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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MYLAN PHARMACEUTICALS INC. and
`AMNEAL PHARMACEUTICALS LLC
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`Petitioners
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`v.
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`YEDA RESEARCH AND DEVELOPMENT CO. LTD.
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`Patent Owner
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`Case IPR2015-00643 (Patent 8,232,250 B2)
`Case IPR2015-00644 (Patent 8,399,413 B2)
`Case IPR2015-00830 (Patent 8,969,302 B2)1,2
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`PATENT OWNER’S OPPOSITION TO
`PETITIONERS’ MOTION TO EXCLUDE
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`1 The word-for-word identical Patent Owner’s Opposition to Petitioners’ Motion to
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`Exclude is filed in each proceeding identified in the caption.
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`2 Cases IPR2015-01976, IPR2015-01980, and IPR2015-01981 have been joined
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`with IPR2015-00643, IPR2015-00644, and IPR2015-00830, respectively.
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`The Board should deny Petitioners’ motion to exclude (1) paragraphs 13-23,
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`26-32, 37-45, and 50-56 of the expert declaration of Henry G. Grabowski, Ph.D.
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`(the “Grabowski Declaration,” Ex. 2133), and (2) Exhibits 2108-2122, which were
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`submitted in support of, and referenced by, the Grabowski Declaration.
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`Petitioners’ motion is flatly inconsistent with the Federal Rules of Evidence.
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`Their recurring objection is that both the exhibits and declarations reference data
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`and other evidence that was not separately admitted into the record. Patent Owner
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`does not argue that the underlying evidence should itself be admitted at this point
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`in the proceeding. But experts may rely on evidence that is not admitted, and
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`parties routinely present the sort of evidentiary summaries and excerpts that Patent
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`Owner has put forward here without submitting the voluminous underlying data.
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`Petitioners’ objections also make little practical sense. Admission of the
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`challenged exhibits and expert opinions could not possibly prejudice Petitioners,
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`because they have unrestricted access to all of the underlying data and evidence. If
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`Petitioners have a basis to argue that the summaries, excerpts, and expert opinions
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`drawn from this evidence are flawed for some reason, they may present their
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`contentions to the Board at trial. But they should not be able to keep out relevant
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`evidence concerning Copaxone 40 mg/mL’s commercial success by manufacturing
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`nonexistent evidentiary hurdles.
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`1
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`FACTUAL BACKGROUND
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`I.
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`The Relevant Documents
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`Since its launch, Copaxone 40 mg/mL has achieved significant commercial
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`success as the only less-than-daily dosed glatiramer acetate product approved as
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`safe and effective for the treatment of relapsing-remitting multiple sclerosis. To
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`support its argument that this commercial success provides objective evidence that
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`the challenged patents are not obvious, Patent Owner submitted the expert
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`declaration of Henry G. Grabowski, Ph.D. Patent Owner also submitted several
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`exhibits in support of the Grabowski Declaration (Exs. 2104-2122).
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`Most relevant to Petitioners’ motion, Exhibits 2108-2114 and 2120-2122 are
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`summary demonstrative exhibits, which present graphs and charts depicting
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`Copaxone® 40 mg/mL sales and prescriptions, including the drug’s market share
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`among treatments approved for relapsing-remitting multiple sclerosis. The
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`exhibits summarize numerous spreadsheets of data obtained from IMS Health—the
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`“leading provider of pharmaceutical data” to “the pharmaceutical industry,
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`government, and academia.” Grabowski Declaration ¶ 26 n.10. In addition,
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`Exhibits 2115-2119 provide relevant excerpts from a document entitled “2015 MS
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`Mid-Year Tracker, FINAL REPORT APPENDIX-SEPTEMBER 2015” (the “Mid-
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`Year Tracker”). The Mid-Year Tracker is a 199-page report describing the results
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`2
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`of an internet-based survey of physicians and patients concerning their awareness,
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`perceptions, and usage of Copaxone 40 mg/mL and its competitors.
