CENTER FOR DRUG EVALUATION AND
`
`- RESEARCH
`
`APPLICA TION NUMBER:
`
`2 1 -976
`
`ADMINISTRATIVE and CORRESPONDENCE
`
`DOCUMENTS
`
`

`

`Department of Health and Human Services
`Food and Drug Administration
`PATENT INFORMATION SUBMITTED WITH THE
`‘
`FILING OF AN NDA, AMENDMENT, CAR SUPPLEMENT
`NAME OF APPUCANT/ NDA HOLDER
`For Each Patent That Claims a Drug Substance
`i Tiboiecv 1110-
`(Active ingredient), Drug Product (Permutation and
`1
`Composition) and/or Methodof Use
`The following is provided'In accordance with Section 505(b) and (c) of the I-ederal Food, Drug, and Cosmetic Act.
`TRADE NAME (OR PROPOSED TRADE NAME)
`
`. Fm“ Apprwed: OMB ”0- 091043513
`engflgtgggfiIZngaL/gge a.
`
`.
`
`ACTIVE INGREDIENT(S)
`Darunavir
`
`DOSAGE FORM
`tablet
`
`STRENGTH(S)
`300 mg
`
`—
`
`’
`
`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 providedIn 21 CFR"i4. 53(d)(4).
`Within thirty (80) days after approval of an NDA or supplement or within thirty (30) days of issuance ot a new patent a new patent
`declaration must be submitted pursuant to 21 CFH 31453(c)(2)(II) with all of
`the rquIi:ed information based on the approved NDA
`or supplement. The information submitted in the declaration form submitted upon or flier 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 file an incomplete patent declaration or the patent declaration indicates the
`patent is not eligible for listing
`~v:f-,
`'or each patent submitted for the pending NDA, atnendment‘, 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 - late above section and sections 5 and 6.
`
`b. Issue Date of Patent
`c'. Expiration Date of Patent
`
`
`
`January 1, 2002 _
`August 25, 2012
`
`Address (ol Patent Owner)
`
`235 East, 42nd Street
`
`a. United States Patent Number
`6,335,460
`
`-
`
`d. Name of Patent Owner
`GD. Scarle & Co. LLC
`c/o General Patent Counsel
`
`I
`
`‘
`
`
`
`_. “
`
`
`
`
`
`
`FAX Number (ll available)
`
`E—Mail Address (ifavailable)
`
`Pfizer Inc.
`
`'
`
`fifiéfifi' T
`-Ncw York. NY
`
`Ill i l
`
`ZIP Code
`iOGI
`
`"Telephone Number
`’2:2; 73a2323
`2
`
`
`Address (of agent or representatia namedIn 1. e)
`
`i;
`
`City/State
`
`1:;I
`
`
`lI l
`
`
`5
`
`| FAX Number (lfavailable)
`
`l
`""_‘” E—Mail Address (ifavailable)
`
`.9. Name of agent or representative who resides or maintains
`
`
`a place of business within the United States authorized to
`
`receive noticeofpatentcertification undersection
`
`505(b)(3) and (j)(2)(B) oi the Federal Food, Drug, and
`Cosmetic Act and 21 CFR 314.52 and 314.95 (if patent
`ovmer or NDA applicant/holder does not reside or have a
`place of businesswilhin the United States)
`CF
`
`_
`
`_
`_
`-.
`L
`Is the patent referenced above a patentthat has been submitted previously for the
`'
`approved NDA or supplement referenced above?
`if the patent referenced above has been submitted previously for listing, is the expiration
`date a new expiration date?
`. ,. "wen I;.~II\-v.-.~-mI:-»ww.-.«I swap N‘V‘KI-nmwnpqm‘urhrm
`avar.m,t.m,,._
`..t..
`I
`EMS
`
`MW--.
`
`, _..___a,_
`
`_
`
`D Yes
`
`l.
`
`
`9.
`
`
`
`.
`
`No
`
`W)
`
`FOFIM FDA 3542a (7/03)
`
`Page 1
`PSC Mcdia Am (30I ) LIB-I090
`EF
`
`

