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`
`Filed: October 27, 2017
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`
`
`MYLAN PHARMACEUTICALS INC., TEVA PHARMACEUTICALS USA,
`INC. and AKORN INC.,1
`Petitioner,
`
`v.
`
`ALLERGAN, INC.
`Patent Owner.
`
`_____________________________
`
`Case IPR2016-01127 (US 8,685,930 B2)
`Case IPR2016-01128 (US 8,629,111 B2)
`Case IPR2016-01129 (US 8,642,556 B2)
`Case IPR2016-01130 (US 8,633,162 B2)
`Case IPR2016-01131 (US 8,648,048 B2)
`Case IPR2016-01132 (US 9,248,191 B2)
`_____________________________
`
`PETITIONER’S NOTICE OF OBJECTION TO EVIDENCE
`
`
`1 Cases IPR2017-00576 and IPR2017-00594, IPR2017-00578 and IPR2017-
`00596, IPR2017-00579 and IPR2017-00598, IPR2017-00583 and IPR2017-00599,
`IPR2017-00585 and IPR2017-00600, and IPR2017-00586 and IPR2017-00601,
`have respectively been joined with the captioned proceedings. The word-for-word
`identical paper is filed in each proceeding identified in the caption pursuant to the
`Board’s Scheduling Order (Paper 10).
`
`
`
`
`
`
`
`
`
`I.
`II.
`
`TABLE OF CONTENTS
`
`INTRODUCTION ........................................................................................ 1
`OBJECTIONS .............................................................................................. 1
`1.
`Thereon ..................................................................................... 1
`2.
`Thereon ..................................................................................... 2
`3.
`Thereon ..................................................................................... 4
`4.
`Thereon ..................................................................................... 4
`5.
`Thereon ..................................................................................... 6
`6.
`Thereon ..................................................................................... 7
`III. CONCLUSION ............................................................................................ 8
`
`Objections to EX2106, and any Reference to/Reliance
`
`Objections to EX2107, and any Reference to/Reliance
`
`Objections to EX2108, and any Reference to/Reliance
`
`Objections to EX2109, and any Reference to/Reliance
`
`Objections to EX2110, and any Reference to/Reliance
`
`Objections to EX2111, and any Reference to/Reliance
`
`
`
`
`-i-
`
`
`
`
`
`I.
`
`INTRODUCTION
`
`Pursuant to 37 C.F.R. § 42.64(b)(1), Petitioner submits the following
`
`objections to Exhibits 2106-2111 as listed on each List of Exhibits filed by the St.
`
`Regis Mohawk Tribe (“Tribe”) and any reference to or reliance on the foregoing
`
`Exhibits in Tribe’s filings. As required by 37 C.F.R. §42.62, Petitioner’s objections
`
`below apply the Federal Rules of Evidence (“F.R.E.”).
`
`II. OBJECTIONS
`1. Objections to EX2106, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 402 (Relevance); 403 (Prejudice); F.R.E. 701,
`
`(lay testimony) F.R.E. 702 (expert testimony); 37 C.F.R. §42.65 (underlying data);
`
`F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay).
`
`Tribe describes EX2106 as “Richard Baker, American Invents Act Cost the
`
`U.S. Economy over $1 Trillion, Patently-O (June 8, 2015),
`
`https://patentlyo.com/patent/2015/06/america-invents-trillion.html.” Tribe relies on
`
`this exhibit to claim that “the AIA’s implementation has resulted in the decline in
`
`the value of U.S. patents in the trillions of dollars.” Reply at 13 (emphasis in
`
`original).
`
`This exhibit has no relevance to any issue properly before the Board for
`
`decision. Instead, Tribe provides the exhibit to evoke prejudice against these
`
`proceedings and “the prior administration’s implementation” of the AIA. Reply at
`
`
`-1-
`
`
`
`13-14. But prejudice against the these proceedings is not a basis for dismissal
`
`under chapter 31 of the Patent Code (35 U.S.C.). EX2106 is inadmissible under
`
`F.R.E. 402 and under F.R.E. 403.
