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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`Paper No. ___
`Filed: January 5, 2018
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
`
`ACRUX DDS PTY LTD., ACRUX LIMITED, and
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioners,
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`v.
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`KAKEN PHARMACEUTICAL CO., LTD. and
`VALEANT PHARMACEUTICALS INTERNATIONAL, INC.,
`Patent Owner.
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`
`
`Case: IPR2017-001901
`U.S. Patent No. 7,214,506
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`
`
`PATENT OWNER’S OPPOSITION TO
`PETITIONERS’ MOTION TO EXCLUDE EVIDENCE
`SUBMITTED BY PATENT OWNER UNDER 37 C.F.R. § 42.64(C)
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`1 Case IPR2017-01429 has been joined with the instant proceeding.
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`Table of Contents
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`INTRODUCTION ........................................................................................... 1
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`I.
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`II. ARGUMENT ................................................................................................... 1
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`A. Mr. Thomas’s Opinions Are Admissible Under FRE 702 .................... 1
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`1.
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`Petitioners’ Disagreement with Mr. Thomas’s Analysis
`of Commercial Success Goes to Weight and not
`Admissibility ............................................................................... 2
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`2. Mr. Thomas Properly Relied on Commercial Data
`Collected by Others ..................................................................... 5
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`3. Mr. Thomas Appropriately Evaluated Nexus ............................. 8
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`B.
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`Exhibits 2093, 2095, 2098, and 2099 Are Admissible .......................11
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`1.
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`2.
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`3.
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`4.
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`Petitioners Failed to Preserve the FRE 1006 Objection ...........11
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`Exs. 2093 & 2095 Are Authentic and Exceptions to
`Hearsay ......................................................................................13
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`Petitioners Failed to Preserve the FRE 805 Objection .............14
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`Petitioners Failed to Preserve the FRE 402 Objection .............15
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`III. CONCLUSION ..............................................................................................15
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`TABLE OF AUTHORITIES
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`Cases
`Brown & Williamson Tobacco Corp. v. Philip Morris Inc.,
`229 F.3d 1120 (Fed. Cir. 2000) ............................................................................ 9
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`Page(s)
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`Eaton & Co. v. Atlantic Paste & Glue Co.,
`106 F.3d 1563 (Fed. Cir. 1997) ....................................................................... 2, 4
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`Google, Inc. v. WhitServe LLC,
`IPR2013-00249 (PTAB April 29, 2014) (Paper 30)............................................. 1
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`Merck Sharp & Dohme Corp. v. Hospira, Inc.,
`874 F.3d 724, 730 (Fed. Cir. 2017) ...................................................................... 9
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`Mylan Pharms Inc. v. Yeda R&D Co. Ltd.,
`IPR2015-00643 (PTAB Dec. 2, 2016) (Paper 90).................................. 11, 12, 13
`
`Novo Nordisk v. Caraco Pharm.,
`719 F.3d 1346 (Fed. Cir. 2013) ............................................................................ 4
`
`Ormco Corp. v. Align Tech., Inc.,
`463 F.3d 1299 (Fed. Cir. 2006) ....................................................................... 2, 4
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`Shaw Industries Group, Inc. v. Automated Creel Systems, Inc.,
`IPR2013-00132 (PTAB July 24, 2014) (Paper 41) ............................................ 11
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`Valeo North America Inc. v. Magna Elect., Inc.,
`IPR2014-01204 (PTAB Jan. 26, 2016) (Paper 52) ....................................... 12, 14
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`
`Regulations and Statutes
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`Page(s)
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`37 C.F.R. § 42.64 ......................................................................................... 12, 14, 15
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`
`Rules
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`Page(s)
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`Fed. R. Evid. 106 ..................................................................................................... 11
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`Fed. R. Evid. 402 ............................................................................................... 11, 15
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`iii
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`Fed. R. Evid. 702 ....................................................................................................... 1
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`Fed. R. Evid. 703 ....................................................................................................... 5
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`Fed. R. Evid. 802 ..................................................................................................... 11
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`Fed. R. Evid. 803 ............................................................................................... 13, 14
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`Fed. R. Evid. 805 ............................................................................................... 11, 14
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`Fed. R. Evid. 901 ............................................................................................... 11, 14
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`Fed. R. Evid. 1006 ............................................................................................. 11, 12
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`iv
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`I.