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`In total, the Grabowski Declaration cites 51 documents, which are listed in
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`Exhibit 2106. Of those 51 documents, 47 are either generally accessible to
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`interested members of the public or available for purchase, including the IMS data
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`(which pharmaceutical companies routinely purchase), analyst reports, drug labels,
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`patents, expert reports and depositions, and websites. The remaining four
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`documents are internal documents from Teva Pharmaceuticals. Patent Owner has
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`produced all four internal documents to counsel for Petitioners in the parallel
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`district court litigation, In re Copaxone 40 mg Consolidated Actions, 14-cv-1171
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`(D. Del.). In particular, Patent Owner produced the Mid-Year Tracker on
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`November 25, 2015.
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`II. Relevant Procedural History
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`Petitioners filed objections to Patent Owner’s exhibits, including to Exhibits
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`2108-2114, 2120-2122, and 2115-2119, on November 30, 2015 in IPR2015-00643
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`and IPR2015-00644, and on December 3, 2015 in IPR2015-00830. In response,
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`counsel for Patent Owner served on Petitioners a declaration authenticating the
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`documents and providing that “the original” of each document “will be made
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`available for inspection and copying” by Petitioners at the law offices of Patent
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`Owner’s counsel. December 14, 2015 Declaration of Eleanor M. Yost ¶¶ 15-29 in
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`3
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`IPR2015-00643 and IPR2015-00644 (Ex. 2149 and Ex. 2150, respectively);
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`December 17, 2015 Declaration of Eleanor M. Yost ¶¶ 15-29 in IPR2015-00830
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`(Ex. 2151). Subsequently, on January 12, 2016, Mylan notified Patent Owner that
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`the materials identified in Exhibit 2106 had not been filed or produced in the IPR
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`proceedings. Ex. 2140. Patent Owner responded by letter dated January 19, 2016.
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`Ex. 1075. In the letter, Patent Owner authorized Petitioners to use in these
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`proceedings all the materials identified in Exhibit 2106 that had been produced in
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`the district court litigation, including materials like the Mid-Year Tracker that were
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`filed with confidentiality designations. Id. at 5.
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`Patent Owner also moved the Board for permission to file nine additional
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`documents identified in Exhibit 2106 as supplemental exhibits. On February 1,
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`2016, the Board granted the motion to supplement in part, allowing Patent Owners
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`to file four analyst reports (Exhibits 2141-2144) that had been produced in the
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`district court litigation without confidentiality designations. See Board Decision at
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`4-5. The Board denied the motion with respect to five other documents, including
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`the Mid-Year Tracker. Id. The Board acknowledged that as of January 19, 2016,
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`all counsel for Petitioners had access to these excluded documents. Id. at 5.
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`On February 10, 2016, Petitioners’ counsel took the deposition of
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`Dr. Grabowski. During the deposition, counsel questioned Dr. Grabowski about
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`his reliance on IMS data and the results of the Mid-Year Tracker survey. See, e.g.
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`4
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`Ex. 2148 at 48, 61-68. Petitioners subsequently filed a motion to exclude on April
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`13, 2016. In the motion, Petitioners claim that the IMS summary exhibits
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`(Exhibits 2108-2114 and 2120-2122) and the Mid-Year Tracker excerpt exhibits
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`(Exhibits 2115-2119) should be excluded. They also contend that the Board
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`should exclude several paragraphs of the Grabowski Declaration.
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`ARGUMENT
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`Petitioners, as the parties “moving to exclude evidence,” “bear[] the burden
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`of proof to establish that [they are] entitled to the relief requested.” Athena
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`Automation Ltd. v. Husky Injection Molding Sys. Ltd., IPR2013-00290, Paper 45,
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`52 (P.T.A.B. Oct. 23, 2014) (citing 37 C.F.R. § 42.20(c), 42.62(a)). Petitioners
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`have not satisfied their burden. To the contrary, the evidence that they challenge is
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`admissible under well-established evidentiary rules that govern this proceeding.
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`See 37 C.F.R. § 42.62(a)-(b) (explaining that, with immaterial exceptions, the
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`Federal Rules of Evidence apply to this proceeding). Notably, petitioners do not
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`identify any precedents—from the Board or federal courts—where evidence was
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`excluded under anything like the circumstances presented here.
