IPR2017-01621
`U.S. Patent No. 9,358,240 B2
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORP.
`Patent Owner
`
`
`
`Case : IPR2017-01621
`U.S. Patent 9,358,240 B2
`
`Before the Honorable LORA M. GREEN, ERICA A. FRANKLIN, and DAVID
`COTTA, Administrative Patent Judges.
`
`PETITIONER’S SECOND SET OF OBJECTIONS
`TO PATENT OWNER’S EXHIBITS
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), the undersigned, on behalf of and acting
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`in a representative capacity for Petitioner Watson Laboratories, Inc., hereby submit
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`the following objections to Patent Owner United Therapeutics Corp.’s (“Patent
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`Owner”) Exhibits 2032-2036, 2038-2040, 2048-2053, 2055, 2057-2058, 2061-2063,
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`2065-2068, 2071-2075, 2081-2090, 2092-2093, 2096, 2098-2102, and 2104, and
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`any reference to/reliance on the foregoing. These objections are in addition to
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`U.S. Patent No. 9,358,240 B2
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`WATSON LABORATORIES, INC.
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORP.
`Patent Owner
`
`
`
`Case : IPR2017-01621
`U.S. Patent 9,358,240 B2
`
`Before the Honorable LORA M. GREEN, ERICA A. FRANKLIN, and DAVID
`COTTA, Administrative Patent Judges.
`
`PETITIONER’S SECOND SET OF OBJECTIONS
`TO PATENT OWNER’S EXHIBITS
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), the undersigned, on behalf of and acting
`
`in a representative capacity for Petitioner Watson Laboratories, Inc., hereby submit
`
`the following objections to Patent Owner United Therapeutics Corp.’s (“Patent
`
`Owner”) Exhibits 2032-2036, 2038-2040, 2048-2053, 2055, 2057-2058, 2061-2063,
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`2065-2068, 2071-2075, 2081-2090, 2092-2093, 2096, 2098-2102, and 2104, and
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`any reference to/reliance on the foregoing. These objections are in addition to
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`IPR2017-01621
`U.S. Patent No. 9,358,240 B2
`Petitioner’s Objections to Patent Owner’s Exhibits dated January 26, 2018, which
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`remain operative and have not been waived. As required by 37 C.F.R § 42.62,
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`Petitioners’ objections below apply the Federal Rules of Evidence and are based on
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`currently-applicable law. Petitioner reserves the right to amend or supplement its
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`objections in response to any change in law or fact.
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`
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`OBJECTIONS TO EXHIBIT 2032
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`Evidence objected to: Exhibit 2032
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`Grounds for objection: Exhibit 2032, a document titled “Feb. 23, 2018
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`Conference Call Transcript,” is objected to under Fed. R. Evid. 401 and 403. Exhibit
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`2032 includes statements that do not make any fact relevant to the grounds upon
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`which trial was instituted more or less probable and any facts that might be
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`established based on this exhibit is of no consequence in determining the issues on
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`which trial was instituted. Introduction and evaluation of Exhibit 2032 would further
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`lead to undue delay, confusion, and a waste of time.
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` OBJECTIONS TO EXHIBIT 2033
`Evidence objected to: Exhibit 2033
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`Grounds for objection: Exhibit 2033 is the transcript of the March 28, 2018
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`Deposition of Dr. Scott Bennett. Pursuant to Board Rules 42.53(f)(4) and
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`42.53(f)(8), Petitioner relies on the objections made during the deposition and
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`IPR2017-01621
`U.S. Patent No. 9,358,240 B2
`recorded in Exhibit 2033, which have not been waived. Petitioner reserves the right
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`to file a motion to exclude such testimony.
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` OBJECTIONS TO EXHIBIT 2034
`Evidence objected to: Exhibit 2034
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`Grounds for objection: Exhibit 2034 is the transcript of the April 4, 2018
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`Deposition of Dr. Maureen Donovan. Pursuant to Board Rules 42.53(f)(4) and
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`42.53(f)(8), Petitioner relies on the objections made during the deposition and
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`recorded in Exhibit 2034, which have not been waived. Petitioner reserves the right
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`to file a motion to exclude such testimony.
