UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`HOSPIRA, INC.,
`Patent Owner.
`____________
`
`Case No. IPR2016-01578
`Patent 8,338,470
`____________
`
`
`
`
`PATENT OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64 TO
`PETITIONER’S EVIDENCE SUBMITTED WITH
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,338,470
`
`
`
`
`1
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`
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`HOSPIRA, INC.,
`Patent Owner.
`____________
`
`Case No. IPR2016-01578
`Patent 8,338,470
`____________
`
`
`
`
`PATENT OWNER’S OBJECTIONS UNDER 37 C.F.R. § 42.64 TO
`PETITIONER’S EVIDENCE SUBMITTED WITH
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,338,470
`
`
`
`
`1
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`Patent Owner, Hospira, Inc., respectfully submits the following objections to
`
`exhibits filed by Petitioner on August 10, 2016, in conjunction with its Petition for
`
`Inter Partes Review of U.S. Patent No. 8,338,470 (“the Petition”). These
`
`objections are made within ten business days from the institution of the trial on
`
`February 9, 2017 (see Paper No. 11).
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`The following chart lists Patent Owner’s objections to the admissibility of
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`certain documents (identified below) that accompany the Petition, and the basis for
`
`those objections:
`
`Objected to Exhibit
`
`Basis for Objection
`
`FRE 901: This exhibit has not been authenticated.
`
`Petitioner has not provided evidence regarding the
`
`origin of the document or whether the document is a
`
`true and correct copy.
`
`FRE 802: This evidence cites to and incorporates
`
`hearsay. Because no hearsay exception applies, the
`
`identified exhibit is inadmissible in this proceeding.
`
`35 U.S.C. § 311(b): Petitioner has not provided
`
`evidence that the exhibit is a prior art publication
`
`Exhibit 1015
`
`
`
`
`
`2
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`
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`because Petitioner has not authenticated the exhibit
`
`or provided admissible evidence regarding the date
`
`upon which it became publicly available.
`
`FRE 401-403: This exhibit is irrelevant because it
`
`has not been authenticated and proven as a prior art
`
`reference. Moreover, the exhibit and the statements
`
`therein are irrelevant and therefore inadmissible,
`
`and/or their probative value, if any, is substantially
`
`outweighed by a danger of one or more of the
`
`following: unfair prejudice, confusing the issues,
`
`and/or wasting time.
`
`For example, Exhibit 1015 describes the benefits of
`
`centralized preparation of drugs in “ready to use
`
`syringes” to reduce contamination in pediatric and
`
`neonatal
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`intensive
`
`care
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`units. Centralized
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`preparation of drugs in syringes is irrelevant to drug
`
`compositions that are manufactured in “ready to
`
`use” form. Such disclosure, therefore, is irrelevant
`
`and of little probative value in light of the confusion
`
`3
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`Exhibit 1016
`
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`that would be introduced by this exhibit.
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`FRE 901: This exhibit has not been authenticated.
`
`Petitioner has not provided evidence regarding the
`
`origin of the document or whether the document is a
`
`true and correct copy.
`
`FRE 802: This evidence cites to and incorporates
`
`hearsay. Because no hearsay exception applies, the
`
`exhibit is inadmissible in this proceeding.
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`35 U.S.C. § 311(b): Petitioner has not provided
`
`evidence that the exhibit is a prior art publication
`
`because Petitioner has not authenticated the exhibit
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`or provided admissible evidence regarding the date
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`upon which it became publicly available.
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`FRE 401-403: This exhibit is irrelevant because it
`
`has not been authenticated and proven as a prior art
`
`reference. Moreover, the exhibit and the statements
`
`therein are irrelevant and therefore inadmissible,
`
`and/or their probative value, if any, is substantially
`
`
`
`4
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`outweighed by a danger of one or more of the
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`following: unfair prejudice, confusing the issues,
`
`and/or wasting time.
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`For example, Exhibit 1016 discusses a variety of
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`strategies for reducing medication error that are
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`irrelevant to ready to use compositions, focusing
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`primarily on centralized preparation of drug
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`dilutions in syringes. Such disclosure is, therefore,
`
`irrelevant and of little probative value in light of the
`
`confusion and waste of
`
`time
`
`that would be
`
`introduced by this exhibit.
