Case 1:18-cv-12029-ADB Document 25 Filed 12/04/18 Page 1 of 65
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`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MASSACHUSETTS
`
`
`TEVA PHARMACEUTICALS
`INTERNATIONAL GMBH, and
`TEVA PHARMACEUTICALS USA, INC.,
`
`
`Plaintiffs/Counterclaim
`Defendants
`
`Civil Action No. 1:18-CV-12029-
`ADB
`
`))))))))))))
`
`PLAINTIFFS’ ANSWER TO DEFENDANT’S COUNTERCLAIMS
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`Plaintiffs Teva Pharmaceuticals International GmbH (“Teva GmbH”) and Teva
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`Pharmaceuticals USA, Inc. (“Teva USA”) (collectively, “Counterclaim-Defendants” or “Teva”)
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`by and through the undersigned attorneys, answers the Counterclaims of Defendant Eli Lilly and
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`Company (“Lilly” or “Counterclaim-Plaintiff”) in Lilly’s Answer and Affirmative Defenses to
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`Plaintiffs’ Complaint (D.I. 17), as follows:
`
`THE PARTIES1
`
`1.
`Counterclaim-Plaintiff Eli Lilly and Company is an Indiana Corporation that has
`its corporate offices and principal place of business at Lilly Corporate Center, Indianapolis,
`Indiana 46285.
`
`ANSWER:
`
`Upon information and belief, Teva admits that Counterclaim-Plaintiff Eli Lilly and
`
`
`1 For ease of reference, Teva includes the headings contained in Lilly’s Answer and Affirmative
`Defenses to Plaintiffs’ Complaint. Although Teva believes that no response is necessary for each
`of those headings, to the extent a response is required and that the headings could be construed to
`contain factual allegations, Teva denies the allegations.
`
`
`ACTIVE/97543457.7
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`1
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`ELI LILLY AND COMPANY,
`
`
`v.
`
`Defendant/Counterclaim
`Plaintiff
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`
`
`
`
`

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`Case 1:18-cv-12029-ADB Document 25 Filed 12/04/18 Page 2 of 65
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`Company is an Indiana Corporation that has its corporate offices and principal place of business
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`at Lilly Corporate Center, Indianapolis, Indiana 46285.
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`2.
`Upon information and belief, Counterclaim-Defendant 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.
`
`ANSWER:
`
`
`
`Admitted.
`
`3.
`Upon information and belief, Counterclaim Defendant 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.
`
`ANSWER:
`
`
`
`Admitted.
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`JURISDICTION AND VENUE
`
`4.
`These counterclaims arise under the Patent Laws of the United States and the
`Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`ANSWER:
`
`
`
`Paragraph 4 states legal conclusions to which no response is required. To the extent that
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`a response is required, Teva admits that Lilly’s counterclaims purport to bring an action under
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`the Patent Laws of the of the United States and the Declaratory Judgment Act, 28 U.S.C. §§
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`2201 and 2202.
`
`5.
`This Court has jurisdiction over the subject matter of this action pursuant to 28
`U.S.C. §§ 1331 and 1338(a) and the Declaratory Judgment Act, 28 U.S.C. §§ 2201 and 2202.
`
`ANSWER:
`
`
`
`Paragraph 5 states legal conclusions to which no response is required. To the extent that
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`a response is required and for the purposes of this action only, Teva does not contest that this
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`Court has jurisdiction over the subject matter of this action.
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`6.
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`This Court has personal jurisdiction over Counterclaim-Defendants because
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`Case 1:18-cv-12029-ADB Document 25 Filed 12/04/18 Page 3 of 65
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`Counterclaim-Defendants have availed themselves of the rights and privileges of this forum by
`bringing this civil action in this judicial district.
`
`ANSWER:
`
`
`
`Paragraph 6 states legal conclusions to which no response is required. To the extent that
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`a response is required, Teva does not contest this Court’s personal jurisdiction in this judicial
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`district for the limited purpose of this action only. Teva admits that it brought this civil action in
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`this judicial district.
`
`7.
