Case 1:18-cv-01363-CFC Document 66 Filed 01/31/19 Page 1 of 94 PageID #: 9103
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 18-1363-CFC
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`JURY TRIAL DEMANDED
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`)))))))))
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`GENENTECH, INC., AND CITY OF HOPE,
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`Plaintiffs,
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`v.
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`SAMSUNG BIOEPIS CO., LTD.,
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`Defendant.
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`DEFENDANT SAMSUNG BIOEPIS CO., LTD.’S
`ANSWER, DEFENSES, AND COUNTERCLAIMS
`TO PLAINTIFFS’ FIRST AMENDED COMPLAINT
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`Samsung Bioepis Co., Ltd. (“Bioepis” or “Defendant”), by and through its attorneys,
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`hereby submits this Answer, Defenses, and Counterclaims to the First Amended Complaint filed
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`by Plaintiffs Genentech, Inc. (“Genentech”) and City of Hope (collectively, “Plaintiffs”) on
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`January 17, 2019 (the “Amended Complaint”).
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`ANSWER TO AMENDED COMPLAINT
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`Each of the paragraphs below corresponds to the same-numbered paragraphs (each a
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`“Paragraph”) in the Amended Complaint. Bioepis denies all allegations in the Amended
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`Complaint, whether express or implied, that are not specifically admitted below. Any factual
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`allegation below is admitted only as to the specific admitted facts, not as to any purported
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`conclusions, characterizations, implications, or speculations that arguably follow from the
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`admitted facts. Moreover, to the extent that any of Plaintiffs’ allegations are vague or ambiguous,
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`Bioepis denies said allegations. To the extent that any of the Amended Complaint’s headings or
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`footnotes constitute allegations, Bioepis specifically denies each and every one of them. Bioepis
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`reserves the right to amend this Answer or to assert other defenses as this action proceeds. Bioepis
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`Case 1:18-cv-01363-CFC Document 66 Filed 01/31/19 Page 2 of 94 PageID #: 9104
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`denies that Plaintiffs are entitled to the relief requested or any other relief. Bioepis responds to the
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`Amended Complaint as follows:
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`NATURE OF THE CASE
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`1.
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`Bioepis admits that breast cancer is a serious disease affecting women in the United
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`States. Bioepis lacks knowledge or information sufficient to form a belief about the truth of the
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`remaining allegations in Paragraph 1 and, therefore, denies the same.
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`2.
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`Bioepis lacks knowledge or information sufficient to form a belief about the truth
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`of the allegations in Paragraph 2 and, therefore, denies the same.
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`3.
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`Bioepis admits that Herceptin® contains an antibody called trastuzumab. Bioepis
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`lacks knowledge or information sufficient to form a belief about the truth of the remaining
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`allegations in Paragraph 3 and, therefore, denies the same.
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`4.
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`To the extent the allegations in Paragraph 4 purport to describe or characterize
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`publicly available documents, Bioepis objects to such characterization or description of those
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`documents and notes that such documents speak for themselves and no response is required.
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`Bioepis lacks knowledge or information sufficient to form a belief about the truth of the remaining
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`allegations in Paragraph 4 and, therefore, denies the same.
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`5.
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`Bioepis lacks knowledge or information sufficient to form a belief about the truth
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`of the allegations in Paragraph 5 and, therefore, denies the same.
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`6.
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`Bioepis admits that the United States Patent and Trademark Office has granted
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`patents assigned to Genentech. To the extent that the allegations in Paragraph 6 purport to describe
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`or characterize publicly available documents, Bioepis objects to such characterization or
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`description of those documents and notes that those documents speak for themselves and no
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`response is required. Bioepis lacks knowledge or information sufficient to form a belief about the
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`truth of the remaining allegations in Paragraph 6 and, therefore, denies the same.
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`7.
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`Bioepis admits that it submitted an abbreviated Biologic License Application
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`(“aBLA”) to the United States Food and Drug Administration (“FDA”) seeking licensure of its
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`trastuzumab product (“SB3”). Paragraph 7 otherwise contains Plaintiffs’ characterization of their
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`claims, applicable law and regulations, and/or legal conclusions, to which no response is required.
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`To the extent a response is required, Bioepis denies such allegations.
