This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`
`/S/
`
`S.W. Johnny Lau
`2/20/04 05:20:51 PM
`BIOPHARMACEUTICS
`
`Hae—Young Ahn
`2/20/04 05:25:42 PM
`BIOPHARMACEUTICS
`
`

`

`CENTER FOR DRUG EVALUATION AND
`
`-
`
`RESEARCH
`
`APPLICA TION NUMBER:
`
`'
`
`'
`
`2 1-688
`
`ADMINISTRATIVE and CORRESPONDENCE
`
`DOCUMENTS
`
`

`

`
`Department of Health and Human Services
`Food and Drug Administration
`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
`
`The following is provided in accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act.
`
`.
`21-688
`
`
`NAME OF APPLICANT / NDA HOLDER
`
`
`
`
`Amgen Inc.
`
`
`
`Form Approved: OMB No. 0910-0513
`Explradon Date: 07/31/08
`See OMB Statement on Page 3.
`
`NDA NUMBER
`
`TRADE NAME (OR PROPOSED TRADE NAME)
`SENSIPARW
`
`.
`
`,
`
`,
`
`>
`
`.
`
`.
`
`ACTIVE iNGREDIENT(S)
`N-[1-(R)-(l-naphthyl)cthyl]-3-[3-(tn'fluoromcthyl)phenyi]-l-
`aminopropane hydrochloride
`
`*
`
`STRENGTH(S)
`30mg, 60mg and 90mg strengths
`
`DOSAGE FORM
`Tablet
`
`
`
`This patent declaration term 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 31453(c)(2)(II) with all of the required information based on the approved NDA
`or supplement. The information submitted in the declaration lorm 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 0.9., 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 file 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,
`com.clete above section and sections 5 and 6.
`
`b issue Date oi Patent
`a. United States Patent Number
`4/3/2001
`621 1244
`Address (of Patent Owner)
`d. Name of Patent Owner
`
`
`
`420 Chipeta Way
`NPS Pharmaceuticals, Inc.
`
`
`
`
`City/State
`
`Salt Lake City, Utah
`
`0. Expiration Date of Patent
`10/23/2015
`,
`-,
`
`.
`
`ZIP Code
`84108
`
`Telephone Number
`(801) 583-4939
`
`FAX Number (if available)
`(801) 583-4961
`
`E-Mail Address 6/ available)
`
`
`9.Wm who resides or maintains Address (ofagent or representative named in 1.e)
`
`a place of business within the United States authorized to
`_
`receive notice of patent certification under section
`
`505(b)(3) and (|)(2)(B) of the Federal Food. Drug. and
`
`
`City/State
`Cosmetic Act and 21 CFH 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)
`
`0’ N/A
`
`
`
`ZlP Code
`
`FAX Number (if available)
`
`Telephone Number
`
`E Mail Address (if available)
`
`1.
`
`Is the patent referenced above a patent that has been submitted previously for the
`approved NDA or supplement referenced above?
`‘- g. It the patent referenced above has been submitted previously tor listing, is the expiration
`date a new expiration date?
`,
`
`D Yes
`
`E No
`
`D Yes
`
`[I No
`
`FORM FDA 35423 (7/03)
`
`Page 1
`Pscmumoonunoao 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.
`
`. E Yes
`
`D Yes
`
`D No
`
`E No
`
`'2. Drug Substance (Active Ingredient)
`2.1 Does 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 that rs 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 dmg product containing the polymorph wrll perform the same as the dmg product
`described In the NBA? The type of test data requrred is described at 21 CFR 314.53(b).
`2.4 Specify the polymorphic torm(s) claimed by the patent for which you have the test results described in 2.3.
`
`El Yes.
`
`D No
`
`[I Yes
`
`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 referencedin 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.)
`
`
`
`E No
`
`3. Drug Product (Composition/Formulation)
`
`: 3.1 Does the patent claim the drug product, as detrned'In 21 CFR 314.3, in the pending NDA.
`’
`amendment, or supplement?
`V
`3.2 Does the patent claim only an intermediate?
`*
`3.3 lithe patent referenced in 3.1 Is a product-by-process patent is the product claimed in the
`
`E Yes
`
`D No
`
`El Yes
`
`E No
`
`
`
`patent novel? (An answer is required only it the patent is a product-by-process patent.)
`4. Method of Use
`
`Sponsors must submit the information In section 4 separately for each patent claim claiming a method of using the pending drug
`product for which approval is being sought. For each method of use claim referenced, provide the following information.-
`4.1 Does the patent claim one or more methods of use for Which approval is being soughtin
`the pending NDA, amendment. or supplement?
`'
`
`E Yes
`
`E] No
`
`Does the patent claim referenced In 4.2 claim a pending method
`4.2 Patent Claim Number (as listed in the patent)
`at use for which approval is being sought in the pending NDA,
`21 ' 25, 30-31-
`.
`|
`Yes
`amendment. or su gr ement?
`'
`.
`Use. (Submit mdication or method of use infomration as identified specifically in the approved labeling.)
`4.2: if the answer to 4.2 is
`'Yes,‘ identify with SpecioW See the
`ficit‘y the use with refer-
`ence to the proposed
`copy of sections of the proposed label for the drug product'in EXHIBIT 1 (9 pages) attached hereto
`labeling for the drug
`product
`
`
`
`5. No Relevant Patents
`
`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.
`
`D Yes
`
`FORM FDA 3542a (7/03)
`
`Page 2
`PSC Media M\(“” «1- i090
`EF
`
`

