UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`STEADYMED LTD.
`
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`
`Patent Owner.
`
`
`
`Case IPR 2016-00006
`
`Patent No. 8,497,393B2
`
`____________
`
`PETITIONER’S OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`Mail Stop "Patent Board"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`WEST\270070187.1
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`
`
`
`
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________
`
`STEADYMED LTD.
`
`Petitioner,
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`
`Patent Owner.
`
`
`
`Case IPR 2016-00006
`
`Patent No. 8,497,393B2
`
`____________
`
`PETITIONER’S OBJECTIONS TO EVIDENCE
`PURSUANT TO 37 C.F.R. § 42.64
`
`
`
`
`Mail Stop "Patent Board"
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`WEST\270070187.1
`
`
`
`
`
`
`
`
`
`Petitioner SteadyMed Ltd. (“Petitioner”) hereby files its objections to the
`
`exhibits submitted with Patent Owner United Therapeutics’ Response to Petition
`
`for Inter Partes Review, Paper 31, in Case No. IPR2016-00006 (the “Response”).
`
`Petitioner’s objections to the below identified exhibits include the following:
`
`Exhibit
`
`Objection(s)
`
`Ex. 2020 (Declaration of Robert M.
`
`This exhibit is objected to as irrelevant
`
`Williams, Ph.D)1
`
`to the grounds upon which trial has been
`
`instituted (FRE 401-402), and as more
`
`prejudicial than probative (FRE 403).
`
`Petitioner further objects to Ex. 2020,
`
`under FRE 701, because the opinion
`
`testimony contained in this exhibit
`
`reaches legal conclusions for which the
`
`declarant has not established that he is
`
`credible for providing, as shown in
`
`Paragraphs 73 and 76, among others.
`
`Ex. 2021 (Curriculum Vitae of Robert
`
`This exhibit is objected to as irrelevant
`
`M. Williams, Ph.D)
`
`to the grounds upon which trial has been
`
`
`1 Patent Owner has filed certain exhibits under seal, including portions of Exs. 2020
`and 2022, and 2052-2054 in their entirety. Petitioner sets forth all of its objections
`to both Patent Owner’s sealed and non-sealed evidence in the foregoing objections.
`WEST\270070187.1
`2
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`
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`Exhibit
`
`Objection(s)
`
`instituted (FRE 401-402), and as more
`
`prejudicial than probative (FRE 403).
`
`Ex. 2022 (Declaration of Robert R.
`
`This exhibit is objected to as irrelevant
`
`Ruffolo, Jr., Ph.D)
`
`to the grounds upon which trial has been
`
`instituted (FRE 401-402), and as more
`
`prejudicial than probative (FRE 403).
`
`Petitioner further objects to Ex. 2022,
`
`under FRE 701, because the opinion
`
`testimony contained in this exhibit
`
`reaches legal conclusions for which the
`
`declarant has not established that he is
`
`credible for providing, as shown in
`
`Paragraphs 64, 67, 69, and 74, among
`
`others. Petitioner further objects to Ex.
`
`2022 under FRE 702 (improper expert
`
`testimony) and Daubert v. Merrell Dow
`
`Pharmaceuticals, Inc., 509 U.S. 579
`
`(1993). Indeed, Dr. Ruffolo does not
`
`possess the requisite credentials or
`
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`3
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`
`
`Exhibit
`
`Objection(s)
`
`expertise to render opinions in this trial,
`
`as he has no background in analytical
`
`chemistry/HPLC, medicinal chemistry,
`
`or organic chemistry, nor does he have
`
`any experience working for the FDA
`
`(yet opines as to what would be
`
`“significant and clinically meaningful to
`
`the FDA”, Ex. 2022 at Para. 67).
`
`Additionally, Dr. Ruffolo’s declaration
`
`is used to support Patent Owner’s claim
`
`regarding an alleged long-felt unmet
`
`need for the ‘393 Patent, but does not,
`
`for example, contain sufficient evidence
`
`of a nexus between the claimed
`
`invention and Patent Owner’s
`
`commercial success. See Decision,
`
`Paper 28, at 51; Ex. 2022, at Para. 31.
