CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`APPLICATION NUMBER:
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`204592Orig1s000
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`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
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`Department of Health and Human Services
`Fm“ ”PW/9d: 0MB “0- 0910-0513
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`FOOd and Drug Administration
`Expiration Date: 10/31/2013
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`See OMB Statement on Page 3.
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`PATENT INFORMATION SUBMITTED WITH THE FILING um MBER
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`OF AN NDA, AMENDMENT, OR SUPPLEMENT
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`For Each Patent That Claims a Drug Substance
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`(Active Ingredient), Drug Product (Formulation and Composition)
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`Imko thmmwalsi LLC
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`18 mg and 35 mg
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`This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) with an NDA application,
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`amendment. or supplement as required by 21 CFR 314.53 at the address provided in 21 CFR 314.53(d)(4).
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`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
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`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
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`supplement. The information submitted in the declaration form submitted upon or after approval will be the only information relied
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`upon by FDA for listing a patent in the Orange Book.
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`For handwritten or typewriter versions (only) of this report: if additional space is required for any narrative answer (i.e.. one that
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`does not require a "Yes" or "No" response), please attach an additional page referencing the question number.
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`FDA will not list patent information ifyou submit an incomplete patent declaration or the patent declaration indicates the
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`' patent is not eligible for listing.
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`For each patent submitted for the pending NDA, amendment, or supplement referenced above, you must submit all the
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`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.
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`1.6ENE'R—AL V.
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`«eo'Pateiii Number
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`US 2010/0092563
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`One Kew Place, 150 Rouse Blvd.
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`8. ‘arneo0%? otreEresem law
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`receive notice of patent certification under section 505(b)(3)
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`and (j)(2)(8) of the Federal Food. Drug. and Cosmetic Act
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`and 21 CFR 314.52 and 314.95 (if patent owner or NDA
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`applicantlhoider does not reside or have a place of
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`business within the United States)
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`Telephone Number
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`FAX Number (if available)
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`(267) 546-3004
`E-Mail Address fifavailabie)
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`Won—1W0? available)
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`The following is provided in accordance with Section 505(1)) and (c) of the Federal Food, Drug, and Cosmetic Act.
`0' "O’OS TRADENAME)
`TRADEN
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`Zorvolex Capsules
`ACTIVE INGREDIENT S)
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`' date a new expiration date?
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`FORM FDA 3542: (10110)
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`Page 1
`PSC lehiu(301)443—l090 EF
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`For the patent referenced above, provide the following lnfonnation on the drug substance, drug product and/or method of
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`use that is theLusubject ofthe pending NDA, amendment,or supplement.
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`‘ ,ctiveingredient)
`2.1 Does the patent claim the drug substance that is the active ingredient In the drug product
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`described'in the pending NDA, amendment. or supplement?
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`2.2 Does the patent claim a drug substance that is a different polymorph of the active
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`ingredient described in the pending NDA, amendment. or supplement?
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`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
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`data demonstrating that a drug product containing the polymorph will perform the same as the drug product
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`described in the NBA? The type of test data required is described at 21 CFR 314.53(b).
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`2.4 Specify the polymorphic formfs) claimed by the patent for which you have the test results described In 2.3.
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`2.5 Does the patent claim only a metabolite of the active ingredient pending in the NDA or supplement?
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`(Complete the lnfonnation in section 4 below lithe patent claims a pending method of using the pending
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`drug product to administer the metabolite.)
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`1:] Yes
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`8] No
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`2.6 Does the patent claim only an intennadiate?
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`2.7 lithe patent referenced in 2.1 is a product-by-process patent, is the product claimed in the
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`patent novel? (An answer is required only if the patent is a product-by-process patent.)
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`‘posrtion/Fonnulation)
`3. Drug Product ‘
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`3.1 Does the patent claim: the drug product. as defined in 21 CFR 3143 inthepending NDA, amendment.
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`or supplement?
