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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`MYLAN PHARMACEUTICALS INC.
`Petitioner
`
`v.
`
`QUALICAPS CO. LTD.
`Patent Owner
`
`Case IPR2017-00203
`Patent No. 6,649,180
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S RESPONSE TO
`PATENT OWNER’S MOTION FOR OBSERVATION
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`EXHIBIT LIST
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`Exhibit No. Description
`1001
`United States Patent No. 6,649,180
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
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`1012
`
`1013
`
`1014
`
`Complaint, Warner Chilcott (US), LLC et al. v. Mylan
`Pharmaceuticals, Inc., et al., Case No. 2:15-cv-01740-JRG-
`RSP (E.D. Texas)
`
`Proof of Service of Complaint, Case No. 2:15-cv-01740-JRG-
`RSP (E.D. Texas)
`
`United States Patent No. 5,756,123 (“Yamamoto”)
`
`The Japanese Pharmacopeia (The Society of Japanese
`Pharmacopeia, 13th ed. 1996) (“Japanese Pharmacopeia”)
`
`United States Patent No. 3,493,407 (“Greminger”)
`
`21 C.F.R. § 172.874 (1998)
`
`National Formulary (American Pharmaceutical Association,
`12th ed. 1965)
`
`Handbook of Pharmaceutical Excipients (1986)
`
`File History of United States Patent No. 6,649,180
`
`Expert Declaration of Arthur H. Kibbe
`
`Shin-Etsu Chemical Co., Ltd. PHARMACOAT Technical
`Information Shin-Etsu Chemical Co., Ltd. TC-5 Technical
`Information
`
`Chichester, C.O., E.M. Mrak, and G.F. Stewart, “Utilization of
`Synthetic Gums in the Food Industry,” Advances in Food
`Research, Volume 12, Technical Center, General Foods
`Corporation, Tarrytown, N.Y., 1963.
`
`Deposition Transcript of Jason T. McConville, Ph.D., Case No.
`2:15-cv-1471-JRG-RSP (E.D. Tex.), July 8, 2016
`
`1
`
`
`
`
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`1015
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`1016
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`1017
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`1018
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`1019
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`1020
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`1021
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`1022
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`1023
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`1024
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`1025
`
`1026
`
`1027
`
`Declaration Of Mr. Jonathan D. Olinger In Support Of
`Petitioner’s Unopposed Motion For Pro Hac Vice Admission
`Under 37 C.F.R. § 42.10(C)
`United States Patent No. 5,756,123 (“Yamamoto”) (Served but
`not filed, June 14, 2017)
`
`The Japanese Pharmacopeia (The Society of Japanese
`Pharmacopeia, 13th ed. 1996) (“Japanese Pharmacopeia”)
`(Served but not filed, June 14, 2017)
`
`21 C.F.R. § 172.874 (1998) (Served but not filed, June 14,
`2017)
`
`National Formulary (American Pharmaceutical Association,
`12th ed. 1965) (Served but not filed, June 14, 2017)
`
`Handbook of Pharmaceutical Excipients (1986) (Served but not
`filed, August 11, 2017)
`
`Email exchange between counsel July 25, 2017 (Served but not
`filed, August 11, 2017)
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`Email exchange between counsel August 4, 2017 (Served but
`not filed, August 11, 2017)
`
`Email exchange between counsel August 10, 2017 (Served but
`not filed, August 11, 2017)
`Mylan Pharmaceuticals Inc., Mylan Laboratories Limited, and
`Mylan Inc.’s Amended Notice Of Videotaped Deposition Of
`Representative(s) Of Qualicaps Co., Ltd. Pursuant To Federal
`Rule Of Civil Procedure 30(B)(6) (Served but not filed, August
`11, 2017)
`Email exchange between counsel March 21, 2017 (Served but
`not filed, August 11, 2017)
`
`Email exchange between counsel April 25, 2017 (Served but not
`filed, August 11, 2017)
`
`Amended Docket Control Order, Warner Chilcott (US), LLC v.
