Department of Health and Human Services
`Food and Drug Administration
`
`Form Approved: OMB No. 0910-0513
`Etp'ral'o" Dali-‘3 10’31’2015
`See OMB Statement on Page 3.
`
`PATENT INFORMATION SUBMITTED UPON AND
`
`AFTER APPROVAL OF AN NDA 0R SUPPLEMENT
`
`For Each Patent That Claims a Drug Substance
`(Active ingredient), Drug Product (Formulation or
`Composition) and/or Method of Use
`
`United Therapeutics C0113
`
`The following is provided in accordance with Section 505be and (c) of the Federal Food. Drug, and Cosmetic Act.
`. 1r
`
`- . .
`
`TYVASO
`
`ACTIVE INGREDIENTS)
`
`trepostinil
`
`STRENGTHtS)
`
`0.6 mglmI
`
`Inhalation solution
`
`July 30. 200‘)
`
`APPRVAL DATE F NBA 0 R UPPLEMENT
`
`This patent declaration forth is required to be submitted to the Food and Drug Administration {FDA} within thirty {30) days afler
`approval of an MBA or supplement or within thirty (30) days of issuance of a patent as required by 21 CFR 314.53(c}(2){ii} at the
`address provided in 21 CFR 314.53td}(4}. To expedite review of this patent declaration form, you may submit an additional copy of
`this declaration form to the Center for Drug Evaluation and Research 'Orange Book" staff.
`
`If additional space is required for any narrative answer {i.e., one that does
`For hand-written or typewriter versions of this report:
`not require a "Yes" or "No" response), please attach an additional page referencing the question number.
`
`FDA will not list patent information it you file an incomplete patent declaration or the patent declaration indicates the patent
`is not eligible for listing.
`
`For each patent submitted for the approved MBA or supplement referenced above. you must submit all the information
`described below. if you are not submitting any patents for this MBA or supplement. complete above section and sections 5
`and 6‘.
`
`1. GENERAL
`
`3. United States Patent Number
`
`b. issue Date of Patent
`
`c. Expiration Date of Patent
`
`
`
`9,339,507
`
`United Therapeutics Corporation
`
`e.
`
`ame 0 agent or representative who resrdes or marn-
`larns a place of Business within the United States author-
`ized to receive notice of patent codification undersection
`505(h](3) and (j)(2)[EI) of the Federal Food, Drug, and
`Cosmetic Act and 21 CFR 314.52 and 314.95 hr patent
`owner or NDA applicantlholder does not reside or have a
`place of business within the United States)
`
`May 17, 20l6
`Address (of Patent Owner)
`55 T.W. Alexander Drive
`
`March I0. 2028
`
`' CitytState
`Research Triangle Park. North Carolin
`' ZIP Code
`' FAX Number (ifavailablej
`2?"?09
`(9I9) 313-1298
`Telephone Number
`‘ E-Mail Address {if available)
`(919) 485-8350
`nnauthcfirtttnithctcom
`* dress {of agent or representative named in tel
`
`.
`
`.
`C'UtStale
`
`ZIP Code
`FAX Number (if available)
`
`' Telephone Number
`
`‘ E-Mait Address {if available)
`
`s the patent re erenoed above a patent that has been submitted previously or the
`approved MBA or supplement referenced above?
`
`9.
`
`t e patent re erence- an we as een su-umIt-le prevrousy ur rating, Ist e expiration
`date a new expiration date?
`
`FORM FDA 3542 (11l13]
`
`Page 1
`Peat hit-Irdurm mutational-mm El"
`
`UNITED THERAPEUTICS, EX. 2015
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR2017—D1621
`Page 1 014
`
`