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`3.2 Does the patent claim only an intermediate?
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`3.3 lithe patent referenced in 3.1 is a pmduct‘by-process patent. is the product claimed in the
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`patent novel? (An answer is required only if the patent is a product-by-prooees patent.)
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`E] Yes
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`E No
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`4. Method or:Use:
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`Sponsors must submit the infonnatlon insection4 for each method ofusing the pending drug product for which approval is being
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`sought that is claimed by the patent. For each pending method of use claimed by the patent, provide the following information:
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`4.1 Does the patent claim one or more methods of use for which approval is being sought'in
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`the pending NDA. amendment. or supplement?
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`4.2 Patent Claim Number(s) (as listed in the patent)
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`Does (Do) the patent ctaim(s) referenced in 4.2 claim a
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`pending method of use for which approval is being sought
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`in the pending NDA. amendment, or supplement?
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`C] Yes
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`E] No
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`Use: (Submit indication or method ofuse infomraticn as identified specifically in the proposed labeling.)
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`4.2a lithe answer to 4.2 is
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`"Yes.” identify with speci-
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`ence to the proposed
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`labeling for the drug
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`product.
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`For this pending NDA, amendment. or supplement, there are no relevant patents that claim the drug substance (active ingredient).
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`drug product (formulation or composition) or method(s) of use, for which the applicant is seeking approval and with respect to which
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`a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the
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`manufacture. use, or sale of the drug product.
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`FORM FDA 3542a (10/10)
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`Page 2
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`6. Declaration Certification ‘
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`6-1 The undersigned declares that this Is an accurate and complete submission of patent Information for the NDA,
`amendment, or supplement pending under sec-don 505 of the Federal Food, Drug, and Cosmetic Act. This time-
`sensltive patent inlonnation is submitted pursuant to 21 CFR 314.53. iatteet that i am familiar with 21 CFR 314.53 and
`this submission complies with the requirements of the regulation. l verify under penalty of perjury that the foregoing is
`true and comet.
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`Wamlng: A willfully and knowingly false statement is I criminal oti‘onse under 18 0.8.6. 1001.
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`6.2 Authorized Signature or NDA Applicantll'loldet or Patent . ~
`other Authorized Ofiiclal) (Provide Inforrrretion below)
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`Date Signed
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`, directly to the FDA. A oatent emu ’4' not the NDA applicant!
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`NOTE: Only an NDA appllcnntlholder may submit .
`holder is autheflaod to sign the declarntion but may not 3 y 1 itdlrootly to FDA. 21 CFR 314.53qu a : (10(4).
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`Check applicable box and provide information below.
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`1:] NBA Applicant/Honor
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`8] NBA Ammonia/Holders Attorney. Agent (Repreoentatlve) or other
`Authorized Official
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`C] Patent Owner
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`Name
`Anita L. Meikicjohn
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`Mdrees
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`[:1 Patent Owner’s Attornw. Agent (Representative) or Other Authorized
`Ofiloiet
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`CItyiSteto
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`mfilman'an wrlm it dispkno a currently valid 0m control Rumba“.
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`Boston, Massachusetts
`Fish & Richardson PC.
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`One Marina Park Drive
`1-mge-‘-onoumr
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`02210-1878
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`FAX Number (if available)
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`877-769-7945
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`617-542-5070
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`- ' all Address if available)
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`ALM@FR.COM
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`The public reporting binder: for this collection of information has been estimated to average 20 hours per response, includingthe time for reviewing
`inwuctions, searching existing data sources. gathering and maintaining the data needed. and completing and reviewing the collection of information. Send
`comments regarding rh'o burden estimate or any miner aspect ofthis collection ofinfomiation. including suggestions for reducingtln's burden to:
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`Depmmem of Health and Human Services
`Food and Drug Administration
`Office of Chief Information Officer
`1350 Piocard Drive, Room 400
`Rockvilie, MD 20850
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`An agency may not contort or sponsor: andaperm is not required (a rerpond la, a collection of
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`Form FDA 35423 (who)
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`P39. 3
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`describes the authorized signature.