`
`Ex. 2023 (Curriculum Vitae of Robert
`
`This exhibit is objected to as irrelevant
`
`R. Ruffolo, Jr., Ph.D)
`
`to the grounds upon which trial has been
`
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`4
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`
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`Exhibit
`
`Objection(s)
`
`instituted (FRE 401-402), and as more
`
`prejudicial than probative (FRE 403).
`
`Ex. 2025 (Prosecution History of U.S.
`
`This exhibit is objected to as irrelevant
`
`Patent No. 6,209,259)
`
`to the grounds upon which trial has been
`
`instituted (FRE 401-402), and as unduly
`
`prejudicial (FRE 403). Ex. 2025
`
`concerns statements from the
`
`prosecution history of unrelated patent,
`
`and is used solely to buttress the claim
`
`that the Board should overturn its
`
`previous claim construction ruling. It
`
`has no relevance to any issue in this
`
`proceeding.
`
`Ex. 2026 (Williams, et.al., Asymmetric,
`
`This exhibit is objected to as irrelevant
`
`Stereocontrolled Total Synthesis of
`
`to the grounds upon which trial has been
`
`Paraherquamide A, J. Am. Chem. Soc.
`
`instituted (FRE 401-402), and as more
`
`2003, 125, 12172-12178.)
`
`prejudicial than probative (FRE 403). It
`
`is not substantively relied upon by
`
`Patent Owner in its Response.
`
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`5
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`
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`Exhibit
`
`Objection(s)
`
`Petitioner further objects to Ex. 2026 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2026 for lack of authentication
`
`(FRE 901).
`
`Ex. 2027 (Williams, et.al.,
`
`This exhibit is objected to as irrelevant
`
`Stereocontrolled Total Synthesis of (+)-
`
`to the grounds upon which trial has been
`
`Paraherquamide B, J. Am. Chem. Soc.
`
`instituted (FRE 401-402), and as more
`
`1996, 118, 557-579.)
`
`prejudicial than probative (FRE 403). It
`
`is not substantively relied upon by
`
`Patent Owner in its Response.
`
`Petitioner further objects to Ex. 2027 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2027 for lack of authentication
`
`(FRE 901).
`
`Ex. 2028 (Williams, et.al., Synthetic
`
`This exhibit is objected to as irrelevant
`
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`6
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`
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`Exhibit
`
`Objection(s)
`
`Studies on Et-743. Assembly of the
`
`to the grounds upon which trial has been
`
`Pentacyclic Core and a Formal Total
`
`instituted (FRE 401-402), and as more
`
`Synthesis, J. Org. Chem. 2008, 73,
`
`prejudicial than probative (FRE 403). It
`
`9594-9600.)
`
`is not substantively relied upon by
`
`Patent Owner in its Response.
`
`Petitioner further objects to Ex. 2028 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2028 for lack of authentication
`
`(FRE 901).
`
`Ex. 2029 (Winkler, J., et.al., A Pauson-
`
`This exhibit is objected to as irrelevant
`
`Khand Approach to the Synthesis of
`
`to the grounds upon which trial has been
`
`Ingenol, Org. Lett., 2005, 8, 1489-1491)
`
`instituted (FRE 401-402), and as more
`
`prejudicial than probative (FRE 403). It
`
`is not substantively relied upon by
`
`Patent Owner in its Response.
`
`Petitioner further objects to Ex. 2029 as
`
`constituting hearsay for which no
`
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`7
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`
`
`Exhibit
`
`Objection(s)
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2029 for lack of authentication
`
`(FRE 901).
`
`Ex. 2030 (R. Adhiyaman, et.al., Crystal
`
`This exhibit is objected to as irrelevant
`
`modification of dipyridamole using
`
`to the grounds upon which trial has been
`
`different solvents and crystallization
`
`instituted (FRE 401-402), and as more
`
`conditions, Int’l J. Pharm. 2006, 321,
`
`prejudicial than probative (FRE 403).
`
`27-34)
`
`Petitioner further objects to Ex. 2030 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2030 for lack of authentication
`
`(FRE 901).
