Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 1 of 56
`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 1 of 56
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`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF MASSACHUSETTS
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBHand
`TEVA PHARMACEUTICALSUSA,INC.,
`
`Plaintiffs,
`
`V.
`
`ELI LILLY AND COMPANY,
`
`Defendant.
`
`YS1
`
`Case No. 1:18-cv-12029-ADB
`
`Po
`
`Leave to File Under Seal Granted on
`May6, 2022 (ECF No. 341)
`
`DEFENDANT ELI LILLY AND COMPANY’S RESPONSE TO PLAINTIFFS’
`LR 56.1 STATEMENT OF UNDISPUTED MATERIAL FACTS
`
`IN SUPPORT OF THEIR MOTION FOR SUMMARY JUDGMENT OF NO
`INEQUITABLE CONDUCT AND UNCLEAN HANDS
`
`

`

`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 2 of 56
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`Abbreviation
`’045 patent
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`’394 application
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`’623 provisional
`application
`’816 application
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`’871 application
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`’907 patent
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`’908 patent
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`’925 application
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`App’x
`BBB
`Blake Tr.
`
`Blumenfeld Resp.
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`Bold and italicized
`Br.
`
`TABLE OF ABBREVIATIONS
`
`Description
`Patent-in-suit. U.S. Patent No. 8,586,045 to Joerg Zeller et al., issued
`November 19, 2013, entitled “Methods of Using Anti-CGRP
`Antagonist Antibodies”; currently assigned to Teva Pharmaceuticals
`International GmbH
`U.S. Patent Application No. 13/835,394 to Joerg Zeller et al., filed
`March 14, 2013, entitled “Antagonist Antibodies Directed Against
`Calcitonin Gene-Related Peptide and Methods Using Same”;
`abandoned January 9, 2014
`U.S. Provisional Patent Application No. 60/736,623, filed November
`14, 2005
`U.S. Patent Application No. 14/086,816 to Joerg Zeller et al., filed
`November 21, 2013, entitled “Methods of Treating Vasomotor
`Symptoms Using Antibodies”; issued as U.S. Patent No. 8,734,802 on
`May 27, 2014
`U.S. Patent Application No. 13/870,871 to Joerg Zeller et al., filed
`April 25, 2013, entitled “Antagonist Antibodies Directed Against
`Calcitonin Gene-Related Peptide and Methods Using Same”; issued as
`U.S. Patent No. 8,597,649 on December 3, 2013
`Patent-in-suit. U.S. Patent No. 9,884,907 to Joerg Zeller et al., issued
`February 6, 2018, entitled “Methods for Treating Headache Using
`Antagonist Antibodies Directed Against Calcitonin Gene-Related
`Peptide”; currently assigned to Teva Pharmaceuticals International
`GmbH
`Patent-in-suit. U.S. Patent No. 9,884,908 to Joerg Zeller et al., issued
`February 6, 2018, entitled “Methods for Treating Headache Using
`Antagonist Antibodies Directed Against Calcitonin Gene-Related
`Peptide”; currently assigned to Teva Pharmaceuticals International
`GmbH
`U.S. Patent Application No. 14/251,925 to Joerg Zeller et al., filed
`April 14, 2014, entitled “Antagonist Antibodies Directed Against
`Calcitonin Gene-Related Peptide and Methods Using Same”; issued as
`U.S. Patent No. 9,115,194 on August 25, 2015
`Appendix
`blood-brain barrier
`Transcript of deposition of expert Pamela Blake, M.D., FAHS, on
`behalf of Teva, dated January 10, 2022
`Responsive Expert Report of Andrew Blumenfeld, M.D. Regarding
`Validity, on behalf of Teva, served November 1, 2021
`emphasis added unless indicated otherwise
`Plaintiffs Teva Pharmaceuticals International GmbH And Teva
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 3 of 56
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`Charles Op.1
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`Charles Reply2
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`Charles Tr.
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`CSD
`ECF No.
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`Ex. __
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`Pharmaceuticals USA, Inc.’s Memorandum of Law in Support of
`Motion for Summary Judgment Regarding Inequitable Conduct and
`Unclean Hands (ECF No. 302); filed March 28, 2022
`Code of Federal Regulations
`C.F.R.