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`le) Answer this question if applicable. If patent owner and NDA
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`applicant/holder reside in the United States, leave space
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`blank.
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`2. Drug Substance (Active Ingredient)
`Complete all items in this section if the patent claims the drug
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`substance that is the subject ofthe pending NDA, amendment, or
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`supplement.
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`2.4) Name the polymorphic form of the drug identified by the
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`2.5) A patent for a metabolite of the approved active ingredient
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`may not be submitted. If the patent claims an approved
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`method of using the approved drug product to administer the
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`metabolite, the patent may be submitted as a method of use
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`patent depending on the responses to section 4 of this form.
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`2.7) Answer this question only if the patent is a product-by-
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`process patent.
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`3. Drug Product (Composition/Formulation)
`Complete all items in this section if the patent claims the drug
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`product that is the subject of the pending NDA, amendment, or
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`supplement.
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`3.3) An answer to this question is required only if the referenced
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`patent is a product-by-process patent.
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`4. Method of Use
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`Complete all items in this section if the patent claims a method of
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`use ofthe drug product that is the subject ofthe pending NDA,
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`amendment, or supplement (pending method ofuse).
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`4.2) For each pending method ofuse claimed by the patent,
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`identify by number the claim(s) in the patent that claim the
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`pending use of the drug. An applicant may list together
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`multiple patent claim numbers and information for each
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`pending method of use, if applicable. However, each
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`pending method of use must be separately listed within this ,
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`section of the form.
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`4.23) Specify the part of the proposed drug labeling that is
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`claimed by the patent.
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`General Information
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`' To submit patent information to the agency the appropriate
`patent declaration form must be used. Two forms are available
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`for patent submissions. The approval status ofyour New Drug
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`Application will determine which form you should use.
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`' Form 3542a should be used when submitting patent information
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`with original NDA submissions, NDA amendments and NDA
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`supplements prior to approval.
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`’ Form 3542 should be used after NDA or supplement approval.
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`This form is to be submitted within 30 days afier approval of an
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`application. This form should also be used to submit patent
`information relating to an approved supplement under 21 CFR
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`314.53(d) to change the formulation, add a new indication or
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`other condition ofuse, change the strength, or to make any other
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`patented change regarding the drug, drug product, or any
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`method of use.
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`' Form 3542 is also to be used for patents issued after drug
`approval. Patents issued afier drug approval are required to be
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`submitted within 30 days ofpatent issuance for the patent to be -
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`considered "timely filed."
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`' Only information fi'orn form 3542 will be used for Orange Book
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`publication purposes.
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`' Forms should be submitted as described in 2l CFR 3l4.53.
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`Sending an additional copy of form 3542 to the Orange Book
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`Staff will expedite patent publication in the Orange Boole The
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`Orange Book Staff address (as of April 2007) is: Orange Book
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`Staff, Office of Generic Drugs OGD/HFD-élo, 7500 Standish
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`Place, Rockville, MD 20855.
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`' The receipt date is the date that the patent information is date
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`stamped in the central document room. Patents are considered
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`listed on flte date received.
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`' Additional copies of these forms may be downloaded from the
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`lntemetat; http://wwwfda.gov/apacoIn/morechoices/fdajbnns/
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`fdaforms.html.
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`
`
`First Section
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`
`Complete all items in this section.
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`1. General Section
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`Complete all items in this section with reference to the patent
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`itself.
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`1c) Include patent expiration date, including any Hatch-Waxman
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`patent extension already
`granted. Do not include any
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`applicable pediatric exclusivity. The agency will include
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`pediatric exclusivities where applicable upon publication.
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`1d) Include full address of patent owner. If patent owner resides
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`outside the U.S. indicate the country in the zip code block.
