Case 1:18-cv-00924-CFC-SRF Document 82 Filed 02/07/19 Page 1 of 69 PageID #:
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`GENENTECH, INC. and CITY OF HOPE,
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`Plaintiffs and Counterclaims
`Defendants,
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`Case No. 18-00924-CFC
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`PUBLIC VERSION
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`v.
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`AMGEN INC.
`
`Defendant and Counterclaim
`Plaintiff.
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`AMGEN INC.’S ANSWER, AFFIRMATIVE DEFENSES, AND COUNTERCLAIMS
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`Defendant Amgen Inc. (“Amgen”), by and through its undersigned attorneys, hereby
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`submits its Answer, Affirmative Defenses, and Counterclaims to the Second Amended Complaint
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`for declaratory and injunctive relief (“Complaint”), filed by Plaintiffs Genentech, Inc.
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`(“Genentech”) and City of Hope (“City of Hope,” collectively, “Plaintiffs”) on January 17, 2019.
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`Pursuant to Fed. R. Civ. P. 8(b)(3), Amgen denies each and every allegation in the
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`Complaint, whether express or implied, except those specifically and expressly admitted below.
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`Any factual allegation admitted below is admitted only as to the specific admitted facts, not as to
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`any purported conclusions, characterizations, implications, or speculations that may arguably
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`follow from the admitted facts. To the extent any allegation in the Complaint is vague and/or
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`ambiguous, Amgen denies such allegations. Amgen denies that Plaintiffs are entitled to the relief
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`requested or any other relief.
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`The headings and subheadings in Amgen’s Answer are used solely for purposes of
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`convenience and organization to mirror those appearing in the Complaint; to the extent that any
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`headings or other non-numbered statements in the Complaint contain or imply any allegations,
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`Amgen denies each and every allegation therein. Each of the numbered paragraphs in the Answer
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`below corresponds to the same-numbered paragraphs in the Complaint.
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`NATURE OF THE CASE
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`1.
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`Amgen admits that breast cancer is a serious disease affecting women in the United
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`States. Amgen further admits that overexpression of HER2 has been found in about 25% to 30%
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`of human breast cancers and overexpression correlates with poor prognosis in patients with such
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`cancers. Amgen lacks sufficient knowledge or information to form a belief as to the truth of the
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`allegations of paragraph 1, and on that basis denies them.
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`2.
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`Amgen lacks sufficient knowledge or information to form a belief as to the truth of
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`the allegations of paragraph 2, and on that basis denies them.
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`3.
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`Amgen admits that Herceptin® (hereinafter “Herceptin”) contains the antibody
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`trastuzumab. Amgen lacks sufficient knowledge or information to form a belief as to the truth of
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`the remaining allegations of paragraph 3, and on that basis denies them.
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`4.
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`Amgen lacks sufficient knowledge or information to form a belief as to the truth of
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`the allegations of paragraph 4, and on that basis denies them.
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`5.
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`Amgen admits that the FDA initially approved Herceptin in 1998. Amgen lacks
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`sufficient knowledge or information to form a belief as to the truth of the remaining allegations of
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`paragraph 5, and on that basis denies them.
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`6.
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`Amgen admits that the Patent Office has issued patents relating to trastuzumab.
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`Amgen lacks sufficient knowledge or information to form a belief as to the truth of the remaining
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`allegations of paragraph 6, and on that basis denies them.
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`7.
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`Amgen admits that pursuant to the Biologics Price Competition and Innovation Act
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`(“BPCIA”), it is seeking FDA approval of a trastuzumab biosimilar called ABP 980. Amgen
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`further admits that it has included in its application for FDA approval of ABP 980 publicly
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`available information regarding the FDA’s previous determination that Genentech’s trastuzumab
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`product is safe, pure, and potent. Amgen also admits that it has submitted to FDA a proposed draft
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`label that contains the same indications for which Herceptin is also approved. Amgen denies the
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`remaining allegations of paragraph 7.
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`8.
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`Amgen admits that Congress enacted the BPCIA in 2010. Amgen further admits
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`that it has complied with 42 U.S.C. § 262(l). The remaining allegations of paragraph 8 are legal
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`conclusions that require no response, and on that basis Amgen denies them.
