Department of Health and Human Services
`Food and Drug Administration
`
`Form Approved: OMB No. 091041513
`EXP'VEI'O” 03“” 1053132015
`See OMB Statement on Page 3
`
`PATENT INFORMATION SUBMITTED UPON AND N—IANUM'
`AFTER APPROVAL or AN NBA on SUPPLEMENT
`
`For Each Patent That Claims a Drug Substance
`(Active Ingredient), Drug Product (Formulation or
`Composition) and/or Method of Use
`
`‘ '"
`United Therapeutics C0111
`
`The following is provided'in accordance with Section 505m) and (c) of the Federal Food, Drug, and Cosmetic Act.
`
`A TIVE IN REDIENT(S)
`
`trcpostinil
`
`STREN TH(S}
`
`Inhalation solution
`
`July 30. 2009
`
`This patent declaration form is required to be submitted to the Food and Drug Administration (FDA) within thirty (30) days alter
`approval of an NBA 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 listpatent information if 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
`a. United States Patent Number
`
`9.339.507
`d. Name 0 Patent Owner
`United Therapeutics Corporation
`
`e.
`
`ame o agent or representative who resides or main‘
`Ins a p ace 0
`usmess wt
`II'I
`e United States author—
`ized to receive notice of patent certification under section
`505(b)[3} and (j)[2)[B) oi the Federal Food, Dmg. and
`Cosmetic Act and 21 CFR 314.52 and 314.95 {if patent
`owner or NDA applicantlholder does not reside or have a
`place Of business within the United States)
`
`In. Issue Date of Patent
`
`0. Expiration Date oi Patent
`
`May 17.20I6
`Address (0! Patent Owner}
`55 T.W. Alexander Drivc
`
`March 10. 2028
`
`' CitylState
`Research Triangle Park. North Carolin
`' ZIP Code
`‘ FAX Number rifevailable)
`27709
`(919) 313-1298
`' Telephone Number
`1 E-Mail Address (if available)
`{919) 485-8350
`m1authcfirii-unithcr.com
`A-dress (of agent or representative named in Le.)
`
`.
`
`.
`C'Msmle
`
`' ZIP Code
`
`' FAX Number fifeveri'able)
`
`' Telephone Number
`
`' E-Mail Address (if available)
`
`st e patent re erenoe- an e a patentt at as neen su-umltte prevIoLsy ort e
`approved NDA or supplement referenced above?
`
`9.
`
`-
`date a new expiration date?
`
`--
`
`previousy or Isting. Is
`
`eexpirahon
`
`FORM FDA 3542 {11l13}
`
`Page 1
`Psi. minim sen-mun] Hirer-In
`15F
`
`UNITED THERAPEUTICS, EX. 2015
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR2017—D1622
`Page 1 of4
`
`

`

`For the patent referenced above, provide the following infonnation 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 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 NDA or supplement?
`
`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 2| CFR 314.53(b).
`
`Specify the polymorphic formts) 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 it the patent claims an approved method at using the approved drug product to administer
`the metabolite.)
`
`2.6 Does the patent claim only an intermediate?
`
`2.? If the patent referenced in 2.1 is a product-by-process patent, is the product claimed in the
`patent novel? (An answer is required only if the patent is a pmduct-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 [Compositioanormulatlon]
`3.1 Does the patent claim the approved drug product as defined in 21 CFR 3143‘?
`
`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."
`
`4. Method of Use
`
`Sponsors must submit the information in section 4 for each approved method of 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“?
`
`[1 Yes
`
`E| No
`
`4.2 Patent Claim Number(s] (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?
`
`|:| Yes
`
`[I No
`
`4.23 If the answer to 4.2 is
`'Yesf' identify the use
`with specific reference to
`the approved labeling for
`the drug product.
`
`Use: (Submit indicaan or method of use ll‘lfOf‘l‘l‘laiiOl‘l as identified specifically in the approved labeling.)