`

`For the patent referenced above, provide the folio ‘ n Information on the drug substance, drug product and/or method of
`use that is the subject of the pending NDA, amendm -- or supplement.
`
` 1 Doesthe patent claim the drug substance that
`:
`the drug product
`. described in the pending NDA, amendment, or supplement“?
`E Yes
`D No
`orph ot the active
`2.2 Does the patent claim a drug substance that is a different -'-
`ingredient described in the pending NDA, amendment, or supplement?
`2.3 It 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
`
`I
`
`[:1 No
`
`El Yes
`
`IE No
`
`2.4 Specify the polymorphic tonn(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 it 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?
`
`w
`
`"
`
`' D‘Yes
`
`W No
`
`2.7 lithe patent referenced in 2.1 is a product—by-process patent, is the product claimed in the
`El No
`D Yes
`patent novel? (An answer is required only it the patent is a product-by-process patent.)
`
`
` ‘oes the patent claim the drug product, as defined In 21 CFR 3143, In the pending NDA,
`amendment, or supplement?
`E Yes
`[:1 No
`3.2 Does the patent claim only an intermediate?
`
`3.3 It 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.)
`
`D Yes
`
`I: No
`
`Sponsors must submit the Information m section 4 separately for each patent clarm claiming a method of using the pending drug
`product for which approval is being sought. For each method of use claim referenced, provideI the following information:
`4.1 Does the patent claim one or more methods of use for which approval is being sought in
`”A
`the pending NDA, amendment, or supplement?
`
`
`
`
`4.2 Patent Claim Number (aslisted in the patent)
`4
`
`Does the patent claim referenced in 4.2 claim a pending method
`of use for which approval is being sought in the pending NDA,
`El No
`amendment,- or su-plement?
`[2 Yes
`Use: (Submit indication or method of use information as identified specifically in the approved labeling.)
`treatment of human immunodeficiency virus (HIV) infection
`
`,
`4.2a It the answer to 4.2 is
`"Yes." identity with speci-
`iicity the use with refer
`ence to the proposed
`labeling for the drug
`product.
`
`FORM FDA 3542a (7/03)
`
`Page 2
`PSI; Main. Am iMIlMS-ifm)
`El:
`
`

`

`a. t
`
`[:1 No 7
`
`
`
`.4.
`m.
`
`
`
`Sponsors must submit the information in section 4
`_
`ly for each mm claim claiming a method of using the pending drug
`vduct for which approval is being sought. For each methdfl ' f use claim refemnced, provide the following Information:
`, Does the patent claim one or more methods of use for which Epproval is being sought in
`-
`E Yes
`the pending NDA, amendment, or supplement?
`Does the patent claim referenced in 42 claim a pending method
`4.2 Patent Claim Number (as listed in the patent)
`of use for which approval is being sought inthe pending NDA,
`5
`
`
`Yesamendment, or su- lement? E] No
`Use: (Submit indication or method of use information as identified specifically in the approved labeling.)
`4.2a It the answer to 4.2 is
`"Yes,“identily with specl-
`cat on
`i
`u
`when
`v'ru
`i
`ficity the use with reter-
`tr
`rn
`tof human mm nodef
`cy 1
`5 (HIV) nfecmn
`ence to the proposed
`labeling for the drug
`i
`product.
`
`
`
`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 sought in
`the pending NDA, amendment, or supplement?
`
`E Yes
`
`[:1 No
`
`4.2 Patent Claim Number (as listed in the patent)
`6
`
`Does the patent claim referenced in 4.2 claimma pending method
`of use for which approval is being sought if} the pending NDA,
`{:1 No
`amendment, or su- clement?
`_
`.- E Yes
`Use: (Submit indication or method of use information as identified specifically in the approved labeling.)
`treatment of human. immunodeficiency virus (HIV) infection
`
`'
`4.2a if the answer to 4.2 is
`“Yes," identify with speci-
`licity the use with refer-
`ence to the proposed
`labeling for the drug
`product.
`
`
`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 sought in
`Yes i
`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
`7
`of use for which approval is being sought in the pending NDA,
`E Yesamendment, or su- ulement‘? D No
`
`
`USe: (Submit indication or method of use information as identified specifically in the approved labeling.)
`4.23 if the answer to 4.2 is
`".Yes‘" identify with SpeCi‘
`treatment of human immunodeficiency virus (HIV) infection
`hch the use With refer-
`ence to the proposed
`labeling for the drug
`product.
`
`
`
`D No
`
`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'informatian:
`4.1 Does the patent claim one or more methods of use fcr which approval ls being sought in
`the pending NDA, amendment, or supplement?
`
`E Yes
`
`D No
`
`4.2 Patent Claim Number (as listed in the patent)
`8
`
`Does the patent claim referenced in 4.2 olefin a pending method
`of use lot which approval ls being sought in the pending NDA,
`1:] No
`amendment, or supplement?
`.
`IX Yes
`Use: (Submit indication or method of use information as identified specifically in the approved labeling.)
`treatment of human immunodeficiency virus (HIV) infegiion
`
`4.2a If the answer to 4.2 is
`"Yes,“ identity with specl~
`fici’ly the use with refer-
`ence to the proposed
`labeling lor the drug
`product.
`
`
`
`FORM FDA 3542a (7/03)
`
`Page 3
`PSC Merlin Arlallflliui-Hfltl
`EF
`
`

