Case 1:18-cv-12029-ADB Document 17 Filed 11/02/18 Page 1 of 107
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`Case No. 1:18-CV-12029-ADB
`
`ANSWER, AFFIRMATIVE
`DEFENSES, AND COUNTERCLAIMS
`OF DEFENDANT ELI LILLY AND
`COMPANY
`
`)))))))))))
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH, and
`TEVA PHARMACEUTICALS USA, INC.
`
`Plaintiffs,
`
`v.
`
`ELI LILLY and COMPANY
`
`Defendant.
`
`LILLY’S ANSWER AND AFFIRMATIVE DEFENSES TO
`PLAINTIFFS’ COMPLAINT
`
`Defendant Eli Lilly and Company (“Lilly”) respectfully submits this answer, affirmative
`
`defenses, and counterclaims to the Complaint filed by Plaintiffs Teva Pharmaceuticals
`
`International GmbH (“Teva GmbH”) and Teva Pharmaceuticals USA, Inc. (“Teva USA”)
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`(collectively, “Plaintiffs” or “Teva”), and states as follows:
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`NATURE OF THE ACTION
`
`1. Teva brings this action to protect its intellectual property rights covering breakthrough
`treatments for migraine headaches. Teva has invested heavily in this innovative technology, and
`the potential benefit to the public is enormous. Over 1 billion people suffer from migraine
`headaches worldwide. More than 38 million people experience migraine headaches in the
`United States alone.
`
`ANSWER: Lilly admits, on information and belief, that over 1 billion people suffer from
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`migraine headaches worldwide, and more than 38 million people experience migraine headaches
`
`in the United States alone. Lilly admits that Teva filed a Complaint for Patent Infringement
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`against Lilly on September 27, 2018. Lilly is otherwise without knowledge or information
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`sufficient to form a belief as to the truth of the remaining allegations contained in Paragraph 1 of
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`1
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`Case 1:18-cv-12029-ADB Document 17 Filed 11/02/18 Page 2 of 107
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`the Complaint, and therefore denies the same.
`
`2. Migraine is a complex, common neurological condition that is characterized by severe,
`episodic attacks of headache. Migraine can also cause nausea, vomiting, and sensitivity to light,
`sound, or movement. In the United States and Western Europe, over 10% of the general
`population suffers from migraine.
`
`ANSWER: Lilly admits the allegations of Paragraph 2 of the Complaint on information and
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`belief.
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`3. Teva’s corporate affiliate, Labrys Biologics, Inc. (“Labrys”), made a major
`breakthrough in research for migraine treatment. Through years of painstaking study, Labrys
`made important discoveries concerning the role that calcitonin gene-related peptide (“CGRP”)
`plays in migraine headaches. Armed with that knowledge, Labrys developed a biologic product
`with an active ingredient, fremanezumab—a humanized monoclonal antibody that targets CGRP.
`This new product has been shown to prevent and/or reduce the incidence of migraines.
`Fremanezumab has the potential to help tens of millions of migraine sufferers in the United
`States.
`
`ANSWER: Lilly admits that the FDA has approved Ajovy™ (fremanezumab-vfrm) injection
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`for the preventive treatment of migraine in adults, and the Patient Information for Ajovy™ states
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`that the active ingredient in Ajovy is fremanezumab-vfrm. Lilly further admits that the Full
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`Prescribing Information for Ajovy™ states that “[f]remanezumab-vfrm is a humanized
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`monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its
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`binding to the receptor.” Lilly is otherwise without knowledge or information sufficient to form
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`a belief as to the truth of the allegations contained in Paragraph 3 of the Complaint, and therefore
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`denies the same.