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`INTRODUCTION
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`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
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`Pursuant to the Scheduling Order (Paper No. 13), Kaken Pharmaceutical
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`Co., Ltd. and Valeant Pharmaceuticals International, Inc. (collectively “PO”)
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`hereby oppose Petitioners’ motion (Paper No. 52) to exclude portions of the
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`testimony of PO’s expert, Mr. Thomas, and certain exhibits he relied on.
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`II. ARGUMENT
`A. Mr. Thomas’s Opinions Are Admissible Under FRE 702
`Petitioners move to exclude ¶¶ 9-11 and 20-30 of Mr. Thomas’s declaration
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`(Ex. 2028) based on a substantive disagreement with his commercial success
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`analysis, which is improper. Google, Inc. v. WhitServe LLC, IPR2013-00249,
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`Paper 30, at 2 (PTAB April 29, 2014) (“A motion to exclude is not the proper
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`mechanism to address an opponent’s substantive arguments”). Petitioners contend
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`that Mr. Thomas did not consider “relevant” facts (Paper 52 at 1), but this boils
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`down to an argument over how best to measure commercial success—an issue of
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`weight not admissibility. Petitioners then seek to exclude Mr. Thomas’s testimony
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`because he did not “collect or supervise” the data underlying his opinion (id. at 2)
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`yet tellingly cite no authority requiring this. Finally, Petitioners argue Mr. Thomas
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`did not properly analyze nexus between Jublia®’s commercial success and the
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`claims of the ’506 patent (id.), but in fact Mr. Thomas was the only expert who did
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`so. As such, Petitioners’ motion to exclude is baseless and should be denied.
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`1
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`1.
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`Petitioners’ Disagreement with Mr. Thomas’s Analysis of
`Commercial Success Goes to Weight and not Admissibility
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`Petitioners move to exclude Mr. Thomas’s testimony because he did not
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`consider “gross-to-net or net-to-profit information for Jublia®” but tellingly do not
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`cite any legal authority requiring consideration of these features. Paper 52, 3: Paper
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`37, 21-23; cf Eaton & Co. v. Atlantic Paste & Glue Co., 106 F.3d 1563, 1571 (Fed.
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`Cir. 1997) (commercial success “usually shown by significant sales in a relevant
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`market,” i.e., by revenue not profit); see also Ormco Corp. v. Align Tech., Inc., 463
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`F.3d 1299, 1312 (Fed. Cir. 2006). Instead, Petitioners cite to their own expert (Mr.
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`Staines) and his view that profit is the appropriate measure for commercial success.
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`Id., 3-4 (citing Ex. 1511, ¶¶ 25-26, 31-32). Mr. Staines’s declaration is not legal
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`authority (Ex. 2116A, 30:14-18), and even he seemed confused when asked
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`whether revenue or profit was relevant for evaluating commercial success. Id.,
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`32:3-33:3, 102:12-21. Regardless, Mr. Staines’s speculative position goes to the
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`weight of the evidence and is not a valid basis to exclude Mr. Thomas’s contrary
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`testimony.
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`In fact, Mr. Thomas explained that Jublia®’s total revenue of over a billion
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`dollars, as well as its market-leading prescription numbers, indicated commercial
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`success. Ex. 2028, ¶¶ 9-11. His analysis relied on data from IMS and Symphony
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`Health, two industry-standard commercial databases. Mr. Thomas explained that
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`2
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`he did not need to evaluate drug pricing strategies or underlying costs. Rather, he
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`saw from the available prescription numbers that many patients took Jublia®,
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`which in turn generated high gross revenue, indicating that patients found the drug
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`effective. Ex. 1507, 37:17-38:4, 69:7-70:20. Petitioners do not contest this
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`analysis. They merely argue that Mr. Thomas should have also taken into account
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`the cost to sell Jublia®. Paper 52, 3-4. This speaks to weight, not admissibility.