`calcitonin gene-related peptide
`CGRP
`Charles Declaration Declaration of Dr. Andrew Charles, in Support of Defendant Eli Lilly
`and Company’s Opposition to Plaintiffs’ Motion for Summary
`Judgment of No Inequitable Conduct and Unclean Hands, filed
`concurrently
`Opening Expert Report of Dr. Andrew Charles Regarding Invalidity of
`U.S. Patent Nos. 8,586,045, 9,884,907, and 9,884,908, on behalf of
`Lilly, served September 16, 2021
`Reply Expert Report of Dr. Andrew Charles Regarding Invalidity of
`U.S. Patent Nos. 8,586,045, 9,884,907, and 9,884,908, on behalf of
`Lilly, served December 7, 2021
`Transcript of deposition of expert Dr. Andrew Charles, defended by
`Lilly counsel, dated January 27, 2022
`cortical spreading depression
`Documents from the public docket filed through the CM/ECF system.
`Unless otherwise noted, citations are to the public docket of Case No.
`1:18-cv-12029-ADB, D. Mass.
`Exhibits to concurrently-filed Declaration of Emily Gabranski in
`Support of Defendant Eli Lilly and Company’s Opposition to
`Plaintiffs’ Motion for Summary Judgment of No Inequitable Conduct
`and Unclean Hands
`Declaration of Emily Gabranski in Support of Defendant Eli Lilly and
`Company’s Opposition to Plaintiffs’ Motion for Summary Judgment of
`No Inequitable Conduct and Unclean Hands, filed concurrently
`Transcript of deposition of fact witness Jeffery C. Giering, defended by
`Teva counsel, dated June 4, 2021.
`Responsive Expert Report of Geoffrey Hale, Ph.D., Regarding
`Validity, on behalf of Teva, served November 1, 2021
`Transcript of deposition of expert Geoffrey Hale, Ph.D., on behalf of
`Teva, dated January 25, 2022
`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, on behalf of
`Teva, served November 1, 2021
`Eli Lilly and Company’s Memorandum in Opposition to Plaintiffs’
`
`1 An excerpted copy of Charles Op. is included as Ex. A to the Gabranski Declaration. A full,
`unexcerpted copy is attached as Exhibit A to the Charles Declaration.
`2 An excerpted copy of Charles Reply is included as Ex. V to the Gabranski Declaration. A full,
`unexcerpted copy is attached as Exhibit B to the Charles Declaration.
`ii
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`Gabranski
`Declaration
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`Giering Tr.
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`Hale Resp.
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`Hale Tr.
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`Hill Reb.
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`McDonnell
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 4 of 56
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`Daubert Opp.
`
`McDonnell
`Declaration
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`McDonnell Op.3
`
`Motion to Exclude Certain Opinions of James M. McDonnell, Ph.D.,
`filed under seal on May 10, 2022
`Declaration of James M. McDonnell, Ph.D., in Support of Defendant
`Eli Lilly and Company’s Opposition to Plaintiffs’ Motion for Summary
`Judgment of No Inequitable Conduct and Unclean Hands, filed
`concurrently
`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, on
`behalf of Lilly, served September 16, 2021
`McDonnell Reply4 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, on
`behalf of Lilly, served December 7, 2021
`Transcript of deposition of expert James M. McDonnell, Ph.D., on
`behalf of Teva, dated January 7, 2022
`Manual of Patent Examining Procedure
`Transcript of deposition of Jaume Pons, Ph.D., named inventor of the
`patents-in-suit, dated August 20, 2021
`person of ordinary skill in the art
`Transcript of deposition of Kristian T. Poulsen, named inventor of the
`patents-in-suit, dated August 5, 2021
`Patent Trial and Appeal Board of the U.S. Patent and Trademark
`Office
`U.S. Patent and Trademark Office
`Request for Admission
`Transcript of deposition of Arnon Rosenthal, Ph.D., named inventor of
`the patents-in-suit, dated July 30, 2021
`Research Review Committee, Rinat
`Citation to paragraph number(s) of Lilly’s Responsive Local Rule 56.1
`Statement of Material Facts, served May 10, 2022
`Shaw et al., The effect of monoclonal antibodies to calcitonin gene-
`related peptide (CGRP) on CGRP-induced vasodilatation in pig
`coronary artery rings, 106 BR. J. PHARMACOL. 196-98 (1992)
`Citation to paragraph number(s) of one of Lilly’s Local Rule 56.1
`Statement of Facts, served March 28, 2022
`Lilly’s Supplemental Second Amended Answer and Affirmative
`Defenses To Plaintiffs’ Complaint (ECF No. 275), filed February 24,
`2022
`
`3 An excerpted copy of McDonnell Op. is included as Ex. B to the Gabranski Declaration. A full,
`unexcerpted copy is attached as Exhibit A to the McDonnell Declaration.
