UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`Vv.
`
`UNITED THERAPEUTICS CORP.
`Patent Owner
`
`Cases! IPR2017-01621; Patent 9,358,240
`IPR 2017-01622; Patent 9,339,507
`
`DECLARATION OF DEAN BUNCE
`
`' The word-for-word identical paperis filed in each proceedingidentified in the
`
`heading.
`
`UNITED THERAPEUTICS, EX. 2085
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 1 of 6
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`Vv.
`
`UNITED THERAPEUTICS CORP.
`Patent Owner
`
`Cases! IPR2017-01621; Patent 9,358,240
`IPR 2017-01622; Patent 9,339,507
`
`DECLARATION OF DEAN BUNCE
`
`' The word-for-word identical paperis filed in each proceedingidentified in the
`
`heading.
`
`UNITED THERAPEUTICS, EX. 2085
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 1 of 6
`
`
`
`IPR2017-01621; IPR2017-01622
`
`Declaration of Dean Bunce
`
`I, Dean Bunce, hereby declare as follows:
`
`1.
`
`I am currently Executive Vice President of Regulatory Affairsat
`
`United Therapeutics Corporation (“UTC”).
`
`2.
`
`I have been involved in regulatory affairs and compliance at UTC
`
`since 1999.
`
`I currently overseeall interactions of UTC with regulatory agencies,
`
`including the Food and Drug Administration (“FDA”).
`
`I was ultimately
`
`responsible for the New Drug Application (“NDA”) and supplements thereto for
`
`UTC’s Tyvaso® product.
`
`3.
`
`Exhibit 2049is a true and correct copy of excerpts of the Tyvaso®
`
`NDAIntegrated Summary of Efficacy (ISE). This is a documentcreated in the
`
`regular course of UTC’s business and was submitted to FDA aspart of the process
`
`of obtaining regulatory approval to market Tyvaso® in the United States.
`
`4.
`
`Exhibit 2050is a true and correct copy of the Clinical Investigation
`
`Report Synopsis for Study LRX-INH-0004. This is a documentcreated in the
`
`regular course of UTC’s business and was submitted to FDA aspart of the process
`
`of obtaining regulatory approval to market Tyvaso® in the United States.
`
`5.
`
`Exhibit 2051 is a true and correct copy ofthe Clinical Investigation
`
`Report Synopsis for Study LRX-INH-0007. This is a documentcreated in the
`
`regular course of UTC’s business and was submitted to FDAaspart of the process
`
`of obtaining regulatory approval to market Tyvaso® in the United States.
`
`4819-7765-8701
`
`1
`
`UNITED THERAPEUTICS, EX. 2085
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 2 of 6
`
`
`
`IPR2017-01621; IPR2017-01622
`
`Declaration of Dean Bunce
`
`6.
`
`Exhibits 2049-2051 are records made from information regularly kept
`
`and maintained by UTCin the courseofits regular clinical testing activities and
`
`thus contain accurate information generated and maintained for the purposes of
`
`ensuring compliance with regulatory and best practices requirements. For
`
`example, FDA regulations require that a drug sponsor maintain, prepare, and
`
`submit accurate information concerningclinical studies. See e.g. 21 CFR § 312.33.
`
`7.
`
`Exhibit 2083 is a true and correct copy of the TRIUMPHI Clinical
`
`Trial Protocol. This is a document created by January 11, 2005 (as reflected on the
`
`document) in the regular course of UTC’s business and was submitted to FDA as
`
`part of the process of obtaining regulatory approval to market Tyvaso® in the
`
`United States. Morespecifically, the protocol was submitted to FDA on March28,
`
`2005 as part of UTC’s original Investigational New Drug Application (“IND”)
`
`70,362 for Inhaled Treprostinil. Exhibit 2052 is a true and correct copy of an
`
`acknowledgementletter dated April 13, 2005 from FDA acknowledgingreceipt of
`
`IND 70,362 on March 29, 2005.
`
`8.
`
`Exhibits 2049 (at page 59) and 2050 (at page 3) state that study LRX-
`
`INH-004 wasperformedin 2003.
`
`9.
`
`Exhibits 2049 (at page 61) and 2051 (at page 3) state that LRX-INH-
`
`007 was performedin 2003.
`
`10.
`
`Exhibit 2083 includesthe following information:
`
`eae
`
`UNITED THERAPEUTICS, EX. 2085
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 3 of 6
`
`2
`
`
`
`IPR2017-01621; IPR2017-01622
`
`Declaration of Dean Bunce
`
`i. Reference to investigator studies in Germany (at pages 17, 21, 25)
`
`including “approximately 200 patients in the five investigations,
`
`and the 13 patients in the clinical and chronic compassionate use
`
`trials”;
`
`ii. “Treatment doses” indicating the investigational product plannedis
`
`treprostinil sodium at “600 mcg/mL delivered via an ultrasonic
`
`nebulizer (0, 4, 8, 12 hours daily)” with “[e]ach of the four doses
`
`will consist of 9 breaths. Each breath will deliver 5 mcg of TRE to
`
`the mouthpiece of the nebulizer (emitted dose).” (at page 11); and
`
`iii. A section on “Clinical Investigations Following Inhalation of
`
`Treprostinil” that summarizesfive investigations (at pages 22-25):
`
`1. Investigation 1: Inhalation of Treprostinil and of [loprost
`
`2. Investigation 2: Inhalation of treprostinil and of placebo
`
`3. Investigation 3: Inhalation times of Treprostinil sodium with
`
`higher concentrations with reducedinhalation time;
`
`4. Investigation 4: Inhalation of metacresolfree treprostinil;
`
`5. Investigation 5: Inhalation of Treprostinil and Sildenafil.
`
`11.
`
`Exhibit 2083 states that the original Phase II Protocol wasfinalized by
`
`January 11, 2005 with an anticipated First Patient In (FPI) in April/May 2005.
`
`4819-7765-8701
`
`3
`
`UNITED THERAPEUTICS, EX. 2085
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 4 of 6
`
`
`
`IPR2017-01621; IPR2017-01622
`
`Declaration of Dean Bunce
`
`12.
`
`As reflected in Exhibit 2049, the first patient was enrolled in the
`
`PhaseII study in June 2005.
`
`13.
`
`The United States National Library of Medicine ClinicalTrials.gov
`
`database, whichis a database of clinical studies conducted around the world,
`
`https://clinicaltrials.gov/ct2/show/NCT00147199, gives a date of “June 2005”as
`
`the date a first participant was enrolled for TRIUMPH I. A true and correct copy
`
`of this recordis labelled as Exhibit 2084.
`
`[The remainderofthis page is intentionally left blank]
`
`UESere!
`
`4
`
`UNITED THERAPEUTICS, EX. 2085
`WATSON LABORATORIES v. UNITED THERAPEUTICS, IPR2017-01622
`Page 5 of 6
`
`
`
`IPR2017-01621; IPR2017-01622
`
`Declaration of Dean Bunce
`
`14.
`
`I hereby declare thatall statements made herein of my knowledgeare
`
`true andthat all statements made on information and belief are believed to be true;
`
`and further that these statements were made with the knowledgethat willful false
`
`statements and the like so made arc punishable by fine or imprisonment, or both
`
`under Section 1001 of Title 18 of the United States Code.
`
`Date:44a j / 2018
`
`
`
`Dean Bunce
`
`4819-7765-8701
`
`5
`
`UNITED THERAPEUTICS, EX. 2085
`WATSON LABORATORIESv. UNITED THERAPEUTICS, IPR2017-01622
`Page 6 of 6
`
`
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