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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC.
`Petitioner
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`v.
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`QUALICAPS CO. LTD.
`Patent Owner
`
`Case IPR2017-00203
`Patent No. 6,649,180
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`PETITIONER MYLAN PHARMACEUTICALS INC.’S OBJECTIONS
`PURSUANT TO 37 C.F.R. § 42.64 TO PATENT OWNER’S
`SUPPLEMENTAL EVIDENCE SERVED ON AUGUST 11, 2017
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`Pursuant to 37 C.F.R. § 42.64(b), Petitioner Mylan Pharmaceuticals Inc.
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`(“Mylan”) submits the following objections to supplemental evidence served by
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`Patent Owner Qualicaps Co. Ltd. (“Patent Owner”) on August 11, 2017. These
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`objections are timely filed within five (5) business days from service of the
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`evidence.
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`1
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`Petitioner reserves the right to present further objection to these or additional
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`Exhibits submitted by Patent Owner, as allowed by the applicable rules or
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`authority.
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`The following table identifies Petitioner’s objections to the respective
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`exhibits.
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` The alleged evidence presented in the respective exhibits are
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`inadmissible for at least the reasons presented in the right-hand column of the table
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`below.
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`Evidence
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`Objections
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`Exhibit 2052
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`FRE 401 and 402: The exhibit is not relevant to any ground
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`upon which trial was instituted.
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`FRE 403: The exhibit’s probative value to any ground upon
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`which trial was instituted is substantially outweighed by the
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`danger of unfair prejudice, confusing the issues, undue delay,
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`wasting time, or needlessly presenting cumulative evidence.
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`FRE 802: The exhibit is inadmissible hearsay if offered to prove
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`the truth of any matter allegedly asserted therein.
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`Lack of Foundation: Patent Owner has not provided sufficient
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`explanation of what the exhibit is or what it allegedly shows.
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`FRE 703: Patent Owner’s Response, Dr. McConville’s
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`declaration, and Dr. Bennett’s declaration do not establish that
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`2
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`
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`Evidence
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`Objections
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`this exhibit includes the type of facts or data that would normally
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`be reasonably relied on by experts in the particular field. Thus,
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`this exhibit and any paragraph in the expert declaration citing to
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`this exhibit are inadmissible under FRE 703. Further, Patent
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`Owner has also failed to establish that this exhibit’s probative
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`value substantially outweighs any prejudicial effect.
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`Exhibit 2053
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`FRE 401 and 402: The exhibit is not relevant to any ground
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`upon which trial was instituted.
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`FRE 403: The exhibit’s probative value to any ground upon
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`which trial was instituted is substantially outweighed by the
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`danger of unfair prejudice, confusing the issues, undue delay,
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`wasting time, or needlessly presenting cumulative evidence.
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`FRE 802: The exhibit is inadmissible hearsay if offered to prove
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`the truth of any matter allegedly asserted therein.
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`Lack of Foundation: Patent Owner has not provided sufficient
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`explanation of what the exhibit is or what it allegedly shows.
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`FRE 703: Patent Owner’s Response, Dr. McConville’s
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`declaration, and Dr. Bennett’s declaration do not establish that
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`this exhibit includes the type of facts or data that would normally
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`3
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`Evidence
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`Objections
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`be reasonably relied on by experts in the particular field. Thus,
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`this exhibit and any paragraph in the expert declaration citing to
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`this exhibit are inadmissible under FRE 703. Further, Patent
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`Owner has also failed to establish that this exhibit’s probative
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`value substantially outweighs any prejudicial effect.
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`Exhibit 2054
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`FRE 401 and 402: The exhibit is not relevant to any ground
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`upon which trial was instituted.
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`FRE 403: The exhibit’s probative value to any ground upon
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`which trial was instituted is substantially outweighed by the
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`danger of unfair prejudice, confusing the issues, undue delay,
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`wasting time, or needlessly presenting cumulative evidence.
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`FRE 802: The exhibit is inadmissible hearsay if offered to prove
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`the truth of any matter allegedly asserted therein.
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`Lack of Foundation: Patent Owner has not provided sufficient
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`explanation of what the exhibit is or what it allegedly shows.
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`FRE 703: Patent Owner’s Response, Dr. McConville’s
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`declaration, and Dr. Bennett’s declaration do not establish that
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`this exhibit includes the type of facts or data that would normally
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`be reasonably relied on by experts in the particular field. Thus,
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`4
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`Evidence
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`Objections
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`this exhibit and any paragraph in the expert declaration citing to
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`this exhibit are inadmissible under FRE 703. Further, Patent
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`Owner has also failed to establish that this exhibit’s probative
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`value substantially outweighs any prejudicial effect.
