Case 1:18-cv-12029-ADB Document 296 Filed 03/28/22 Page 1 of 13
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH and
`TEVA PHARMACEUTICALS USA, INC.,
`
`Plaintiffs,
`
`v.
`
`ELI LILLY AND COMPANY,
`
`Defendant.
`
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`)
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`
`Case No. 1:18-cv-12029-ADB
`
`DECLARATION OF EMILY GABRANSKI IN SUPPORT OF DEFENDANT
`ELI LILLY AND COMPANY’S MOTION FOR
`SUMMARY JUDGMENT OF INVALIDITY FOR LACK OF WRITTEN DESCRIPTION
`
`I, Emily Gabranski, declare as follows:
`
`I am an associate with Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, counsel
`
`for Eli Lilly and Company in this matter. I am licensed to practice in the Commonwealth of
`
`Massachusetts and the District of Columbia. I have personal knowledge of the matters set forth
`
`herein, and if called upon would testify as follows.
`
`1.
`
`Attached hereto as Exhibit 1 is a true and correct copy of U.S. Patent No. 8,586,045
`
`(“’045 patent”).
`
`2.
`
`Attached hereto as Exhibit 2 is a true and correct copy of U.S. Patent No. 9,884,907
`
`(“’907 patent”).
`
`3.
`
`Attached hereto as Exhibit 3 is a true and correct copy of U.S. Patent No. 9,884,908
`
`(“’908 patent”).
`
`4.
`
`Attached hereto as Exhibit 4 is a true and correct copy of Eli Lilly v. Teva Pharm
`
`Int’l GmbH, Case No. 20-1876, ECF No. 28 (Appellee’s Response Brief) (Fed. Cir. Jan. 25, 2021)
`
`(“No. 20-1876, Teva Response Brief”).
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH and
`TEVA PHARMACEUTICALS USA, INC.,
`
`Plaintiffs,
`
`v.
`
`ELI LILLY AND COMPANY,
`
`Defendant.
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`Case No. 1:18-cv-12029-ADB
`
`DECLARATION OF EMILY GABRANSKI IN SUPPORT OF DEFENDANT
`ELI LILLY AND COMPANY’S MOTION FOR
`SUMMARY JUDGMENT OF INVALIDITY FOR LACK OF WRITTEN DESCRIPTION
`
`I, Emily Gabranski, declare as follows:
`
`I am an associate with Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, counsel
`
`for Eli Lilly and Company in this matter. I am licensed to practice in the Commonwealth of
`
`Massachusetts and the District of Columbia. I have personal knowledge of the matters set forth
`
`herein, and if called upon would testify as follows.
`
`1.
`
`Attached hereto as Exhibit 1 is a true and correct copy of U.S. Patent No. 8,586,045
`
`(“’045 patent”).
`
`2.
`
`Attached hereto as Exhibit 2 is a true and correct copy of U.S. Patent No. 9,884,907
`
`(“’907 patent”).
`
`3.
`
`Attached hereto as Exhibit 3 is a true and correct copy of U.S. Patent No. 9,884,908
`
`(“’908 patent”).
`
`4.
`
`Attached hereto as Exhibit 4 is a true and correct copy of Eli Lilly v. Teva Pharm
`
`Int’l GmbH, Case No. 20-1876, ECF No. 28 (Appellee’s Response Brief) (Fed. Cir. Jan. 25, 2021)
`
`(“No. 20-1876, Teva Response Brief”).
`
`
`
`Case 1:18-cv-12029-ADB Document 296 Filed 03/28/22 Page 2 of 13
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`5.
`
`Attached hereto as Exhibit 5 is a true and correct excerpted copy of the Opening
`
`Expert Report of Pamela Blake, M.D., FAHS, Regarding Infringement, served September 16,
`
`2021 (“Blake Op.”).
`
`6.
`
`Attached hereto as Exhibit 6 is a true and correct copy of the Prescribing
`
`Information for Emgality (galcanezumab-gnlm), as revised 12/2019 and introduced as Exhibit 59
`
`in the June 10, 2021 deposition of Marcelo Bigal (“Emgality Label”).
`
`7.
`
`Attached hereto as Exhibit 7 is a true and correct excerpted copy of a document
`
`produced by Lilly bearing Bates numbers LLY-GALCA-00018917–80 and introduced as Exhibit
`
`35 in the June 24, 2021 deposition of Robert Benschop (“Benschop Ex. 35”).
