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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
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`) Case No. 1:18-cv-10242-ADB
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`TEVA PHARMACEUTICALS
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`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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`DECLARATION OF STEPHEN H. INGHAM IN SUPPORT OF DEFENDANT ELI
`LILLY AND COMPANY’S MOTION TO EXCLUDE DR. GEOFFREY HALE AS AN
`EXPERT AND PREVENT DISCLOSURE OF PROTECTED INFORMATION
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`I, Stephen H. Ingham, declare as follows:
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`1.
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`I am a Senior Director and Assistant General Patent Counsel at Eli Lilly and
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`Company (“Lilly”). I am based in Bracknell, London, United Kingdom. I hold a Bachelor of
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`Science degree in Biochemistry with Biotechnology from the University of St. Andrews, and a
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`Master of Science degree in Management of Intellectual Property from the Queen Mary
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`University of London. I additionally have earned a Diploma in European Patent Litigation from
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`Université Robert Schuman (Strasbourg III) in Strasbourg, France. I am licensed as a United
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`Kingdom Patent Attorney by the Chartered Institute of Patent Attorneys, and licensed as a
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`European Patent Attorney by the European Patent Office. I have personal knowledge of the
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`matters set forth herein, and if called upon would testify as follows.
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`2.
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`Attached hereto as Exhibit 1 is a true and correct copy of a document
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`Case 1:18-cv-12029-ADB Document 198 Filed 10/20/21 Page 2 of 12
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`5.
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`Attached hereto as Exhibit 2 I believe to be a true and correct copy of
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`Attached hereto as Exhibit 3 I believe to be a true and correct copy of
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`Case 1:18-cv-12029-ADB Document 198 Filed 10/20/21 Page 3 of 12
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`7.
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`Attached hereto as Exhibit 4 is a true and correct copy of European Patent No.
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`1,994,937 B1, entitled “Prevention and treatment of amyloidogenic disease,” assigned on its
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`face to Janssen Alzheimer Immunotherapy Limited.
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`8.
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`Claims 1-3 of the European patent read as follows:
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`1. A pharmaceutical composition comprising an antibody to Aβ and a
`pharmaceutically acceptable non-toxic carrier or diluent, for use in preventing or
`treating a disease characterized by amyloid deposit in a patient, wherein the
`isotype of the antibody is human IgG1.
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`2. The pharmaceutical composition for use in preventing or treating a disease
`characterized by amyloid deposit in a patient of claim 1, wherein the antibody is
`a monoclonal antibody.
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`3. The pharmaceutical composition for use in preventing or treating a disease
`characterized by amyloid deposit in a patient of claim 1, wherein the antibody is
`a humanized antibody or a human antibody.
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`Ex. 4 at 30:50-57 (emphases in original).
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`9.
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`Case 1:18-cv-12029-ADB Document 198 Filed 10/20/21 Page 4 of 12
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`Attached hereto as Exhibit 5 is a true and correct redacted copy of
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`10.
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`11.
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`12.
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` Lilly
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`opposition to EP1994937, which Lilly filed at the European Patent Office on September 27,
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`2011, and its UK revocation action, which Lilly filed on September 30, 2011. Attached
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`hereto as Exhibit 6 is a true and correct copy of Lilly’s Notice of Opposition for European
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`Patent No. 1,994,937, which I signed as an authorized representative of Lilly. Attached hereto as
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`Exhibit 7 is a true and correct copy of the minutes of oral proceedings before the European
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`Patent Office held on June 10, 2013, which I attended on behalf of Lilly. Attached hereto as
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`4
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`Case 1:18-cv-12029-ADB Document 198 Filed 10/20/21 Page 5 of 12
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`Exhibit 8 is a true and correct copy of the as-filed Claim Form in the English Patents Court
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`dated September 30, 2011, with a seal from the Court chambers dated October 12, 2011.
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`13.
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`Attached hereto as Exhibit 9 is a true and correct redacted copy of
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`14.
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`15.
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`Attached hereto as Exhibit 10 is a true and correct redacted copy of
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`17.
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`18.
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`Attached hereto as Exhibit 11, is what I believe to be a true and correct copy of
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`Case 1:18-cv-12029-ADB Document 198 Filed 10/20/21 Page 6 of 12
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`19.
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`Attached hereto as Exhibit 12 is a true and correct copy of European Patent
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`No. 1,641,822 B1, entitled “IL-17 A/F Heterologous Polypeptides and Therapeutic Uses
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`Thereof,” assigned on its face to Genentech, Inc.
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`20.
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`21.
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`Claims 27-28 of EP1641822 as granted read as follows:
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`27. An isolated antibody which specifically binds to the IL-17A/F heterodimeric complex
`according to Claim 23 or Claim 24 and which inhibits the activity of the IL-17A/F
`heterodimeric complex to induce production of IL-8 and IL-6.
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`28. The isolated antibody of Claim 27, wherein said antibody is a monoclonal antibody,
`a humanized antibody or a single-chain antibody.
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`Ex. 12 at 93:15-20.
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`22.
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`Case 1:18-cv-12029-ADB Document 198 Filed 10/20/21 Page 7 of 12
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`25.
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`27.
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`Attached hereto as Exhibit 13 I believe is a true and correct redacted copy of
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`28.
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`30.
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`Case 1:18-cv-12029-ADB Document 198 Filed 10/20/21 Page 8 of 12
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`31.
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`Attached hereto as Exhibit 15 is a
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`32.
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`Attached hereto as Exhibit 16 is a
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`34.
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`Attached hereto as Exhibit 17 is what I believe is a true and correct redacted copy
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`of
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`35.
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`Case 1:18-cv-12029-ADB Document 198 Filed 10/20/21 Page 9 of 12
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`37.
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`Attached hereto as Exhibit 18 is a true and correct redacted copy of a
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`38.
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` I understand that Dr. Hale was at one time a non-executive director of Absolute
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`Antibody Ltd.
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`39.
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`of
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`of
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`40.
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`Attached hereto as Exhibit 19 is what I believe is a true and correct redacted copy
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`41.
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`Attached hereto as Exhibit 20 is what I believe is a true and correct redacted copy
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`42.
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`Case 1:18-cv-12029-ADB Document 198 Filed 10/20/21 Page 10 of 12
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`43.
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`Attached hereto as Exhibit 21 is a true and correct copy of
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`44.
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`45.
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`Attached hereto as Exhibit 22 is a true and correct copy of
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`47.
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`Attached hereto as Exhibit 23 are true and correct copies of documents
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`Case 1:18-cv-12029-ADB Document 198 Filed 10/20/21 Page 11 of 12
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`48.
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`Attached hereto as Exhibit 24 are true and correct copies of documents
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`49.
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`I am informed by counsel that Exhibits 1-3, 5, 9-11, and 13-24 to this declaration
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`are subject to Lilly’s pending Uncontested Motion for Leave to Impound Confidential
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`Defendant’s Motion to Exclude Dr. Geoffrey Hale as an Expert and Prevent Disclosure of
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`Protected Information and Exhibits (ECF No. 180) and will be provisionally filed under seal.
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`50.
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`Complete copies of any excerpted and/or redacted documents identified above
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`will be provided to the Court upon request.
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`11
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`Case 1:18-cv-12029-ADB Document 198 Filed 10/20/21 Page 12 of 12
`Executed on this 12th day of October, 2021, in London, United Kingdom.
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`Ayob
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`Stephen H. Ingham
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