Case 1:17-cv-00227-VAC-MPT Document 9 Filed 04/26/17 Page 1 of 26 PageID #: 225
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
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`Plaintiffs,
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`C.A. No. 17-227-VAC-MPT
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`))))))))))
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`TEVA PHARMACEUTICALS USA, INC.,
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`v.
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`Defendant.
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`DEFENDANT TEVA PHARMACEUTICALS USA, INC.’s
`ANSWER, AFFIRMATIVE DEFENSES AND COUNTERCLAIMS
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`In response to the Complaint filed by Plaintiffs Novo Nordisk Inc. (“NNI”) and Novo
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`Nordisk A/S (“NNAS”) (collectively, “Novo Nordisk”), Defendant Teva Pharmaceuticals USA,
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`Inc., (“Teva”) through its attorneys, hereby submits its Answer, Defenses, and Counterclaims.
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`ANSWER TO COMPLAINT
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`Each of the paragraphs below corresponds to the same-numbered paragraphs in the
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`Complaint. Defendant denies all allegations in the Complaint, whether express or implied, that
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`are not specifically admitted below. Any factual allegation below is admitted only as to the
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`specific admitted facts, not as to any purported conclusions, characterizations, implications, or
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`speculations that arguably follow from the admitted facts. Defendant denies that Plaintiffs are
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`entitled to the relief requested or any other relief.
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`Defendant, through its attorneys, answers as follows:
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF DELAWARE
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`NOVO NORDISK INC. and NOVO
`NORDISK A/S,
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`Plaintiffs,
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`C.A. No. 17-227-VAC-MPT
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`))))))))))
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`TEVA PHARMACEUTICALS USA, INC.,
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`v.
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`Defendant.
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`DEFENDANT TEVA PHARMACEUTICALS USA, INC.’s
`ANSWER, AFFIRMATIVE DEFENSES AND COUNTERCLAIMS
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`In response to the Complaint filed by Plaintiffs Novo Nordisk Inc. (“NNI”) and Novo
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`Nordisk A/S (“NNAS”) (collectively, “Novo Nordisk”), Defendant Teva Pharmaceuticals USA,
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`Inc., (“Teva”) through its attorneys, hereby submits its Answer, Defenses, and Counterclaims.
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`ANSWER TO COMPLAINT
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`Each of the paragraphs below corresponds to the same-numbered paragraphs in the
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`Complaint. Defendant denies all allegations in the Complaint, whether express or implied, that
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`are not specifically admitted below. Any factual allegation below is admitted only as to the
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`specific admitted facts, not as to any purported conclusions, characterizations, implications, or
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`speculations that arguably follow from the admitted facts. Defendant denies that Plaintiffs are
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`entitled to the relief requested or any other relief.
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`Defendant, through its attorneys, answers as follows:
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`Case 1:17-cv-00227-VAC-MPT Document 9 Filed 04/26/17 Page 2 of 26 PageID #: 226
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`NATURE OF THE ACTION
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`1.
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`Defendant admits that the Complaint purports to state an action for patent
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`infringement brought pursuant to the Patent Laws of the United States, Titles 35 of the United
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`States Code arising from filing of an Abbreviated New Drug Application (“ANDA”) seeking
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`approval to market a generic version of Victoza® prior to the expiration of U.S. Patent Nos.
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`6,268,343, 8,114,833, 8,846,618, 9,265,893, and RE41,956; Defendant denies the remaining
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`allegations of paragraph 1.
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`THE PARTIES
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`2.
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`Defendant lacks knowledge or information sufficient to form a belief about the
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`truth of the allegations of paragraph 2 and therefore denies same.
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`3.
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`Defendant lacks knowledge or information sufficient to form a belief about the
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`truth of the allegations of paragraph 3 and therefore denies same.
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`4.
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`Defendant does not contest personal jurisdiction over Teva for purposes of this
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`action only. Teva admits that it is incorporated in the State of Delaware, and otherwise denies
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`the allegations of paragraph 4.
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`THE PATENTS-IN-SUIT
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`5.
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`Defendant admits that the face of the ’343 patent lists the title as “Derivatives of
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`GLP-1 Analogs,” identifies the issue date as July 31, 2001, and that Exhibit A to the Complaint
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`purports to be a copy of the ’343 patent. Defendant lacks knowledge or information sufficient to
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`form a belief about the truth of the remaining allegations of paragraph 5 and, therefore denies
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`same.