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`INFORMATION AND INSTRUCTIONS FOR FORM 3542a
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`PATENT INFORMATION SUBMITTED WITH THE FILING
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`OF AN NDA, AMENDMENT OR SUPPLEMENT
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`5. No Relevant Patents
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`Complete this section only if applicable.
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`6. Declaration Certification
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`Complete all items in this section.
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`6.2) Authorized signature. Check one ofthe four boxes that best
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`FORM FDA 3542:: (10/10)
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`Page 4
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`

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`Form Approved: OMB No. 0910-0513
`Department of Health and Human Services
`Expiration Date: 10/31/2013
`mm'istrati
`See OMB Statement on Page 3. '
`Food and Drug Ad
`on
`v ; :1.
`x
`PATENT INFORMATION SUBMITTED WITH THE FILING l . .
`OF AN NDA, AMENDMENT, OR SUPPLEMENT
`NDA 204592
`V . Vt
`T
`. ‘-'- a‘
`
`For Each Patent That Claims a Drug Substance
`(Active Ingredient), Drug Product (Formulation and Composition)
`and/or Method of Use
`
`18 mg and 35 mg
`
`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 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)(i|) with all of the required infomatlon based on the approved NDA or
`supplement. The intormation 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 ifyou 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. i!you are notsubmitting any patents for this pending NDA, amendment, or supplement,
`complete above section and sections 5 and 6.
`
`-.Narne
`
`iCeutica
`
`:l-Jssuete 'atent
`
`NA-pending application
`~71.
`-.~. Monte
`
`One Kew Place, 150 Rouse Blvd.
`
`.
`
`.
`
`.
`
`;
`
`NA—pcnding application
`
`.rsm
`
`AX Number filaveilable)
`
`business within the United States)
`
`receive notlce of patent certification undersection 505le3)
`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
`
`date a new expiation date?
`
`
`FORM FDA 3542a (10! 0)
`
`
`Paget
`moweonm-mo £11
`
`

`

`For the patent referenced above, provide the following lnfonnatlon on the drug substance. drug product and/or method of
`use that Is the subject of the pending NDA,amendment,or supplement
`2- Drug Sublime" meowingredient)
`2.1 Does the patent claim the drug substance thatis the active Ingredient In the drug product
`described in the pending NDA. amendment, or supplement?
`
`2.2 Doesthe patentciaim a drug substance lhetisedittetent polymorphotthe active
`ingmdient described it the pending NDA, amendment, or supplement?
`
`2.3 it the answer to question 2.2 is 'Yee.‘ do you certify that, as oi the date ot this declaration, you have test
`date demnstratlng that a drug woduct containing the poiymorph will perform the same as the drug product
`described in the NBA? The type of test data required is described at 21 CFR 314.5302).
`
`[:1 Yes
`
`D No
`
`2.4 Specify the potyrnorphic tennis) claimed hythe 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 oi using the pending
`drug product to administer the metabolite.)
`
`D Yes
`
`8] No
`
`2.6 Does the patent claim only an intemtediete?
`
`2.7 it the patent referenced In 2.1 is a product-by—proceee patent. is the product claimed in the
`patent novel? (An answer Is required only it the patent is a produd~by-ptooeee patent.)
`
`3. Drug Product(Composition/Fonnutation)
`3.1 Does the patent clakn the drug product. as defined in 21 CFR 314.3, in the pending NDA amendment
`or supplement?
`
`3.2 Does the patent clam only an htermediale?
`
`3.3 It the patent referenced in 3.1 is a produm—by-pmcess patent. is the product claimed in the
`patent novel? (An answer is required only it the patent Is a pmduwbyprocese potent.)
`
`4. Method of Us.
`Sponsors must submit the lnionneh'on in section 4 for each methodof using Ute pending drug product for which approval is being
`sought that is claimed by the patent. For each pending method of use claimed by the potent. provide the following lnibrmetlon:
`
`4.1 Does the patent claim one or more methods of use tor which approval is being soughtm
`the pending NDA, amendment, or supplement?