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`9.
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`Amgen admits that Plaintiffs have brought an action alleging patent infringement
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`seeking relief against Amgen. Amgen denies Plaintiffs are entitled to any such relief, requested
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`or otherwise. Amgen denies the remaining allegations of paragraph 9.
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`PARTIES
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`10.
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`11.
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`Upon information and belief, Amgen admits the allegations of paragraph 10.
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`Upon information and belief, Amgen admits that Genentech was founded in 1976
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`and that Genentech is the sponsor for a number of products that have received FDA approval.
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`Amgen lacks sufficient knowledge or information to form a belief as to the truth of the remaining
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`allegations of paragraph 11, and on that basis denies them.
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`12.
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`13.
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`Upon information and belief, Amgen admits the allegations of paragraph 12.
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`Upon information and belief, Amgen admits that City of Hope was founded in
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`1913. Amgen lacks sufficient knowledge or information to form a belief as to the truth of the
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`remaining allegations of paragraph 13, and on that basis denies them.
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`14.
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`15.
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`Amgen admits the allegations of paragraph 14.
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`Amgen admits the allegations of paragraph 15.
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`– 3 –
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`JURISDICTION AND VENUE
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`16.
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`The allegations of paragraph 16 are legal conclusions that require no response, and
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`on that basis Amgen denies them.
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`17.
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`Amgen admits that it is incorporated in the State of Delaware. The remaining
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`allegations of paragraph 17 contain legal conclusions that require no response, and on that basis
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`Amgen denies them.
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`18.
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`Amgen admits that it is incorporated in the State of Delaware. Amgen admits that
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`it has submitted a Biologics License Application (hereinafter “Amgen’s BLA”) seeking FDA
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`approval of ABP 980. The remaining allegations of paragraph 18 contain legal conclusions that
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`require no response, and on that basis Amgen denies them.
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`THE PARTIES’ EXCHANGES UNDER THE BPCIA
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`19.
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`Amgen admits that on July 31, 2017, it announced the submission of Amgen’s BLA
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`to the FDA for ABP 980, which is being developed as a biosimilar to trastuzumab. Upon
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`information and belief, Amgen admits that Genentech’s trastuzumab is subject to BLA No.
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`103792. Amgen denies the remaining allegations of paragraph 19.
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`20.
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`21.
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`Amgen admits the allegations of paragraph 20.
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`Amgen admits that on October 16, 2017, Amgen provided Genentech a copy of
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`Amgen’s BLA. Amgen denies the remaining allegations of paragraph 21.
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`22.
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`23.
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`Amgen admits the allegations of paragraph 22.
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`Amgen admits that on November 20, 2017, Genentech requested specific
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`information concerning the manufacture of Amgen’s biosimilar product and that Amgen provided
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`additional manufacturing information to Genentech on December 1, 2017, and December 4, 2017.
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`Amgen further admits that Genentech responded on December 15, 2017. Amgen denies the
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`remaining allegations of paragraph 23.
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`– 4 –
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`24.
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`25.
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`Amgen denies the allegations of paragraph 24.
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`Amgen admits that on December 15, 2017, Amgen received a list of 36 patents
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`from Genentech purporting to comply with Genentech’s statutory obligations pursuant to 42
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`U.S.C. § 262(l)(3)(A) (“Genentech’s 3A Statement”). Amgen denies the remaining allegations of
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`paragraph 25.
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`26.
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`27.
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`Amgen admits the allegations of paragraph 26.
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`Amgen admits that Genentech responded on December 27, 2017. Amgen denies
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`the remaining allegations of paragraph 27.
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`28.
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`29.
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`Amgen admits the allegations of paragraph 28.
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`Amgen admits
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`that on February 6, 2018, Genentech supplemented
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`its
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`§ 262(l)(3)(A) list to include U.S. Patent No. 9,868,760. Amgen denies the remaining allegations
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`of paragraph 29.
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`30.