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`6.
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`Defendant admits that the face of the ’833 patent lists the title as “Propylene
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`Glycol-containing Peptide Formulations Which Are Optimal For Production and For Use in
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`Injection Devices,” identifies the issue date as February 14, 2012, and that Exhibit B to the
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`2
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`Case 1:17-cv-00227-VAC-MPT Document 9 Filed 04/26/17 Page 3 of 26 PageID #: 227
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`Complaint purports to be a copy of the ’833 patent. Defendant lacks knowledge or information
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`sufficient to form a belief about the truth of the remaining allegations of paragraph 6 and
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`therefore denies same.
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`7.
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`Defendant admits that the face of the ’618 patent lists the title as “Stable
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`Formulation of Modified GLP-1,” identifies the issue date as September 30, 2012, and that
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`Exhibit C to the Complaint purports to be a copy of the ’618 patent. Defendant lacks knowledge
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`or information sufficient to form a belief about the truth of the remaining allegations of
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`paragraph 7 and therefore denies same.
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`8.
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`Defendant admits that the face of the ’893 patent lists the title as “Injection
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`Button,” identifies the issue date as February 23, 2016, and that Exhibit D to the Complaint
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`purports to be a copy of the ’893 patent. Defendant lacks knowledge or information sufficient to
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`form a belief about the truth of the remaining allegations of paragraph 8 and therefore denies
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`same.
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`9.
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`Defendant admits that the face of the RE ’956 patent lists the title as “Dose
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`Setting Limiter,” identifies the issue date as November 23, 2010, and that Exhibit E to the
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`Complaint purports to be a copy of the RE ’956 patent. Defendant lacks knowledge or
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`information sufficient to form a belief about the truth of the remaining allegations of paragraph 9
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`and therefore denies same.
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`VICTOZA®
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`10.
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`Defendant admits that the Approved Drug Products with Therapeutic Equivalence
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`Evaluations (“the Orange Book”) identifies NNI as the holder of NDA No. 022341 for Victoza®,
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`Liraglutide Recombinant Solution Injection, 18 mg/3 ml (6 mg/ml). Defendant lacks knowledge
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`or information sufficient to form a belief about the truth of the remaining allegations of
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`paragraph 10 and therefore denies same.
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`3
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`Case 1:17-cv-00227-VAC-MPT Document 9 Filed 04/26/17 Page 4 of 26 PageID #: 228
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`11.
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`Defendant admits that the Orange Book appears to list the ’343, ’833, ’618, ’893,
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`and RE ’956 patents with respect to Victoza®. Defendant lacks knowledge or information
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`sufficient to form a belief about the truth of the remaining allegations of paragraph 11 and
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`therefore denies same.
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`TEVA’S ANDA
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`12.
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`13.
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`14.
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`Admitted.
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`Admitted.
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`Defendant admits that Teva sent Plaintiffs a “Notification of Certification for US
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`Patent Nos. 6,268,343; 8,114,833; 8,846,618; 9,265,893; and RE41,956 Pursuant
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`to
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`§ 505(j)(2)(B)(iv) of the Federal Food, Drug, and Cosmetic Act” dated January 20, 2017
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`(“Notice Letter”). Defendant further admits that the Notice Letter represented that Teva had
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`submitted to the FDA ANDA No. 210884 (“Teva’s ANDA”) and paragraph IV certifications,
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`and admits that Teva attached a memorandum to its Notice Letter in which it alleged factual and
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`legal bases for its paragraph IV certifications, and that the paragraph IV certifications allege that
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`the ’343, ’833, ’618, ’893 and RE ’956 are invalid and/or would not be infringed by the
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`commercial manufacture, use or sale of the drug product described in Teva’s ANDA, and denies
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`the remaining allegations of paragraph 14.
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`15.
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`Defendant admits that in its Notice Letter, Teva offered, pursuant to 21 U.S.C.
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`§ 355(j)(C)(i)(III) Confidential Access to Plaintiffs of certain information from Teva’s ANDA,
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`with certain restrictions, and on information and belief, Plaintiffs rejected that offer. Defendant
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`denies the remaining allegations of paragraph 15.
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`JURISDICTION AND VENUE
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`16.