`

`
`
`
`Sponsors must submit the Information in section 4 ‘
`‘ j eiy for each potent claim claiming a method of using the pending drug
`aduct for which approval is being sought. For each math
`:0! use claim refeihnood, provide the following information:
`' -..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 (as listed in the patent)
`15
`,
`
`El No
`
`E Yes
`_
`Does the patent clalrn referenced in 4.2 claim a pending method
`of use for which approval is being sought in the pending NDA,
`[I No
`amendment. or su-plement?
`.--.
`[Z] Yes
`Use: (Submit indication or method of use information as identified specifically in the approved labeling.)
`treatment of human immunodeficiency virus (HIV) infection
`
`4.23 ll the answer to 4.2 is
`"Yes.“ identify with speci-
`ficity the use with refer-
`ence to the proposed
`labeling for the drug
`product.
`
`~=
`
`
`
`Sponsors must submit the information in section 4 separately for each patent claim r .Iming a method of using the pending drug
`product for which approval is being sought. For each method of use claim referenced, promote 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? E Yes D No
`
`4.2 Patent Claim Number (as listed in the patent)
`Does the patent claim referenced in 4.2 claim a pending method
`16
`'
`of use for which approval is being sought in the pending NDA,
`D No
`amendment, or supplement?
`._
`[E Yes
`Use: (Submit indication or method of use information as identified specifically in the approved labeling.)
`treatment of human immunodeficiency virus (HIV) infection
`
`
`
`4.2a it the answer to 4.2 is
`"Yes," identify with speci-
`ficity the use wlth refer-
`ence to the proposed
`labeling for the drug
`product.
`
`
`
`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 sought in
`M
`the pending NDA, amendment. or supplement?
`4.2 Patent Claim Number (as listed in the patent)
`17
`
`D No
`
`E Yes
`Does the patent claim referenced in 4.2 claim a pending method
`of use for which approval ls being sought in the pending NDA,
`D No
`amendment. or supplement?
`.
`8 Yes
`Use: (Submit indication or method of use information as identified specifically in the approved labeling.)
`treatment of human immunodeficiency virus (HIV) infection
`
`4.2a If the answer to 4.2 is
`'Yes,‘ identify with speci—
`ticity the use with refer-
`ence to the proposed
`labeling for the drug
`product.
`
`
`
`
`Sponsors must submit the information in section 4 separately for each patent claim claiming a method of usrng 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 sought in
`the pending NDA, amendment. or supplement?
`4.2 Patent Claim Number (as listed in the patent)
`13
`'
`
`E] No
`
`Yes
`.
`Does the patent claim referenced in 4.2 claim a pending method
`oi use for which approval is being sought in the pending NDA,
`D No
`amendment, or supplement?
`E Yes
`Use: (Submit indication or method of use information as identifier-7 specifically in the approved labeling.)
`treatment of human immunodeficiency Virus (HIV ) infection
`
`4.2a it the answer to 4.2 is
`"Yes," identity with speci-
`ficity the use with refer-
`ence to the proposed
`labeling for the drug
`product.
`
`
`
`FORM FDA 3542a (7/03)
`
`Page 4
`PSCAkumAmraonue-Itrio
`ElT
`
`

