Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 1 of 62
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`
`
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH and
`TEVA PHARMACEUTICALS
`USA, INC.,
`
`
`Plaintiffs,
`
`
`Civil Action No.
`1:18-cv-12029-ADB
`
`
`
`
`
`
`
`FILED UNDER SEAL
`LEAVE TO FILE GRANTED
`06/06/2022 (ECF NO. 385)
`
`
`
`v.
`
`ELI LILLY AND COMPANY,
`
`
`Defendant.
`
`
`
`
`
`
`
`
`
`L.R. 56.1 REPLY STATEMENT OF MATERIAL FACTS IN SUPPORT OF
`PLAINTIFFS’ MOTION FOR SUMMARY JUDGMENT OF
`NO INEQUITABLE CONDUCT AND UNCLEAN HANDS
`
`
`
`

`

`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 2 of 62
`
`
`
`TABLE OF CONTENTS
`
`
`TABLE OF ABBREVIATIONS .................................................................................................... ii
`PLAINTIFF’S PRELIMINARY STATEMENT ............................................................................ 1
`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 ........................................ 2
`I.
`BACKGROUND .................................................................................................... 2
`II.
`LILLY’S INEQUITABLE CONDUCT THEORIES ............................................. 6
`III.
`EXPERT OPINION AND FACT TESTIMONY REGARDING LILLY’S FIRST
`COUNTERCLAIM FOR INEQUITABLE CONDUCT ........................................ 9
`EXPERT OPINION AND FACT TESTIMONY REGARDING ALLEGEDLY
` AND REFERENCES ............................................................. 12
`PLAINTIFFS’ REPLY TO DEFENDANT’S ADDITIONAL LR 56.1 STATEMENT OF
`UNDISPUTED MATERIAL FACTS IN SUPPORT OF ITS OPPOSITION TO PLAINTIFFS’
`MOTION FOR SUMMARY JUDGMENT OF NO INEQUITABLE CONDUCT AND
`UNCLEAN HANDS ..................................................................................................................... 43
`I.
`BACKGROUND .................................................................................................. 43
`II.
`INEQUITABLE CONDUCT OF
`
`(COUNTERCLAIM XXI) .................................................................................... 43
`INEQUITABLE CONDUCT AND UNCLEAN HANDS OF PATENT
`PROSECUTORS COLE AND GIERING (COUNTERCLAIMS XIX-XX) ....... 48
`
`IV.
`
`III.
`
`
`
`
`
`
`i
`
`

`

`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 3 of 62
`
`TABLE OF ABBREVIATIONS
`
`
`
`Abbreviation
`’045 patent
`
`’907 patent
`
`’908 patent
`
`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
`’394 application 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,
`’623 provisional
`2005
`application
`’816 application 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
`’871 application 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
`’925 application 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
`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
`
`App’x
`BBB
`Blake Tr.
`
`Blumenfeld
`Resp.
`Bold and
`i
`li i d
`
`Br.
`
`ii
`
`

`

`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 4 of 62
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`
`
`Abbreviation
`C.F.R.
`CGRP
`Charles
`
`D l
`ti
`Charles Op.1
`
`Charles Tr.
`
`CSD
`ECF No.
`
`Ex. __
`
`Description
`Code of Federal Regulations
`calcitonin gene-related peptide
`Declaration of Dr. Andrew Charles, in Support of Defendant Eli Lilly and
`C
`’ O
`iti
` t Pl i tiff ’ M ti
` f
` S
` J d
`t f N
`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
`Charles Reply2 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’ Motion
`for Summary Judgment Regarding Inequitable Conduct and Unclean Hands
`(ECF No. 348)
`Eli Lilly and Company’s Memorandum in Opposition to Plaintiffs’ Motion
`to Exclude Certain Opinions of James M. McDonnell, Ph.D., filed under seal
`on May 10, 2022
`
`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.
`
`Gabranski
`Declaration
`
`Giering Tr.
`
`Hale Resp.
`
`Hale Tr.
`
`Hill Reb.
`
`Lilly’s
`Opposition or
`Opp.
`McDonnell
`Daubert Opp.
`
`iii
`
`