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`Likewise, Petitioners contend that Mr. Thomas should have considered
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`Valeant’s use of alternative fulfillment through Philidor in his evaluation. But,
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`once again, they cite no legal authority for why different mechanisms of delivering
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`prescriptions to patients should impact commercial success or why that is a legal
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`prerequisite to admissible testimony. Instead, Petitioners again cite their own
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`expert, Mr. Staines. Paper 52, 4 (citing Ex. 1511, ¶¶ 9, 11-17, 22, 24, 53). Mr.
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`Staines is not legal authority, and citing only his declaration shows this is simply a
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`substantive dispute between experts. Ex. 2116A, 30:14-31:15. Indeed, Mr. Staines
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`had no adequate explanation for why prescriptions made through Philidor should
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`be disregarded, how many sales were impacted, or why those sales undermined
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`commercial success. Id., 22:16-23:20, 27:12-15. Petitioners’ reliance on their
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`expert’s speculative theory cannot be a legal basis to exclude Mr. Thomas’s
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`testimony simply because he reaches an alternate conclusion.
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`3
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`At the end of the day, Petitioners’ objections boil down to an argument on
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`what data to consider—whether to look at gross revenue and prescription trends or
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`to ignore this actual data and speculate about costs and fulfillment strategies.
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`Notably, Petitioners cite only a footnote in one case as legal authority for the latter
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`option (Novo Nordisk v. Caraco Pharm., 719 F.3d 1346, 1356 n5 (Fed. Cir. 2013)),
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`but that case undermines their position. The court in Novo did not exclude
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`testimony on revenue; rather, it considered all the available evidence. Id. The cited
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`footnote simply indicates that commercial success must be evaluated in a market
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`context to determine “whether those sales represent a substantial quantity.” Id.
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`Mr. Thomas provided exactly that analysis when he testified that Jublia® not
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`only made over one billion dollars in its first two years on the market, but it also
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`“singlehandedly shifted the market for onychomycosis treatment from oral to
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`topical therapy” and quickly became a “market-leading prescription” that brought
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`many new patients into the market. Ex. 2028, ¶¶ 9-11. Nothing in Novo, or
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`anything else cited by Petitioners, suggests an expert must consider cost, net
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`revenue, and profit rather than the sales volume and revenue Mr. Thomas used. cf
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`Eaton, 106 F.3d at 1571; see also Ormco, 463 F.3d at 1312.
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`4
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`2. Mr. Thomas Properly Relied on Commercial Data
`Collected by Others
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`Petitioners attack on how Mr. Thomas obtained his data is similarly
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`groundless and notably devoid of any supporting legal authority. Petitioners offer
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`no explanation for why Mr. Thomas must personally download data from IMS and
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`Symphony Health before providing admissible testimony. Mr. Thomas obtained
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`the data via other custodians, who testified by declaration to the accuracy of the
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`material provided. See Ex. 1661, ¶¶ 1-4; Ex. 1664, ¶¶ 1-4.2 And even if that data
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`had been hearsay (which it is not), Petitioners point to no authority indicating that
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`an expert’s testimony should be excluded as unreliable on that basis alone. Paper
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`52, 5; FRE 703 (“If experts in the particular field would reasonably rely on those
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`kinds of facts or data in forming an opinion on the subject, they need not be
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`admissible for the opinion to be admitted.”)
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`As explained infra with regard to Petitioners’ baseless attacks on the
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`underlying exhibits (Exs. 2093 and 2095), Mr. Thomas relied on authenticated
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`documents that qualify under exceptions to hearsay. The data in those documents
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`came from commercial sources such as IMS and Symphony Health, which
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`Petitioners do not dispute are reliable sources of sales and prescription data. Ex.
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`1662, ¶ 6. Indeed, Petitioners’ own expert acknowledged IMS as a reputable
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`2 PO produces herewith the original Japanese-language declaration as Ex. 2113.
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`5
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`source. Ex. 2116A, 39:5-40:12. This reliability does not change merely because
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`others downloaded the data. To hold otherwise would put an unreasonably onerous
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`burden on experts, one not required by law or the Federal Rules. Indeed, PO
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`provided declarations (Exs. 1661 and 1664) from the custodians of the data Mr.
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`Thomas analyzed, explaining when and how they downloaded the data from the
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`commercial databases. Petitioners could have deposed the custodians but chose not
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`to do so. As such, the only testimony of record supports the accuracy and
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`completeness of the data Mr. Thomas evaluated.