`

`6. Declaration Certification
`
`,
`
`_
`
`,
`
`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 o! the Federal Food, Drug, and Cosmetic Act. This time-
`sensidve patent information is submitted pursuant to 21 CFR 314.53. I attest that lam 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.
`
`
`
`NOTE: Only an NDA applicant/holder may ubmlt this declaration directly to the FDA. A patent owner who Is not the NDA applicant]
`holder is' authorized to slgn the declaration but may not submit It directly to FDA. 21 CPR 314.53(e)(4) and (d)(4).
`
`Check applicable box and provide Information below.
`
`' E] NDA Applicant/Holder
`,
`
`‘
`
`‘
`
`E NDA Applicant's/Holder's Attorney. Agent (Representative) or other
`Authorized Official
`-
`'
`
`Name
`
`Frank Ungemach, Assoc. General Counsel
`
`Official
`
`_
`
`City/State
`Address
`
`One Amgen Center Drive
`Thousand Oaks. CA
`
`
`ZIP Code
`91320—1799
`
`Telephone Number
`(805) 447-1000
`
`FAX Number (if available)
`
`E-Maii Address (if available)
`
`
`
`including the time for reviewing
`The public reporting burden for this collection of information has been estimated to average 9 hours per response,
`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:
`
`Food and Drug Administration
`CDER (HFD—007)
`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
`‘
`r‘rtfonnation unless it displays a currently valid OMB control number.
`
`FORM FDA 3542a (7/03)
`
`-
`
`’
`
`Page 3
`PSCMdammt) «we» 3
`
`

`

`.
`Department of Health and Human SerVIces
`Food and Drug Administration
`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
`Compositlon) and/or Method of Use
`
`,
`
`,
`
`'
`
`,
`
`Form Approved: OMB No. 0910-0513
`Emma”, Date: 07/31/06
`s“ 0MB Statement on page a.
`
`21-688
`NAME OF APPLICANT / NDA HOLDER
`Amgen Inc:-
`
`'
`
`
`
`
`The following ls provided In accordance with Section 505(b) and (c) of the Federal Food, Drug, and Cosmetic Act. '
`TRADE NAME (OR PROPOSED TRADE NAME)
`SENSIF‘ARTM
`
`ACTIVE lNGREDIEN'HS)
`N—[ l -(R)—( l-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyll- 1 -
`aminopropane hydrochloride
`
`STHENGTI'KS)
`30mg, 60mg and 90mg strengths
`
`DOSAGE FORM
`Tablet
`
`
`
`This patent declaration. term 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 NDA or supplement, or within thirty (30) days of issuance of a new patent, a new patent
`declaration must be submitted pursuant to 21 OFF! 314.53(c)(2)(ii) with all of the required information based on the approved MBA
`or supplement. The inlormation submitted in the declaration Iorrn 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 tor 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 file 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,
`com ' leteabove section and sections 5 and 6.
`'
`
`‘
`
`»
`
`’
`
`a. United States Patent Number
`6031003 -
`‘
`d. Name oi Patent Owner
`NPS Pharmaceuticals. Inc. and
`
`‘
`
`
`
`
`
`
`.
`
`b. issue Date of Patent
`»
`.
`2/29/2000
`Address (of Patent Owner)
`
`420 Chipeta Way
`
`)
`
`c. Expiration Date of Patent
`12/14/2016
`
`
`
`City/State
`Salt Lake City, Utah
`
`,
`
`ZIP Code
`84108
`
`Telephone Number
`(801) 583-4939
`
`.
`
`Address (of Patent Owner)
`
`.
`
`,
`
`FAX Number (If available)
`(801) 583-4961
`
`E-Mail Address (if available)
`
`The Brigham and Women's Hospital
`
`75 Francis Sheet
`
`City/State
`Boston, MA
`ZIP Code
`02115
`
`Telephone Number
`(617) 732-5500
`
`_
`
`FAX Number (if available)
`
`E-Mail Address (ii available)
`
`FORM FDA 3542a (7/03) modified
`
`-
`
`Page 1
`muse-moonuumo EF
`
`