`
`4. Labrys’ innovations are protected by at least U.S. Patent Nos. 8,586,045; 8,597,649;
`9,266,951; 9,340,614; 9,346,881; 9,884,907; 9,884,908; 9,890,210; and 9,890,211 (“the Patents-
`in-Suit”). Labrys assigned the Patents-in-Suit to Teva on September 19, 2016. Teva, in turn, has
`continued to invest in fremanezumab to bring the product to market. On October 16, 2017, Teva
`Branded Pharmaceutical Products R&D, Inc. submitted a Biologics License Application
`(“BLA”) to the Food and Drug Administration (“FDA”) seeking approval to market
`fremanezumab for the treatment of episodic and chronic migraine. On or about March 22, 2018,
`Teva Branded Pharmaceuticals Products R&D, Inc. transferred the BLA seeking approval to
`market fremanezumab for the treatment of episodic and chronic migraine to Teva
`Pharmaceuticals USA, Inc. On September 19, 2018, Teva received FDA approval to market
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`2
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`Case 1:18-cv-12029-ADB Document 17 Filed 11/02/18 Page 3 of 107
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`fremanezumab in the United States under the brand name Ajovy™. See Ex. 28. Teva
`Pharmaceuticals USA, Inc. is the exclusive distributor of Ajovy™ within the United States.
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`ANSWER: On October 17, 2017, Teva Pharmaceutical Industries Ltd., announced that a BLA
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`for fremanezumab for the preventative treatment of migraine had been submitted to FDA. On
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`September 14, 2018, Teva Pharmaceutical Industries Ltd., announced that the FDA approved
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`Ajovy™ (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. Lilly
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`is otherwise without knowledge or information sufficient to form a belief as to the truth of the
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`remaining allegations contained in Paragraph 4 of the Complaint, and therefore denies the same.
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`5. Eli Lilly is aware of the Patents-in-Suit, but nonetheless is, upon information and
`belief, in the process of launching its own competing biologic product with the active ingredient
`galcanezumab, which will undermine the value of Teva’s substantial investment in the Patents-
`in-Suit. This product is also known as LY2951742 (the “Galcanezumab Product”). Like Teva’s
`patented fremanezumab product, Eli Lilly’s infringing Galcanezumab Product is an antibody that
`targets CGRP. On October 24, 2017, Eli Lilly publicly stated that it had submitted its own BLA
`for the Galcanezumab Product. Ex. 1 at 3. Through its public statements and commercial
`activity, Eli Lilly made clear that it intended to enter the market with its Galcanezumab Product
`as soon as it received FDA approval.
`
`ANSWER: Lilly admits that it is aware of U.S. Patent Nos. 8,586,045; 8,597,649; 9,266,951;
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`9,340,614; 9,346,881; 9,884,907; 9,884,908; 9,890,210; and 9,890,211 (“the Patents-in-Suit”),
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`but denies that the marketing of a biologic product with the active ingredient galcanezumab
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`would infringe any valid and enforceable claim of the Patents-in-Suit. Lilly admits that on
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`October 24, 2017, on its third-quarter earnings call, Lilly stated that “[w]e submitted the BLA for
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`galcanezumab for migraine prevention” and that it was a “U.S. submission.” Lilly denies that
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`Lilly’s biologic product with the active ingredient galcanezumab is also known as LY2951742
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`(defined by Teva herein as the “Galcanezumab Product”). Except as expressly admitted, Lilly
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`denies the remaining allegations of Paragraph 5 of the Complaint.
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`6. On September 27, 2018, Eli Lilly obtained FDA approval to market its Galcanezumab
`Product in the United States under the brand name Emgality™. See Ex. 29. The Eli Lilly press
`release describing the approval states that “Emgality will be available to patients shortly after
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`3
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`Case 1:18-cv-12029-ADB Document 17 Filed 11/02/18 Page 4 of 107
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`approval.” Id. This demonstrates that the commercial launch of Emgality™ is imminent, and
`upon information and belief, Lilly is offering for sale, selling, manufacturing and/or importing,
`Emgality™ into the United States.
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`ANSWER: Lilly admits that on September 27, 2018, the FDA approved Emgality™
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`(galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in adults, and
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`Lilly subsequently launched Emgality™ (galcanezumab-gnlm) in the United States. Lilly further
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`admits that the press release attached to the Complaint as Exhibit 29 states “Emgality will be
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`available to patients shortly after approval.” Lilly denies that Lilly’s biologic product with the
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`active ingredient galcanezumab is also known as LY2951742 (defined by Teva herein as the
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`“Galcanezumab Product”). Except as expressly admitted, Lilly denies the remaining allegations
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`of Paragraph 6 of the Complaint.
