Department of Health and Human Services
`Food and Drug Administration
`
`Form Approved: OMB NO. 0910-0513
`Expiratlon Date: 10l31i2016
`See OMB Statement on Page 3.
`
`PATENT INFORMATION SUBMITTED UPON AND
`
`AFTER APPROVAL OF AN NDA OR SUPPLEMENT
`
`For Each Patent That Claims a Drug Substance
`(Active ingredient), Drug Product (Formulation or
`Composition) and/or Method of Use
`
`ACTIVE INGREDIENT(S)
`treprostinil
`
`STRENGTHS}
`0.6 mglmL
`
`Inhalation solution
`
`July 30, 2009
`
`This patent declaration ionn is required to be submitted to the Food and Drug Administration (FDA) within thirty [30} days after
`approval of an NBA or supplement or within thirty {30) days of issuance of a patent as required by 21 CFR 314.53lc}[2}(ii) at the
`address provided in 21 CFR 314.53(d)(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 iiyou 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.
`
`a. United States Patent Number
`
`9.358.240
`_ ‘ame .
`'atent Owner
`United Therapeutics Corporation
`
`b. Issue Date ofPatent
`
`c. Expiration Date of Patent
`
`June 7, 2016
`a: mass {oi Patent Owner)
`55 T.W. Alexander Drive
`
`May 5. 2028
`
`' CitylSlate
`Research Triangle Park, North Carolina
`' ZIP Code
`' FAX Number fifavailabie)
`27709
`{919) 313-1298
`' Telephone Number
`' E—Mail Address (it available)
`
`(91 9) 485-8350
`rmauthe@unither.com
`' Address fol agent orlepresentative named in Le.)
`
`
`
`e. Name of agent or representative who resides or main-
`tame a filace 6i Eislness within the United States author—
`ized to receive notice of patent codification under section
`505(b)(3) and unzue) ot the Federal Food. Dmg. and
`Cosmetic Act and 21 CFR 314.52 and 314.95 (il' patent
`owner or MBA applicantlholder does not reside or have a
`plaoeot business within the United States)
`
`.
`
`,
`CW’SP‘E
`
`' ZIP Code
`
`' FAX number (appellants)
`
`' Telephone Number
`
`‘ E-Meil Address {if available)
`
`st epatentre renoe- a-oveapatentt at as oeen su--mltte pI'SVIOLs
`approved MBA or supplement referenced above?
`
`r1 e
`
`.
`
`l a patent re erence-
`date a new expiration date?
`
`-een su-mitteo prev-ousy or isting. Isl eexptratlon
`
`FORM FDA 3542 {11l13}
`
`Page 1
`PM Mmlxsmunimuu—e-ao l-Ii'
`
`UNITED THERAPEUTICS, EX. 2016
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR2017-01622
`Page 1 of4
`
`

`

`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 NBA or supplement. FDA will not list patent information it
`you tile 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 oi the active
`ingredient described in the NBA?
`
`2.3 If the answer to question 2.2 is "res.“ do you certify that. as of the date of this declaration. you have test data
`demonstrating that a drug product containing the polymorph will perlorrn the same as the drug product
`described in the NBA? The type of test data required is described at 21 CFR 314.5303).
`
`2.4 Specify the polymorphic torm(s) claimed by the patent for which you have the test results described in 2.3.
`
`2.5 Does the patent claim only a metabolite of the approved active ingredient? (Complete the intormation 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.? It the patent referenced in 2.1 is a product-by-process patent. is the product claimed in the
`patent novel? (An answer is required only if the patent is a product—by—prwess 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 (Compositioanorrnulation)
`3.1 Does the patent claim the approved dmg product as defined in 21 CFR 314.3?
`
`3.2 Does the patent claim only an intermediate?
`
`
`
`3.3 If the patent rcicrcnccd in 3.1 is a product-by-proccss patent. is the product claimed in the
`patent novel? (An answer is required only it the patent is a product—by—prDDess 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 answerto question 3.3 is "No."
`
`Sponsors must submit the information in section 4 for each approved method ot using the approved drug 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?
`
`Yes
`
`E] No
`
`4.2 Patent Claim Number(s) (as listed in the patent)
`1_9
`4.2a If the answer to 4.2 is
`
`Does (Do) the patent claim[s) referenced in 4.2 claim an
`D No
`Yes
`approved method of use of the approved drug product?
`Use: (Submit indication ormelhod of use hilarmalion as identified specifically in the approved labellhg.)
`
`"(88' identity the use
`with specific referent“e ‘0
`m: :mmlfife'm f”
`‘
`
`Tyvaso is a prostacyclin vasodilator indicated for the treatment of pulmonary
`arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Tyvaso is intended
`for oral inhalation using the Tyvaso Inhalation System. which consists of an ultrasonic.
`pulsed delivery device and its accessories.
`
`FORM FDA 3542 [11l13]
`
`Page 2
`
`UNITED THERAPEUTICS, EX. 2016
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR2017-01622
`Page 2 of4
`
`