`

`For the patent referenced above, provide the following information on each patent that claims the drug substance. drug
`product. or method of use that is the subject of the approved MBA or supplement. 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. FDA will
`consider an incomplete patent declaration to be a declaration that does not include a response to all the questions
`contained within each section below applicable to the patent referenced above.
`
`2. Drug Substance [Active Ingredient)
`2.1 Does the patent claim the drug substance that is the active ingredient in the drug product
`described in the approved MBA or supplement?
`2.2 Does the patent claim a drug substance that is a different polymorph of the active
`ingredient described in the NDA?
`
`If the answer to question 2.2 is “Yes." do you certify that. as of the date of this declaration. you have test data
`demonstrating that a drug product containing the polymorph will perform the same as the drug product
`described in the NBA? The type of test data required is described at 21 CFR 314.53(b}.
`
`Specify the polymorphic fon'nts) claimed by the patent for which you have the test results described in 2.3.
`
`Does the patent claim only a metabolite of the approved active ingredient? (Complete the information in
`section 4 below if the patent claims an approved method of using the approved drug product to administer
`the metabolite.)
`
`2.6 Does the patent claim only an intermediate?
`
`2.? II the patent referenced in 2.1 is a product—by—process patent. is the product claimed in the
`patent novel? (An answer is required onlyf if the patent is a product-by-process patent.)
`FDA will not list the patent in the Orange Book as claiming the drug substance if:
`the answers to 2.1 and 2.2 are “No." or.
`the answer to 2.2 is "Yes" and the answer to 2.3 is "No." or.
`the answer to 2.3 is "Yes" and there is no response to 2.4, or,
`' the answer to 2.5 or 2.6 is "Yes.“
`. the answer to 2.? Is "No."
`
`
`
`3. Drug Product (CompositioniFormulation)
`3.1 Does the patent claim the approved drug product as defined in 21 CFR 314.3?
`
`3.2 Does the patent claim only an intermediate?
`
`3.3 If the patent referenced in 3.1 is a product-by-process patent. is the product claimed in the
`patent novel? (An answer is required only if the patent is a product-by-process patent.)
`
`FDA will not list the patent in the Orange Book as claiming the drug product if:
`' the answer to question 3.1 is "No," or.
`' the answer to question 3.2 is "Yes." or.
`' the answer to question 3.3 is "No."
`
`E No
`
`Sponsors must submit the information in section 4 for each approved method of using the approved dlmg product claimed by the patent.
`For each approved method of use claimed by the patent, provide the following information:
`4.1 Does the patent claim one or more approved methods of using the approved drug product?
`
`4.2 Patent Claim Numberts) (as listed in the patent)
`
`Does (Do) the patent claim(s} referenced in 4.2 claim an
`approved method of use of the approved drug product?
`
`- Use: (Submit indication or method of use inionnatr‘on as identified specifically in the approved labeling.)
`
`4.2a If the answer to 4.2 is
`”Yes.” identify the use
`with specific reference to
`the approved labeling for
`the drug product.
`
`FORM FDA 3542 (11:13]
`
`Page 2
`
`UNITED THERAPEUTICS, EX. 2015
`WATSON LABORATORIES V. UNlTED THERAPEUTICS, IPR2017-D1621
`Page 2 of4
`
`

`

`4.2b If the answer to 4.2 is
`"Yes." also provide the
`information on the
`indication or method of
`
`Use: (Submit the description of the approved indication or method of use that you propose FDA include as
`the "Use Code‘in the Orange Book. using no more than 240 total characters including spaces.)
`
`use for the Orange Book
`"Use Code“ description.
`
`FDA will not list the patent In the Orange Book as claiming the method of use if:
`
`' the answer to question 4.1 or 4.2 is "No." or
`
`" ifthe answer to 4.2 Is "Yes" and the information requested in 4.2a and 4.2!) is not provided In full.
`
`5. No Relevant Patents
`
`For this MBA or supplement. there are no relevant patents that claim the approved dmg substance (active
`ingredient) or the approved drug product {formulation or composition} or approved methodls} of use with
`respect to which a daim 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.
`
`6. Declaration Codification
`
`6-1 The undersigned declares that this is an accurate and complete submission of patent information for the NBA or
`supplement approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This time-sensitive patent
`information is submitted pursuant to 21 CFR 314. 53. l 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
`
`Warning: A willfully and knowingly false statement is a criminal offense under 1‘8 U.S.C. 1001.
`
`6.2 Authorized Signature of NBA ApplicantlHolder or Patent Owner {Attorney Agent, Representative or
`other Authorized Oliiciai} (Provide information below]
`Diglalisqned by nuandieQunimalLom
`‘
`rmauthe@unlther.com ffiafaflfimfl'
`paw-zeroes” IJ'Em-mw
`
`Date Signed
`
`(BIN/2016
`
`NOTE: Only an NBA applicantiholder 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. 21 CFR 314.53tc){4} and {d)(4).
`
`Check applicable box and provide information below.
`
`|
`
`. F
`
`X: NDA ApplicantlHolder
`
`: NDA Applicant'sll-Iolder's Altomey. Agent (Representative) or other
`Authorized Official
`
`
`__ Patent Owner
`
`I Name
`
`r Patent Owner's Attorney. Agent (Representative) or Other Authorized
`Ofidm
`
`ch Mantlic. Vice President Regulatory Affairs. Uniicd Therapeutics Corp
`"Address
`' CityiState
`55 T.W. Alexander Drive
`Research Triangle Park. North Carolin
`
`I ZIP Code
`2770‘)
`'FAx Number (if available}
`(9 i 9} 313-1298
`
`' Telephone Number
`(919) 485-8350
`'E-Mail Address (if available)
`nnaulhcniiuniihcrsom
`
`This section applics only to requirements of the l‘apem orlr. Reduction Act (il1995.
`"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMA". ADDRESS III-11‘0“"!
`
`The burden time for this collection of inthrmulion is estimated to average 5 hours per response. including the time to
`review instructions. search existing data sources. gather and mainlain the data needed and complete and review the
`collection of information. Send continents regarding this burden estimate or any other aspect oflhis information collection.
`including suggestions for reducing this burden. to:
`
`Department of Health and Human Services
`Food and Drug Administration
`.
`.
`.
`on'
`- m: ‘1'] r
`1
`on'u
`Papfr'ivtork lscduztgunisfrltkrkligiafl
`.
`t
`PR.4310mt!"Ida. Mir.gar
`
`tJlIA'Oi"
`.._m u Mm. mar "m. minim-t or ‘
`I
`'
`j"
`'
`'
`.p
`ind u person is not ieqiu'rai lo lt‘spt‘Jild to. u
`‘
`collection ryrmfiimmiion miter: ll' riixpirn‘s u
`citi'i'criiir I'ui'iri (ll-{ermbeiz "
`
`ORM FDA 3542 (11:13]
`
`Page 3
`
`UNITED THERAPEUTICS, EX. 2015
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR2017—D1621
`Page 3 of4
`
`