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`I.
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`The Summary Exhibits and Expert Opinion Paragraphs That Use IMS
`Data Should Be Admitted
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`The exhibits summarizing IMS data are fully admissible, as are the
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`paragraphs from the Grabowski Declaration referencing those exhibits. In fact, the
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`Board recently denied a motion to exclude in remarkably similar circumstances.
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`5
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`The Board admitted summary exhibits of IMS data and corresponding paragraphs
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`in an expert report about the patent owner’s commercial success. See Phigenix,
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`Inc. v. Immunogen, Inc., IPR2014-00676, Paper 39, 28-29 (P.T.A.B. Oct. 27,
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`2015). Petitioners’ assertion that the Board should exclude this highly relevant
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`evidence merely because the underlying IMS data has not been admitted is
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`contrary to basic principles of evidence law.
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`A. The Summary Exhibits Using IMS Data Are Admissible
`Under Federal Rule of Evidence 1006, a party “may use a summary, chart,
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`or calculation” when the original data is too “voluminous” to conveniently
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`examine in court, so long as the proponent makes “the originals or duplicates
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`available” for other parties to review “at a reasonable time and place.” There is no
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`question that summary charts and graphs are appropriate here, and Petitioners do
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`not appear to argue otherwise. See Phigenix, Inc., Paper 39 at 28-29 (recognizing
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`that it was appropriate to summarize IMS data because it was “voluminous”).
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`Exhibits 2108-2114 and 2120-2122 condense a large amount of data, consisting of
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`monthly new prescriptions, total prescriptions, source of business, wholesale sales
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`dollars, extended unit sales, total promotional spending, and promotional spending
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`by category of therapies for relapsing-remitting multiple sclerosis between 2009
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`and 2015.
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`6
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`Petitioners’ primary objection (at 3) is that the underlying IMS Health data
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`has not been separately admitted into the record. But it is black-letter law that
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`“[t]he materials underlying Rule 1006 summaries need not be admitted into
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`evidence.” 6 Weinstein’s Federal Evidence § 1006.02 (2d ed. 2015); see also
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`United States v. Irvin, 682 F.3d 1254, 1261 (10th Cir. 2012) (same); Air Safety,
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`Inc. v. Roman Catholic Archbishop of Boston, 94 F.3d 1, 7 n.14 (1st Cir. 1996) .
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`Indeed, in “most cases” where a Rule 1006 summary is used it “will be the only
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`evidence the fact finder will examine concerning a voluminous record of
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`documents.” United States v. Milkiewicz, 470 F.3d 390, 396 (1st Cir. 2006) (first
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`emphasis added) (citations omitted). Summaries are often featured in expert
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`reports, and exhibits prepared as summary evidence to accompany an expert report
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`are “almost never excluded under Rule 1006.” 6 Weinstein’s Federal Evidence
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`§ 1006.08[2]. The Board confirmed this accepted understanding in Phigenix, Inc.,
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`where it rejected the petitioner’s motion to exclude exhibits providing “a summary
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`of voluminous IMS [Health] revenue and prescription data.” Paper 39 at 27.
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`Petitioners provide no reason to depart from standard practice here.
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`Rule 1006 merely requires that Patent Owner make the underlying IMS data
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`“available” to Petitioners, Fed. R. Evid. 1006, which Patent Owner has done. Not
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`only is IMS data available for purchase and regularly obtained by pharmaceutical
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`companies like Petitioners, but Patent Owner has already disclosed IMS data to
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`7
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`Petitioners in the district court litigation. See pp. 3-4, supra. Patent Owner also
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`made clear in its January 19, 2016 letter that Petitioners could use in these IPR
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`proceedings the IMS data that had already been disclosed. Ex. 1075 at 5 (listing
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`the disclosure of “IMS Data Cited in Ex. 2108-2114 and 2120-2122” and making
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`clear that “Patent Owner authorizes Petitioners to use” the listed documents).