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` OBJECTIONS TO EXHIBIT 2035
`Evidence objected to: Exhibit 2035
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`Grounds for objection: Exhibit 2035 is the transcript of the April 6, 2018
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`Deposition of Dr. DeForest McDuff. Pursuant to Board Rules 42.53(f)(4) and
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`42.53(f)(8), Petitioner relies on the objections made during the deposition and
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`recorded in Exhibit 2035, which have not been waived. Petitioner reserves the right
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`to file a motion to exclude such testimony.
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` OBJECTIONS TO EXHIBIT 2036
`Evidence objected to: Exhibit 2036
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`Grounds
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`for objection: Exhibit 2036, a document
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`titled “Email
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`Correspondence with Petitioner regarding Deposition of Christopher Butler,” is
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`objected to under Fed. R. Evid. 401 and 403. Exhibit 2036 is a discussion between
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`U.S. Patent No. 9,358,240 B2
`the parties regarding deposition of a declarant that does not make any fact relevant
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`to the grounds upon which trial was instituted more or less probable and any facts
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`that might be established based on this exhibit is of no consequence in determining
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`the issues on which trial was instituted.
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` OBJECTIONS TO EXHIBIT 2038
`Evidence objected to: Exhibit 2038
`
`Grounds for objection: Exhibit 2038, a document titled “Second Declaration
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`of Dr. Richard Dalby,” is objected to under Fed. R. Evid. 401, 403, 801, and 802.
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`Exhibit 2038 includes statements that do not make any fact relevant to the grounds
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`upon which trial was instituted more or less probable and any facts that might be
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`established based on this exhibit is of no consequence in determining the issues on
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`which trial was instituted. Introduction and evaluation of Exhibit 2038 would further
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`lead to undue delay, confusion, and a waste of time. Exhibit 2038 also contains out-
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`of-court statements made by one or more declarants for the purpose of proving the
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`truth of the matter asserted, and on which Petitioner has not had a chance to cross
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`exam. Introduction and evaluation of Exhibit 2038 would further lead to undue
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`delay, confusion, and a waste of time.
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` OBJECTIONS TO EXHIBIT 2039
`Evidence objected to: Exhibit 2039
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`Grounds for objection: Exhibit 2039, U.S. Patent No. 4,319,155, is objected
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`to under Fed. R. Evid. 401 and 403. Exhibit 2039 does not make any fact relevant
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`to the grounds upon which trial was instituted more or less probable and any facts
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`that might be established based on this exhibit is of no consequence in determining
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`the issues on which trial was instituted. Introduction and evaluation of Exhibit 2039
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`would further lead to undue delay, confusion, and a waste of time.
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` OBJECTIONS TO EXHIBIT 2040
`Evidence objected to: Exhibit 2040
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`Grounds for objection: Exhibit 2040, a document titled “Declaration of Dr.
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`Aaron Waxman,” is objected to under Fed. R. Evid. 401, 403, 801, and 802. Exhibit
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`2040 includes statements that do not make any fact relevant to the grounds upon
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`which trial was instituted more or less probable and any facts that might be
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`established based on this exhibit is of no consequence in determining the issues on
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`which trial was instituted. Introduction and evaluation of Exhibit 2040 would further
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`lead to undue delay, confusion, and a waste of time. Exhibit 2040 also contains out-
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`of-court statements made by one or more declarants for the purpose of proving the
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`truth of the matter asserted, and on which Petitioner has not had a chance to cross
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`exam.
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` OBJECTIONS TO EXHIBIT 2048
`Evidence objected to: Exhibit 2048
`
`Grounds for objection: Exhibit 2048, a document titled “Declaration of Dr.
`
`Robert Roscigno,” is objected to under Fed. R. Evid. 401, 403, 801, and 802. Exhibit
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`2048 includes statements that do not make any fact relevant to the grounds upon
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`which trial was instituted more or less probable and any facts that might be
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`established based on this exhibit is of no consequence in determining the issues on
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`which trial was instituted. Introduction and evaluation of Exhibit 2048 would further
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`lead to undue delay, confusion, and a waste of time. Exhibit 2048 also contains out-
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`of-court statements made by one or more declarants for the purpose of proving the
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`truth of the matter asserted.
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` OBJECTIONS TO EXHIBIT 2049
`Evidence objected to: Exhibit 2049
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`Grounds for objection: Exhibit 2049, a document titled “Excerpts from
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`Tyvaso® NDA Integrated Summary of Efficacy (ISE)” is objected to under Fed. R.