`
`8.
`
`Attached hereto as Exhibit 8 is a true and correct excerpted copy of the transcript
`
`of the deposition of Robert Benschop, held June 24, 2021 (“Benschop Tr.”).
`
`9.
`
`Attached hereto as Exhibit 9 is a true and correct copy of a document produced by
`
`Lilly bearing Bates numbers LLY-GALCA-00486471-73, which was introduced as Exhibit 11 in
`
`the June 24, 2021 deposition of Robert Benschop (“Benschop Ex. 11”).
`
`10.
`
`Attached hereto as Exhibit 10 is a true and correct excerpted copy of the transcript
`
`of the deposition of Kalpana Merchant, held June 9, 2021 (“Merchant Tr.”).
`
`11.
`
`Attached hereto as Exhibit 11 is a true and correct copy of a document produced
`
`by Lilly bearing Bates numbers LLY-GALCA-00686181–87 and introduced as Exhibit 14 in the
`
`June 18, 2021 deposition of Ryan Darling (“Darling Ex. 14”).
`
`12.
`
`Attached hereto as Exhibit 12 is a true and correct excerpted copy of the transcript
`
`of the deposition of Pamela Blake, held January 10, 2022 (“Blake Tr.”).
`
`13.
`
`Attached hereto as Exhibit 13 is a true and correct excerpted copy of the transcript
`
`of the deposition of Geoffrey Hale, held January 25, 2022 (“Hale Tr.”).
`
`2
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`Case 1:18-cv-12029-ADB Document 296 Filed 03/28/22 Page 3 of 13
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`14.
`
`Attached hereto as Exhibit 14 is a true and correct excerpted copy of the Rebuttal
`
`Expert Report of Dr. Andrew Charles Regarding Noninfringement, served November 1, 2021
`
`(“Charles Reb.”).
`
`15.
`
`Attached hereto as Exhibit 15 is a true and correct excerpted copy of the Opening
`
`Expert Report of James M. McDonnell, Ph.D., Regarding Invalidity of U.S. Patent Nos. 8,586,045,
`
`9,884,907, and 9,884,908, served September 16, 2021 (“McDonnell Op.”).
`
`16.
`
`Attached hereto as Exhibit 16 is a true and correct excerpted copy of the transcript
`
`of the deposition of Barrett Allan, held June 17, 2021 (“Allan Tr.”).
`
`17.
`
`Attached hereto as Exhibit 17 is a true and correct excerpted copy of the transcript
`
`of the deposition of Jennifer Stratton, held June 29, 2021 (“Stratton Tr.”).
`
`18.
`
`Attached hereto as Exhibit 18 is a true and correct copy of a document produced
`
`by Teva bearing Bates numbers TEVA_FREM_000136489-97 and introduced as Exhibit 10 in the
`
`June 29, 2021 deposition of Jennifer Stratton (“Stratton Ex. 10”).
`
`19.
`
`Attached hereto as Exhibit 19 is a true and correct copy of a document produced
`
`by Teva bearing Bates numbers TEVA_FREM_000136272-91 and introduced as Exhibit 11 in the
`
`June 29, 2021 deposition of Jennifer Stratton (“Stratton Ex. 11”).
`
`20.
`
`Attached hereto as Exhibit 20 is a true and correct copy of a document produced
`
`by Teva bearing Bates numbers TEVA_FREM_000206270-95 and introduced as Exhibit 17 in the
`
`June 29, 2021 deposition of Jennifer Stratton (“Stratton Ex. 17”).
`
`21.
`
`Attached hereto as Exhibit 21 is a true and correct copy of a document produced
`
`by Teva on behalf of Joerg Zeller bearing Bates numbers Zeller_FREM_00014548-78 and
`
`introduced as Exhibit 41 in the August 11, 2021 deposition of Joerg Zeller (“Zeller Ex. 41”).
`
`22.
`
`Attached hereto as Exhibit 22 is a true and correct copy of a document produced
`
`3
`
`
`
`Case 1:18-cv-12029-ADB Document 296 Filed 03/28/22 Page 4 of 13
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`by Teva on behalf of Joerg Zeller bearing Bates numbers Zeller_FREM_00004726-28 and
`
`introduced as Exhibit 33 in the August 11, 2021 deposition of Joerg Zeller (“Zeller Ex. 33”).