`

`9.WW who resudes or maintains Address (of agent or representative named in 1.9.)
`a place of business within the United States authorized to
`receive notice of patent certillcatron under section
`505(b)(3) and (1)(2)(B) of the Federal Food, Dmg. and
`Cosmetic Act and 21 cm 314.52 and 314.95 (11 patent
`5 owner or NDA applicant/holder does not reside or have a
`place of business within the United States)
`
`,
`City/State
`
`Telephone Number
`
`E-Maii Address (If available)
`
`1
`
`Is the patent referenced above a patent thathas been submrtted prevrously for the
`approved NDA or supplement referenced above?
`9 If the patent referenced above has been submitted prevrously for listing. rs the expiration
`date a new expiration date?
`
`D Yes
`
`D Yes
`
`E No
`
`D No
`
`For the patent referenced above, provide the followlng information on the drug substance, drug product and/or method of
`use that Is the subject of the pending NDA, amendment, or supplement.
`,
`‘
`
`‘
`
`. D Yes
`'
`D Yes
`
`E No
`
`8 No
`
`2. Drug Substance (Active Ingredient)
`2.1 Does the patent claim the drug substance that Is the active ingredient in the drug product
`descnbed 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 pendlng 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 wfll perform the same as the drug product
`descnbed In the NDA? The type of test data required is described at 21 CFR 314.53(b).
`
`X No
`
`2.4 Spectfy the polymorphic form(s) clalmed by the patent for which you have the test results described in 2.3.
`
`1 2 5 Does the patent claim only a metabolrte of the active ingredient pending in the NDAor supplement’l
`‘
`. (Complete the information in section 4 below it the patent claims a pending method of using the pendrng
`drug product to admlnister the metabolite.)
`2.6 Does the patent claim only an intermediate?
`
`D Yes
`
`El Yes
`
`
`
`2.7 it 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. Drug Product (Composition/Formulation)
`3.1 Does the patent claim the drug product, as defined in 21 CFR 314.3, in the pending NDA,
`amendment, or supplement? ‘
`.
`1
`-
`
`‘
`
`
`
`A
`
`E No
`
`,3-2 Does the patent claim only an intermediate?
`‘
`
`[I Yes
`
`E No
`
`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 rs a product-by-process patent.)
`
`
`
`D Yes
`
`D No
`
`4. Method et‘Use
`
`,
`
`'
`
`D No
`
`‘ E] No
`
`Sponsors must submit the information in section 4 separately for each patent clalm clalmlng a method .0! using the pending drug
`. product for whlch approval Is being sought For each method of use clalm referenced, provide the following lnfonrratlon:
`4.1 Does the patent claim one or more methods of use for which approval is being sought in
`X Yes
`the pending NDA, amendment. or supplement?
`.
`4.2 Patent Claim Number (as listed in the patent)
`Does the patent claim referenced In 4.2 claim a pending method
`1-2, 4, 9, 13-14. 16-17, 19, 31-32. 34-37, 40-
`of use for which approval is being sought 1n the pending NBA.
`45, 51-52, 82-86. 89-93, 99—109, 115-116,
`amendment. or supplement?
`121 Yes
`131, 132,138, 142-145
`4.2a If the answer to 4.2 is
`'Yes,‘ identify with specr.
`ficity the use with reler-
`ence to the proposed
`labeling for the drug
`product.
`
`page») attacncu 1151 cw.
`
`_—
`
`‘
`
`Use: (Submit indication or method of use infomralion as identified specifically in the approved labeling.) _
`'
`'mx
`_ H EXHIBIT 1 (9
`
`FORM FDA 35423 (7/03) modified
`
`Page 2
`PSC Med.“ Mk (101)“11090
`EF
`
`