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`8.
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`Bioepis admits that the Biologics Price Competition and Innovation Act (“BPCIA”)
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`was enacted in 2010. Bioepis further admits that it exchanged information with Genentech
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`pursuant to the BPCIA to narrow the scope of the patent disputes involving SB3. Paragraph 8
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`otherwise contains Plaintiffs’ characterization of their claims, applicable law and regulations,
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`and/or legal conclusions, to which no response is required. To the extent a response is required,
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`Bioepis denies such allegations.
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`9.
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`Bioepis admits that the Amended Complaint purports to bring a civil action for
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`patent infringement pursuant to 35 U.S.C. § 271(e)(2). Bioepis further admits that the Amended
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`Complaint purports to seek declaratory judgment pursuant to 42 U.S.C. § 262(l)(9) and 28 U.S.C.
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`§ 2201; a preliminary or permanent injunction pursuant to 35 U.S.C. § 271(e)(4)(B), 35 U.S.C. §
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`271(a), (b), or 35 U.S.C. § 283; and monetary damages. Bioepis admits that in the Amended
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`Complaint, Plaintiffs purport to assert 21 patents against Bioepis. Paragraph 9 otherwise contains
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`Plaintiffs’ characterization of their claims, applicable law and regulations, and/or legal
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`conclusions, to which no response is required. To the extent a response is required, Bioepis denies
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`the allegations.
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`3
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`PARTIES
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`10.
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`Bioepis lacks knowledge or information sufficient to form a belief as to the truth of
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`the allegations in Paragraph 10 and, therefore, denies the same.
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`11.
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`Bioepis lacks knowledge or information sufficient to form a belief as to the truth of
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`the allegations in Paragraph 11 and, therefore, denies the same.
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`12.
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`Bioepis lacks knowledge or information sufficient to form a belief as to the truth of
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`the allegations in Paragraph 12 and, therefore, denies the same.
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`13.
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`Bioepis lacks knowledge or information sufficient to form a belief as to the truth of
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`the allegations in Paragraph 13 and, therefore, denies the same.
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`14.
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`15.
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`Admitted.
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`Bioepis admits that it develops biologic drugs. Bioepis further admits that it filed
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`an aBLA seeking licensure for SB3, and that Merck & Co., Inc. is Bioepis’s commercialization
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`partner for SB3 in the United States. Bioepis otherwise denies the allegations in Paragraph 15.
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`JURISDICTION AND VENUE
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`16.
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`Bioepis admits the Amended Complaint purports to bring an action under the
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`BPCIA, 42 U.S.C. § 262(l), and the Patent Laws of the United States, Title 35, United States Code,
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`and the Declaratory Judgment Act, 28 U.S.C. §§ 2201–2202. Paragraph 16 otherwise contains
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`conclusions of law to which no response is required. Bioepis admits that the Court has subject
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`matter jurisdiction over this case.
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`17.
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`Bioepis admits that it is a company organized and existing under the laws of the
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`Republic of Korea. Paragraph 17 otherwise contains conclusions of law to which no response is
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`required. Bioepis does not contest venue for the purposes of this action only.
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`4
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`18.
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`Bioepis admits that it filed an aBLA with the FDA for SB3. Paragraph 18 otherwise
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`contains conclusions of law to which no response is required. Bioepis does not contest personal
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`jurisdiction for purposes of this action only.
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`THE PARTIES’ PRE-SUIT EXCHANGES
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`19.
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`Bioepis admits that it submitted a press release on December 20, 2017, announcing
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`the FDA had accepted for review Bioepis’s aBLA for SB3. To the extent the allegations in
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`Paragraph 19 purport to describe or characterize publicly available documents, Bioepis objects to
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`such characterization or description of those documents and notes that such documents speak for
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`themselves and no response is required.
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`20.
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`Paragraph 20 contains Plaintiffs’ characterization of their claims, applicable law
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`and regulations, and/or legal conclusions, to which no response is required. To the extent that a
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`response is required, Bioepis denies the allegations.
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`21.
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`Bioepis admits that Genentech sent a letter on December 27, 2017, requesting a
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`copy of the aBLA for SB3. Bioepis otherwise denies the remaining allegations in Paragraph 21.