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`The fact PO later produced, as supplemental evidence, a spreadsheet from
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`IMS containing additional data for unrelated drugs (Ex. 1663)3 has no bearing on
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`the reliability of Mr. Thomas’s testimony. Paper 52 at 6. Mr. Thomas explained
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`that he used the data in Ex. 2095 for Jublia® and the other listed drugs because he
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`considered them suitable comparators in the onychomycosis market. Ex. 1507,
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`30:2-12, 33:11-17. Notably, despite having full access to Ex. 1663, Petitioners
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`identified no errors in Ex. 2095. Instead, they simply argued Mr. Thomas should
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`have considered additional unspecified drugs from Ex. 1663 in his market analysis.
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`Any such disagreement Petitioners have on how to define the market again speaks
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`to weight, not admissibility.
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`3 PO produces herewith a translation of non-English portions. Exs. 2111, 2112.
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`6
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`Similarly, Petitioners provide no explanation for why Mr. Thomas’s
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`testimony is unreliable just because it relies in part on a spreadsheet (Ex. 2093)
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`prepared at Valeant in the regular practice of its business activities to evaluate the
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`onychomycosis market. PO provided a declaration of Mr. Shupenus confirming he
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`prepared Ex. 2093 in the course of his regularly conducted business activities at
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`Valeant to analyze the data shown in the exhibit for the company’s internal uses.
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`Ex. 1661, ¶¶ 2-4. He also explained that he obtained the data in Ex. 2093 from
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`Symphony Health, a reputable, commercially-available source of prescription data.
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`Id. Petitioners’ chose not to depose Mr. Shupenus to evaluate his testimony.
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`Petitioners provide no explanation for why Mr. Thomas’s use of Ex. 2093
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`renders his testimony unreliable merely because that exhibit also included
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`additional analysis prepared by Mr. Shupenus in the course of his regularly
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`conducted business activities at Valeant,
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`. Paper 52, 7. Petitioners do not deny in
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`their motion that Ex. 2093 also included the raw Jublia® prescription data prior to
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`normalization, as Mr. Thomas explained in his deposition. Ex. 1507, 46:17-48:19.
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`Thus, it is entirely unclear why an extra column of Mr. Shupenus’s analysis in Ex.
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`2093 renders Mr. Thomas’s testimony unreliable or subject to exclusion.
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`Finally, in footnote 3 of the motion to exclude (Paper 52), Petitioners
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`mention additional prescription data in Ex. 2094 that they contend provides a
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`7
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`different market definition, one Mr. Thomas allegedly ignored in favor of Ex.
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`2093. But Petitioners disregard Mr. Thomas’s explanation of why Valeant’s
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`market definition in Ex. 2093 was “appropriate” and more useful, i.e.,
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`67:21-69:6. Notably, Petitioners’ own expert agreed
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`. Ex. 1507,
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`. Ex. 2116A, 61:10-63:8. Regardless, as
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`explained above, Petitioners have not demonstrated that Mr. Thomas’s use of an
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`alternate market definition in Ex. 2093 justifies excluding his testimony—that
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`dispute goes to weight and not admissibility.
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`3. Mr. Thomas Appropriately Evaluated Nexus
`Finally, Petitioners contend that Mr. Thomas did not properly evaluate nexus
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`because he allegedly did not consider blocking patents and the impact of marketing
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`costs. Paper 52, 8. But Mr. Thomas did in fact consider these features, and at any
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`rate Petitioners offer no legal authority indicating that they are a prerequisite for
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`admissibility. Instead, Petitioners offer generic quotes about the noncontroversial
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`requirement to establish nexus between sales and the patented features of the
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`marketed product. Id., 9. Mr. Thomas provided exactly that analysis.
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`Mr. Thomas testified that he saw no evidence tying the earlier use of
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`efinaconazole on skin to Jublia®’s success, only its use on nail, which was first
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`8
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`claimed and disclosed in the ’506 patent. Ex. 2028, ¶ 24. Thus, the feature that
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`drove Jublia®’s success was not available in the prior art, only in the claims of the
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`’506 patent. Brown & Williamson Tobacco Corp. v. Philip Morris Inc., 229 F.3d
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`1120, 1130 (Fed. Cir. 2000) (Where the marketed product is coextensive with the
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`patented features, the court should presume that commercial success of the product
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`derives from the patented invention). Petitioners do not contend otherwise.