`4 An excerpted copy of McDonnell Reply is included as Ex. H to the Gabranski Declaration. A
`full, unexcerpted copy is attached as Exhibit B to the McDonnell Declaration.
`iii
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`McDonnell Tr.
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`MPEP
`Pons Tr.
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`POSA
`Poulsen Tr.
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`PTAB
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`PTO
`RFA
`Rosenthal Tr.
`
`RRC
`RSUMF
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`Shaw
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`SOF
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`SSAA
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 5 of 56
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`SUMF
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`Teva
`
`U.S.C.
`USPTO
`WSGR
`
`Citation to paragraph number(s) of Teva’s Local Rule 56.1 Statement
`of Material Facts, served March 28, 2022
`Plaintiffs Teva Pharmaceuticals International GmbH and Teva
`Pharmaceuticals USA, Inc.
`United States Code
`United States Patent and Trademark Office
`Wilson Sonsini Goodrich & Rosati
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`iv
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 6 of 56
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`Pursuant to Local Rule 56.1, Defendant Eli Lilly and Company (“Lilly”) submits the
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`following response to Plaintiffs’ Statement of Undisputed Material Facts in support of Plaintiffs’
`
`Motion for Summary Judgment of No Inequitable Conduct and Unclean Hands (ECF No. 303).
`
`Numerous items within Plaintiffs’ Statement of Undisputed Material Facts consist of argument,
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`characterizations, legal conclusions, statements or characterization of laws or rules, hypothetical
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`scenarios, or otherwise contain little or no factual matter. Lilly disputes any alleged fact unless it is
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`specifically undisputed below. Lilly further disputes the arguments Plaintiffs provide in their
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`headings and sub-headings but have not provided a separate response because Plaintiffs did not
`
`provide evidence in support.
`
`I. BACKGROUND
`
`1.
`U.S. Patent No. 8,586,045 (the “’045 patent”) is titled “Methods of Using Anti-
`CGRP Antagonist Antibodies.” Ex. 1.
`
`LILLY’S RESPONSE: Undisputed.
`
`2.
`Joerg Zeller, Kristian T. Poulsen, Yasmina Noubia Abdiche, Jaume Pons, Sierra Lee
`Jones Collier, and Arnon Rosenthal are named inventors of the ’045 patent. Ex. 1.
`
`LILLY’S RESPONSE: Undisputed.
`
`3.
`U.S. Patent No. 9,884,907 (the “’907 patent”) is titled “Methods for Treating
`Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide.” Ex. 2.
`
`LILLY’S RESPONSE: Undisputed.
`
`4.
`Joerg Zeller, Kristian T. Poulsen, Yasmina Noubia Abdiche, Jaume Pons, Sierra Lee
`Jones Collier, and Arnon Rosenthal are named inventors of the ’907 patent. Ex. 2.
`
`LILLY’S RESPONSE: Undisputed.
`
`5.
`U.S. Patent No. 9,884,908 (the “’908 patent”) is titled “Methods for Treating
`Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide.” Ex. 3.
`
`LILLY’S RESPONSE: Undisputed.
`
`6.
`Joerg Zeller, Kristian T. Poulsen, Yasmina Noubia Abdiche, Jaume Pons, Sierra Lee
`Jones Collier, and Arnon Rosenthal are named inventors of the ’908 patent. Ex. 3.
`
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`1
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 7 of 56
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`LILLY’S RESPONSE: Undisputed.
`
`7.
`U.S. Patent Nos. 8,586,045, 9,884,907, and 9,884,908 are the patents-in-suit in this
`litigation. Exs. 1–3.
`
`LILLY’S RESPONSE: Undisputed.
`
`8.
`The patent claims at issue in this case are directed to treating migraines by using
`antibodies that bind to the peptide calcitonin gene-related peptide (“CGRP”) and inhibit its
`function. See, e.g., Ex. 1 at 100:3–7 (claim 17).
`
`LILLY’S RESPONSE: Disputed. This statement provides a legal conclusion as opposed to
`
`a factual statement. As such, it cannot be put forth as an “undisputed fact.” At the outset, “CGRP” is
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`not a single “peptide”; it consists of alpha and beta isoforms in both humans and rats that have
`
`different amino acid sequences. Ex. A [Charles Op.] at ¶ 19; Ex. B [McDonnell Op.] at ¶ 75. Further,
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`all of the antibodies tested in the specification of the patents-in-suit bind only to the C-terminal end
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`of CGRP.
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`
`
`
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` The specification of the patents-in-suit
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`does not disclose any antibodies that bind to the middle-region or N-terminal end of CGRP.