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`22.
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`Bioepis admits that on January 8, 2018, it provided Genentech with access to
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`documents and information concerning SB3 pursuant to 42 U.S.C. § 262(l)(2)(A). Paragraph 22
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`otherwise contains Plaintiffs’ characterization of their claims, applicable law and regulations,
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`and/or legal conclusions, to which no response is required. To the extent that a response is
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`required, Bioepis denies the allegations.
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`23.
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`Bioepis admits that Genentech sent a letter to counsel for Bioepis on January 12,
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`2018. Bioepis otherwise denies the allegations in Paragraph 23.
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`24.
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`Bioepis admits that Genentech and Bioepis engaged in further correspondence in
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`January and February 2018. Bioepis otherwise denies the allegations in Paragraph 24.
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`5
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`25.
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`Bioepis admits that it provided Genentech with additional documents and
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`information requested by Genentech on February 15, 2018, and February 20, 2018. Bioepis
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`otherwise denies the remaining allegations in Paragraph 25.
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`26.
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`Bioepis admits that Genentech wrote to Bioepis on March 1, 2018, agreeing to
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`provide Bioepis with a list of patents within 60 days from Bioepis’s production of additional
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`documents on February 20, 2018. Bioepis otherwise denies the remaining allegations in Paragraph
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`26.
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`27.
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`Bioepis admits that Genentech sent a letter to Bioepis on March 30, 2018, regarding
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`Bioepis’s production of documents and information concerning SB3. Bioepis further admits that
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`it responded to Genentech’s letter on April 16, 2018. Bioepis denies the remaining allegations in
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`Paragraph 27.
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`28.
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`Bioepis admits that Genentech provided a list of patents to Bioepis on April 23,
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`2018, and informed Bioepis it was not prepared to license any of the listed patents to Bioepis.
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`Paragraph 28 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
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`regulations, and/or legal conclusions, to which no response is required. To the extent that a
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`response is required, Bioepis denies the allegations.
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`29.
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`30.
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`Bioepis denies the allegations in Paragraph 29.
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`Bioepis admits that it provided a statement to Genentech on June 22, 2018, in
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`accordance with 42 U.S.C. § 262(l)(3)(B). Bioepis denies the remaining allegations in Paragraph
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`30.
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`31.
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`Bioepis admits that on August 17, 2018, Genentech provided a statement to Bioepis
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`purporting to be in response to Bioepis’s June 22, 2018 statement. Bioepis admits that Genentech
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`proposed that 21 patents be included in a patent infringement action. Bioepis further admits that
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`6
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`it responded in writing to Genentech on August 23, 2018, and that the parties engaged in further
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`discussions thereafter. Bioepis denies the remaining allegations in Paragraph 31.
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`32.
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`Bioepis admits that on September 3, 2018, it sent a letter to Genentech regarding
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`the patents to be included in an infringement action pursuant to 42 U.S.C. § 262(l)(6). Bioepis
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`otherwise denies the allegations in Paragraph 32.
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`33.
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`Bioepis admits that Genentech sent a letter to Bioepis on November 7, 2018,
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`identifying 10 patents it intended to assert against Bioepis and notifying Bioepis of its intention to
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`assert claims 10 and 11 of U.S. App. No. 14/073,659 (“the ’659 application”). Bioepis admits that
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`the United States Patent and Trademark Office issued the ’659 application as U.S. Patent No.
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`10,160,811 (the “’811 patent”) on December 25, 2018, and that claims 10 and 11 of the ’659
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`application issued as claims 6 and 7 of the ’811 patent. Bioepis further admits that Genentech
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`purported to supplement its April 23, 2018 list pursuant to 42 U.S.C. § 262(l)(3)(A) to include the
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`’811 patent. Paragraph 33 otherwise contains Plaintiffs’ characterization of their claims,
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`applicable law and regulations, and/or legal conclusions, to which no response is required. To the
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`extent a response is required, Bioepis denies the allegations.
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`BIOEPIS’S aBLA PRODUCT
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`34.