`
`Ex. 2031 (Marti, E., Purity
`
`This exhibit is objected to as irrelevant
`
`determination by differential scanning
`
`to the grounds upon which trial has been
`
`calorimetry, Thermochimica Acta,
`
`instituted (FRE 401-402), and as more
`
`1972, 5, 173-220)
`
`prejudicial than probative (FRE 403).
`
`Petitioner further objects to Ex. 2031 as
`
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`8
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`
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`Exhibit
`
`Objection(s)
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2031 for lack of authentication
`
`(FRE 901).
`
`Ex. 2032 (U.S. Patent No. 4,306,075)
`
`This exhibit is objected to as irrelevant
`
`to the grounds upon which trial has been
`
`instituted (FRE 401-402), and as more
`
`prejudicial than probative (FRE 403).
`
`Ex. 2032 concerns a patent directed to
`
`the preparation of treprostinil generally,
`
`which is unrelated to any issue in this
`
`proceeding.
`
`Ex. 2033 (U.S. Patent Nos. 5,153,222)
`
`This exhibit is objected to as irrelevant
`
`to the grounds upon which trial has been
`
`instituted (FRE 401-402), and as more
`
`prejudicial than probative (FRE 403).
`
`Ex. 2033 concerns a patent directed to
`
`the use of treprostinil for treatment of
`
`WEST\270070187.1
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`9
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`
`
`Exhibit
`
`Objection(s)
`
`pulmonary hypertension, which is
`
`unrelated to any issue in this
`
`proceeding.
`
`Ex. 2034 (ICH Guidance For Industry:
`
`This exhibit is objected to as irrelevant
`
`Q7A Good Manufacturing Practice
`
`to the grounds upon which trial has been
`
`Guidance for Active Pharmaceutical
`
`instituted (FRE 401-402), and as more
`
`Ingredients (2001))
`
`prejudicial than probative (FRE 403). It
`
`is not substantively relied upon by
`
`Patent Owner in its Response.
`
`Petitioner further objects to Ex. 2034 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2034 for lack of authentication
`
`(FRE 901).
`
`Ex. 2035 (Reviewer Guidance:
`
`This exhibit is objected to as irrelevant
`
`Validation of Chromatographic Methods
`
`to the grounds upon which trial has been
`
`(1994))
`
`WEST\270070187.1
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`instituted (FRE 401-402), and as more
`
`prejudicial than probative (FRE 403). It
`
`10
`
`
`
`Exhibit
`
`Objection(s)
`
`is not substantively relied upon by
`
`Patent Owner in its Response.
`
`Petitioner further objects to Ex. 2035 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2035 for lack of authentication
`
`(FRE 901).
`
`Ex. 2036 (Certificate of Analysis data
`
`This exhibit is objected to as irrelevant
`
`for 56 samples of treprostinil product as
`
`to the grounds upon which trial has been
`
`produced by the prior art process
`
`instituted (FRE 401-402), and as more
`
`according to Moriarty through 2004)
`
`prejudicial than probative (FRE 403).
`
`Petitioner further objects to Ex. 2036 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2036 for lack of authentication
`
`(FRE 901).
`
`Ex. 2037 (Certificate of Analysis data
`
`This exhibit is objected to as irrelevant
`
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`11
`
`
`
`Exhibit
`
`Objection(s)
`
`for 157 samples of treprostinil product
`
`to the grounds upon which trial has been
`
`as produced by the ’393 patent
`
`instituted (FRE 401-402), and as more
`
`processes)
`
`prejudicial than probative (FRE 403).
`
`Petitioner further objects to Ex. 2037 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2037 for lack of authentication
`
`(FRE 901).
`
`Ex. 2038 (ICH Harmonised Tripartite
`
`This exhibit is objected to as irrelevant
`
`Guideline: Impurities in New Drug
`
`to the grounds upon which trial has been
`
`Substances Q3A(R2) (2006))
`
`instituted (FRE 401-402), and as more
`
`prejudicial than probative (FRE 403).
`
`Petitioner further objects to Ex. 2038 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2038 for lack of authentication
`
`(FRE 901).