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`7. Eli Lilly’s commercial manufacture, importation, offers to sell, and sales of its
`Galcanezumab Product will directly infringe, and/or will actively induce and/or contribute to
`infringement of, claims of each of the Patents-in-Suit. Teva files this action to recover damages
`suffered as result of Lilly’s infringing conduct, to secure a judicial declaration that Eli Lilly has
`infringed the Patents-in-Suit, and to prevent Eli Lilly from any future infringement.
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`ANSWER: Lilly admits that Teva filed this infringement action and this declaratory judgment
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`action for patent infringement of the Patents-in-Suit alleging that Lilly has or will directly
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`infringe, or induce and/or contribute to infringement of the Patents-in-Suit. Paragraph 7 of the
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`Complaint contains legal conclusions to which no response is required. To the extent any
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`response is required, Lilly denies those allegations. Lilly denies that Lilly has or will directly
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`infringe, or induce and/or contribute to infringement of, any valid and enforceable claim of the
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`Patents-in-Suit. Lilly denies that Lilly’s biologic product with the active ingredient
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`galcanezumab is also known as LY2951742 (defined by Teva herein as the “Galcanezumab
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`Product”). Except as expressly admitted, Lilly denies the remaining allegations of Paragraph 7
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`of the Complaint.
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`4
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`Case 1:18-cv-12029-ADB Document 17 Filed 11/02/18 Page 5 of 107
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`THE PARTIES
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`8. Teva GmbH is a limited liability company organized and existing under the laws of
`Switzerland, having its corporate offices and principal place of business at Schlüsselstrasse 12,
`Jona (SG) 8645, Switzerland. Teva GmbH owns the Patents-in-Suit.
`
`ANSWER: Lilly admits, on information and belief, that Teva GmbH is a limited liability
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`company existing under the laws of Switzerland. As to the remaining allegations contained in
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`Paragraph 8 of the Complaint, Lilly is without knowledge or information sufficient to form a
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`belief as to their truth, and therefore denies the same.
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`9. Teva USA is a Delaware corporation organized and existing under the laws of
`Delaware, having its principal place of business at 1090 Horsham Road, North Wales,
`Pennsylvania, 19454-1090. Teva USA holds an exclusive license to the Patents-in-Suit.
`
`ANSWER: Lilly admits, on information and belief, that Teva USA is a Delaware corporation
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`with its principal place of business at 1090 Horsham Road, North Wales, Pennsylvania, 19454-
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`1090. As to the remaining allegations contained in Paragraph 9 of the Complaint, Lilly is
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`without knowledge or information sufficient to form a belief as to their truth, and therefore
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`denies the same.
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`10. Upon information and belief, Eli Lilly is a corporation organized and existing under
`the laws of the State of Indiana. Eli Lilly has corporate offices at Corporate Center, Indianapolis,
`Indiana 46285. Eli Lilly also has regular and established places of business in other
`jurisdictions, including in the Commonwealth of Massachusetts.
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`ANSWER: Lilly admits that it is a corporation organized and existing under the laws of the
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`State of Indiana. Paragraph 10 of the Complaint contains legal conclusions to which no response
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`is required. To the extent any response is required, Lilly admits that it has U.S. locations in other
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`jurisdictions, including at 450 Kendall Street, Cambridge, Massachusetts, 02142, but denies the
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`remaining allegations of Paragraph 10 of the Complaint.
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`JURISDICTION AND VENUE
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`11. This Court has jurisdiction over the subject matter of this action pursuant to 28 U.S.C.
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`5
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`Case 1:18-cv-12029-ADB Document 17 Filed 11/02/18 Page 6 of 107
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`§§ 1331 and 1338(a) and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
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`ANSWER: Paragraph 11 of the Complaint contains legal conclusions to which no response is
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`required. To the extent any response is required, Lilly is not contesting that this Court has
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`jurisdiction over the subject matter of this action pursuant to 28 U.S.C. §§ 1331 and 1338(a) and
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`the Declaratory Judgment Act 28 U.S.C. §§ 2201 and 2202.