`

`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 5 of 62
`
`
`
`Abbreviation
`McDonnell
`Declaration
`
`Description
`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
`McDonnell Op.3 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
`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
`McDonnell Tr. Transcript of deposition of expert James M. McDonnell, Ph.D., on behalf of
`Teva, dated January 7, 2022
`
`McDonnell
`Reply4
`
`MPEP
`Pons Tr.
`
`POSA
`Poulsen Tr.
`
`PTAB
`PTO
`RFA
`Rosenthal Tr.
`
`RRC
`RSUMF
`
`Shaw
`
`SOF
`
`SSAA
`
`SUMF
`
`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
`Citation to paragraph number(s) of Teva’s Local Rule 56.1 Statement of
`Material Facts, served March 28, 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.
`
`iv
`
`

`

`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 6 of 62
`
`
`
`Abbreviation
`Teva
`
`U.S.C.
`USPTO
`WSGR
`
`Description
`Plaintiffs Teva Pharmaceuticals International GmbH and Teva
`Pharmaceuticals USA, Inc.
`United States Code
`United States Patent and Trademark Office
`Wilson Sonsini Goodrich & Rosati
`
`v
`
`

`

`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 7 of 62
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`
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`PLAINTIFF’S PRELIMINARY STATEMENT
`
`Plaintiffs Teva Pharmaceuticals International GMBG and Teva Pharmaceuticals USA, Inc.
`
`(collectively, “Teva” or “Plaintiffs”) submit this Reply Statement of Material Facts in Support of
`
`Plaintiffs’ Motion for Summary Judgment of No Inequitable Conduct or Unclean Hands in reply
`
`to Lilly’s Response (ECF No. 349) to Plaintiffs’ Statement of Undisputed Material Facts in
`
`Support of Plaintiffs’ Motion for Summary Judgment Regarding Judicial Estoppel (ECF No. 303).
`
`This document collects, in a single document:
`
`1. Plaintiffs’ Local Rule 56.1 statement of undisputed material facts in support of
`Plaintiffs’ Motion for Summary Judgment of No Inequitable Conduct and Unclean
`Hands (ECF No. 303);
`
`2. Lilly’s response to each paragraph of Teva’s Local Rule 56.1 statement;
`
`3. Lilly’s Local Rule 56.1 statement of additional undisputed material facts in support
`of Lilly’s Opposition to Teva’s Motion (ECF No. 349); and
`
`4. Teva’s response to each paragraph of Lilly’s Local Rule 56.1 statement.
`
`Lilly indicated there may be a waiver issue if the parties did not respond to facts introduced
`
`in the opposition briefing round. Teva disagrees, but out of an abundance of caution, Teva
`
`provides responses to Lilly’s additional facts below.
`
`To clarify, the parties submit respective statements of facts as follows:
`
`Paragraphs
`1 – 57
`
`58 – 91
`
`Party’s Statement
`Teva’s Statement of Undisputed Material Facts in Support of Plaintiffs’ Motion
`for Summary Judgment of No Inequitable Conduct and Unclean Hands
`Lilly’s Additional Statement of Undisputed Material Facts in Support of Its
`Opposition to Teva’s Motion for Summary Judgment of No Inequitable Conduct
`and Unclean Hands
`
`For the Court’s convenience, the other party’s responsive statement for each numbered
`
`paragraph immediately follows each paragraph.
`
`
`
`1
`
`

`

`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 8 of 62
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`
`
`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
`
`Pursuant to Local Rule 56.1, Defendant Eli Lilly and Company (“Lilly”) submits the
`
`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,
`
`characterizations, legal conclusions, statements or characterization of laws or rules, hypothetical
`
`scenarios, or otherwise contain little or no factual matter. Lilly disputes any alleged fact unless it
`
`is specifically undisputed below. Lilly further disputes the arguments Plaintiffs provide in their
`
`headings and sub-headings but have not provided a separate response because Plaintiffs did not
`
`provide evidence in support.
`
`I.
`
`BACKGROUND
`
`U.S. Patent No. 8,586,045 (the “’045 patent”) is titled “Methods of Using Anti-
`1.
`CGRP Antagonist Antibodies.” Ex. 1.
`
`LILLY’S RESPONSE: Undisputed.
`
`Joerg Zeller, Kristian T. Poulsen, Yasmina Noubia Abdiche, Jaume Pons, Sierra
`2.
`Lee Jones Collier, and Arnon Rosenthal are named inventors of the ’045 patent. Ex. 1.
`
`LILLY’S RESPONSE: Undisputed.
`
`U.S. Patent No. 9,884,907 (the “’907 patent”) is titled “Methods for Treating
`3.
`Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide.” Ex.
`2.
`
`LILLY’S RESPONSE: Undisputed.
`
`Joerg Zeller, Kristian T. Poulsen, Yasmina Noubia Abdiche, Jaume Pons, Sierra
`4.
`Lee Jones Collier, and Arnon Rosenthal are named inventors of the ’907 patent. Ex. 2.
`
`LILLY’S RESPONSE: Undisputed.
`
`2
`
`