`
`12
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`WEST\270070187.1
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`
`
`Exhibit
`
`Objection(s)
`
`Ex. 2039 (ICH Guidance for Industry:
`
`This exhibit is objected to as irrelevant
`
`M7 Assessment and Control of DNA
`
`to the grounds upon which trial has been
`
`Reactive (Mutagenic) Impurities in
`
`instituted (FRE 401-402), and as more
`
`Pharmaceuticals to Limit Potential
`
`prejudicial than probative (FRE 403).
`
`Carcinogenic Risk (2015))
`
`Petitioner further objects to Ex. 2039 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2039 for lack of authentication
`
`(FRE 901).
`
`Ex. 2040 (Olsen, Bernard A., What’s
`
`This exhibit is objected to as irrelevant
`
`New with Impurities in
`
`to the grounds upon which trial has been
`
`Pharmaceuticals?, Southern California
`
`instituted (FRE 401-402), and as more
`
`Pharmaceutical Discussion Group,
`
`prejudicial than probative (FRE 403).
`
`January 15, 2015)
`
`Petitioner further objects to Ex. 2040 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2040 for lack of authentication
`
`WEST\270070187.1
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`13
`
`
`
`Exhibit
`
`Objection(s)
`
`(FRE 901).
`
`Ex. 2041 (“Janet Woodcock,” available
`
`This exhibit is objected to as irrelevant
`
`at
`
`to the grounds upon which trial has been
`
`http://www.fiercebiotech.com/special-
`
`instituted (FRE 401-402), and as more
`
`report/janet-woodcock-fda (accessed
`
`prejudicial than probative (FRE 403). It
`
`July 6, 2016))
`
`is not substantively relied upon by
`
`Patent Owner in its Response. Petitioner
`
`further objects to Ex. 2041 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2041 for lack of authentication
`
`(FRE 901). Ex. 2041 relates solely to
`
`approval of new drugs by the FDA,
`
`which is unrelated to any issue in this
`
`proceeding.
`
`Ex. 2042 (Carpenter, The Political
`
`This exhibit is objected to as irrelevant
`
`Economy of FDA Drug Review:
`
`to the grounds upon which trial has been
`
`Processing, Politics and Lessons for
`
`instituted (FRE 401-402), and as more
`
`WEST\270070187.1
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`14
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`
`
`Exhibit
`
`Objection(s)
`
`Policy (2004))
`
`prejudicial than probative (FRE 403). It
`
`is not substantively relied upon by
`
`Patent Owner in its Response.
`
`Petitioner further objects to Ex. 2042 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2042 for lack of authentication
`
`(FRE 901).
`
`Ex. 2043 (ICH Draft Consensus
`
`This exhibit is objected to as irrelevant
`
`Guideline: Guideline for Elemental
`
`to the grounds upon which trial has been
`
`Impurities Q3D (2013))
`
`instituted (FRE 401-402), and as more
`
`prejudicial than probative (FRE 403). It
`
`is not substantively relied upon by
`
`Patent Owner in its Response. Petitioner
`
`further objects to Ex. 2043 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
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`15
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`
`
`Exhibit
`
`Objection(s)
`
`Ex. 2043 for lack of authentication
`
`(FRE 901).
`
`Ex. 2044 (ICH Guidance For Industry:
`
`This exhibit is objected to as irrelevant
`
`Q7A Good Manufacturing Practice
`
`to the grounds upon which trial has been
`
`Guidance for Active Pharmaceutical
`
`instituted (FRE 401-402), and as more
`
`Ingredients (2001))
`
`prejudicial than probative (FRE 403).
`
`Petitioner further objects to Ex. 2044 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2044 for lack of authentication
`
`(FRE 901).
`
`Ex. 2045 (Schrager et al.,
`
`This exhibit is objected to as irrelevant
`
`Diethylstilbestrol Exposure, American
`
`to the grounds upon which trial has been
`
`Family Physician, 2004, 10, 2395-
`
`instituted (FRE 401-402), and as more
`
`2400.)
`
`prejudicial than probative (FRE 403).