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`Amgen admits that on February 13, 2018, pursuant to 42 U.S.C. § 262(l)(3)(B),
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`Amgen provided Genentech with its detailed statement concerning non-infringement and
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`invalidity of the 36 patents identified in Genentech’s December 15, 2017 disclosure (“Amgen’s
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`3B Statement”). On March 3, 2018, Amgen supplemented its February 13, 2018 disclosure with
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`its § 262(l)(3)(B) disclosure for U.S. Patent No. 9,868,760. Genentech’s allegation regarding the
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`sufficiency of Amgen’s 3B statement contains legal conclusions that require no response, and on
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`that basis Amgen denies them. Amgen denies the remaining allegations of paragraph 30.
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`31.
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`Amgen admits that on
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`Amgen produced additional documents regarding
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`. Amgen denies the remaining allegations of paragraph 31.
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`– 5 –
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`32.
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`Amgen admits that on April 13, 2018, Amgen received Genentech’s responses to
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`Amgen’s 3B Statement purporting to comply with Genentech’s statutory obligations pursuant to
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`42 U.S.C. § 262(l)(3)(C) (“Genentech’s 3C Statement”). Amgen admits that Genentech
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`maintained that ABP 980 will infringe 18 of the 37 Genentech patents identified in Genentech’s
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`3A Statement, and that Genentech proposed that all 18 of these patents be included in a first-phase
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`infringement action. Amgen denies the merits of Genentech’s allegations of infringement. Amgen
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`denies the remaining allegations of paragraph 32.
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`33.
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`Amgen admits that on
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`additional documents regarding
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`, Amgen provided
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`
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`. Amgen denies the remaining allegations of paragraph 33.
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`34.
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`Amgen admits that after Genentech served its 3C Statement, the parties initiated
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`negotiations under § 262(l)(4). Amgen further admits that Genentech and Amgen agreed that the
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`37 patents addressed in Genentech’s 3A Statement shall be the subject of an action for patent
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`infringement under § 262(l)(6)(A). Amgen denies the merits of Genentech’s allegations of
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`infringement. Amgen denies the remaining allegations of paragraph 34.
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`35.
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`Amgen denies the merits of Genentech’s allegations of infringement. The
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`remaining allegations of paragraph 35 are legal conclusions that require no response, and on that
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`basis Amgen denies them.
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`36.
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`Amgen admits that on
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`, Amgen notified Genentech pursuant to 42
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`U.S.C. § 262(l)(8)(A) that it intends to commence first commercial marketing of ABP 980 in the
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`United States no earlier than 180 days from
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` (i.e.,
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`). Amgen
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`denies the remaining allegations of paragraph 36.
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`37.
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`Amgen admits the allegations of paragraph 37.
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`– 6 –
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`38.
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`Amgen admits that on November 7, 2018, Genentech identified a list of 9 patents
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`and 1 patent application which it intended to assert against Amgen in this litigation. Amgen admits
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`that Genentech notified Amgen that it intended to assert infringement of claims 10 and 11 of U.S.
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`App. No. 14/073,659 (“the ’659 application”) once issued by the Patent Office. Amgen admits
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`the ’659 application issued as U.S. Patent No. 10,160,811 (“the ’811 patent”), and that the face of
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`the ’811 patent reflects an issue date of December 25, 2018. Amgen further admits that on
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`December 26, 2018, Genentech supplemented its § 262(l)(3)(A) list to include the ’811 patent.
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`Amgen denies the remaining allegations of paragraph 38.
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`AMGEN’S BLA PRODUCT
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`39.
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`Amgen admits that it has publicly stated that its BLA product is a biosimilar
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`candidate to trastuzumab. Amgen admits the remaining allegations of paragraph 39.
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`40.
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`Amgen admits that Amgen’s BLA for trastuzumab included “information
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`demonstrating that Amgen’s BLA product and trastuzumab utilize the same mechanism of action
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`. . . for the condition or conditions of use prescribed, recommended, or suggested in the proposed
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`labeling” submitted in Amgen’s BLA pursuant to 42 U.S.C. § 262(k)(2)(A)(i)(II). Amgen denies
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`the remaining allegations of paragraph 40.
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`41.
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`The allegations of paragraph 41 are legal conclusions that require no response, and
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`on that basis Amgen denies them.
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`GENENTECH’S ASSERTED PATENTS
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`42.
