`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH and
`TEVA PHARMACEUTICALS USA, INC.,
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`Plaintiffs,
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`v.
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`ELI LILLY AND COMPANY,
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`Defendant.
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`Case No. 1:18-cv-12029-ADB
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`Leave to File Granted on
`Feb. 22, 2022 (ECF No. 272)
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`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
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`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
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`herein, and if called upon would testify as follows.
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`1.
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`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
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`(“’907 patent”).
`
`3.
`
`Attached hereto as Exhibit 3 is a true and correct copy of U.S. Patent No. 9,884,908
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`(“’908 patent”).
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`4.
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`Attached hereto as Exhibit 4 is a true and correct copy of U.S. Patent Application
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`Publication No. 2009/0220489.
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`
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`Case 1:18-cv-12029-ADB Document 300 Filed 03/28/22 Page 2 of 9
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`5.
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`Attached hereto as Exhibit 5 is a true and correct excerpted copy of the Opening
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`Expert Report of Pamela Blake, M.D., FAHS, Regarding Infringement, served September 16,
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`2021 (“Blake Op.”).
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`6.
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`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”).
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`7.
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`Attached hereto as Exhibit 7 is a true and correct excerpted copy of a document
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`produced by Lilly bearing Bates numbers LLY-GALCA-00018917–80 and introduced as Exhibit
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`35 in the June 24, 2021 deposition of Robert Benschop (“Benschop Ex. 35”).
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`8.
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`Attached hereto as Exhibit 8 is a true and correct excerpted copy of the transcript
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`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
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`Lilly bearing Bates numbers LLY-GALCA-00486471-73 and introduced as Exhibit 11 in the June
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`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
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`by Lilly bearing Bates numbers LLY-GALCA-00686181–87 and introduced as Exhibit 14 in the
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`June 18, 2021 deposition of Ryan Darling (“Darling Ex. 14”).
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`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.”).
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`13.
`
`Attached hereto as Exhibit 13 is a true and correct excerpted copy of the transcript
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`of the deposition of Geoffrey Hale, held January 25, 2022 (“Hale Tr.”).
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`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.
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`Attached hereto as Exhibit 14 is a true and correct excerpted copy of the Reply
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`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.”).
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`16.
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`Attached hereto as Exhibit 16 is a true and correct excerpted copy of the Reply
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`Expert Report of Pamela Blake, M.D. FAHS, Regarding Infringement, served December 7, 2021
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`(“Blake Reply”).
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`17.
`
`Attached hereto as Exhibit 17 is a true and correct excerpted copy of the transcript
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`of the deposition of Jennifer Stratton, held June 29, 2021 (“Stratton Tr.”).
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`18.
`
`Attached hereto as Exhibit 18 is a true and correct copy of a document produced
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`by Teva bearing Bates numbers TEVA_FREM_000136489-97 and introduced as Exhibit 10 in the
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`June 29, 2021 deposition of Jennifer Stratton (“Stratton Ex. 10”).
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`19.
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`Attached hereto as Exhibit 19 is a true and correct copy of a document produced
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`by Teva bearing Bates numbers TEVA_FREM_000136272-91 and introduced as Exhibit 11 in the
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`June 29, 2021 deposition of Jennifer Stratton (“Stratton Ex. 11”).
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`20.
`
`Attached hereto as Exhibit 20 is a true and correct copy of a document produced
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`by Teva bearing Bates numbers TEVA_FREM_000206270-95 and introduced as Exhibit 17 in the
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`June 29, 2021 deposition of Jennifer Stratton (“Stratton Ex. 17”).
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`21.
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`Attached hereto as Exhibit 21 is a true and correct copy of a document produced
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`by Teva on behalf of Joerg Zeller bearing Bates numbers Zeller_FREM_00014548-78 and
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`introduced as Exhibit 41 in the August 11, 2021 deposition of Joerg Zeller (“Zeller Ex. 41”).
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`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.
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`Attached hereto as Exhibit 22 is a true and correct copy of a document produced
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`by Teva on behalf of Joerg Zeller bearing Bates numbers Zeller_FREM_00004726-28 and
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`introduced as Exhibit 33 in the August 11, 2021 deposition of Joerg Zeller (“Zeller Ex. 33”).
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`23.
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`Attached hereto as Exhibit 23 is a true and correct copy of a document produced
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`by Teva on behalf of Kristian Poulsen bearing Bates numbers Poulsen_FREM_00004829-38 and
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`introduced as Exhibit 16 in the August 5, 2021 deposition of Kristian Poulsen (“Poulsen Ex. 16”).
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`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.”).
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`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.”).
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`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
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`June 15, 2021 deposition of Kathryn Ramseyer (“Ramseyer Ex. 7”).
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`28.
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`Attached hereto as Exhibit 28 is a true and correct copy of a publication Lamb,
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`“Galcanezumab: First Global Approval,” Drugs (2018) 78: 1769-75 (“Lamb 2018”).
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`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
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`U.S. Patent Application No. 13/179,846 (“Notice of Allowability”).
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`30.
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`Attached hereto as Exhibit 30 is a true and correct excerpted copy of the Opening
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`Expert Report of Jeffrey V. Ravetch, M.D., Ph.D., Regarding Infringement, served September 16,
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`2021 (“Ravetch Op.”).
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`4
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`Case 1:18-cv-12029-ADB Document 300 Filed 03/28/22 Page 5 of 9
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`31.
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`Attached hereto as Exhibit 31 is a true and correct excerpted copy of the
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`Responsive Expert Report of Geoffrey Hale, Ph.D., Regarding Validity, served November 1, 2021
`
`(“Hale Resp.”).
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`32.