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`
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`
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` However,
`
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`5 To the extent an exhibit was also cited in Lilly’s Second Supplemental Amended Answer (ECF
`No. 261), a parallel cite is provided to that version of the exhibit in brackets [SSAA, Ex. at __ ].
`2
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 8 of 56
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`while all of the antibodies tested for epitope binding in the patents-in-suit bind only to the C-terminal
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`end of CGRP, the patents-in-suit each contain claims to therapeutic methods using any and all human
`
`or humanized antibodies that bind to and antagonize CGRP, regardless of the region of CGRP to
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`which they bind and without any meaningful limitation as to the structure of such antibodies that
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`would confer the constellation of properties needed to obtain the therapeutic effects recited in the
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`claimed methods. Supplemental Second Amended Answer (“SSAA”), ECF No. 275 at ¶ 191; ECF
`
`No. 292, Ex. 1 [’045 patent] at Claims 17-21, 24, 27; ECF No. 292, Ex. 2 [’907 patent] at Claims 1,
`
`4-6, 15, 17; ECF No. 292, Ex. 3 [’908 patent] at Claims 1, 4-6, 15, 17. Further, several asserted claims
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`of the patents-in-suit are directed to treating conditions in addition to migraine. See ECF No. 291 at
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`SOF 201 (“Claim 19 depends from claim 17 and it recites that the headache treated is one of a specific
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`set of headache disorders”) (citing
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` ECF No. 292, Ex. 1 [’045 patent]; see also ECF No. 292, Ex. 2 [’907
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`patent] and ECF No. 292, Ex. 3 [’908 patent] (“A method for treating headache…).
`
`9.
`CGRP has three regions: an N-terminal region, a mid-region, and a C-terminal
`region. See Ex. 9 (Responsive Expert Report of Geoffrey Hale Regarding Validity, dated
`November 1, 2021) ¶ 112.
`
`LILLY’S RESPONSE: Undisputed. However, CGRP is sometimes described as having four
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`functional regions: (1) the N-terminal end required for receptor activation (amino acids 1-7); (2) the
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`mid-region that forms an α-helix and is involved in receptor binding (amino acids 8-18); (3) a hinge-
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`like region (amino acids 19-27); and (4) the C-terminal end, which is characterized by two bends and
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`is also involved in receptor binding (amino acids 28-37). ECF No. 291 at SOF 28 (citing ECF No.
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`292, Ex. 48 [Charles Op.] at ¶¶ 19, 20; ECF No. 292, Ex. 33 [Hill Reb.] at ¶ 45; ECF No. 292, Ex.
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`31 [Hale Resp.] at ¶¶ 110, 112).
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`10.
`The specification in the ’045 patent shows C-terminal antibodies that bind, but do
`not antagonize CGRP. Ex. 1 at 26:60–27:2; 51:5–28, 52:1–28.
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 9 of 56
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`LILLY’S RESPONSE: Undisputed. Like earlier applications in the priority chain (U.S.
`
`Provisional Patent Application No. 60/736,623 and PCT International Patent Application No.
`
`PCT/IB2006/003181), the patents-in-suit only describe antibodies that bind to the C-terminal end of
`
`CGRP. See, e.g., ECF No. 292, Ex. 1 [’045 patent] at 50:38-51:3, 67:16-51; SSAA at ¶ 235 (citing
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`SSAA, Ex. T at 193:2-14; SSAA, Ex. Q at 191:24-192:7; SSAA, Ex. Z at 91:6-8 (“[a]n epitope is
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`not something that you can rationally change once you have an antibody binding to a specific
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`place”)). The specification of the patents-in-suit describes a humanized anti-CGRP antagonist
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`antibody, referred to as Antibody G1 and later re-named fremanezumab. ECF No. 291 at SOF 145
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`(citing ECF No. 292, Ex. 1 [’045 patent] at Example 4;
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` The
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`most preferred embodiment, Antibody G1, binds to the C-terminal end of CGRP and makes no
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`contact to other regions of CGRP. See, e.g., ECF No. 292, Ex. 1 [’045 patent] at 67:16-51; SSAA at
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`¶ 235 (citing SSAA, Ex. AQ at 85:19-87:23; SSAA, Ex. AR at TEVA_FREM_000076652). The
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`patents-in-suit provide no information about antibodies that bind to the N-terminal region or mid-
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`region of CGRP. See, e.g.,
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`specific human anti-CGRP antagonist antibody. ECF No. 291 at SOF 169
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`
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` The specification does not disclose any
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`II. LILLY’S INEQUITABLE CONDUCT THEORIES
`
`11.