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`Paragraph 16 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, Defendant admits that the Complaint purports to state claims
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`4
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`Case 1:17-cv-00227-VAC-MPT Document 9 Filed 04/26/17 Page 5 of 26 PageID #: 229
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`arising under the patent laws of the United States, and that this Court has subject matter
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`jurisdiction over the action; Defendant denies the remaining allegations of paragraph 16.
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`17.
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`Paragraph 17 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, for purposes of this case only, Defendant does not contest
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`jurisdiction in this Court; Defendant denies the remaining allegations of paragraph 17.
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`18.
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`Paragraph 18 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, for purposes of this case only, Defendant does not contest venue in
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`this Court; Defendant denies the remaining allegations of paragraph 18.
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 6,268,343
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`19.
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`Defendant repeats and incorporates here by reference its responses to paragraphs
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`1-18.
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`20.
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`Defendant admits that Teva submitted ANDA No. 210084 to the FDA, pursuant
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`to 21 U.S.C. § 355(j), seeking approval to market liraglutide recombinant solution injection, 18
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`mg/3 ml (6 mg/ml); Defendant denies the remaining allegations of paragraph 20.
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`21.
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`22.
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`23.
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`24.
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`Denied.
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`Denied
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`Denied.
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`Paragraph 24 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, Defendant lacks knowledge or information sufficient to form a
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`belief about the truth of the allegations of paragraph 24 and therefore denies same.
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`25.
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`Denied.
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 8,114,833
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`26.
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`Defendant repeats and incorporates here by reference its responses to paragraphs
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`1-25.
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`5
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`27.
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`Defendant admits that Teva submitted ANDA No. 210084 to the FDA, pursuant
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`to 21 U.S.C. § 355(j), seeking approval to market liraglutide recombinant solution injection, 18
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`mg/3 ml (6 mg/ml); Defendant denies the remaining allegations of paragraph 27.
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`28.
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`29.
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`30.
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`Denied.
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`Denied
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`Paragraph 30 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, Defendant lacks knowledge or information sufficient to form a
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`belief about the truth of the allegations of paragraph 30 and therefore denies same.
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`31.
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`Denied.
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 8,846,618
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`32.
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`Defendant repeats and incorporates here by reference its responses to paragraphs
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`1-31.
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`33.
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`Defendant admits that Teva submitted ANDA No. 210084 to the FDA, pursuant
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`to 21 U.S.C. § 355(j), seeking approval to market liraglutide recombinant solution injection, 18
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`mg/3 ml (6 mg/ml); Defendant denies the remaining allegations of paragraph 33.
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`34.
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`35.
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`36.
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`Denied.
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`Denied
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`Paragraph 36 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, Defendant lacks knowledge or information sufficient to form a
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`belief about the truth of the allegations of paragraph 36 and therefore denies same.
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`37.
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`Denied.
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. 9,265,893
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`38.
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`Defendant repeats and incorporates here by reference its responses to paragraphs
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`1-37.
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`6
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`39.
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`Defendant admits that Teva submitted ANDA No. 210084 to the FDA, pursuant
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`to 21 U.S.C. § 355(j), seeking approval to market liraglutide recombinant solution injection, 18
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`mg/3 ml (6 mg/ml); Defendant denies the remaining allegations of paragraph 39.
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`40.
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`41.
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`42.
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`Denied.
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`Denied
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`Paragraph 42 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, Defendant lacks knowledge or information sufficient to form a
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`belief about the truth of the allegations of paragraph 42 and therefore denies same.
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`43.
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`Denied.
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`COUNT FOR INFRINGEMENT OF U.S. PATENT NO. RE41,956
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`44.
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`Defendant repeats and incorporates here by reference its responses to paragraphs
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`1-43.
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`45.
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`Defendant admits that Teva submitted ANDA No. 210084 to the FDA, pursuant
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`to 21 U.S.C. § 355(j), seeking approval to market liraglutide recombinant solution injection, 18
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`mg/3 ml (6 mg/ml); Defendant denies the remaining allegations of paragraph 45.
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`46.
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`47.
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`48.
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`Denied.
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`Denied
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`Paragraph 48 contains legal conclusions to which no answer is required. To the
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`extent an answer is required, Defendant lacks knowledge or information sufficient to form a
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`belief about the truth of the allegations of paragraph 48 and therefore denies same.
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`49.
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`Denied.