`

`
`
`
`Soonsors must submit the information in section 4 swar— ely’ for each potent claim claiming a method of using the pending drug
`tduct for which approval Is being sought. For each met ‘ «inf use claim referenced, provide the following information:
`-..I Does the patent claim one or more methods of 'use tor whlehiapprovai is being sought in
`the pending. NDA, amendment, or supplement?
`
`Yes
`
`[:I No
`
`
`
`'
`
`4.2 Patent Claim Number (as listed in the patent)
`19
`
`Does the patent claim referenced in 4.2 olefin—a pending method
`of use for which approval is being sought in the pending NDA,
`[:I No
`Yes
`amendment, or sup-lament?
`'
`Use: (Submit indication or method of use infon'nation as identified specifically in the approved labeling.)
`treatment of human immunodeficiency virus (HIV) infection
`
`-
`4.2a if the answer to 4.2 is
`"its" identify with Spec“
`licrty 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 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.
`
`El Yes
`
`
`
`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 OFF? 314.53. Iattest that lam familiar with 21 CFR 314.53 and
`this submission complies with the requirements of the regulation. 1 verify under penalty of perjury that the foregoing
`is true and correct.
`
`Warning: A willfully and knowingly false statement is a criminal offense under is us. C. 1001..
`
`6.2 Authorized Signature of NBA Applicant/Holder or Patent Owner (Attorney, Agent, Representahio'or
`other Authorized Official) (Provide information below)
`
`-
`
`(349m Mam
`
`Date Signed
`05 December 2005
`
`NOTE: Only an NBA 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.
`E] NDA Applicant/Holder
`I
`t
`, E] NDA Applicant’s/Holder’s Attorney, Agent (Representative) or other
`
`i
`.
`Authorized Official
`
`[1 Patent Owner‘s Attorney, Agent (Representative) or Other Authorized
`Official
`
`El Patent Owner
`
`Name
`
`Alana G. Kriegsman
`Address
`
`Office of the General Counsel
`Johnson & Johnson
`One Johnson & Johnson Drive
`
`ZIP Code
`08933 -
`
`FAX Number (if available)
`(732) 524—2134
`
`City/State
`
`New Brunswick, NJ
`
`
`
`
`
`
`
`Telephone NumheT
`732—524— 1495
`
`E-Mail Address (if available)
`akriegsm @corus.j nj .corn
`
`FORM FDA 3542a (7/03)
`
`Page 5
`l’SC Mull-l Arts (301) 443. 1090
`EF
`
`

`

`including the time for reviewing
`insu-uctions. searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send
`cements regarding this burden estimate or any other aspect of this collection of information. including suggestions for reducing this burden to:
`
` The public reponing burden for this collection of information has been estimated to average 9 .‘nours per response,
`
`
`
`
`
`Food and Drug Administration
`CDER (Hm-007)
`5600 fishers Lane
`Rockviile, MD 20857
`
` An ag entry may not conduct or sponsor, and a person is not required to respond to. a collection of
`
`information unlesx it displays a currently valid OMB contra? number.
`
`
`
`FORM FDA 3542a (7/03)
`
`Page 6
`PSC Media Nl5(30!)4~33>l090
`El:
`
`