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`Exhibit 2055
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`FRE 401 and 402: The exhibit is not relevant to any ground
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`upon which trial was instituted.
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`FRE 403: The exhibit’s probative value to any ground upon
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`which trial was instituted is substantially outweighed by the
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`danger of unfair prejudice, confusing the issues, undue delay,
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`wasting time, or needlessly presenting cumulative evidence.
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`FRE 802: The exhibit is inadmissible hearsay if offered to prove
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`the truth of any matter allegedly asserted therein.
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`Lack of Foundation: Patent Owner has not provided sufficient
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`explanation of what the exhibit is or what it allegedly shows.
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`FRE 703: Patent Owner’s Response, Dr. McConville’s
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`declaration, and Dr. Bennett’s declaration do not declarations
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`establish that this exhibit includes the type of facts or data that
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`would normally be reasonably relied on by experts in the
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`particular field. Thus, this exhibit and any paragraph in the
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`5
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`Evidence
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`Objections
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`expert declaration citing to this exhibit are inadmissible under
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`FRE 703. Further, Patent Owner has also failed to establish that
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`this exhibit’s probative value substantially outweighs any
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`prejudicial effect.
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`Exhibit 2056
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`FRE 401 and 402: The exhibit is not relevant to any ground
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`upon which trial was instituted.
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`FRE 403: The exhibit’s probative value to any ground upon
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`which trial was instituted is substantially outweighed by the
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`danger of unfair prejudice, confusing the issues, undue delay,
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`wasting time, or needlessly presenting cumulative evidence.
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`FRE 802: The exhibit is inadmissible hearsay if offered to prove
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`the truth of any matter allegedly asserted therein.
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`Lack of Foundation: Patent Owner has not provided sufficient
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`explanation of what the exhibit is or what it allegedly shows.
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`FRE 703: Patent Owner’s Response, Dr. McConville’s
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`declaration, and Dr. Bennett’s declaration do not declarations
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`establish that this exhibit includes the type of facts or data that
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`would normally be reasonably relied on by experts in the
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`particular field. Thus, this exhibit and any paragraph in the
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`6
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`Evidence
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`Objections
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`expert declaration citing to this exhibit are inadmissible under
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`FRE 703. Further, Patent Owner has also failed to establish that
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`this exhibit’s probative value substantially outweighs any
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`prejudicial effect.
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`Exhibit 2057
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`FRE 401 and 402: The exhibit is not relevant to any ground
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`upon which trial was instituted. The Patent Owner does not cite
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`this exhibit at any point in its Patent Owner Response.
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`FRE 802: This exhibit contains hearsay. Because this exhibit is
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`not cited in the Patent Owner Response, it is unclear how this
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`exhibit is intended to be used. As such, Petitioner objects to any
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`use of this exhibit as hearsay.
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`FRE 703: Dr. McConville’s declaration and Dr. Bennett’s
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`declaration do not establish that this exhibit includes the type of
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`facts or data that would normally be reasonably relied on by
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`experts in the particular field. Thus, this exhibit and any
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`paragraph in the expert declaration citing to this exhibit are
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`inadmissible under FRE 703. Further, Patent Owner has also
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`failed to establish that this exhibit’s probative value substantially
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`outweighs any prejudicial effect. Indeed, the omission of any
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`7
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`Evidence
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`Objections
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`citation to this exhibit in the Patent Owner’s response suggests
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`that this exhibit has little if any probative value. As such, this
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`exhibit is inadmissible as evidence to be presented to the Board
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`under FRE 703.
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`Exhibit 2058
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`FRE 401 and 402: The exhibit is not relevant to any ground
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`upon which trial was instituted. The Patent Owner does not cite
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`this exhibit at any point in its Patent Owner Response.
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`FRE 802: This exhibit contains hearsay. Because this exhibit is
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`not cited in the Patent Owner Response, it is unclear how this
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`exhibit is intended to be used. As such, Petitioner objects to any
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`use of this exhibit as hearsay.
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`FRE 703: Dr. McConville’s declaration and Dr. Bennett’s
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`declaration do not establish that this exhibit includes the type of
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`facts or data that would normally be reasonably relied on by
`
`experts in the particular field. Thus, this exhibit and any
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`paragraph in the expert declaration citing to this exhibit are
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`inadmissible under FRE 703. Further, Patent Owner has also
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`failed to establish that this exhibit’s probative value substantially
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`outweighs any prejudicial effect. Indeed, the omission of any
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`8
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`Evidence
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`Objections
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`citation to this exhibit in the Patent Owner’s response suggests
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`that this exhibit has little if any probative value. As such, this
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`exhibit is inadmissible as evidence to be presented to the Board
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`under FRE 703.
