Case 1:18-cv-12029-ADB Document 419 Filed 07/27/22 Page 1 of 10
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`
`
`Civil Action No.
`1:18-cv-12029-ADB
`
`
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH and
`TEVA PHARMACEUTICALS
`USA, INC.,
`
`Plaintiffs,
`
`
`
`
`
`
`
`
`v.
`
`ELI LILLY AND COMPANY,
`Defendant.
`
`
`
`
`
`
`LOCAL RULE 56.1 STATEMENT OF UNDISPUTED MATERIAL FACTS
`IN SUPPORT OF PLAINTIFFS TEVA PHARMACEUTICALS INTERNATIONAL
`GMBH AND TEVA PHARMACEUTICALS USA, INC.’S MOTION FOR SUMMARY
`JUDGMENT OF NO INEQUITABLE CONDUCT AND UNCLEAN HANDS
`
`Pursuant to Local Rule 56.1, Plaintiffs Teva Pharmaceuticals International GmbH and Teva
`
`Pharmaceuticals USA, Inc. (“Teva”) submit, in support of their Motion for Summary Judgment of
`
`No Inequitable Conduct and Unclean Hands, the following concise statement of the material facts
`
`of record as to which Teva contends there are no genuine issues to be tried.
`
`I.
`
`BACKGROUND
`
`1.
`
`U.S. Patent No. 8,586,045 (the “’045 patent”) is titled “Methods of Using Anti-
`
`CGRP Antagonist Antibodies.” Ex. 1.
`
`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.
`
`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.
`
`
`
`1
`
`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`
`
`Civil Action No.
`1:18-cv-12029-ADB
`
`
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH and
`TEVA PHARMACEUTICALS
`USA, INC.,
`
`Plaintiffs,
`
`
`
`
`
`
`
`
`v.
`
`ELI LILLY AND COMPANY,
`Defendant.
`
`
`
`
`
`
`LOCAL RULE 56.1 STATEMENT OF UNDISPUTED MATERIAL FACTS
`IN SUPPORT OF PLAINTIFFS TEVA PHARMACEUTICALS INTERNATIONAL
`GMBH AND TEVA PHARMACEUTICALS USA, INC.’S MOTION FOR SUMMARY
`JUDGMENT OF NO INEQUITABLE CONDUCT AND UNCLEAN HANDS
`
`Pursuant to Local Rule 56.1, Plaintiffs Teva Pharmaceuticals International GmbH and Teva
`
`Pharmaceuticals USA, Inc. (“Teva”) submit, in support of their Motion for Summary Judgment of
`
`No Inequitable Conduct and Unclean Hands, the following concise statement of the material facts
`
`of record as to which Teva contends there are no genuine issues to be tried.
`
`I.
`
`BACKGROUND
`
`1.
`
`U.S. Patent No. 8,586,045 (the “’045 patent”) is titled “Methods of Using Anti-
`
`CGRP Antagonist Antibodies.” Ex. 1.
`
`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.
`
`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.
`
`
`
`1
`
`
`
`Case 1:18-cv-12029-ADB Document 419 Filed 07/27/22 Page 2 of 10
`
`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.
`
`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.
`
`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.
`
`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.
`
`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).
`
`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.
`
`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.
`
`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.
`
`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.
`
`
`
`2
`
`
`
`Case 1:18-cv-12029-ADB Document 419 Filed 07/27/22 Page 3 of 10
`
`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).
`
`14.
`
`Lilly also alleges that
`
` committed inequitable conduct by
`
`failing to disclose to the PTO
`
`
`
`
`
`
`
`15.
`
`Lilly also alleges that
`
` committed inequitable conduct by
`
` E.g., SSAA¶ 193.
`
`failing to disclose to the PTO
`
`
`
` E.g., SSAA¶ 198.
`
`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).
`
`
`
`3
`
`
`
`Case 1:18-cv-12029-ADB Document 419 Filed 07/27/22 Page 4 of 10
`
`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.
`
`18.
`
`Dr. Giering’s name appeared in the signature block of those Petitions, but he did
`
`not sign them. See Exs. 20–22.
`
`19.
`
`20.
`
`Lilly did not depose Dr. Cole.
`
`Dr. Giering testified at his deposition that
`
`
`
`
`
`
`
`21.
`
`Dr. Giering did not believe that that the statements in the Petitions that the “entire
`
`delay” was “unintentional” were false.
`
`
`
`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).
`
`23.
`
`24.
`
`Lilly did not serve any expert reports on PTO practice or procedure.