`To the extent that venue is appropriate for Counterclaim-Defendants’ claims
`against Lilly, venue is also appropriate in this Court for Lilly’s counterclaims. Venue is also
`proper in this Judicial District pursuant to 28 U.S.C. §§ 1391(b) and 1391(c).
`
`ANSWER:
`
`
`
`Paragraph 7 states legal conclusions to which no response is required. To the extent that
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`a response is required and for the purposes of this action only, Teva does not contest that venue
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`in this judicial district is proper for Lilly’s counterclaims.
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`Case 1:18-cv-12029-ADB Document 25 Filed 12/04/18 Page 4 of 65
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`FACTUAL BACKGROUND
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`A.
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`Lilly’ Migraine Treatment: Emgality (galcanezumab-gnlm)
`
`8.
`Migraine is a debilitating neurologic disorder that affects roughly one in seven
`Americans annually. It imposes a profound socioeconomic burden on society through healthcare
`costs and loss of productivity. For individual sufferers, migraine significantly impairs quality of
`life and ability to function, often resulting in disability.
`
`ANSWER:
`
`
`
`Upon information and belief, Teva admits the allegations in Paragraph 8 of the
`
`Counterclaim.
`
`9.
`Lilly is a global healthcare leader that has been committed to the discovery and
`development of life-changing medicines for more than 140 years. Lilly’s research has both
`accelerated the understanding of migraine and advanced development of therapeutic agents to
`treat migraine. Lilly has investigated more than a dozen different compounds for the treatment of
`migraine and disabling headache disorders. Two of those compounds, lasmiditan and
`galcanezumab, are currently in clinical trials.
`
`ANSWER:
`
`
`
`Teva admits that Lilly has conducted clinical trials for its application for FDA approval to
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`market a product with the active ingredient galcanezumab (“Galcanezumab Product”) in the
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`United States. Teva lacks sufficient information to admit or deny the remaining allegations of
`
`this paragraph and therefore, denies them.
`
`10.
`Lilly’s original research on galcanezumab dates back at least a dozen years. After
`conducting extensive preclinical screening and safety testing, Lilly designed and conducted
`multiple large-scale clinical trials to evaluate the safety and efficacy of galcanezumab to prevent
`and treat migraine. These trials have demonstrated therapeutic potential.
`
`ANSWER:
`
`Teva admits that Lilly has conducted clinical trials for its application for FDA approval to
`
`market the Galcanezumab Product in the United States. Teva lacks sufficient information to
`
`admit or deny the remaining allegations of this paragraph and therefore, denies them.
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`Case 1:18-cv-12029-ADB Document 25 Filed 12/04/18 Page 5 of 65
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`11.
`On October 24, 2017, Lilly announced that it had submitted a Biologics License
`Application (“BLA”) to the FDA to market Emgality™ (galcanezumab-gnlm) for the prevention
`of migraine. On September 27, 2018, the FDA approved Emgality™ (galcanezumab-gnlm) 120
`mg injection for the preventive treatment of migraine in adults.
`
`ANSWER:
`
`
`
`Teva admits that on October 24, 2017, Lilly publicly stated that it had submitted a BLA
`
`to the FDA to market the Galcanezumab Product. Teva admits that on September 27, 2018 Lilly
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`obtained FDA approval to market its Galcanezumab Product in the United States under the brand
`
`name Emgality™ 120 mg for the preventive treatment of migraine in adults. Teva lacks
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`sufficient information to admit or deny the remaining allegations of this paragraph and therefore,
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`denies them.
`
`B.
`
`Teva’s Migraine Treatment: Ajovy™ (fremanezumab)
`
`12.
`On information and belief, fremanezumab was originally discovered and
`developed at Rinat Neuroscience. On information and belief, Pfizer acquired Rinat in 2006,
`continued research and development of fremanezumab, including conducting a Phase I clinical
`trial of fremanezumab.