`
`Petitioner further objects to Ex. 2045 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`WEST\270070187.1
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`16
`
`
`
`Exhibit
`
`Objection(s)
`
`801/802). Petitioner further objects to
`
`Ex. 2045 for lack of authentication
`
`(FRE 901). Ex. 2045 relates to
`
`diethylstilbestrol exposure and animal
`
`safety studies, which are unrelated to
`
`any issue in this proceeding.
`
`Ex. 2046 (NTP Report on Carcinogens
`
`This exhibit is objected to as irrelevant
`
`Background Document for Saccharin
`
`to the grounds upon which trial has been
`
`(1999))
`
`instituted (FRE 401-402), and as more
`
`prejudicial than probative (FRE 403). It
`
`is not substantively relied upon by
`
`Patent Owner in its Response.
`
`Petitioner further objects to Ex. 2046 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2046 for lack of authentication
`
`(FRE 901). Ex. 2046 relates to
`
`saccharin and animal safety studies,
`
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`17
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`
`
`Exhibit
`
`Objection(s)
`
`which are unrelated to any issue in this
`
`proceeding.
`
`Ex. 2047 (FDA Guidance for Industry:
`
`This exhibit is objected to as irrelevant
`
`Non-Penicillin Beta-Lactam Drugs: A
`
`to the grounds upon which trial has been
`
`CGMP Framework for Preventing
`
`instituted (FRE 401-402), and as more
`
`Cross-Contamination (2013)))
`
`prejudicial than probative (FRE 403). It
`
`is not substantively relied upon by
`
`Patent Owner in its Response.
`
`Petitioner further objects to Ex. 2047 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2047 for lack of authentication
`
`(FRE 901). Ex. 2047 relates to
`
`impurities in beta-lactam antibiotics,
`
`which is unrelated to any issue in this
`
`proceeding.
`
`Ex. 2048 (Heinemann and Richter,
`
`This exhibit is objected to as irrelevant
`
`Clinical Pharmacology of Human
`
`to the grounds upon which trial has been
`
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`18
`
`
`
`Exhibit
`
`Objection(s)
`
`Insulin, Diabetes Care, 1993, 3, 90-
`
`instituted (FRE 401-402), and as more
`
`100.)
`
`prejudicial than probative (FRE 403). It
`
`is not substantively relied upon by
`
`Patent Owner in its Response.
`
`Petitioner further objects to Ex. 2048 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2048 for lack of authentication
`
`(FRE 901). Ex. 2048 pertains to the
`
`manufacture of insulin, which is
`
`unrelated to any issue in this
`
`proceeding. It is not substantively relied
`
`upon by Patent Owner in its Response.
`
`Ex. 2049 (“FDA: Drug Shortages,”
`
`This exhibit is objected to as irrelevant
`
`available at
`
`to the grounds upon which trial has been
`
`http://www.fda.gov/Drugs/DrugSafety/
`
`instituted (FRE 401-402), and as more
`
`DrugShortages/ (accessed July 5, 2016))
`
`prejudicial than probative (FRE 403). It
`
`is not substantively relied upon by
`
`WEST\270070187.1
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`19
`
`
`
`Exhibit
`
`Objection(s)
`
`Patent Owner in its Response.
`
`Petitioner further objects to Ex. 2049 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2049 for lack of authentication
`
`(FRE 901). Ex. 2049 relates to
`
`shortages in drug supply, which is not
`
`related to any issue in this proceeding.
`
`Ex. 2050 (FDA Guidance for Industry:
`
`This exhibit is objected to as irrelevant
`
`Changes to an Approved NDA or
`
`to the grounds upon which trial has been
`
`ANDA, (2004))
`
`instituted (FRE 401-402), and as more
`
`prejudicial than probative (FRE 403).
`
`Ex. 2050 is not substantively relied
`
`upon by Patent Owner in its Response.
`
`Indeed, nowhere in the Response does
`
`Patent Owner cite or otherwise
`
`reference Ex. 2050. Petitioner further
`
`objects to Ex. 2050 as constituting
`
`WEST\270070187.1
`
`
`20
`
`
`
`Exhibit
`
`Objection(s)
`
`hearsay for which no exception has been
`
`established (FRE 801/802). Petitioner
`
`further objects to Ex. 2050 for lack of
`
`authentication (FRE 901).