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`FRE 901: This exhibit has not been authenticated.
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`Petitioner has not provided evidence regarding the
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`origin of the document or whether the document is a
`
`true and correct copy.
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`FRE 802: This evidence cites to and incorporates
`
`hearsay. Because no hearsay exception applies, the
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`exhibit is inadmissible in this proceeding.
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`Exhibit 1017
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`
`
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`5
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`
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`35 U.S.C. § 311(b): Petitioner has not provided
`
`evidence that the exhibit is a prior art publication
`
`because Petitioner has not authenticated the exhibit
`
`or provided admissible evidence regarding the date
`
`upon which it became publicly available.
`
`FRE 401-403: This exhibit is irrelevant because it
`
`has not been authenticated and proven as a prior art
`
`reference. Moreover, the exhibit and the statements
`
`therein are irrelevant and therefore inadmissible,
`
`and/or their probative value, if any, is substantially
`
`outweighed by a danger of one or more of the
`
`following: unfair prejudice, confusing the issues,
`
`and/or wasting time.
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`For example, Exhibit 1017 discusses adsorption
`
`tests for different drugs at different concentrations to
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`a variety of materials. Moreover, the reference
`
`reveals no drug loss at concentrations significantly
`
`lower than the claimed concentration ranges, further
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`
`
`6
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`demonstrating the irrelevance of the reference.
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`Such disclosure is, therefore, of little probative
`
`value in light of the confusion that would be
`
`introduced by this exhibit, and the unfair prejudice
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`that would result from misrepresentations of the data
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`and its significance.
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`FRE 901: This exhibit has not been authenticated.
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`Petitioner has not provided evidence regarding the
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`origin of the document or whether the document is a
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`true and correct copy.
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`FRE 802: This evidence cites to and incorporates
`
`hearsay. Because no hearsay exception applies, the
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`exhibit is inadmissible in this proceeding.
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`35 U.S.C. § 311(b): Petitioner has not provided
`
`evidence that the exhibit is a prior art publication
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`because Petitioner has not authenticated the exhibit
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`or provided admissible evidence regarding the date
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`upon which it became publicly available.
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`Exhibit 1018
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`7
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`FRE 401-403: This exhibit is irrelevant because it
`
`has not been authenticated and proven as a prior art
`
`reference. Moreover, the exhibit and the statements
`
`therein are irrelevant and therefore inadmissible,
`
`and/or their probative value, if any, is substantially
`
`outweighed by a danger of one or more of the
`
`following: unfair prejudice, confusing the issues,
`
`and/or wasting time.
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`For example, Exhibit 1018 is a pharmaceutical label
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`advertising 0.9% sodium chloride solutions in four
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`different packaging materials, only one of which is
`
`glass, and does not indicate a preference for one
`
`over the other. Moreover, Exhibit 1018 instructs that
`
`when a drug is added to the solution, the admixture
`
`should be dispensed instantly, so the described
`
`containers are not intended or suitable for preparing
`
`a ready to use drug composition. Such disclosure is,
`
`therefore, irrelevant to the selection of storage
`
`container for a ready to use drug composition, and
`
`8
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`of little probative value in light of the confusion that
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`would be introduced by this exhibit.
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`FRE 901: This exhibit has not been authenticated.
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`Petitioner has not provided evidence regarding the
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`origin of the document or whether the document is a
`
`true and correct copy.
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`FRE 802: This evidence cites to and incorporates
`
`hearsay. Because no hearsay exception applies, the
`
`exhibit is inadmissible in this proceeding.
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`FRE 901: These exhibits have not been
`
`authenticated. Petitioner has not provided evidence
`
`regarding the origin of the documents or whether the
`
`documents are true and correct copies.
`
`FRE 802: This evidence cites to and incorporates
`
`hearsay. Because no hearsay exception applies, the
`
`exhibits are inadmissible in this proceeding.