`

`4.2!: If the answer to 4.2 is
`“Yes." also provide the
`information 0" "“3
`indication or method 01'
`use for the Orange Book
`“Use Code” description.
`
`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.)
`Method of treating pulmonary hypertension by administering treprostinil or a salt thereof by
`I
`- h
`-
`-
`.
`In aiat on usmg a device
`
`FDfl will not list the patient in the Orange Book as claiming the method of use if:
`' the answer to question 4.1 or 4.2 Is "No." or
`‘ if the answer to 4.2 is “Yes“ and the Information requested in 4.2a and 4.2h is not provided in full.
`
`5. No Relevant Patents
`
`For this NDA 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 methodis) of use with
`respect to which a claim of patent infringement could reasonably be asserted ifa person not licensed by the
`owner of the patent engaged in the manufacture. use. or sale of the drug product.
`
`6. Declaration Certification
`
`8-1 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. fattest 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
`correct.
`
`Warning: A willfully and knowingly false statement is a criminal offense under 18 U.S.C. 1001.
`
`6.2 Authorized Signature of NBA ApplicantlHotder or Patent Owner (Attorney. Agent. Representative or
`other Authorized Oliicial] (Provide information below)
`Bugle" sense by Warner»
`.
`DID: 2010.06.09 09:06:01 {MW
`rmauthe@unither.com memos?
`
`Date Signed
`
`06.08.2015
`
`NOTE: Only an NBA 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. 21 CFR 314.5333“) and {dull}.
`
`Check applicable box and provide information below.
`
`x NDA ApplicantlHoldar
`
`;
`
`_ NDA Applicant'slHoldaI‘s Attomey. Agent [Representative] or other
`Authorized Official
`
`
`
`__ Patent Owner
`
`: Name
`
`l— Patent Owner’s Attorney. Agent (Representative) or Other Authorized
`Official
`
`Rex Mauthe, Vice President, Regulatory Affairs. United Therapeutics Corp
`' Address
`' CityiSlate
`55 T.W. Alexander Drive
`Research Triangle Park. North Carolina
`
`5 ZIP Code
`27709
`: FAX Number fil'available}
`(919) 313-1298
`
`' Telephone Number
`(919) 48 58350
`'E-Mail Address (if available)
`rmauthe@unither.corn
`
`'
`
`This section applies only In requirurnans nflhr: I‘apcm‘o‘rk Reduction Acl or 1995.
`'DO NOT til-IND YOI'R (‘05Il’LI-Z‘I'i‘ill FUR.“ T0 THE PRr\ STAFF EMAIL ADDRESS BELOW.‘
`
`Thu burdcn lime Ibr lllis cullcctiun of infunnaliorl is. cslimulcd 'tu ax‘cragc 5 hours per response. including thc lime to
`review li‘lsli’l—Ictinlh. search existing data mvurcca. gather and maintain the data flooded and complcle and review the
`collection nl‘irllbrnlutlon. Send cunuucnls regarding this burden estimate or an): olhcr aspect ol‘tl'lis information collection.
`including. suggcsliuns for rctlucing this burden. l0:
`
`Dcparlmcnt of l lcullh and liulnan Sm'iccs
`Food and Drug Administration
`Office of Chief Informalinn ()I'l'lccr
`l’apcnt'utk Reduction Act IPRA] Staff
`PR.-iSiuJ§ltn".fiiu.hittgm'
`
`".-in agenci- man nor remind or sponsor,
`anti u pt-rswr r.r no: rcqlill‘l’ri m i't’Jer't’i w, (l
`('oliwirrnr Minna-marina union r'l dirplurr n
`currently valid ill-ill mrrnr'rc-i'. "
`
`FORM FDA 3542 {11:13}
`
`Page 3
`
`UNITED THERAPEUTICS. EX. 2016
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR2017-D1622
`Page 3 of4
`
`