`
`Evid. 401, 403, 801, and 802. Exhibit 2049 includes statements that do not make any
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`fact relevant to the grounds upon which trial was instituted more or less probable
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`and any facts that might be established based on this exhibit is of no consequence in
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`determining the issues on which trial was instituted. Introduction and evaluation of
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`Exhibit 2049 would further lead to undue delay, confusion, and a waste of time.
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`U.S. Patent No. 9,358,240 B2
`Exhibit 2049 also contains out-of-court statements made by one or more declarants
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`for the purpose of proving the truth of the matter asserted.
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` OBJECTIONS TO EXHIBIT 2050
`Evidence objected to: Exhibit 2050
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`Grounds for objection: Exhibit 2050, a document titled “Clinical Investigation
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`Report Synopsis for LungRx Study No: LRXTRE- INH-0004” is objected to under
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`Fed. R. Evid. 401, 403, 801, and 802. Exhibit 2050 includes statements that do not
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`make any fact relevant to the grounds upon which trial was instituted more or less
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`probable and any facts that might be established based on this exhibit is of no
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`consequence in determining the issues on which trial was instituted. Introduction
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`and evaluation of Exhibit 2050 would further lead to undue delay, confusion, and a
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`waste of time. Exhibit 2050 also contains out-of-court statements made by one or
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`more declarants for the purpose of proving the truth of the matter asserted.
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` OBJECTIONS TO EXHIBIT 2051
`Evidence objected to: Exhibit 2051
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`Grounds for objection: Exhibit 2051, a document titled “Clinical Investigation
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`Report Synopsis for LungRx Study No: LRXTRE- INH-0007” is objected to under
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`Fed. R. Evid. 401, 403, 801, and 802. Exhibit 2051 includes statements that do not
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`make any fact relevant to the grounds upon which trial was instituted more or less
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`probable and any facts that might be established based on this exhibit is of no
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`IPR2017-01621
`U.S. Patent No. 9,358,240 B2
`consequence in determining the issues on which trial was instituted. Introduction
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`and evaluation of Exhibit 2051 would further lead to undue delay, confusion, and a
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`waste of time. Exhibit 2051 also contains out-of-court statements made by one or
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`more declarants for the purpose of proving the truth of the matter asserted.
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` OBJECTIONS TO EXHIBIT 2052
`Evidence objected to: Exhibit 2052
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`Grounds for objection: Exhibit 2052, a document titled “Letter from FDA
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`confirming IND filing” is objected to under Fed. R. Evid. 401, 403, 801, and 802.
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`Exhibit 2052 includes statements that do not make any fact relevant to the grounds
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`upon which trial was instituted more or less probable and any facts that might be
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`established based on this exhibit is of no consequence in determining the issues on
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`which trial was instituted. Introduction and evaluation of Exhibit 2052 would further
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`lead to undue delay, confusion, and a waste of time. Exhibit 2052 also contains out-
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`of-court statements made by one or more declarants for the purpose of proving the
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`truth of the matter asserted.
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` OBJECTIONS TO EXHIBIT 2053
`Evidence objected to: Exhibit 2053
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`Grounds for objection: Exhibit 2053, a document titled “Declaration of Dr.
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`Jeffrey Stec,” is objected to under Fed. R. Evid. 401, 403, 801, and 802. Exhibit
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`2053 includes statements that do not make any fact relevant to the grounds upon
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`IPR2017-01621
`U.S. Patent No. 9,358,240 B2
`which trial was instituted more or less probable and any facts that might be
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`established based on this exhibit is of no consequence in determining the issues on
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`which trial was instituted. Introduction and evaluation of Exhibit 2053 would further
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`lead to undue delay, confusion, and a waste of time. Exhibit 2053 also contains out-
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`of-court statements made by one or more declarants for the purpose of proving the
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`truth of the matter asserted, and on which Petitioner has not had a chance to cross
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`exam.
