UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`QUALICAPS CO., LTD,
`Patent Owner
`
`_____________
`
`Case IPR2017-00203
`Patent 6,649,180
`_____________
`
`PATENT OWNER’S MOTION FOR OBSERVATIONS
`REGARDING THE CROSS-EXAMINATION
`TESTIMONY OF ARTHUR H. KIBBE
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`_____________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner
`
`v.
`
`QUALICAPS CO., LTD,
`Patent Owner
`
`_____________
`
`Case IPR2017-00203
`Patent 6,649,180
`_____________
`
`PATENT OWNER’S MOTION FOR OBSERVATIONS
`REGARDING THE CROSS-EXAMINATION
`TESTIMONY OF ARTHUR H. KIBBE
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`IPR2017-00203
`Patent 6,649,180 B1
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`I.
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`Introduction
`In accordance with: (i) The Trial Practice Guide, Federal Register Vol. 77,
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` Patent Owner’s Motion for Observations
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`No. 157, 48756 at 48767–68 and (ii) the Scheduling Order (Paper No. 11) and
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`Amended Scheduling Order (Paper No. 42), Patent Owner hereby submits the
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`instant Motion for Observations Regarding the Cross-Examination Testimony of
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`Arthur H. Kibbe, Ph.D. taken on October 6, 2017. The transcript of this testimony
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`has been filed as Exhibit 2076.
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`Patent Owner requests that the Board enter the instant Motion and consider
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`the observations. Observations 1–15 below pertain to the deposition testimony of
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`Arthur H. Kibbe, Ph.D., obtained on October 6, 2017, after Patent Owner filed its
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`last substantive paper. In accordance with the Scheduling Order and Trial Guide,
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`each of observations 1–15 below provides in a single, short paragraph a concise
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`statement of the relevance of the precisely identified testimony to a precisely
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`identified argument.
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`II. Observations
`In Exhibit 2076 at 12:9–19, Dr. Kibbe testified that he did not
`1.
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`remember having any part of the Petition when drafting the Declaration of Arthur
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`H. Kibbe in Support of Petition for Inter Partes Review of U.S. Patent No.
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`6,649,180 (Ex. 1011; “original Declaration”). This testimony is relevant because it
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`contradicts his prior testimony stating: “I have reviewed the legal section of the
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`1
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`IPR2017-00203
`Patent 6,649,180 B1
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`Petition filed concurrently . . . I accept Petitioner's summary as accurate and have
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` Patent Owner’s Motion for Observations
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`used that legal framework in my evaluation of the prior art presented in this
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`matter.” Ex. 1011 at ¶ 48; see also Ex. 2029 at 23:18 to 25:8 (Dr. Kibbe testified
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`that he reviewed multiple drafts of the Petition before it was submitted on the day
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`he signed his declaration).
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`2.
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`In Exhibit 2076 at 38:22–39:10, Dr. Kibbe affirmed he would expect
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`experimenters to have controlled for residual salts to ensure capsule quality, unless
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`there is some indication of deviation from such common practice. At 39:11–24,
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`Dr. Kibbe also testified that he cites no evidence of the inventors deviating from
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`such common practice. This testimony is relevant to Dr. Kibbe’s prior assertions
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`that the “inventors performed no control over the presence of such residual salts in
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`conducting their experiments” and the data in the ’180 patent and the Tanjoh
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`prosecution declaration “fail[ed] to account for content of residual salts.” Ex. 1029
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`¶ 8.
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`3.