`
`Additionally, this exhibit is not testimony, yet Tribe relies on statements
`
`therein to prove the truth of the matters asserted. To the extent Tribe relies on
`
`EX2106 or on any statements in it for the truth of the matter asserted, such
`
`statements are inadmissible hearsay. F.R.E. 801, 802, 803, 805. Moreover these
`
`statements are not properly supported as either lay or expert testimony and
`
`EX2106 fails to disclose sufficiently the underlying data relied upon. F.R.E. 701,
`
`702; 37 C.F.R. §42.65.
`
`2. Objections to EX2107, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 402 (Relevance); 403 (Prejudice); F.R.E. 701,
`
`(lay testimony) F.R.E. 702 (expert testimony); 37 C.F.R. §42.65 (underlying data);
`
`F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay).
`
`Tribe describes EX2107 as “The Roots of Innovation, U.S. Chamber
`
`International IP Index (Fifth Ed. February 2017).” Tribe relies on this exhibit to
`
`claim that the “Chamber of Commerce report attributes” a decline in the U.S.
`
`patent system “specifically to inter partes review and its ‘high rate of trial and of
`
`rejection … with challenges … disproportionately funded by bad faith actors and
`
`with steeply increasing defense costs for patent holders.’” Reply at 14 (ellipses and
`
`-2-
`
`
`
`italics in original). EX2107 discusses a “constantly shrinking, gap between the U.S
`
`and other economies,” and explains that “[o]ne reason for this shrinking gap is the
`
`continued refinement of the Index as an assessment tool,” i.e., a change in
`
`methodology. Far from concluding that IPR challenges are “disproportionately
`
`funded by bad faith actors,” EX2107 merely asserts that this is “considered” to be
`
`the case “by some experts” who remain unidentified by EX2107.
`
`This exhibit has no relevance to any issue properly before the Board for
`
`decision. Instead, Tribe provides the exhibit to evoke prejudice against these
`
`proceedings and “the prior administration’s implementation” of the AIA. Reply at
`
`13-14. But prejudice against these proceedings is not a basis for dismissal under
`
`chapter 31 of the Patent Code (35 U.S.C.). EX2107 is inadmissible under F.R.E.
`
`402 and under F.R.E. 403.
`
`Additionally, this exhibit is not testimony, yet Tribe relies on statements
`
`therein to prove the truth of the matters asserted. To the extent Tribe relies on
`
`EX2107 or on any statements in it for the truth of the matter asserted, such
`
`statements are inadmissible hearsay. F.R.E. 801, 802, 803, 805. Moreover these
`
`statements are not properly supported as either lay or expert testimony and fail to
`
`disclose sufficiently the underlying data relied upon. F.R.E. 701, 702; 37 C.F.R.
`
`§42.65.
`
`-3-
`
`
`
`3. Objections to EX2108, and any Reference to/Reliance Thereon
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`Grounds for Objection: F.R.E. 402 (Relevance); 403 (Prejudice); F.R.E. 801,
`
`802, 803, 805 (Inadmissible Hearsay).
`
`Tribe describes EX2108 as “Ryan Davis, PTAB’s ‘Death Squad’ Label Not
`
`Totally Off-Base Chief Says, Law360 (Aug. 14, 2014).” Tribe relies on this exhibit
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`to attribute a hearsay statement to “[a] former chief judge of the Federal Circuit.”
`
`Reply at 14.
`
`This exhibit has no relevance to any issue properly before the Board for
`
`decision. Instead, Tribe provides the exhibit to evoke prejudice against these
`
`proceedings and “the prior administration’s implementation” of the AIA. Reply at
`
`13-14. But prejudice against these proceedings is not a basis for dismissal under
`
`chapter 31 of the Patent Code (35 U.S.C.). EX2108 is inadmissible under F.R.E.
`
`402 and under F.R.E. 403.
`
`Additionally, this exhibit is not testimony, yet Tribe relies on statements
`
`therein to prove the truth of the matters asserted. To the extent Tribe relies on
`
`EX2107 or on any statements in it for the truth of the matter asserted, such
`
`statements are inadmissible hearsay. F.R.E. 801, 802, 803, 805.
`
`4. Objections to EX2109, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 402 (Relevance); 403 (Prejudice); F.R.E. 601
`
`(foundation); F.R.E. 701, (lay testimony) F.R.E. 702 (expert testimony); 37 C.F.R.
`
`-4-
`
`
`
`§42.65 (underlying data); F.R.E. 801, 802, 803, 805 (Inadmissible Hearsay). F.R.E.