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` OBJECTIONS TO EXHIBIT 2055
`Evidence objected to: Exhibit 2055
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`Grounds for objection: Exhibit 2055, a document
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`titled “Tyvaso®
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`(treprostinil) An Inhaled Prostacyclin Analogue, Internal Presentation,” is objected
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`to under Fed. R. Evid. 401, 403, 801, and 802. Exhibit 2055 includes statements that
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`do not make any fact relevant to the grounds upon which trial was instituted more or
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`less probable and any facts that might be established based on this exhibit is of no
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`consequence in determining the issues on which trial was instituted. Introduction
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`and evaluation of Exhibit 2055 would further lead to undue delay, confusion, and a
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`waste of time. Exhibit 2055 contains out-of-court statements made by one or more
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`declarants for the purpose of proving the truth of the matter asserted.
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`U.S. Patent No. 9,358,240 B2
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` OBJECTIONS TO EXHIBIT 2057
`Evidence objected to: Exhibit 2057
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`Grounds for objection: Exhibit 2057, a document titled “FDA Approves
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`TYVASO (Treprostinil) Inhalation Solution for the Treatment of Pulmonary Arterial
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`Hypertension” is objected to under Fed. R. Evid. 401, 403, 801, 802, and 901.
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`Exhibit 2057 includes statements that do not make any fact relevant to the grounds
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`upon which trial was instituted more or less probable and any facts that might be
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`established based on this exhibit is of no consequence in determining the issues on
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`which trial was instituted. Introduction and evaluation of Exhibit 2057 would further
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`lead to undue delay, confusion, and a waste of time. Exhibit 2057 contains out-of-
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`court statements made by one or more declarants for the purpose of proving the truth
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`of the matter asserted. Exhibit 2057 has not been properly authenticated.
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` OBJECTIONS TO EXHIBIT 2058
`Evidence objected to: Exhibit 2058
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`Grounds for objection: Exhibit 2058, a document titled “2014 Fourth-Quarter
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`and Annual Financial Results, Investor Conference Call Q&A” is objected to under
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`Fed. R. Evid. 401, 403, 801, 802, and 901. Exhibit 2058 includes statements that do
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`not make any fact relevant to the grounds upon which trial was instituted more or
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`less probable and any facts that might be established based on this exhibit is of no
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`consequence in determining the issues on which trial was instituted. Introduction
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`IPR2017-01621
`U.S. Patent No. 9,358,240 B2
`and evaluation of Exhibit 2058 would further lead to undue delay, confusion, and a
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`waste of time. Exhibit 2058 contains out-of-court statements made by one or more
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`declarants for the purpose of proving the truth of the matter asserted. Exhibit 2058
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`has not been properly authenticated.
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`OBJECTIONS TO EXHIBIT 2061
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`Evidence objected to: Exhibit 2061
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`Grounds for objection: Exhibit 2061, a document titled “The World's Biggest
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`Public Companies – United Therapeutics” is objected to under Fed. R. Evid. 401,
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`403, 801, and 802. Exhibit 2061 includes statements that do not make any fact
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`relevant to the grounds upon which trial was instituted more or less probable and
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`any facts that might be established based on this exhibit is of no consequence in
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`determining the issues on which trial was instituted. Introduction and evaluation of
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`Exhibit 2061 would further lead to undue delay, confusion, and a waste of time.
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`Exhibit 2061 contains out-of-court statements made by one or more declarants for
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`the purpose of proving the truth of the matter asserted.
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` OBJECTIONS TO EXHIBIT 2062
`Evidence objected to: Exhibit 2062
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`Grounds for objection: Exhibit 2062, a document titled “America’s Best Small
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`Public Companies” is objected to under Fed. R. Evid. 401 and 403. Exhibit 2062
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`includes statements that do not make any fact relevant to the grounds upon which
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`IPR2017-01621
`U.S. Patent No. 9,358,240 B2
`trial was instituted more or less probable and any facts that might be established
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`based on this exhibit is of no consequence in determining the issues on which trial
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`was instituted. Introduction and evaluation of Exhibit 2062 would further lead to
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`undue delay, confusion, and a waste of time.
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` OBJECTIONS TO EXHIBIT 2063
`Evidence objected to: Exhibit 2063
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`Grounds for objection: Exhibit 2063, a document titled “Fastest-Growing
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`Companies” is objected to under Fed. R. Evid. 401, 403, 801, and 802. Exhibit 2063
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`includes statements that do not make any fact relevant to the grounds upon which
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`trial was instituted more or less probable and any facts that might be established
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`based on this exhibit is of no consequence in determining the issues on which trial
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`was instituted. Introduction and evaluation of Exhibit 2063 would further lead to
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`undue delay, confusion, and a waste of time. Exhibit 2063 contains out-of-court
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`statements made by one or more declarants for the purpose of proving the truth of
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`the matter asserted.