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`Amgen admits that the United States Patent and Trademark Office has issued
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`patents relating to trastuzumab, its manufacture, and its use. Amgen lacks sufficient knowledge
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`or information to form a belief as to the truth of the remaining allegations of paragraph 42, and on
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`that basis denies them.
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`– 7 –
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`43.
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`Amgen admits that Genentech has asserted the following patents in this lawsuit:
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`U.S. Patent No. 6,331,415, U.S. Patent No. 7,923,221, U.S. Patent No. 6,407,213, U.S. Patent No.
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`7,846,441, U.S. Patent No. 7,892,549, U.S. Patent No. 6,627,196, U.S. Patent No. 7,371,379, U.S.
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`Patent No. 10,160,811, U.S. Patent No. 6,417,335, , U.S. Patent No. 9,249,218, U.S. Patent No.
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`8,574,869, U.S. Patent No. 6,620,918, U.S. Patent No. 7,993,834, U.S. Patent No. 8,076,066, U.S.
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`Patent No. 8,440,402, U.S. Patent No. 6,121,428, U.S. Patent No. 8,512,983, and U.S. Patent No.
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`9,714,293. Amgen denies the remaining allegations of paragraph 43, and denies the merits of
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`Genentech’s allegations of infringement.
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`The Cabilly Patents
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`44.
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`Amgen admits that U.S. Patent Nos. 6,331,415 and 7,923,221 purport to relate to a
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`process for producing monoclonal antibodies from recombinant DNA. Amgen lacks sufficient
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`knowledge or information to form a belief as to the truth of the remaining allegations of paragraph
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`44, and on that basis denies them.
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`45.
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`Amgen admits that U.S. Patent No. 6,331,415 (“the ’415 patent”) is titled “Methods
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`of Producing Immunoglobulins, Vectors and Transformed Host Cells for Use Therein.” Amgen
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`further admits that the face of the ’415 patent reflects (1) an issue date of December 18, 2001 and
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`(2) that the patent was assigned to Genentech and City of Hope. Amgen admits that Exhibit A to
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`the Complaint purports to be a copy of the ’415 patent. Amgen denies that the ’415 patent was
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`“duly and legally” issued. Amgen lacks sufficient knowledge or information to form a belief as to
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`the truth of the remaining allegations of paragraph 45, and on that basis denies them.
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`46.
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`Amgen admits that U.S. Patent No. 7,923,221 (“the ’221 patent”) is titled “Methods
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`of Making Antibody Heavy and Light Chains Having Specificity for a Desired Antigen.” Amgen
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`further admits that the face of the ’221 patent reflects (1) an issue date of April 12, 2011 and (2)
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`that the patent was assigned to Genentech and City of Hope. Amgen admits that Exhibit B to the
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`– 8 –
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`Complaint purports to be a copy of the ’221 patent. Amgen denies that the ’221 patent was “duly
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`and legally” issued. Amgen lacks sufficient knowledge or information to form a belief as to the
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`truth of the remaining allegations of paragraph 46, and on that basis denies them.
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`The ’213 Patent
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`47.
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`Amgen admits that U.S. Patent No. 6,407,213 (“the ’213 patent”) purports to relate
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`to a humanized antibody and/or a humanized antibody variable domain. Amgen lacks sufficient
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`knowledge or information to form a belief as to the truth of the remaining allegations of paragraph
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`47, and on that basis denies them.
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`48.
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`Amgen admits that the ’213 patent is titled “Methods of Making Humanized
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`Antibodies.” Amgen further admits that the face of the ’213 patent reflects (1) an issue date of
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`June 18, 2002 and (2) that the patent was assigned to Genentech. Amgen admits that Exhibit C to
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`the Complaint purports to be a copy of the ’213 patent. Amgen denies that the ’213 patent was
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`“duly and legally” issued. Amgen lacks sufficient knowledge or information to form a belief as to
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`the truth of the remaining allegations of paragraph 48, and on that basis denies them.
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`The Combination Chemotherapy Patents
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`49.
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`Amgen admits that U.S. Patent No. 7,846,441 (“the ’441 patent”) purports to relate
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`to a method of administering anti-ErbB2 antibodies. Amgen lacks sufficient knowledge or
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`information to form a belief as to the truth of the remaining allegations of paragraph 49, and on
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`that basis denies them.