`
`ANSWER:
`
`
`
`Upon information and belief, Teva admits fremanezumab was originally discovered at
`
`Rinat Neuroscience, that Pfizer acquired Rinat in 2006, and that Pfizer began clinical
`
`development of fremanezumab. Teva lacks sufficient information to admit or deny the
`
`remaining allegations of this paragraph and therefore, denies them.
`
`13.
`On information and belief, in 2013 Labrys Biologics, Inc. (“Labrys”) acquired the
`rights to fremanezumab from Pfizer. On information and belief, Labrys continued to develop
`fremanezumab, including conducting additional clinical trials in humans.
`
`ANSWER:
`
`Upon information and belief, Teva admits that in 2012 Pfizer assigned rights to
`
`fremanezumab to Labrys. Teva admits that Labrys continued development of fremanezumab
`
`including conducting clinical trials in humans. Teva denies any remaining allegations in
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`Case 1:18-cv-12029-ADB Document 25 Filed 12/04/18 Page 6 of 65
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`Paragraph 13.
`
`14.
`On information and belief, Teva Pharmaceutical Industries Ltd., acquired Labrys
`in 2014 in an agreement that includes an upfront payment of $200 million and up to $625 million
`in additional milestone payments.
`
`ANSWER:
`
`Admitted that Teva Pharmaceuticals Industries Ltd. acquired Labrys Biologics, Inc.
`
`(“Labrys”) on July 21, 2014 in an agreement that includes an upfront payment of $200 million
`
`and up to $625 million in contingent payments upon achievement of certain pre-launch
`
`milestones.
`
`15.
`On information and belief, on October 16, 2017, Teva Branded Pharmaceutical
`Products R&D, Inc. submitted a BLA to the FDA seeking approval to market fremanezumab to
`treat migraine. On information and belief, Teva used a “priority review voucher” purchased from
`a third party for $150 million to obtain accelerated FDA review for its fremanezumab BLA.
`
`ANSWER:
`
`Teva admits that on October 16, 2017, Teva Branded Pharmaceutical Products R&D, Inc.
`
`submitted a BLA to the FDA seeking approval to market fremanezumab to treat episodic and
`
`chronic migraine. Teva admits it used a “priority review voucher” purchased from a third party
`
`for $150 million to obtain accelerated FDA review for its fremanezumab BLA.
`
`16.
`On December 18, 2017, Teva Pharmaceutical Industries Ltd. announced that the
`FDA had accepted the company’s BLA for fremanezumab, and regulatory action was anticipated
`by mid-2018.
`
`ANSWER:
`
`Teva admits the allegations in Paragraph 16 of the Counterclaim.
`
`
`
`
`17.
`On February 8, 2018, Teva announced that the third-party manufacturer of the
`fremanezumab active pharmaceutical ingredient (“API”) had received a warning letter from the
`FDA describing serious violations of current good manufacturing practices. On information and
`belief, Teva submitted a major amendment to its BLA on May 14, 2018, which extended the
`Prescription Drug User Fee Act (“PDUFA”) goal date by three months to September 16, 2018.
`
`ANSWER:
`
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`Case 1:18-cv-12029-ADB Document 25 Filed 12/04/18 Page 7 of 65
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`
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`Admitted that Teva’s third-party source for API production for fremanezumab received
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`an FDA warning letter for its facility in Incheon, South Korea. Admitted that Teva submitted an
`
`amendment to its BLA on May 14, 2018 to the FDA. Admitted that on May 23, 2018, Teva
`
`Pharmaceutical Industries Ltd. confirmed that the PDUFA action date for fremanezumab was set
`
`for September 16, 2018. Teva denies the remaining allegations of this paragraph.
`
`18.
`On September 14, 2018, Teva announced that FDA had approved fremanezumab
`for the preventive treatment of migraine under the propriety name Ajovy™.
`
`ANSWER:
`
`Teva admits the allegations in Paragraph 18 of the Counterclaim.
`
`COUNT I
`(Declaratory Judgment of Non-Infringement of the ‘045 Patent)
`
`19.
`Lilly repeats and incorporates by reference the allegations contained in
`Paragraphs 1-18 as though fully set forth herein.