`
`FORM FDA 3542 {11i13}
`
`Page 2
`
`UNITED THERAPEUTICS, EX. 2015
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR2017-D1622
`Page 2 of4
`
`

`

`- Use: (Submit the description ollne 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.)
`
`the answer to 4.2 is
`42b It
`"Yes." also provide the
`information On the
`indication or method of
`use for the Orange Book
`“Use Code“ description.
`
`FDA IIiirill not list the patent in the Orange Book as claiming the method of use it:
`' the answer to question 4.1 or 4.2 is “No." or
`' lithe answer to 4.2 is “Yes“ and the information requested in 4.2a and 42b is not provided in full.
`
`5. No Relevant Patents
`
`For this NDA or supplement, there are no relevant patents that claim the approved drug substance (active
`ingredient] or the approved drug product (formulation or composition) or approved melhodts) of use with
`respect to which a claim of patent infringement could reasonably be asserted ii a person not licensed by the
`owner of the patent engaged in the manufacture. use. or sale of the drug product.
`
`6. Declaration Certification
`
`6.1 The undersigned declares that this is an accurate and complete submission of patent information for the MBA 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. lattast that i am familiar with 21' CFR 314.53 and this submission
`complies with the requirements of the regulation. l verity under penalty ofperjury that the foregoing is true and
`correct.
`
`Warning: A willfully and knowingly false statement is a criminal offense under 18 ULS. C. t001.
`
`6.2 Authorized Signature of NBA Appli-ntlHolder or Patent Owner (Attomey. Agent, Representative or
`other Authorized Official) (Provide lnfonnation below)
`
`W)‘ signed or l‘mflulhaflumlhlfl com
`
`Date Signed
`
`nnauthe@unither.com $tmtflflfl'
`Minions.” 133954 olw
`
`(15“712016
`
`NOTE: Only an NBA applicantlholdar may submit this declaration directly to the FDA. A patent owner who is not the NDA applicant! holder
`Is authorized to sign the declaration but may not submit it directly to FDA. 21 CPR 314.53tc}(4) and (dint).
`
`Check applicable box and provide information below.
`
`Xi NBA ApplicantlHolder
`
`= NBA Applicant'slHolder’s Attorney. Agent (Representative) or other
`Authorized Official
`
`_: Patent Owner
`
`' Name
`
`_; Patent Owner's Attorney, Agent {Representative} or Other Authorized
`Official
`
`
`
`Rex Malttltc. Vice President chulalory Affairs. Unilcd Therapeutics Corp
`‘ Address
`‘ CitylState
`55 T.W. Alexander Drive
`Research Triangle Park. North Carolin
`
`' ZIP Code
`27709
`' FAX Number (if available)
`
`(919) 313-1298
`
`' Telephone Number
`(919) 485-8350
`'EL'ii'éiI' fiddié’éé’iii'éiié‘iiéfiié’)‘
`
`'
`
`nnaulhcfiiiiunilhcrtmm
`
`This section applies only to requirements ol'thc Papimtork Reduction Act of I995.
`"DO NOT til-END YUITR [‘OMPlJ-E'I‘I'ID FORM TO Till-Z I’RA STAFF EMAIL ADDRESS BELOW!l
`
`including The lime to
`The burden limo For this collcmiun nl' inlhrmalion is L'slimatcr] lo arc-mgr: 5 hours per response.
`review inslnlclions. search existing data sources. gnlhcr and mainluin Ihc data needed and mmplctc and review the
`collection of information. Send comments- rvgurding this burden miniatu- or any other aspect ot‘lllis inthrmatitm collection.
`including suggestion-L For reducing this burden. Io:
`
`Department of i [calth and llurnan Services
`Find and Drug Administmlion
`()Iiicc of Chief Intim'nntion Officer
`Pope-mot}: Reduction Act (PRA) Slut?
`PEA Sltg'ifiifiluJihs. gar
`
`"All ugwtcjl’ lilt’lj‘ not conduct or sponsor.
