IPR2015-00990; -01093
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`COALITION FOR AFFORDABLE DRUGS II LLC,
`
`Petitioner,
`
`v.
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`NPS PHARMACEUTICALS, INC.
`
`Patent Owner.
`____________
`
`
`Cases IPR2015-00990 and IPR2015-01093
`(Patent 7,056,886 B2)1
`
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`PATENT OWNER’S RESPONSE TO INTRODUCTION IN PETITIONER’S
`RESPONSE TO MOTION PRESENTING PATENT OWNER’S
`OBSERVATIONS REGARDING CROSS-EXAMINATION
`OF IVAN HOFMANN
`
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`
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`
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`1 Pursuant to the Board’s Scheduling Order in these IPRs, “the word-for-word
`identical paper is filed in each proceeding identified in the heading.” See, e.g.,
`IPR2015-00990, Paper 29, footnote 1.
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`28621119v1
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`
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`
`COALITION FOR AFFORDABLE DRUGS II LLC,
`
`Petitioner,
`
`v.
`
`NPS PHARMACEUTICALS, INC.
`
`Patent Owner.
`____________
`
`
`Cases IPR2015-00990 and IPR2015-01093
`(Patent 7,056,886 B2)1
`
`
`PATENT OWNER’S RESPONSE TO INTRODUCTION IN PETITIONER’S
`RESPONSE TO MOTION PRESENTING PATENT OWNER’S
`OBSERVATIONS REGARDING CROSS-EXAMINATION
`OF IVAN HOFMANN
`
`
`
`
`
`
`1 Pursuant to the Board’s Scheduling Order in these IPRs, “the word-for-word
`identical paper is filed in each proceeding identified in the heading.” See, e.g.,
`IPR2015-00990, Paper 29, footnote 1.
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`28621119v1
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`IPR2015-00990; -01093
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`I.
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`Introduction
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`This is in response to Petitioner’s objections in the Introduction to its
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`Response to Patent Owner’s Observations Regarding Cross-Examination of Ivan
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`Hofmann. See, e.g., IPR2015-00990, Paper 57 (“Paper 57”) at 1-4. Petitioner
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`objects because the Observations allegedly are too long, are argumentative, raise
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`new issues, and introduce new exhibits. Petitioner is incorrect because the
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`observations: (1) provide citations encompassing the relevant testimony and
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`context necessary for understanding its relevance and succinctly (i.e., in two
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`sentences or less) explain the relevancy to Petitioner’s submissions; (2)
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`scrupulously avoid any argument; (3) do not raise any new issues; and (4) provide
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`exhibits against which all objections have been waived and which are used for
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`rebuttal.
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`Furthermore, Petitioner’s objections should not be considered and should be
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`expunged because they go far beyond what was authorized by the Board.
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`Objections are presented outside of the introduction (see, e.g., Paper 57 at 6),
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`which Petitioner acknowledges is the only place in its response that the Board
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`authorized for such objections. See Paper 57 at 1.
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`II. The Observations Cite the Appropriate Testimony
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`Petitioner complains, without reason, that certain testimony citations are
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`simply too long. Paper 57 at 3. There is no per se citation length rule. If the entire
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`IPR2015-00990; -01093
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`citation is relevant to a stated issue, the entire citation is proper. Patent Owner
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`should not be required to truncate important cross-examination testimony simply
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`because Petitioner believes it is long, and Petitioner and the witness should not be
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`able to manipulate Observations and be rewarded by unduly complicating
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`questioning and giving non-responsive answers.
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` More importantly, the citation to 62:12-83:19 (Observation (“Ob.”) 3) was
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`necessary because the question of whether the ‘886 patent claims encompassed
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`formulations of many different analogs had to be asked claim-by-claim in order to
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`avoid confusing the witness, because, in some instances, the witness requested that
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`(see, e.g., Ex. 2070 at 69:13-21), and because the witness gave long, non-
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`responsive answers. See, e.g., id. at 68:4-17. The citations to 159:9-169:14 (Ob.
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`7) (commercial success/nexus), 120:9-128:22 (Ob. 14) (long felt need), 192:15-
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`200:19 (Ob. 17) (patient penetration), and 257:20-267:13 (Ob. 21) (sale of NPS
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`and valuation) each concern testimony developed through a series of questions and
`
`answers on opinions given by Mr. Hofmann. This type of questioning is a useful
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`cross-examination technique, and Patent Owner should not be precluded from it by
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`a per se length exclusion rule.
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`It should be noted that Petitioner also made multiple citations and multi-page
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`citations (see, e.g.,Paper 57, at II.2., II.4., II.5., II.7., II.9., II.12., II.14., II.19.,
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`II.20., II.21.; Paper 56, Resp. II.A.ii., II.A. iii., II.D.iii., II.H.i.), and did not use the
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`IPR2015-00990; -01093
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`precise phrasing.
