Case 1:18-cv-12029-ADB Document 164 Filed 09/16/21 Page 1 of 7
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`Case 1:18-cv-12029-ADB Document 164 Filed 09/16/21 Page 2 of 7
`Case 1:18-cv-12029-ADB Document 164 Filed 09/16/21 Page 2 of 7
`
`(“IPR”) proceedingsfiled by Lilly as to certain challenged claimsin each ofthe nine Patents-in-Suit.
`
`(See Dkt. No. 44.)
`
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`! The challenged claims are: claims 1-7 and 15-20 of U.S. Patent No. 9,340,614; claims 1-6 and 14-19 of U.S. Patent
`No. 9,266,951; claims 1-15 of U.S. Patent No. 9,890,210; claims 1-6 and 14-19 of U.S. Patent No. 9,346,881; claims 1-
`15 of U.S. Patent No. 9,890,211; and claims 1-9 of U.S. Patent No. 8,597,649.
`? The challenged claimsare: claims 1, 3, 4, 8-17, 19, 20, and 24-31 of U.S. Patent Nos. 8,586,045; claims 1-18 of U.S.
`Patent No. 9,884,907; and claims 1-18 of U.S. Patent No. 9,884,908.
`
`WHEREAS,on August 16, 2021, the U.S. Court of Appeals for the Federal Circuit issued
`
`three decisions on appeal from the PTAB’s final written decisions in the nine IPR proceedings
`
`involving the Patents-in-Suit, affirming the PTAB’s findings that (1) the challenged claimsofsix!
`
`of the Patents-in-Suit are unpatentable as obvious and (2) the challenged claims of the remaining
`
`three” Patents-in-Suit are not unpatentable as obvious on the single obviousness ground considered.
`
`(See Dkt. Nos. 140, 141.)
`
`WHEREAStheparties have met and conferred and have reached an agreementto narrow the
`
`issues pending in this matter in view of the recent Federal Circuit decisions.
`
`WHEREASTevahasagreed to withdraw its infringement allegations against Lilly based on
`
`the six Patents-in-Suit that contain claims that were affirmed as unpatentable as obvious by the
`
`Federal Circuit;
`
`WHEREASthe infringement allegations Teva brought against Lilly based on the three
`
`Patents-in-Suit with claims that were affirmed by the Federal Circuit as not unpatentable remain
`
`before this Court;
`
`WHEREASLilly has agreed to withdraw its allegations, set forth in its preliminary patent-
`
`related disclosures pursuant to Local Rule 16.6(d), that the asserted claims in the remaining three
`
`Patents-in-Suit are invalid as anticipated under 35 U.S.C. § 102 by Tan, Application of Monoclonal
`
`Antibodies to the Investigation of the Role of Calcitonin Gene-Related Peptide as a Vasodilatory
`
`Neurotransmitter, Dissertation Submitted to the University of Cambridge (1994) (“the Tan Thesis’)
`
`2
`
`

`

`Case 1:18-cv-12029-ADB Document 164 Filed 09/16/21 Page 3 of 7
`Case 1:18-cv-12029-ADB Document 164 Filed 09/16/21 Page 3 of 7
`
`and/or rendered obvious under 35 U.S.C. § 103 by the Tan Thesis alone or in combination with one
`
`or more of the following references:
`
`Lassenet al., CGRP May Play a Causative Role in Migraine, Cephalalgia (2002) 22:
`54-61 (“Lassen’’);
`
`Doods et al., Pharmacological Profile of BIBN4096BS, the First Selective Small
`Molecule CGRP Antagonist, Br. J. Pharmacol. (2000) 129: 420-423 (“Doods”);
`
`Olesen et al., Calcitonin Gene-Related Peptide Receptor Antagonist BIBN 4096 BS
`for the Acute Treatment of Migraine, N. Engl. J. Med. (2004) 350: 1104-1110
`(“Olesen”);
`
`Petersen et al., BIBN4096BS Antagonizes Human a-Calcitonin Gene Related
`Peptide-Induced Headache and Extracerebral Artery Dilation, Clinical Pharmacology
`& Therapeutics: (2005) 77(3): 202-213 (“Petersen 2005”);
`
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`c ÿ( ÿ)2bÿ5ÿ+#ÿ"c ÿ
`ÿ
`
`Messlingeret al., Inhibition of Neurogenic Blood Flow Increases in the Rat Cranial
`Dura Mater by a CGRP-Binding Spiegelmer, Cephalalgia (2005) 25: 923 (F022)
`(“Messlinger’’);
`
`Covell et al., Pharmacokinetics of Monoclonal Immunoglobulin G1, F(ab’)2, and
`Fab’ in Mice, Cancer Res. (1986) 46: 3969-3978 (“Covell”);
`
`Wimalawansa, Calcitonin Gene-Related Peptide and its Receptors: Molecular
`Genetics, Physiology, Pathophysiology, and Therapeutic Potentials, 17 Endocrine
`Reviews 5, 533-85 (1996) (“Wimalawansa”); and
`
`Queenet al., U.S. Patent No. 6,180,370 B1, issued Jan. 30, 2001 (“Queen”);
`
`WHEREAStheParties’ aforementioned agreement renders moot any potential motion for
`
`summary judgment, by Teva, that Lilly is “statutorily estopped from asserting prior art based
`
`invalidity defenses” as to the asserted claims of the three Patents-in-Suit upheld by the Federal
`
`Circuit. (Dkt. No. 141.)
`
`NOW, THEREFORE, IN RECOGNITION OF THE FEDERAL CIRCUIT’S DECISIONS
`
`ON APPEAL FROM THE IPR PROCEEDINGS,IT IS HEREBY STIPULATED AND AGREED,
`
`by and between the Parties hereto, and subject to the approval of the Court, as follows:
`
`A.
`
`All claims, counterclaims, and defenses relating to U.S. Patent Nos. 8,597,649;
`
`9,266,951; 9,340,614; 9,346,881; 9,890,210; or 9,890,211 in Teva’s Complaint (Dkt. No. 1), Lilly’s
`
`