`
`ANSWER:
`
`Teva repeats and fully incorporates its responses to each of the preceding paragraphs 1-
`
`18 as if fully set forth herein.
`
`20.
`Upon information and belief, on or about November 19, 2013, United States
`Patent and Trademark Office (“USPTO”) issued U.S. Patent No. 8,586,045 (“the ’045 patent”),
`titled “Methods of Using Anti-CGRP Antagonist Antibodies,” to assignee Labrys Biologics, Inc.
`In this action, Teva GmbH has pled that it is the owner of the ’045 patent, and Teva USA has
`pled that it has an exclusive license to the ’045 patent.
`
`ANSWER:
`
`
`
`Teva admits that U.S. Patent No. 8,586,045 (“the ’045 patent”) is titled “Methods of
`
`Using Anti-CGRP Antagonist Antibodies,” and on the face of the patent, lists an issue date of
`
`November 19, 2013. Teva admits that, on the face of the patent, Labrys Biologics, Inc. is listed
`
`as the assignee. Teva responds to the remaining allegations regarding allegations in Teva’s
`
`Complaint that the Complaint Teva filed in this action speaks for itself. To the extent that a
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`Case 1:18-cv-12029-ADB Document 25 Filed 12/04/18 Page 8 of 65
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`response is required, Teva admits Teva GmbH has pled that it is the owner of the ’045 patent,
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`and that Teva USA has pled that it has an exclusive license to the ’045 patent.
`
`21.
`Counterclaim-Defendants allege that the manufacture, use, offer for sale, sale, or
`importation of a biologic product with the active ingredient galcanezumab infringes the ’045
`patent.
`
`
`ANSWER:
`
`
`
`Teva responds that the Complaint Teva filed in this case speaks for itself. To the extent a
`
`further response is required, Teva admits that the Complaint alleges that Lilly’s commercial
`
`manufacture, importation, offers to sell, and sales of its Galcanezumab Product will directly
`
`infringe, and/or actively induce and/or contribute to infringement of claims of the ’045 patent.
`
`22.
`By asserting their claims against Lilly for infringement of the ’045 patent,
`Counterclaim-Defendants have created an actual, substantial, and continuing justiciable case or
`controversy regarding the infringement of the claims of the ’045 patent.
`
`ANSWER:
`
`Paragraph 22 states legal conclusions to which no response is required. To the extent that
`
`a response is required and for the purposes of this action only, Teva admits that there is an actual,
`
`substantial and continuing justiciable case or controversy regarding Lilly’s infringement of the
`
`claims of the ’045 patent.
`
`23.
`Lilly has not infringed, does not infringe, and would not, if a biologic product
`with the active ingredient galcanezumab were marketed for migraine prevention, infringe,
`directly or indirectly, any valid or enforceable claim of the ’045 patent.
`
`ANSWER:
`
`Paragraph 23 states legal conclusions to which no response is required. To the extent that
`
`a response is required, Teva denies the allegations in Paragraph 23 of the Counterclaim.
`
`24.
`Under 28 U.S.C. sections 2201 and 2202, Lilly is entitled to a declaratory
`judgment that it has not infringed, does not infringe, and would not, if a biologic product with the
`active ingredient galcanezumab were marketed, infringe, directly or indirectly, any valid and
`enforceable claim of the ’045 patent.
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`Case 1:18-cv-12029-ADB Document 25 Filed 12/04/18 Page 9 of 65
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`
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`ANSWER:
`
`Paragraph 24 states legal conclusions to which no response is required. To the extent that
`
`a response is required, Teva denies the allegations in Paragraph 24 of the Counterclaim.
`
`COUNT II
`(Declaratory Judgment of Invalidity of the ‘045 Patent)
`
`25.
`Lilly repeats and incorporates by reference the allegations contained in
`Paragraphs 1-24 as though fully set forth herein.
`
`ANSWER:
`
`Teva repeats and fully incorporates its responses to each of the preceding paragraphs 1-
`
`24 as if fully set forth herein.
`
`26.