`

`5.No Relevant Patents
`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 ls seeking approval and with respect to
`“ wh_ich a claim of patent infringement could reasonably be asserted it a person not licensed by the owner of the patent engaged in
`the manufacture, use, or sale of the drug product.
`
`D Yes
`
`
`
`
`
`
`
`6.Deelaratlon Certification
`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. 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 lmowingly false statement is a criminal offense under 18 u.s.c. 1001.
`
`
`6.2 Authorized Signature of ND ~ Applicant/Holder or Patent Owner (Attorney, Agent, Representative or
`Date Signed
`
`2/5/67
`
`
`
`NOTE: Only an NDA applicant/holder rn submit this declaration directly to theFDA. 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).
`
`Cheek applicable box and provide information below.
`
`U NDA Applicant/Holder
`
`8 NBA Applicant's/Holder's Attorney, Agent (Representative) or other
`Authorized Official
`
`I] Patent Owner
`
`Name
`
`D Patent Owner's Attorney. Agent (Representative) or Other Authorized
`Official
`
`Frank Ungemach, Assoc General Counsel
`Address
`City/State
`Thousand Oaks, CA
`One Amgen Center Drive
`
`ZIP Code
`‘
`Telephone Number
`91320-1799
`(805) 447-1000
`
`including the time for reviewing
`.The public reporting burden for this collection of information has been estimated to average 9 hours per response,
`instructions. searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of intonation. Send
`comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to:
`
`Food and Drug Administration
`CDER (BED—007)
`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.
`
`FORM FDA 3542a (7/03) modified
`
`-
`
`'
`
`Page 3
`Pscm-moonus-roeo BF
`
`

`

`Department of Health and Human Services
`Food and Drug Administration
`PATENT INFORMATION SUBMITTED WITH THE
`FILING OF AN NDA,‘AMENDMENT, OR SUPPLEMENT .
`For Each Patent That Claims a Drug sabstance
`(Active Ingredient), Drug Product (Formulation and
`Composition) and/or Method of Use
`
`.
`
`'
`Fm ”pm: OMB N°' 09100513
`ration Date: 07/31/08
`599E314); Statement on Page 3.
`
`W NUMBER
`.
`,
`
`
`
`
`NAME OF APPUCANT I NDA HOLDER
`Amsen Inc.
`
`
`
`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)
`.
`SENSIPARTM
`
`AC1'lVEiNGREDIENT(S)
`N-[1—(R)-(l-naphthyl)ethyl]-3-[3-(trifluoromethyl)phcnyl]—1—
`aminopropanc hydrochloride
`
`,
`STRENGTHS) .
`30mg, 60mg and 90mg strengths
`‘
`
`DOSAGE FORM
`Tablet
`
`
`
`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 alter approval 01 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 intormation submitted in the declaration torm submitted upon or after approval will be the only intormation relied
`upon by FDA for listing a patent in the Orange Book.
`
`For hand-written or typewriter versions (only) of this report: It 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 file 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
`:iinformation described below. If you are not submitting any patents for this pending NDA, amendment, or supplement,
`com iete above section and sections 5 and 6.
`
`a. United States Patent Number
`6313146
`
`b. Issue Date of Patent
`11/6/2001
`
`c. Expiration Date of Patent
`~ 12/14/2016
`'
`_
`
`'
`
`
`
`‘
`
`d.‘ Name of Patent Owner
`Address (of Patent Owner)
`NPS Pharmaceuticals, Inc.
`420 Chipeta Way
`
`
`and
`
`
`
`
` City/State
`Salt Lake City, Utah
`
`
`
`ZIP Code
`84108
`
`FAX Number (if available)
`(801) 583-4961
`
`~
`
`-
`
`Telephone Number
`(801) 583-4939
`
`.
`
`-
`
`E-Mail Address (if available)
`'
`‘
`
`,
`
`
`
`,
`.
`The Brigham and Women's Hospital
`
`Address (of Patent Owner)
`75 Francis Street
`
`City/State
`Boston, MA
`
`ZIP Code
`021 15
`
`Telephone Number
`(617) 732-5500
`
`FAX Number (if available)“
`
`E-Mail Address (if available)
`
`FORM FDA 35428 (7/03) modified
`
`Page 1 ’
`PSC MIN: (311)443-1090 EF
`
`

