CENTER FOR DRUG EVALUATION AND
`RESEARCH
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`
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`APPLICATION NUMBER:
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`204824Orig1s000
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`ADMINISTRATIVE and CORRESPONDENCE
`DOCUMENTS
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`Medac Exhibit 2071
`Frontier Therapeutics v. Medac
`IPR2016-00649
`Page 00001
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`

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`F°""‘ APP'°"°d¢ OMB N°- °91°'°513
`Department of Health and Human Services
`see%5';‘§;E;‘;(1:;3;;2g‘:13
`Food and Drug Administration
`PATENT INFORMATION SUBMITTED WITH THE FILING DA NUMBER
`or 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
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`‘ " '
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`' ' " ‘ ‘
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`'
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`STRENGTH(S)
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`ro mg/0.4 mi, 15 my 0.4 ml, 20 mg/0.4 mi and 25 mg/0.4 ml
`
`Subcutaneous Injection
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`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 3t4.53(d)(4).
`within thirty (30) days after approval of an NDA or supplement. or within thirty (30) days of issuance of a new patent. 3! 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.
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`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 informaflon if you submit an incomplete patent declaration or the patent declaration indicates the
`patent is not eligible for listing.
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`For each parent submitted for the pending NDA, amendment, or supplement referenced above, you must submit all the
`information described below. Ifyou are not submitting any patents for this pending NDA, amendment, or supplement,
`complete above section and sections 5 and 6.
`1. GENERAL
`a. United States Patent Number
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`c. Exprra on Date of Paten
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`b. Issue Date 0 Patent
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`7,776,015
`cl. Name oi Patent Owner
`Antares Phamta, Inc.
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`Aug. I7, 2010
`Address (of Patent Owner)
`100 Princeton South Corporate Center, Suite 300
`
`08/ l0/2019
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`e. ameo agen or represen a we w - res es or me n ins
`a place oi iiusiness wnifirn the United States authorized to
`receive notice of patent certification under section 505(b)(3)
`and (j)(2)(B) of the Federal Food, Drug, and Cosmetic Act
`and 21 CFR 314.52 and $14.95 (if patent owner or NDA
`applicantiholder does not reside or have a place of
`business within the United States)
`
`E
`Ewing, NJ
` .__........___ AYNfin_b_é?.(fl a.vh”é_6I_o)___._.._. _ . -_..____._.. .
`08628
`609 359 3015
` “*"_" E-Mall Adress (i'r”éi/§'iiéb_I‘e')_" W" T
`609 359 3020
`kdave@antarespharma.com
`
`.
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`'
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`"'"’
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`‘
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`‘l-‘A")(Nu’rFb'el""(iiTa‘\7r'aTIWe')
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`Not applicable
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`‘EVar‘i7$d8ress fr? svairaoiei
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`. s the patent rerence aove a parent: at has een su
`approved NDA or supplement referenced above?
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`g.
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`e patent re erenca a ve has een s mtte prev ous y or sng, st e exp raon
`date a new expiration date?
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`FORM FDA 3542a (10110)
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`Page 1
`r~st:<i:-mt-stsriln-u-in-In
`[~.F
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`Page 00002
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`For the patent referenced above, provide the following information on the drug substance, drug product and/or method of
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`use that is the subject of the pending NDA, amendment, or supplement.
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`2. Drug Substance (Active Ingredient)
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`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 NDA? The type of test data required is described at 21 CFR 314.53(b).
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`2.4 Specify the polymorphic r'orm(s) 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 information in section 4 below if the patent claims a pending method of using the pending
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`drug product to administer the metabolite.)
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`2.6 Does the patent claim only an intermediate?
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`2.7 if the 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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`3. Drug Product (Composition/Formulation)
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`3.1 Does the patent claim the drug product, as defined in 21 CFR 314.3, in the pending NDA, amendment,
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`or supplement’?
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`"3j§‘”i56E‘s"iiiE‘Eét7ent claim only an intermediate?
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`[: Yes
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`No
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`3.3 if the patent referenced in 3.1 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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`4. Method of Use
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`Sponsors must submit the information in section 4 for each method of using 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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`42 Patent Claim Numbar(s) (as listed in the patent)
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`Does (Do) the patent c|aim(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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`[: No
`|’_' Yes
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`Use: (Submit indication or method of use information as identified specifically in the proposed labeling.)
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`4.23 if the answer to 4.2 is
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`"Yes," identify with speci-
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`ficity the use with refer-
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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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`5. No Relevant Patents
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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 melhodts) 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 35423 (10/10)
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`Page 00003
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`6. Declaration Certification
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`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. lattes: that I am familiar with 21 CFR 314.53 and
`this submission complies with the requirements of the regulation. I verify under penalty of perjury that the foregoing is
`true and correct.