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` OBJECTIONS TO EXHIBIT 2065
`Evidence objected to: Exhibit 2065
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`Grounds for objection: Exhibit 2065, a document titled “Tyvaso 2014 Brand
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`Plan, Internal” is objected to under Fed. R. Evid. 401, 403, 801, 802, and 901.
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`Exhibit 2065 includes statements that do not make any fact relevant to the grounds
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`IPR2017-01621
`U.S. Patent No. 9,358,240 B2
`upon which trial was instituted more or less probable and any facts that might be
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`established based on this exhibit is of no consequence in determining the issues on
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`which trial was instituted. Introduction and evaluation of Exhibit 2065 would further
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`lead to undue delay, confusion, and a waste of time. Exhibit 2065 contains out-of-
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`court statements made by one or more declarants for the purpose of proving the truth
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`of the matter asserted. Exhibit 2065 has not been properly authenticated.
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` OBJECTIONS TO EXHIBIT 2066
`Evidence objected to: Exhibit 2066
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`Grounds for objection: Exhibit 2066, a document titled “2013 Marketing Plan,
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`Internal” is objected to under Fed. R. Evid. 401, 403, 801, 802, and 901. Exhibit
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`2066 includes statements that do not make any fact relevant to the grounds upon
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`which trial was instituted more or less probable and any facts that might be
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`established based on this exhibit is of no consequence in determining the issues on
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`which trial was instituted. Introduction and evaluation of Exhibit 2066 would further
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`lead to undue delay, confusion, and a waste of time. Exhibit 2066 contains out-of-
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`court statements made by one or more declarants for the purpose of proving the truth
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`of the matter asserted. Exhibit 2066 has not been properly authenticated.
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`OBJECTIONS TO EXHIBIT 2067
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`Evidence objected to: Exhibit 2067
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`Grounds for objection: Exhibit 2067, a document titled “Tyvaso Marketing
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`Overview, August 19, 2015, Internal” is objected to under Fed. R. Evid. 401, 403,
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`801, 802, and 901. Exhibit 2067 includes statements that do not make any fact
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`relevant to the grounds upon which trial was instituted more or less probable and
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`any facts that might be established based on this exhibit is of no consequence in
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`determining the issues on which trial was instituted. Introduction and evaluation of
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`Exhibit 2067 would further lead to undue delay, confusion, and a waste of time.
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`Exhibit 2067 contains out-of-court statements made by one or more declarants for
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`the purpose of proving the truth of the matter asserted. Exhibit 2067 has not been
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`properly authenticated.
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`OBJECTIONS TO EXHIBIT 2068
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`Evidence objected to: Exhibit 2068
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`Grounds for objection: Exhibit 2068, a document titled “Pulmonary Arterial
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`Hypertension (PAH) Therapeutics – Global Drug Forecasts and Treatment Analysis
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`to 2020, Internal” is objected to under Fed. R. Evid. 401, 403, 801, 802, and 901.
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`Exhibit 2068 includes statements that do not make any fact relevant to the grounds
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`upon which trial was instituted more or less probable and any facts that might be
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`established based on this exhibit is of no consequence in determining the issues on
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`U.S. Patent No. 9,358,240 B2
`which trial was instituted. Introduction and evaluation of Exhibit 2068 would further
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`lead to undue delay, confusion, and a waste of time. Exhibit 2068 contains out-of-
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`court statements made by one or more declarants for the purpose of proving the truth
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`of the matter asserted. Exhibit 2068 has not been properly authenticated.
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` OBJECTIONS TO EXHIBIT 2071
`Evidence objected to: Exhibit 2071
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`Grounds for objection: Exhibit 2071, a document titled “Project Clock
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`Discussion Materials, February 3, 2016, Internal” is objected to under Fed. R. Evid.