`

`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 9 of 62
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`
`
`U.S. Patent No. 9,884,908 (the “’908 patent”) is titled “Methods for Treating
`5.
`Headache Using Antagonist Antibodies Directed Against Calcitonin Gene-Related Peptide.” Ex.
`3.
`
`LILLY’S RESPONSE: Undisputed.
`
`Joerg Zeller, Kristian T. Poulsen, Yasmina Noubia Abdiche, Jaume Pons, Sierra
`6.
`Lee Jones Collier, and Arnon Rosenthal are named inventors of the ’908 patent. Ex. 3.
`
`LILLY’S RESPONSE: Undisputed.
`
`U.S. Patent Nos. 8,586,045, 9,884,907, and 9,884,908 are the patents-in-suit in this
`7.
`litigation. Exs. 1–3.
`
`LILLY’S RESPONSE: Undisputed.
`
`The patent claims at issue in this case are directed to treating migraines by using
`8.
`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 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, all of the antibodies tested in the specification of the patents-in-suit bind only to the
`
`C-terminal end of CGRP.
`
`
`
`
`
`
`
`
`
`
`
`
`
` The specification
`
`
`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 __ ].
`
`3
`
`

`

`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 10 of 62
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`
`
`of the patents-in-suit does not disclose any antibodies that bind to the middle-region or N-terminal
`
`end of CGRP.
`
`
`
`However, while all of the antibodies tested for epitope binding in the patents-in-suit bind
`
`only to the C-terminal 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 which they bind and without any meaningful limitation as to the structure of
`
`such antibodies that would confer the constellation of properties needed to obtain the therapeutic
`
`effects recited in the 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 of the patents-in-suit are directed to treating conditions in addition to migraine.
`
`See ECF No. 291 at SOF 201 (“Claim 19 depends from claim 17 and it recites that the headache
`
`treated is one of a specific set of headache disorders”) (citing
`
`
`
`ECF No. 292, Ex. 2 [’907 patent] and ECF No. 292, Ex. 3 [’908 patent] (“A method for treating
`
`ECF No. 292, Ex. 1 [’045 patent]; see also
`
`headache...).
`
`CGRP has three regions: an N-terminal region, a mid-region, and a C-terminal
`9.
`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 functional regions: (1) the N-terminal end required for receptor activation (amino acids 1-7);
`
`(2) the mid-region that forms an α-helix and is involved in receptor binding (amino acids 8-18);
`
`(3) a hingelike region (amino acids 19-27); and (4) the C-terminal end, which is characterized by
`
`4
`
`

`

`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 11 of 62
`
`
`
`two bends and is also involved in receptor binding (amino acids 28-37). ECF No. 291 at SOF 28
`
`(citing
`
`
`
`).
`
`The specification in the ’045 patent shows C-terminal antibodies that bind, but do
`10.
`not antagonize CGRP. Ex. 1 at 26:60–27:2; 51:5–28, 52:1–28.
`
`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 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 not something that you can rationally change once you have an antibody binding to a
`
`specific place”)). The specification of the patents-in-suit describes a humanized anti-CGRP
`
`antagonist antibody, referred to as Antibody G1 and later re-named fremanezumab. ECF No. 291
`
`at SOF 145 (citing ECF No. 292, Ex. 1 [’045 patent] at Example 4;
`
`
`
`
`
`). The most preferred embodiment, Antibody G1, binds to the C-terminal end of CGRP
`
`and makes no contact to other regions of CGRP. See, e.g., ECF No. 292, Ex. 1 [’045 patent] at
`
`67:16-51; SSAA at ¶ 235 (citing SSAA, Ex. AQ at 85:19-87:23; SSAA, Ex. AR at
`
`TEVA_FREM_000076652). The patents-in-suit provide no information about antibodies that bind
`
`to the N-terminal region or mid-region of CGRP. See, e.g.,
`
`5
`
`
`
`
`
`
`
`
`
`