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`PRAYER FOR RELIEF
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`Defendant denies that Plaintiff is entitled to any of the relief sought in the prayer for
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`relief or any relief whatsoever.
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`7
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`AFFIRMATIVE AND SEPARATE DEFENSES
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`First Defense
`(Failure to State a Claim)
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`The Complaint fails to state a claim upon which relief can be granted.
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`Second Defense
`(Non-infringement of the ’343 Patent)
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`The manufacture, use, sale, offer for sale, or importation into the United States of the
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`drug products described in ANDA No. 210084 has not infringed, does not infringe, and will not
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`infringe any valid and enforceable claim of the ’343 patent directly, indirectly, by inducement,
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`contributorily, literally, under the doctrine of equivalents, or in any other manner.
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`Third Defense
`(Invalidity of the ’343 Patent)
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`Each and every claim of the ’343 patent is invalid for failure to satisfy one or more
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`provisions of Title 35 of the United States Code, including but not limited to 35 U.S.C. §§ 101,
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`102, 103, and 112, and/or is invalid under the doctrine of obviousness-type double patenting.
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`Fourth Defense
`(Non-infringement of the ’833 Patent)
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`The manufacture, use, sale, offer for sale, or importation into the United States of the
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`drug products described in ANDA No. 210084 has not infringed, does not infringe, and will not
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`infringe any valid and enforceable claim of the ’833 patent directly, indirectly, by inducement,
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`contributorily, literally, under the doctrine of equivalents, or in any other manner.
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`Fifth Defense
`(Invalidity of the ’833 Patent)
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`Each and every claim of the ’833 patent is invalid for failure to satisfy one or more
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`provisions of Title 35 of the United States Code, including but not limited to 35 U.S.C. §§ 101,
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`102, 103, and 112, and/or is invalid under the doctrine of obviousness-type double patenting.
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`8
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`Sixth Defense
`(Non-infringement of the ’618 Patent)
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`The manufacture, use, sale, offer for sale, or importation into the United States of the
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`drug products described in ANDA No. 210084 has not infringed, does not infringe, and will not
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`infringe any valid and enforceable claim of the ’618 patent directly, indirectly, by inducement,
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`contributorily, literally, under the doctrine of equivalents, or in any other manner.
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`Seventh Defense
`(Invalidity of the ’618 Patent)
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`Each and every claim of the ’618 patent is invalid for failure to satisfy one or more
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`provisions of Title 35 of the United States Code, including but not limited to 35 U.S.C. §§ 101,
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`102, 103, and 112, and/or is invalid under the doctrine of obviousness-type double patenting.
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`Eighth Defense
`(Non-infringement of the ’893 Patent)
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`The manufacture, use, sale, offer for sale, or importation into the United States of the
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`drug products described in ANDA No. 210084 has not infringed, does not infringe, and will not
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`infringe any valid and enforceable claim of the ’893 patent directly, indirectly, by inducement,
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`contributorily, literally, under the doctrine of equivalents, or in any other manner.
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`Ninth Defense
`(Invalidity of the ’893 Patent)
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`Each and every claim of the ’893 patent is invalid for failure to satisfy one or more
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`provisions of Title 35 of the United States Code, including but not limited to 35 U.S.C. §§ 102,
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`103, and 112, and/or is invalid under the doctrine of obviousness-type double patenting.
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`Tenth Defense
`(Non-infringement of the RE ’956 Patent)
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`The manufacture, use, sale, offer for sale, or importation into the United States of the
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`drug products described in ANDA No. 210084 has not infringed, does not infringe, and will not
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`9
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`Case 1:17-cv-00227-VAC-MPT Document 9 Filed 04/26/17 Page 10 of 26 PageID #: 234
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`infringe any valid and enforceable claim of the RE ’956 patent directly, indirectly, by
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`inducement, contributorily, literally, under the doctrine of equivalents, or in any other manner.
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`Eleventh Defense
`(Invalidity of the RE ’956 Patent)
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`Each and every claim of the RE ’956 patent is invalid for failure to satisfy one or more
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`provisions of Title 35 of the United States Code, including but not limited to 35 U.S.C. §§ 102,
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`103, and 112, and/or is invalid under the doctrine of obviousness-type double patenting.
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`Twelfth Defense
`(No costs)
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`Plaintiff is barred by 35 U.S.C. § 288 from recovering costs associated with this suit.