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`401, 403, 801, 802, and 901. Exhibit 2071 includes statements that do not make any
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`fact relevant to the grounds upon which trial was instituted more or less probable
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`and any facts that might be established based on this exhibit is of no consequence in
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`determining the issues on which trial was instituted. Introduction and evaluation of
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`Exhibit 2071 would further lead to undue delay, confusion, and a waste of time.
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`Exhibit 2071 contains out-of-court statements made by one or more declarants for
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`the purpose of proving the truth of the matter asserted. Exhibit 2071 has not been
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`properly authenticated.
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`OBJECTIONS TO EXHIBIT 2072
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`Evidence objected to: Exhibit 2072
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`Grounds for objection: Exhibit 2072, a document titled “Actelion Delivers
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`Outstanding 2014 Results” is objected to under Fed. R. Evid. 401, 403, 801, and
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`802. Exhibit 2072 includes statements that do not make any fact relevant to the
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`grounds upon which trial was instituted more or less probable and any facts that
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`might be established based on this exhibit is of no consequence in determining the
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`issues on which trial was instituted. Introduction and evaluation of Exhibit 2072
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`would further lead to undue delay, confusion, and a waste of time. Exhibit 2072
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`contains out-of-court statements made by one or more declarants for the purpose of
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`proving the truth of the matter asserted.
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`OBJECTIONS TO EXHIBIT 2073
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`Evidence objected to: Exhibit 2073
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`Grounds for objection: Exhibit 2073, a document titled “Bloomberg L.P.
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`WACC Report for UTHR” is objected to under Fed. R. Evid. 401, 403, 801, 802,
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`and 901. Exhibit 2073 includes statements that do not make any fact relevant to the
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`grounds upon which trial was instituted more or less probable and any facts that
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`might be established based on this exhibit is of no consequence in determining the
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`issues on which trial was instituted. Introduction and evaluation of Exhibit 2073
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`would further lead to undue delay, confusion, and a waste of time. Exhibit 2073
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`contains out-of-court statements made by one or more declarants for the purpose of
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`proving the truth of the matter asserted. Exhibit 2073 has not been properly
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`authenticated.
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` OBJECTIONS TO EXHIBIT 2074
`Evidence objected to: Exhibit 2074
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`Grounds for objection: Exhibit 2074, a document titled “Pulmonary Arterial
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`Hypertension Market Surveillance ATU: Wave (Q2 ’15) – Final Report, Fielded July
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`2015, Internal” is objected to under Fed. R. Evid. 401, 403, 801, 802, and 901.
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`Exhibit 2074 includes statements that do not make any fact relevant to the grounds
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`upon which trial was instituted more or less probable and any facts that might be
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`established based on this exhibit is of no consequence in determining the issues on
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`which trial was instituted. Introduction and evaluation of Exhibit 2074 would further
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`lead to undue delay, confusion, and a waste of time. Exhibit 2074 contains out-of-
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`court statements made by one or more declarants for the purpose of proving the truth
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`of the matter asserted. Exhibit 2074 has not been properly authenticated.
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`OBJECTIONS TO EXHIBIT 2075
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`Evidence objected to: Exhibit 2075
`
`Grounds for objection: Exhibit 2075, a document titled “2014 Fourth-Quarter
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`and Annual Financial Results, Investor Conference Call Q&A, Internal” is objected
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`to under Fed. R. Evid. 401, 403, 801, 802, and 901. Exhibit 2075 includes statements
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`that do not make any fact relevant to the grounds upon which trial was instituted
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`more or less probable and any facts that might be established based on this exhibit
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`is of no consequence in determining the issues on which trial was instituted.
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`Introduction and evaluation of Exhibit 2075 would further lead to undue delay,
`
`confusion, and a waste of time. Exhibit 2075 contains out-of-court statements made
`
`by one or more declarants for the purpose of proving the truth of the matter asserted.
`
`Exhibit 2075 has not been properly authenticated.
`
` OBJECTIONS TO EXHIBIT 2081
`Evidence objected to: Exhibit 2081
`
`Grounds for objection: Exhibit 2081, U.S. Patent No. 8,410,121, is objected
`
`to under Fed. R. Evid. 401 and 403. Exhibit 2081 includes statements that do not
`
`make any fact relevant to the grounds upon which trial was instituted more or less
`
`probable and any facts that might be established based on this exhibit is of no
`
`consequence in determining the issues on which trial was instituted. Introduction
`
`and evaluation of Exhibit 2081 would further lead to undue delay, confusion, and a
`
`waste of time.