`
`23.
`
`Attached hereto as Exhibit 23 is a true and correct copy of a document produced
`
`by Teva on behalf of Kristian Poulsen bearing Bates numbers Poulsen_FREM_00004829-38 and
`
`introduced as Exhibit 16 in the August 5, 2021 deposition of Kristian Poulsen (“Poulsen Ex. 16”).
`
`24.
`
`Attached hereto as Exhibit 24 is a true and correct excerpted copy of the transcript
`
`of the deposition of Raymond Hill, held January 20, 2022 (“Hill Tr.”).
`
`25.
`
`Attached hereto as Exhibit 25 is a true and correct excerpted copy of the transcript
`
`of the deposition of Joerg Zeller, held August 11, 2021 (“Zeller Tr.”).
`
`26.
`
`Attached hereto as Exhibit 26 is a true and correct excerpted copy of the transcript
`
`of the deposition of Kristian Poulsen, held August 5, 2021 (“Poulsen Tr.”).
`
`27.
`
`Attached hereto as Exhibit 27 is a true and correct copy of a document produced
`
`by Lilly bearing Bates numbers LLY-GALCA-00188757–73 and introduced as Exhibit 7 to the
`
`June 15, 2021 deposition of Kathryn Ramseyer (“Ramseyer Ex. 7”).
`
`28.
`
`Attached hereto as Exhibit 28 is a true and correct copy of a document produced
`
`by Teva bearing Bates numbers TEVA_FREM_000588738–71 and was introduced as Exhibit 37
`
`to the January 26, 2022 deposition of Andrew Blumenfeld (“Blumenfeld 37”).
`
`29.
`
`Attached hereto as Exhibit 29 is a true and correct excerpted copy of the Reply
`
`Expert Report of Dr. Andrew Charles Regarding Invalidity of U.S. Patent Nos. 8,586,045,
`
`9,884,907, and 9,884,908, served December 7, 2021 (“Charles Rep.”).
`
`30.
`
`Attached hereto as Exhibit 30 is a true and correct excerpted copy of the Opening
`
`Expert Report of Jeffrey V. Ravetch, M.D., Ph.D., Regarding Infringement, served September 16,
`
`2021 (“Ravetch Op.”).
`
`4
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`Case 1:18-cv-12029-ADB Document 296 Filed 03/28/22 Page 5 of 13
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`31.
`
`Attached hereto as Exhibit 31 is a true and correct excerpted copy of the
`
`Responsive Expert Report of Geoffrey Hale, Ph.D., Regarding Validity, served November 1, 2021
`
`(“Hale Resp.”).
`
`32.
`
`Attached hereto as Exhibit 32 is a true and correct excerpted copy Plaintiffs’
`
`Objections and Responses to Defendant Eli Lilly and Company’s Requests for Admission (Nos.
`
`1-32), dated March 31, 2021 (“Teva Responses to RFAs”).
`
`33.
`
`Attached hereto as Exhibit 33 is a true and correct excerpted copy of the Rebuttal
`
`Expert Report of Raymond Hill, Ph.D., Regarding Validity of U.S. Patent Nos. 8,586,045,
`
`9,884,907, and 9,884,908, served November 1, 2021 (“Hill Reb.”).
`
`34.
`
`Attached hereto as Exhibit 34 is a true and correct excerpted copy of the Rebuttal
`
`Expert Report of James M. McDonnell, Ph.D., Regarding Noninfringement of U.S. Patent Nos.
`
`8,586,045, 9,884,907, and 9,884,908, served November 1, 2021 (“McDonnell Reb.”).
`
`35.
`
`Attached hereto as Exhibit 35 is a true and correct excerpted copy of the
`
`Supplemental Reply Expert Report of James M. McDonnell, Ph.D. Regarding Invalidity of U.S.
`
`Patent Nos. 8,586,045, 9,884,907, and 9,884,908, served on January 21, 2022 (“McDonnell
`
`Supp.”).
`
`36.
`
`Attached hereto as Exhibit 36 is a true and correct excerpted copy of the transcript
`
`of deposition of Marcelo Bigal, held June 10, 2021 (“Bigal Tr.”).
`
`37.
`
`Attached hereto as Exhibit 37 is a true and correct excerpted copy of Charles A.
`
`Janeway et al., Immunobiology: The Immune System in Health and Disease (5th ed. 2001)
`
`(“Janeway”).