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`35 U.S.C. § 311(b): Petitioner has not provided
`
`9
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`Exhibit 1019
`
`
`Exhibit 1020
`Exhibit 1021
`Exhibit 1022
`Exhibit 1023
`Exhibit 1024
`Exhibit 1025
`Exhibit 1026
`Exhibit 1027
`Exhibit 1028
`Exhibit 1029
`Exhibit 1030
`Exhibit 1034
`Exhibit 1035
`Exhibit 1040
`Exhibit 1041
`Exhibit 1042
`Exhibit 1043
`Exhibit 1045
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`evidence that the exhibits are prior art publications
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`because Petitioner has not authenticated the exhibits
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`or provided admissible evidence regarding the dates
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`upon which they became publicly available.
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`FRE 401-403: At least because these exhibits have
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`not been authenticated and proven to have been
`
`publicly available prior to January 4, 2012, the
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`exhibits are irrelevant
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`to this proceeding and
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`therefore inadmissible, and/or their probative value,
`
`if any, is substantially outweighed by a danger of
`
`one or more of the following: unfair prejudice,
`
`confusing the issues, and/or wasting time.
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`FRE 401-403: Exhibits 1006 and 1037 were only
`
`relied upon by Petitioner in Ground 2 of its Petition,
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`and Ground 2 was not instituted by the Board.
`
`Therefore these exhibits are irrelevant to this IPR
`
`proceeding.
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`FRE 901: This exhibit has not been authenticated.
`
`10
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`Exhibit 1006
`Exhibit 1037
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`Exhibit 1036
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`Petitioner has not provided evidence regarding the
`
`origin of the document or whether the document is a
`
`true and correct copy.
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`FRE 802: This evidence cites to and incorporates
`
`hearsay. Because no hearsay exception applies, the
`
`exhibit is inadmissible in this proceeding.
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`35 U.S.C. § 311(b): Petitioner has not provided
`
`evidence that the exhibit is a prior art publication
`
`because Petitioner has not authenticated the exhibit
`
`or provided admissible evidence regarding the date
`
`upon which it became publicly available.
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`FRE 401-403: At least because this exhibit has not
`
`been authenticated and proven to have been publicly
`
`available prior to January 4, 2012, the exhibit is
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`irrelevant
`
`to
`
`this proceeding and
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`therefore
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`inadmissible, and/or their probative value, if any, is
`
`substantially outweighed by a danger of one or more
`
`of the following: unfair prejudice, confusing the
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`
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`11
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`Exhibit 1038
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`issues, and/or wasting time. Moreover, this exhibit
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`is only relied upon by Petitioner in Ground 2 of the
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`Petition, and Ground 2 was not instituted by the
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`Board. Therefore Exhibit 1036 is irrelevant to this
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`IPR proceeding.
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`FRE 802: This evidence cites to and incorporates
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`hearsay. Because no hearsay exception applies, the
`
`exhibit is inadmissible in this proceeding.
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`35 U.S.C. § 311(b): Petitioner has not provided
`
`evidence that this exhibit is a prior art publication.
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`Moreover, on its face, the exhibit appears to have
`
`been published on April 1, 2012, which is after the
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`priority date of the challenged patent. Therefore this
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`evidence is inadmissible in this proceeding because
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`it is not a prior art publication.
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`FRE 401-403: At least because this exhibit is not
`
`prior art to the challenged patent, it is irrelevant to
`
`this proceeding and therefore inadmissible, and/or
`
`
`
`12
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`Exhibit 1039
`
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`its probative value,
`
`if any,
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`is substantially
`
`outweighed by a danger of one or more of the
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`following: unfair prejudice, confusing the issues,
`
`and/or wasting time.
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`FRE 901: The documents in this exhibit have not
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`been authenticated. Petitioner has not provided
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`evidence regarding the origin of the documents or
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`whether the documents are true and correct copies.
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`FRE 802: This evidence cites to and incorporates
`
`hearsay. Because no hearsay exception applies, the
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`documents are inadmissible in this proceeding.