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`12. This Court has personal jurisdiction over Eli Lilly because Eli Lilly has extensive
`contacts with the Commonwealth of Massachusetts that directly relate to this suit.
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`ANSWER: Paragraph 12 of the Complaint contains legal conclusions to which no response is
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`required. To the extent any response is required, Lilly is not contesting personal jurisdiction in
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`the United States District Court for the District of Massachusetts for the limited purposes of this
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`civil action only. Lilly denies the remaining allegations of Paragraph 12 of the Complaint.
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`13. Venue is proper in this Judicial District pursuant to 28 U.S.C. § 1391(b) because Eli
`Lilly resides in this District. See 28 U.S.C. § 1391(c)(2). Venue is also proper in this Judicial
`District pursuant to 28 U.S.C. § 1400(b) because Eli Lilly has a regular and established place of
`business in Massachusetts and plans imminently to commit acts of infringement in the
`Commonwealth upon FDA approval of Eli Lilly’s Galcanezumab Product.
`
`ANSWER: Paragraph 13 of the Complaint contains legal conclusions to which no response is
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`required. To the extent any response is required, Lilly is not contesting venue in the United
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`States District Court for the District of Massachusetts for the limited purposes of this civil action
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`only, but Lilly reserves the right to move to transfer this action to the Southern District of
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`Indiana under 28 U.S.C. § 1404(a). Lilly denies the remaining allegations of Paragraph 13 of the
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`Complaint.
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`A.
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`[Heading Omitted]1
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`1 For ease of reference, a placeholder is used instead of Teva’s argumentative heading contained in the
`Complaint (“Eli Lilly Has Received FDA Approval, Allowing the Immediate Commercial
`Launch of its Galcanezumab Product.”). Although Lilly believes that no response is required to such
`headings, to the extent a response is deemed required and to the extent those headings and titles could be
`construed to contain factual allegations, those allegations are denied.
`6
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`Case 1:18-cv-12029-ADB Document 17 Filed 11/02/18 Page 7 of 107
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`14. There is an actual controversy regarding Eli Lilly’s infringement of the Patents-in-
`Suit by commercially manufacturing, offering to sell, and selling the Galcanezumab Product. Eli
`Lilly engaged in extensive preparations to bring its Galcanezumab Product to market in the
`immediate future, including submitting a BLA to the FDA for approval to market and sell the
`Galcanezumab Product for the prevention of both episodic and chronic migraine.
`
`ANSWER: Paragraph 14 of the Complaint contains legal conclusions to which no response is
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`required. To the extent any response is required, Lilly denies that Lilly infringes any valid claim
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`of the Patents-in-Suit by commercially manufacturing, offering to sell, and/or selling a biologic
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`product with the active ingredient galcanezumab in the United States. Lilly admits that it
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`submitted a BLA to the FDA for approval to market a biologic product with the active ingredient
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`galcanezumab for the prevention of migraine in adults. Lilly denies that Lilly’s biologic product
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`with the active ingredient galcanezumab is also known as LY2951742 (defined by Teva herein as
`
`the “Galcanezumab Product”). Except as expressly admitted, Lilly denies the remaining
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`allegations of Paragraph 14 of the Complaint.
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`15. Over the course of the past year, Eli Lilly made many public statements representing
`that it expected to receive FDA approval of its Galcanezumab Product and indicating that it
`planned to commercially launch the Galcanezumab Product as soon as the FDA approved its
`BLA.
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`ANSWER: Paragraph 15 of the Complaint repeats allegations that were raised in Teva’s
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`Amended Complaints in Teva Pharmaceuticals International GmbH v. Eli Lilly & Company, No.
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`17-cv-120872 (“Teva I”) and Teva Pharmaceuticals International GmbH v. Eli Lilly & Company,
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`No. 18-cv-102423 (“Teva II”), and addressed in the Court’s Memorandum and Order granting
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`Lilly’s Motions to Dismiss. The Court found that Lilly “has not, as the Amended Complaints
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`allege, publicly expressed confidence that FDA approval of galcanezumab is imminent. At most,
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`Defendant has stated that it expects regulatory action on galcanezumab in 2018 (which could
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`2 Dkt. 21 at ¶ 14.