`
`D Yes
`
`g] No
`
`4.2 Patent Claim Numbeds) (as listed in the patent)
`
`Does (Do) the patent ciaim(s) reierenced in 4.2 claim a
`pending method of use iorwhich approval is being sought
`in the pending NDA. amendment. or supplement?
`
`1] Yes
`
`E] No
`
`
`
`Use: (Submit indication or method of use information as identified specifically in the proposed labeling.)
`
`42:: ll the answer to 4.2 is
`'Yes." identity with speci-
`ficity the use with refer—
`ence to the proposed
`labeling forthe drug
`product.
`
`5. No Relevant-"3"onto
`For this pend‘ng NDA, amendment.or supplement thereare norelevant patenfi that claim the drug substance (active ingredient),
`drug product (tonmlation or composition) or melhod(e) 01 use, for chh the mplicant is seeking approvd and with respect to which
`aciairnofpatenthtrlngementcouid reasonablybeeeeertedie pemon not Iceneed bytheownerolthe patentengaged inthe
`manufacture. use. oreeIeotthedrug product.
`
`FORM FDA 3542a (10/10)
`
`Page 2
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`

`

`V
`& mwmwmmfim .
`6.1 The undersigned declares that this is an accurate and complete submission efpetent lnfonnotion for the NDA,
`amendment, or supplement pending under section 505 of the Federal Food. Drug, and Cosmetic Act. This time-
`sensltive patent Information is submitted pursuant to 21 cm 314.53. 1 attest that l am familiar with 21 CFR 314. 53 and
`this submission complies with the requirements of the reguletion. l verity under penalty ofperjury that the foregoing is
`true and correct.
`
`Warning: A wllilwly and knowingly false statement is a criminal offense under 18 use. 1001.
`
`8.2 Authorized Slmetune of NBA ApplieentII-lotder or Patent 0
`other Authorized Official) (Provide information below)
`
`-
`
`(Attorney, Agent. Representative or
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`1
`
`NOTE: Only an non Welder may ’4’“, dechratlon directly to the FDA. A potent owner who u not the non applicant!
`holder is mm to sign the decbrltl -
`.
`- may not submit it dimly to son. 21 on summer and (am).
`
`Check applicable box and provide information below.
`
`i] NDA ApplicantiHolder
`
`NDA Applcant'slHoldel’s Attorney, Agent (Reprmntative) or other
`Authorized Official
`
`Name
`
`_
`
`Anita L. Meiklejohn
`Address
`
`Fish & Richardson P.C.
`One Marina Park Drive
`' m ;
`
`02210-1878
`
`umber 'amliable
`877469-7945
`
`Ofildd
`
`.
`
`City/State
`Boston, Massachusetts
`
`“"7 m ‘u r .
`
`617-542-5070
`
`"r" “'5 as (ifavalieblo)
`ALM@FR.COM
`
`iry‘brman‘on unless it displays a currently valid om control number.
`
`The public reporting burden for this collection of information hm been estimated to average 20 hours per response, including the time for reviewing
`inmcttom, smelting existing data sources, gathering and maintaining the data mo, and completing and reviewing the collection of information. Send
`comments regarding this burden minute 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
`l350 PiccaId Drive, Room 400
`Rockville, MD 20850
`
`An agency may not conduct or sponsor. and a perm is not aquiradio remand to, a collection of
`
`FORM FDA 3542: (who)
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`. Page a
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`

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`describes the authorized signature.
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`1e) Answer this question if applicable. Ifpatent owner and NDA
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`applicant/holder reside in the United States, leave space
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`blank.
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`2. Drug Substance (Active Ingredient)
`Complete all items in this section if the patent claims the drug
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`substance that is the subject ofthe pending NDA, amendment, or
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`supplement.
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`2.4) Name the polymorphic form of the drug identified by the
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`patent.