`
`OBJECTIONS TO EXHIBIT 2082
`
`
`Evidence objected to: Exhibit 2082
`
`Grounds for objection: Exhibit 2082, U.S. Patent No. 9,550,716, is objected
`
`to under Fed. R. Evid. 401 and 403. Exhibit 2082 includes statements that do not
`
`make any fact relevant to the grounds upon which trial was instituted more or less
`
`probable and any facts that might be established based on this exhibit is of no
`
`consequence in determining the issues on which trial was instituted. Introduction
`
`
`
`18
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`IPR2017-01621
`U.S. Patent No. 9,358,240 B2
`and evaluation of Exhibit 2082 would further lead to undue delay, confusion, and a
`
`waste of time.
`
`OBJECTIONS TO EXHIBIT 2083
`
`
`Evidence objected to: Exhibit 2083
`
`Grounds for objection: Exhibit 2083, a document titled “TRIUMPH I Phase
`
`II Clinical Trial Protocol” is objected to under Fed. R. Evid. 401, 403, 801, and 802.
`
`Exhibit 2083 includes statements that do not make any fact relevant to the grounds
`
`upon which trial was instituted more or less probable and any facts that might be
`
`established based on this exhibit is of no consequence in determining the issues on
`
`which trial was instituted. Introduction and evaluation of Exhibit 2083 would further
`
`lead to undue delay, confusion, and a waste of time. Exhibit 2083 also contains out-
`
`of-court statements made by one or more declarants for the purpose of proving the
`
`truth of the matter asserted.
`
` OBJECTIONS TO EXHIBIT 2084
`Evidence objected to: Exhibit 2084
`
`Grounds for objection: Exhibit 2084, a document titled “ClinicalTrials.gov
`
`entry for TRIUMPH trial, NCT00147199” is objected to under Fed. R. Evid. 401,
`
`403, 801, and 802. Exhibit 2084 includes statements that do not make any fact
`
`relevant to the grounds upon which trial was instituted more or less probable and
`
`any facts that might be established based on this exhibit is of no consequence in
`
`
`
`19
`
`
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`IPR2017-01621
`U.S. Patent No. 9,358,240 B2
`determining the issues on which trial was instituted. Introduction and evaluation of
`
`Exhibit 2084 would further lead to undue delay, confusion, and a waste of time.
`
`Exhibit 2084 also contains out-of-court statements made by one or more declarants
`
`for the purpose of proving the truth of the matter asserted.
`
` OBJECTIONS TO EXHIBIT 2085
`Evidence objected to: Exhibit 2085
`
`Grounds for objection: Exhibit 2085, a document titled “Declaration of Dean
`
`Bunce,” is objected to under Fed. R. Evid. 401, 403, 801, and 802. Exhibit 2085
`
`includes statements that do not make any fact relevant to the grounds upon which
`
`trial was instituted more or less probable and any facts that might be established
`
`based on this exhibit is of no consequence in determining the issues on which trial
`
`was instituted. Introduction and evaluation of Exhibit 2085 would further lead to
`
`undue delay, confusion, and a waste of time. Exhibit 2085 also contains out-of-court
`
`statements made by one or more declarants for the purpose of proving the truth of
`
`the matter asserted, and on which Petitioner has not had a chance to cross exam.
`
`OBJECTIONS TO EXHIBIT 2086
`
`
`Evidence objected to: Exhibit 2086
`
`Grounds for objection: Exhibit 2086, a document titled “February 17, 2010
`
`Withdrawal Letter” is objected to under Fed. R. Evid. 401, 403, 801, 802, and 901.
`
`Exhibit 2086 includes statements that do not make any fact relevant to the grounds
`
`
`
`20
`
`
`
`IPR2017-01621
`U.S. Patent No. 9,358,240 B2
`upon which trial was instituted more or less probable and any facts that might be
`
`established based on this exhibit is of no consequence in determining the issues on
`
`which trial was instituted. Introduction and evaluation of Exhibit 2086 would further
`
`lead to undue delay, confusion, and a waste of time. Exhibit 2086 contains out-of-
`
`court statements made by one or more declarants for the purpose of proving the truth
`
`of the matter asserted. Exhibit 2086 has not been properly authenticated.