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`Thirteenth Defense
`(Reservation of rights)
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`Defendant reserve the right to allege additional affirmative defenses as they become
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`known through the course of discovery.
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`COUNTERCLAIMS
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`Without admitting any of the allegations of Plaintiffs other than those expressly admitted
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`herein, and without prejudice of the rights of Defendant to plead additional Counterclaims as the
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`facts of the matter warrant, Teva hereby asserts the following Counterclaims against Novo
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`Nordisk Inc. and Novo Nordisk A/S (collectively, “Novo Nordisk”).
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`THE PARTIES
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`1.
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`Teva is a corporation organized and existing under the laws of the State of
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`Delaware, having a place of business at 1090 Horsham Road, North Wales, Pennsylvania, 19454.
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`2.
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`Upon information and belief, Plaintiff Novo Nordisk Inc. (“NNI”) is a corporation
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`organized and existing under the laws of the State of Delaware, having its principal place of
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`business at 800 Scudders Mill Road, Plainsboro, New Jersey, 08536.
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`10
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`3.
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`Upon information and belief, Plaintiff Novo Nordisk A/S (“NNAS”) is an entity
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`organized and existing under the laws of the Kingdom of Denmark, having its principal place of
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`business at Novo Allé, 2880 Bagsværd, Denmark. Upon information and belief, NNI is an
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`indirect, wholly-owned subsidiary of NNAS.
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`JURISDICTION AND VENUE
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`4.
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`This is a declaratory judgment action arising under the patent laws of the United
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`States, Title 35, United States Code. The Court has subject matter jurisdiction pursuant to 28
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`U.S.C. §§ 1331 and 1338(a). The requested relief is authorized by the Declaratory Judgment Act,
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`28 U.S.C. §§ 2201 and 2202.
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`5.
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`Personal jurisdiction over Novo Nordisk is proper because, inter alia, Novo
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`Nordisk initiated and is prosecuting this action, and because, upon information and belief, either
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`directly or through its agents, it transacts business in, and derives substantial revenue from,
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`Delaware.
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`6.
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`7.
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`Venue is proper in this Judicial District under 28 U.S.C. §§ 1391 and 1400.
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`FACTUAL BACKGROUND
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`U.S. Patent No. 6,268,343 (the “’343 patent”) is entitled “Derivatives of GLP-1
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`Analogs,” and states it was issued on July 31, 2001.
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`8.
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`U.S. Patent No. 8,114,833 (the “’833 patent”) is entitled “Propylene Glycol-
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`containing Peptide Formulations Which Are Optimal For Production and For Use in Injection
`
`Devices,” and states it was issued on February 14, 2012.
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`9.
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`U.S. Patent No. 8,846,618 (the “’618 patent”) is entitled “Stable Formulation of
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`Modified GLP-1,” and states it was issued on September 30, 2012.
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`10.
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`U.S. Patent No. 9,265,893 (the “’893 patent”) is entitled “Injection Button,” and
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`states it was issued on February 23, 2016.
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`11
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`Case 1:17-cv-00227-VAC-MPT Document 9 Filed 04/26/17 Page 12 of 26 PageID #: 236
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`11.
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`U.S. Patent No. RE41,956 (the “RE ’956 patent”) is entitled “Dose Setting
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`Limiter,” and states it was issued on November 23, 2010.
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`12.
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`Upon information and belief, NNAS is the owner of the ’343, ’833, ’618, ’893,
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`and RE ’956 patents.
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`13.
`
`Upon information and belief, NNI is the holder of New Drug Application
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`(“NDA”) No. 022341 for Victoza®, Liraglutide Recombinant Solution Injection, 18 mg/3 ml (6
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`mg/ml).
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`14.
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`The ’343, ’833, ’618, ’893, and RE ’956 patents are listed in the Approved Drug
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`products with Therapeutic Equivalence Evaluations (“the Orange Book”) in connection with
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`NDA No. 022341.
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`15.
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`Teva submitted Abbreviated New Drug Application (“ANDA”) No. 210084 to the
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`FDA under 21 U.S.C. § 355(j) seeking approval for the commercial manufacture, use, or sale in
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`the United States of liraglutide recombinant solution injection, 18 mg/3 ml (6 mg/ml) prior to the
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`expiration of ’343, ’833, ’618, ’893, and RE ’956 patents.
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`16.
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`ANDA No.