`

`Department of Health and Human Services
`Fm“ Appmved‘ OMB N°' 0910435”
`.
`.
`.
`Expiration Date: 07/31/06
`Food and Drug AdmInIstratIon
`See OMB Statement on Page 3.
`PATENT INFORMATION SUBMITTED WITH THE
`'
`FILING OF AN NDA, AMENDMENT, on 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(1)) and
`TRADE NAME (OR PROPOSED TRADE NAME)
`
`
`
`NAME OF APPLICANT! NDA HOLDER
`Tibotece 1%
`
`
`
` (c) of the Federal Food, Drug, and Cosmetic Act.
`
`ACTIVE INGREDlENT(S)
`Darunavir
`
`DOSAGE FORM
`tablet
`
`STRENGTH(S)
`
`300 mg
`
`
`
`
`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 alter 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 file an incomplete patent declaration or the patent declaration indicates the
`patent is not eligible for listing. m
`
`Jr 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 lete above section and sections 5 and 6.
`
`
`
`
`‘
` b. Issue Date oi Patent
`June 19, 2001
`
`Address (of Patent Owner)
`
`
`235 East 42nd Street
`
`
`
`c. Expiration Date of Fatent
`August 25, 2012
`
`
`
`
`Telephone Number
`(2 l 2) 733—2323
`
`E—Mail Address (ifavailable)
`
`
`Address {of agent or representative named in 1.6-.)
`
`FAX Number (if available)
`
`
`
`d. Name of Patent Owner
`G.D. Scarle & Co. LLC
`c/o General Patent Counsel
`
`Pfizer Inc.
`City/State
`
`
`New York, NY
`
`ZiP Code
`
`10017
`
`
`
`e. Name of agent or representative who resides or maintains
`
`a place of business within the United States authorized to
`receive notice of patent certification under section
`505(b)(3) and (j)(2)(B) ot the Federal Food. Drug, and
`Cosmetic Act and 21 CFR 314.52 and 314.95 (it patent
`owner or NDA applicant/holder does not reside or have a
`place of business within the United States)
`as
`
`a. UnIted States Patent Number
`6,248,775
`
`
`
`
`
`,
`on)”State
`
`?
`.lP Code
`
`l l
`
`‘Teiephone Number
`
`
`
`ZIP Code
`
`‘i'leiephone Number
`
`i
`
`t.
`
`Q.
`
`
`
`
`is the patent referenced above a patent that has been submitted previously for the
`approved NDA or supplement referenced above?
`”mm
`It the patent referenced above has been submitted previously for listing, is the expiration
`date a new expiration date?
`.
`. wwvnmuwzmmmwwmmmmmmmmuwmmmnmmm
`[ll Yes
`
`_
`Ll Yes
`
`FORM FDA 3542a (7/03)
`
`E No
`
`[XI No
`
`Page 1
`l’SC Media Am (T‘GIJAJF-lllélfl
`EF
`
`

`

`For the patent referenced above, provide the tollowi '5' information an the drug substance, drug product and/or method of
`*orsupphunent
`
`-
`
`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 lithe answer to question 2.2 is "Yes," do you certify that, as‘ ot'the date of this declaration, you have test data
`demonstrating that a drug product containing the polymorph will periorm the same as the drug product
`described in the NBA? The type of test data required is described at 21 CFR 314.53(b).
`
`. L4 Yes
`
`El No
`
`E] Yes
`
`E No
`
`D Yes
`
`[:1 No
`
`2.4 Specify the polymorphic torm(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 it the patent claims a pending method of using the pending
` - E No E] Yes
`
`drug product to administer the metabolite.)
`2.6 Does the patent claim only an intermediate?
`
`
`
`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.)
`
`-
`
`D Yes
`
`[:I No
`
`
`
`calm e rug pr
`amendment, or supplement?
`3.2 Does the patent claim only an intermediate?
`
`, as
`
`e med in 21 CF 314.3, in the pending NDA,
`_
`
`1:] Yes
`
`E No
`
` p
`
`it 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 it the patent is a product-by-process patent.)
`
`
`
`Sponsors must submit the information in section 4 separately for each patent claim ciaiming 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 tor which approval is being sought in
`the pending NDA, amendment, or supplement?
`4.2 Patent Claim Number (as listed in the patent)
`
`E 'No
`
`E] Yes
`Does the patent claim referenced in 4.2 claim a pending method
`of use for which approval is being sought in the pending NDA,
`E} No
`amendment, or suulement?
`[:I Yes
`Use: (Submit indication or method of use information as identified specifrbally 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.
`
`
`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
`re manufacture, use. or sale of the drug product.
`
`D Yes
`
`FORM FDA 35423 (7/03)
`
`Page 2
`i‘SC tilt-dinArtlsilfllNri‘i-HMI
`Fl‘
`
`