`Lilly’s amended counterclaims assert two counts of inequitable conduct. Lilly’s
`Supplemental Second Amended Answer, Dkt No. 275 (“SSAA”) ¶¶ 139–84, 187–287.
`
`
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`4
`HIGHLY CONFIDENTIAL ‒ OUTSIDE COUNSEL ONLY
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 10 of 56
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`LILLY’S RESPONSE: Undisputed. Lilly’s SSAA also asserts a counterclaim directed to
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`unenforceability due to unclean hands. SSAA at Counterclaim XX.
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`12.
`Lilly’s first counterclaim for inequitable conduct alleges that an unspecified person
`committed inequitable conduct relating to the filing of three Petitions to Accept An Unintentionally
`Delayed Priority Claim Under 35 U.S.C. § 120. SSAA, Count XIX.
`
`LILLY’S RESPONSE: Disputed. Lilly’s first counterclaim for inequitable conduct inter
`
`alia specifies that during the prosecution of at least the applications leading to the ’907 and ’908
`
`patents, “attorneys at Wilson Sonsini Goodrich & Rosati, including, Adam J. Cole ([former] patent
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`agent [and current associate] at Wilson Sonsini Goodrich & Rosati), and Jeffery C. Giering (former
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`patent attorney at Wilson Sonsini Goodrich & Rosati)” intentionally failed to fulfill their duty of
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`candor and good faith toward the U.S. Patent & Trademark Office.” SSAA at ¶ 141; see also at ¶¶
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`168-72. Acknowledging this, Teva focuses its arguments on Messrs. Cole and Giering in its motion.
`
`(Br. at 19-20.)
`
`13.
`
`Lilly’s second counterclaim for inequitable conduct alleges that named inventors
` committed inequitable conduct by failing to disclose to the U.S. Patent and
`Trademark Office (“PTO”) prior art literature they were allegedly aware of, The effect of
`monoclonal antibodies to calcitonin gene-related peptide (CGRP) on CGRP-induced
`vasodilatation in pig coronary artery rings, 106 Br. J. Pharmacol. 196-198 (1992) (“Shaw” or “the
`Shaw reference”), that allegedly demonstrated that a monoclonal antibody binding to the mid-
`region of CGRP failed to block CGRP and instead enhanced its effects. E.g., SSAA ¶ 192; Ex. 11
`(Shaw).
`
`LILLY’S RESPONSE: Disputed. The allegations in Lilly’s second counterclaim related to
`
`the inequitable conduct committed by named inventors
`
` relating to the Shaw
`
`reference are set forth in detail in Lilly’s SSAA at ¶¶ 192, 195, 197, 221-225 and 258-262, and are
`
`incorporated herein by reference in their entirety. Lilly’s second counterclaim for inequitable conduct
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`inter alia specifies that before the filing of the ’623 provisional application to which all of the patents-
`
`in-suit purport to claim priority, and continuing throughout prosecution of the applications that issued
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`as the patents-in-suit,
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` was aware of Shaw (ECF No. 296, Ex. 59 [Zeller Ex. 29] [SSAA,
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`5
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 11 of 56
`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 11 of 56
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`Ex. E]) clearly demonstrating that a monoclonal antibody binding the mid-region of CGRP “‘fail[ed]
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`to block and even enhanc[ed]
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`the action of CGRP.” See, e.g., Po
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`In email correspondence dated April 16, 2005, seven months before the earliest priority date
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`ofany patent-in-suit, named inventorsec
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`I 11:20” which
`P| confirmed was Shaw, also contained additional information confirming that effective
`binding to the N-terminal end of CGRP did not equate with a blocking effect.Po
`Po Shaw taught that the CGRP-blocking effect was highly variable and
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`unpredictable and that no mid-region binder evaluated therein blocked CGRP activity. ECF No. 296,
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`Ex. 59 [Zeller Ex. 29] [SSAA,Ex.E].
`
`Lilly also alleges that
`14.