`and or person in not required to impoml to, a
`collection (brll’lfiil'l'llflflilfl mite.” ll dra‘pirnzr u
`Ctll'l'l’tll-{i' rufiti OMB number. "
`
`FORM FDA 3542 {11i13}
`
`Page 3
`
`UNITED THERAPEUTICS, EX. 2015
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201T-01622
`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. Two forms are available
`for patent submissions. The approval status ot‘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 ofan
`application. This form should also be used to submit patent
`information relating to an approved supplement under 2t CPR
`3 |4.53{d} to change the fonnulation. 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 ol'use. Form 354?. is also to be used for patents issued
`alter 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 tilt.
`
`2. Drug Substance (Active Ingredient)
`Complete all items in this section ifthe patent claitns the drug
`substance that is the subject of the approved NDA or supplement.
`
`2.4) Name the polymorphic form of the drug identified by the
`patent.
`
`2.5) A patent for a metabolite ofthe approved active ingredient
`may not be listed. Ifthc patent claims an approved method
`of using the approved drug product to administer the
`metabolite, the patent may be listed as a method of use
`patent depending on the responses to section 4 of this form.
`
`2.?) Answer this question only if the patent is a product-by-
`process patent.
`
`3. Drug Product (Compositioanormulation)
`Complete atl items in this section it‘thc patent claims the drug
`product that is the subject of the approved NDA or supplement.
`
`3.3] An answer to this question is required only ifthc referenced
`patent is a prtxluct—by-process patent.
`
`' Only information from form 3542 will he used for Orange Book
`publication purposes.
`
`4. Method of Use
`
`describes the authorized signature.
`
`' Forms should be submitted as described in 2] CFR 314.53.
`Sending an additional copy of form 3542 to the Orange Book
`Staft‘will expedite patent publication in the Orange Book. The
`Orange Book Staff address (as ot‘April 2007) is: Orange Book
`Stall: Office of Generic Drugs (roommate, T620 Standish
`Place, Rockville, MD 20355.
`
`° The receipt date is the date that the patent infonnaliou is date
`stamped in the central document room. Patents are considered
`listed on the date received.
`
`' Additional copies ol'thcsc forms may be downloaded from the
`Internet at:
`littosi’r’nnwulifrrgo vfopncorrrfrrroreciroicexifit'afonnsf
`fdrg‘omrxjmrri.
`First Section
`
`Complete all items irt this section.
`
`1. General Section
`
`Complete all items in this section with reference to the patent
`itself.
`
`lc) Include patent expiration date. including any lIatch-Waxman
`patent extension already granted. Do not include any
`applicable pediatric exclusivity. 'lhc agency will include
`pediatric cxclusivities where applicable upon publication.
`
`ld) Include full address ofpatent owner. lt'palent owner resides
`outside the [1.8. indicate the country in the zip code block.
`
`lc) Anchr this question il'applicablc. If patent owner and NBA
`applicantfholdcr reside in the United States. leave space
`blank.
`
`Complete all items in this section iftlre patent claims one or more
`methods of use ofthe drug product that is the subject of the
`approved NDA or supplement.
`
`4.2]
`
`For each approved use of the drug claimed by the patent.
`identify by number the claintls) in the patent that claim the
`approved use ol‘the drug. An applicant may list together
`multiple patent claim numbers and information for each
`approved method ot'use. il'applicable. However. each
`approved method ofuse must be separately listed within
`this section of the form.
`
`4.2a)
`
`Identify the precise words of the appmVal labeling that
`describe with specificity the patented method ofuse.
`
`4.2b} The answer to this question will be what FDA uses to create a
`"use-code" for Orange Book publication. The use code
`designates a metltod of use patent that claims art approved
`method of rising 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 ANDA
`applicants in dctcnnining whether a listed method of use
`patent claims a method of use for which the 505(b)(2) or
`ANDA applicant is not 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 [11l13)
`
`Page 4
`
`UNITED THERAPEUTICS, EX. 2015
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR2017—D1622
`Page 4 0M
`
`