`
`Ex. 2051 (Winkler deposition transcript) This exhibit is objected to as irrelevant
`
`to the grounds upon which trial has been
`
`instituted (FRE 401-402), and as more
`
`prejudicial than probative (FRE 403), to
`
`the extent: (1) Patent Owner relies on
`
`selective misstatements or misquotes
`
`from Dr. Winkler in its Response, which
`
`are not reflected in Ex. 2051 (see, e.g.,
`
`Response, at 30), or (2) cites to portions
`
`of the transcript that have no relevance
`
`to any issue in this proceeding (see, e.g.,
`
`Response, at 30, fn. 2).
`
`Ex. 2052 (UT-15 Injection Drug
`
`This exhibit is objected to as irrelevant
`
`Substance Volume 1.2 Chemistry,
`
`to the grounds upon which trial has been
`
`Manufacturing and Controls, NDA 21-
`
`instituted (FRE 401-402), and as more
`
`WEST\270070187.1
`
`
`21
`
`
`
`272))
`
`Exhibit
`
`Objection(s)
`
`prejudicial than probative (FRE 403).
`
`Petitioner further objects to Ex. 2052 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2052 for lack of authentication
`
`(FRE 901).
`
`Ex. 2053 (United Therapeutics NDA
`
`This exhibit is objected to as irrelevant
`
`Annual Report, Remodulin®
`
`to the grounds upon which trial has been
`
`(treprostinil sodium) Injection))
`
`instituted (FRE 401-402), and as more
`
`prejudicial than probative (FRE 403).
`
`Petitioner further objects to Ex. 2053 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2053 for lack of authentication
`
`(FRE 901).
`
`Ex. 2054 (United Therapeutics Silver
`
`This exhibit is objected to as irrelevant
`
`Spring Process Optimization Report for
`
`to the grounds upon which trial has been
`
`WEST\270070187.1
`
`
`22
`
`
`
`Exhibit
`
`Objection(s)
`
`the Conversion of UT-15C Intermediate
`
`instituted (FRE 401-402), and as more
`
`to UT-15 API (Treprostinil))
`
`prejudicial than probative (FRE 403).
`
`Petitioner further objects to Ex. 2054 as
`
`constituting hearsay for which no
`
`exception has been established (FRE
`
`801/802). Petitioner further objects to
`
`Ex. 2054 for lack of authentication
`
`(FRE 901).
`
`
`
`Petitioner reserves the right to further object to this and other evidence based
`
`on Patent Owner’s subsequent use of and arguments based on such evidence.
`
`
`
`
`
`Date: July 13, 2016
`
`
`/s Stuart E. Pollack /
`Stuart E. Pollack, J.D. Ph.D.
`Reg. No. 43,862
`DLA Piper LLP (US)
`
`
`
`Respectfully submitted,
`
`/s Lisa A. Haile / __________
`Lisa A. Haile, J.D., Ph.D.
` Reg. No. 38,347
`DLA Piper LLP (US)
`
`WEST\270070187.1
`
`
`23
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the attached Petitioner’s Objections
`
`to Patent Owner’s Response Evidence was served via electronic mail to the
`
`following:
`
`Stephen B. Maebius
`George Quillin
`FOLEY & LARDNER LLP
`UT393-IPR@foley.com
`
`Shaun R. Snader
`UNITED THERAPEUTICS CORP.
`ssnader@unither.com
`
`Douglas Carsten
`Richard Torczon
`Robert Delafield
`WILSON, SONSINI, GOODRICH & ROSATI
`dcarsten@wsgr.com
`rtorczon@wsgr.com
`bdelafield@wsgr.com
`
`
`
`
`/s Lisa A. Haile /
`Lisa A. Haile, J.D., Ph.D.
`Reg. No. 38,347
`DLA Piper LLP (US)
`
`
`
`
`
`Date: July 13, 2016
`
`
`/s Stuart E. Pollack /
`Stuart E. Pollack, J.D., Ph.D.
`Reg. No. 43,862
`DLA Piper LLP (US)
`
`
`
`WEST\270070187.1
`
`
`24
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