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`Moreover, Patent Owner provided back on December 14, 2015 that it would make
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`the originals of the challenged exhibits—including the IMS data—available for
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`inspection and copying by Petitioners. See p. 3, supra. Petitioners have thus had
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`ample time to review and analyze this evidence.
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`Aside from their misguided objection about the record, Petitioners briefly
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`note (at 3-4) that summary exhibits must be accurate. But they provide no reason
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`in their motion to doubt either the underlying IMS data or the accuracy of the
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`summaries representing that data. IMS data is routinely accessed and used by
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`major pharmaceutical companies like Petitioners. Indeed, IMS data has been
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`referred to as “the gold standard” in pharmaceutical data, and it has repeatedly
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`been relied on by experts and accepted by courts. In re Actiq Sales & Mktg.
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`Practices Litig., No. 07-cv-4492, 2014 WL 3572932, at *10 (E.D. Pa. July 21,
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`2014) (collecting decisions); see also New England Carpenters v. First Bank, 248
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`F.R.D. 363, 370-71 (D. Mass. 2008) (citations omitted) (“Many courts have relied
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`on IMS data in litigation involving the pharmaceutical markets.”).
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`8
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`If Petitioners believe that there is some unique reason to doubt the IMS data
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`here—or to doubt whether the summary exhibits accurately report the data—
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`Petitioners were free to make that argument in their motion. They did not.
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`Petitioners’ claim that neither they nor the Board can even evaluate the data is
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`meritless. As discussed, pp. 3-4, supra, Patent Owner already provided IMS data
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`to Petitioners, and Petitioners have questioned Dr. Grabowski about his reliance on
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`IMS data at his deposition, see p. 4, supra. Moreover, if the Board concludes that
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`it needs to review the underlying IMS data, it has discretion under Rule 1006 to
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`order its production. See Fed. R. Evid. 1006 (“[T]he court may order the
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`proponent [of a summary] to produce [the originals] in court.” (emphasis added)).
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`B.
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`The Paragraphs of the Grabowski Declaration Referencing IMS
`Data Should Not Be Excluded or Discounted
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`Petitioners next contend (at 4-6) that the paragraphs of the Grabowski
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`Declaration that cite the summary IMS data exhibits should be excluded. Because
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`Petitioners’ objection to the summary exhibits is itself meritless, the Board should
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`also reject their attempt to extend that objection to Dr. Grabowski’s expert opinion.
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`Even if the summaries were excluded, the Board should still admit the
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`paragraphs in the Grabowski Declaration. Petitioners’ contrary argument depends
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`on the premise that Dr. Grabowski cannot rely on IMS data that is not admitted
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`into evidence. That premise is wrong. Federal Rule of Evidence 703 “expressly
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`authorizes the admission of expert opinion that is based on ‘facts or data’ that
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`9
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`themselves are inadmissible, as long as the evidence relied upon is ‘of a type
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`reasonably relied upon by experts in the particular field in forming opinions.’”
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`Monsanto Co. v. David, 516 F.3d 1009, 1015-16 (Fed. Cir. 2008) (quoting Fed. R.
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`Evid. 703).
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`There is no question that IMS data is “of a type reasonably relied upon by
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`experts.” Fed. R. Evid. 703. Experts have used IMS data in numerous cases, see
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`In re Actiq Sales & Mktg. Practices Litig., 2014 WL 3572932, at *10 (describing
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`IMS data as the “gold standard”), and, as discussed, the Board has previously
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`admitted expert opinions that rely on it, see Phigenix, Inc., Paper 39. Petitioners
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`do not identify a single case in which an expert opinion was excluded as unreliable
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`because it used IMS data. Instead, they assert in conclusory fashion (at 5) that Dr.
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`Grabowski’s testimony is not “based on sufficient facts or data” under Federal
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`Rule of Evidence 702(b). But their suggestion that facts and data are not reliable
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`just because they are not admitted into evidence is completely irreconcilable with
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`the plain text of Rule 703.
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`Petitioners’ cursory argument (at 5) that Dr. Grabowski’s opinions “should
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`be given no weight” does not fare any better. The authority that Petitioners cite
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`concerns situations in which an expert’s opinion is conclusory, because the expert
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`“does not disclose the underlying facts or data on which the opinion is based.” 37
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`C.F.R. § 42.65(a); see also Westlake Servs., LLC v. Credit Acceptance Corp., No.