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`210084
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`includes
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`a
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`certification
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`under
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`21 U.S.C.
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`§ 355(j)(2)(A)(vii)(IV) of the Federal Food, Drug and Cosmetic Act that the ’343, ’833, ’618,
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`’893, and RE ’956 patents are invalid and/or will not be infringed by the commercial
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`manufacture, use, or sale of the products described therein.
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`17.
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`Teva sent notice of its certification to NNI on or about January 20, 2017. Upon
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`information and belief, NNI received those notifications.
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`18.
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`On March 3, 2017, Novo Nordisk filed this lawsuit alleging infringement of the
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`’343, ’833, ’618, ’893, and RE ’956 patents.
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`12
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`Case 1:17-cv-00227-VAC-MPT Document 9 Filed 04/26/17 Page 13 of 26 PageID #: 237
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`19.
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`ANDA No. 210084 has not received either tentative or final approval, and Teva
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`has not engaged in the manufacture, use, sale, offer for sale in the United States, or importation
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`into the United States, of liraglutide recombinant solution injection, 18 mg/3 ml (6 mg/ml), for
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`commercial purposes. Nonetheless, a justiciable controversy exists as to the infringement and
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`validity of the ’343, ’833, ’618, ’893, and RE ’956 patents because Novo Nordisk brought an
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`action alleging that the importation, manufacture, use, offer for sale, or sale of the products that
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`are the subject of ANDA No. 210084 would infringe those patents, and Teva has denied the
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`alleged infringement and further alleges that the claims of the ’343, ’833, ’618, ’893, and RE
`
`’956 patents are invalid. This controversy is of sufficient immediacy and reality to warrant the
`
`issuance of a Declaratory Judgment.
`
`COUNT I
`DECLARATORY JUDGMENT OF INVALIDITY
`OF THE ’343 PATENT
`
`20.
`
`Teva re-alleges and incorporates by reference the allegations in paragraphs 1-19
`
`of these Counterclaims.
`
`21.
`
`There is an actual, substantial, continuing, and justiciable controversy between the
`
`parties regarding the invalidity of the ’343 patent, based on Plaintiffs’ allegation in their
`
`Complaint that Defendant has infringed or will infringe the ’343 patent.
`
`22.
`
`Each and every claim of the ’343 patent is invalid for failure to satisfy one or
`
`more provisions of Title 35 of the United States Code, including but not limited to 35 U.S.C.
`
`§§ 102 and 103, the bases for which include:
`
`(a)
`
`The ’343 patent describes and claims an alleged invention, the making of
`
`which did not involve the inventive faculty but only the obvious judgment, knowledge, and
`
`mechanical skill possessed by persons having ordinary skill in the art to which the alleged
`
`invention pertains.
`
`
`
`13
`
`
`
`Case 1:17-cv-00227-VAC-MPT Document 9 Filed 04/26/17 Page 14 of 26 PageID #: 238
`
`
`
`(b)
`
`The alleged invention of the ’343 patent does no more than combine
`
`familiar elements according to known methods to yield predictable results. Any alleged
`
`improvement over the prior art set forth in the ’343 patent is no more than the predictable use of
`
`prior art elements according to their established functions. A person of ordinary skill in the art
`
`would have been motivated to combine the teachings of the prior art to achieve the alleged
`
`invention of the ’343 patent and would have had a reasonable expectation of success in doing so.
`
`(c)
`
`The subject matter claimed in the ’343 patent fails to comply with 35
`
`U.S.C. §§ 102 and/or 103 in that the differences between the subject matter claimed in the patent
`
`and the prior art are such that the subject matter as a whole was either fully anticipated by the
`
`prior art or would have been obvious at the time the alleged invention was made to a person
`
`having knowledge of such prior art and having ordinary skill in the art to which the claimed
`
`subject matter pertains.
`
`23.
`
`For example, claims 1-3, 14, 28, 29, 31, 32, and 39 of the ’343 patent are invalid
`
`for at least failure to comply with one or more of the conditions for patentability set forth in Title
`
`35 of the United States Code, including but not limited to 35 U.S.C. § 103. Said claims are
`
`invalid at least as obvious pursuant to § 103(a) in view of at least Buckley et al. WO 91/11457,
`
`GLP-1 Analogs Useful for Diabetes Treatment; Markussen, J. et al., “Soluble, Fatty Acid
`
`Acylated Insulins Bind to Albumin and Show Protracted Action in Pigs,” Diabetologia 39:281-
`
`88 (1996); and Tonsgard, J.H. et al., “Binding of Straight-Chain Saturated Dicarboxylic Acids to
`
`Albumin,” J. Clin. Invest. 82:1567-73 (1988).