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`2.5) A patent for a metabolite of the approved active ingredient
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`may not be submitted. Ifthe patent claims an approved
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`method of using the approved drug product to administer the
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`metabolite, the patent may be submitted as a method of use
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`patent depending on the responses to section 4 of this form.
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`2.7) Answer this question only if the patent is aproduct—by-
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`process patent.
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`
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`3. Drug Product (Composition/Formulation)
`Complete all items in this section if the patent claims the drug
`
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`
`
`product that is the subject of the pending NDA, amendment, or
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`supplement.
`
`3.3) An answer to this question is required only ifthe referenced
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`patent is a product-by-process patent. ’
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`4. Method of Use
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`Complete all items in this section if the patent claims a method of
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`use ofthe drug product that is the subject of the pending NDA,
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`amendment, or supplement (pending method ofuse).
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`4.2) For each pending method of use claimed by the patent,
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`identify by number the claim(s) in the patent that claim the
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`pending use ofthe drug. An applicant may list together
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`multiple patent claim numbers and information for each
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`pending method of use, if applicable. However, each
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`pending method of use must be separately listed within this
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`section ofthe form.
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`4.2a) Specify the part of the proposed drug labeling that is
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`claimed by the patent.
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`
`General Information
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`
`
`
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`
`
`
`' To submit patent information to the agency the appropriate
`
`patent declaration form must be used. Two forms are available
`
`
`
`
`
`
`
`
`
`for patent submissions. The approval status of your New Drug
`
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`Application will determine which form you should use.
`
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`Form 3542a should be used when submitting patent information
`
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`
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`with original NDA submissions, NDA amendments and NDA
`
`
`
`
`
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`supplements prior to approval.
`
`
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`
`
`
`
`Form 3542 should be used afier NDA or supplement approval.
`
`
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`
`
`
`
`
`
`This form is to be submitted within 30 days afier approval of an
`
`
`
`
`
`
`
`
`
`
`
`
`application. This form should also be used to submit patent
`
`
`
`
`
`
`
`
`
`
`information relating to an approved supplement under 21 CFR
`
`
`
`
`
`
`
`
`
`314.53(d) to change the formulation, add a new indication or
`
`
`
`
`
`
`
`
`
`
`other condition of use, change the strength, or to make any other
`
`
`
`
`
`
`
`
`
`
`
`
`patented change regarding the drug, drug product, or any
`
`
`
`
`
`
`
`
`
`method ofuse.
`
`
`
`
`
`
`
`Form 3542 is also to be used for patents issued after drug
`
`
`
`
`
`
`
`
`
`
`
`approval. Patents issued alter drug approval are required to be
`
`
`
`
`
`
`
`
`
`
`submitted within 30 days of patent issuance for the patent to be
`
`
`
`
`
`
`
`
`
`
`
`
`considered "timely filed."
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Only information from form 3542 will be used for Orange Book
`publication purposes.
`
`
`
`
`
`Forms should be submitted as described in 21 CFR 314.53.
`
`
`
`
`
`
`
`
`
`Sending an additional copy of form 3542 to the Orange Book
`
`
`
`
`
`
`
`
`
`
`
`Stafi‘ will expedite patent publication in the Orange Book. The
`
`
`
`
`
`
`
`
`
`
`
`Orange Book Staff address (as of April 2007) is: Orange Book
`
`
`
`
`
`
`
`
`
`Staff, Office of Generic Drugs OGD/HFD-GIO, 7500 Standish
`
`
`
`
`
`
`
`
`Place, Rockville, MD 20855.
`
`
`
`
`
`
`
`The receipt date is the date that the patent information is date
`
`
`
`
`
`
`
`
`
`
`
`
`stamped in the central document room. Patents are considered
`
`
`
`
`
`
`
`
`
`listed on the date received.
`
`
`
`
`
`
`' Additional copies ofthese forms may be downloaded from the
`
`
`
`
`
`
`
`
`
`
`
`Internet at:
`ht!p://www.fda.gov/opacom/morechoiceslfdafimns/
`
`
`
`qufonns. html.