`to disclose to the PTO
`
`
`
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`committed inequitable conduct by failing
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`LILLY’S RESPONSE: Disputed. The allegations in Lilly’s second counterclaim related to
`
`the inequitable conduct committed by named inventorsPo relating to thea
`GE 2x¢ set forth in detail in Lilly’s SSAA at J 193, 195, 197, 207-220, 226-236,
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`256-258, and 261-262 and are incorporated herein by reference in their entirety. Lilly’s second
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`counterclaim for inequitable conductinteralia specifies that from the November2, 2006,filing of a
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`separate PCT patent application coauthored by named inventorsa. to whichall of
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`6
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 12 of 56
`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 12 of 56
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`the patents-in-suit purport
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`to claim priority, and continuing throughout prosecution of the
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`applications that issued as the ’045, ’907, and ’908 patents,P| repeatedly reported to||
`including|| that a hadtried but failed to obtain antibodies that bound to the N-
`terminal end or mid-region of CGRP andeffectively antagonized CGRP. For example, in 2005, a
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`experimented with polyclonal antibodies that bound different regions of CGRP. None were
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`abe to block the effets ofCGR
`
`with those polyclonal
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`antibodies were not disclosed in the ’623 provisional application filed in November 2005. Nor were
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`they disclosed in the November 2006 PCT Application, which led to the patents-in-suit. In addition,
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`also sought to make monoclonal antibodies that bound different regions of
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`CGRP.
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`Lilly also alleges that
`15.
`to disclose to the PTO
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`
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`committed inequitable conduct by
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`failing
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`LILLY’S RESPONSE: Disputed. The allegations in Lilly’s second counterclaim related to
`
`the inequitable conduct committed by namedinventorsPo as it relates toa
`|| are set forth in detail in Lilly’s SSAA at §§ 198 and 264-287, and are incorporated herein by
`
`reference in their entirety. Lilly’s second counterclaim for inequitable conduct infer alia specifies
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`thatee withheld evidence in their possession during
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`7
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 13 of 56
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`prosecution of each of the patents-in-suit demonstrating the failure of an anti-CGRP antagonist
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`antibody to induce central nervous system effects (i.e., inside the blood brain barrier) in a preferred
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`in vivo assay for evaluating the central aspect of migraine pathophysiology,
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` See
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`SSAA at ¶¶ 198, 279-280.
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`III. EXPERT OPINION AND FACT TESTIMONY REGARDING LILLY’S FIRST
`COUNTERCLAIM FOR INEQUITABLE CONDUCT
`
`16.
`The law firm Wilson Sonsini Goodrich & Rosati, including Drs. Adam Cole and
`Jeffrey Giering, participated in prosecution of the patents-in-suit. See, e.g., Ex. 19 (deposition
`transcript of Jeffrey Giering, dated June 4, 2021) at 143:10–144:5; Exs. 20–22 (Giering Dep. Exs.
`15, 20, 21).
`
`LILLY’S RESPONSE: Undisputed. However, Lilly notes that the cited Ex. 22 (Giering
`
`Dep. Ex. 21) is not a Petition Under 37 C.F.R. § 1.78 to Accept an Unintentionally Delayed Priority
`
`Claim Under 35 U.S.C. §§ 120, 121 and 365(c). It is a certified file history of U.S. Patent No.
`
`9,115,194. The proper cite should be to Giering Dep. Ex. 22 (Ex. AK), which was not included as an
`
`exhibit to Teva’s motion. See ECF No. 304 (Declaration of Elaine Herrmann Blais in Support of
`
`Plaintiffs’ Motion for Summary Judgment of No Inequitable Conduct and Unclean Hands).
`
`17.
`During prosecution, Dr. Cole signed three Petitions Under 37 C.F.R. § 1.78 to
`Accept An Unintentionally Delayed Priority Claim Under 35 U.S.C. §§ 120, 121 and 365(c)—
`dated January 15, 2015; April 1, 2015; and June 16, 2015—stating that the “entire delay” in making
`a priority claim was “unintentional.” See Exs. 20–22.
`
`LILLY’S RESPONSE: Undisputed. However, Lilly notes that the cited Ex. 22 (Giering
`
`Dep. Ex. 21) is not a Petition Under 37 C.F.R. § 1.78 to Accept an Unintentionally Delayed Priority
`
`Claim Under 35 U.S.C. §§ 120, 121 and 365(c). It is a certified file history of U.S. Patent No.
`
`9,115,194. The proper cite should be to Giering Dep. Ex. 22 (Ex. AK), which was not included as an
`
`exhibit to Teva’s motion. See ECF No. 304 (Declaration of Elaine Herrmann Blais in Support of
`
`Plaintiffs’ Motion for Summary Judgment of No Inequitable Conduct and Unclean Hands).
`
`18.
`Dr. Giering’s name appeared in the signature block of those Petitions, but he did not
`sign them. See Exs. 20–22.
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 14 of 56
`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 14 of 56
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`LILLY’S RESPONSE: Disputed. Inclusion of Dr. Giering’s name and USPTO Registration
`
`Numberin the signature block of the three Petitions Under 37 C.F.R. § 1.78 to Accept An
`
`Unintentionally Delayed Priority Claim Under 35 U.S.C. §§ 120, 121 and 365(c)—dated January 15,
`
`2015; April 1, 2015; and June 16, 2015, along with the fact (undisputed by Teva, see SUMF16) that
`
`Dr. Giering was an attorney employed at the same law firm as Dr. Cole (WSGR),indicates that Dr.
