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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`Case IPR 2017-01053
`Patent 8,268,299
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner
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`v.
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`ALCON RESEARCH, LTD,
`Patent Owner
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`Case IPR2017-01053
`Patent 8,268,299
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`ALCON RESEARCH, LTD.’S MOTION FOR OBSERVATIONS ON THE
`SECOND DEPOSITION OF PETITIONER’S EXPERT
`DR. YVONNE M. BUYS, M.D.
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`Case IPR 2017-01053
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`Patent 8,268,299
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`Pursuant to 77 Fed. Reg. 48,767-68, Paper 7 at 6, and Paper 34 at 2, Patent
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`Owner Alcon Research, Ltd. (“Alcon”) submits this motion for observations
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`regarding cross-examination of Petitioner’s reply declarant Dr. Yvonne M. Buys,
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`M.D., following her deposition on May 14, 2018 (Exhibit 2167).
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`Observation 1. Dr. Buys testified:
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`Q. Why is medical therapy the most common initial
`intervention to lower IOP?
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`A. Because the other interventions, which would be
`surgery and laser, can have higher side—or higher risks
`associated with them.
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`Ex. 2167 at 10:11-15. This testimony is relevant to Petitioner’s argument that
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`there was no need for a glaucoma “drug” because “by 2006 there were many
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`options available for treating glaucoma while avoiding BAK, such as surgery and
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`laser treatments.” The testimony is relevant because it undermines the premise of
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`Petitioner’s argument—that surgery and laser treatments are suitable or equivalent
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`options to medical therapy.
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`Observation 2. Dr. Buys testified:
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`Q. What are the advantages of multiuse medications over
`single unit dose medications?
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`A. To have one container that has multiple drops is easier
`than having one container for each drop for the patient.
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`Ex. 2167 at 22:16-20. This testimony is relevant to Petitioner’s argument that
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`there were “many treatment options available as of 2006, including the ability to
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`Case IPR 2017-01053
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`Patent 8,268,299
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`package any of the ophthalmic drugs known in 2006 (including travoprost) in
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`single-use form, thereby avoiding preservatives such as BAK altogether.” Paper
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`35 at 26. The testimony is relevant because it undermines the premise of
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`Petitioner’s argument—that single-use containers are just as desirable as multi-use
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`containers.
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`Observation 3. Dr. Buys testified:
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`Q. Can we agree that as of September 2006 there were
`some glaucoma patients or patients with elevated
`intraocular pressure who had symptoms of ocular surface
`disease and who would benefit from an eye drop that
`contained a prostaglandin analog and which also did not
`contain a traditional chemical preservative agent?
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`A. They would benefit from that as an option. They
`would benefit from an option of a treatment that did not
`have a preservative agent.
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`Q. And you used the word “treatment,” but I want to be
`clear that –
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`A. With medical treatment being one of those options,
`like a preservative-free prostaglandin analog.
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`Ex. 2167 at 13:21-14:10. This testimony is relevant to Petitioner’s argument that
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`“the need was nonexistent or modest at best, and that there were virtually no
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`patients who did not have adequate treatment options as of 2006.” Paper 35 at 26.
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`The testimony is relevant because it contradicts Petitioner’s argument.
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`Case IPR 2017-01053
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`Patent 8,268,299
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`Observation 4. Dr. Buys testified regarding Exhibit 2132:
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`Q. So in your declaration you quoted the results that
`don’t show a statistical difference, and you omitted the
`results that do show a statistical difference?
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`A. The point of my declaration was to show the faults
`with this paper, so this was highlighting where the issues
`are with this paper.
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`Q. Okay. And you did not report in your declaration the
`results of that first sentence under Mean change in OSDI
`scores; is that right?
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`A. Correct.
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`Q. And on Page 1258, this is at the bottom of the left-
`hand column under the heading Outcomes stratified by
`duration of pretreatment; do you see that?
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`A. Yes.
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`. . .
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`Q. And just to be clear, you didn’t quote or cite this result
`in your declaration?
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`A. I did not.
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`Ex. 2167 at 27:20-30:6. This testimony is relevant to Petitioner’s argument that
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`the studies relied upon by Alcon “do not contain data supporting the papers’
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`conclusory statements regarding TRAVATANZ® and its alleged advantages from
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`being BAK-free” and that “study after study fails to confirm any improvement in
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`OSD symptoms from BAK-free treatments.” Paper 35 at 26. The testimony is
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`relevant because it contradicts Petitioner’s argument.