`
`Lilly did not serve any expert report that provided an opinion that any of the claims
`
`in the patent would not have issued had Shaw,
`
`25.
`
`Lilly’s expert Dr. McDonnell opined in his report
`
`.
`
`
`
`
`
`
`
`
`
`4
`
`
`
`Case 1:18-cv-12029-ADB Document 419 Filed 07/27/22 Page 5 of 10
`
` Ex. 17 (deposition transcript of James McDonnell, dated January
`
`7, 2022) at 151:5–10.
`
`26.
`
`Dr. McDonnell testified during his deposition that
`
`
`
`27.
`
`Dr. McDonnell did not consider whether Shaw and
`
`was cumulative of information disclosed to the PTO.
`
`28.
`
`Lilly’s expert Dr. Charles opined in his report that
`
`
`
`
`
`
`
`
`
`
`
`
`
`.
`
`29.
`
`The
`
` disclosed the Shaw reference during prosecution of the ’907
`
`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.
`
`30.
`
`During patent prosecution, if an examiner does not strikethrough a reference, it
`
`means the reference was considered. MPEP § 609.05(b).
`
`31.
`
`The examiner indicated that he considered Shaw in deciding whether to issue the
`
`’907 and ’908 patents. Ex. 4 at TEVA_FREM_000052797; Ex. 5 at TEVA_FREM_000025387;
`
`see MPEP § 609.05(b).
`
`32.
`
`The Shaw reference included data on an antibody that bound to the mid-region of
`
`CGRP and failed to block the effects of CGRP. SSAA ¶ 192.
`
`33.
`
`The Shaw reference included data on an antibody that bound to the N-terminal
`
`region of CGRP and did block the effects of CGRP. See Ex. 11.
`
`
`
`5
`
`
`
`Case 1:18-cv-12029-ADB Document 419 Filed 07/27/22 Page 6 of 10
`
`34.
`
`The Shaw reference shows that some non-C-terminal binding antibodies antagonize
`
`CGRP. See Ex. 11.
`
`35.
`
`The PTO issued the ’907 and ’908 patents even though the Shaw reference was
`
`cited during prosecution. See generally Exs. 2–3.
`
`36.
`
`The Shaw reference was submitted to the PTO during the prosecution of U.S. Patent
`
`Nos. 9,266,951, 9,340,614, and 9,346,881 on November 30, 2015. Ex. 6 (Certified File History
`
`of U.S. Patent No. 9,266,951) at TEVA_FREM_000047844; Ex. 7 (Certified File History of U.S.
`
`Patent No. 9,340,614) at TEVA_FREM_000052156; Ex. 8 (Certified File History of U.S. Patent
`
`No. 9,346,881) at TEVA_FREM_39450.
`
`37.
`
`The Shaw reference and
`
` were cumulative of
`
`disclosures
`
` made during prosecution of the patents-in-suit. Ex. 9 ¶¶ 378–84, 397.
`
`38.
`
`Both
`
`and Shaw were “duplicative of disclosures in
`
`the specification and prior art non-antagonist anti-CGRP antibodies with a variety of different
`
`epitopes”—i.e., that bound to different regions of CGRP. Ex. 9 ¶¶ 390, 397.
`
`39.
`
`Lilly did not disclose an expert opinion addressing whether Shaw and the
`
` were duplicative of disclosures
`
` made to the Patent Office. See
`
`generally Ex. 17.
`
`40.
`
`Certain
`
` Lilly alleges was withheld from the PTO
`
`shows that some N-terminal antibodies bind but do not antagonize CGRP. Ex. 9 ¶¶ 298, 379, 384.
`
`41.
`
`Certain
`
` Lilly alleges was withheld from the PTO
`
`addressed polyclonal antibodies, not monoclonal antibodies. Ex. 9 ¶¶ 376–77.
`
`
`
`6
`
`
`
`Case 1:18-cv-12029-ADB Document 419 Filed 07/27/22 Page 7 of 10
`
`42.
`
`The
`
` was preliminary.
`
`
`
`
`
`
`
`43.
`
`The PTO would not need Shaw or
`
` to conclude that
`
`a certain level of binding affinity is insufficient for an anti-CGRP antibody to be an antagonist.
`
`44.
`
`Dr. Hale opined that Shaw and
`
`
`
`
`
`
`
`
`
`
`
`
`
`45.
`
`Lilly did not disclose an expert opinion addressing whether
`
` was
`
`duplicative of disclosures the inventors made to the Patent Office. See generally Ex. 17.