`

`INFORMATION AND INSTRUCTIONS FOR FORM 3542
`
`PATENT INFORMATION SUBMITTED UPON AND AFTER
`APPROVAL OF AN NDA OR SUPPLEMENT
`
`General Information
`
`2. Drug Substance (Active Ingredient)
`
`' To submit patent information to the agency the appropriate
`patent declaration form must be used. Two I'onns are available
`for patent submissions. The approval status of your New Drug
`Application will determine which form you should use.
`
`I’orm 3542a should he used when subtnitting patent iiifonnatioit
`with original NDA submissions. NDA amendments and NBA
`suppleiuean prior to approval.
`-
`s
`s
`-
`Ԥ
`-
`s
`t
`s
`Form ' 542 should bk "bad alter NBA or supplement approval.
`This I'on'n is to be submitted within 30 days after approval of an
`application. This form should also be used to submit patent
`inl'omiation relating to an approved supplement under 2] CFR
`3 [4.53M] to change the Ionnulation. add a new indication or
`other condition ol‘use. change the strength. or to make any other
`patented change regarding the dmg, drug product, or any
`method ofuse. l-‘onn 3542 is also to he used for patents issued
`after drug approval. Patents issued atler drug approval are
`required to be submitted within 30 days ofpatent issuance for
`the patent to be considered "timely filed."
`
`Complete all items in this section ifthe patent claims the drug
`substance that Is the subject of the approved Nlm or supplement.
`
`2'4) Name the polymorphic form oflhe drug identified by the
`patent.
`
`2.5} A patent for a metabolite of the approved active ingredieitl
`may not be listed. “the patent claims an approved method
`01‘ rising the approved drug product to administer the
`metabolite, the patent may be listed as a method ofuse
`patent depending on the responses to section 4 of this form.
`
`2.?) Answer this question only il‘the patent is a product-by-
`process patent.
`
`.
`. .
`3' Drug Product (Compostnoanurmulanon)
`Cm-nplclc 3“ items in this section "‘1“; peter“ claims [he drug
`pmduct that is the subject of the approved NDA or supplement.
`3.3) An answer to this question is required only it‘tbc referenced
`patent is u product-by—proceSs patent.
`
`' Only information from form 3542 will he used for Orange Book
`publication ptirposes.
`
`' l—‘onns should be submitted as described in 2| C FR 314.53.
`Sending an additional copy of form 3542 to the Orange Book
`Stal‘fwill expedite patent publication Ill the (hinge Book. The
`Orange Book Stafl‘address (as or April 200?) is: Orange Book
`Siatr. Office ofGeneric Drugs onumroéio, 162i} Standish
`Place. Rockville. MD 20851
`
`' 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 of these forms may be downloaded from [he
`Intemetat:
`Jilin-Mu-uwfii'agovfiaymmnu’inomclioieesj’filnflimisfi
`fo’ty‘omim'ttml.
`.
`_
`Fm“ Secnnlt
`Complete 511 items in this section.
`
`1. General Section
`.
`.
`.
`.
`.
`.
`Loinplele all items in this section With reference to the patent
`Itself.
`lc) Include patent expiration date. including any Ilatch-Waxman
`patent extension already granted. Do not include arty
`applicable pediatric exclusivity. The agency will include
`pediatric exclusivities where applicable upon publication.
`
`Id) include full address ol‘patent owner. If patent owner resides
`outside the US. indicate the country in the zip code block.
`
`4-2)
`
`4.2a)
`
`4- Mflllfltl 01' USE
`Complete all items in this section if the patent claims one or more
`methods of use of the drug product that is the subject of the
`approved NDA or supplement.
`‘
`‘
`I"or each approved use uflhe drug claimed by the Patent.
`idenlify by number the |Mime) inthe patent that claim the
`approved use ofthe drug. An applicant may list together
`multiple palenl claim numbers and infomtation for each
`approved method ofuse, ifapplicable. I [DWQVCT- Cth _
`l‘PPth-‘d method ofuse “ll-15‘ be separately “Sled Wilhln
`this section ofthe I'onn,
`Identify the precise words of the approval labeling that
`describe with specificin the patented method of “Si
`4.2b) The answer to this question will be what l-‘DA uses to create a
`"use-code" for Orange Book publication. The use code
`designates a method ot‘use patent that claims an approved
`method of using a drug product. l-Iueh 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(h)(2) and ANDA
`“1:,“me in determining whether a listed method ol‘use
`patent claims a method of use thr which the 505(b)(2) or
`ANDA applicant is nul seeking approval. Use a maximum of
`240 characters lot 09611 "use coda"
`
`
`
`5' N0 Relevant Patents
`Complete this section only il‘ appl icaltle.
`
`6' ”adulation Certification
`Complete all items in this section.
`
`Ie} Answer this question if applicable. [I‘patenl owner and NDA
`applieanu’holder reside in the United States, leave space
`blank.
`
`6.2) Authorized signature. Check one “1- the four boxes that best
`descnbes the authorized stgnature.
`
`FORM FDA 3542 {11:13}
`
`Page 4
`
`UNITED THERAPEUTICS, EX. 2016
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPRZD1T—D1622
`Page 4 0M
`
`