`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`V.
`
`UNITED THERAPEUTICS, INC.
`Patent Owner
`
`Patent No. 9,339,507
`Issue Date: July 13, 2017
`Title: TREPROSTINlL ADMNISTRATION BY INHALATION
`
`Inter Panes Review No. 2017—01622
`
`DECLARATION OF DR. FRANK REICHENBERGER
`
`4323-6498-6961
`
`UNITED THERAPEUTICS. EX. 2027
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201?-O1B22
`Page1of5
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`
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`IPRZO l 7-01622
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`Declaration of Dr. Frank Reichenberger
`
`I, Dr. Frank Reichenberger, hereby declare as follows:
`
`1.
`
`I was a member of University of Giessen and Marng Lung Center
`
`(‘TJGMLC”), a research center at the University Hospital Giessen studying
`
`pulmonary hypertension.
`
`9
`
`I am not a paid consultant for United Therapeutics Corporation, which
`
`I understand is the assignee of US. Patent No. 9,339,507, in connection with
`
`911201101622.
`
`3.
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`I am a co—author of the German language article: Hossein Ardeschir
`
`Ghofrani er a1. “Neue Therapieoptionen in der Behandlung der pulmonalarteriellen
`
`Hypertonie,”l Herz, 30, 4 (June 2005): 296-302 (“the Ghofi-ani article”). I
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`understand that Watson Laboratories, Inc. (“Watson”) submitted an English
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`language translation of this article in this proceeding (Exhibit 1005), which I have
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`reviewed-
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`4.
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`Dr. Friedrich Grimminger and I both have experience in the use of
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`selective endothelin A receptor agonists for treatment pulmonary hypertension.
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`Therefore, we were asked by Dr. Werner Seeger to drafi the section of the
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`Ghofrani article relating to selective endothelin A receptor agonists. And indeed,
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`we did draft this section. In Exhibit 1005, this section is on page 3. In line with
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`I The title is translated as “New therapies in the treanncnt of pulmonary
`
`hypertension” in Exhibit 1005.
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`4823—6498-6981
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`UNITED THERAPEUTICS. EX. 202?
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR201?-01622
`Page 2 of 5
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`
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`IPR2017-01622
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`Declaration of Dr. Frank Reichenberger
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`the normal practice in the UGMLC research center, both Dr. Grimminger and I
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`were listed as authors on the Ghofrani article for this contribution.
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`5.
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`I did not make material contributions to any other section of the
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`Ghofrani article, and I specifically did not contribute to the following excerpt:
`
`Initial trials in Giessen have shown proof of efficacy of inhaled
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`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 teprostinil showed a stronger pulmonary selectivity, so that it
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`is possible to increase the dosage to up to 90 mcg (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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`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.
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`4823—6493—5961
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`In)
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`UNITED THERAPEUTICS. EX. 202?
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR201?-01622
`Page 3 of 5
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`
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`IPR2017-01622
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`Declaration of Dr. Frank Reichenberger
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`6. Dr. Hossein A. Ghofiaoi — the first listed author —drafted the section of the
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`Ghofi-ani article reiating to phosphodiesterase mhibitors, and the remaining
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`sections on vasoactive therapy, inhaled iloprost, combination therapies, and
`
`treatment of eariy forms of treatment of pulmonary hypertension, as well as the
`
`introduction were drafted by Dr. Hossein A. Ghofrani and Dr. Werner Seeger.
`
`[The remainder oftkis page is intentionafb/ iefi Manic]
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`4323—6455—6961
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`Lu}
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`UNITED THERAPEUTICS. EX. 202?
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR201?-O1622
`Page 4 of 5
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`
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`[PR2017-01622
`
`Declaration of Dr. Frank Reichenberger
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`7- I hereby declare that all statements made herein of my knowledge are true
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`and that all statements made on information and belief are believed to be true; and
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`fixrther 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:
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`.
`
`/
`'flflg 46,2017
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`’"fi‘!
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`
`
`
`
`
`
`Dr. Frank Reichenberger
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`4823~Sd 933961
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`UNITED THERAPEUTICS. EX. 202?
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR201?-O1622
`Page 5 of 5
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