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`Bioepis admits that it has issued press releases concerning SB3. Bioepis further
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`admits that SB3 is a biosimilar drug and that the reference product for SB3 is Herceptin®. To the
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`extent the allegations in Paragraph 34 purport to describe or characterize publicly available
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`documents, Bioepis objects to such characterization or description of those documents and notes
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`that such documents speak for themselves and no response is required. To the extent a response
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`is required, Bioepis denies the allegations.
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`7
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`35.
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`Bioepis admits that it submitted an aBLA for SB3 seeking approval for the same
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`indications for which Herceptin® was approved in the United States. To the extent the allegations
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`in Paragraph 35 purport to describe or characterize publicly available documents, Bioepis objects
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`to such characterization or description of those documents and notes that such documents speak
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`for themselves and no response is required. Paragraph 35 otherwise contains Plaintiffs’
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`characterization of their claims, applicable law and regulations, and/or legal conclusions, to which
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`no response is required. To the extent that a response is required, Bioepis denies the allegations.
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`36.
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`Bioepis admits that it submitted an aBLA for SB3 to the FDA. Paragraph 36
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`otherwise contains Plaintiffs’ characterization of their claims, applicable law and regulations,
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`and/or legal conclusions, to which no response is required. To the extent that a response is
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`required, Bioepis denies the allegations.
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`GENENTECH’S ASSERTED PATENTS
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`37.
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`Bioepis lacks knowledge or information sufficient to form a belief as to the truth of
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`the allegations in Paragraph 37 and, therefore, denies the same.
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`38.
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`Bioepis admits that Genentech has asserted U.S. Patent No. 6,331,415, U.S. Patent
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`No. 7,923,221, U.S. Patent No. 6,407,213, U.S. Patent No. 7,846,441, U.S. Patent No. 7,892,549,
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`U.S. Patent No. 6,627,196, U.S. Patent No. 7,371,379, U.S. Patent No. 10,160,811, U.S. Patent
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`No. 6,339,142, U.S. Patent No. 6,417,335, U.S. Patent No. 9,249,218, U.S. Patent No. 8,574,869,
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`U.S. Patent No. 7,993,834, U.S. Patent No. 8,076,066, U.S. Patent No. 8,440,402, U.S. Patent No.
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`6,610,516, U.S. Patent No. 7,390,660, U.S. Patent No. 7,485,704, U.S. Patent No. 7,807,799, U.S.
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`Patent No. 8,512,983, and U.S. Patent No. 9,714,293. Bioepis denies the remaining allegations in
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`Paragraph 38.
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`The Cabilly Patents
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`39.
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`To the extent the allegations in Paragraph 39 purport to describe or characterize
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`publicly available documents, Bioepis objects to such characterization or description of those
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`documents and notes that such documents speak for themselves and no response is required.
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`Paragraph 39 contains Plaintiffs’ characterization of their claims, applicable law and regulations,
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`and/or legal conclusions, to which no response is required. To the extent a response is required,
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`Bioepis denies the allegations.
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`40.
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`Bioepis admits
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`that
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`the ’415 patent
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`is
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`titled “Methods of Producing
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`Immunoglobulins, Vectors and Transformed Host Cells for Use Therein,” that the United States
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`Patent and Trademark Office issued the ’415 patent on December 18, 2001, and that what purports
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`to be a copy of the ’415 patent is attached to the Amended Complaint as Exhibit A. Bioepis lacks
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`knowledge or information sufficient to form a belief about the truth of the allegations in the last
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`sentence of Paragraph 40 and, therefore, denies the same. Paragraph 40 otherwise contains
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`Plaintiffs’ characterization of their claims, applicable law and regulations, and/or legal
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`conclusions, to which no response is required. To the extent that a response is required, Bioepis
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`denies the allegations.
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`41.
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`Bioepis admits that the ’221 patent is titled “Methods of Making Antibody Heavy
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`and Light Chains Having Specificity for a Desired Antigen,” that the United States Patent and
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`Trademark Office issued the ’221 patent on April 12, 2011, and that what purports to be a copy of
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`the ’221 patent is attached to the Amended Complaint as Exhibit B. Bioepis lacks knowledge or
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`information sufficient to form a belief about the truth of the allegations in the last sentence of
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`Paragraph 41 and, therefore, denies the same. Paragraph 41 otherwise contains Plaintiffs’
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`characterization of their claims, applicable law and regulations, and/or legal conclusions, to which
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`no response is required. To the extent that a response is required, Bioepis denies the allegations.