`
`24.
`
`Teva is entitled to a judicial declaration that all claims of the ’343 patent are
`
`invalid.
`
`
`
`14
`
`
`
`Case 1:17-cv-00227-VAC-MPT Document 9 Filed 04/26/17 Page 15 of 26 PageID #: 239
`
`
`
`COUNT II
`DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF THE ’343 PATENT
`
`25.
`
`Teva re-alleges and incorporates by reference the allegations in paragraphs 1-24
`
`of these Counterclaims.
`
`26.
`
`There is an actual, substantial, continuing, and justiciable controversy between the
`
`parties regarding whether the filing of ANDA No. 210084 and/or the manufacture, use, offer to
`
`sell, sale and/or importation into the United States of the ANDA Products infringes, has
`
`infringed, or will infringe any valid and enforceable claim of the ’343 patent either directly or
`
`indirectly, and either literally or under the doctrine of equivalents.
`
`27.
`
`Teva has not infringed, contributed to the infringement of, or induced the
`
`infringement of any valid and enforceable claim of the ’343 patent either literally or under the
`
`doctrine of equivalents and is not liable for such infringement.
`
`28.
`
`Teva is entitled to a judicial declaration that it has not infringed, contributed to the
`
`infringement of, or induced the infringement of the ’343 patent either literally or under the
`
`doctrine of equivalents; and that the manufacture, use, sale, offer for sale, or importation of the
`
`products described in ANDA No. 210084 has not infringed, does not infringe, and will not
`
`infringe any valid and enforceable claims of the ’343 patent.
`
`COUNT III
`DECLARATORY JUDGMENT OF INVALIDITY OF THE ’833 PATENT
`
`29.
`
`Teva re-alleges and incorporates by reference the allegations in paragraphs 1-28
`
`of these Counterclaims.
`
`30.
`
`There is an actual, substantial, continuing, and justiciable controversy between the
`
`parties regarding the invalidity of the ’833 patent, based on Plaintiffs’ allegation in their
`
`Complaint that Defendant has infringed or will infringe the ’833 patent.
`
`
`
`15
`
`
`
`Case 1:17-cv-00227-VAC-MPT Document 9 Filed 04/26/17 Page 16 of 26 PageID #: 240
`
`
`
`31.
`
`Each and every claim of the ’833 patent is invalid for failure to satisfy one or
`
`more provisions of Title 35 of the United States Code, including but not limited to 35 U.S.C.
`
`§§ 102, 103, and 112, the bases for which include:
`
`(a)
`
`The alleged invention of the ’833 patent was known or used by others in
`
`this country or patented or described in a printed publication in this or a foreign country, before
`
`the invention thereof by the applicant for patent.
`
`(b)
`
`The ’833 patent describes and claims an alleged invention, the making of
`
`which did not involve the inventive faculty but only the obvious judgment, knowledge, and
`
`mechanical skill possessed by persons having ordinary skill in the art to which the alleged
`
`invention pertains.
`
`(c)
`
`The alleged invention of the ’833 patent does no more than combine
`
`familiar elements according to known methods to yield predictable results. Any alleged
`
`improvement over the prior art set forth in the ’833 patent is no more than the predictable use of
`
`prior art elements according to their established functions. A person of ordinary skill in the art
`
`would have been motivated to combine the teachings of the prior art to achieve the alleged
`
`invention of the ’833 patent and would have had a reasonable expectation of success in doing so.
`
`(d)
`
`The subject matter claimed in the ’833 patent fails to comply with 35
`
`U.S.C. §§ 102 and/or 103 in that the differences between the subject matter claimed in the patent
`
`and the prior art are such that the subject matter as a whole was either fully anticipated by the
`
`prior art or would have been obvious at the time the alleged invention was made to a person
`
`having knowledge of such prior art and having ordinary skill in the art to which the claimed
`
`subject matter pertains.