`Teva Pharmaceuticals USA, Inc., No. 2:15-cv-1471 (E.D. Tex.
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`2
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`
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`
`
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`
`
`1028
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`1029
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`May 19, 2017), ECF No. 165 (Served but not filed, August 11,
`2017)
`
`Deposition Transcript of Jason T. McConville, Ph.D., August
`17, 2017
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`Reply Expert Declaration of Arthur H. Kibbe
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`3
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`II. Response to Motion for Observation
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`1.
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`Patent Owner argues that there is some inconsistency in Dr. Kibbe’s
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`testimony regarding what parts of the Petition he may have had when he drafted
`
`his initial declaration. Motion for Ob., p. 1. Despite Patent Owner’s futile
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`fascination with the Declaration, and the Board’s advice that wading into this issue
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`is a waste of time, its observation is wrong. Dr. Kibbe’s testimony has been
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`consistent throughout the proceedings:
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` Ex. 1011, ¶ 48 – Dr. Kibbe reviewed before filing the legal section of
`
`the Petition
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` Ex. 2029, 23:18-25:8 – Dr. Kibbe reviewed draft portions of the
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`Petition before executing his already written declaration
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` Ex. 1029, ¶3 – Dr. Kibbe did not have the Petition when he wrote his
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`declaration
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` Ex. 2078, 12:9-19 – Dr. Kibbe did not have the Petition when he
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`wrote his declaration.
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`2.
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`Patent Owner argues that Dr. Kibbe’s testimony that he would expect
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`experimenters to control for residual salts (Ex. 2076, 38:22-39:10) contradicts his
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`declaration that the inventors performed no control of residual salts (Ex. 1029, ¶ 8).
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`There is no contradiction here. Dr. Kibbe explained in his declaration that the
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`documents of inventor Tanjoh-san (Exs. 2064, 2065-2072) show no “analysis of
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`4
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`
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`the chemical make up of the undesirable precipitates of Table 1 [of the ‘180
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`patent].” Moreover, Dr. Kibbe expressly states that “[c]ontrolling for the presence
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`of these residual salts is common practice for ensuring capsule quality.” Ex. 1029,
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`¶ 7. Thus, there is no inconsistency in Dr. Kibbe’s testimony.
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`3.
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`Patent Owner’s argument is simply a continued objection to the scope of
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`argument and testimony supporting the Petition’s assertion that any secondary
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`considerations do not outweigh the case of obviousness and that Patent Owner
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`cannot demonstrate nexus. Paper No. 46.
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`4.
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`Patent Owner again mischaracterizes what the Petition stated and attempts to
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`create an inconsistency where none exists. As explained in Petitioner’s Response
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`to New Argument, it is Patent Owner that presumed the spots of Table 1 were the
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`result of gelling aid precipitation. Paper 46, p. 3. Repeating its doctored quote
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`does not change the rebuttal nature of Dr. Kibbe’s testimony.
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`5.
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`Patent Owner’s argument is its continued objection to the scope of argument
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`and testimony furthering the Petition’s assertion that any secondary considerations
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`do not outweigh the case of obviousness and that Patent Owner cannot demonstrate
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`nexus. Paper No. 46.
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`6.
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`Patent Owner argues that because Dr. Kibbe admitted that acceptable cloud
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`spotting is subjective, a position he has continually maintained, Petitioner’s
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`argument that Patent Owner cannot demonstrate that the upper end of the claimed
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`5
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`
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`range represents merely a matter of degree, and not a difference in kind as it is
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`required is weakened. See Reply, p. 20-21. But it is not. That one person of
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`ordinary skill in the art might fight some unspecified level of spotting acceptable,
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`and another person of skill might not, is precisely Petitioner’s point.
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`7.
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`As with Observation Number 6, Patent Owner’s critique misses the mark.
`
`That Dr. Kibbe has not seen any document saying how much spotting is acceptable
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`again demonstrates that the claim’s upper end merely evidences differences in
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`degree, not in kind.