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`50.
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`Amgen admits that the ’441 patent is titled “Treatment with Anti-ErbB2
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`Antibodies.” Amgen further admits that the face of the ’441 patent reflects (1) an issue date of
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`December 7, 2010 and (2) that the patent was assigned to Genentech. Amgen admits that Exhibit
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`D to the Complaint purports to be a copy of the ’441 patent. Amgen denies that the ’441 patent
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`– 9 –
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`was “duly and legally” issued. Amgen lacks sufficient knowledge or information to form a belief
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`as to the truth of the remaining allegations of paragraph 50, and on that basis denies them.
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`51.
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`Amgen admits that U.S. Patent No. 7,892,549 (“the ’549 patent”) purports to be a
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`continuation of the ’441 patent, and purports to relate to a method of treating a patient with HER2-
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`positive breast cancer using anti-ErbB2 antibodies. Amgen lacks sufficient knowledge or
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`information to form a belief as to the truth of the remaining allegations of paragraph 51, and on
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`that basis denies them.
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`52.
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`Amgen admits that the ’549 patent is titled “Treatment with Anti-ErbB2
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`Antibodies.” Amgen further admits that the face of the ’549 patent reflects (1) an issue date of
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`February 22, 2011 and (2) that the patent was assigned to Genentech. Amgen admits that Exhibit
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`E to the Complaint purports to be a copy of the ’549 patent. Amgen denies that the ’549 patent
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`was “duly and legally” issued. Amgen lacks sufficient knowledge or information to form a belief
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`as to the truth of the remaining allegations of paragraph 52, and on that basis denies them.
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`The Method of Administration Patents
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`53.
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`Amgen admits that U.S. Patent Nos. 6,627,196, 7,371,379, and 10,160,811 purport
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`to relate to a method of administering anti-ErbB2 antibodies. Amgen lacks sufficient knowledge
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`or information to form a belief as to the truth of the remaining allegations of paragraph 53, and on
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`that basis denies them.
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`54.
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`Amgen admits that U.S. Patent No. 6,627,196 (“the ’196 patent”) is titled “Dosages
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`for Treatment with Anti-ErbB2 Antibodies.” Amgen further admits that the face of the’196 patent
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`reflects (1) an issue date of September 30, 2003 and (2) that the patent was assigned to Genentech.
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`Amgen admits that Exhibit G to the Complaint purports to be a copy of the’196 patent. Amgen
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`denies that the ’196 patent was “duly and legally” issued. Amgen lacks sufficient knowledge or
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`– 10 –
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`information to form a belief as to the truth of the remaining allegations of paragraph 54, and on
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`that basis denies them.
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`55.
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`Amgen admits that U.S. Patent No. 7,371,379 (“the ’379 patent”) is titled “Dosages
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`for Treatment with Anti-ErbB2 Antibodies.” Amgen further admits that the face of the ’379 patent
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`reflects (1) an issue date of May 13, 2008 and (2) that the patent was assigned to Genentech.
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`Amgen admits that Exhibit H to the Complaint purports to be a copy of the ’379 patent. Amgen
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`denies that the ’379 patent was “duly and legally” issued. Amgen lacks sufficient knowledge or
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`information to form a belief as to the truth of the remaining allegations of paragraph 55, and on
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`that basis denies them.
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`56.
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`Amgen admits that U.S. Patent No. 10,160,811 is titled “Treatment with Anti-
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`ErbB2 Antibodies.” Amgen further admits that the face of the ’811 patent reflects (1) an issue
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`date of December 25, 2018 and (2) that the patent was assigned to Genentech. Amgen admits that
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`Exhibit F to the Complaint purports to be a copy of the ’811 patent. Amgen denies that the ’811
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`patent was “duly and legally” issued. Amgen lacks sufficient knowledge or information to form a
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`belief as to the truth of the remaining allegations of paragraph 56, and on that basis denies them.
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`The Acidic Variants Patents
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`57.
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`Amgen admits that U.S. Patent Nos. 6,417,335 and 9,249,218 purport to relate to a
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`method for purifying a polypeptide by ion exchange chromatography. Amgen lacks sufficient
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`knowledge or information to form a belief as to the truth of the remaining allegations of paragraph
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`57, and on that basis denies them.