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`35 U.S.C. § 311(b): Petitioner has not provided
`
`evidence, and does not appear to assert, that the
`
`exhibit is a prior art publication. Petitioner has not
`
`authenticated the exhibit or provided admissible
`
`evidence regarding the date upon which it became
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`publicly available. Moreover, the only citation to
`
`this exhibit is in Dr. Cain’s declaration, which refers
`
`
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`13
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`to “March 2015” as a publication date. Therefore
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`this evidence is inadmissible because it is not a prior
`
`art publication.
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`FRE 401-403: At least because this exhibit has not
`
`been proven or alleged to be prior art to the
`
`challenged patent, the exhibit is irrelevant to this
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`proceeding and therefore inadmissible, and/or its
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`probative value, if any, is substantially outweighed
`
`by a danger of one or more of the following: unfair
`
`prejudice, confusing the issues, and/or wasting time.
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`Moreover, certain pages of this exhibit are not cited
`
`anywhere in the Petition or Expert Declarations and
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`are, therefore, irrelevant.
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`FRE 901: This exhibit has not been authenticated.
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`Petitioner has not provided evidence regarding the
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`origin of the document or whether the document is a
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`true and correct copy.
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`FRE 802: This evidence cites to and incorporates
`
`Exhibit 1044
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`
`
`14
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`hearsay. Because no hearsay exception applies, the
`
`exhibit is inadmissible in this proceeding.
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`35 U.S.C. § 311(b): Petitioner has not provided
`
`evidence that the exhibit is a prior art publication
`
`because Petitioner has not authenticated the exhibit
`
`or provided admissible evidence regarding the date
`
`upon which it became publicly available.
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`FRE 401-403: At least because the exhibit and the
`
`statements
`
`therein are
`
`irrelevant and
`
`therefore
`
`inadmissible, and/or their probative value, if any, is
`
`substantially outweighed by a danger of one or more
`
`of the following: unfair prejudice, confusing the
`
`issues, and/or wasting time.
`
`For example, Exhibit 1044 is a definition for
`
`“injectable medicines” which
`
`contains
`
`an
`
`explanation of the term “ready-to-use.” The only
`
`date listed on the document is an access date of
`
`August 9, 2016. A published definition of a term
`
`
`
`15
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`
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`available
`
`in 2016
`
`is
`
`irrelevant
`
`to a POSA’s
`
`knowledge and understanding of the relevant art as
`
`of the priority date of January 4, 2012. Such
`
`disclosure is, therefore, irrelevant and of little
`
`probative value in light of the confusion that would
`
`be introduced by this exhibit.
`
`FRE 702: Dr. Cain is not qualified to testify as an
`
`expert witness under FRE 702 with respect to issues
`
`concerning the technology involved in this IPR
`
`proceeding,
`
`including
`
`stereochemistry,
`
`pharmaceutical development, drug storage systems,
`
`and stability testing. Moreover, several of his
`
`opinions are not based on sufficient facts or data.
`
`Therefore, Dr. Cain’s expert declaration
`
`is
`
`inadmissible expert testimony under FRE 702.
`
`FRE 702: Dr. Cain’s statement that one of ordinary
`
`skill would have been “well aware of the properties
`
`of dexmedetomidine and the benefits of ready to use
`
`medications” based on particular references is not an
`
`16
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`Exhibit 1002
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`Exhibit 1002 - ¶ 20
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`admissible expert opinion, at least because it is not
`
`based on sufficient facts or data. In particular, the
`
`cited references do not relate to the use of ready to
`
`use formulations, but rather to standardized drug
`
`preparations.
`
`FRE 702: The opinions expressed
`
`in
`
`these
`
`paragraphs regarding the understanding of the term
`
`“ready to use” by a person of skill in the art are
`
`inadmissible because Dr. Cain’s opinions do not
`
`help the trier of fact determine a fact at issue, and
`
`his opinions are not based on sufficient facts or data.
`
`Moreover, Dr. Cain cites to a single reference to
`
`support his opinion, and
`
`that reference only
`
`indicates on its face that it was publicly available on
`
`August 9, 2016. Therefore, Dr. Cain’s opinion is
`
`not an admissible expert opinion because it does not
`
`assist the trier of fact in understanding the evidence
`
`or determining a fact at issue as of the filing date of
`
`the challenged patent.