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`8.
`
`Patent Owner points to half of an answer and argues that Dr. Kibbe
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`contradicted his prior position that simple math tells a person of ordinary skill in
`
`the art that the minimum amount of substitution for an HPMC type is described by
`
`the Japanese Pharmacopeia. Motion for Ob., p. 5. But Dr. Kibbe explained that it
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`follows that given the minimum and maximum amounts of the various substitution
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`groups, a person of skill in the art can readily determine the minimums. Ex. 2076,
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`73:3-14. Moreover, Federal Rule of Evidence 106 would require considering the
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`remainder of the answer given by Dr. Kibbe.
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`9.
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`Patent Owner completely mischaracterizes the question and answer
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`referenced in Observation No. 9. The question was whether Dr. Kibbe wrote in
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`that specific paragraph of his Reply Declaration that a person of ordinary skill in
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`the art would have understood there could be other causes for the described
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`6
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`
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`spotting. He testified that in his opinion, they would. Moreover, Dr. Kibbe
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`explained in Ex. 2076, 59:11-17, that “everything I write in here is from the
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`perspective of a person of ordinary skill in the art. So if I have a statement in here,
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`then it’s from that perspective.”
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`10. Patent Owner’s Observation is based on conflating two positions that are not
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`supported. First, Patent Owner asserts the nonsensical position by Dr. McConville
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`concerning whether a person of skill in the art would have predicted specific
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`effects of changes to MO and HPO content. But this position is not relevant given
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`Dr. McConville admitted a person of ordinary skill in the art would have been able
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`to mix different HPMC types. Reply, p. 14. Then Patent Owner points out that Dr.
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`Kibbe did not address this position to argue a person of skill in the art would not be
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`motivated to blend HPMC. But these two positions do not add up to what Patent
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`Owner suggests as addressed in detail in the Reply at pp. 13-15.
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`11. Patent Owner again ignores the combination at issue in the IPR – Yamamoto
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`plus the Japanese Pharmacopeia. The irrelevance of prior art selectively narrowed
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`to the HPMCs described in the Japanese Pharmacopeia is explained in the Reply at
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`p. 3.
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`12. This observation is not relevant because whether the person can rely on the
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`labeling fails to make any fact at issue in the proceeding more or less true. Fed. R.
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`Evid. 401.
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`7
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`13. The impact of this observation – that is, whether a person of skill would
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`have been motivated to blend HPMC types – is addressed in the Reply at pp. 3-15.
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`The observation testimony has no impact on that analysis.
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`14. This observation is not relevant because whether the person of ordinary skill
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`in the art would have predicted the allegedly discovered spotting properties is not
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`the test for motivation to combine and thus fails to make any fact at issue in the
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`proceeding more or less true. Fed. R. Evid. 401. Moreover, the evidence that a
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`person of skill in the art could mix two HPMC types together is undisputed. Reply
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`at pp. 13-15.
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`15. This observation is not relevant because whether the person of ordinary skill
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`in the art would have predicted an exact chemical reaction of two HPMC types is
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`not the test for motivation to combine and thus fails to make any fact at issue in the
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`proceeding more or less true. Fed. R. Evid. 401. Moreover, the evidence that a
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`person of skill in the art could mix two HPMC types together is undisputed. Reply
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`at pp. 13-15.
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`Dated: November 10, 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
`
`
`
`Lead Counsel
`Mitchell G. Stockwell
`
`Back-Up Counsel
`D. Clay Holloway
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`8
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`Reg. No. 39,389
`mstockwell@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`
`
`
`
`Reg. No. 58,011
`cholloway@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`9
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that on November 10, 2017 a copy of the
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`foregoing Petitioner Mylan Pharmaceuticals Inc.’s Response to Patent Owner’s
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`Motion for Observation was served by electronic mail by agreement of the parties
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`on the following counsel of record for Patent Owner.
`
`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: November 10, 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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`10
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