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`58.
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`Amgen admits that U.S. Patent No. 6,417,335 (“the ’335 patent”) is titled “Protein
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`Purification.” Amgen further admits that the face of the ’335 patent indicates (1) an issue date of
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`July 9, 2002 and (2) that the patent was assigned to Genentech. Amgen admits that Exhibit I to
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`the Complaint purports to be a copy of the ’335 patent. Amgen denies that the ’335 patent was
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`– 11 –
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`“duly and legally” issued. Amgen lacks sufficient knowledge or information to form a belief as to
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`the truth of the remaining allegations of paragraph 58, and on that basis denies them.
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`59.
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`Amgen admits that U.S. Patent No. 9,249,218 (“the ’218 patent”) is titled “Protein
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`Purification.” Amgen further admits that the face of the ’218 patent indicates (1) an issue date of
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`February 2, 2016 and (2) that the patent was assigned to Genentech. Amgen admits that Exhibit J
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`to the Complaint purports to be a copy of the ’218 patent. Amgen denies that the ’218 patent was
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`“duly and legally” issued. Amgen lacks sufficient knowledge or information to form a belief as to
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`the truth of the remaining allegations of paragraph 59, and on that basis denies them.
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`HER2 Diagnostic Patents
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`60.
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`Amgen admits that U.S. Patent Nos. 7,993,834, 8,076,066, and 8,440,402 purport
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`to relate to techniques for identifying patients who might benefit from ErbB2 antibody therapy
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`using gene amplification. Amgen lacks sufficient knowledge or information to form a belief as to
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`the truth of the remaining allegations of paragraph 60, and on that basis denies them.
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`61.
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`Amgen admits that U.S. Patent No. 7,993,834 (“the ’834 patent”) is titled
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`“Detection of ErbB2 Gene Amplification to Increase the Likelihood of the Effectiveness of ErbB2
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`Antibody Breast Cancer Therapy.” Amgen further admits that the face of the ’834 patent indicates
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`(1) an issue date of August 9, 2011 and (2) that the patent was assigned to Genentech. Amgen
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`admits that Exhibit K to the Complaint purports to be a copy of the ’834 patent. Amgen denies
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`that the ’834 patent was “duly and legally” issued. Amgen lacks sufficient knowledge or
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`information to form a belief as to the truth of the remaining allegations of paragraph 61, and on
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`that basis denies them.
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`62.
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`Amgen admits that U.S. Patent No. 8,076,066 (“the ’066 patent”) is titled “Gene
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`Detection Assay for Improving the Likelihood of an Effective Response to a HER2 Antibody
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`Cancer Therapy.” Amgen further admits that the face of the ’066 patent indicates (1) an issue date
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`– 12 –
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`of December 13, 2011 and (2) that the patent was assigned to Genentech. Amgen admits that
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`Exhibit L to the Complaint purports to be a copy of the ’066 patent. Amgen denies that the ’066
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`patent was “duly and legally” issued. Amgen lacks sufficient knowledge or information to form a
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`belief as to the truth of the remaining allegations of paragraph 62, and on that basis denies them.
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`63.
`
`Amgen admits that U.S. Patent No. 8,440,402 (“the ’402 patent”) is titled “Gene
`
`Detection Assay for Improving the Likelihood of an Effective Response to a HER2 Antibody
`
`Cancer Therapy.” Amgen further admits that the face of the ’402 patent indicates (1) an issue date
`
`of May 14, 2013 and (2) that the patent was assigned to Genentech. Amgen admits that Exhibit
`
`M to the Complaint purports to be a copy of the ’402 patent. Amgen denies that the ’402 patent
`
`was “duly and legally” issued. Amgen lacks sufficient knowledge or information to form a belief
`
`as to the truth of the remaining allegations of paragraph 63, and on that basis denies them.
`
`Cell Culture, Purification, and Antibody Manufacturing Patents
`
`64.