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`10
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`CBM2014-00176, Paper 15, 26 (P.T.A.B. Feb. 9, 2015) (applying this regulation).
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`Here, the paragraphs in the Grabowski Declaration clearly disclose the “underlying
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`facts or data” that he relied on: IMS data, which is summarized in several exhibits.
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`As a result, the Board can evaluate whether Dr. Grabowski’s opinions are sound.
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`II. The Summary Exhibits and Expert Opinion Paragraphs that Use
`Excerpts of a Physician Survey Data Are Admissible
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`Petitioners’ objections to the excerpts from the Mid-Year Tracker (Exhibits
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`2115-2119) and the corresponding paragraphs of the Grabowski Declaration
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`referencing those exhibits (Paragraphs 38 and 40-44) are equally meritless. It is
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`entirely proper for Patent Owner to present report excerpts in lieu of the entire
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`report, and Dr. Grabowski’s use of the report is well founded.
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`A. The Use of Excerpts Is Appropriate and Fully Supported by
`Federal Rule of Evidence 106
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`Exhibits 2115-2119 present survey data from the Mid-Year Tracker in which
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`both patients and physicians indicated that they value the less frequent dosing
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`regimen allowed by Copaxone® 40 mg/mL. As with the IMS summaries,
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`Petitioners do not provide any reason to doubt the data’s accuracy. Instead, citing
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`Federal Rule of Evidence 106, they claim (at 7) that the exhibits should be
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`excluded because they are excerpts from a larger report that is not in the record.
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`Petitioners again distort basic evidentiary rules.
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`11
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`Rule 106 is a rule of completeness that lets Petitioners supplement the
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`record. See Beech Aircraft Corp. v. Rainey, 488 U.S. 153, 171-72 (1988). The
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`Rule does not require Patent Owner to introduce the full document in the first
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`instance. See 1 Weinstein on Evidence § 106.02[1] (“Rule 106 does not prohibit
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`admission of an incomplete document. Instead, it allows the party against whom
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`the document is introduced to place the remainder in evidence[.]”); United States v.
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`Phillips, 543 F.3d 1197, 1203 (10th Cir. 2008) (same).
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`Petitioners have the burden of specifying what other parts of the Mid-Year
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`Tracker should be introduced to provide context to the excerpts discussed in the
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`Grabowski Declaration. See United States v. King, 351 F.3d 859, 866 (8th Cir.
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`2003) (“[T]he party urging admission of . . . excluded [evidence] must specify the
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`portion . . . that is relevant to the issue at trial and that qualifies or explains
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`portions already admitted.” (quotation marks omitted)). Yet Petitioners have not
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`identified any concerns about whether the Mid-Year Tracker excerpts are fair and
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`accurate, even though they could have done so when they filed their reply to Patent
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`Owner’s response. Their claim (at 7) that they “cannot review and evaluate” the
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`rest of the Mid-Year Tracker is baseless. Patent Owner disclosed the Mid-Year
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`Tracker to Petitioners on November 25, 2015, and it made clear in its January 19,
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`2016 letter that Petitioners may use the document in these IPRs. See pp. 3-4,
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`12
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`supra. Patent Owner also made the “original” of the Mid-Year Tracker available
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`for Petitioners to review at the office of Patent Owner’s counsel. See p. 3, supra.
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`B.
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`The Paragraphs of the Grabowski Declaration Referencing the
`Mid-Year Tracker Should Not Be Excluded or Discounted
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`Petitioners object (at 8) to the paragraphs of the Grabowski declaration that
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`reference the Mid-Year Tracker, asserting that they are based on an “incomplete
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`third-party survey.” But the fact that Patent Owner has presented excerpts of the
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`survey does not show that the survey is “incomplete.” To the extent Petitioners
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`base this characterization on the assumption that Dr. Grabowski is confined to the
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`existing evidentiary record when forming his opinions, their underlying premise is
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`wrong for reasons previously explained. See pp. 9-10, supra.