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`Attached hereto as Exhibit 32 is a true and correct excerpted copy Plaintiffs’
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`Objections and Responses to Defendant Eli Lilly and Company’s Requests for Admission (Nos.
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`1-32), dated March 31, 2021 (“Teva Responses to RFAs”).
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`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,
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`9,884,907, and 9,884,908, served November 1, 2021 (“Hill Reb.”).
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`34.
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`Attached hereto as Exhibit 34 is a true and correct excerpted copy of the Rebuttal
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`Expert Report of James M. McDonnell, Ph.D., Regarding Noninfringement of U.S. Patent Nos.
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`8,586,045, 9,884,907, and 9,884,908, served November 1, 2021 (“McDonnell Reb.”).
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`35.
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`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.”).
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`36.
`
`Attached hereto as Exhibit 36 is a true and correct excerpted copy of the transcript
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`of deposition of Marcelo Bigal, held June 10, 2021 (“Bigal Tr.”).
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`37.
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`Attached hereto as Exhibit 37 is a true and correct excerpted copy of Charles A.
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`Janeway et al., Immunobiology: the immune system in health and disease (5th ed. 2001)
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`(“Janeway”).
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`38.
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`Attached hereto as Exhibit 38 is a true and correct excerpted copy of a document
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`produced by Lilly bearing Bates numbers LLY-GALCA-00188125-79.
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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-00263352-60.
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`5
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`Case 1:18-cv-12029-ADB Document 300 Filed 03/28/22 Page 6 of 9
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`40.
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`Attached hereto as Exhibit 40 is a true and correct excerpted copy of the transcript
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`of the deposition of Jaume Pons, held August 20, 2021 (“Pons Tr.”).
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`41.
`
`Attached hereto as Exhibit 41 is a true and correct copy of the prescribing
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`Information for Ajovy (fremanezumab-vfrm), as revised 1/2020 and introduced as Exhibit 60 in
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`the June 10, 2021 deposition of Marcelo Bigal (“Ajovy Label”).
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`42.
`
`Attached hereto as Exhibit 42 is a true and correct excerpted copy of the transcript
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`of the deposition of Douglas Harnish, held July 29, 2021 (“Harnish Tr.”).
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`43.
`
`Attached hereto as Exhibit 43 is a true and correct excerpted copy of the transcript
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`of the deposition of Jeffrey Ravetch, held September 30, 2020 (“Ravetch CC Tr.”).
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`44.
`
`Attached hereto as Exhibit 44 is a true and correct excerpted copy of the
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`Supplemental Responsive Expert Report of Geoffrey Hale, Ph.D., Regarding Validity, served
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`January 7, 2022 (“Hale Supp.”).
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`45.
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`Attached hereto as Exhibit 45 is a true and correct copy of an “Amendment and
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`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.
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`13/179,846 (“Feb. 11, 2013 Response”).
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`46.
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`Attached hereto as Exhibit 46 is a true and correct copy of an Office Action mailed
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`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”).
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`47.
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`Attached hereto as Exhibit 47 is a true and correct copy of an “Amendment and
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`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”).
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`6
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`Case 1:18-cv-12029-ADB Document 300 Filed 03/28/22 Page 7 of 9
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`48.
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`Attached hereto as Exhibit 48 is a true and correct excerpted copy of the Opening
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`Expert Report of Dr. Andrew Charles Regarding Invalidity of U.S. Patent Nos. 8,586,045,
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`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
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`of the deposition of Thomas Rainey, held August 10, 2021 (“Rainey Tr.”).
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`50.
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`Attached hereto as Exhibit 50 is a true and correct excerpted copy of the transcript
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`of the deposition of Andrew Blumenfeld, held January 26, 2022 (“Blumenfeld Tr.”).
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`51.
`
`Attached hereto as Exhibit 51 is a true and correct excerpted copy of the
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`Responsive Expert Report of Dr. Andrew Blumenfeld, M.D. Regarding Validity, served
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`November 1, 2021 (“Blumenfeld Resp.”).
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`52.
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`Attached hereto as Exhibit 52 is a true and correct copy of a document produced
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`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”).
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`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
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`Exhibit 27 in the June 24, 2021 deposition of Robert Benschop (“Benschop Ex. 27”).
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`54.
`
`Attached hereto as Exhibit 54 is a true and correct copy of U.S. Patent No.
`
`9,505,838 (“’838 patent”).
`
`55.
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`Attached hereto as Exhibit 55 is a true and correct excerpted copy of the
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`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
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`19, 2022 deposition of Jeffrey Ravetch (“Ravetch Ex. 4”).
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`7
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`Case 1:18-cv-12029-ADB Document 300 Filed 03/28/22 Page 8 of 9
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`56.
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`Attached hereto as Exhibit 56 is a true and correct copy of International Publication
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`No. WO 2007/054809.
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`57.
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`Attached hereto as Exhibit 57 is a true and correct excerpted copy of the transcript
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`of the deposition of Ryan Darling, held June 18, 2021 (“Darling Tr.”).
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`58.
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`Exhibits 5, 7-27, 30-36, 38-40, 42, 44, 48-53, and 57 to this declaration are subject
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`to Lilly’s Assented-to Motion for Leave to Impound Confidential Portions of Defendant’s
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`Memoranda and Certain Exhibits (ECF No. 284; granted at ECF No. 285) and will be provisionally
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`filed under seal.
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`59.
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`Complete copies of any excerpted documents identified above will be provided to
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`the Court upon request.
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`I declare under the penalty of perjury that the foregoing is true and correct to the best of
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`my knowledge.
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`Executed on this 28th day of March, 2022, in Washington, DC.
`
` /s/ Emily Gabranski
`Emily Gabranski
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`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
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`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
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`Andrea L. Martin, Esq.
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`9
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