Federal Food, Drug, and Cosmetic Act
`and 21 CFR 314.52 and 314.95 (if patent owner or NDA
`applicant/holder does not reside or have a place of
`business within the United States)
`
`Charlotte Barney, Esq.
`
`
`
`1041 Route 202/206
`
`.
`C"Y_’S‘a‘e
`Brldgewater, New Jersey
`ZIP Code
`08807
`Telephone Number
`(908) 23 1-455 1
`ls the patent re erenced above a patent that as been su-mitted preVIously or the
`approved NDA or supplement referenced above?
`
`
`
`
`
`FAX Number (if available)
`(908) 231-2840
`E-Mail Address (if available)
`Charlotte.bamey@sanofi-aventis.com
`
`.
`
`.
`
`t e patent re erence: a-ove as oeen su-.mitte preVIousy or isting, ist e expiration
`date a new expiration date?
`
`1.0
`Version
`FORM FDA '
`.
`-
`
`
`
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`Page 1
`P50 anhics (301) 443-1090
`EF
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`For the patent referenced above, provide the following information on the drug substance, drug product and/or method of
`use that is the subject of the pending NDA. amendment, or supplement.
`
`2.1 Ds the patent claim the drug substance that is the active ingredient in the drug product
`describedIn the pending NDA, amendment, or supplement?
`
`2.2 Does the patent claim a drug substance thatIs a different polymorph of the active
`ingredient descnbed in the pending NDA, amendment, or supplement?
`
`2.3 If the answer to question 2. 2Is "Yes," do you certify that. as of the date of this declaration you have test
`data demonstrating that a drug product containing the polymorph will perform the same as the drug product
`described in the NDA7 The type of test data required is described at 21 CFR 314.53(b).
`
`2.4 Specify the polymorphic form(s) claimed by the patent for which you have the test results described in 2.3.
`
`Yes
`
`D No
`
`
`
`E Yes
`
`
`
`|_ No
`
`r
`
`For thIs pendIng‘NDA. amendment, or supplement there are no relevant patents that claIm the drug substance (actIve IngredIent),
`drug product (formulation or composition) or method(s) of use, for which the applicant'Is seeking approval and with respect to which
`a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the
`manufacture, use, or sale of the drug product.
`
`Version
`1 0
`FORM FDA ’
`
`
`Applicant understands Question 2.2 to ask whether the patent claims only a polymorph of the drug substance that is different from
`that described in the pending NDA. The patent contains claims that encompass any form of the active ingredient, and is submitted
`for listing on that basis.
`
`2.5 Does the patent claim only a metabolite of the active ingredient pending in the NDA or supplement?
`(Complete the information in section 4 below if the patent claims a pending method of using the pending
`drug product to administer the metabolite.)
`
`2.6 Does the patent claim only an intermediate?
`
`27 If the patent referencedIn 2.1 is a product-by-process patent, is the product claimed'In the
`patent novel7 (An answer is required only if the patent'Is a product-by-process patent.)
`
`Does the patent claim the drug product as define in 21 CFR 314.3, in the pending NDA amendment,
`or supplement?
`
`3.2 Does the patent claim only an intermediate?
`
`3.3 If the patent referencedIn 3.1 is a product-by-process patent, is the product claimedIn the
`patent novel? (An answer is required only if the patentIs a product-by-process patent.)
`
`
`
`g] No
`
`D Yes
`
`
`
`Sponsors must submit the information In section 4 for each method of using the pending drug product for which approval is beIng
`sought that is claimed by the patent. For each pending method of use claimed by the patent, provide the following information:
`
`4.1 Does the patent claim one or more methods of use for which approval is being sought in
`the pending NDA, amendment, or supplement?
`
`4.2 Patent Claim Number(s) (as listed in the patent)
`
`Does (Do) the patent claim(s) referenced in 4.2 claim a
`pending method of use for which approval is being sought
`in the pending NDA. amendment, or supplement?
`
`
`
`E Yes
`
`D No
`
`4.2a If the answer to 4.2 is
`"Yes," identify with speci-
`ficity the use with refer-
`ence to the proposed
`labeling for the drug
`
`Use: (Submit indication or method of use information as identified specifically in the proposed labeling.)
`
`