`

`Case 1:18-cv-12029-ADB Document 164 Filed 09/16/21 Page 4 of 7
`Case 1:18-cv-12029-ADB Document 164 Filed 09/16/21 Page 4 of 7
`
`Answer to Teva’s Complaint (Dkt No. 17), and Teva’s Answer to Counterclaims (Dkt. No. 25) are
`
`hereby dismissed with prejudice.’
`
`B.
`
`Lilly will not assert that U.S. Patent Nos. 8,586,045, 9,884,907, and 9,884,908 are
`
`invalid as anticipated under 35 U.S.C. § 102 by the Tan Thesis or rendered obvious under 35 U.S.C.
`
`§ 103 by the Tan Thesis alone or in combination with one or more of Lassen, Doods, Olesen,
`
`Petersen 2005, Messlinger, Covell, Wimalawansa, and Queen, and hereby withdraws the
`
`correspondingportionsofits preliminary patent-related disclosures pursuant to Local Rule 16.6(d).*
`
`C.
`
`The Parties shall bear their own costs and attorney fees in connection with the
`
`claims and defenses dismissed or withdrawn by this Stipulation and Order.
`
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`3 For the avoidance ofdoubt, these claims, counterclaims, and defenses include Counts II-V, VIII-IX, XI-XIV, and XVII-
`XVIII in Teva’s Complaint (Dkt. No. 1), Counts III-X and XV-XVIII of Lilly’s Counterclaims as well as Lilly’s Third-
`Tenth and Fifteenth-Eighteenth Affirmative Defenses in Lilly’s Answer to Teva’s Complaint (Dkt No. 17). Further,
`Counts XIX and XX of Lilly’s Counterclaims as well as Lilly’s Twenty-Second, Twenty-Third, and Twenty-Fourth
`Affirmative Defenses in Lilly’s Answer to Teva’s Complaint (Dkt No. 17) are hereby dismissed with prejudice, in part,
`to the extent they relate to U.S. Patent Nos. 8,597,649; 9,266,951; 9,340,614; 9,346,881; 9,890,210; or 9,890,211.
`4 For the avoidance of doubt, Lilly maintainsits assertions, set forth in its preliminary patent-related disclosures pursuant
`to Local Rule 16.6(d), that U.S. Patent Nos. 8,586,045, 9,884,907, and 9,884,908 are invalid for, inter alia, improper
`inventorship and derivation under 35 U.S.C. § 102(f) as well as for statutory and obviousness-type double patenting. For
`the further avoidance of doubt, nothing in this Stipulation and Order precludes the parties from referencing the claims,
`counterclaims and defenses dismissed hereby with prejudice, or the content ofthe Federal Circuit decisions pertaining to
`the patents and assertions covered by those claims, counterclaims, and defenses.
`
`IT IS SO STIPULATED:
`
`Dated: September 15, 2021
`
`/s/ Robert Frederickson IT
`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)
`Shaobo Zhu (BBO# 697669)
`GOODWIN PROCTER LLP
`100 Northern Avenue
`Boston, MA 02210
`Tel.: (617) 570-1000
`
`/s/Andrea L. Martin
`Andrea L. Martin (BBO# 666117)
`BURNS & LEVINSON LLP
`125 High Street
`Boston, MA 02110-1624
`(617) 345-3000
`amartin@burnslev.com
`
`Charles E. Lipsey
`Ryan O’ Quinn
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`Two Freedom Square
`
`4
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`

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`Case 1:18-cv-12029-ADB Document 164 Filed 09/16/21 Page 5 of 7
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`Case 1:18-cv-12029-ADB Document 164 Filed 09/16/21 Page 6 of 7
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`Case 1:18-cv-12029-ADB Document 164 Filed 09/16/21 Page 7 of 7
`Case 1:18-cv-12029-ADB Document 164 Filed 09/16/21 Page 7 of 7
`
`CERTIFICATE OF SERVICE
`
`I, Andrea L. Martin, hereby certify that this documentfiled 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 September 15,
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`34356789:ÿ<=ÿ>:8?@6ÿ
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`BCB-CCDC-CEF/ÿ
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`2021.
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`4847-8868-8379.1
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`/s/Andrea L. Martin
`Andrea L. Martin, Esq.
`
`ÿÿ
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`