UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`V.
`
`UNITED THERAPEUTICS CORP.
`
`Patent Owner
`
`Cases’ 1PR2017-01621; Patent 9,353,240
`IPR 201 7-03 622; Patent 9,339,507
`
`SECOND DECLARATION OF DR. HOSSEIN A. GHOFRANI
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`1 The word-for—word identical paper is filed in each proceeding identified in the
`
`heading.
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`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017—01621
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`UNITED THERAPEUTICS, EX. 2099
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`Page 1 of 7
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`
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`V.
`
`UNITED THERAPEUTICS CORP.
`
`Patent Owner
`
`Cases’ 1PR2017-01621; Patent 9,353,240
`IPR 201 7-03 622; Patent 9,339,507
`
`SECOND DECLARATION OF DR. HOSSEIN A. GHOFRANI
`
`1 The word-for—word identical paper is filed in each proceeding identified in the
`
`heading.
`
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017—01621
`
`UNITED THERAPEUTICS, EX. 2099
`
`Page 1 of 7
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`IPR2017-0162l
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`Declaration ofDi'. Hossein A. Ghofi‘ani
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`I, Dr. Hossein A. Ghofrani, hereby declare as foliows:
`
`i.
`
`I am a member of University of Giessen and Marburg Lung Center
`
`(“UGMLC”), a research center at the University Hospital Giessen studying
`
`pulmonary hypertension.
`
`2.
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`United Therapeutics Corporation is compensating me for my time
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`spent in connectiori with IPR2017~01621 and IPR2017~01622 based on my
`
`standard hourly consulting rate. My compensation does not depend on the content
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`of this declaraticm, the substance of any other testimony that I may offer in
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`connection with this proceeding, or the disposition of this proceeding.
`
`I
`
`understand that United Therapeutics Corporation is the assignee of US. Patent No.
`
`9,358,240 (“the ‘240 patent”) and US Patent No. 9,399,507 (“the “507 patent”).
`
`3.
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`I am a co—author of the German language article: Hossein Ardeschir
`
`Ghofrani er a2. “Neue Therapieoptionen in der Behandlung der pulmonalarteriellen
`
`Hypertonie,”2 Hera, 30, 4 (June 2005): 296602 (“the Ghofrani article”) (Ex.
`
`2103).
`
`I understand that Watson Laboratories, Inc. (“Watson”) submitted an
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`English language translation of this article in this proceeding as Exhibit 1005,
`
`which I have reviewed.
`
`2 The title is translated as “New therapies in the treatment of pulmonary
`
`hypertension” in Exhibit 1005.
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`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017—01621
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`UNITED THERAPEUTICS, EX. 2099
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`Page 2 of 7
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`IPR2017-Ol 621
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`Declaration ofDr. Hossein A. Ghofrani
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`4.
`
`Iain included as an author because I contributed to several sections of
`
`the article as I detailed in my first Declaration (Ex. 2026), including the sections on
`
`phosphodiesterase inhibitors, vasoactive therapy, inhaled iloprost, combination
`
`therapies, treatment of early forms of pulmonary hypertension, and the
`
`introduction.
`
`5.
`
`As stated in my previous declaration, I did not make material
`
`contributions to any section of the Ghofrani article other than those in paragraph 4,
`
`above. I specifically did not have the idea to design the patient study, to select the
`
`dosing regimen or type of inhalation device, nor did 1 otherwise contribute to the
`
`patient study described in the following excerpt:
`
`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~
`
`capillary pulmonary hypertension. were administered inhaled
`
`treprostinil (15 moglinhalation). This led to a major reduction in
`
`pulmonary selective pressure and resistance with an overall duration
`
`of action of > 180 min.
`
`in direct comparison with. inhaled iloprost,
`
`inhaled treprostinil showed a stronger pulmonary selectivity, so that it
`
`is possible to increase the dosage to up to 90 meg (absolute inhaled
`
`dose per inhalation exercise) without adverse effects occurring [6].
`
`Due to these unique properties (pronounced pulmonary selectivity and
`
`long duration of action after an individual inhalation), it is possible to
`
`reduce the number inhalations necessary to up to four per day; the
`
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017—01621
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`UNITED THERAPEUTICS, EX. 2099
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`Page 3 of 7
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`
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`IPR20l7-01621
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`Declaration ofDr. Hossein A. Ghoti-ani
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`inhalation period can be reduced to < l min. by selecting a suitable
`
`device. Additionally, the initial data shows that it is technically
`
`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
`
`Voswinckel and Dr. Werner Seeger, who jointly designed this patient study
`
`together with contributions from Horst Olschewski, Robert Roscigno, Lewis
`
`Rubin, Thomas Schmehl, and Carl Sterritt.