`

`e.W who resides or maintains Address (of agent or representative named in 1.9.)
`a place of business within the United States authorized to
`mceive notice of patent certification under section
`505(b)(3) and (i)(2)(B) of the Federal Food. Drug. and
`Cosmetic Act and 21 cm 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)
`~
`
`City/State
`
`ZIP Code
`
`FAX Number if available
`
`'
`
`Telephone Number
`
`E-Mail Address (ifavaiieble)
`
`‘
`
`l. is the patent referenced above a patent that has been submitted previously for the
`approved NDA or supplement referenced above?
`.
`.
`9. If the patent referenced above has been submitted previously for listing, is the emiration
`date a new expiration date?
`.
`,
`,
`
`D Yes
`
`D Yes
`
`8 No
`
`D No
`
`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. Drug Substance (Active Ingredient)
`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 poiymorph 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 dmg product
`described in the NBA? 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.
`
`El Yes
`
`D No
`
`8 Yes
`
`D No
`
`_
`
`D Yes
`
`E No
`
`}
`
`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.)
`
`D Yes
`
`E No
`
`2.6 Does the patent claim only an intermediate?
`
`2.1 elf 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 producHry-process patent.)
`
`.
`
`‘
`
`3. Drug Product (Composition/Formulation)
`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 ciairn only an intermediate?
`
`‘
`
`D Yes
`
`' D Yes
`
`'
`E Yes
`
`E No
`
`‘
`D No
`
`[I No
`
`[3 Yes
`
`E No
`
`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-piocess patent)
`
`4. Method of Use
`
`Sponsors must submit the Information In section 4 separately for each patent claim claiming a method of using the pending drug
`product for which approval is being sought. Foreach method of use claim referenced, 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. amendmentor supplement?
`
`‘
`
`D Yes ~
`
`8 No
`
`4.2 Patent Claim Number (as listed in the patent)
`
`
`
`Does the patent claim referenced in 4.2 claim a pending method
`of use for which approval is being sought in the pending NDA,
`amendment, or su dement?
`D Yes
`Use: (Submit indication or method of use information as identified specifically in the approved 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.
`
`—_
`
`'l
`
`FORM FDA 3542a (7/03) modified
`
`page 2
`Psc Meta-moor) «nose EF
`
`

`

`5. No Relevant Patents
`
`,
`
`.
`
`.
`
`A
`
`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
`.whlchaclaimoipatentintringementcould reesonablybeassertediia person notllcensed bytheownerotthe patentengaged in
`i the manufacture, use. or sale of the dmg product.
`.
`p
`.
`
`,
`
`J
`
`BY“
`
`>
`
`.
`
`6. Declaration Codification
`
`’
`
`6.1 The undersigned declares that this is an accurate and complete submission ofpatent lnformaflon for the NDA,
`amendment, or supplement pending undersecflon 505 of the Federal Food, Drug, and Cosmetic Act. This time-
`sensitive patent Information is submitted pursuant to 21 CFR 314.53. I attest that lam familiar with 21 CFR 314.53 and
`this submission complies with the requirements of the regulation. I verify under penalty of perlury that the foregoing
`Is true and conect.
`’
`
`Wamlng: A willfully and knowingly false smement Is a criminal offense under 18 use. 1001.
`6.2 Authorized Signature of NDA Applicant/Holder or Patent Owner (Attorney, Agent, Representative or
`other Authorized
`-
`’ (Provide I onnatlon below)
`
`
`
`
`
`
`
`
`
`
`
`
`1/
`
`
`
`
`
`
`ay submit thls declaration diréctiy to the FDA. A patent owner who is not the NDA applicant]
`NOTE:’OnIy an DA applicant/hot :
`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.
`
`-
`
`1:] NBA Applicant/Holder " '
`
`E NDA Applicant‘s/Holder’s Attorney. Agent (Representative) or other
`Authorized Official
`\
`
`D Patent Owner‘s Attorney, Agent (Representative) or Other Authorized
`Olilcial
`
`Name
`
`Frank Ungemach, Assoc. General Counsel
`
`‘
`
`‘
`
`Address
`
`City/State
`
`,
`
`One Amgen Center Drive
`
`‘
`
`Thousand Oaks, CA
`
`
`
`
`t
`
`Telephone Number
`ZIP Code
`(805) 447—1000
`91320-1799
`’
`E-Mail Address (rfavaileble)
`FAX Number (ifavailable)
`
`
`'
`
`including. the time for reviewing
`The public reporting burden for this collection of information has been estimated to average 9 hours per response,
`instructions. searching existing data sum, gathering and maintaining the data 11m, 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:
`
`Food and Drug Administration
`CDER (RFD-007)
`'5600 fishers lane
`Rockwlle, MD 20857
`
`An agency may not conduct orsponsor, and a person is not required to respond to, a collection of
`information unless it displays a cumully valid OMB control number.
`
`
`
`FORM FDA 3542a (ma) modified
`
`'
`
`0
`
`page 3
`PSC Ma MI [10]) unoeo a:
`
`

