`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`V.
`
`UNITED THERAPEUTICS, INC.
`Patent Owner
`
`Patent No. 9,358,240
`Issue Date: June 7, 2016
`Title: 'I'REPROSTINIL ADMINISTRATION BY INHALATION
`
`Inter Panes Review No. 20 I 7-01 621
`
`DECLARATION OF DR. HOSSEIN A. GHOFRANI
`
`4313-7482-2642
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`Scanned by CamScanner
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`UNITED THERAPEUTICS. EX. 2026
`WATSON LABORATORIES V. UNITED THERAPEUTICS, iPR2017-D1621
`Page 1 of 5
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`{PRA‘I ‘4‘1 031
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`Declaration of Dr. Romain A. Ghofnni
`
`l. I}. Hogan A. Ghofnni. hut-by declare as follows:
`
`1.
`
`II!!! a member ofUniVuxity :3me and Mating Lung Center
`
`H‘Gmcu e teccuch cutter It the University Hospital Giessen studying
`
`Pum')‘ bimon-
`
`l
`
`ImmapaidcmmflnnlqunidecsCupmlfimWhiCh
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`1 mm is the achighee of us. Patent No. 9,353,240, in connection with
`
`“2017-01621.
`
`3.
`
`lmam—unhorofmeGumanlanguageuticle:HminArdeschir
`
`Ghofi'ani et at. “New: Thu-apiecpticnett in der Behandltmg der pulmonalanaricllen
`
`HEW" Hen. 30, 4 (June 2005): 2mm (“the Ghofi'ani article”).
`
`1
`
`mdu'sund tint Watson Inbonmda, Inc. (“Watson") submitted an English
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`m tnmlnion ofthis article in this ptueccding as Exhibit 1005, which I have
`
`miewcd.
`
`4-
`
`Imminflruseofphowhodiminhihimfor
`
`mofpuhnonuyhypmmsiou. Thutfuglwnsaskedbybr. Wm
`
`SwamdrnfimindeeidmfledfllesecfionofflteGhofimiuficlemlafingm
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`Winfibitms. lnExhibit 1005,d1issectionbeginsa1dtebottomof
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`hyputmsion” in Exhibit 1005.
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`UNITED THERAPEUTICS. EX. 2026
`WATSON LABORATORIES V. UNiTED THERAPEUTICS, IPR2017-D1621
`Page 2 of 5
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`lPR20l7-0162l
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`Declaration of Dr. Hossein A. Ghofrani
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`sections on vasoactive therapy, inhaled iloprost, combination therapies, and
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`treatment of early forms of treatment of pulmonary hypertension, as well as the
`
`introduction. In line with the normal practice in the UGNEC research center, I
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`was included as the first author on the Ghofi'ani 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:
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`Initial trials in Giessen have shown proof of efficacy of inhaled
`
`treprostinil for the effective reduction of the pulmonary vascular
`
`resistance (PVR) [6]. In this first study, 17 patients with severe pre-
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`capillary pulmonary hypertension were administered inhaled
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`treprostinil (15 mcg/inhalation). This led to a major reduction in
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`pulmonary selective pressure and resistance with an overall duration
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`of action of > 180 min. In direct comparison with inhaled iloprost,
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`inhaled treprostinil showed a stronger pulmonary selectivity, so that it
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`is possible to increase the dosage to up to 90 meg (absolute inhaled
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`dose per inhalation exercise) without adverse effects occurring [6].
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`Due to these unique properties (pronounced pulmonary selectivity and
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`long duration of action after an individual inhalation), it is possible to
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`reduce the number inhalations necessary to up to four per day; the
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`inhalation period can be reduced to < l min. by selecting a suitable
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`device. Additionally, the initial data shows that it is technically
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`feasible for there to be only one to two breaths in an application.
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`4813-?fl-2542
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`UNITED THERAPEUTICS. EX. 2026
`WATSON LABORATORIES V. UNITED THERAPEUTICS, lPR2017-01621
`Page 3 of 5
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`IPR201?-01621
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`Declaration of Dr. Hussein A. Ghofrani
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`The information in this excerpt was compiled and composed by Dr. Robert
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`Voswinckel and Dr. Werner Seeger, and the idea to perform the underlying work
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`originated with them.
`
`6.
`
`The section of the Ghofrani article relating to selective endothelin A
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`receptor agonists was drafted by Dr. Friedrich Grimminger and Dr. Frank
`
`Reichenberger; both having experience in this field. In Exhibit 1005, this section
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`is on page 3.
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`[The remainder ofthis page is intentionally Iefl‘ blank]
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`«term-2542
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`UNITED THERAPEUTICS. EX. 2026
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR2017-D1621
`Page 4 of 5
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`lPRZOl 7-0 | 62I
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`Declaration of Dr. llossein A. Ghofrani
`
`7.
`
`I hereby declare that all statements made herein ofmy knowledge are two
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`and that all statements made on information and beliefare believed to be true; and
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`further that these statements were made with the knowledge that willful false
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`statements and the like so made are punishable by fine or imprisonment, or both
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`under Section 1001 of Title 18 of the United States Code.
`
`Date: H ' OCT
`
`2017
`
`fir—
`
`Dr. Hussein A. Ghofrani
`
`4519-?462-292
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`
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`Scanned by CamScanner
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`UNITED THERAPEUTICS. EX. 2026
`WATSON LABORATORIES V. UNiTED THERAPEUTICS, IPR2017-D1621
`Page 5 of 5
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`
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