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`As such, Mr. Thomas addressed nexus between Jublia®’s success and the
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`claimed features of the ’506 patent rather than features in the prior art. He did not
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`directly refer by serial number to the earlier Kaken patents, which claim the use of
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`efinaconazole to treat other mycoses, but then he had no reason to do so because
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`Petitioners did not raise the blocking patent argument until their Reply, long after
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`Mr. Thomas submitted his declaration and was deposed. It would be improper to
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`exclude expert testimony simply because it contradicts Petitioners’ legal theory on
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`blocking patents. Merck Sharp & Dohme Corp. v. Hospira, Inc., 874 F.3d 724, 730
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`(Fed. Cir. 2017) (“Merck’s evidence of commercial success should not have been
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`discounted simply because of the existence of another [blocking] patent.”)
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`Regarding marketing costs, Petitioners once again attempt to rehash their
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`theory of commercial success based on profit rather than sales. But that is still not
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`an appropriate basis to exclude contrary expert testimony. And, at any rate, Mr.
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`Thomas did consider advertising before concluding that it supported a finding of
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`9
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`nexus rather than detracting from it. He testified that the marketing of Jublia® was
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`reasonable in volume—even using the numbers alleged by Petitioners—and that
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`it focused on the novel features of the ’506 patent. Ex. 2028, ¶¶ 10, 25-29. He also
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`explained why advertising alone could not explain Jublia®’s success. Id. Mr.
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`Thomas evaluated sample advertisements and indicated he did not need to know
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`the overall cost of advertising because he felt the ads reflected the patented features
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`of the ’506 patent and therefore supported nexus. Id., ¶¶ 26-29; Ex. 1507, 69:7-
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`70:20.
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`In notable contrast to this detailed nexus analysis, Petitioners’ expert
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`admitted he had no idea whether Valeant’s advertising aligned with the patented
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`features of the ’506 patent, did not even know what those features were, and did
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`not think he needed to investigate those features when assessing nexus. Ex. 2116A,
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`159:9-161:22. Instead, Mr. Staines assumed without support that Valeant’s
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`advertising had nothing to do with the novel features of the ’506 patent. Id.
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`Petitioners also argued (Paper 52, footnote 5) that Valeant may have spent more on
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`advertising than the hundreds of millions they themselves alleged in the Petition
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`(Paper 1, 62), but Petitioners have not come forward with any other information
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`supporting an alternate number.4 Even their expert’s estimate on advertising cost
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`4 Petitioners object to PO’s failure to produce documents on advertising cost yet
`Petitioners did not move to compel any additional information.
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`10
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`matched the original range from the Petition. Ex. 1511, ¶ 44 and Ex. 9a. Mr.
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`Thomas evaluated similar numbers and found them normal for the industry. Ex.
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`2028, ¶ 29. Petitioners may disagree, but that again is not a basis to exclude the
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`testimony. See Shaw Industries Group, Inc. v. Automated Creel Systems, Inc.,
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`IPR2013-00132 at 47 (PTAB July 24, 2014) (Paper 41) (denying motion to
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`exclude based on mere disagreement with expert’s testimony).
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`Exhibits 2093, 2095, 2098, and 2099 Are Admissible
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`B.
`Petitioners move to exclude Exs. 2093, 2095, 2098, and 2099 under various
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`combinations of FRE 402, 802, 805, 901, and 1006, despite having failed to
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`preserve most of those objections. Substantively, none of the objections have
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`merit, as they focus on exhibits Mr. Thomas prepared (Exs. 2098 and 2099) from
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`spreadsheets provided by Kaken and Valeant (Exs. 2095 and 2093) that were in
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`turn derived from industry-standard commercial sources: IMS Health and
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`Symphony Health, respectively. Ex. 1662, ¶¶ 5-6.
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`Petitioners Failed to Preserve the FRE 1006 Objection
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`1.
`Rather than object under FRE 1006, Petitioners previously alleged Exs. 2093
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`and 2099 were “[i]nadmissible as incomplete” under FRE 106. Paper 28, 12-13.5
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`5 Incompleteness does not merit exclusion. Mylan Pharms Inc. v. Yeda R&D Co.