`
`17
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`Exhibit 1002 - ¶ 30-31
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`FRE 401-403: The opinions expressed in these
`
`paragraphs are irrelevant because they do not assist
`
`the trier of fact in understanding the evidence or
`
`determining a fact at issue as of the filing date of the
`
`challenged patent. Moreover, the opinions expressed
`
`in these paragraphs are irrelevant because they are
`
`in violation of 37 C.F.R. § 42.65(a), as Dr. Cain
`
`does not disclose the underlying facts or data upon
`
`which his opinions are based. To the extent Dr.
`
`Cain relies on Exhibit 1044 for these opinions, the
`
`opinions are irrelevant because they are based on an
`
`unauthenticated exhibit that, on its face, only
`
`indicates that it was publicly available on August 9,
`
`2016. Therefore, the paragraphs and opinions
`
`expressed
`
`therein are
`
`irrelevant and of
`
`little
`
`probative value in light of the confusion, unfair
`
`prejudice, and waste of
`
`time
`
`that would be
`
`introduced by their admission.
`
`Exhibit 1002 - ¶ 34-37
`
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`FRE 702: Dr. Cain is not qualified to testify as an
`
`
`
`18
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`Exhibit 1002 - ¶ 38
`
`
`expert witness under FRE 702 with respect to issues
`
`concerning the technology involved in this IPR
`
`proceeding, including pharmaceutical development
`
`and drug storage systems.
`
`FRE 802: This evidence cites to and incorporates
`
`hearsay. Because no hearsay exception applies, the
`
`identified paragraphs are
`
`inadmissible
`
`in
`
`this
`
`proceeding.
`
`FRE 702: Dr. Cain is not qualified to testify as an
`
`expert witness under FRE 702 with respect to issues
`
`concerning the technology involved in this IPR
`
`proceeding, including pharmaceutical development
`
`and drug storage systems.
`
`Moreover, this paragraph includes inadmissible
`
`expert opinions because Dr. Cain does not disclose
`
`sufficient facts or data upon which his testimony is
`
`based.
`
`FRE 802: This evidence cites to and incorporates
`
`
`
`19
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`hearsay. Because no hearsay exception applies, the
`
`identified paragraph
`
`is
`
`inadmissible
`
`in
`
`this
`
`proceeding.
`
`§ 42.65(b): Dr. Cain provides no information
`
`regarding the technical test or data that was relied
`
`upon in reaching the conclusions expressed in this
`
`paragraph.
`
`35 U.S.C. § 311(b): This paragraph describes an
`
`alleged
`
`prior
`
`public
`
`use
`
`of
`
`4µg/mL
`
`dexmedetomidine, which is inadmissible in an IPR
`
`proceeding because it is neither a patent nor a
`
`printed publication. To the extent Dr. Cain relies
`
`on Ex. 1035, such reference does not disclose
`
`sufficient facts or data to support his opinions. To
`
`the extent Dr. Cain relies on Ex. 1038, the exhibit
`
`has not been authenticated, does not relate to Dr.
`
`Cain’s described practice, constitutes hearsay, and
`
`appears on its face to have been published after the
`
`priority date and therefore is not prior art.
`
`20
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`FRE 401-403: This paragraph is irrelevant at least
`
`because the opinions expressed therein constitute
`
`inadmissible expert testimony, relate only to an
`
`alleged prior public use which is inadmissible in
`
`IPR proceedings, and fail to disclose any facts or
`
`data upon which the opinions are based. The two
`
`cited references are Ex. 1035, which contains
`
`inadmissible hearsay and does not support the
`
`assertions made in the paragraph, and Ex. 1038,
`
`which also constitutes hearsay and furthermore has
`
`not been asserted as prior art to the challenged
`
`patent. Neither of the references contains sufficient
`
`facts or data to support this testimony. Therefore,
`
`the paragraph and opinions expressed therein are
`
`irrelevant and of little probative value in light of the
`
`confusion
`
`that would be
`
`introduced by
`
`their
`
`admission.
`
`FRE 802: This paragraph incorporates hearsay.