`
`901 (authentication); 37 C.F.R. §42.6(a)(3) (incorporating one’s own arguments by
`
`reference and combining documents prohibited); 37 C.F.R. § 42.63 (requiring
`
`unique exhibit numbering of individual documents).
`
`Tribe describes EX2109 as “Letter from Saint Regis Mohawk Tribal
`
`Counsel to Senator Charles Grassley sent on Oct. 12, 2017.” Tribe relies on this
`
`exhibit to claim that “encouraging ‘economic development’” is “exactly what the
`
`Tribe is doing here, as it explained in a recent letter to Senators Charles Grassley
`
`and Dianne Feinstein.” Reply at 14.
`
`This exhibit has no relevance to any issue properly before the Board for
`
`decision. Instead, Tribe provides the exhibit to evoke prejudice against these
`
`proceedings and “the prior administration’s implementation” of the AIA. Reply at
`
`13-14. EX2109 confirms that Tribe’s motion in these proceedings is an attempt to
`
`undermine AIA proceedings, repeating Tribe’s contention that IPR proceedings
`
`lack “due process” and are “systematically unfavorable to patentees.” EX2109 at 6.
`
`But prejudice against these proceedings is not a basis for dismissal under
`
`chapter 31 of the Patent Code (35 U.S.C.). EX2109 is inadmissible under F.R.E.
`
`402 and under F.R.E. 403.
`
`Additionally, this exhibit is not testimony, yet Tribe relies on its own prior
`
`statements to prove the truth of the matters asserted. To the extent Tribe relies on
`
`-5-
`
`
`
`EX2109 or on any statements in it for the truth of the matter asserted, such
`
`statements are inadmissible hearsay. F.R.E. 801, 802, 803, 805.
`
`Exhibit 2109 is an inadmissible attempt by Tribe to incorporate by reference
`
`its own prior arguments regarding the Transaction and also contains multiple
`
`documents submitted as a single exhibit without adequate foundation or
`
`authentication for the underlying documents. F.R.E. 601, 901; 37 C.F.R.
`
`§42.6(a)(3), §42.63.
`
`5. Objections to EX2110, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 402 (Relevance); 403 (Prejudice); F.R.E. 801,
`
`802, 803, 805 (Inadmissible Hearsay).
`
`Tribe describes EX2110 as “Adam Perlman et al, ‘Reverse’ Patent Trolling:
`
`Nontraditional Participants in the Inter Partes Review Process, 33 Westlaw Journal
`
`Pharmaceutical 9 (2017).” Tribe relies on this exhibit to claim that Tribe’s motion
`
`should be granted because these IPRs “are also being exploited by ‘reverse trolls’”
`
`who “either demand cash as a payoff for not filing an IPR petition or take a short
`
`term position before filing an IPR petitions [sic] that cause the stock to drop.”
`
`Reply at 13.
`
`This exhibit has no relevance to any issue properly before the Board for
`
`decision. Instead, Tribe provides the exhibit to evoke prejudice against Petitioners.
`
`But petitioners are not “reverse trolls” and each of petitioners was sued by
`
`-6-
`
`
`
`Allergan for infringement of the involved patents. EX1023. Prejudice against
`
`petitioners is no basis for dismissal under chapter 31 of the Patent Code
`
`(35 U.S.C.). EX2110 is inadmissible under F.R.E. 402 and under F.R.E. 403.
`
`Additionally, this exhibit is not testimony, yet Tribe relies on statements
`
`therein to prove the truth of the matters asserted. To the extent Tribe relies on
`
`EX2110 or on any statements in it for the truth of the matter asserted, such
`
`statements are inadmissible hearsay. F.R.E. 801, 802, 803, 805.
`
`6. Objections to EX2111, and any Reference to/Reliance Thereon
`
`Grounds for Objection: F.R.E. 106 (incomplete); 402 (Relevance); 403
`
`(confusion, waste of time).
`
`Tribe describes EX2111 as “Imprimis Pharmaceuticals to Offer
`
`Compounded Cyclosporine.” Tribe relies on this exhibit to claim that “Yesterday,
`
`Imprimis Pharmaceuticals, Inc. announced plans to launch a compounded-based
`
`non-FDA-approved cyclosporine product to compete directly with Restasis®. EX.