`
`38.
`
`Attached hereto as Exhibit 38 is a true and correct excerpted copy of the transcript
`
`of the deposition of Yasmina Abdiche, held August 17, 2021 (“Abdiche Tr.”).
`
`5
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`Case 1:18-cv-12029-ADB Document 296 Filed 03/28/22 Page 6 of 13
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`39.
`
`Attached hereto as Exhibit 39 is a true and correct copy of a document produced
`
`by Lilly bearing Bates numbers LLY-GALCA-00718711-41 and introduced as Exhibit 37 to the
`
`August 17, 2021 deposition of Yasmina Abdiche (“Abdiche Ex. 37”).
`
`40.
`
`Attached hereto as Exhibit 40 is a true and correct excerpted copy of the transcript
`
`of the deposition of Jaume Pons, held August 20, 2021 (“Pons Tr.”).
`
`41.
`
`Attached hereto as Exhibit 41 is a true and correct copy of the prescribing
`
`Information for Ajovy (fremanezumab-vfrm), as revised 1/2020 and introduced as Exhibit 60 in
`
`the June 10, 2021 deposition of Marcelo Bigal (“Ajovy Label”).
`
`42.
`
`Attached hereto as Exhibit 42 is a true and correct excerpted copy of the transcript
`
`of the deposition of Douglas Harnish, held July 29, 2021 (“Harnish Tr.”).
`
`43.
`
`Attached hereto as Exhibit 43 is a true and correct excerpted copy of the transcript
`
`of the deposition of Jeffrey Ravetch, held September 30, 2020 (“Ravetch CC Tr.”).
`
`44.
`
`Attached hereto as Exhibit 44 is a true and correct excerpted copy of the
`
`Supplemental Responsive Expert Report of Geoffrey Hale, Ph.D., Regarding Validity, served
`
`January 7, 2022 (“Hale Supp.”).
`
`45.
`
`Attached hereto as Exhibit 45 is a true and correct excerpted copy of the Reply
`
`Expert Report of James M. McDonnell, Ph.D., Regarding Invalidity of U.S. Patent Nos. 8,586,045,
`
`9,884,907, and 9,884,908, served December 7, 2021 (“McDonnell Reply”).
`
`46.
`
`Attached hereto as Exhibit 46 is a true and correct copy of a document produced
`
`by Teva on behalf of Joerg Zeller bearing Bates numbers Zeller_FREM_00000670 and introduced
`
`as Exhibit 30 in the August 11, 2021 deposition of Joerg Zeller (“Zeller Ex. 30”).
`
`47.
`
`Attached hereto as Exhibit 47 is a true and correct excerpted copy of the Opening
`
`Expert Report of Diane R. Mould, Ph.D., FCP, FAAPS, served September 16, 2021 (“Mould
`
`6
`
`
`
`Case 1:18-cv-12029-ADB Document 296 Filed 03/28/22 Page 7 of 13
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`Op.”).
`
`48.
`
`Attached hereto as Exhibit 48 is a true and correct excerpted copy of the Opening
`
`Expert Report of Dr. Andrew Charles Regarding Invalidity of U.S. Patent Nos. 8,586,045,
`
`9,884,907, and 9,884,908, served September 16, 2021 (“Charles Op.”).
`
`49.
`
`Attached hereto as Exhibit 49 is a true and correct excerpted copy of the transcript
`
`of the deposition of Thomas Rainey, held August 10, 2021 (“Rainey Tr.”).
`
`50.
`
`Attached hereto as Exhibit 50 is a true and correct excerpted copy of the transcript
`
`of the deposition of Andrew Blumenfeld, held January 26, 2022 (“Blumenfeld Tr.”).
`
`51.
`
`Attached hereto as Exhibit 51 is a true and correct excerpted copy of the
`
`Responsive Expert Report of Dr. Andrew Blumenfeld, M.D. Regarding Validity, served
`
`November 1, 2021 (“Blumenfeld Resp.”).
`
`52.
`
`Attached hereto as Exhibit 52 is a true and correct copy of a document produced
`
`by Teva bearing Bates numbers TEVA_FREM_000132147–48 and introduced as Exhibit 52 in
`
`the June 10, 2021 deposition of Marcelo Bigal (“Bigal Ex. 52”).
`
`53.