`

`
`6.1 The undersigned declares that this is an accurate and complete suhInIssion ofpatent infomiation for the NDA,
`amendment, or supplement pending under section535 of the Fedetial Food, Drug, and Cosmetic Act. This time-
`sensitive patent information is submitted pursuantto 21 CFR 314.53. lattest 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.
`
`6.2 Authorized Signature oi NDA Applicant/Holder or Patent Owner {Attomey, Agent, Hepresentai1we
`other Authorized Official) (Provide Information below)
`
`Date Signed-
`05 December 2005
`
`fiat/ya mwm
`
`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.f3(c)(4) and (d)(4)
`Check applicable box and provide information below.
`
`
`
`D NDA Applicant/Holder
`
`E NDA Applicant's/Holder’s Attorney, Agent (Representative) or other
`Authorized Official
`
`[:1 Patent Owner
`
`Name
`
`Alana G. Kriegsman
`
`E] Patent Owners Attorney Agent (Representative) or Other Authorized
`Official
`‘—
`
`~
`
`' u..-
`
`
`
`Address
`Office of the General Counsel
`Johnson & Johnson
`One Johnson & Johnson Drive
`
`
`_
`
`City/State
`New Brunswick, NJ
`
`ZIP Code
`08933
`
`FAX Number (if available)
`(732) 524-2134
`
`
`-
`
`Telephone Numb;
`732—524—1495 ,
`
`E-Mall Address (Ifavailable)
`akriegsm @corus.jnj.com
`
`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 infomation including sug>I.=,':stions for reducing this burden to:
`Food and Drug Administration
`CDER (HFD-OO7)
`5600 fishers Lane
`Rockville, MD 20857
`
`.An agency mav not conduct or sponsor and (1 [mean is not requiied to respond to a colleclion of
`information unless it displays a Currently valid OMB control:I..ImlIer.
`
`FORM FDA 3542a (7/03)
`
`>
`
`Page 3
`PSC Media Am (301) 443-1090
`El:
`
`Immu-snmm‘mm-mmmunmmmlWwwammwmmmmwm ,
`
`.
`
`.
`
`