`
`Amgen admits that U.S. Patent Nos. 6,121,428, 6,620,918, 8,512,983, 8,574,869,
`
`and 9,714,293 purport to relate to various subject matter including cell culture, purification, and
`
`antibody purification. Amgen lacks sufficient knowledge or information to form a belief as to the
`
`truth of the remaining allegations of paragraph 64, and on that basis denies them.
`
`65.
`
`Amgen admits that U.S. Patent No. 6,121,428 (“the ’428 patent”) is titled “Protein
`
`Recovery.” Amgen further admits that the face of the ’428 patent indicates (1) an issue date of
`
`September 19, 2000 and (2) that the patent was assigned to Genentech. Amgen admits that Exhibit
`
`N to the Complaint purports to be a copy of the ’428 patent. Amgen denies that the ’428 patent
`
`was “duly and legally” issued. Amgen lacks sufficient knowledge or information to form a belief
`
`as to the truth of the remaining allegations of paragraph 65, and on that basis denies them.
`
`66.
`
`Amgen admits that U.S. Patent No. 6,620,918 (“the ’918 patent”) is titled
`
`“Separation of Polypeptide Monomers.” Amgen further admits that the face of the ’918 patent
`
`– 13 –
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`indicates (1) an issue date of September 16, 2003 and (2) that the patent was assigned to Genentech.
`
`Amgen admits that Exhibit O to the Complaint purports to be a copy of the ’918 patent. Amgen
`
`denies that the ’918 patent was “duly and legally” issued. Amgen lacks sufficient knowledge or
`
`information to form a belief as to the truth of the remaining allegations of paragraph 66, and on
`
`that basis denies them.
`
`67.
`
`Amgen admits that U.S. Patent No. 8,512,983 (“the ’983 patent”) is titled
`
`“Production of Proteins in Glutamine-Free Cell Culture Media.” Amgen further admits that the
`
`face of the ’983 patent indicates (1) an issue date of August 20, 2013 and (2) that the patent was
`
`assigned to Genentech. Amgen admits that Exhibit P to the Complaint purports to be a copy of
`
`the ’983 patent. Amgen denies that the ’983 patent was “duly and legally” issued. Amgen lacks
`
`sufficient knowledge or information to form a belief as to the truth of the remaining allegations of
`
`paragraph 67, and on that basis denies them.
`
`68.
`
`Amgen admits that U.S. Patent No. 8,574,869 (“the ’869 patent”) is titled
`
`“Prevention of Disulfide Bond Reduction During Recombinant Production of Polypeptides.”
`
`Amgen further admits that the face of the ’869 patent indicates (1) an issue date of November 5,
`
`2013 and (2) that the patent was assigned to Genentech. Amgen admits that Exhibit Q to the
`
`Complaint purports to be a copy of the ’869 patent. Amgen denies that the ’869 patent was “duly
`
`and legally” issued. Amgen lacks sufficient knowledge or information to form a belief as to the
`
`truth of the remaining allegations of paragraph 68, and on that basis denies them.
`
`69.
`
`Amgen admits that U.S. Patent No. 9,714,293 (“the ’293 patent”) is titled
`
`“Production of Proteins in Glutamine-Free Cell Culture Media.” Amgen further admits that the
`
`face of the ’293 patent indicates (1) an issue date of July 25, 2017 and (2) that the patent was
`
`assigned to Genentech. Amgen admits that Exhibit R to the Complaint purports to be a copy of
`
`– 14 –
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`the ’293 patent. Amgen denies that the ’293 patent was “duly and legally” issued. Amgen lacks
`
`sufficient knowledge or information to form a belief as to the truth of the remaining allegations of
`
`paragraph 69, and on that basis denies them.
`
`COUNT I
`INFRINGEMENT OF U.S. PATENT NO. 6,331,415
`
`70.
`
`Amgen incorporates each of its responses to the preceding paragraphs as if fully set
`
`forth herein.
`
`71.
`
`Amgen admits that Genentech included the ’415 patent in its 3A and 3C Statements.
`
`Amgen denies the remaining allegations in paragraph 71.
`
`72.
`
`Amgen admits that it submitted its BLA to the FDA on
`
`. Amgen
`
`denies the remaining allegations of paragraph 72.
`
`73.
`
`74.
`
`75.
`
`Amgen denies the allegations in paragraph 73.