`
`
`
`First Section
`
`
`Complete all items in this section.
`
`
`
`
`
`
`
`1. General Section
`
`
`
`Complete all items in this section with reference to the patent
`
`
`
`
`
`
`
`
`
`
`
`itself.
`
`lc) Include patent expiration date, including any Hatch-Waxman
`
`
`
`
`
`
`
`
`patent extension already
`granted. Do not include any
`
`
`
`
`
`
`
`
`applicable pediatric exclusivity. The agency will include
`
`
`
`
`
`
`
`
`
`
`
`
`
`pediatric exclusivities where applicable upon publication
`
`ld) Include full address of patent owner. If patent owner resides
`
`
`
`
`
`
`
`
`
`
`
`outside the US. indicate the country in the zip code block.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`INFORMATION AND INSTRUCTIONS FOR FORM 3542a
`
`
`
`
`
`
`
`
`PATENT INFORMATION SUBMITTED WITH THE FILING
`
`
`
`
`
`
`OF AN NDA, AMENDMENT OR SUPPLEMENT
`
`
`
`5. No Relevant Patents
`
`
`
`
`Complete this section only if applicable.
`
`
`
`
`
`
`
`6. Declaration Certification
`
`
`
`Complete all items in this section.
`
`
`
`
`
`
`
`6.2) Authorized signature. Check one of the four boxes that best
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`FORM FDA 3542a (10/10)
`
`
`
`
`
`
`Page 4
`
`
`
`

`

`Department of Health and Human Services
`F
`Adm
`fl
`00d and Drug
`WSW on
`PATENT INFORMATION SUBMITTED WITH THE FILING
`OF AN NDA, AMENDMENT, on SUPPLEMENT
`
`F0"?! Appmved: 0MB No. 0910-0513
`Expiration Date: 10/31/2013
`See OMB Statement on Page 3.
`z
`.
`
`.A r
`
`For Each Patent That Claims a Drug Substance
`(Active Ingredient), Drug Product (Fonnuiation and Composition)
`and/or Method of Use
`
`m" ' A"
`
`Diclofenac Acid
`
`18 mg and 35 mg
`
`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 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 MBA or
`supplement. The iniomtation submitted in the declaration form submitted upon or alter approval will be the only information relied
`upon by FDA for iisting a patent in the Orange Book.
`
`For hand-Mitten or typewriter versions (only) of this report: if additional space is required for any narrative answer 0.6., one that
`does not require a "Yes" or “No" response). please attach an waitionai page referencing the question number.
`
`FDA will not list patent inionnetion ifyou submit an incomplete patent declaration or the patent declaration indicates the
`patent is not eligible for listing.mfl-Wm
`
`For each patent submitted for the pending NDA, amendment. orsuppiement reformed above, you must submit all the
`information described below. ii you are not submitting any patents for this pending NDA, amendment, orsuppiement,
`complete above section and sections 5 and 6.
`
`
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`tent certification under section 505(b)(3)
`tice
`receive
`and (ixzxe) or the Federal Food. Drug. and Cosmetic Act
`and 21 CFR 314.52 and 314.95 (if patent owneror NDA
`applwflhoiderdoes not reside or have a place of
`business within the United States)
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`is a new expiration date?
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`FOR“ FDA 3542: (1M0)
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`Page 1
`PSCOnpth' (mien-mu EP
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`For the patent reMnced above, provide the renewing information on the drug substance, drug product and/or method of
`use that is thesubjectofthe pending NDA, amendment,orsupplement.
`
`2.1 Does thepatent claim the drug substance. thatre the active ingredient'tn the drug product
`described in the pending NDA amendment, or supplement?
`
`2.2 Does the patent claim a drug substance that is a ditterent polymorph oi the active
`ingredient described in the pending NDA, amendment. or supplement?
`
`2.3 i