`
`Because no hearsay exception applies, the identified
`
`21
`
`Exhibit 1002 - ¶ 39
`
`
`
`
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`
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`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
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`paragraph is inadmissible in this proceeding.
`
`FRE 702: Dr. Cain is not qualified to testify as an
`
`expert witness under FRE 702 with respect to issues
`
`concerning the technology involved in this IPR
`
`proceeding, including pharmaceutical development,
`
`drug
`
`storage
`
`systems, and
`
`stability
`
`testing.
`
`Moreover, Dr. Cain provides no supporting
`
`references for his opinion, and the testimony is not
`
`based on sufficient facts or data.
`
`FRE 401-403: This paragraph is irrelevant at least
`
`because Dr. Cain is not qualified to testify as an
`
`expert on these issues, and Dr. Cain’s testimony is
`
`not based on sufficient facts or data. Because Dr.
`
`Cain does not disclose the underlying facts or data
`
`upon which the paragraph and opinions expressed
`
`therein are based, the opinions expressed in this
`
`paragraph are entitled to little or no weight under 37
`
`C.F.R. § 42.65(a).
`
`22
`
`Exhibit 1002 - ¶ 40
`
`
`
`
`
`
`
`
`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
`
`Exhibit 1002 - ¶ 41
`
`
`FRE 702: Dr. Cain provides no supporting
`
`references for his opinion, and the testimony is not
`
`based on sufficient facts or data. Moreover, Dr.
`
`Cain’s opinion relates to suitability of an off-label,
`
`unapproved use of 100 µg/mL dexmedetomidine,
`
`and Dr. Cain has not demonstrated that his opinion
`
`is the product of reliable principles and methods
`
`applied to the facts.
`
`FRE 401-403: This paragraph is irrelevant at least
`
`because Dr. Cain is not qualified to testify as an
`
`expert on these issues, and Dr. Cain’s testimony is
`
`not based on sufficient facts or data. Because Dr.
`
`Cain does not disclose the underlying facts or data
`
`upon which the paragraph and opinions expressed
`
`therein are based, the opinions expressed in this
`
`paragraph are entitled to little or no weight under 37
`
`C.F.R. § 42.65(a).
`
`Exhibit 1002 - ¶ 42
`
`
`FRE 702: Dr. Cain provides no supporting
`
`
`
`23
`
`
`
`
`
`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
`
`references for his opinion, and the testimony is not
`
`based on sufficient facts or data. Moreover, Dr.
`
`Cain’s opinion relates to suitability of an off-label,
`
`unapproved use of 100 µg/mL dexmedetomidine,
`
`and Dr. Cain has not demonstrated that this opinion
`
`is the product of reliable principles and methods
`
`applied to the facts.
`
`FRE 401-403: This paragraph is irrelevant at least
`
`because Dr. Cain is not qualified to testify as an
`
`expert on these issues, and Dr. Cain’s testimony is
`
`not based on sufficient facts or data. Because Dr.
`
`Cain does not disclose the underlying facts or data
`
`upon which the paragraph and opinions expressed
`
`therein are based, the opinions expressed in this
`
`paragraph are entitled to little or no weight under 37
`
`C.F.R. § 42.65(a).
`
`FRE 702: Dr. Cain provides no supporting
`
`references for his opinion, and the testimony is not
`
`based on sufficient facts or data. Moreover, Dr.
`
`24
`
`Exhibit 1002 - ¶ 43
`
`
`
`
`
`
`
`
`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
`
`Cain’s opinion relates to suitability of an off-label,
`
`unapproved use of 100 µg/mL dexmedetomidine,
`
`and Dr. Cain has not demonstrated that this opinion
`
`is the product of reliable principles and methods
`
`applied to the facts. The opinions expressed in this
`
`paragraph are also inadmissible expert testimony
`
`because they do not help the trier of fact understand
`
`the evidence or determine a fact at issue.
`
`35 U.S.C. § 311(b): This paragraph contains
`
`testimony regarding an alleged prior public use of
`
`100 µg/mL dexmedetomidine, which is inadmissible
`
`in an IPR proceeding because it is neither a patent
`
`nor a printed publication.