`

`Department of Health and Human Services
`Food and Drug Administration
`
`Form film 82:: gig/£33305”
`' . See OMB Statement on Page 3.
`
`NDA NUMBER
`
`PATENT INFORMATION SUBMITTED WITH THE
`FILING OF AN NDA, AMENDMENT, CW! SUPPLEflENT
`,
`For Each Patent That Claims a Drug Substance
`(Active ingredient), Drug Product (Femwation and
`
`Composition) and/or Method of Use
`
`NAME 0" APPUCANT / NDA HOLDER
`Tibotec, 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)
`"
`
`300 mg
`
`ACTiVE lNGFlEDIENT(S)
`Darunavir
`
`DOSAGE FORM
`tablet
`
`STRENGTHS)
`
`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 OFF; 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 file an incomplete patent declaration or the patent declaration indicates the
`patent is not eligible for listing.
`
`"or each patent submitted for the pending NDA, amendment, or sapplement referenced above, you must submit all the
`nformation 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
`
`
`
` b. Issue Date of Patent
` a. United States Patent Number
`c. Expiration Date of Patent
`
`1 December 2015
`
`5,843,946
`lZ/l/l998
`
`
`
`(1. Name of Patent Owner
`Address (of Patent Owner)
`
`G.D. Searle & Co. LLC
`235 East 42nd Street
`
`c/o General Patent Counsel
`
`Pfizer Inc.
`City/State
`New York, NY
`
`
`
`'
`
`ZIP Code
`
` FAX Number (if available)
`
`100 l 7
`
`
`
`
`EaMail Address (ifavailable)
`Telephone Number
`(212) 733-2323
`
`e. Name of agent or representative who resides or maintains
`Address (of agent or representative named in 1.5.)
`a place of business within the United States authorized to
`-
`receive notice of patent certification under section
`505(b)(3) and (j)(2)(B) oi the Federal Food, Drug, and
`Cosmetic Act and 21 CFR 314.52 and 314.95 (it patent
`owner or NDA applicant/holder does not reside or have a
`place of business within the United States)
`(1:.
`
`i i
`
`,
`
`,
`. CITY/State
`-......~_. .........
`
`1’"V.
`Zip Code
`'
`ZlP'Code
`
`n”?elephonevNumber
`..
`—
`Telephone Number
`
`L._.
`_-_ __...
`Is the patent referenced above a patent that has been subm itied previously for the
`f.
`
`approved NDA or supplement referenced above?
`It the patent referenced above has been submitted previously tor listing, is the expiration
`9.
`
`date a new expiration date?
`
`FORM FDA 35423 (7/03)
`
`__
`
`[:1 Yes
`
`X No
`
`[:I Yes
`
`E No'
`
`Page 1
`PSC Media Arls (30!) 4434090
`EF
`
`

`

`use that is the subject of the pending NDA, amend
`..
`t-~
`». W E
`e".
`
`
`
`
`
`
`
`lent in the dnigproduct
`
`For the patent referenced above, provide the follow information on the drug substance, drug product and/or method of
`_ or supplement;
`-
`.c L.
`n.
`
`
` ”-1 Does the patent claim the drug substance that is activ ‘ V
`
`
`I: Yes
`E No
`described in the pending NDA, amendment, or supplement?
`orph of the active
`2.2 Does the patent claim a drug substance that is a different
`' n .
`ingredient described in the pending NDA. amendment, or supplement?
`2.3 if the answer to question 2.2 ls “Yes,“ do you certify that, a‘s oi 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 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 desrilbed in 2.3.
`
`El Yes
`
`E No
`
`[:1 Yes
`
`v E] No
`
`2.5 Does the patent claim only a metabolite of the active ingredient pending in the MBA or supplement?
`(Complete the information in section 4 below it the patent ciaims a pending method of using the pending
`drug product to administer the metabolite)
`2.6 Does the patent claim only an intermediate?
`
`D Yes
`
`W No
`
`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.)
`
`-
`
`D Yes
`
`1:] No.
`
` Does the patent claim the drug product, as d
`
`.
`
`amendment, or supplement? '
`3.2 Does the patent claim only an intermediate?
`
`.
`
`E Yes
`
`[:I No
`
`
`3.3 it the patent referenced in 3.1 is a product-by—process patent, is the product claimed in the
`E] No
`[:I Yes
`patent novel? (An answer is required only lithe patent is a product-by‘process patent.)
`
`
`
`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 sought in
`the pending NDA, amendment, or supplement?
`4.2 Patent Claim Number (as listed in the patent)
`8
`’
`
`E Yes
`[:I No
`
`Does the patent claim referenced in 4.2 claim a pending method
`of use for which approval is being sought in the pending NDA,
`
`Yes
`[:1 No
`amendment, or supplement?
`Use: (Submit indication or method of use information as identified specifically in the approved labeling.)
`treatment of human immunodeficiency virus (HIV) infection
`
`v 4.2a lithe answer to 4.2 is
`“Yes