`

`INFORMATION AND INSTRUCTIONS FOR FORM 3542
`
`PATENT INFORMATION SUBMITTED UPON AND AFTER
`APPROVAL OF AN NDA OR SUPPLEMENT
`
`General Information
`
`' To submit patent information to the agency the appropriate
`patent declaration form must be used. 'l‘wo forms are available
`for patent submissions. The approval status ol'your New Drug
`Application will determine which form you should use.
`
`Form 3542a should be used when submitting patent information
`with original NDA submissions, NDA amendments and NBA
`supplements prior to approval.
`
`Form 3542 should be used after NDA or supplement approval.
`This form is to be submitted within 30 days alter approval ot‘an
`application. This form should also be used to submit patent
`information relating to an approved supplement under 21 CPR
`3 l4.53(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 of use. Form 3542 is also to be used for patents issued
`after drug approval. Patents issued after drug approval are
`required to be submitted within 30 days of patent issuance for
`the patent to be considered “timely filed."
`
`2. Drug Substance (Active Ingredient)
`
`Complete all items in this section if the patent claims the drug
`substance that is the subject of the approved NDA or supplement.
`
`2.4) Name the polymorphic form ofthe drug identified by the
`patent.
`
`2.5) A patent for a metabolite of the approved active ingredient
`may not be listed. lfthc patent claims an approved method
`of using the approved drug prodtlct to administer the
`metabolite. the patent may be listed as a method of use
`patent depending on the responses to section 4 of this fomi.
`
`2.7) Answer this question only il‘the patent is a product-by-
`proccss patent.
`
`3. Drug Product (CompositioniFormulation)
`
`Complete all items in this section if the patent claims the drug
`product that is the subject ofthe approved NDA or supplement.
`
`3.3) An answer to this question is required only il'thc referenced
`patent is a prtuluct-by-prtxess patent.
`
`' Only information from form 3542 will be used for Orange Book
`publication purposes.
`
`4. Method of Use
`
`describes the authorized signature.
`
`° Forms should be submitted as described in 21 C FR 314.53.
`Sending an additional copy of form 3542 to the Orange Book
`Staff will expedite patent publication in the Orange Book. The
`Orange Book Stafl‘address (as of April 200?) is: Orange Book
`Staff, Office ol‘Gcneric Drugs OGD/III-‘D-(iltl, 762D Standish
`Place. Rockville. MD 20855.
`
`' The receipt date is tltc date that the patent information is date
`stamped in the central document room. Patents are considered
`listed on the date received.
`
`’ Additional copies of these fomts ntay be downloaded from the
`lntcmetal:
`http://nwwfdngotVoprtcottr/momeltoicesfqufimts/
`fdtyrnmtthmti.
`
`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 llatch-Waxman
`patent extension already granted. Do not include any
`applicable pediatric exclusivity. The agency will include
`pediatric exclusivities where applicable upon publication.
`
`1d) Include full address of patent owner. If patent owner resides
`outside the U.S. indicate the country in the zip code block.
`
`1e) Answer this question ifapplicable. pratent owner and NDA
`applicanu'holder reside in the United States. leave space
`blank.
`
`Complete all items in this section if the patent claims one or more
`methods of use of the dnlg product that is the subject of the
`approved NDA or supplement.
`
`4.2) For each approved use of the dntg claimed by the patent.
`identify by number the elaim(s} in the patent that claim the
`approved use ofthc drug. An applicant mayr list together
`multiple patent claim numbers and information for each
`approved method ofttsc. ifapplicablc. However. each
`approved method of use tnust be separately listed within
`this section of the form.
`
`4.2a)
`
`Identify the precise Words of the approval labeling that
`describe with specificity the patented method ot‘use.
`
`4%) The answer to this question will be what FDA uses to create a
`"use-code" for Orange Book publication. The use code
`designates a method of use patettt that claims an approved
`method ofttsing a drug product. Each approved method of
`use claimed by the patent should be separately and specifically
`identified in this section and the use code created should
`contain adequate detail to assist 505(b)(2) and AN DA
`applicants in determining whether a listed method ofuse
`patent claims a method ot'use for which the 505(b}(2} or
`ANDA applicant is ttot seeking approval. Use a maximum of
`240 characters for each "use code."
`
`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 3542 (11l13l
`
`Page 4
`
`UNITED THERAPEUTICS, EX. 2015
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR2017—D1621
`Page 4 0M
`
`