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`In Ex. 2076 at 49:11–15, Dr. Kibbe affirmed that his opinion on
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`accounting for residual salts in capsule cloud spotting is based only on the data in
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`the ’180 patent and Tanjoh declaration submitted during prosecution. At 31:3–6,
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`Dr. Kibbe affirmed that he reviewed Table 1 of the ’180 patent when he prepared
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`his original Declaration. At 32:8–11, Dr. Kibbe affirmed that he reviewed the ’180
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`patent prosecution history when he prepared his original Declaration. This
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`2
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`IPR2017-00203
`Patent 6,649,180 B1
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`testimony is relevant because Petitioner relies on the ’180 patent data and Tanjoh
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` Patent Owner’s Motion for Observations
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`prosecution declaration for two Reply arguments not in the Petition: the inventors
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`insufficiently inferred gelling aids caused cloud spotting, Petitioner Mylan
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`Pharmaceutical Inc.’s Reply (Paper No. 38; “Reply”) p. 18, l. 3 to p. 19, l. 13; Ex.
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`1029 ¶¶ 6–8; and the claimed invention does not prevent cloud spotting defects,
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`Reply p. 19, l. 14–p. 21, l. 14; Ex. 1029 ¶¶ 9–12.
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`4.
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`In Ex. 2076 at 50:14–16, Dr. Kibbe testified: “There is no evidence
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`that supports any conclusion that those -- cloud is the direct result of the potassium
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`chloride [gelling aid in ’180 patent examples].” This testimony is relevant because
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`the Petition and Dr. Kibbe previously assumed that the capsule cloud spotting
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`reported in the ’180 patent was from gelling aid precipitation. Petition, Section C,
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`p. 51, l. 11 – p. 55, l. 6; p. 52, l. 5–8 (“the properties of the capsule shell that
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`prevent [gelling aid] precipitation are . . . inherent and foreseeable . . . .”); Ex. 1011
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`¶148. This testimony is also relevant because this argument was not in the Petition
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`and was presented for the first time with Petitioner’s Reply.
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`5.
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`In Ex. 2076 at 90:19–92:2, Dr. Kibbe affirmed that when preparing
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`his original Declaration, he was familiar with the Table 1 capsule precipitation data
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`reported for the claimed invention of the ’180 patent. This testimony is relevant
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`because Petitioner argues that the claimed invention does not prevent precipitation
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`3
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`IPR2017-00203
`Patent 6,649,180 B1
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`defects in capsules, Reply at p. 19, l. 14 — p. 21, l. 14, but this argument was not
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` Patent Owner’s Motion for Observations
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`in the Petition and was presented for the first time with Petitioner’s Reply.
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`6.
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`In Ex. 2076 at 54:24–55:8, Dr. Kibbe testified that “I think, from my
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`experience, we would reject capsules that are spotted if we're going to use them in
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`manufacturing. But I assume that somebody else might say, well, those spots won't
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`matter to my capsules, so I'll accept them. And that would be an individualized,
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`subjective measure, but not a standardized, subjective measure.” This testimony is
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`relevant because of Dr. Kibbe’s prior assertion that subjective determinations of
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`capsule cloud spotting are not appropriate. Ex. 1029 at ¶¶ 10–12 (id. at ¶ 11: “I
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`am unaware of, and have seen no evidence in this matter, objective and
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`quantifiable metrics for determining an acceptable amount of spotting on a
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`capsule”); (id. at ¶ 12: “Again, the upper end of the range is a subjective
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`determination of acceptable amount of spotting. Thus, given the mere reduction of
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`spotting given the mere reduction of spotting in an area where reducing spotting is
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`always desired, that reducing the spots from unacceptable to acceptable is a matter
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`of degree.”).
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`7.
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`In Ex. 2076 at 52:13–19, Dr. Kibbe testified that “I don't remember
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`seeing any document that said anything other than clear for clear capsules . . . . So
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`no, I don’t think there’s anything in the industry that says you can have this
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`amount of spotting.” This testimony is relevant because it contradicts the argument
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`4
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`IPR2017-00203
`Patent 6,649,180 B1
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`against unexpected results in the Petition and Dr. Kibbe’s original Declaration,
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` Patent Owner’s Motion for Observations
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`both of which relied on at least one prior art document setting forth subjective
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`visual descriptions of capsule film quality. Petition at 54–55; Ex. 1011 at ¶¶ 157–
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`160.
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`8.
