UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`V.
`
`UNITED THERAPEUTICS, INC.
`Patent Owner
`
`Patent No. 9,339,507r
`
`Issue Date: July 13, 2017
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`
`Inter Partes Review No. 2017-01622
`
`
`DECLARATION OF DR. WERNER SEEGER
`
`4833-8838-66311
`
`UNITED THERAPEUTICS, EX. 2020
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201?-01622
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`V.
`
`UNITED THERAPEUTICS, INC.
`Patent Owner
`
`Patent No. 9,339,507r
`
`Issue Date: July 13, 2017
`Title: TREPROSTINIL ADMINISTRATION BY INHALATION
`
`Inter Partes Review No. 2017-01622
`
`
`DECLARATION OF DR. WERNER SEEGER
`
`4833-8838-66311
`
`UNITED THERAPEUTICS, EX. 2020
`WATSON LABORATORIES V. UNITED THERAPEUTICS, IPR201?-01622
`
`
`
`IPR2017-01622
`
`Declaration of Dr. Werner Seeger
`
`I, Dr. Werner Seeger, hereby declare as follows:
`
`1.
`
`I am a named inventor of US. Patent No. 9,339,50?l and am the
`
`director of University of Giessen and Marburg Lung Center (“UGMLC”), a
`
`research center at the University Hospital Giessen studying pulmonary
`
`hypertension.
`
`2.
`
`1 am a paid consultant for United Therapeutics, which i understand is
`
`the assignee of U.S. Patent No. 9,339,507, in connection with IPR2017—01622. My
`
`compensation does not depend on the content of this declaration, the substance of
`
`any other testimony that I may offer in connection with this proceeding or the
`
`disposition of this proceeding.
`
`3.
`
`I am a co—author of the German language article: Hossein Ardeschi
`
`Ghofrani er a1. “Neue Therapieoptionen in der Behandlung der pulmonalaiteriellen
`
`Hypertonie,”l Herz, 30, 4 (June 2005): 296-302 (“the Ghofrani article”). I
`
`understand that Watson Laboratories, Inc. (“Watson”) submitted an English
`
`language translation of the Ghofrani article in this proceeding as Exhibit 1005,
`
`which I have reviewed.
`
`4.
`
`The Ghofrani article was an overview review article, drafted under my
`
`direction and control by members of my research center at University Hospital
`
`1 The title is translated as “New therapies in the treatment of pulmonary
`
`hypertension” in Exhibit 1005.
`
`4333333866311
`
`UNITED THERAPEUTICS, EX. 2020
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR201?-O1622
`
`
`
`IPR2017-01622
`
`Declaration of Dr. Werner Seeger
`
`Giesscn. The intent of the article was to compile and review information, not to
`
`communicate primary data. Each of the listed authors was selected based on their
`
`expertise in particular areas covered in particular sections of the Ghofrani article.
`
`5.
`
`Dr. Hossein A. Ghofrani — the first listed author - has experience in
`
`the use of phosphodiesterase inhibitors for treatment of pulmonary hypertension.
`
`I-Ie drafted the section of the Ghofi'ani article relating to phOSphodiesterase
`
`inhibitors. I know Dr. Ghofrani drafted this section of the Ghofi'ani article because
`
`I asked him to draft this section and communicated with him about it. In Exhibit
`
`1005, this section begins at the bottorn of page 3 and continues through page 5. Dr.
`
`Ghofrani was listed as a co—author on the Ghofrani article because he drafted this
`
`portion of the article and the other portions noted below.
`
`6.
`
`Drs. Frank Reichenberger and Friedrich Grimminger both have
`
`experience in the use of selective endothelin A receptor agonists for treating
`
`pulmonary hypertension.
`
`I know Drs. Reichenberger and Grinuninger drafted this
`
`section of the Ghofrani article because I asked them to draft this section and
`
`communicated with them about it. Together they drafted the section of the
`
`Ghofrani article relating to selective endothelin A receptor agonists. In Exhibit
`
`1005, this section is on page 3. Drs. Reichenberger and Grimminger were listed as
`
`a co-author on the Ghofrani article because they drafted this portion of the article.