`Counterclaim-Defendants allege that the manufacture, use, offer for sale, sale, or
`importation of a biologic product with the active ingredient galcanezumab infringes the ’045
`patent.
`
`
`ANSWER:
`
`
`
`Teva responds that the Complaint Teva filed in this case speaks for itself. To the extent a
`
`further response is required, Teva admits that the Complaint alleges that Lilly’s commercial
`
`manufacture, importation, offers to sell, and sales of its Galcanezumab Product will directly
`
`infringe, and/or actively induce and/or contribute to infringement of claims of the ‘045 patent.
`
`27.
`By asserting their claims against Lilly for infringement of the ’045 patent,
`Counterclaim-Defendants have created an actual, substantial, and continuing justiciable case or
`controversy regarding the validity of the claims of the ’045 patent.
`
`ANSWER:
`
`Paragraph 27 states legal conclusions to which no response is required. To the extent that
`
`a response is required and for the purposes of this action only, Teva admits that there is an actual,
`
`substantial and continuing justiciable case or controversy regarding the validity of the ’045
`
`patent.
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`28.
`One or more of the claims of the ’045 patent are invalid for failure to comply with
`one or more of the requirements for patentability set forth in Title 35 of the U.S. Code, including
`§§ 101, 102, 103, and/or 112.
`
`ANSWER:
`
`Paragraph 28 states legal conclusions to which no response is required. To the extent that
`
`a response is required, Teva denies the allegations in Paragraph 28 of the Counterclaim.
`
`29.
`For example, one or more of the claims of the ’045 patent are invalid as obvious
`under 35 U.S.C. § 103 over at least one or more prior art references, including Olesen, J. et al.,
`New Engl. J. Med. (2004) 350:1104-10; K.K.C. Tan et al., Clin. Sci. (1995) 89:565-573; and
`U.S. Patent No. 6,180,370.
`
`ANSWER:
`
`Paragraph 29 states legal conclusions to which no response is required. To the extent that
`
`a response is required, Teva denies the allegations in Paragraph 29 of the Counterclaim.
`
`30.
`As a further example, the ’045 patent is invalid under 35 U.S.C. § 112 for lack of
`written description. The specification of the ’045 patent fails to provide adequate written
`description to reasonably convey to those skilled in the art that the inventor had possession of the
`claimed subject matter, including the entire genus of antibodies (human or humanized
`monoclonal anti-CGRP antagonist antibodies) recited in the claimed method of treatment.
`
`ANSWER:
`
`Paragraph 30 states legal conclusions to which no response is required. To the extent that
`
`a response is required, Teva denies the allegations in Paragraph 30 of the Counterclaim.
`
`31.
`Under 28 U.S.C. sections 2201 and 2202, Lilly is entitled to a declaratory
`judgment that the claims of the ’045 patent are invalid for failure to comply with one or more of
`the requirements for patentability set forth in Title 35 of the U.S. Code, including §§ 101, 102,
`103, and/or 112.
`
`ANSWER:
`
`Paragraph 31 states legal conclusions to which no response is required. To the extent that
`
`a response is required, Teva denies the allegations in Paragraph 31 of the Counterclaim.
`
`COUNT III
`(Declaratory Judgment of Non-Infringement of the ‘649 Patent)
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`32.
`Lilly repeats and incorporates by reference the allegations contained in
`Paragraphs 1-31 as though fully set forth herein.
`
`ANSWER:
`
`Teva repeats and fully incorporates its responses to each of the preceding paragraphs 1-
`
`31 as if fully set forth herein.
`
`33.
`Upon information and belief, on or about December 3, 2013, the USPTO issued
`U.S. Patent No. 8,597,649 (“the ’649 patent”), titled “Antagonist Antibodies Directed Against
`Calcitonin Gene-Related Peptide and Methods Using Same,” to assignee Labrys Biologics, Inc.
`In this action, Teva GmbH has pled that it is the owner of the ’649 patent, and Teva USA has
`pled that it has an exclusive license to the ’649 patent.