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`In a footnote (at 8-9 n.10), Petitioners raise various methodological
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`objections to the Mid-Year Tracker survey, and they claim that the surveys “do not
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`meet a minimum threshold of scientific validity.” Their arguments provide no
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`basis to exclude the survey. As Dr. Grabowski testified at his deposition when he
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`was questioned by Petitioners’ counsel about the survey, the Mid-Year Tracker
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`was developed “in the ordinary course of business”—i.e., not in preparation for
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`litigation—to aid Teva Pharmaceutical’s business and marketing strategy by
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`“develop[ing] insights about why people are using three times a week Copaxone
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`40.” Ex. 2148, at 64:19-25. In light of the incentives Teva’s contractor had to
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`13
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`produce reliable, commercially useful data, Dr. Grabowski reasonably determined
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`that he could rely on it.
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`Petitioners’ claim (at 8 n.10) that there is “[n]o information on the survey
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`methodology” is false; the Mid-Year Tracker itself discloses its methodology,
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`including by describing the number of patients and physicians surveyed. If
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`Petitioners thought it would help them to contest the methodology at trial, they
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`could have moved to introduce the relevant portions of the Mid-Year Tracker
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`under Federal Rule of Evidence 106 or 703. But their objections to the data from
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`the Mid-Year Tracker go, at best, “to the weight, not admissibility, of [Dr.
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`Grabowski’s] opinion.” i4i Ltd. P’ship v. Microsoft Corp., 598 F.3d 831, 854-55
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`(Fed. Cir. 2010), aff’d, 564 U.S. 91 (2011) (rejecting a challenge to admission of
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`an expert report that relied on, inter alia, a survey used to estimate the incidence of
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`infringing uses); see also PBM Prods., LLC v. Mead Johnson & Co., 639 F.3d 111,
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`123-24 (4th Cir. 2011) (critiques about a customer survey were relevant to the
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`survey’s evidentiary “weight,” “not . . . admissibility”).
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`III. Petitioners’ Remaining Objections to the Grabowski Declaration Are
`Meritless
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`Finally, Petitioners object (at 9-10) to several additional paragraphs in the
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`Grabowski Declaration (Paragraphs 15, 19, 20-23, 37, and 50-56) on the ground
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`that Dr. Grabowski cites websites, academic literature, Copaxone® 40 mg/mL’s
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`label, promotional materials, and other documents that are not in the record. Once
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`14
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`again, this argument is flawed: experts may form their opinions based on sources
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`that are not admitted. See pp. 9-10, supra.
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`
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`Petitioners’ arguments on this point effectively illustrate the weakness of
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`their position. It borders on the absurd to suggest that an expert cannot rely on
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`background materials such as academic articles (Grabowski Declaration ¶ 53) or
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`the official website of the National Multiple Sclerosis Society (id. ¶ 20) merely
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`because Patent Owner did not formally submit these publicly accessible sources
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`into the record. Excluding these paragraphs from the Grabowski Declaration
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`would serve no purpose and has no basis in evidence law.
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`CONCLUSION
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`The Board should deny Petitioners’ motion to exclude.
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`Respectfully submitted,
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`Dated: April 22, 2016
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`
`
`
`
`/Elizabeth J. Holland/
`Elizabeth J. Holland, Reg. No. 47,657
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`15
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that the foregoing PATENT OWNER’S
`OPPOSITION TO PETITIONERS’ MOTION TO EXCLUDE and
`EXHIBITS 2149, 2150, and 2151 were served electronically via e-mail on April
`22, 2016 on the following:
`
`Jeffrey W. Guise
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`jguise@wsgr.com
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`Brandon M. White
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`BMWhite@perkinscoie.com
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`Shannon Bloodworth
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`Sbloodworth@perkinscoie.com
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`David Anstaett
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`DAnstaett@perkinscoie.com
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`Richard Torczon
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`rtorczon@wsgr.com
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`
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`/Nicholas K. Mitrokostas/
`Nicholas K. Mitrokostas
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`
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`Dated:
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`April 22, 2016