`
`Attached hereto as Exhibit 53 is a true and correct copy of a document produced
`
`by Lilly bearing Bates numbers LLY-GALCA-R-00113958–74 and introduced as Exhibit 27 in
`
`the June 24, 2021 deposition of Robert Benschop (“Benschop Ex. 27”).
`
`54.
`
`Attached hereto as Exhibit 54 is a true and correct excerpted copy of the Reply
`
`Expert Report of Diane R. Mould, Ph.D., served December 7, 2021 (“Mould Reply”).
`
`55.
`
`Attached hereto as Exhibit 55 is a true and correct copy of a document produced
`
`by Teva on behalf of Joerg Zeller bearing Bates numbers Zeller_FREM_00000565–66 and
`
`introduced as Exhibit 9 in the August 11, 2021 deposition of Joerg Zeller (“Zeller Ex. 9”).
`
`56.
`
`Attached hereto as Exhibit 56 is a true and correct copy of a document produced
`
`7
`
`
`
`Case 1:18-cv-12029-ADB Document 296 Filed 03/28/22 Page 8 of 13
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`by Teva on behalf of Joerg Zeller bearing Bates numbers Zeller_FREM_00000550–51 and
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`introduced as Exhibit 32 in the August 11, 2021 deposition of Joerg Zeller (“Zeller Ex. 32”).
`
`57.
`
`Attached hereto as Exhibit 57 is a true and correct copy of a document produced
`
`by Lilly bearing Bates numbers LLY-GALCA-00723219–21 and introduced as Exhibit 56 in the
`
`July 30, 2021 deposition of Arnon Rosenthal (“Rosenthal Ex. 56”).
`
`58.
`
`Attached hereto as Exhibit 58 is a true and correct excerpted copy of Plaintiffs’
`
`Supplemental and Amended Objections and Responses to Defendant Eli Lilly and Company’s
`
`First Set of Interrogatories to Plaintiffs (Nos. 1, 6, 8-13, 15, 18, 21-23, 26, and 30), served on
`
`September 1, 2021 (“Teva Responses to Interrogatories”).
`
`59.
`
`Attached hereto as Exhibit 59 is a true and correct copy of a document produced by
`
`Teva on behalf of Joerg Zeller bearing Bates numbers Zeller_FREM_00003406–10 and introduced
`
`as Exhibit 29 in the August 11, 2021 deposition of Joerg Zeller (“Zeller Ex. 29”).
`
`60.
`
`Attached hereto as Exhibit 60 is a true and correct excerpted copy of Teva
`
`Pharmaceuticals International GmbH’s Patent Owner’s Surreply, filed in Eli Lilly & Co. v. Teva
`
`Pharms. Int’l GmbH, IPR2018-01710, Paper 43 (PTAB Nov. 13, 2019) (“IPR2018-01710
`
`Surreply”).
`
`61.
`
`Attached hereto as Exhibit 61 is a true and correct copy of the Declaration of
`
`Steven M. Foord, Ph.D., filed in Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, IPR2018-01710, Ex.
`
`2265 (PTAB July 3, 2019) (“Foord Decl.”).
`
`62.
`
`Attached hereto as Exhibit 62 is a true and correct excerpted copy of the
`
`Declaration of Dr. Michel D. Ferrari, M.D., Ph.D., filed in Eli Lilly & Co. v. Teva Pharms. Int’l
`
`GmbH, IPR2018-01710, Ex. 2268 (PTAB July 3, 2019) (“Ferrari Decl.”).
`
`63.
`
`Attached hereto as Exhibit 63 is a true and correct excerpted copy of the transcript
`
`8
`
`
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`Case 1:18-cv-12029-ADB Document 296 Filed 03/28/22 Page 9 of 13
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`of the deposition of Michel D. Ferrari, Ph.D., held September 20, 2019, in Eli Lilly & Co. v. Teva
`
`Pharms. Int’l GmbH, IPR2018-01710 (“Ferrari Tr.”).
`
`64.
`
`Attached hereto as Exhibit 64 is a true and correct copy of a document produced
`
`by Teva bearing Bates number TEVA_FREM_001178100 and introduced as Exhibit 5 in the
`
`August 20, 2021 deposition of Jaume Pons (“Pons Ex. 5”).
`
`65.