`

`NDA Applicant/Holder
`
`
`
` Patent Owner
`
`
`
`information unless it displays a currently valid OMB control number.
`
`5-1 The undersigned declares that this is an accurate and complete submission of patent information for the NDA,
`amendment, or supplement pending under section 505 of the Federal Food, Drug, and Cosmetic Act. This time-
`sensitive patent information is submitted pursuant to 21 CFR 314.53. lattest that I am familiar with 21 CFR 314.53 and
`this submission complies with the requirements of the regulation. I verify under penalty of perjury that the foregoing is
`true and correct.
`
`Warning: A willfully and knowingly false statement is a criminal offense under 18 U.S.C. 1001.
`
`6.2 Authon'zed Signature of NBA Applicant/Holder or Patent Owner (Attorney, Agent, Representative or
`otherAuthon'zed Official) (Provide Information below)
`
`Date Signed
`
`1% Q
`
`.
`
`Fat
`
`/7, 20/0
`
`NOTE: Only an NBA ap Iicantlholder may submit this decl‘tion directly to the FDA. A patent owner who is not the NDA applicant]
`holder is authorized to sign the declaration but may not submit it directly to FDA. 21 CFR 314.53(c)(4) and (d)(4).
`
`Check applicable box and provide information below.
`
`
`
`
`
`
`
`NDA Applicant’s/Holder’s Attorney, Agent (Representative) or other
`Authon'zed Official
`
`
`
`
`Patent Owner’s Attorney, Agent (Representative) or Other Authorized
`Official
`
`
`City/State
`
`
`
`Name
`
`John D. Conway
`
`Address
`
`08807
`
`FAX Number (if available)
`(908) 231-2626
`
`Bridgewater, New Jersey
`sanofi-aventis US. Inc.
`1041 Route 202-206
`
`ZIP Code
`Telephone Number
`
`(908) 231-5617
`
`E-Mail Address (if available)
`john.conway@sanofi-aventis.com
`
`The public reporting burden for this collection of information has been estimated to average 20 hours per response, including the time for reviewing
`instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send
`comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
`
`Department of Health and Human Services
`Food and Drug Adminisu'ation
`Office of Chief Information Officer (HFA-710)
`5600 Fishers Lane
`Rockville, MD 20857
`
`An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
`
`1 0
`Version
`FORM FDA m 1c "38)
`
`
`
`
`Page 3
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`