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`III. Each Observation Explains Its Relevancy in only One or Two Sentences
`and Avoids Argument
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`Each observation includes only one or two sentences that explain the
`
`relevancy of the cited cross-examination testimony, i.e., a short paragraph. Each
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`Observation includes citations to Petitioner’s Reply or the Witness’s Reply
`
`Declaration showing to what the Observation relates. Finally, each Observation
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`suitably groups the testimony citations according to a common issue of relevance.
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`Petitioner persistently characterizes cross-examination citations that are
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`inconsistent with or rebut Mr. Hofmann’s opinions in his Reply Declaration as
`
`reargument or argumentative. See, e.g., Paper 57 at 2 and Resp. to Obs. 3, 4, 5, 7,
`
`and 9. Petitioner essentially asserts that if Patent Owner raised an issue first (such
`
`as a blocking patent or commercial success) and then Mr. Hofmann replied in his
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`declaration, Patent Owner should be precluded (based upon theories of reargument
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`and being argumentative) from offering Hofmann’s cross-examination testimony
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`on that issue in an Observation because Mr. Hofmann did not raise the issue first.
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`No tribunal could sanction such an illogical approach (which would prevent testing
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`any of Mr. Hofmann’s opinions) to cross-examination.
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` The present Observations merely indicate the issues to which they apply.
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`Each issue was addressed by Mr. Hofmann in his Declaration. Therefore, these
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`issues were properly cross-examined. Argument would include application of facts
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`IPR2015-00990; -01093
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`to law with reasons why the citations demonstrate a lack of expertise and use of
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`hindsight. The Observations deliberately avoid that.
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`Furthermore, Petitioner now argues relevancy to Mr. Hofmann’s expertise
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`and qualifications (Paper 57 at Resp. to Ob. 1), to Mr. Hofmann’s previous
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`explanation that coupons, rebates, and patient insulation were not properly taken
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`into account by Patent Owner (id. at Resp. to Ob. 10), the price of Gattex as a non-
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`indication of commercial success (id. at Resp. to Ob. 11), whether the patient
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`population for other drugs is relevant to the commercial success and long-felt need
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`analysis for Gattex (id. at Resp. to Obs. 17-18), and that “the price paid by Shire
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`for NPS is not evidence of any commercial success of Gattex” (id. at Resp. to Ob.
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`21). Petitioner’s double standard shows its objections are baseless.
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`IV. The Rebuttal Exhibits Were Properly Introduced during Cross-
`Examination; Petitioner Did Not Make a Timely Motion to Exclude
`
`Petitioner argues that Patent Owner has improperly introduced Exs. 2161-
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`2169, 2172, and 2173. Paper 57 at 3-4. However, each was properly introduced
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`as a rebuttal exhibit during the Hofmann cross-examination. See Ex. 2170 at 2-3.
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`37 CFR 42.53(f)(8) states: “Any objection to the content, form, or manner of
`
`taking the deposition, including the qualifications of the officer, is waived unless
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`made on the record during the deposition and preserved in a timely filed motion to
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`exclude.” Petitioner never made a motion to exclude, and the deadline (i.e., May
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`18, 2016) has passed. Any objections to these exhibits have been waived. Further,
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`IPR2015-00990; -01093
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`the Board has previously rejected Petitioner’s argument that it could not have filed
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`a motion to exclude because it “had no way of to know [the exhibits] would be
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`used improperly as part of the Hofmann Observations.” Paper 57 at 4; Respironics,
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`Inc. v. Zoll Medical Corp., IPR2013-00322, Paper 30 at 3 (motion to exclude
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`should state that it “applies to the extent Patent Owner relies upon the subject
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`evidence”).
`
`Medtronic, Inc. v. Nuvasive, Inc., IPR203-00506, 00507, 00508, Paper 37, p.
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`4, n. 2 does not support Petitioner, either. The Medtronic Board did not expect
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`earlier testimony of a different witness under the circumstances in that case.
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`V. Conclusion
`
`The Observations are proper and in good form and should be considered.
`
`Respectfully submitted,
`
`/Joseph R. Robinson/
`Joseph R. Robinson, PTO Reg. No. 33,448
`Heather M. Ettinger, PTO Reg. No. 51,658
`Dustin B. Weeks, PTO Reg. No. 67,466
`Attorneys for Patent Owner
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`Dated: June 14, 2016
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`IPR2015-00990; -01093
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing PATENT
`
`OWNER’S RESPONSE TO
`
`INTRODUCTION
`
`IN PETITIONER’S
`
`RESPONSE TO MOTION PRESENTING PATENT OWNER’S
`
`OBSERVATIONS REGARDING CROSS-EXAMINATION OF
`
`IVAN
`
`HOFMANN has been on attorney for Petitioner, served via electronic mail on June
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`14, 2016, to the following addresses provided by Petitioner:
`
`Jeffrey D. Blake, Esq.
`jblake@merchantgould.com
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`Dated: June 14, 2016
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`Respectfully submitted,
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`/Dustin B. Weeks/
`Dustin B. Weeks, PTO Reg. No. 67,466
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`28621119v1
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