`
`Giering at the very least reviewed those Petitions. See, e.g., Ex. F [Giering Tr.] at 144:11-20. a
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`Again, Lilly notes that the cited Ex. 22 (Giering Dep. Ex. 21) is not a Petition Under 37 C.F.R.
`
`§ 1.78 to Accept an Unintentionally Delayed Priority Claim Under 35 U.S.C. §§ 120, 121 and 365(c).
`
`It is a certified file history of U.S. Patent No. 9,115,194. The propercite should be to Giering Dep.
`
`Ex. 22 (Ex. AK), which was not included as an exhibit to Teva’s motion. See ECF No. 304
`
`(Declaration of Elaine Herrmann Blais in Support of Plaintiffs’ Motion for Summary Judgment of
`
`No Inequitable Conduct and Unclean Hands).
`
`19.
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`Lilly did not depose Dr. Cole.
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`LILLY’S RESPONSE: Undisputed. Lilly did, however, depose Dr. Gierne
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`9
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 15 of 56
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`
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`LILLY’S RESPONSE: Disputed. Teva’s
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`summary of Dr. Giering’s
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`testimony
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`mischaracterizes Dr. Giering’s testimony.
`
`If
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`your name appeared inthe signature block, would it have been
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`21.—Dr. Giering did not believe that that the statements in the Petitions that the “entire
`delay” was “unintentional” werefalse.Po
`
`LILLY’S RESPONSE: Disputed. Teva’s excerpted and strung together quotations
`
`mischaracterize Dr. Giering’s testimony. At his depositioninthis case,
`
`_ o
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 16 of 56
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`
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`IV. EXPERT OPINION AND FACT TESTIMONY REGARDING ALLEGEDLY
`OMITTED DATA AND REFERENCES
`
`22.
`The ’045 Patent includes data on antibodies that bind to CGRP but do not block its
`effects. See Ex. 1 at 51:5–28, 52:1–27 (Tables 2 and 3).
`
`LILLY’S RESPONSE: Undisputed. However, all of the antibodies tested in the
`
`specification of the patents-in-suit bind to the C-terminal end of CGRP. ECF No. 291 at SOF 159
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`(citing
`
`
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`
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` The specification of the patents-in-suit does not disclose any antibodies that
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`bind to the middle-region or N-terminal end of CGRP. ECF No. 291 at SOF 164 (citing
`
`
`
`
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`
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`3), there is very limited in vitro data provided in the specification of the ’045 patent. ECF No. 291 at
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`SOF 152, 158 (“The specification of the Patents-in-Suit does not report in vitro or in vivo experiments
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` Further, even with Example 1 (Tables 2 and
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`evaluating the ability of antibodies M1-M84 to inhibit CGRP biological activity.”) (citing
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`11
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 17 of 56
`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 17 of 56
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`23.
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`Lilly did not serve any expert reports on PTO practice or procedure.
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`LILLY’S RESPONSE: Undisputed. However, Lilly served technical expert reports from
`
`Dr. James McDonnell and Dr. Andrew Charles analyzing the patents-in-suit, relevant prosecution
`
`history, and priorart based on their expertise, which support Lilly’s inequitable conduct allegations
`
`Lilly did not serve any expert report that provided an opinion that any of the claims
`24.
`in the patent would not have issued had Shaw,
`
`been provided to the PTO.
`
`LILLY’S RESPONSE: Undisputed. However, Lilly served technical expert reports from
`
`Dr. James McDonnell and Dr. Andrew Charles analyzing the patents-in-suit, relevant prosecution
`
`history, and priorart based on their expertise, which support Lilly’s inequitable conduct allegations
`
` Ex. 17 (deposition transcript of James McDonnell, dated January 7,
`
`
`
`2022) at 151:5—10.
`
`LILLY’S RESPONSE: Undisputed. However, Teva’s excerpted quotations mischaracterize
`
`Dr. MeDonne!'s opnins,
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`12
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 18 of 56
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`With regard tof| Dr. McDonnell explained that
`
`With regard to Shaw, Dr. McDonnell opinedthat
`
`Dr. McDonnellis not an attorney, legal expert, or patent examiner, and thus properly refrained
`
`from stepping into the shoes of the PTO in forming anultimate opinion on“but-for” materiality. By
`
`contrast, even though Dr. Hale is not an attorney, legal expert, or patent examiner (Ex. AL [Hale
`
`Resp.] at §§ 4-12), he did speculate on what a patent examiner would or would not have done. To the
`
`extent the parties’ experts disagree onthis topic, that is a factual issue to be exploredattrial.