`3 Dkt. 10 at ¶ 14.
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`7
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`Case 1:18-cv-12029-ADB Document 17 Filed 11/02/18 Page 8 of 107
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`result in rejection) . . .” Teva I, Dkt. 42 at 15; Teva II, Dkt. 23 at 15. Lilly denies that Lilly’s
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`biologic product with the active ingredient galcanezumab is also known as LY2951742 (defined
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`by Teva herein as the “Galcanezumab Product”). Lilly denies the allegations of Paragraph 15 of
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`the Complaint.
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`16. Eli Lilly has completed all of the Phase III clinical trials it believes are necessary to
`support its application for FDA approval to market the Galcanezumab Product in the United
`States. On October 24, 2017, Eli Lilly confirmed that it has submitted a BLA with the FDA to
`market and sell the Galcanezumab Product for the prevention of both episodic and chronic
`migraine. This filing signaled a serious commitment by Eli Lilly to imminently launch the
`Galcanezumab Product, because filing a BLA represents a substantial undertaking and
`investment.
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`ANSWER: Lilly admits that it conducted Phase III clinical trials in support of its biologics
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`license application related to a biologic product with the active ingredient galcanezumab for the
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`prevention of migraine in adults. Lilly admits that on October 24, 2017, on its third-quarter
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`earnings call, Lilly stated that “[w]e submitted the BLA for galcanezumab for migraine
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`prevention” and that it was a “U.S. submission.” Lilly denies that Lilly’s biologic product with
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`the active ingredient galcanezumab is also known as LY2951742 (defined by Teva herein as the
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`“Galcanezumab Product”). Except as expressly admitted, Lilly denies the remaining allegations
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`of Paragraph 16 of the Complaint.
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`17. Eli Lilly publicly expressed confidence that the FDA would approve its BLA in 2018.
`Eli Lilly made these statements in a special call with investors and at the Annual J.P. Morgan
`Healthcare Conference. See Ex. 2 at 19-20; Ex. 3 at 19. Several of these statements were made
`by C-level executives at Eli Lilly. In its June 28, 2017 Form 10-Q submitted to the U.S.
`Securities and Exchange Commission, Eli Lilly identified the Galcanezumab Product as being in
`Eli Lilly’s “late-stage pipeline.” Ex. 4 at 38.
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`ANSWER: Paragraph 17 of the Complaint repeats allegations that were raised in Teva’s
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`Amended Complaints in Teva I4 and Teva II5 and addressed in the Court’s Memorandum and
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`4 Dkt. 21 at ¶ 16.
`5 Dkt. 10 at ¶ 16.
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`8
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`Case 1:18-cv-12029-ADB Document 17 Filed 11/02/18 Page 9 of 107
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`Order granting Lilly’s Motions to Dismiss. The Court found that Lilly “has not, as the Amended
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`Complaints allege, publicly expressed confidence that FDA approval of galcanezumab is
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`imminent. At most, Defendant has stated that it expects regulatory action on galcanezumab in
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`2018 (which could result in rejection) . . .” Teva I, Dkt. 42 at 15; Teva II, Dkt. 23 at 15. Lilly
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`admits that Lilly held a call with its investors on May 24, 2016, and that Robert Conley and
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`Andrew Ahn made statements regarding galcanezumab during the call. Lilly admits that at the
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`time of that call, Robert Conley held the title of Development Leader and Distinguished Scholar,
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`Neuroscience at Eli Lilly and Company and Andrew Ahn held the title of Chief Scientific
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`Officer - Pain/Headache at Lilly Research Laboratories. Lilly denies that Exhibit 2 or Exhibit 3
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`to the Complaint reflect statements made at the Annual J.P. Morgan Healthcare Conference.