`
`ANSWER:
`
`
`
`Teva admits that U.S. Patent No. 8,597,649 (“the ’649 patent”) is titled “Antagonist
`
`Antibodies Directed Against Calcitonin Gene-Related Peptide and Methods Using Same,” and
`
`on the face of the patent, lists an issue date of December 3, 2013. Teva admits that, on the face
`
`of the patent, Labrys Biologics, Inc. is listed as the assignee. Teva responds to the remaining
`
`allegations regarding allegations in Teva’s Complaint that the Complaint Teva filed in this action
`
`speaks for itself. To the extent that a response is required, Teva admits Teva GmbH has pled that
`
`it is the owner of the ’649 patent, and that Teva USA has pled that it has an exclusive license to
`
`the ’649 patent.
`
`34.
`Counterclaim-Defendants allege that the manufacture, use, offer for sale, sale, or
`importation of a biologic product with the active ingredient galcanezumab infringes the ’649
`patent.
`
`
`ANSWER:
`
`
`
`Teva responds that the Complaint Teva filed in this case speaks for itself. To the extent a
`
`further response is required, Teva admits that the Complaint alleges that Lilly’s commercial
`
`manufacture, importation, offers to sell, and sales of its Galcanezumab Product will directly
`
`infringe, and/or actively induce and/or contribute to infringement of claims of the ‘649 patent.
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`35.
`By asserting their claims against Lilly for infringement of the ’649 patent,
`Counterclaim-Defendants have created an actual, substantial, and continuing justiciable case or
`controversy regarding the infringement of the claims of the ’649 patent.
`
`ANSWER:
`
`Paragraph 35 states legal conclusions to which no response is required. To the extent that
`
`a response is required and for the purposes of this action only, Teva admits that there is an actual,
`
`substantial and continuing justiciable case or controversy regarding Lilly’s infringement of the
`
`claims of the ’649 patent.
`
`36.
`Lilly has not infringed, does not infringe, and would not, if a biologic product
`with the active ingredient galcanezumab were marketed, infringe, directly or indirectly, any valid
`or enforceable claim of the ’649 patent.
`
`ANSWER:
`
`Paragraph 36 states legal conclusions to which no response is required. To the extent that
`
`a response is required, Teva denies the allegations in Paragraph 36 of the Counterclaim.
`
`37.
`Under 28 U.S.C. sections 2201 and 2202, Lilly is entitled to a declaratory
`judgment that it has not infringed, does not infringe, and would not, if a biologic product with the
`active ingredient galcanezumab were marketed, infringe, directly or indirectly, any valid and
`enforceable claim of the ’649 patent.
`
`ANSWER:
`
`Paragraph 37 states legal conclusions to which no response is required. To the extent that
`
`a response is required, Teva denies the allegations in Paragraph 37 of the Counterclaim.
`
`COUNT IV
`(Declaratory Judgment of Invalidity of the ‘649 Patent)
`
`38.
`Lilly repeats and incorporates by reference the allegations contained in
`Paragraphs 1-37 as though fully set forth herein.
`
`ANSWER:
`
`Teva repeats and fully incorporates its responses to each of the preceding paragraphs 1-
`
`37 as if fully set forth herein.
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`Case 1:18-cv-12029-ADB Document 25 Filed 12/04/18 Page 13 of 65
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`39.
`Counterclaim-Defendants allege that the manufacture, use, offer for sale, sale, or
`importation of a biologic product with the active ingredient galcanezumab infringes the ’649
`patent.
`
`
`ANSWER:
`
`
`
`Teva responds that the Complaint Teva filed in this case speaks for itself. To the extent a
`
`further response is required, Teva admits that the Complaint alleges that Lilly’s commercial
`
`manufacture, importation, offers to sell, and sales of its Galcanezumab Product will directly
`
`infringe, and/or actively induce and/or contribute to infringement of claims of the ‘649 patent.
`
`40.
`By asserting their claims against Lilly for infringement of the ’649 patent,
`Counterclaim-Defendants have created an actual, substantial, and continuing justiciable case or
`controversy regarding the validity of the claims of the ’649 patent.