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`In Ex. 2076 at 73:3–10, Dr. Kibbe affirmed that the Japanese
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`Pharmacopoeia (Exs. 1005, 2016) does not necessarily teach a combined total
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`minimum of hydroxylpropoxyl/methoxyl (“HPO/MO”) substitution for HPMC
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`2208. This testimony is relevant because it contradicts the positions in the Reply
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`and Reply Declaration that the Japanese Pharmacopoeia provides a combined total
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`minimum of HPO/MO substitution for each HPMC type disclosed therein. Reply
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`at p. 6, ll. 4–7 (“simple math, and Dr. Kibbe’s straightforward testimony, confirms
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`the minimum total substitution for HPMC type 2910 is 35% (28% methoxyl, plus
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`7% hydroxpropoxyl); Ex. 1029 ¶ 19.
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`9.
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`In Ex. 2076 at 43:11–24, Dr. Kibbe affirmed that his testimony
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`concerning the cause of cloud spotting was not what a person of ordinary skill in
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`the art (“POSA”) would think, but rather his opinion. This is relevant to the lack of
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`scientific support and evidence for Dr. Kibbe’s opinion that the likely cause of
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`cloud spotting reported in the ’180 patent was from precipitation of residual salts
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`or HPMC. Ex. 1029 at ¶ 7.
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`5
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`IPR2017-00203
`Patent 6,649,180 B1
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` Patent Owner’s Motion for Observations
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`10.
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`In Ex. 2076 at 61:17–62:2, Dr. Kibbe affirmed that, in his Reply
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`Declaration, he did not refute
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`the
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`testimony of Patent Owner’s expert
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`Dr. McConville
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`that a POSA was unlikely
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`to have familiarity with or
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`understanding of the [effect of] changing HPO and MO percentage on the
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`properties of HPMC. This testimony is relevant to Petitioner’s arguments that a
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`POSA would be motivated to try HPMC types other than type 2910, Reply at p. 4,
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`l. 18 — p. 5, l. 2, p. 6, ll. 8–11, p. 7, l. 14 — p. 10, l. 17, p. 11, l. 16 — p. 12, l. 16,
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`and would have a reasonable expectation of successfully making capsules using
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`HPMC 2208 or 2906, id. at p. 12, l. 16 — p. 13, l. 7.
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`11.
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`In Ex. 2076 at 62:3–10, Dr. Kibbe affirmed that, in his Reply
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`Declaration, he did not refute Dr. McConville’s testimony that the Handbook of
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`Pharmaceutical Excipients in 1999 and the U.S. Pharmacopeia in 1999 both list
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`HPMC 1828, along with types 2208 and 2906 and 2910. Further, at 62:12–22,
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`Dr. Kibbe affirmed
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`that,
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`in his Reply Declaration, he did not refute
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`Dr. McConville’s testimony that the substitution percentage range for HPMC 1828
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`is entirely outside the range claimed in the ’180 patent. This testimony is relevant
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`to Petitioner’s argument that a POSA would choose among any HPMC types and
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`still be within or overlapping the claim scope. Reply at p. 4, l. 18 — p. 5, l. 2, p. 6,
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`ll. 8–11, p. 7, l. 14 — p. 10, l. 17, p. 11, l. 16 — p. 12, l. 16.
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`6
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`IPR2017-00203
`Patent 6,649,180 B1
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` Patent Owner’s Motion for Observations
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`12.
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`In Ex. 2076 at 68:8–23, Dr. Kibbe affirmed that, in his Reply
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`Declaration, he did not refute the testimony of Dr. McConville that the point of a
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`pharmacopeia standard and label is that the ordinary artisan can rely on them to be
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`assured
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`that pharmacopeia-grade material will perform consistently and
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`predictively with all other similarly labeled material. This testimony is relevant to
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`Petitioner’s argument that Dr. McConville provides an erroneous analysis of how a
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`POSA would work. Reply at 13, l. 8 — p. 14, l. 6.
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`13.