`
`Attached hereto as Exhibit 65 is a true and correct excerpted copy of Teva
`
`Pharmaceuticals International GmbH’s Patent Owner Response, filed in Eli Lilly & Co. v. Teva
`
`Pharms. Int’l GmbH, IPR2018-01710, Paper 21 (PTAB July 3, 2019) (“IPR2018-01710 POR”).
`
`66.
`
`Attached hereto as Exhibit 66 is a true and correct excerpted copy of Teva
`
`Pharmaceuticals International GmbH’s Patent Owner Response, filed in Eli Lilly & Co. v. Teva
`
`Pharms. Int’l GmbH, IPR2018-01422, Paper 24 (PTAB May 31, 2019) (“IPR2018-01422 POR”).
`
`67.
`
`Attached hereto as Exhibit 67 is a true and correct excerpted copy of the PTAB’s
`
`Final Written Decision in Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, IPR2018-01422, Paper 80
`
`(PTAB Feb. 18, 2020) (“IPR2018-01422 FWD”).
`
`68.
`
`Attached hereto as Exhibit 68 is a true and correct excerpted copy of The
`
`International Classification Headache Disorders: 2nd Edition, which was introduced in complete,
`
`unabbreviated form as Exhibit 30 in the January 26, 2022 deposition of Andrew Blumenfeld
`
`(“ICHD-II”).
`
`69.
`
`Attached hereto as Exhibit 69 is a true and correct excerpted copy of the transcript
`
`of the deposition of Alan M. Rapoport, M.D., held August 22, 2019, in Eli Lilly & Co. v. Teva
`
`Pharms. Int’l GmbH, IPR2018-01710 (“Rapoport Tr.”).
`
`70.
`
`Attached hereto as Exhibit 70 is a true and correct copy of the publication Hill and
`
`Oliver, “Neuropeptide and Kinin Antagonists,” HEP (2006) 177:181-216, which was introduced
`
`9
`
`
`
`Case 1:18-cv-12029-ADB Document 296 Filed 03/28/22 Page 10 of 13
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`as Exhibit 136 in the January 20, 2022 deposition of Raymond Hill (“Hill 2006”).
`
`71.
`
`Attached hereto as Exhibit 71 is a true and correct is a true and correct excerpted
`
`copy of the transcript of the deposition of Ian M. Tomlinson, M.A., Ph.D., held August 7, 2019, in
`
`Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, IPR2018-01710 (“Tomlinson Tr.”).
`
`72.
`
`Attached hereto as Exhibit 72 is a true and correct copy of International Publication
`
`Number WO 2021/234402 A2, which was introduced in complete, unabbreviated form as Exhibit
`
`26 in the January 25, 2022 deposition of Geoffrey Hale (“Hale Ex. 26.”)
`
`73.
`
`Attached hereto as Exhibit 73 is a true and correct copy of the Declaration of Dr.
`
`Jeffrey V. Ravetch in Support of Petition for Post Grant Review of U.S. Patent Number
`
`10,611,836, which was introduced in complete, unabbreviated form as Exhibit 4 in the January 19,
`
`2022 deposition of Jeffrey Ravetch (“Ravetch Ex. 4”).
`
`74.
`
`Attached hereto as Exhibit 74 is a true and correct excerpted copy of the
`
`Declaration of Ian M. Tomlinson, M.A., Ph.D., filed in Eli Lilly & Co. v. Teva Pharms Int’l GmbH,
`
`IPR2018-01710, Ex. 2271 (PTAB July 3, 2019) (“Tomlinson Decl.”).
`
`75.
`
`Attached hereto as Exhibit 75 is a true and correct copy of the publication by Aya
`
`Jakobovits, “The long-awaited magic bullets: therapeutic human monoclonal antibodies from
`
`transgenic mice,” Exp. Opin. Invest. Drugs (1998) 7:607-14 (“Jakobovits”).
`
`76.
`
`Attached hereto as Exhibit 76 is a true and correct copy of the Mathieu Dondelinger
`
`et al., “Understanding the Significance and Implications of Antibody Numbering and Antigen-
`
`Binding Surface/Residue Definition,” Front. Immunol. (2018) 9:2278 (“Dondelinger”).
`
`77.
`
`Attached hereto as Exhibit 77 is a true and correct copy of a press release titled
`
`“Teva Announces Update on Fremanezumab Clinical Development for Use in Episodic Cluster
`
`Headache,” dated April 23, 2019 (“Teva 2019 Press Release”).