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`The ’213 Patent
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`42.
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`To the extent the allegations in Paragraph 42 purport to describe or characterize
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`publicly available documents, Bioepis objects to such characterization or description of those
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`documents and notes that such documents speak for themselves and no response is required.
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`Paragraph 42 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
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`regulations, and/or legal conclusions, to which no response is required. To the extent a response
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`is required, Bioepis denies the allegations.
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`43.
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`Bioepis admits that the ’213 patent is titled “Method for Making Humanized
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`Antibodies,” that the United States Patent and Trademark Office issued the ’213 patent on June
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`18, 2002, and that what purports to be a copy of the ’213 patent is attached to the Amended
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`Complaint as Exhibit C. Bioepis lacks knowledge or information sufficient to form a belief about
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`the truth of the allegations in the last sentence of Paragraph 43 and, therefore, denies the same.
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`Paragraph 43 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
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`regulations, and/or legal conclusions, to which no response is required. To the extent that a
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`response is required, Bioepis denies the allegations.
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`The Combination Chemotherapy Patents
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`44.
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`To the extent the allegations in Paragraph 44 purport to describe or characterize
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`publicly available documents, Bioepis objects to such characterization or description of those
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`documents and notes that such documents speak for themselves and no response is required.
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`Paragraph 44 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
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`10
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`regulations, and/or legal conclusions, to which no response is required. To the extent a response
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`is required, Bioepis denies the allegations.
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`45.
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`Bioepis admits that the ’441 patent is titled “Treatment with Anti-ErbB2
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`Antibodies,” that the United States Patent and Trademark Office issued the ’441 patent on
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`December 7, 2010, and that what purports to be a copy of the ’441 patent is attached to the
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`Amended Complaint as Exhibit D. Bioepis lacks knowledge or information sufficient to form a
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`belief about the truth of the allegations in the last sentence of Paragraph 45 and, therefore, denies
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`the same. Paragraph 45 otherwise contains Plaintiffs’ characterization of their claims, applicable
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`law and regulations, and/or legal conclusions, to which no response is required. To the extent that
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`a response is required, Bioepis denies the allegations.
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`46.
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`To the extent the allegations in Paragraph 46 purport to describe or characterize
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`publicly available documents, Bioepis objects to such characterization or description of those
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`documents and notes that such documents speak for themselves and no response is required.
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`Paragraph 46 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
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`regulations, and/or legal conclusions, to which no response is required. To the extent a response
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`is required, Bioepis denies the allegations.
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`47.
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`Bioepis admits that the ’549 patent is titled “Treatment with Anti-ErbB2
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`Antibodies,” that the United States Patent and Trademark Office issued the ’549 patent on
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`February 22, 2011, and that what purports to be a copy of the ’549 patent is attached to the
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`Amended Complaint as Exhibit E. Bioepis lacks knowledge or information sufficient to form a
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`belief about the truth of the allegations in the last sentence of Paragraph 47 and, therefore, denies
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`the same. Paragraph 47 otherwise contains Plaintiffs’ characterization of their claims, applicable
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`law and regulations, and/or legal conclusions, to which no response is required. To the extent that
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`a response is required, Bioepis denies the allegations.
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`The Method of Administration Patents
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`48.
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`To the extent the allegations in Paragraph 48 purport to describe or characterize
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`publicly available documents, Bioepis objects to such characterization or description of those
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`documents and notes that such documents speak for themselves and no response is required.
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`Paragraph 48 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
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`regulations, and/or legal conclusions, to which no response is required. To the extent a response
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`is required, Bioepis denies the allegations.
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`49.
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`Bioepis admits that the ’196 patent is titled “Dosages for Treatment with Anti-
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`ErbB2 Antibodies,” that the United States Patent and Trademark Office issued the ’196 patent on
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`September 30, 2003, and that what purports to be a copy of the ’196 patent is attached to the
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`Amended Complaint as Exhibit G. Bioepis lacks knowledge or information sufficient to form a
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`belief about the truth of the allegations in the last sentence of Paragraph 49 and, therefore, denies
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`the same. Paragraph 49 otherwise contains Plaintiffs’ characterization of their claims, applicable
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`law and regulations, and/or legal conclusions, to which no response is required. To the extent that
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`a response is required, Bioepis denies the allegations.