`
`Warning: A willfully and knowingly false statement is a criminal offense under 18 U. S. C. 1001.
`
`6.2 Authorized signature of NDA AppticantlHolder or Patent Owner (Attorney. Agent. Representative or
`otherAuthon'zed Official) (Provide Information below)
`
`Date Signed
`
`New 30/ zot 7..
`NOTE: Only an NDA applicantlholder 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 subrnlt It directly to FDA. 21 CFR 314.53(c)(4) and (d)(4).
`
`NDA AppticantlHolder
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`[J NDA AppIicant'slHolder's Attorney. Agent (Representative) or other
`Authorized Ofllclal
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`lj Patent Owner
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`El Patent Owners Attorney, Agent (Representative) or other Authorized
`
`Name
`
`~-
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`Kaushik J. Dave R.Ph.,Ph.D.,MBA, Executive Vice President Product Development, Antares, Pharma, Inc.
`Aitaréss’
`" ’
`'
`
`100 Princeton South Corporate Center, Suite 300
`
`'
`
`"ZlP'Co‘c't'e
`08628
`NFnibEFfii?vEl‘al:T)”
`609-359-30 l 5
`
`um r
`éiep one
`609-359-3017 (direct)
`E-Mai “
`kdave@antarespha.rma.com
`
`The public reporting burden for this collection of infonnation has been estimated to average 20 hours per response, including the time for reviewing
`instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of infonnation. Send
`comments regarding this burden estimate or any other mpect of this collection of information, including suggestions for reducing this burden to:
`
`Department of Health and Human Services
`Food and Drug Administration
`Officc ofChief lnfonnation Officer
`1350 Piccard Drive, Room 400
`Rockvillc. MD 20850
`
`An agency may not conduct or sponsor, and a person is not required to respond to. a collection of
`irgfonnailon unless it displays a currently valid OMB control number.
`
`FORM FDA 35423 (10/10)
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`Page 00004
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`

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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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`le) Answer this question ifapplieablc. lfpatcnt 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)
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`Complete all items in this section ifthe 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 ofthe drug identilied 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. 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 fomi.
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`General Information
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`' To submit patent information to the agency the appropriate
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`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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`liorm 3542a should be used when submitting patent information
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`with original NI)/t submissions, NDA amendments and NDA
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`supplements prior to approval.
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`Fonn 3542 should be used after NDA or supplement approval.
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`This form is to be submitted within 30 days alter approval of an
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`application. This form should also be used to submit patent
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`information relating to an approved supplement under 21 CPR
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`31/l.S3(d) to change the formulation, add a new indication or
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`other condition of use, 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
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`approval. Patents issued after drug approval are required to be
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`submitted within 30 days ofpatenl issuance for the patent to be
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`considered "timely filed."
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`(July inl'orn‘1ation from 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 Cl‘R 314.53.
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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 Book. The
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`Orange Book Staff address (as of April 2007) is: Orange Book
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`Staff, Office of‘Gcucric Drugs OGD/I-llil’)-610, 7500 Standish
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`Place, Roclwille, Ml) 20855.
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`Answer this question only if the patent is a protluct-by-
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`process patent.
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`3. Drug Product (Composition/Formulation)
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`Complete all items in this section ifthe patent claims the drug
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`product that is the subject of the pending ND/\, 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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`4.2)
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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 of use).
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`For each pending method ofusc 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 infonnatiou for each
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`pending method of use, ifapplieable. 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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`‘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 the date received.
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`' Additional copies ofthese fomis may be downloaded from the
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`Internet at:
`imp://www.fda.gov/opacommzoreclmices/fdaformy
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`fdaforms./71ml’.
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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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`Include patent expiration date, including any Hatch-Waxnian
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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 exclusivilics where applicable upon publication.
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`lc)
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`Id)
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`Include full address ofpatent 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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`4.2a) Specify the part ofthe proposed drug labeling that is
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`claimed by the patent.
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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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`6.2) Authorized signature. Check one ofthe four boxes that best
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`describes the authorized signature.
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`FORM FDA 3542a (10/10)
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`Page 00005
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`F°"“ APP'°"°"’ OMB N°' 09100513
`Department of Health and Human Services
`SeeEg3§g‘:glE;:(1:;3F1fgg13
`Food and Drug Administration
`PATENT INFORMATION SUBMITTED WITH THE FILING V .. UMB .
`OF AN NDA, AMENDMENT, OR SUPPLEMENT
`204824
`
`For Each Patent That Claims a Drug Substance
`(Active ingredient), Drug Product (Formulation and Composition) A"“"°5 Phamav ‘“°-
`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.