`
`46.
`
`The
`
` was not fully complete at the time
`
`of the filing date of the patent.
`
`
`
`47.
`
`Tan et al., Demonstration of the neurotransmitter role of calcitonin gene-related
`
`peptides (CGRP) by immunoblockade with anti-CGRP monoclonal antibodies, 111 Br. J.
`
`Pharmacol. 703–710 (1994) (“Tan 1994”) was disclosed during prosecution of the patents-in-suit.
`
`Ex. 12; see, e.g., Ex 4 at TEVA_FREM_000052797; Ex. 5 at TEVA_FREM_000025387.
`
`48.
`
`Tan discloses, citing Shaw: “The binding of an antibody to a peptide does not
`
`always result in blockade of biological activity.” Ex. 12 at 708.
`
`49.
`
` participated in some form in drafting or reviewing at least
`
`portions of the November 2006 PCT Application, to which each of the patents-in-suit claim
`
`
`
`7
`
`
`
`Case 1:18-cv-12029-ADB Document 419 Filed 07/27/22 Page 8 of 10
`
`priority.
`
`
`
`50.
`
` did not know whether Shaw,
`
` was submitted to the PTO.
`
`
`
`
`
`
`
`51.
`
`The inventors’ disclosed information to the PTO during prosecution of the patents-
`
`in-suit disclosing that not all antibodies that bind CGRP also antagonize it. Ex. 1 at 51:5–28, 52:1–
`
`27 (Tables 2 and 3).; Ex. 4; Ex. 5; Ex. 12.
`
`52.
`
`Cortical spreading depression only occurs in a subset of patients.
`
`
`
`53.
`
` is an animal model that models a very specific aspect of migraine.
`
`
`
`
`
`54.
`
`A negative result in
`
` does not mean that the antibody does not work to
`
`treat migraine.
`
`55.
`
`56.
`
`control. See
`
`57.
`
` data did not have a positive control. See
`
`
`
`
`
`
`
` data was inconclusive because the experiment lacked a positive
`
` believed that
`
` was inconclusive because
`
`.
`
`the experiment lacked a positive control. See
`
`
`
`
`
`
`
`
`
`8
`
`
`
`Case 1:18-cv-12029-ADB Document 419 Filed 07/27/22 Page 9 of 10
`
`Respectfully Submitted,
`
`/s/ Elaine Herrmann Blais
`Douglas J. Kline (BBO# 556680)
`Elaine Herrmann Blais (BBO# 656142)
`Robert Frederickson III (BBO# 670111)
`Joshua S. Weinger (BBO# 690814)
`Alexandra Lu (BBO# 691114)
`Eric T. Romeo (BBO# 691591)
`Kathleen A. McGuinness (BBO# 693760)
`GOODWIN PROCTER LLP
`100 Northern Avenue
`Boston, MA 02210
`Tel.: (617) 570-1000
`Fax: (617) 523-1231
`dkline@goodwinlaw.com
`eblais@goodwinlaw.com
`rfrederickson@goodwinlaw.com
`jweinger@goodwinlaw.com
`alu@goodwinlaw.com
`eromeo@goodwinlaw.com
`kmcguinness@goodwinlaw.com
`
`I. Neel Chatterjee (pro hac vice)
`GOODWIN PROCTER LLP
`601 Marshall St.
`Redwood City, CA 94063
`Tel.: (650) 752-3100
`Fax: (650) 853-1038
`nchatterjee@goodwinlaw.com
`
`Natasha E. Daughtrey (pro hac vice)
`GOODWIN PROCTER LLP
`601 S. Figueroa St.
`Los Angeles, CA 90017
`Tel.: (213) 426-2500
`Fax: (213) 623-1673
`ndaughtrey@goodwinlaw.com
`
`Attorneys for Plaintiffs
`
`
`
`
`Dated: March 28, 2022
`
`
`
`
`
`
`
`9
`
`
`
`Case 1:18-cv-12029-ADB Document 419 Filed 07/27/22 Page 10 of 10
`
`CERTIFICATE OF SERVICE
`
`I, Elaine Hermann Blais, 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 July 27, 2022.
`
`/s/ Elaine Herrmann Blais
`Elaine Herrmann Blais (BBO# 656142)
`GOODWIN PROCTER LLP
`100 Northern Avenue
`Boston, MA 02210
`Tel.: (617) 570-1000
`Fax: (617) 523-1231
`eblais@goodwinlaw.com
`
`
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