`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WATSON LADORA TORIES, INC.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS,
`INC.
`Patent
`Owner
`
`Patent
`No. 9,358,240
`Issue Date: June 7, 2016
`Title:
`TREPROSTINIL
`ADMINISTRATION
`BY INHALATION
`
`Review
`No. 2017-01621
`Inter Portes
`
`DECLARATION
`OF DR. HOSSEIN A. GHOF'RANI
`
`Scanned by CamScanner
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`UNITED THERAPEUTICS,
`EX. 2026
`WATSON LABORATORIES V. UNITED THERAPEUTICS,
`IPR2017-01621
`Page 1 of 5
`
`IPR2021-00406
`United Therapeutics EX2067
`
`
`
`IPRIVITOEL
`
`Declaration of Dr. Hossein A. Ghofrani
`
`L, De. Hossein A. Ghofrani, hereby declare as follows:
`
`1.
`
`Lam a member ofUniversity ofGiessen and Marburg Lung Center
`
`(CUGMLC”), a research center at the University Hospital Giessen studying
`
`pulmonary hypertension.
`
`
`
`2. 1 am notapaid consultant for United Therapeutics Corporation, which
`
`l understand is the assignee ofU.S. Patent No. 9,358,240, in connection with
`
`IPR2017-01621.
`
`3.
`
`1 ama co-author ofthe German language article: Hossein Ardeschir
`
`Ghofrani et ai. “Neue Therapieoptionen in der Behandlung der pulmonalarteriellen
`
`Hypertonie,”' Herz, 30, 4 (June 2005): 296-302 (“the Ghofrani article”).
`
`understand that Watson Laboratories, Inc. (“Watson”) submitted an English
`
`language translation of this article in this proceeding as Exhibit 1005, which I have
`
`reviewed.
`
`4.
`
`Ihave experience in the use of phosphodiesterase inhibitors for
`
`treatment ofpulmonary hypertension. Therefore, I was asked by Dr. Werner
`
`Seeger to draft and, indeed, drafted the section ofthe Ghofrani article relating to
`phosphodiesterase inhibitors. In Exhibit 1005,this section begins at the bottom of
`page 3 and continues through page 5. Dr. Seeger andIalsojointly drafted the
`' The title is translated as “New therapies in thetreatment ofpulmonary
`
`hypertension” in Exhibit 1005.
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`
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`IPR2017-01621
`
`Declaration of Dr. Hossein A. Ghofrani
`
`sections on vasoactivetherapy, inhaled iloprost, combination therapies, and
`
`treatmentof early formsof treatment of pulmonary hypertension, as well as the
`
`introduction. In line with the normal practice in the UGMLCresearch center,I
`
`was included as thefirst author on the Ghofrani article for these significant
`
`contributions.
`
`5.
`
`I did not make material contributions to any other section of the
`
`Ghofrani article, and I specifically did not contribute to the following excerpt:
`
`Initial trials in Giessen have shown proofofefficacy of inhaled
`
`treprostinil for the effective reduction of the pulmonary vascular
`
`resistance (PVR)[6]. In this first study, 17 patients with severe pre-
`
`capillary pulmonary hypertension were administered inhaled
`
`treprostinil (15 mcg/inhalation). This led to a major reduction in
`
`pulmonary selective pressure andresistance with an overall duration
`
`of action of > 180 min. In direct comparison with inhaled iloprost,
`
`inhaled treprostinil showed a stronger pulmonary selectivity, so thatit
`
`is possible to increase the dosage to up to 90 mcg (absolute inhaled
`dose per inhalation exercise) without adverse effects occurring[6].
`Dueto these unique properties (pronounced pulmonary selectivity and
`long duration ofaction after an individualinhalation),it is possible to
`reduce the number inhalations necessary to up to four per day; the
`inhalation period can be reduced to < 1 min.byselecting a suitable
`device. Additionally, the initial data showsthatit is technically
`feasible for there to be only oneto two breaths in an application.
`
`4819-7462-2542
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`
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`IPR2017-01621
`
`Declaration of Dr. Hossein A. Ghofrani
`
`The information in this excerpt was compiled and composed by Dr. Robert
`
`Voswinckel and Dr. Werner Seeger, andthe idea to perform the underlying work
`
`originated with them.
`
`6.
`
`The section of the Ghofraniarticle relating to selective endothelin A
`
`receptor agonists wasdrafted by Dr. Friedrich Grimminger and Dr. Frank
`
`Reichenberger; both having experiencein this field. In Exhibit 1005, this section
`
`is on page3.
`
`[The remainderofthis pageis intentionally left blank]
`
`
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`
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`IPR2017-01621
`
`Declaration of Dr. Hossein A. Ghofrani
`
`7.
`
`Thereby declarethatall statements made herein of my knowledgeare true
`
`and thatall statements madeon information andbeliefare believed to be true; and
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`further that these statements were made with the knowledgethat willful false
`
`statements andthe like so made are punishable byfine or imprisonment, or both
`
`under Section 1001 of Title 18 of the United States Code.
`
`Date: //- OCT
`
`__,2017
`
`Meea.
`
`Dr. Hossein A. Ghofrani
`
`4819-7462-2542
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`
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`Scanned by CamScanner
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`
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