`
`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 ADMINJSTRA TION BY INHALATION
`
`
`
`Inter Partes Review No. 2017-01621
`
`
`
`DECLARATION OF DR. FRANK REICBENBERGER
`
`4818-5875-5150
`
`UNITED THERAPEUTICS, EX. 2027
`
`
`WATSON LABORATORIES V. UNITED THERAPEUTICS. IPR2017-01621
`Page 1 of 5
`
`
`
`IPR2021-00406
`United Therapeutics EX2068
`
`
`
`IPR2017-0162!
`
`Declaration of Dr. Frank Reichenberger
`
`I, Dr. Frank Reichenberger, hereby declare as follows:
`
`1.
`
`I was a memberof University of Giessen and Marburg Lung Center
`
`(“UGMLC”), a research centerat the University Hospital Giessen studying
`
`pulmonary hypertension.
`
`2.
`
`Lam nota paid consultant for United Therapeutics Corporation, which
`
`I understand is the assignee of U.S. Patent No. 9,358,240, in connection with
`
`JTPR2017-01621.
`
`3.
`
`I am aco-author of the German language article: Hossein Ardeschir
`
`Ghofrani ef ai. “Neue Therapieoptionen in der Behandlung der pulmonalarteriellen
`
`Hypertonie,”’ Herz, 30, 4 (June 2005): 296-302 (“the Ghofraniarticle”). I
`
`understand that Watson Laboratories, Inc. (“Watson”) submitted an English
`
`languagetranslation ofthis article in this proceeding (Exhibit 1005), which I have
`
`reviewed.
`
`4,
`
`Dr. Friedrich Grimminger and I both have experience in the use of
`
`selective endothelin A receptor agonists for treatment pulmonary hypertension.
`
`Therefore, we were asked by Dr. Werner Seegerto draft the section of the
`
`Ghofraniarticle relating to selective endothelin A receptor agonists. And indeed,
`
`wedid draft this section. In Exhibit 1005,this section is on page 3. In line with
`
`' Thetitle is translated as “Newtherapiesin the treatmentofpulmonary
`
`hypertension” in Exhibit 1005.
`
`4618-5875-5150
`
`
`
`IPR2017-01621
`
`Declaration ofDr. Frank Reichenberger
`
`the normalpractice in the UGMLCresearch center, both Dr. Grimminger and I
`
`were listed as authors on the Ghofrani article for this contribution.
`
`5.
`
`I did not make material contributionsto any other section of the
`
`Ghofrani article, and J specifically did not contribute to the following excerpt:
`
`Initial trials in Giessen have shown proofofefficacy of inhaled
`treprostinil for the effective reduction of the pulmonaryvascular
`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
`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].
`
`Dueto 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 showsthatit 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, and the idea to perform the underlying work
`
`originated with them.
`
`4818-5875-5150
`
`
`
`IPR2017-01621
`
`Declaration of Dr. Frank Reichenberger
`
`6. Dr. Hossein A. Ghofrani — thefirst listed author drafted the section of the
`
`Ghofrani article relating to phosphodiesterase inhibitors, and 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 were drafted by Dr. Hossein A. Ghofrani and Dr. Werner Seeger.
`
`[The remainderofthis pageis intentionally left blank]
`
`4818-5875-5150
`
`
`
`IPR2017-01621
`
`Declaration of Dr. Frank Reichenberger
`
`7. Ihereby declare thatall statements made herein of my knowledgearetrue
`
`andthat all statements made on information and belief are believed to be true; and
`
`further that these statements were made with the knowledgethat 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: AHA f___,2017
`
`ary »
`
`
` Dr. Frank Reichenbe:
`
`4818-5875-5150
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