`

`Department of Health and Human Services
`Food and Drug Administration
`
`Form Approved: OMB No. 0910-0513
`Expiration Date: 7/31/10
`See OMB Statement on Page 3.
`
`PATENT INFORMATION SUBMITTED WITH THE FILING NDA NUMBER
`
`
`For Each Patent That Claims a Drug Substance
`(Actlve Ingredient), Drug Product (Formulation and Composition)
`and/or Method of Use
`
`NAME OF APPL'CANT’NDA HOLDER
`saHOfi'aventiS US LLC
`
`The following is provided in accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
`TRADE NAME (OR PROPOSED TRADE NAME)
`JEVTANA®
`
`ACTIVE |NGRED|ENT(S)
`cabazitaxel
`
`STRENGTH(S)
`Single dose vials containing 60 mg/1.5mL (40 mg/mL)
`
`I O
`
`t
`
`O ' V
`
`concentrate for solution for infusion
`
`This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) with an NDA application,
`amendment, or supplement as required by 21 CFR 314.53 at the address provided in 21 CFR 314.53(d)(4).
`Within thirty (30) days after approval of an NDA or supplement, or within thirty (30) days of issuance of a new patent, a new patent
`declaration must be submitted pursuant to 21 CFR 314.53(c)(2)(ii) with all of the required information based on the approved NDA or
`supplement. The information submitted in the declaration form submitted upon or after approval will be the
`only information relied
`upon by FDA for listing a patent in the Orange Book.
`
`For hand-written or typewriter versions (only) of this report: If additional space is required for any narrative answer (i.e., one that
`does not require a "Yes" or "No" response), please attach an additional page referencing the question number.
`
`FDA will not list patent information if you submit an incomplete patent declaration or the patent declaration indicates the
`patent is not eligible for listing.
`
`For each patent submitted for the pending NDA, amendment, or supplement referenced above, you must submit all the
`information described below. If you are not submitting any patents for this pending NDA, amendment, or supplement,
`complete above section and sections 5 and 6.
`
`‘
`"
`“a
`a. UnIted States Patent Number
`6,331,635
`d. Name of Patent Owner
`Aventis Pharma SA.
`
`»
`
`-'
`
`e. ‘ameo agen or represen a Ive w o resues or mam aIns
`a place of Busmess Within the United States authorized to
`receive notice of patent certification under section 505(b)(3)
`and (j)(2)(B) of the Federal Food, Drug, and Cosmetic Act
`and 21 CFR 314.52 and 314.95 (if patent owner or NDA
`applicant/holder does not reside or have a place of
`business within the United States)
`
`Charlotte Barney, Esq.
`
`.
`
`was;
`0. EprratIon Date of Patent
`March 26, 2016
`
`.
`
`Address (of Patent Owner)
`174 Avenue de France
`
`
`City/State
`
`750 1 3 Paris
`
`ZIP Code
`
`FRANCE
`Telephone Number
`
`FAX Number (if available)
`
`.
`
`
`
`
`
`1041 Route 202/206
`
`,
`CItylState
`Brrdgewater, New Jersey
`ZIP Code
`08807
`Telephone Number
`(908) 231-455 1
`Is the patent re erenced above a patent that as been submitte- previously ort e
`approved NDA or supplement referenced above?
`
`AX Number (if available)
`(908) 231-2840
`E-Mail Address (if available)
`Charlotte.barney@sanofi-aventis.com
`
`g.
`
`t e patent re erenceo a-ove as oeen su--mItte preVIousy or IstIng, Ist e eprratIon
`date a new expiration date?
`
`Version
`1 0
` Page 1
`FORM FDA 3m 1 l08)
`PSC Graphics (301) 443-1090
`EF
`
`
`

`

`For the patent referenced above, provide the following information on the drug substance, drug product and/or method of
`use that is the subject of the pending NDA, amendment, or supplement.
`
`described in the pending NDA, amendment, or supplement?
`
`2.2 Does the patent claim a drug substance that is a different polymorph of the active
`ingredient described in the pending NDA, amendment, or supplement?
`
`2.3 if the answer to question 2.2 is "Yes," do you certify that, as of the date of this declaration. you have test
`data demonstrating that a drug product containing the polymorph will perform the same as the drug product
`described in the NDA? The type of test data required is described at 21 CFR 314.53(b).
`
`D Yes
`
`2.4 Specify the polymorphic form(s) claimed by the patent for which you have the test results described in 2.3.
`
`Applicant understands Question 2.2 to ask Whether the patent claims only a polymorph of the drug substance that is different from
`that described in the pending NDA. The patent contains claims that encompass any form of the active ingredient, and is submitted
`for listing on that basis.
`
`2.5 Does the patent claim only a metabolite of the active ingredient pending in the NDA or supplement?
`(Complete the information in section 4 below if the patent claims a pending method of using the pending
`drug product to administer the metabolite.)
`
`2.6 Does the patent claim only an intermediate?
`
`2.7 If the patent referenced in 2.1 is a product-by-process patent, is the product claimed in the
`patent novel? (An answer is required