`
`
`
`16
`
`
`
`Case 1:17-cv-00227-VAC-MPT Document 9 Filed 04/26/17 Page 17 of 26 PageID #: 241
`
`
`
`(e)
`
`The ’833 patent does not contain a written description of the alleged
`
`invention, and of the manner and process of making and using it, in such full, clear, concise and
`
`exact terms as required by the statutes of the United States to enable any person skilled in the art
`
`to practice the invention purported to be covered thereby.
`
`(f)
`
`The claims of the ’833 patent are invalid because they do not inform those
`
`skilled in the art about the scope of the invention with reasonable certainty and they do not
`
`particularly point out and distinctly claim the subject matter of the alleged invention, as required
`
`by 35 U.S.C. § 112.
`
`32.
`
`For example, claims 1-31 of the ’833 patent are invalid for at least failure to
`
`comply with one or more of the conditions for patentability set forth in Title 35 of the United
`
`States Code, including but not limited to 35 U.S.C. § 102. Said claims are invalid at least as
`
`anticipated and/or obvious pursuant to §§ 102(b) and 103(a) by at least Flink et al., WO
`
`03/002136 A2, Stable Formulations of Modified GLP-1.
`
`33.
`
`Teva is entitled to a judicial declaration that all claims of the ’833 patent are
`
`invalid.
`
`COUNT IV
`DECLARATORY JUDGMENT OF NON-INFRINGEMENT OF THE ’833 PATENT
`
`34.
`
`Teva re-alleges and incorporates by reference the allegations in paragraphs 1-32
`
`of these Counterclaims.
`
`35.
`
`There is an actual, substantial, continuing, and justiciable controversy between the
`
`parties regarding whether the filing of ANDA No. 210084 and/or the manufacture, use, offer to
`
`sell, sale and/or importation into the United States of the ANDA Products infringes, has
`
`infringed, or will infringe any valid and enforceable claim of the ’833 patent either directly or
`
`indirectly, and either literally or under the doctrine of equivalents.
`
`
`
`17
`
`
`
`Case 1:17-cv-00227-VAC-MPT Document 9 Filed 04/26/17 Page 18 of 26 PageID #: 242
`
`
`
`36.
`
`Teva has not infringed, contributed to the infringement of, or induced the
`
`infringement of any valid and enforceable claim of the ’833 patent either literally or under the
`
`doctrine of equivalents and is not liable for such infringement.
`
`37.
`
`Teva is entitled to a judicial declaration that it has not infringed, contributed to the
`
`infringement of, or induced the infringement of the ’833 patent either literally or under the
`
`doctrine of equivalents; and that the manufacture, use, sale, offer for sale, or importation of the
`
`products described in ANDA No. 210084 has not infringed, does not infringe, and will not
`
`infringe any valid and enforceable claims of the ’833 patent.
`
`COUNT V
`DECLARATORY JUDGMENT OF INVALIDITY OF THE ’618 PATENT
`
`38.
`
`Teva re-alleges and incorporates by reference the allegations in paragraphs 1-37
`
`of these Counterclaims.
`
`39.
`
`There is an actual, substantial, continuing, and justiciable controversy between the
`
`parties regarding the invalidity of the ’618 patent, based on Plaintiffs’ allegation in their
`
`Complaint that Defendant has infringed or will infringe the ’618 patent.
`
`40.
`
`Each and every claim of the ’618 patent is invalid for failure to satisfy one or
`
`more provisions of Title 35 of the United States Code, including but not limited to 35 U.S.C.
`
`§§ 102 and 103, and/or is invalid under the doctrine of obviousness-type double patenting, the
`
`bases for which include:
`
`(a)
`
`The alleged invention of the ’618 patent was known or used by others in
`
`this country or patented or described in a printed publication in this or a foreign country, before
`
`the invention thereof by the applicant for patent.
`
`(b)
`
`The ’618 patent describes and claims an alleged invention, the making of
`
`which did not involve the inventive faculty but only the obvious judgment, knowledge, and
`
`
`
`18
`
`
`
`Case 1:17-cv-00227-VAC-MPT Document 9 Filed 04/26/17 Page 19 of 26 PageID #: 243
`
`
`
`mechanical skill possessed by persons having ordinary skill in the art to which the alleged
`
`invention pertains.
`
`(c)
`
`The alleged invention of the ’618 patent does no more than combine
`
`familiar elements according to known methods to yield predictable results. Any alleged
`
`improvement over the prior art set forth in the ’
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