`
`4833-8338-5631
`
`UNITED THERAPEUTICS, EX. 2020
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR201?-O1622
`
`
`
`IPR2017—01622
`
`Declaration of Dr. Werner Seeger
`
`7.
`
`Dr. Robert Voswinckel and I both have experience in the use of
`
`inhaled iloprost and inhaled treprostinil for treatment of pulmonary hypertension.
`
`Together, we drafied the sections of the Ghofrani article relating to inhaled iloprost
`
`and inhaled treprostinil. In Exhibit 1005, this section begins at the bottom of page
`
`2 and continues through page 3. Although the bulk of the Ghofrani article is a
`
`review of prior literature, additional information not previously reported in the
`
`literature was contributed by Dr. Voswinckel and myself in the inhaled treprostinil
`
`section and is contained 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 meg!inhalation). This led to a major reduction in
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`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 mcg (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
`
`inhalation period can be reduced to < 1 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.
`3
`
`4533-3833—66311
`
`UNITED THERAPEUTICS, EX. 2020
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR201?-O1622
`
`
`
`IPR20] 7-0 I 622
`
`Declaration of Dr. Werner Seeger
`
`The information in this excerpt was compiled and composed by Dr. Voswinckel
`
`and myself. The idea to perform the underlying work described in this section
`
`originated with Dr. Voswinckel and myself, in View of our work with other
`
`inventors listed on the ’50? patent. The other authors listed in the Ghofrani article
`
`-— Drs. Ghofrani, Reichenberger and Grimminger — did not contribute to this
`
`excerpt or the underlying work.
`
`8.
`
`The remaining sections on vasoactive therapy, inhaled iloprost,
`
`combination therapies, and treatment of early forms of treatment of pulmonary
`
`hypertension, as well as the introduction and compiled literature were drafted by
`
`Dr. Hossein A. Ghofrani and myself.
`
`9.
`
`Upon completion of the drafi and prior to submission thereof, I
`
`reviewed and edited the Ghofrani article in my capacity as director of my research
`
`center. In addition to myself, the four members of my research center who had
`
`contributed to the aforementioned sections of the Ghofrani article were listed as
`
`authors.
`
`10.
`
`The selection of authors for the Ghofrani article fits with the normal
`
`practice in my research center. In general, when my research center submits
`
`abstracts to a conference or articles for publication, we include members of the
`
`research group who contributed in some way to the abstract or article as authors.
`
`4833—8338456371
`
`UNITED THERAPEUTICS, EX. 2020
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR201?-O1622
`
`
`
`IPR2017—01622
`
`Declaration of Dr. Werner Seeger
`
`1 1.
`
`For example, the abstract titled “Pulmonary Arterial Hypertension:
`
`New Therapies,” which I understand was submitted by Watson as Exhibit 1003,
`
`lists as authors members of my research center who contributed by performing the
`
`administrative work supporting the trial, taking care of patients enrolled in the trial,
`
`andlor collecting data for the trial. Drs. Ghofrani, Reichenberger, and Grimminger
`
`are among the authors who contributed to the trial in this manner.
`
`[The remainder ofthis page is intentionally 16}? blank]
`
`4833383 8—6637]
`
`UNITED THERAPEUTICS, EX. 2020
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR201?-01622
`
`
`
`IPR20 ] 7-0 I 622
`
`Declaration of Dr. Werner Seeger
`
`12.
`
`I hereby declare that all statements made herein of my knowledge are
`
`true and that all statements made on information and belief are believed to be true;
`
`and further that these statements were made with the knowledge that willful false
`
`statements and the like so made are punishable by fine or imprisonment, or both
`
`under Section 1001 of Title 18 of the United States Code.
`
`Date: 5
`
`(fl/mo
`
`,2017
`
`__/
`
`Dr. Werner Seeger
`
`4333833866311
`
`UNITED THERAPEUTICS‘ EX. 2020
`WATSON LABORATORIES V. UNITED THERAPEUTICS, |PR201?-O1622
`
`
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