`
`ANSWER:
`
`Paragraph 40 states legal conclusions to which no response is required. To the extent that
`
`a response is required and for the purposes of this action only, Teva admits that there is an actual,
`
`substantial and continuing justiciable case or controversy regarding Lilly’s validity of the ’649
`
`patent.
`
`41.
`One or more of the claims of the ’649 patent are invalid for failure to comply with
`one or more of the requirements for patentability set forth in Title 35 of the U.S. Code, including
`§§ 101, 102, 103, and/or 112.
`
`ANSWER:
`
`Paragraph 41 states legal conclusions to which no response is required. To the extent that
`
`a response is required, Teva denies the allegations in Paragraph 41 of the Counterclaim.
`
`42.
`For example, one or more of the claims of the ’649 patent are invalid as obvious
`under 35 U.S.C. § 103 over at least one or more prior art references, including K.K.C. Tan, et al.,
`Clin. Sci. (1995) 89:565-573; S.J. Wimalawansa, Endocrine Reviews (1996) 17(5):533-585; and
`U.S. Patent No. 6,180,370.
`
`ANSWER:
`
`Paragraph 42 states legal conclusions to which no response is required. To the extent that
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`a response is required, Teva denies the allegations in Paragraph 42 of the Counterclaim.
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`43.
`As a further example, the ’649 patent is invalid under 35 U.S.C. § 112 for lack of
`written description. The specification of the ’649 patent fails to provide adequate written
`description to reasonably convey to those skilled in the art that the inventor had possession of the
`entire genus of antibodies claimed (“human or humanized monoclonal anti-CGRP antagonist
`antibod[ies] with a binding affinity (KD) to human α-CGRP of 50 nM or less as measured by
`surface plasmon resonance at 37°C”).
`
`ANSWER:
`
`Paragraph 43 states legal conclusions to which no response is required. To the extent that
`
`a response is required, Teva denies the allegations in Paragraph 43 of the Counterclaim.
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`44.
`Under 28 U.S.C. sections 2201 and 2202, Lilly is entitled to a declaratory
`judgment that the claims of the ’649 patent are invalid for failure to comply with one or more of
`the requirements for patentability set forth in Title 35 of the U.S. Code, including §§ 101, 102,
`103, and/or 112.
`
`ANSWER:
`
`Paragraph 44 states legal conclusions to which no response is required. To the extent that
`
`a response is required, Teva denies the allegations in Paragraph 44 of the Counterclaim.
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`COUNT V
`(Declaratory Judgment of Non-Infringement of the ‘951 Patent)
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`45.
`Lilly repeats and incorporates by reference the allegations contained in
`Paragraphs 1-44 as though fully set forth herein.
`
`ANSWER:
`
`Teva repeats and fully incorporates its responses to each of the preceding paragraphs 1-
`
`44 as if fully set forth herein.
`
`46.
`Upon information and belief, on or about February 23, 2016, the USPTO issued
`U.S. Patent No. 9,266,951 (“the ’951 patent”), titled “Antagonist antibodies directed against
`calcitonin gene-related peptide and methods using same,” to assignee Labrys Biologics, Inc. In
`this action, Teva GmbH has pled that it is the owner of the ’951 patent, and Teva USA has pled
`that it has an exclusive license to the ’951 patent.
`
`ANSWER:
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`Teva admits that U.S. Patent No. 9,266,951 (“the ’951 patent”) is titled “Antagonist
`
`antibodies directed against calcitonin gene-related peptide and methods using same,” and on the
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`face of the patent, lists an issue date of February 23, 2016. Teva admits that, on the face of the
`
`patent, Labrys Biologics, Inc. is listed as the assignee. Teva responds to the remaining
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`allegations regarding allegations in Teva’s Complaint that the Complaint Teva filed in this action
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`speaks for itself. To the extent that a response is required, Teva admits Teva GmbH has pled that
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`it is the owner of the ’951 patent, and that Teva USA has pled that it has an exclusive license to
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`the ’951 patent.