`Ltd., IPR2015-00643 at 38-39 (PTAB Dec. 2, 2016) (Paper 90) (“Rule 106 does
`not prohibit admission of an incomplete document. Instead, it allows the party
`against whom the document is introduced to place the remainder in evidence.”)
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`11
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`Only now have Petitioners switched to a new objection under FRE 1006. Paper 52,
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`11-12. Petitioners did not list and therefore waived an FRE 1006 objection when
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`submitting their Rule 42.64(b)(1) objections.6
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`Further, exclusion under FRE 1006 is inapplicable. Petitioners allege that
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`PO refused to produce underlying Symphony Health data (Paper 52, footnote 6
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`(citing Ex. 1666)), but PO only refused Petitioners’ request for additional
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`discovery of “marketing spend,” which is not the subject of this motion. Ex. 1666.
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`Indeed, PO sought to address Petitioners’ concerns during a meet and confer on the
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`specific topic of the Symphony and IMS data. Ex. 2202. No clarification or follow-
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`up was received and PO reasonably concluded that “[Petitioner’s] concerns have
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`been addressed.” Id. Petitioners cannot properly resurrect their challenge now.
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`Moreover, Petitioners’ reliance on Mylan Pharms Inc. is unavailing. Paper
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`52, 12. As that case explains, “[t]he fact that the underlying IMS data are not of
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`record in this case does not justify the exclusion of these exhibits. Indeed, Federal
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`Rule of Evidence 1006 mandates not that the underlying document be admitted,
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`Nevertheless, Exs. 2093 and 2099 are complete documents. Ex. 1661, ¶ 3; Ex.
`1662, ¶ 5; Ex. 1507, 31:18-22.
`6 Petitioners waived the FRE 1006 objection even if the wording of its objections
`arguably encompasses alternative rules of evidence. See Valeo North America Inc.
`v. Magna Elect., Inc., IPR2014-01204 at 20 (PTAB Jan. 26, 2016) (Paper 52) (PO
`objected to evidence as “severely prejudice[ial]” but that was insufficient because
`PO did not previously identify FRE 403 as a basis for the objection).
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`12
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`but only [the underlying document] is admissible.” Mylan Pharms Inc., Paper 90 at
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`37.
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`Exs. 2093 & 2095 Are Authentic and Exceptions to Hearsay
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`2.
`Petitioners object to Exs. 2093 and 2095 (Paper 52, 12-14), but PO provided
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`unchallenged declarations from Mr. Shupenus and Mr. Miyakawa that address
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`authenticity and hearsay for Exs. 2093 and 2095. Petitioners now claim to need
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`additional information yet did not depose either declarant and cite no authority for
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`that belated claim. Paper 52, 6, 10-14.
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`Mr. Shupenus established the requirements of FRE 803(6) for Ex. 2093,
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`testifying that he obtained and evaluated data from Symphony Health’s
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`commercial database as part of his regular duties at Valeant, and that he was the
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`custodian of the resulting exhibit. Ex. 1661, ¶¶ 1-4. As to the “how, when or why”
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`Petitioners complain of (Paper 52, 12), Mr. Shupenus states that he generated Ex.
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`2093 (1) from the commercial data, (2) in January 2017, and (3) he kept Ex. 2093
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`as part of his regular business responsibilities at Valeant to analyze that data. He
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`therefore did not prepare the document for Mr. Thomas. Id. Nor did Mr. Thomas
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`testify otherwise. Rather, Mr. Thomas explains that he wanted to see “what
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`Valeant had done” previously in analyzing the marketplace. Ex. 1507, 68:2-69:6
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`(emphasis added). Hence, Ex. 2093 was provided to him, but it was an existing
`
`document prepared in the ordinary course of business at Valeant.
