Filed: April 28, 2016
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`————————————————
`
`MYLAN PHARMACEUTICALS INC. and
`AMNEAL PHARMACEUTICALS LLC
`
`Petitioners,
`
`v.
`
`YEDA RESEARCH & DEVELOPMENT CO. LTD.
`
`Patent Owner.
`
`————————————————
`
`Case No. IPR2015-00643 (8,232,250 B2)
`Case No. IPR2015-00644 (8,399,413 B2)
` Case No. IPR2015-00830 (8,969,302 B2)1,2
`
`————————————————
`
`PETITIONERS’ REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE
`
`
`
`1 Case Nos. IPR2015-01976, IPR2015-01980 and IPR2015-01981 have been
`
`joined with these proceedings.
`
`2 A word-for-word identical Reply is being filed in each proceeding.
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`————————————————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`————————————————
`
`MYLAN PHARMACEUTICALS INC. and
`AMNEAL PHARMACEUTICALS LLC
`
`Petitioners,
`
`v.
`
`YEDA RESEARCH & DEVELOPMENT CO. LTD.
`
`Patent Owner.
`
`————————————————
`
`Case No. IPR2015-00643 (8,232,250 B2)
`Case No. IPR2015-00644 (8,399,413 B2)
` Case No. IPR2015-00830 (8,969,302 B2)1,2
`
`————————————————
`
`PETITIONERS’ REPLY IN SUPPORT OF ITS MOTION TO EXCLUDE
`
`
`
`1 Case Nos. IPR2015-01976, IPR2015-01980 and IPR2015-01981 have been
`
`joined with these proceedings.
`
`2 A word-for-word identical Reply is being filed in each proceeding.
`
`
`
`
`
`Petitioners brought this Motion because Patent Owner failed to file evidence
`
`upon which it relies. The Board and Petitioners thus cannot assess the accuracy or
`
`reliability of this evidence, so it must be excluded.
`
`I. The IMS Related Exhibits and Declaration Testimony Are Inadmissible
`The Board previously refused to admit Patent Owner’s IMS data when it
`
`denied Patent Owner’s motion for leave to file the IMS data that it omitted from its
`
`Response. Paper 48 (IPR2015-00643) (“Supp. Filing Order”) at 4-6. Patent
`
`Owner now seeks to admit documents purporting to be “summary exhibits” based
`
`on the inadmissible IMS data. Summary exhibits are admissible only when the
`
`underlying data is admitted or, at the very least, made available for copying and
`
`inspection. Fed. R. Evid. 1006. But the IMS data is not admitted, and Patent
`
`Owner never served it on Petitioners in this proceeding. That the underlying IMS
`
`data has not been made of record is of particular concern here—in this
`
`administrative proceeding, the Board only has the administrative record to
`
`consider, and will not see Dr. Grabowski testify. Patent Owner’s purported
`
`“summary exhibits” based on the IMS data (Exhibits 2108-2114 and 2120-2122)—
`
`and the corresponding paragraphs of Dr. Grabowski’s Declaration relying on these
`
`exhibits—are thus inadmissible under Federal Rule of Evidence 1006.
`
`Patent Owner principally relies on the Board’s decision in Phigenix, Inc. v.
`
`Immunogen, Inc., IPR2014-00676, Paper 39, at 28-29 (P.T.A.B. Oct. 27, 2015).
`
`
`
`1
`
`
`
`
`
`Opposition at 6-7, 10. But Patent Owner omits that in Phigenix the patent owner
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`actually filed the IMS data. Exhibits 2347 and 2348 in Phigenix are the IMS data
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`from which the economics expert prepared the summary exhibits. Phigenix
`
`accordingly did not address the issue here: whether Rule 1006 summaries are
`
`admissible where the underlying data is not of record and was not made available.
`
`Patent Owner’s remaining arguments are red herrings. Patent Owner argues
`
`the IMS data is too voluminous, Opposition at 6, but, of course, that is not the only
`
`requirement for admissibility under Rule 1006. Patent Owner next asserts that
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`“[s]ummaries are often featured in expert reports, and exhibits prepared as
`
`summary evidence to accompany an expert report are almost never excluded under
`
`Rule 1006.” Id. at 7 (internal quotations omitted). Summary exhibits may be
`
`common, but they must be based on data that can be verified as accurate. Here,
`
`neither Petitioners nor the Board are able to scrutinize the IMS data based on the
`
`administrative record. Patent Owner then complains that it produced the IMS data
`
`to Petitioners in the district court litigation. However, as Petitioners noted and the
`
`Board credited in relation to Patent Owner’s Motion to File Supplemental
`
`Information, Mylan’s lead counsel is not subject to the protective order in the
`
`district court litigation. Supp. Filing Order at 4-5. Production in the district court
`
`litigation also does not allow the Board to assess the exhibits’ reliability. Patent
`
`Owner finally contends that IMS data is a common source of information on
`
`2
`
`
`
`
`
`pharmaceutical sales, but this assertion is irrelevant because the Board has ruled
`
`this IMS data inadmissible here.3
`
`II. The Mid-Year Tracker Survey And Related Declaration Testimony Are
`Inadmissible
`
`Similarly, Patent Owner’s failure to file the complete Mid-Year Tracker
`
`survey renders its excerpted portions inadmissible. “If a party introduces all or
`
`part of a writing or recorded statement, an adverse party may require the
`
`introduction, at that time, of any other part—or any other writing or recorded
`
`statement—that in fairness ought to be considered at the same time.” Fed. R. Evid.