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`47.
`Counterclaim-Defendants allege that the manufacture, use, offer for sale, sale, or
`importation of a biologic product with the active ingredient galcanezumab infringes the ’951
`patent.
`
`
`ANSWER:
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`
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`Teva responds that the Complaint Teva filed in this case speaks for itself. To the extent a
`
`further response is required, Teva admits that the Complaint alleges that Lilly’s commercial
`
`manufacture, importation, offers to sell, and sales of its Galcanezumab Product will directly
`
`infringe, and/or actively induce and/or contribute to infringement of claims of the ‘951 patent.
`
`48.
`By asserting their claims against Lilly for infringement of the ’951 patent,
`Counterclaim-Defendants have created an actual, substantial, and continuing justiciable case or
`controversy regarding the infringement of the claims of the ’951 patent.
`
`ANSWER:
`
`Paragraph 48 states legal conclusions to which no response is required. To the extent that
`
`a response is required and for the purposes of this action only, Teva admits that there is an actual,
`
`substantial and continuing justiciable case or controversy regarding Lilly’s infringement of the
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`claims of the ’951 patent.
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`49.
`Lilly has not infringed, does not infringe, and would not, if a biologic product
`with the active ingredient galcanezumab were marketed, infringe, directly or indirectly, any valid
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`or enforceable claim of the ’951 patent.
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`ANSWER:
`
`Paragraph 49 states legal conclusions to which no response is required. To the extent that
`
`a response is required, Teva denies the allegations in Paragraph 49 of the Counterclaim.
`
`50.
`Under 28 U.S.C. sections 2201 and 2202, Lilly is entitled to a declaratory
`judgment that it has not infringed, does not infringe, and would not, if a biologic product with the
`active ingredient galcanezumab were marketed, infringe, directly or indirectly, any valid and
`enforceable claim of the ’951 patent.
`
`ANSWER:
`
`Paragraph 50 states legal conclusions to which no response is required. To the extent that
`
`a response is required, Teva denies the allegations in Paragraph 50 of the Counterclaim.
`
`COUNT VI
`(Declaratory Judgment of Invalidity of the ‘951 Patent)
`
`51.
`Lilly repeats and incorporates by reference the allegations contained in
`Paragraphs 1-50 as though fully set forth herein.
`
`ANSWER:
`
`Teva repeats and fully incorporates its responses to each of the preceding paragraphs 1-
`
`50 as if fully set forth herein.
`
`52.
`Counterclaim-Defendants allege that the manufacture, use, offer for sale, sale, or
`importation of a biologic product with the active ingredient galcanezumab infringes the ’951
`patent.
`
`
`ANSWER:
`
`
`
`Teva responds that the Complaint Teva filed in this case speaks for itself. To the extent a
`
`further response is required, Teva admits that the Complaint alleges that Lilly’s commercial
`
`manufacture, importation, offers to sell, and sales of its Galcanezumab Product will directly
`
`infringe, and/or actively induce and/or contribute to infringement of claims of the ‘951 patent.
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`53.
`
`By asserting their claims against Lilly for infringement of the ’951 patent,
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`Counterclaim-Defendants have created an actual, substantial, and continuing justiciable case or
`controversy regarding the validity of the claims of the ’951 patent.
`
`ANSWER:
`
`Paragraph 53 states legal conclusions to which no response is required. To the extent that
`
`a response is required and for the purposes of this action only, Teva admits that there is an actual,
`
`substantial and continuing justiciable case or controversy regarding the validity of the ’951
`
`patent.
`
`54.
`One or more of the claims of the ’951 patent are invalid for failure to comply with
`one or more of the requirements for patentability set forth in Title 35 of the U.S. Code, including
`§§ 101, 102, 103, and/or 112.
`
`ANSWER:
`
`Paragraph 54 states legal conclusions to which no response is required. To the extent that
`
`a response is required, Teva denies the allegations in Paragraph 54 of the Counterclaim.
`
`55.
`For example, one or more of the claims of the ’951 patent are invalid as obvious
`under 35