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`Case IPR 2017-01053
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`Patent 8,268,299
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`Observation 5. Dr. Buys testified regarding Exhibit 2132:
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`Q. . . . Do you see Table 2 on Page 1259 of Exhibit
`2132?
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`A. Yes, I do.
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`Q. All of the adverse events in Table 2 are adverse events
`that were known to be associated with prostaglandin
`analog use, right?
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`A. And BAK, yes.
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`Q. You have no idea whether the numerical differences
`in these adverse events between BAK-free travoprost and
`latanoprost are statistically significant, do you?
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`A. No, that’s not provided on the table. There’s just
`numerically more in the BAK-free travoprost group.
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`Q. And you don’t know whether those differences are
`statistically significant?
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`A. No.
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`Ex. 2167 at 37:25-38:16. This testimony is relevant to Petitioner’s argument that
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`“multiple studies [including Exhibit 1232] report that TRAVATANZ® actually
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`makes OSD symptoms worse, not better,” Paper 35 at 26, and Dr. Buys’ statements
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`of the same, Ex. 1092 ¶ 37. The testimony is relevant because it contradicts
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`Petitioner’s argument and undermines Dr. Buys’ credibility.
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`Observation 6. Dr. Buys testified regarding Exhibit 1091:
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`Q. Exhibit 1091 is a paper that you rely upon in your
`second declaration, right?
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`A. Yes.
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`Case IPR 2017-01053
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`Patent 8,268,299
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`Q. And you mention in Paragraph 34 of your declaration
`that this study is particularly reliable, right, . . .?
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`A. Correct.
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`. . .
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`Q. And you note also that this study was not funded by
`Alcon, right?
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`A. It was not directly paid for by Alcon, correct.
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`Q. But it was funded by Allergan, right?
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`A. Yes.
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`. . .
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`Q. Okay. So two of the authors of this study were
`Allergan employees, right?
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`A. Correct.
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`Q. Allergan is a competitor of Alcon?
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`A. Yes.
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`Q. And it’s the manufacturer of Lumigan, which is a
`direct competitor to Travatan Z, correct?
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`A. Correct.
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`Q. You didn’t note that in your declaration, did you?
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`A. No, because I didn’t note it for the other studies too,
`which all had Alcon not necessarily employees but
`consultants, et cetera, as the authors. I was only looking
`if the studies itself were funded. But you’re right; this is
`another level of issue with disclosures.
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`Ex. 2167 at 49:19-51:25. This testimony is relevant to Petitioner’s argument that
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`the studies relied upon by Alcon are “all Alcon funded,” Paper 35 at 26, and Dr.
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`Case IPR 2017-01053
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`Patent 8,268,299
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`Buys’ statements regarding industry-funded studies, Ex. 1092 ¶¶ 21, 23, 26, 32,
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`34-35. The testimony is relevant because it demonstrates that Petitioner is also
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`relying upon an industry-funded study, and it undermines Dr. Buys’ credibility to
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`criticize Alcon’s reliance on industry-funded studies but then herself describe as
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`“particularly reliable” a study funded by Alcon’s direct competitor.
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`Dated: May 18, 2018
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`Respectfully submitted,
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`/David M. Krinsky/
`David M. Krinsky
`Reg. No. 72,339
`Lead Counsel for
`Patent Owner
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`Williams & Connolly LLP
`725 Twelfth Street NW
`Washington, D.C. 20005
`202-434-5338 (Telephone)
`202-434-5029 (Facsimile)
`dkrinsky@wc.com
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`Case IPR 2017-01053
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`Patent 8,268,299
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`CERTIFICATE OF SERVICE (37 C.F.R. § 42.6(e))
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`The undersigned hereby certifies that the foregoing “ALCON RESEARCH,
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`LTD.’S MOTION FOR OBSERVATIONS ON THE SECOND DEPOSITION OF
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`PETITIONER’S EXPERT DR. YVONNE M. BUYS, M.D.” was served on May
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`18, 2018, via electronic mail upon the following attorneys of record for the
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`Petitioner:
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`Michael R. Houston
`Joseph P. Meara
`James P. McParland
`FOLEY & LARDNER LLP
`mhouston@foley.com
`jmeara-pgp@foley.com
`jmcparland@foley.com
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`Tyler C. Liu
`ARGENTUM PHARMACEUTICALS LLC
`tliu@agpharm.com
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`Dated: May 18, 2018
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`Respectfully submitted,
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`/David M. Krinsky/
`David M. Krinsky
`Reg. No. 72,339
`Lead Counsel for Patent Owner
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