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`50.
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`Bioepis admits that the ’379 patent is titled “Dosages for Treatment with Anti-
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`ErbB2 Antibodies,” that the United States Patent and Trademark Office issued the ’379 patent on
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`May 13, 2008, and that what purports to be a copy of the ’379 patent is attached to the Amended
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`Complaint as Exhibit H. Bioepis lacks knowledge or information sufficient to form a belief about
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`the truth of the allegations in the last sentence of Paragraph 50 and, therefore, denies the same.
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`Paragraph 50 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
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`regulations, and/or legal conclusions, to which no response is required. To the extent that a
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`response is required, Bioepis denies the allegations.
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`51.
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`Bioepis admits that the ’811 patent is titled “Treatment with Anti-ErbB2
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`Antibodies,” that the United States Patent and Trademark Office issued the ’811 patent on
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`December 25, 2018, and that what purports to be a copy of the ’811 patent is attached to the
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`Amended Complaint as Exhibit F. Bioepis lacks knowledge or information sufficient to form a
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`belief about the truth of the allegations in the last sentence of Paragraph 51 and, therefore, denies
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`the same. Paragraph 51 otherwise contains Plaintiffs’ characterization of their claims, applicable
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`law and regulations, and/or legal conclusions, to which no response is required. To the extent that
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`a response is required, Bioepis denies the allegations.
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`The Acidic Variants Patents
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`52.
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`To the extent the allegations in Paragraph 52 purport to describe or characterize
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`publicly available documents, Bioepis objects to such characterization or description of those
`
`documents and notes that such documents speak for themselves and no response is required.
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`Paragraph 52 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`regulations, and/or legal conclusions, to which no response is required. To the extent a response
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`is required, Bioepis denies the allegations.
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`53.
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`Bioepis admits that the ’142 patent is titled “Protein Purification,” that the United
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`States Patent and Trademark Office issued the ’142 patent on January 15, 2002, and that what
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`purports to be a copy of the ’142 patent is attached to the Amended Complaint as Exhibit I. Bioepis
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`lacks knowledge or information sufficient to form a belief about the truth of the allegations in the
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`last sentence of Paragraph 53 and, therefore, denies the same. Paragraph 53 otherwise contains
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`Plaintiffs’ characterization of their claims, applicable law and regulations, and/or legal
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`conclusions, to which no response is required. To the extent that a response is required, Bioepis
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`denies the allegations.
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`54.
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`Bioepis admits that the ’335 patent is titled “Protein Purification,” that the United
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`States Patent and Trademark Office issued the ’335 patent on July 9, 2002, and that what purports
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`to be a copy of the ’335 patent is attached to the Amended Complaint as Exhibit J. Bioepis lacks
`
`knowledge or information sufficient to form a belief about the truth of the allegations in the last
`
`sentence of Paragraph 54 and, therefore, denies the same. Paragraph 54 otherwise contains
`
`Plaintiffs’ characterization of their claims, applicable law and regulations, and/or legal
`
`conclusions, to which no response is required. To the extent that a response is required, Bioepis
`
`denies the allegations.
`
`55.
`
`Bioepis admits that the ’218 patent is titled “Protein Purification,” that the United
`
`States Patent and Trademark Office issued the ’218 patent on February 2, 2016, and that what
`
`purports to be a copy of the ’218 patent is attached to the Amended Complaint as Exhibit K.
`
`Bioepis lacks knowledge or information sufficient to form a belief about the truth of the allegations
`
`in the last sentence of Paragraph 55 and, therefore, denies the same. Paragraph 55 otherwise
`
`contains Plaintiffs’ characterization of their claims, applicable law and regulations, and/or legal
`
`conclusions, to which no response is required. To the extent that a response is required, Bioepis
`
`denies the allegations.
`
`HER2 Diagnostic Patents
`
`56.
`
`To the extent the allegations in Paragraph 56 purport to describe or characterize
`
`publicly available documents, Bioepis objects to such characterization or description of those
`
`documents and notes that such documents speak for themselves and no response is required.