`
`2111. If this product infringes the Patents-at-Issue, the Tribe will have the first
`
`right to bring and control an infringement suit and retain the proceeds. EX. 2087 at
`
`§ 5.2.5.” Reply at 12. EX2111 states that Imprimis will provide “unique
`
`customized medication that are not commercially available,” and references
`
`published data demonstrating “the clinical value of topical Cyclosporine
`
`formulations at concentrations greater than those currently available in
`
`-7-
`
`
`
`commercially available medications.” EX2111 at 1. EX2111 identifies Restasis®
`
`as “the commercially available form” of topical cyclosporin, thereby indicating
`
`that the “greater” concentration of cyclosporin in the Imprimis product will not be
`
`the same as that required by the involved claims. Thus, this exhibit does not
`
`support Tribe’s hypothetical “right” to sue and has no relevance to any issue
`
`properly before the Board for decision. EX2111 is inadmissible under F.R.E. 402
`
`and under F.R.E. 403.
`
`The exhibit is also incomplete to the extent it omits Allergan’s complaint
`
`against Imprimis related to compounded cyclosporin. Allergan USA, Inc. v.
`
`Imprimis Pharmaceuticals, Inc., Case No. 8:17-cv-01551-DOC-JDE, Dkt. No. 1
`
`(Sep. 7, 2017 C.D. Cal.).
`
`
`III. CONCLUSION
`
`The aforementioned exhibits are not admissible for the reasons stated above.
`
`
`
`Dated: October 27, 2017
`
`
`
`
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`
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`
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
`
`
`
`
`
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`
`
`-8-
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`
`
`CERTIFICATE OF SERVICE
`
`
`
`This is to certify that I caused to be served a true and correct copy of the
`
`foregoing Petitioner’s Notice of Objection to Evidence, on this 27th day of
`
`October, 2017, on Allergan and St. Regis Mohawk Tribe at the correspondence
`
`address of Allergan and St. Regis Mohawk Tribe as follows:
`
`Dorothy P. Whelan
`Michael Kane
`Susan Morrison Colletti
`Robert M. Oakes
`Jonathan Singer
`Fish & Richardson P.C.
`3200 RBC Plaza
`60 South Sixth Street
`Minneapolis, MN 55402
`Email: IPR13351-0008IP1@fr.com
`Email: IPR13351-0008IP2@fr.com
`Email: IPR13351-0008IP3@fr.com
`Email: IPR13351-0008IP4@fr.com
`Email: IPR13351-0008IP5@fr.com
`Email: IPR13351-0008IP6@fr.com
`Email: PTABInbound@fr.com
`
`
`Alfonso Chan
`Joseph DePumpo
`Michael W. Shore
`Christopher L. Evans
`Shore Chan DePumpo LLP
`901 Main Street, Suite 3300
`Dallas, TX 75201
`Email: achan@shorechan.com
`Email: jdepumpo@shorechan.com
`Email: mshore@shorechan.com
`Email: cevans@shorechan.com
`
`
`-9-
`
`
`
`Marsha K. Schmidt
`14928 Perrywood Drive
`Burtonsville, MD 20866
`Email: marsha@mkschmidtlaw.com
`
`And on the remaining petitioners as follows:
`
`
`Gary Speier
`Mark Schuman
`CARLSON, CASPERS, VANDENBURGH,
`LINDQUIST & SCHUMAN, P.A.
`225 South Sixth Street, Suite 4200
`Minneapolis, MN 55402
`Email: gspeier@carlsoncaspers.com
`Email: mschuman@carlsoncaspers.com
`Attorneys for Teva Pharmaceuticals USA, Inc.
`
`
`Michael Dzwonczyk
`Azadeh Kokabi
`Travis Ribar
`SUGHRUE MION, PLLC
`2100 Pennsylvania Ave., NW
`Washington, DC 20037
`Email: mdzwonczyk@sughrue.com
`Email: akokabi@sughrue.com
`Email: tribar@sughrue.com
`Attorneys for Akorn Inc.
`
`
`
`Dated: October 27, 2017
`
`
`
`
`
`
`Respectfully submitted,
`
`/ Steven W. Parmelee /
` Steven W. Parmelee
` Reg. No. 31,990
`
`
`
`
`
`-10-
`
`
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