`

`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 12 of 62
`
`
`
`). The specification does not disclose any specific human anti-CGRP antagonist
`
`antibody. ECF No. 291 at SOF 169 (citing
`
`
`
`II.
`
`LILLY’S INEQUITABLE CONDUCT THEORIES
`
`).
`
`Lilly’s amended counterclaims assert two counts of inequitable conduct. Lilly’s
`11.
`Supplemental Second Amended Answer, Dkt No. 275 (“SSAA”) ¶¶ 139–84, 187–287.
`
`LILLY’S RESPONSE: Undisputed. Lilly’s SSAA also asserts a counterclaim directed to
`
`unenforceability due to unclean hands. SSAA at Counterclaim XX.
`
`Lilly’s first counterclaim for inequitable conduct alleges that an unspecified person
`12.
`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
`
`agent [and current associate] at Wilson Sonsini Goodrich & Rosati), and Jeffery C. Giering (former
`
`patent attorney at Wilson Sonsini Goodrich & Rosati)” intentionally failed to fulfill their duty of
`
`candor and good faith toward the U.S. Patent & Trademark Office.” SSAA at ¶ 141; see also at ¶¶
`
`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
`
`6
`
`

`

`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 13 of 62
`
`
`
`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 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 as the patents-in-suit,
`
` was aware of Shaw (ECF No. 296, Ex. 59
`
`[Zeller Ex. 29] [SSAA, Ex. E]) clearly demonstrating that a monoclonal antibody binding the mid-
`
`region of CGRP “fail[ed] to block and even enhanc[ed] the action of CGRP.” See, e.g.,
`
`
`
`
`
`
`
`In email correspondence dated April 16, 2005, seven months before the earliest priority
`
`.).
`
`date of any patent-in-suit, named inventor
`
` stated:
`
`
`
`
`
`
`
` That
`
`“literature,” which
`
` 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.
`
`. Shaw taught that the CGRP-blocking effect
`
`was highly variable and unpredictable and that no mid-region binder evaluated therein blocked
`
`CGRP activity. ECF No. 296, Ex. 59 [Zeller Ex. 29] [SSAA, Ex. E].
`
`Lilly also alleges that
`14.
`failing to disclose to the PTO
`
` committed inequitable conduct by
`
`
`
`
`E.g., SSAA¶ 193.
`
`7
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`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 14 of 62
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`
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`LILLY’S RESPONSE: Disputed. The allegations in Lilly’s second counterclaim related
`
`to the inequitable conduct committed by named inventors
`
` relating to
`
` are set forth in detail in Lilly’s SSAA at ¶¶ 193, 195, 197, 207-220, 226-
`
`236, 256-258, and 261-262 and are incorporated herein by reference in their entirety. Lilly’s
`
`second counterclaim for inequitable conduct inter alia specifies that from the November 2, 2006,
`
`filing of a separate PCT patent application coauthored by named inventors
`
`,
`
`to which all of the patents-in-suit purport to claim priority, and continuing throughout prosecution
`
`of the applications that issued as the ’045, ’907, and ’908 patents,
`
` repeatedly reported
`
`to
`
`, including
`
`, that
`
` had tried but failed to obtain antibodies that bound
`
`to the N-terminal end or mid-region of CGRP and effectively antagonized CGRP. For example, in
`
`2005,
`
` experimented with polyclonal antibodies that bound different regions of CGRP.
`
`None were able to block the effects of CGRP.
`
`
`
`
`
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`
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`
`
`
`
`
`
`
`
` The results of
`
` with those polyclonal antibodies were not disclosed in the ’623 provisional
`
`application filed in November 2005. Nor were they disclosed in the November 2006 PCT
`
`Application, which led to the patents-in-suit. In addition,
`
` also sought to
`
`make monoclonal antibodies that bound different regions of CGRP.
`
`
`
`
`
`
`
`
`
`Lilly also alleges that
`15.
`failing to disclose to the PTO
`
` committed inequitable conduct by
`-
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`
`
`8
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`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 15 of 62
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` E.g., SSAA¶ 198.
`
`
`
`
`
`LILLY’S RESPONSE: Disputed. The allegations in Lilly’s second counterclaim related
`
`to the inequitable conduct committed by named inventors
`
` as it relates to
`
`
`
` 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 inter alia
`
`specifies that
`
`s withheld evidence in their possession
`
`during prosecution of each of the patents-in-suit demonstrating the failure of an anti-CGRP
`
`antagonist antibody to induce central nervous system effects (i.e., inside the blood brain barrier)
`
`in a preferred in vivo assay for evaluating the central aspect of migraine pathophysiology,
`
`
`
`. See SSAA at ¶¶ 198, 279-280.
`
`III.
`
`EXPERT OPINION AND FACT TESTIMONY REGARDING LILLY’S FIRST
`COUNTERCLAIM FOR INEQUITABLE CONDUCT
`
`The law firm Wilson Sonsini Goodrich & Rosati, including Drs. Adam Cole and
`16.
`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).
`
`During prosecution, Dr. Cole signed three Petitions Under 37 C.F.R. § 1.78 to
`17.
`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.
`
`9
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`