`
`13
`
`
`
`While Mr. Miyakawa testified that he prepared Ex. 2095 for this proceeding
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`
`
`in 2016-17, he also explained that it accurately reflected data obtained directly
`
`from the commercial IMS database, and that it was compiled using the kind of IMS
`
`data typically obtained and kept by him in the course of regularly conducted
`
`business activity at Kaken. Ex. 1664, ¶¶ 2, 4. Hence, both sets of data in Ex. 2093
`
`and 2095, derived from IMS and Symphony databases, also qualify under the FRE
`
`803(17) and 803(18) exceptions to hearsay. Ex. 1662, ¶ 6; Ex. 2116A, 39:5-40:2.
`
`Further, Mr. Shupenus and Mr. Miyakawa authenticated Exs. 2093 and 2095
`
`under FRE 901(b)(1), testifying that they are accurate and complete copies of the
`
`documents they generated from the Symphony and IMS databases. Ex. 1661, ¶¶ 2-
`
`3; Ex. 1664, ¶¶ 2-3. Authenticity does not require Ex. 2093 or 2095 to comprise an
`
`entire database or anything more than what Valeant and Kaken needed
`
`
`
`.
`
`Petitioners Failed to Preserve the FRE 805 Objection
`
`3.
`Petitioners previously objected to Exs. 2098 and 2099 under FRE 802, not
`
`FRE 805. Compare Paper 28,13 with Paper 52, 13-15. Failure to specify FRE 805,
`
`per Rule 42.64(b)(1), constitutes waiver of the objection. Valeo North America,
`
`IPR2014-01204. Further, the objection is inapplicable because underlying Exs.
`
`2093 and 2095 qualify as FRE 803(6), (17), and/or (18) exceptions to hearsay.
`
`14
`
`
`
`
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`Petitioners Failed to Preserve the FRE 402 Objection
`
`4.
`Petitioners contend Exs. 2093 and 2095 are irrelevant for lack of nexus.
`
`Paper 52, 15. However, Petitioners did not and cannot “identify the objections in
`
`the record” as they had only previously alleged “the exhibits are not cited or
`
`referenced in either the POR or any supporting declarations.” Paper 28, 12. Thus,
`
`the record is devoid of a specific FRE 402 objection on nexus in compliance with
`
`Rule 42.64(b)(1) (requiring “sufficient particularity”).
`
`Furthermore, Petitioners’ premise is false. Mr. Thomas did evaluate nexus,
`
`explaining that Exs. 2093 and 2095 demonstrated a rapid growth in Jublia®’s sales
`
`revenue and prescription numbers after launch, reflecting market recognition of the
`
`novel elements first disclosed and claimed in the ’506 patent. See supra, § II.A.3.
`
`III. CONCLUSION
`For the above reasons, Petitioners’ motion to exclude should be denied.
`
`Dated: January 5, 2018
`
`Respectfully submitted,
`
`
`By: /John D. Livingstone/
`John D. Livingstone, Reg. No. 59,613
`FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, LLP
`901 New York Avenue, NW
`Washington, DC 20001-4413
`(202) 408-4000
`
`Counsel for Patent Owner in
`IPR2017-00190
`
`
`
`15
`
`
`
`
`
`Case: IPR2017-00190
`U.S. Patent No. 7,214,506
`
`CERTIFICATE OF SERVICE
`
`The undersigned certifies that a copy of the foregoing Patent Owner’s
`
`Opposition to Petitioners’ Motion to Exclude Evidence Submitted by Patent
`
`Owner under 37 C.F.R. § 42.64(C) was served electronically via email on
`
`January 5, 2018, in its entirety on the following:
`
`E. Anthony Figg
`Aydin H. Harston
`Lisa N. Phillips
`Rothwell, Figg, Ernst & Manbeck, P.C.
`607 14th Street, N.W., Suite 800
`Washington, DC 20005
`efigg@rothwellfigg.com
`aharston@rothwellfigg.com
`lphillips@rothwellfigg.com
`litigationparalegals@rothwellfigg.com
`
`Teresa Stanek Rea
`Shannon M. Lentz
`Crowell & Moring LLP
`Intellectual Property Group
`1001 Pennsylvania Ave., NW
`Washington, DC 20004-2595
`trea@crowell.com
`slentz@crowell.com
`
`Tyler C. Liu
`Argentum Pharmaceuticals, LLC
`tliu@agpharm.com
`
`
`
`
`
`
`By: /John D. Livingstone/
`John D. Livingstone
`Reg. No. 59,613
`
`
`
`
`
`
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