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`Lilly further admits that the June 28, 2017, Form 10-Q submitted to the U.S. Securities and
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`Exchange Commission states that galcanezumab is one of “approximately 55 new drugs” in the
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`“late-stage pipeline,” and it is “currently in Phase III clinical trial testing.” Lilly denies that
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`Lilly’s biologic product with the active ingredient galcanezumab is also known as LY2951742
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`(defined by Teva herein as the “Galcanezumab Product”). Except as expressly admitted, Lilly
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`also denies the remaining allegations of Paragraph 17 of the Complaint.
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`18. Eli Lilly publicly confirmed that it had incorporated the expected launch of its
`Galcanezumab Product into its long-term revenue growth guidance for investors. For example,
`during the question and answer portion of a July 25, 2017 Eli Lilly earnings call, Eli Lilly CFO
`and Executive VP of Global Services, Derica Rice, responded to the question “[o]n
`galcanezumab . . . is the launch reflected in your long-term revenue growth guidance?” by saying
`“[y]es, the simple answer is yes.” Ex. 5 at 20, 21.
`
`ANSWER: Paragraph 18 of the Complaint repeats allegations that were raised in Teva’s
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`Amended Complaints in Teva I6 and Teva II7 and addressed in the Court’s Memorandum and
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`6 Dkt. 21 at ¶ 17.
`7 Dkt. 10 at ¶ 17.
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`Case 1:18-cv-12029-ADB Document 17 Filed 11/02/18 Page 10 of 107
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`Order granting Lilly’s Motions to Dismiss. With respect to Teva’s allegations that Lilly factored
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`the launch of galcanezumab into its long-term revenue growth projections, the Court noted that
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`“Plaintiffs omit, however, that Defendant has factored the launch of galcanezumab into its long-
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`term revenue growth projections on a “probabilized basis,” which may incorporate the
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`probability that FDA action is delayed or that the drug is ultimately not approved.” Teva I, Dkt.
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`42 at 15 n.2; Teva II, Dkt. 23 at 15 n.2. Lilly admits that the possible launch of a biologic
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`product with the active ingredient galcanezumab had been incorporated on a probabilized basis
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`into Lilly’s long-term revenue growth guidance. Lilly admits that in the July 25, 2017, Lilly
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`earnings call, Geoffrey Meacham of Barclays PLC asked “[o]n galcanezumab . . . is the launch
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`reflected in your long-term revenue growth guidance?” and Derica Rice responded, “Yes, the
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`simple answer is yes, it is in but on a probabilized basis, as we do with the majority of our late-
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`stage portfolio assets.” Lilly denies that Lilly’s biologic product with the active ingredient
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`galcanezumab is also known as LY2951742 (defined by Teva herein as the “Galcanezumab
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`Product”). Except as expressly admitted, Lilly denies the remaining allegations of Paragraph 18
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`of the Complaint.
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`19. Eli Lilly’s expectation that it would receive FDA approval to market the
`Galcanezumab Product in the very near future was consistent with the FDA’s practice for
`reviewing and approving BLAs. In 2016, the median total approval time for BLAs from the date
`of filing was just 10.1 months. See Ex. 6 at 1. In fact, the FDA has established a goal of acting
`on 90% of BLAs within 10 months of the 60-day filing date (the 60-day filing date is the window
`of time in which the FDA decides whether to accept an application for substantive review). See
`Ex. 7 at 4.
`
`ANSWER: The documents attached to the Complaint as Exhibits 6 and 7 speak for themselves,
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`but Lilly denies that they support an expectation of approval for a biologic product with the
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`active ingredient galcanezumab “in the very near future.” Specifically, Lilly denies that Exhibit
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`6 states that the “median total approval time for BLAs from the date of filing was 10.1 months”;
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`Case 1:18-cv-12029-ADB Document 17 Filed 11/02/18 Page 11 of 107
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`rather, it states that the median approval time for a total of 70 NDA and BLA applications, only
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`eight of which were new drugs, was 10.1 months. Lilly denies that Lilly’s biologic product with
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`the active ingredient galcanezumab is also known as LY2951742 (defined by Teva herein as the
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`“Galcanezumab Product”). The remaining allegations of Paragraph 19 of the Complaint are
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`denied.