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`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 16 of 62
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`
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`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).
`
`Dr. Giering’s name appeared in the signature block of those Petitions, but he did
`18.
`not sign them. See Exs. 20–22.
`
`LILLY’S RESPONSE: Disputed. Inclusion of Dr. Giering’s name and USPTO
`
`Registration Number in 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
`
`SUMF 16) 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.
`
`
`
`
`
`
`
`10
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`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 17 of 62
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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 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).
`
`19.
`
`Lilly did not depose Dr. Cole.
`
`LILLY’S RESPONSE: Undisputed. Lilly did, however, depose Dr. Giering
`
`20.
`
`Dr. Giering testified at his deposition that
`
`
`
`
`
`
`
`
`
`
`
`LILLY’S RESPONSE: Disputed. Teva’s summary of Dr. Giering’s testimony
`
`mischaracterizes Dr. Giering’s testimony.
`
`
`
`
`
`
`
`11
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`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 18 of 62
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`
`
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`
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`Dr. Giering did not believe that that the statements in the Petitions that the “entire
`21.
`delay” was “unintentional” were false.
`
`
`LILLY’S RESPONSE: Disputed. Teva’s excerpted and strung together quotations
`
`mischaracterize Dr. Giering’s testimony. At his deposition in this case,
`
`
`
`
`
`
`
`
`
`IV.
`
`EXPERT OPINION AND FACT TESTIMONY REGARDING ALLEGEDLY
`OMITTED DATA AND REFERENCES
`
`The ’045 Patent includes data on antibodies that bind to CGRP but do not block its
`22.
`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
`
`(citing
`
`
`
`
`
`
`
`
`
`
`
`
`
`disclose any antibodies that bind to the middle-region or N-terminal end of CGRP. ECF No. 291
`
`. The specification of the patents-in-suit does not
`
`12
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`

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`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 19 of 62
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`at SOF 164 (citing
`
`
`
`
`
`
`
`. Further,
`
`even with Example 1 (Tables 2 and 3), there is very limited in vitro data provided in the
`
`specification of the ’045 patent. ECF No. 291 at SOF 152, 158 (“The specification of the Patents-
`
`in-Suit does not report in vitro or in vivo experiments evaluating the ability of antibodies M1-M84
`
`to inhibit CGRP biological activity.”) (citing
`
`
`
`
`
`
`
`
`
`23.
`
`Lilly did not serve any expert reports on PTO practice or procedure.
`
`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 prior art based on their expertise, which support Lilly’s inequitable conduct allegations
`
`related to Shaw,
`
`. See, e.g.,
`
`
`
`
`
`
`
`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 prior art based on their expertise, which support Lilly’s inequitable conduct allegations
`
`related to Shaw,
`
`. See, e.g.,
`
`
`
`13
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`

`

`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 20 of 62
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`
`
`
`
`
`
`25.
`
`7, 2022) at 151:5–10.
`
`Lilly’s expert Dr. McDonnell opined in his report
`
`
`
`Ex. 17 (deposition transcript of James McDonnell, dated January
`
`LILLY’S RESPONSE: Undisputed. However, Teva’s
`
`excerpted quotations
`
`mischaracterize Dr. McDonnell’s opinions.
`
`With regard to
`
`, Dr. McDonnell explained that
`
`
`
`With regard to Shaw, Dr. McDonnell opined that
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Dr. McDonnell is not an attorney, legal expert, or patent examiner, and thus properly
`
`refrained from stepping into the shoes of the PTO in forming an ultimate opinion on “but-for”
`
`
`
`14
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`

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`Case 1:18-cv-12029-ADB Document 449 Filed 07/28/22 Page 21 of 62
`
`
`
`materiality. By contrast, even though Dr. Hale is not an attorn