`
`Amgen denies the allegations of paragraph 74.
`
`Amgen admits that Genentech included the ’415 patent on its 3A and 3C
`
`Statements. Amgen denies the remaining allegations of paragraph 75.
`
`COUNT II
`INFRINGEMENT OF U.S. PATENT NO. 7,923,221
`
`76.
`
`Amgen incorporates each of its responses to the preceding paragraphs as if fully set
`
`forth herein.
`
`77.
`
`Amgen admits that Genentech included the ’221 patent in its 3A and 3C Statements.
`
`Amgen denies the remaining allegations in paragraph 77.
`
`78.
`
`Amgen admits that it submitted its BLA to the FDA on
`
`. Amgen
`
`denies the remaining allegations of paragraph 78.
`
`79.
`
`80.
`
`Amgen denies the allegations in paragraph 79.
`
`Amgen denies the allegations of paragraph 80.
`
`– 15 –
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`
`81.
`
`Amgen admits that Genentech included the ’221 patent on its 3A and 3C
`
`Statements. Amgen denies the remaining allegations of paragraph 81.
`
`COUNT III
`INFRINGEMENT OF U.S. PATENT NO. 6,407,213
`
`82.
`
`Amgen incorporates each of its responses to the preceding paragraphs as if fully set
`
`forth herein.
`
`83.
`
`Amgen admits that Genentech included the ’213 patent in its 3A and 3C Statements.
`
`Amgen denies the remaining allegations in paragraph 83.
`
`84.
`
`Amgen admits that it submitted its BLA to the FDA on
`
`. Amgen
`
`denies the remaining allegations of paragraph 84.
`
`85.
`
`Amgen admits that it notified Genentech pursuant to 42 U.S.C. § 262(l)(8)(A) that
`
`it intends to commence first commercial marketing of ABP 980 in the United States no earlier than
`
`180 days from
`
`in paragraph 85.
`
` (i.e.,
`
`). Amgen denies the remaining allegations
`
`86.
`
`87.
`
`Amgen denies the allegations of paragraph 86.
`
`Amgen admits that Genentech included the ’213 patent on its 3A and 3C
`
`Statements. Amgen denies the remaining allegations of paragraph 87.
`
`88.
`
`89.
`
`Amgen denies the allegations of paragraph 88.
`
`Amgen denies the allegations of paragraph 89.
`
`COUNT IV
`INFRINGEMENT OF U.S. PATENT NO. 7,846,441
`
`90.
`
`Amgen incorporates each of its responses to the preceding paragraphs as if fully set
`
`forth herein.
`
`91.
`
`Amgen admits that Genentech included the ’441 patent in its 3A and 3C Statements.
`
`Amgen denies the remaining allegations in paragraph 91.
`
`– 16 –
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`
`92.
`
`Amgen admits that it submitted its BLA to the FDA on
`
`. Amgen
`
`denies the remaining allegations of paragraph 92.
`
`93.
`
`Amgen admits that it notified Genentech pursuant to 42 U.S.C. § 262(l)(8)(A) that
`
`it intends to commence first commercial marketing of ABP 980 in the United States no earlier than
`
`180 days from
`
`in paragraph 93.
`
` (i.e.,
`
`). Amgen denies the remaining allegations
`
`94.
`
`95.
`
`Amgen denies the allegations of paragraph 94.
`
`Amgen admits that Genentech included the ’441 patent on its 3A and 3C
`
`Statements. Amgen denies the remaining allegations of paragraph 95.
`
`96.
`
`97.
`
`98.
`
`99.
`
`Amgen denies the allegations of paragraph 96.
`
`Amgen denies the allegations of paragraph 97.
`
`Amgen denies the allegations of paragraph 98.
`
`Amgen denies the allegations of paragraph 99.
`
`100. Amgen denies the allegations of paragraph 100.
`
`COUNT V
`INFRINGEMENT OF U.S. PATENT NO. 7,892,549
`
`101. Amgen incorporates each of its responses to the preceding paragraphs as if fully set
`
`forth herein.
`
`102. Amgen admits that Genentech included the ’549 patent in its 3A and 3C Statements.
`
`Amgen denies the remaining allegations in parag