`
`10
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`Case 1:18-cv-12029-ADB Document 296 Filed 03/28/22 Page 11 of 13
`
`78.
`
`Attached hereto as Exhibit 78 is a true and correct copy of U.S. Patent No.
`
`10,556,945, which was introduced as Exhibit 29 in the June 10, 2021 deposition of Marcelo Bigal
`
`(“Bigal Ex. 29”).
`
`79.
`
`Attached hereto as Exhibit 79 is a true and correct copy of an “Amendment in
`
`Reply to Action of April 8, 2016” in the file history of U.S. Patent Application 14/711,705, which
`
`was introduced as Exhibit 31 in the June 10, 2021 deposition of Marcelo Bigal (“Bigal Ex. 31”).
`
`80.
`
`Attached hereto as Exhibit 80 is a true and correct copy of an “Amendment in
`
`Reply to Action of July 29, 2016” in the file history of U.S. Patent Application 14/664,715, which
`
`was introduced as Exhibit 27 in the June 10, 2021 deposition of Marcelo Bigal (“Bigal Ex. 27”).
`
`81.
`
`Attached hereto as Exhibit 81 is a true and correct copy of U.S. Patent No.
`
`9,896,502, which was introduced in complete, unabbreviated form as Exhibit 25 in the June 10,
`
`2021 deposition of Marcelo Bigal (“Bigal Ex. 25”).
`
`82.
`
`Attached hereto as Exhibit 82 is a true and correct copy of a publication by Egilius
`
`Spierings et al., “A Phase 2 Study of Fremanezumab as a Treatment for Posttraumatic Headache
`
`in Adult Patients” Neurology (2021) 9 (15 Supplement):1588 (“Spierings 2021”).
`
`83.
`
`Attached hereto as Exhibit 83 is a true and correct copy of the Declaration of Jaume
`
`Pons, Ph.D., filed in Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, IPR2018-01710, Ex. 2331
`
`(PTAB July 3, 2019) and introduced as Exhibit 66 in the August 20, 2021 deposition of Jaume
`
`Pons (“Pons Ex. 66”).
`
`84.
`
`Attached hereto as Exhibit 84 is a true and correct excerpted copy of the transcript
`
`of the deposition of Steven M. Foord, Ph.D., held July 19, 2019, in Eli Lilly & Co. v. Teva Pharms.
`
`Int’l GmbH, IPR2018-01710, Ex. 1300 (“Foord Tr.”).
`
`85.
`
`Attached hereto as Exhibit 85 is a true and correct excerpted copy of the PTAB’s
`
`11
`
`
`
`Case 1:18-cv-12029-ADB Document 296 Filed 03/28/22 Page 12 of 13
`
`Final Written Decision in Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, IPR2018-01710, Paper 69
`
`(PTAB March 31, 2020) (“IPR2018-01710 FWD”).
`
`86.
`
`Attached hereto as Exhibit 86 is a true and correct excerpted copy of the PTAB’s
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`Final Written Decision in Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, IPR2018-01424, Paper 78
`
`(PTAB Feb. 18, 2020) (“IPR2018-01424 FWD”)
`
`87.
`
`Exhibits 5, 7-36, 38-40, and 42-59, 64 to this declaration are subject to Lilly’s
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`Assented-to Motion for Leave to Impound Confidential Portions of Defendant’s Memoranda and
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`Certain Exhibits and will be provisionally filed under seal.
`
`88.
`
`Complete copies of any excerpted documents identified above will be provided to
`
`the Court upon request.
`
`I declare under the penalty of perjury that the foregoing is true and correct to the best of
`
`my knowledge.
`
`Executed on this 28th day of March, 2022, in Washington, DC.
`
` /s/ Emily Gabranski
`Emily Gabranski
`
`12
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`
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`Case 1:18-cv-12029-ADB Document 296 Filed 03/28/22 Page 13 of 13
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`CERTIFICATE OF SERVICE
`
`I, Andrea Martin, hereby certify that a copy of the foregoing document, filed through the
`CM/ECF system, will be sent electronically to the registered participants as identified on the
`Notice of Electronic Filing (NEF) and paper copies shall be served by first class mail postage
`prepaid on all counsel of record who are not served through the CM/ECF system on March 28,
`2022.
`
`/s/Andrea L. Martin
`Andrea L. Martin, Esq.
`
`13
`
`
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