`
`26.
`
`Dr. McDonnell testified during his deposition that
`
`LILLY’S RESPONSE: Undisputed. However, Teva’s excerpted quotations mischaracterize
`
`13
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`

`

`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 19 of 56
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`With regard to I) Dr.McDor!
`
`With regard to Shaw, Dr. McDonnell opinedthat
`
`Dr. McDonnellis not an attorney, legal expert, or patent examiner, and thus properly refrained
`
`from stepping into the shoes of the PTO in forming anultimate opinion on“but-for” materiality. By
`
`contrast, even though Dr. Hale is not an attorney, legal expert, or patent examiner (Ex. AL [Hale
`
`Resp.] at §§ 4-12), he did speculate on what a patent examiner would have done. To the extent the
`
`patties’ experts disagree on this topic, that is a factual issue to be exploredat trial.
`
`Dr. McDonnell did not consider whether Shaw and
`27.
`was cumulative of information disclosed to the PTO.
`
`LILLY’S RESPONSE: Disputed. Teva’s
`
`excerpted citations muscharacterize Dr.
`
`McDonnell’s testimony. Dr. McDonnell opinedthat
`
`That
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`14
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`

`
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 20 of 56
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`antibody, referred to as MAb C4.19, was reported in a journal article called Tan 1995 (Ex. V to
`
`McDonnell Daubert Opp., concurrently filed). While Tan 1995 was submitted to the USPTO, it does
`
`not identify what region of CGRP is bound by MAb C4.19. Instead, that was reported in a doctoral
`
`thesis that the named inventors did not submit to the USPTO. See ECF No. 292, Ex. 1 [’045 patent]
`
`at 2 (listing, inter alia, Tan 1995); Ex. B [McDonnell Op.] at ¶ 123, n. 8. As Dr. McDonnell explained,
`
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`15
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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 21 of 56
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`Further, Dr. McDonnellis not an attorney, legal expert, or patent examiner. He thus properly
`
`refrained from stepping into the shoes of the PTO in forming an ultimate opinion on “but-for”
`
`materiality, as Teva’s expert Dr. Hale has done in opining on whetheror not the examiner would
`
`have found that Shaw and the non-C-terminal PF was “cumulative to the information
`
`disclosed to the PTO.” To the extent the parties’ experts disagree onthis topic, that is a factual issue
`
`to be exploredattrial.
`
`28.
`
`Lilly’s expert Dr. Charles opined in his report that
`
`LILLY’S RESPONSE: Undisputed. However, Teva’s excerpted quotations mischaracterize
`
`Dr. Charles’s opinions. Dr. Charlestestified that
`
`—_ On
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`

`

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`Case 1:18-cv-12029-ADB Document 349 Filed 05/10/22 Page 22 of 56
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`
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`Dr. Charles is not an attorney, legal expert, or patent examiner, and thus chose not to speculate
`
`on what a patent examiner would have considered “but-for” material. By contrast, even though Dr.
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`Hill is not an attorney, legal expert, or patent examiner (Ex. Y [Hill Reb.] at ¶¶ 2-22), he did speculate
`
`on what a patent examiner would or would not have done. To the extent the parties’ experts disagree
`
`on this topic, that is a factual issue to be explored at trial.
`
`In addition, Teva sponsored a study testing fremanezumab in a
`
` years after the
`
`patents-in-suit were filed and boasted it was the “first study” to test effects of anti-CGRP antibodies.
`
`Ex. J [Melo-Carrillo 2017(a)] at 7159; see also id. at 7161 (“first demonstration”).
`
`29.
` disclosed the Shaw reference during prosecution of the ’907
`The
`and ’908 patents. Ex. 4 (Certified File History of U.S. Patent No. 9,884,907) at
`TEVA_FREM_000052797; Ex. 5 (Certified File History of U.S. Patent No. 9,884,908) at
`TEVA_FREM_000025387.
`
`LILLY’S RESPONSE: Disputed. While the Shaw reference was submitted to the PTO
`
`during prosecution of the ’907 and ’908 patents, it was buried in a list of more than 400 other
`
`references without mention of its significance and was not discussed by the Examiner during
`
`prosecution of the ’907 and ’908 patents. See infra, RSUMF 63-65; SSAA at ¶¶ 196, 224. The MPEP
`
`discourages Applicants from submitt