`
`FRE 401-403: This paragraph is irrelevant at least
`
`because Dr. Cain is not qualified to testify as an
`
`expert on these issues, Dr. Cain’s testimony is not
`
`based on sufficient facts or data, and the testimony
`
`does not assist the trier of fact in understanding the
`
`evidence or determining a fact at issue. Because Dr.
`
`25
`
`
`
`
`
`
`
`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
`
`Cain does not disclose the underlying facts or data
`
`upon which the paragraph and opinions expressed
`
`therein are based, the opinions expressed in this
`
`paragraph are entitled to little or no weight under 37
`
`C.F.R. § 42.65(a). Because prior public uses are not
`
`admissible prior art in IPR proceedings, testimony
`
`regarding an alleged prior public use is irrelevant.
`
`FRE 702: The opinions expressed in this paragraph
`
`are not based on sufficient facts or data. Moreover,
`
`Dr. Cain’s opinion relates to suitability of an off-
`
`label,
`
`unapproved
`
`use
`
`of
`
`100
`
`µg/mL
`
`dexmedetomidine,
`
`and Dr. Cain
`
`has
`
`not
`
`demonstrated that this opinion is the product of
`
`reliable principles and methods applied to the facts.
`
`The opinions expressed in this paragraph are also
`
`inadmissible expert testimony because they do not
`
`help the trier of fact understand the evidence or
`
`determine a fact at issue.
`
`35 U.S.C. § 311(b): The opinions in this paragraph
`
`26
`
`Exhibit 1002 - ¶ 44
`
`
`
`
`
`
`
`
`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
`
`describe an alleged prior public use of 100 µg/mL
`
`dexmedetomidine, which is inadmissible in an IPR
`
`proceeding because it is neither a patent nor a
`
`printed publication. Moreover, the opinions cite a
`
`reference that appears to be from 2015, which is
`
`after the priority date of the challenged patent.
`
`FRE 401-403: This paragraph is irrelevant at least
`
`because Dr. Cain is not qualified to testify as an
`
`expert on these issues, Dr. Cain’s testimony is not
`
`based on sufficient facts or data, and the testimony
`
`does not assist the trier of fact in understanding the
`
`evidence or determining a fact at issue. Because Dr.
`
`Cain does not disclose the underlying facts or data
`
`upon which the paragraph and opinions expressed
`
`therein are based, the opinions expressed in this
`
`paragraph are entitled to little or no weight under 37
`
`C.F.R. § 42.65(a). Because prior public uses are not
`
`admissible prior art in IPR proceedings, testimony
`
`regarding an alleged prior public use is irrelevant.
`
`
`
`27
`
`
`
`
`
`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
`
`Exhibit 1002 - ¶ 47
`
`
`
`
`FRE 702: The opinions expressed in this paragraph
`
`are not based on sufficient facts or data. For
`
`example, Dr. Cain provides no supporting facts or
`
`data for his opinion that “a POSA would have been
`
`motivated to create an embodiment that falls within
`
`the scope of claims 1-7 based on available prior art.”
`
`Moreover, Dr. Cain has not demonstrated that this
`
`opinion is the product of reliable principles and
`
`methods applied to the facts.
`
`FRE 401-403: This paragraph is irrelevant at least
`
`because Dr. Cain is not qualified to testify as an
`
`expert on these issues, and Dr. Cain’s testimony is
`
`not based on sufficient facts or data. Because Dr.
`
`Cain does not disclose the underlying facts or data
`
`upon which the paragraph and opinions expressed
`
`therein are based, the opinions expressed in this
`
`paragraph are entitled to little or no weight under 37
`
`C.F.R. § 42.65(a).
`
`28
`
`
`
`
`
`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
`
`Exhibit 1002 - ¶ 50
`
`
`FRE 702: The opinions expressed in this paragraph
`
`are not based on sufficient facts or data. Moreover,
`
`Dr. Cain has not demonstrated that this opinion is
`
`the product of reliable principles and methods
`
`applied to the facts. To the extent Dr. Cain relies on
`
`Ex. 1035 to support this opinion, the reference does
`
`not disclose sufficient facts or data to support Dr.