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`Exhibit 2059
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`FRE 401 and 402: The exhibit is not relevant to any ground
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`upon which trial was instituted. The Patent Owner does not cite
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`this exhibit at any point in its Patent Owner Response.
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`FRE 802: This exhibit contains hearsay. Because this exhibit is
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`not cited in the Patent Owner Response, it is unclear how this
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`exhibit is intended to be used. As such, Petitioner objects to any
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`use of this exhibit as hearsay.
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`FRE 703: Dr. McConville’s declaration and Dr. Bennett’s
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`declaration do not establish that this exhibit includes the type of
`
`facts or data that would normally be reasonably relied on by
`
`experts in the particular field. Thus, this exhibit and any
`
`paragraph in the expert declaration citing to this exhibit are
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`inadmissible under FRE 703. Further, Patent Owner has also
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`failed to establish that this exhibit’s probative value substantially
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`outweighs any prejudicial effect. Indeed, the omission of any
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`9
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`Evidence
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`Objections
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`citation to this exhibit in the Patent Owner’s response suggests
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`that this exhibit has little if any probative value. As such, this
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`exhibit is inadmissible as evidence to be presented to the Board
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`under FRE 703.
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`Exhibit 2060
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`FRE 401 and 402: The exhibit is not relevant to any ground
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`upon which trial was instituted.
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`FRE 403: The exhibit’s probative value to any ground upon
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`which trial was instituted is substantially outweighed by the
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`danger of unfair prejudice, confusing the issues, undue delay,
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`wasting time, or needlessly presenting cumulative evidence.
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`FRE 602: Paragraphs 8-77 of the exhibit include assertions for
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`which evidence has not been introduced sufficient to show that
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`the witness has personal knowledge of the matters asserted
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`FRE 701/702/703: Paragraphs 8-77 of the exhibit include
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`opinions that are not admissible under FRE 701, 702, or 703, or
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`Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993).
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`
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`Additionally, Petitioner objects to each paragraph citing to
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`an exhibit that is objected to herein under FRE 703 as such
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`paragraphs lack a sufficient foundation.
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`10
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`Evidence
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`Objections
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`FRE 801/802: Paragraphs 8-77 of the exhibit includes
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`statements that are inadmissible hearsay if offered to prove the
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`truth of any matter allegedly asserted therein.
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`FRE 805: The exhibit contains improper hearsay within hearsay.
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`FRE 1006: The exhibit provides an improper summary of the
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`evidence.
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`37 C.F.R. § 42.65: The exhibit includes expert testimony that
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`does not disclose the underlying facts or data and improper
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`discussion of patent law.
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`Dated: August 18, 2017
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`Respectfully submitted,
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`By: s/Mitchell G. Stockwell
`Mitchell G. Stockwell
`Registration No. 39,389
`Lead Counsel for Petitioner
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`
`
`Lead Counsel
`Mitchell G. Stockwell
`Reg. No. 39,389
`mstockwell@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton
`LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`Back-Up Counsel
`D. Clay Holloway
`Reg. No. 58,011
`cholloway@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`Jonathan D. Olinger (pro hac vice)
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`11
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`jolinger@killpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
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`12
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that on August 18, 2017 a copy of the
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`foregoing Petitioner Mylan Pharmaceuticals Inc.’s Objections Pursuant to 37
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`C.F.R. § 42.64 to Patent Owner’s Supplemental Evidence Served on August 11,
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`2017 was served by electronic mail by agreement of the parties on the following
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`counsel of record for Patent Owner.
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`Jessica L. Parezo (jparezo@cov.com)
`Andrea G. Reister( areister@cov.com)
`Scott E. Kamholz (skamholz@cov.com)
`Michael N. Kennedy (mkennedy@cov.com)
`Megan P. Keane (mkeane@cov.com)
`Covington & Burling LLP
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`
`MaryAnne Armstrong (maa@bskb.com)
`Lynde F. Herzbach (lynde.herzbach@bskb.com)
`Birch, Stewart, Kolasch & Birch, LLP
`8110 Gatehouse Road, Suite 100 East
`Falls Church, VA 22042
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`Dated: August 18, 2017
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`By: s/Mitchell G. Stockwell
`Mitchell G. Stockwell
`Registration No. 39,389
`Lead Counsel for Petitioner
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`13
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