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`In Ex. 2076 at 76:11–77:18, Dr. Kibbe testified he did not know
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`whether, in his Reply Declaration, he refuted the testimony of Dr. McConville that
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`the listing of ranges by the Japanese Pharmacopeia, the U.S. Pharmacopeia, and
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`the Handbook of Pharmaceutical Excipients would have indicated to the POSA
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`that the degree of HPO/MO substitution was irrelevant to the suitability of the
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`HPMC. Further, at Ex. 2076 at 77:20–78:19, Dr. Kibbe affirmed that, in his Reply
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`Declaration, he did not refute the testimony of Dr. McConville that, to the extent
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`the POSA was even aware of substitution percentage, it was only as a numerical
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`parameter to be found in the pharmacopeia definitions. This testimony is relevant
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`to Petitioner’s arguments that a POSA would be motivated to try HPMC types
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`other than type 2910. Reply at p. 4, l. 18 — p. 5, l. 2, p. 6, ll. 8–11, p. 7, l. 14 — p.
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`10, l. 17, p. 11, l. 16 — p. 12, l. 16.
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`7
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`IPR2017-00203
`Patent 6,649,180 B1
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` Patent Owner’s Motion for Observations
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`14.
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`In Ex. 2076 at 81:13–82:15, Dr. Kibbe affirmed that, in his Reply
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`Declaration, he did not refute Dr. McConville’s testimony that whatever properties
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`result from HPMC blends would have been difficult to predict even for a doctoral-
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`level scientist. This testimony is relevant to Dr. Kibbe’s prior testimony that
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`“[t]here is no special chemistry needed to blend different types of HPMC.” Ex.
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`1029 at ¶ 20.
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`15.
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`In Ex. 2076 at 70:19–71:14, Dr. Kibbe affirmed that, in his Reply
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`Declaration, he did not refute the testimony of Dr. McConville that the synthetic
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`process for making HPMC involves subjecting the backbone to two simultaneous
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`chemical reactions which compete with one another to make an HPO or MO
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`substitution. This testimony is relevant to the position in the Reply that “simple
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`math” provides a combined total minimum HPO/MO substitution. Reply p. 6, l. 4;
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`Ex. 1029 ¶ 19.
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`8
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`IPR2017-00203
`Patent 6,649,180 B1
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`Date: October 20, 2017
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` Patent Owner’s Motion for Observations
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`Respectfully submitted,
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`By /Scott E. Kamholz/
`Jessica L. Parezo, Reg. No. 50,286
`Andrea G. Reister , Reg. No. 36,253
`Scott E. Kamholz, Reg. No. 48,543
`Michael N. Kennedy, pro hac vice
`Megan P. Keane, pro hac vice
`COVINGTON & BURLING LLP
`One CityCenter, 850 Tenth Street, NW
`Washington, DC 20001
`(202) 662-6000
`
`MaryAnne Armstrong, Reg. No. 40,069
`Lynde F. Herzbach , Reg. No. 74,886
`BIRCH, STEWART, KOLASCH & BIRCH, LLP
`8110 Gatehouse Road, Suite 100 East
`Falls Church, VA 22402
`(703) 205-8000
`
`Counsel for Patent Owner
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`9
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`IPR2017-00203
`Patent 6,649,180 B1
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` Patent Owner’s Motion for Observations
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`CERTIFICATE OF SERVICE
`Pursuant to 37 C.F.R. § 42.6, I certify that on the date listed below, a copy of
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`Patent Owner’s Motion for Observations Regarding the Cross-Examination
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`Testimony of Arthur H. Kibbe was served by electronic mail, by agreement of the
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`parties, to Mylan-WC-IPR@kilpatricktownsend.com on the following counsel of
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`record for Petitioner:
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`Date: October 20, 2017
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`Mitchell G. Stockwell
`D. Clay Holloway
`Miranda C. Rogers
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, Suite 2800
`Atlanta, GA 30309
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`
`
`
` /Scott E. Kamholz/
`Scott E. Kamholz, Reg. No. 48,543
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`10
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