`
`Cain’s statements.
`
`FRE 802: This evidence cites to and incorporates
`
`hearsay. Because no hearsay exception applies, the
`
`identified paragraph
`
`is
`
`inadmissible
`
`in
`
`this
`
`proceeding.
`
`35 U.S.C. § 311(b): This paragraph describes an
`
`alleged
`
`prior
`
`public
`
`use
`
`of
`
`4µg/mL
`
`dexmedetomidine, which is inadmissible in an IPR
`
`proceeding because it is neither a patent nor a
`
`printed publication. To the extent Dr. Cain relies
`
`on Ex. 1035 to support this opinion, such reference
`
`
`
`29
`
`
`
`
`
`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
`
`Exhibit 1002 - ¶ 51
`
`
`does not disclose sufficient facts or data to support
`
`dr. Cain’s statements.
`
`FRE 401-403: This paragraph is irrelevant at least
`
`because the opinions expressed therein relate to an
`
`alleged prior public use, which is not admissible
`
`prior art in this proceeding under 35 U.S.C. §
`
`311(b), and because the opinions are not admissible
`
`expert testimony under FRE 702.
`
`FRE 802: This evidence cites to and incorporates
`
`hearsay. Because no hearsay exception applies, the
`
`identified paragraph
`
`is
`
`inadmissible
`
`in
`
`this
`
`proceeding.
`
`FRE 702: The
`
`testimony expressed
`
`in
`
`this
`
`paragraph is not based on sufficient facts or data and
`
`does not help a trier of fact understand the evidence
`
`or determine a fact at issue. To the extent that Dr.
`
`Cain adopts the determinations of his pharmacy
`
`regarding the acceptability of this practice, Dr. Cain
`
`
`
`30
`
`
`
`
`
`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
`
`has provided no information to suggest that such
`
`opinion is the product of reliable principles and
`
`methods. The opinions expressed in this paragraph
`
`are, therefore, unreliable and inadmissible.
`
`§ 42.65(b): Dr. Cain provides no information
`
`regarding the technical test or data that was relied
`
`upon in reaching the conclusions expressed in this
`
`paragraph.
`
`35 U.S.C. § 311(b): This paragraph describes an
`
`alleged
`
`prior
`
`public
`
`use
`
`of
`
`4µg/mL
`
`dexmedetomidine, which is inadmissible in an IPR
`
`proceeding because it is neither a patent nor a
`
`printed publication. To the extent Dr. Cain relies
`
`on Ex. 1035 to support this opinion, such reference
`
`does not disclose sufficient facts or data to support
`
`Dr. Cain’s statements.
`
`FRE 401-403: This paragraph is irrelevant at least
`
`because the opinions expressed therein relate to an
`
`
`
`31
`
`
`
`
`
`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
`
`Exhibit 1002 - ¶ 52-54
`
`
`alleged prior public use, which is not admissible
`
`prior art in this proceeding under 35 U.S.C. §
`
`311(b), and because the opinions are not admissible
`
`expert testimony under FRE 702.
`
`RE 702: Dr. Cain is not qualified to testify as an
`
`expert witness under FRE 702 with respect to issues
`
`concerning the technology involved in this IPR
`
`proceeding, including pharmaceutical development,
`
`drug
`
`storage
`
`systems, and
`
`stability
`
`testing.
`
`Moreover, Dr. Cain provides no supporting
`
`references for his opinions, and the testimony is not
`
`based on sufficient facts or data.
`
`FRE 802: This evidence cites to and incorporates
`
`hearsay. Because no hearsay exception applies, the
`
`identified paragraphs are
`
`inadmissible
`
`in
`
`this
`
`proceeding.
`
`FRE 401-403: These paragraphs are irrelevant at
`
`least because Dr. Cain is not qualified to testify as
`
`
`
`32
`
`
`
`
`
`Patent Owner’s Objections to Petitioner’s Evidence for IPR2016-01578
`
`an expert on these issues, and Dr. Cain’s testimony
`
`is not based on sufficient facts or data. Because Dr.
`
`Cain does not disclose the underlying facts or data
`
`upon which the paragraph and opinions expressed
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