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`20. On September 21, 2018, Eli Lilly issued a press release announcing that “the
`European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use
`(CHMP) has issued a positive opinion for Emgality™ (galcanezumab) for the prophylaxis of
`migraine in adults who have at least four migraine days per month.” Ex. 36 at 1. Eli Lilly
`characterized this result as “the first regulatory step toward approval for Emgality in Europe.”
`Id. This press release also addressed the FDA approval process for Emgality™ in the United
`States and stated that “a decision regarding approval is expected by the end of September 2018.”
`Id.
`
`ANSWER: Lilly admits that the September 21, 2018, press release that is Exhibit 36 to
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`the Complaint states “Eli Lilly and Company (NYSE: LLY) announced today that the European
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`Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has
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`issued a positive opinion for Emgality™ (galcanezumab) for the prophylaxis of migraine in
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`adults who have at least four migraine days per month.” Lilly further admits that the press
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`release also states, “This is the first regulatory step toward approval for Emgality in Europe.”
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`Lilly admits that the press release also states, “The U.S. Food and Drug Administration (FDA) is
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`currently reviewing Emgality for the preventive treatment of migraine in adults. A decision
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`regarding approval is expected by the end of September 2018.” Except as expressly admitted,
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`Lilly denies the remaining allegations of Paragraph 20 of the Complaint.
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`21. Eli Lilly’s efforts culminated in the announcement on September 27, 2018 that FDA
`had approved Eli Lilly’s BLA, clearing the way for the commercial launch of the Galcanezumab
`Product in the United States. See Ex. 29.
`
`ANSWER: Lilly admits that the September 27, 2018, press release that is Exhibit 29 to the
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`Complaint states “Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and
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`Case 1:18-cv-12029-ADB Document 17 Filed 11/02/18 Page 12 of 107
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`Drug Administration (FDA) approved Emgality™ (galcanezumab-gnlm) 120 mg injection for
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`the preventive treatment of migraine in adults.” Lilly denies that Lilly’s biologic product with
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`the active ingredient galcanezumab is also known as LY2951742 (defined by Teva herein as the
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`“Galcanezumab Product”). Except as expressly admitted, Lilly denies the remaining allegations
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`of Paragraph 21 of the Complaint.
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`B.
`
`[Heading Omitted]8
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`22. Even before receiving FDA approval, Eli Lilly engaged in extensive preparations to
`allow for an immediate commercial launch of its Galcanezumab Product following FDA
`approval. For example, Eli Lilly instituted substantial marketing efforts directed at healthcare
`providers to raise awareness of migraine treatment, developed education materials about
`migraine, and built a sales force to launch the Galcanezumab Product. These activities are
`generally undertaken by a pharmaceutical company when a product’s launch is imminent. Eli
`Lilly is engaged in these efforts in the United States generally and in Massachusetts specifically.
`
`ANSWER: Lilly admits that on September 27, 2018, the FDA approved Emgality™
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`(galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in adults, and
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`Lilly commercially launched Emgality™ (galcanezumab-gnlm) in the United States on October
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`5, 2018. Lilly denies that Lilly’s biologic product with the active ingredient galcanezumab is
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`also known as LY2951742 (defined by Teva herein as the “Galcanezumab Product”). Lilly
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`denies the remaining allegations of Paragraph 22 of the Complaint.
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`23. Eli Lilly has invested heavily in developing an online presence directed to healthcare
`providers, in the United States and Massachusetts, to promote migraine treatments and CGRP’s
`role in migraine. For example, Eli Lilly established a Twitter account named @LillyMigraine in
`June 2017. See Ex. 8 at 1 (“Lilly Migraine U.S. @LillyMigraine,” TWITTER,
`https://twitter.com/lillymigraine (last visited Oct. 24, 2017)).
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`ANSWER: Paragraph 23 of the Complaint repeats allegations that were raised in Teva’s
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`8 For ease of reference, a placeholder is used instead of Teva’s argumentative heading contained in the
`Complaint (“Commercial Sales of The Galcanezumab Product Are Imminent”). Although Lilly believes
`that no response is required to such headings, to the extent a response is deemed required and to the extent
`those headings and titles could be construed to contain factual allegations, those allegations are denied.