`
`106. The Board already denied Patent Owner leave to submit the complete Mid-
`
`Year Tracker. Supp. Filing Order at 5-6. Clearly, the full Mid-Year Tracker
`
`survey is required—without it, the Board and Patent Owner cannot critically assess
`
`its results or Dr. Grabowski’s reliance upon them. Motion at 8 n.10. The Board
`
`should therefore exclude the Mid-Year Tracker survey excerpts (Exhibits 2115-
`
`2119) and related portions of Dr. Grabowski’s Declaration.
`
`Patent Owner tries to shift the burden of filing its evidence to Petitioners,
`
`arguing that Petitioners must state why the Mid-Year Tracker is unreliable and that
`
`Petitioners must themselves introduce other portions of the Mid-Year Tracker.
`
`Opposition at 11-12. But these arguments are absurd—the Mid-Year Tracker has
`
`3 Dr. Grabowski’s opinions relying on the inadmissible summary exhibits should
`
`be excluded for the same reasons described infra at 4-5.
`
`3
`
`
`
`
`
`not been filed or served in this proceeding, so they cannot refute it or admit other
`
`excerpts. Patent Owner’s contentions and case cites all assume a district court
`
`litigation structure, in which Patent Owner produces the full Mid-Year Tracker in
`
`discovery and later seeks to admit only portions at trial. In the context of this
`
`administrative proceeding, however, there was no discovery period, so Petitioners
`
`have never seen the full Mid-Year Tracker survey. Petitioners and Dr. Hay thus
`
`cannot judge the reliability of Dr. Grabowski’s opinions concerning the Mid-Year
`
`Tracker excerpts, and even if they could, the Board could not resolve any
`
`disagreement between the experts based on an incomplete paper record. The Mid-
`
`Year Tracker survey excerpts (Exhibits 2115-2119) and related portions of Dr.
`
`Grabowski’s Declaration must be excluded.
`
`III. Declaration Testimony Based On Undisclosed Evidence Is Inadmissible
`Finally, other portions of Dr. Grabowski’s Declaration cite evidence not of
`
`record. Rather than take Dr. Grabowski’s word for what this evidence says, the
`
`Board should exclude Dr. Grabowski’s opinions that rely on undisclosed evidence
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`(¶¶ 15, 19-23, 37, and 50-56) under Federal Rules of Evidence 702 and 703.
`
`Patent Owner asserts that not all bases for an expert’s opinion must be
`
`admissible, but there are three problems with this argument. First, Rule 702
`
`requires expert testimony to be “based on sufficient facts or data,” and Dr.
`
`Grabowski cites no sources other than unfiled evidence for the opinions Petitioners
`
`4
`
`
`
`
`
`seek to exclude. Second, Rule 703 states that expert opinions’ probative value
`
`must “substantially outweigh[] their prejudicial effect,” but here, prejudice is
`
`overwhelming because the administrative record is confined to exhibits actually
`
`filed. Third, the Board’s rules provide that “[e]xpert testimony that does not
`
`disclose the underlying facts or data on which the opinion is based is entitled to
`
`little or no weight,” so at best for Patent Owner, the Board should not rely on Dr.
`
`Grabowski’s unsupported opinions. 37 C.F.R. § 42.65
`
`IV. Patent Owner’s Supplemental Evidence Did Not Cure Its Failure to File
`Evidence
`
`Patent Owner’s last resort was to rely on its supplemental evidence, a
`
`declaration offering the original exhibits for inspection and copying. See Ex. 2151.
`
`As an initial matter, 37 C.F.R. § 42.61 provides that “[e]vidence that is not taken,
`
`sought, or filed in accordance with [the Board’s rules] is not admissible.” The
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`Board’s rules thus prevent Patent Owner from slipping through the back door what
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`it originally neglected to file. Moreover, Patent Owner buries reference to its
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`supplemental declaration in the middle of a paragraph for a reason: Patent Owner
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`only offered the original exhibit for inspection and copying. See, e.g., Ex. 2151
`
`¶ 18. It did not offer the information underlying the exhibits for inspection and
`
`copying. And regardless of that offer, without Patent Owner introducing its
`
`evidence into the administrative record, the Board cannot examine or rely upon the
`
`evidence or Dr. Grabowski’s corresponding opinions.
`
`
`
`5
`
`
`
`Dated: April 28, 2016
`
`
`
`
`
`
`
`/Brandon M. White/
`Brandon M. White
`Reg. No. 52,354
`Perkins Coie LLP
`700 13th St., NW, Suite 600
`Washington, D.C. 20005
`Telephone: (202) 654-6206
`E-mail: bmwhite@perkinscoie.com
`
`Attorney for Mylan Pharmaceuticals Inc.
`
`6
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that the foregoing Petitioners’ Response to
`
`Yeda’s Observation on Reply was served electronically via email as follows:
`
`Patent Owners:
`
`Elizabeth Holland
`Goodwin Procter LLP
`eholland@goodwinprocter.com
`
`William James
`Goodwin Procter LLP
`wjames@goodwinprocter.com
`
`Eleanor Yost
`Goodwin Procter LLP
`eyost@goodwinprocter.com
`
`Petitioner Amneal Pharmaceuticals LLC:
`
`
`Nicholas Mitrokostas
`Goodwin Procter LLP
`nmitrokostas@goodwinprocter.com
`
`Daryl Wiesen
`Goodwin Procter LLP
`dwiesen@goodwinprocter.com
`
`John Bennett
`Goodwin Procter LLP
`jbennett@goodwinprocter.com
`
`Vincent L. Capuano
`Duane Morris LLC
`VCapuano@duanemorris.com
`
`Christopher S. Kroon
`Duane Morris LLC
`CSKroon@duanemorris.com
`
`
`Dated: April 28, 2016
`
`
`
`/Brandon M. White/
`Brandon M. White
`
`Attorney for Mylan Pharmaceuticals Inc.
`
`
`
`
`
`1
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