`
` OBJECTIONS TO EXHIBIT 2087
`Evidence objected to: Exhibit 2087
`
`Grounds for objection: Exhibit 2087, a document titled “United Therapeutics
`
`Corporation 2017 10-K” is objected to under Fed. R. Evid. 401, 403, 801, 802, and
`
`901. Exhibit 2087 includes statements that do not make any fact relevant to the
`
`grounds upon which trial was instituted more or less probable and any facts that
`
`might be established based on this exhibit is of no consequence in determining the
`
`issues on which trial was instituted. Introduction and evaluation of Exhibit 2087
`
`would further lead to undue delay, confusion, and a waste of time. Exhibit 2087
`
`contains out-of-court statements made by one or more declarants for the purpose of
`
`proving the truth of the matter asserted. Exhibit 2087 has not been properly
`
`authenticated.
`
`
`
`21
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`
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`IPR2017-01621
`U.S. Patent No. 9,358,240 B2
`
` OBJECTIONS TO EXHIBIT 2088
`Evidence objected to: Exhibit 2088
`
`Grounds for objection: Exhibit 2088, a document titled “2012 Tyvaso Brand
`
`Plan, Internal” is objected to under Fed. R. Evid. 401, 403, 801, 802, and 901.
`
`Exhibit 2088 includes statements that do not make any fact relevant to the grounds
`
`upon which trial was instituted more or less probable and any facts that might be
`
`established based on this exhibit is of no consequence in determining the issues on
`
`which trial was instituted. Introduction and evaluation of Exhibit 2088 would further
`
`lead to undue delay, confusion, and a waste of time. Exhibit 2088 contains out-of-
`
`court statements made by one or more declarants for the purpose of proving the truth
`
`of the matter asserted. Exhibit 2088 has not been properly authenticated.
`
` OBJECTIONS TO EXHIBIT 2089
`Evidence objected to: Exhibit 2089
`
`Grounds for objection: Exhibit 2089, a document titled “Tyvaso Marketing
`
`Plan, December 2010, Internal” is objected to under Fed. R. Evid. 401, 403, 801,
`
`802, and 901. Exhibit 2089 includes statements that do not make any fact relevant
`
`to the grounds upon which trial was instituted more or less probable and any facts
`
`that might be established based on this exhibit is of no consequence in determining
`
`the issues on which trial was instituted. Introduction and evaluation of Exhibit 2089
`
`would further lead to undue delay, confusion, and a waste of time. Exhibit 2089
`
`
`
`22
`
`
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`IPR2017-01621
`U.S. Patent No. 9,358,240 B2
`contains out-of-court statements made by one or more declarants for the purpose of
`
`proving the truth of the matter asserted. Exhibit 2089 has not been properly
`
`authenticated.
`
` OBJECTIONS TO EXHIBIT 2090
`Evidence objected to: Exhibit 2090
`
`Grounds for objection: Exhibit 2090, a document titled “GlobalData
`
`Advanced Export - Pulmonary Arterial Hypertension, April 2017” is objected to
`
`under Fed. R. Evid. 401, 403, 801, 802, and 901. Exhibit 2090 includes statements
`
`that do not make any fact relevant to the grounds upon which trial was instituted
`
`more or less probable and any facts that might be established based on this exhibit
`
`is of no consequence in determining the issues on which trial was instituted.
`
`Introduction and evaluation of Exhibit 2090 would further lead to undue delay,
`
`confusion, and a waste of time. Exhibit 2090 contains out-of-court statements made
`
`by one or more declarants for the purpose of proving the truth of the matter asserted.
`
`Exhibit 2090 has not been properly authenticated.
`
` OBJECTIONS TO EXHIBIT 2092
`Evidence objected to: Exhibit 2092
`
`Grounds for objection: Exhibit 2092, a document titled “Email from British
`
`Library regarding Voswinckel” is objected to under Fed. R. Evid. 401, 403, 602,
`
`701, 702, 801, and 802. Exhibit 2092 includes statements that do not make any fact
`
`
`
`23
`
`
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`IPR2017-01621
`U.S. Patent No. 9,358,240 B2
`relevant to the grounds upon which trial was instituted more or less probable and
`
`any facts that might be established b
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