Case 1:18-cv-12029-ADB Document 300 Filed 03/28/22 Page 1 of 9
`
`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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`
`Case No. 1:18-cv-12029-ADB
`
`Leave to File Granted on
`Feb. 22, 2022 (ECF No. 272)
`
`DECLARATION OF EMILY GABRANSKI IN SUPPORT OF
`DEFENDANT ELI LILLY AND COMPANY’S MOTION FOR
`PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT
`
`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 U.S. Patent Application
`
`Publication No. 2009/0220489.
`
`
`
`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
`
`Leave to File Granted on
`Feb. 22, 2022 (ECF No. 272)
`
`DECLARATION OF EMILY GABRANSKI IN SUPPORT OF
`DEFENDANT ELI LILLY AND COMPANY’S MOTION FOR
`PARTIAL SUMMARY JUDGMENT OF NON-INFRINGEMENT
`
`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 U.S. Patent Application
`
`Publication No. 2009/0220489.
`
`
`
`Case 1:18-cv-12029-ADB Document 300 Filed 03/28/22 Page 2 of 9
`
`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 and 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 300 Filed 03/28/22 Page 3 of 9
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`14.
`
`Attached hereto as Exhibit 14 is a true and correct excerpted copy of the Reply
`
`Expert Report of Jeffrey V. Ravetch, M.D., Ph.D., Regarding Infringement, served December 7,
`
`2021 (“Ravetch Reply”).
`
`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 Reply
`
`Expert Report of Pamela Blake, M.D. FAHS, Regarding Infringement, served December 7, 2021
`
`(“Blake Reply”).
`
`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”).
`
`3
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`Case 1:18-cv-12029-ADB Document 300 Filed 03/28/22 Page 4 of 9
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`22.
`
`Attached hereto as Exhibit 22 is a true and correct copy of a document produced
`
`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 in 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 publication Lamb,
`
`“Galcanezumab: First Global Approval,” Drugs (2018) 78: 1769-75 (“Lamb 2018”).
`
`29.
`
`Attached hereto as Exhibit 29 is a true and correct copy of a “Notice of
`
`Allowability” issued by the United States Patent and Trademark Office on August 16, 2013 for
`
`U.S. Patent Application No. 13/179,846 (“Notice of Allowability”).
`
`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 300 Filed 03/28/22 Page 5 of 9
`
`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 transcript
`
`of the deposition of Jeffrey Ravetch, held January 19, 2022 (“Ravetch Tr.”).
`
`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 a document
`
`produced by Lilly bearing Bates numbers LLY-GALCA-00188125-79.
`
`39.
`
`Attached hereto as Exhibit 39 is a true and correct copy of a document produced
`
`by Lilly bearing Bates numbers LLY-GALCA-00263352-60.
`
`5
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`Case 1:18-cv-12029-ADB Document 300 Filed 03/28/22 Page 6 of 9
`
`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 copy of an “Amendment and
`
`Response to Restriction Requirement” electronically filed with the United States Patent and
`
`Trademark Office on February 11, 2013 in connection with U.S. Patent Application No.
`
`13/179,846 (“Feb. 11, 2013 Response”).
`
`46.
`
`Attached hereto as Exhibit 46 is a true and correct copy of an Office Action mailed
`
`by the United States Patent and Trademark Office on March 14, 2013 regarding U.S. Patent
`
`Application No. 13/179,846 (“Mar. 14, 2013 Office Action”).
`
`47.
`
`Attached hereto as Exhibit 47 is a true and correct copy of an “Amendment and
`
`Response to Office Action” electronically filed with the United States Patent and Trademark
`
`Office on June 28, 2013 in connection with U.S. Patent Application No. 13/179,846 (“June 28,
`
`2013 Response”).
`
`6
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`Case 1:18-cv-12029-ADB Document 300 Filed 03/28/22 Page 7 of 9
`
`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 excerpted 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 copy of U.S. Patent No.
`
`9,505,838 (“’838 patent”).
`
`55.
`
`Attached hereto as Exhibit 55 is a true and correct excerpted copy of the
`
`Declaration of Dr. Jeffrey V. Ravetch in Support of Petition for Post Grant Review of U.S. Patent
`
`No. 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”).
`
`7
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`Case 1:18-cv-12029-ADB Document 300 Filed 03/28/22 Page 8 of 9
`
`56.
`
`Attached hereto as Exhibit 56 is a true and correct copy of International Publication
`
`No. WO 2007/054809.
`
`57.
`
`Attached hereto as Exhibit 57 is a true and correct excerpted copy of the transcript
`
`of the deposition of Ryan Darling, held June 18, 2021 (“Darling Tr.”).
`
`58.
`
`Exhibits 5, 7-27, 30-36, 38-40, 42, 44, 48-53, and 57 to this declaration are subject
`
`to Lilly’s Assented-to Motion for Leave to Impound Confidential Portions of Defendant’s
`
`Memoranda and Certain Exhibits (ECF No. 284; granted at ECF No. 285) and will be provisionally
`
`filed under seal.
`
`59.
`
`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
`
`8
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`Case 1:18-cv-12029-ADB Document 300 Filed 03/28/22 Page 9 of 9
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`CERTIFICATE OF SERVICE
`
`I, Andrea Martin, hereby certify that this document filed through the ECF system will be
`sent electronically to the registered participants as identified on the Notice of Electronic Filing
`(NEF) and paper copies will be sent to those indicated as non-registered participants on March 28,
`2022.
`
`/s/Andrea L. Martin
`
`Andrea L. Martin, Esq.
`
`9
`
`
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