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`Case 1:18-cv-12029-ADB Document 17 Filed 11/02/18 Page 13 of 107
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`Amended Complaints in Teva I9 and Teva II10 and addressed in the Court’s Memorandum and
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`Order granting Lilly’s Motions to Dismiss. The Court found that “Plaintiffs’ allegations about
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`Defendant’s Twitter account name @LillyMigraine and the website
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`www.uncoveringmigraine.com are not indicative of an immediate and real controversy because
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`the Twitter account and website do not discuss galcanezumab.” Teva I, Dkt. 42 at 20 n.5; Teva
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`II, Dkt. 23 at 20 n.5. Lilly admits that it operates a twitter account with the username
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`@LillyMigraine. Lilly also admits that the document attached to the Complaint as Exhibit 8 is a
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`screen capture of https://twitter.com/lillymigraine?lang=eng taken on October 24, 2017. Lilly
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`admits that Paragraph 23 of the Complaint contains some, but not all, of the information set forth
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`in Exhibit 8. Except as expressly admitted, Lilly denies the remaining allegations of Paragraph
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`23 of the Complaint.
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`24. As early as October 2017, Eli Lilly was currently building a sales force to support the
`launch of its Galcanezumab Product, including in Massachusetts specifically. Eli Lilly’s job
`board listed open positions for twenty-five sales representative positions who will be assigned to
`market the Galcanezumab Product once it is approved by the FDA. At least one of those
`positions was in Massachusetts. For example, Eli Lilly advertised a “Sales Representative—
`Neuroscience” position for “Boston, Massachusetts.” Eli Lilly’s job board stated that “[u]pon
`the anticipated approval of Galca [i.e., the Galcanezumab Product], this position will primarily
`focus on the successful launch of Galca.” See Ex. 10 at 2.
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`ANSWER: Lilly admits that Exhibit 10 to the Complaint describes a potential position entitled
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`“Sales Representative-Boston South MA Neuroscience” and states “Select Sales Rep-
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`Neuroscience positions will be responsible for Amyvid and Forteo, while others will be only
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`responsible for Forteo, until the anticipated approval of galcanezumab (Galca). Upon the
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`anticipated approval of Galca, this position will primarily focus on the successful launch of
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`Galca.” Lilly denies that Lilly’s biologic product with the active ingredient galcanezumab is also
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`9 Dkt. 21 at ¶ 20.
`10 Dkt. 10 at ¶ 20.
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`Case 1:18-cv-12029-ADB Document 17 Filed 11/02/18 Page 14 of 107
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`known as LY2951742 (defined by Teva herein as the “Galcanezumab Product”). Except as
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`expressly admitted, Lilly denies the remaining allegations of Paragraph 24 of the Complaint.
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`25. On June 27, 2018, Eli Lilly announced that the FDA conditionally accepted a brand
`name for its Galcanezumab Product—Emgality™. Ex. 30 at 1. Eli Lilly has filed trademark
`applications with the U.S. Patent and Trademark Office to protect the Emgality™ name and
`logo, and received Notices of Allowance for these marks on June 6, 2017, and October 17, 2017,
`respectively. Ex. 31.
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`ANSWER: Lilly admits that Exhibit 30 to the Complaint states that “Lilly also announced
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`today that the intended brand name, Emgality™, has been conditionally accepted by the U.S.
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`Food and Drug Administration (FDA).” Lilly further admits that Exhibit 31 to the Complaint
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`includes a Notice of Allowance dated June 6, 2017, for U.S. Trademark Serial Number
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`87263356 for the mark “EMGALITY” owned by Eli Lilly and Company, and a Notice of
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`Allowance dated October 17, 2017, for U.S. Trademark Serial Number 87435081 for the mark
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`“EMGALITY (Stylized/Design)” owned by Eli Lilly and Company. Lilly denies that Lilly’s
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`biologic product with the active ingredient galcanezumab is also known as LY2951742 (defined
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`by Teva herein as the “Galcanezumab Product”). Except as expressly admitted, Lilly denies the
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`remaining allegations of Para