`‘TR‘A7D‘ETl'AME(O "0
`"I--
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`ACTIVE iNGREDIENT(S)
`Methotrexate
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`STRENGTH(S)
`I0 mg/0.4 ml, I5 mg/ 0.4 ml, 20 mg/0.4 ml and 25 mg/0.4 ml
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`Subcutaneous Injection
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`This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) with an NDA application,
`amendment, or supplement as required by 21 CFR 314.53 at the address provided in 21 CFR 314.53(d)(4).
`Within thirty (30) days after approval of an NDA or supplement, or within thirty (30) days of issuance of a new patent, a new patent
`declaration must be submitted pursuant to 21 CFR 314.53(c)(2)(ii) with all of the required information based on the approved NDA or
`supplement. The information submitted in the declaration form submitted upon or after approval will be the only information relied
`upon by FDA for listing a patent in the Orange Book.
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`For hand-written or typewriter versions (only) of this report: if additional space is required for any narrative answer (|.e.. one that
`does not require a "Yes" or "No" response). please attach an additional page referencing the question number.
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`For each patent submitted for the pending NDA, amendment, or supplement referenced above, you must submit all the
`information described below. If you are not submitting any patents for this pending NDA, amendment, or supplement,
`complete above section and sections 5 and 6.
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`d. Name oi Patent Owner
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`Antares Pharma, Inc.
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`B.
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`‘ ame O egen 0|‘ represen -
`a place of Business wiI'Fin tfie United States authorized to
`receive notice oi patent certification under section 505(b)(3)
`and (i)(2)(B) of the Federal Food. Drug, and Cosmetic Act
`and 21 CFR 314.52 and 314.95 (ii patent owner or NDA
`applicanilholder does not reside or have a place of
`business within the United States)
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`Not applicable
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`. sl epa en: re erence a vs a palenll at as een su
`approved NDA or supplement referenced above?
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`9.
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`the patent re erence aove as been subm te
`i
`date a new expiration date?
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`FORM FDA 3542a (10110)
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`Telepfione Numb?‘ "
`609 359 3020
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`609 359 30i5
`‘ - - ress (if available)”
`kdavc@antarespharma.oom
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`Page 1
`1:1...-i:a:..w. I H i- :15»
`iii?
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`Page 00006
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`For the patent referenced above. provide the following information on the drug substance, drug product and/or method of
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`2. Drug Substance (Active Ingredient)
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`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 ifthe 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 NDA? The type of test data required is described at 21 CFR 314.53(b).
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`-23? Specify the polymorphic form(s) 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 information in section 4 below if the patent claims a pending method of using the pending
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`drug product to administer the metabolite.)
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`2.6 Does the patent claim only an intermediate?
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`2.? If the 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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`3. Drug Product (CompositionlFormulation)
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`3.1 Does the patent claim the drug product, as defined in 21 CFR 314.3, in the pending 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 it the patent referenced in 3.1 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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`4. Method of Use
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`Sponsors must submit the information in section 4 for each method of using 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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`(: Yes
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`4.2 Patent Claim Number(s) (as listed in the patent)
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`Does (Do) the patent c|aim(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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`Yes
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`No
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`5 Use: (Submit indication or method of use information as identified specifically in the proposed labeling.)
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`4.2a If the answer to 4.2 is
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`"Yes," identify with speci-
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`ficity the use with refer-
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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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`5. No Relevant Patents
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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 00007
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`

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`8. Declaration Certification
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`'
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`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-
`sensitlve patent Information is submitted pursuant to 21 CFR 314.53. I attest 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.
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`Warning: A willfully and knowingly false statement is a criminal offense under 18 u.s.c. 1001.
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`6.2 Authorized Signature of NDA Applicant/Holder or Patent Owner (Attorney, Agent, Representative or
`other Authorized Ofiicial) (Provide Information below)
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`Date Signed
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`NOTE: only an NDA applicantlholder may submit this declaration directly to the FDA. A patent owner who is not the NDA applicantl
`holder is authorized to sign the declaration but may not submit it directly to FDA. Z1 OFR 314.53(c)(4) and (d)(4).
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`Check applicable box and provide information below.
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`[Xi NDA ApplicantlHolder
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`|:| NDA Applicant's/HoIcier‘s Attorney. Agent (Representative) or other
`Authorized Official
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`“ml 30/ 20'2-
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`|__j Patent Owner
`
`Kaushik 1. Dave R.Ph.,Ph.D.,MBA, Executive Vice President Product Development, Antares, Pharma, inc.