`
`6.
`
`Reference [6] referred to in this excerpt (Voswinckel R. Kohstall M.
`
`Enge B, et at, Inhaled treprostinil is a potent pulmonary vasodila’tor in severe
`
`pulmonary hypertension, Eur Heart 3. 2004: 25:22 (“Voswinkel abstract”)) (Ex.
`
`1046), also lists me as a co—author. Although I did not design the study it describes,
`
`I am listed as a co—author in recognition of my work as a member of the team that
`
`carried out various tasks relating to the routine clinical care in addition to
`
`identification of eligible patients for potential participation in trials, at the request
`
`of other team members, such as Dr. Seeger. In the academic world, it is a common
`
`practice to list as authors of abstracts and summary review articles the members
`
`who helped carry out the work, notjust those members who were directly
`
`responsible for conceiving, analyzing, and designing a particular study. This is
`
`typical of our group and is a. valid publication practice for a research group like
`
`OUTS.
`
`t.»
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`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017—01621
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`UNITED THERAPEUTICS, EX. 2099
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`Page 4 of 7
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`
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`lPR20l "2501621
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`Declaration ofDr. I-Iossein A. Ghofirani
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`7.
`
`In the same way, with respect to the other Voswinckel abstract,
`
`Robert Voswinckel, et al. Inhaled Treprosrinil Sodium (TREjfor the Treatment of
`
`Pulmonary Hypertension, Abstract #1414, CIRCULATION, 110, 17, SUPPLEMENT
`
`(OCT. 2004): 111-295 (Ex. 1003), I am listed as a co-author on that abstract because
`
`we again included as authors of this abstract the members of our group who carried
`
`out certain aspects of the trials, clinical routine management, or related parallel
`
`studies, not just the members who were directly responsible for conceiving,
`
`analyzing, and designing the particular study it describes.
`
`8.
`
`In the case of any studies of inhaled treprostinil described in. these
`
`articles, I. was listed as a co-author because I assisted with the clinical
`
`responsibilities of overseeing patients and was carrying out work related to the
`
`treatment of pulmonary hypertension inside and outside the trials designed by the
`
`inventors.
`
`l was not designing those studies or methods of treatment involving
`
`inhaled treprostinii. I also agree that the other co-authors of these articles who are
`
`not named as inventors of the ‘240 patent or the ‘507 patent were recognized as
`
`authors for similar reasons. Even though we did not design the inhaled treprostinil
`
`clinical trials, we did perform tasks relating to the trials such as identification of
`
`potentially eligible patients out of the group of patients in our pulmonary
`
`hypertension clinic. Moreover, patients with severe pulmonary hypertension have
`
`multiple needs that are mostly not related. to their participatiou in clinical trials,
`
`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017—01621
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`UNITED THERAPEUTICS, EX. 2099
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`Page 5 of 7
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`il’RZGl?«01621
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`Declaration of Dr. Hussein A. Ghofiani
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`such as: a.) adjustments required to be made to their background medications (e. g.
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`diuretics, anti—coagulation, other pulmonary hypertension targeted tic—medications,
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`antibiotics, etc); and b) support of their socioeconomic circumstances (eg.
`
`negotiations with other health care providers, payers, child—care, etc).
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`Furthermore, patients discontinuing clinical trials (either scheduled or
`
`unscheduled) such as the above mentioned, require immediate transitioning into
`
`the routine clinical care again, which was also part of my responsibilities
`
`9.
`
`These three articles do not report on primary data where one is a
`
`review article (Ghofrani article, Ex. 1005) and two are abstracts (Voswinckel
`
`abstracts, Ex. 1003 and 1046). My involvement in any study by our group into
`
`inhaled treprostinil was limited to support and administrative tasks such as
`
`collecting data or checking on patients.
`
`I was not involved in the design or intent
`
`of the study such as selecting treprostinil for inhaled administration, the dosages or
`
`timing of administration, the protocols or devices used, or the selection of study
`
`parameters.
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`[The remainder of this page is intentionally left blank]
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`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR201T-O1621
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`UNITED THERAPEUTICS, EX. 2099
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`Page 6 of 7
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`IPR2017—0162l
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`Declaration ofDr. Hossein A. Ghofi‘ani
`
`10.
`
`I hereby declare that all statements made herein of my knowledge are
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`true and that all statements made on information and belief 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 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: 42 ”Agni «-
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`,2013
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`Dr. Hossein A. Ghofrani
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`WATSON LABORATORIES v. UNITED THERAPEUTICS, |PR2017—01621
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`UNITED THERAPEUTICS, EX. 2099
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`Page I" of 7
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