`

`-
`Department of Health and Human Semces
`Food and Drug Administration
`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
`
`'
`
`',
`
`.
`
`,
`
`Form Approved: OMB No. 0910-0513
`Expiration Date: 07/31/06
`599 0MB summon, m Page 3.
`—NDANUMIB-ER
`21—688
`
`NAME 0" APPLICANT / NDA HOLDER»
`‘ Amgen Ine-
`
`The following ls provided in accordance with Section 505m and (c) of the Federal Food, Drug, and Cosmetic Act.
`TRADE NAME (OR PROPOSED TRADE NAME)
`.
`SENSIPARTM
`
`‘
`
`’
`
`
`
`.
`.
`‘
`STRENGTHS)
`-
`.
`,
`)
`ACTIVE INGREDIENTS)
`30mg, 60mg and 90mg strengths
`N-[1-(R)-(l-naphthyl)ethyl]-3-[3-(h'ifluoromethyl)phcnyl]-1-
`
`
`
`'
`'
`ami nopropane hydrochloride
`
`
` DOSAGE FORM
`
`Tablet
`
`
`required to be submitted to the Food and Drug Administration (FDA) with an NDA application.
`This patent declaration form is
`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 at 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 or therequired information based on the approved NDA
`or supplement. The information submitted in the declaration form submitted upon or alter approval Will be the only inlonnation relied
`
`upon by FDA lor 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 file an incomplete patent declaration or the patent declaration Indicates the
`patent Is not eligible for listing.W
`
`
`
`
`
`. For each patent submitted for the pending NDA, amendment, or supplement referenced above, you must submit all the
`i information described below.” you are not submitting any patents for this pending NDA, amendment, or supplement,
`‘ com . lets above section and sections 5 and 6.
`'
`
`1. GENERAL
`
`_
`
`a. United States Patent Number
`b. issue Date of Patent
`c. Expiration Date of Patent
`6011068
`_
`1/4/2000
`,
`'
`'
`-
`12/14/2016
`A
`,
`.
`(1. Name of Patent Owner
`Address (of Patent Owner)
`
`
`
` NPS Pharmaceuticals, Inc. and 420 Chipeta Way
`
`
`City/State
`Salt Lake City. Utah
`
`'
`
`
`
`ZiP Code
`84108
`
`Telephone Number
`(801) 583-4939
`
`.
`
`‘
`
`'
`
`FAX Number (If available)
`(801) 583-4961
`
`E-_Mail Address (ifavailable)
`
`~
`
`’
`
`‘
`
`The Brigham and Women's Hospital
`
`Address (of Patent Owner)
`75 Francis Street
`
`City/State
`Boston, MA
`
`ZIP Code
`021 15
`
`Telephone Number
`(617) 732-5500
`
`.
`
`.
`
`'
`
`FAX Number (if available)
`
`E-Maii Address (if available)
`
`FORM FDA 3542a (7/03) modified
`
`,
`
`'
`
`Page 1
`rscm-moonunmo EF
`
`

`

`e.W who resides or maintains Address (of agent or representative named In f.e.)
`a place of business within the United States authorized to
`receive notice oi patent certification under section
`505(b)(3) and 0)(2)(B) of the Federal Food. Drug. and
`Cosmetic Act and 21 cm 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)
`(7.» N/A
`
`Charisma
`
`,
`
`ZIP Code
`
`FAX Number (if available)
`
`Telephone Number
`
`5-Mail Address (If available)
`
`is the patent referenced above a patent that has been submittedpreviously for the
`f.
`approved NDA or supplement referenced above?
`,
`g. lithe patent referenced above has been submitted previously tor iisting,‘is the expiration
`date a new expiration date?
`
`.
`
`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.
`
`_
`
`E Yes
`
`D No
`
`D Yes
`
`8 No
`
`2. Drug Substance (Active ingredient)
`2.1 Does the patent ciairn the drug substance that'rs 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 poiymorph oi 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 e dnig product containing the polymorph will perform the same as the drug product
`descnbed in the NDA? The type of test data required is described at 21 CFR 314.53(b).
`
`2.4 Specify the polymorphic forrn(s) claimed by the patent for which you have the test results described in 2.3.
`
`D Yes
`
`'
`
`2.5 Does t