`‘§i£y7"STa'tE_
`Ewing, NJ
`
`i00 Princeton South Corporate Center, Suite 300
`
`'2lFC53?£' ———"""" TEE5% "'_"’
`08628
`609-359-3017 (direct)
`FAX Number (ii available)
`E-Mall Zddress (if available)
`609-359-30 15
`kdave@antarespha.rma.com
`
`The public reporting burden for this collection of infon-nation has been estimated to average 20 hours per response, including the time for reviewing
`instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send
`comments regarding this burden estimate or any other aspect of this collection of infonnation, including suggestions for reducing this burden to:
`
`Department of Health and Human Services
`Food and Drug Administration
`Office of Chief lnfonnation Officer
`1350 Piccerd Drive, Room 400
`Rockvillc. MD 20850
`
`An agency may not conduct oI'.1pon.tor. and a person is not required to respond to. a collection of
`information unless it displays a currently validOMH control number:
`
`FORM FDA 3542a (10/10)
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`Page 00008
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`

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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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`General Information
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`' To submit patent information to the agency the appropriate
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`patent declaration form must be used. Two forms are available
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`forpatcnt submissions. The approval status ofyour New Drug
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`Application will determine which form you should use.
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`Fonn 354221 should be used when submitting patent intbrrnation
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`with original NDA submissions, NDA amendments and NDA
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`supplements prior to approval.
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`Fomi 3542 should be used after NDA or supplement approval.
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`This form is to be submitted within 30 days after approval of an
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`application. This form should also be used to submit patent
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`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 of use, change the strength, or to make any other
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`patented change regarding the dmg, 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
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`approval. Patents issued after drug approval are required to be
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`submitted within 30 days of patent issuance For the patent to be
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`considered “timely tiled."
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`' Only information from 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 21 CFR 314.53.
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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 Book. The
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`Orange Book Staff address (as of April 2007) is: Orange Book
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`Staff, Office ol‘Generic Drugs OGD/HFD-610, 7500 Standish
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`l’lacc, 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 the date received.
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`' Additional copies ofthese t’onns may be downloaded from the
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`Internet at:
`http.'//www.fda.gov/opucom/morec/ioz'ces0a'qfoiviis/
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`fdqfarnzs. /1 rm 1.
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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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`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 cxclusivities where applicable upon publication.
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`to)
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`ld)
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`Include full address of patent owner. Ifpatcnt owner resides
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`outside the US. indicate the country in the zip code block.
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`le) Answer this question it‘ applicable. lfpatent 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)
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`Complete all items in this section ifthc patent claims the drug
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`substance that is the subject of the pending NDA, amendment, or
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`supplement.
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`2.4) Name the polymorphic form ofthe drug identified by the
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`patent.
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`2.5) A patent for a metabolite ofthe 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 ofuse
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`patent depending on the responses to section 4 of this form.
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`Answer this question only if the patent is a produc1-by-
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`process patent.
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`3. Drug Product (Composition/Formulation)
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`Complete all items in this section ifthc patent claims the drug
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`product that is the subject ofthe pending NDA, amendment, or
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`supplement.
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`3.3) An answer to this question is required only it‘ the referenced
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`patent is a product-by-process patent.
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`4.2)
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`4. Method of Use
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`Complete all items in this section ifthe patent claims a method ot‘
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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 of use).
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`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 ofthc drug. An applicant may list together
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`multiple patent claim numbers and information For each
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`pending method ofuse, ifapplicable. However, each
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`pending method ofuse must be separately listed within this
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`section of the 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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`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 lbur boxes that best
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`describes the authorized signature.
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`FORM FDA 3542a (10/10)
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`Page 00009
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`Department of Health and Human Services
`Food and Drug Administration
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`F°"“ APP'°V9d3 OMB N0» 0910-0513
`Expiration Date: 10/31/2013
`See OMB Statement on Page 3.
`PATENT INFORMATION SUBMITTED WITH THE FILING NDA NUMBER
`or 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
`
`A‘“3’°5 "““'"‘3~ “‘°-
`
`-
`Methotrexate
`
`ro -
`
`o - '
`
`Subcutaneous Injection
`
`STR GTl-i(S)
`10 mg/0.4 ml, 15 my 0.4 ml, 20 mg/0.4 ml and 25 mg/0.4 ml
`
`This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) with an NDA application.
`amendment, or supplement as required by 21 CFR 314.53 at the address provided in 21 CFR 314.53(d)(4).
`Within thirty (30) days after approval of an NDA or supplement, or within thirty (30) days of issuance of a new patent. a new patent
`declaration must be submitted pursuant to 21 CFR 314.53(c)(2)(ii) with all of the required Information based on the approved NDA or
`supplement. The information submitted in the declaration form submitted upon or after approval will be the only information relied
`upon by FDA for listing a patent in the Orange Book.
`
`For hand-written or typewriter versions (only) of this report: If additional space is required for any narrative answer (i.e.. one that
`does not require a "Yes" or “No" response). please attach an additional page referencing the question number.
`
`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, amendme