`
`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: TREPROSTINIL ADJ\,fINJSTRATION BY INHALATION
`
`
`
`
`
`Inter Partes Review No. 2017-01621
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`
`
`DECLARATION OF DR. FRIEDRICH GRIMMINGER
`
`4812-7351-8670
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`UNITED THERAPEUTICS, EX. 2028
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR2017-01621
`Page 1 of 5
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`
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`IPR2021-00406
`United Therapeutics EX2069
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`
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`IPR2017-01621
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`Declaration of Dr. Friedrich Grimminger
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`I, Dr. Friedrich Grimminger, hereby declare as follows:
`
`L;
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`I am a memberof University of Giessen and Marburg Lung Center
`
`(“UGMLC”), a research center at the University Hospital Giessen studying
`
`pulmonary hypertension.
`
`2.
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`Lam nota paid consultant for United Therapeutics Corporation, which
`
`I understandis the assignee of U.S. Patent No. 9,358,240, in connection with
`
`IPR2017-01621.
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`3.|lamaco-author of the German languagearticle: Hossein Ardeschir
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`Ghofrani et al. “Neue Therapieoptionen in der Behandlung der pulmonalarteriellen
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`Hypertonie,””! Herz, 30, 4 (June 2005): 296-302 (“the Ghofrani 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 as Exhibit 1005, which I have
`
`reviewed.
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`4.
`
`Dr. Frank Reichenbergerand 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 Seegerto draft and, indeed, drafted the
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`section of the Ghofraniarticle relating to selective endothelin A receptor agonists.
`
`In Exhibit 1005, this section is on page 3. In line with the normal practice in the
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`' Thetitle is translated as “Newtherapiesin the treatment of pulmonary
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`hypertension” in Exhibit 1005.
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`4812-7351-8670
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`
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`IPR2017-01621
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`Declaration of Dr. Friedrich Grimminger
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`UGMLCresearch center, both Dr. Reichenbergerand I were listed as authors on
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`the Ghofrani article for this contribution.
`
`3:
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`I did not make material contributions to any other section ofthe
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`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
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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 thatit
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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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`Dueto 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 numberinhalations necessary to up to four per day; the
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`inhalation period can be reduced to < | min.byselecting a suitable
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`device. Additionally, the initial data showsthat it is technically
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`feasible for there to be only one to two breaths in an application.
`
`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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`4812-7351-8670
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`
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`IPR2017-01621
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`Declaration of Dr. Friedrich Grimminger
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`6.
`
`Dr. Hossein A. Ghofrani — the first listed author —drafted the section
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`of the Ghofrani article relating to phosphodiesterase inhibitors, and the remaining
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`sections on vasoactive therapy, inhaled iloprost, combination therapies, and
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`treatmentof early forms of treatment of pulmonary hypertension, as well as the
`
`introduction were drafted by Dr. Hossein A. Ghofrani and Dr. Werner Seeger.
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`[The remainder ofthis page is intentionally left blank]
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`4812-7351-8670
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`
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`IPR2017-01621
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`Declaration of Dr. Friedrich Grimminger
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`7.
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`[hereby declare that all statements made herein of my knowledge are
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`true and that all statements made on information andbelief are believed to be true;
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`and further that these statements were made with the knowledge that willful false
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`statements and thelike so madeare punishable by fine or imprisonment, or both
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`under Section 1001 of Title 18 of the United States Code.
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`Date: HV0de, AA 2017
`
`Dr. Friedrich Grimminger
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`4812-7351-8670
`
`
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