`
`Paragraph 56 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`14
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`

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`Case 1:18-cv-01363-CFC Document 66 Filed 01/31/19 Page 15 of 94 PageID #: 9117
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`regulations, and/or legal conclusions, to which no response is required. To the extent a response
`
`is required, Bioepis denies the allegations.
`
`57.
`
`Bioepis admits that the ’834 patent is titled “Detection of ErbB2 Gene
`
`Amplification to Increase the Likelihood of the Effectiveness of the ErbB2 Antibody Breast
`
`Cancer Therapy,” that the United States Patent and Trademark Office issued the ’834 patent on
`
`August 9, 2011, and that what purports to be a copy of the ’834 patent is attached to the Amended
`
`Complaint as Exhibit L. Bioepis lacks knowledge or information sufficient to form a belief about
`
`the truth of the allegations in the last sentence of Paragraph 57 and, therefore, denies the same.
`
`Paragraph 57 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`regulations, and/or legal conclusions, to which no response is required. To the extent that a
`
`response is required, Bioepis denies the allegations.
`
`58.
`
`Bioepis admits that the ’066 patent is titled “Gene Detection Assay for Improving
`
`the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy,” that the United
`
`States Patent and Trademark Office issued the ’066 patent on December 13, 2011, and that what
`
`purports to be a copy of the ’066 patent is attached to the Amended Complaint as Exhibit M.
`
`Bioepis lacks knowledge or information sufficient to form a belief about the truth of the allegations
`
`in the last sentence of Paragraph 58 and, therefore, denies the same. Paragraph 58 otherwise
`
`contains Plaintiffs’ characterization of their claims, applicable law and regulations, and/or legal
`
`conclusions, to which no response is required. To the extent that a response is required, Bioepis
`
`denies the allegations.
`
`59.
`
`Bioepis admits that the ’402 patent is titled “Gene Detection Assay for Improving
`
`the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy,” that the United
`
`States Patent and Trademark Office issued the ’402 patent on May 14, 2013, and that what purports
`
`15
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`

`

`Case 1:18-cv-01363-CFC Document 66 Filed 01/31/19 Page 16 of 94 PageID #: 9118
`
`to be a copy of the ’402 patent is attached to the Amended Complaint as Exhibit N. Bioepis lacks
`
`knowledge or information sufficient to form a belief about the truth of the allegations in the last
`
`sentence of Paragraph 59 and, therefore, denies the same. Paragraph 59 otherwise contains
`
`Plaintiffs’ characterization of their claims, applicable law and regulations, and/or legal
`
`conclusions, to which no response is required. To the extent that a response is required, Bioepis
`
`denies the allegations.
`
`Cell Culture, Purification, and Antibody Manufacturing Patents
`
`60.
`
`To the extent the allegations in Paragraph 60 purport to describe or characterize
`
`publicly available documents, Bioepis objects to such characterization or description of those
`
`documents and notes that such documents speak for themselves and no response is required.
`
`Paragraph 60 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`regulations, and/or legal conclusions, to which no response is required. To the extent a response
`
`is required, Bioepis denies the allegations.
`
`61.
`
`Bioepis admits that the ’516 patent is titled “Cell Culture Process,” that the United
`
`States Patent and Trademark Office issued the ’516 patent on August 26, 2003, and that what
`
`purports to be a copy of the ’516 patent is attached to the Amended Complaint as Exhibit O.
`
`Bioepis lacks knowledge or information sufficient to form a belief about the truth of the allegations
`
`in the last sentence of Paragraph 61 and, therefore, denies the same. Paragraph 61 otherwise
`
`contains Plaintiffs’ characterization of their claims, applicable law and regulations, and/or legal
`
`conclusions, to which no response is required. To the extent that a response is required, Bioepis
`
`denies the allegations.
`
`62.
`
`Bioepis admits that the ’660 patent is titled “Methods for Growing Mammalian
`
`Cells In Vitro,” that the United States Patent and Trademark Office issued the ’660 patent on June
`
`16
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`

`

`Case 1:18-cv-01363-CFC Document 66 Filed 01/31/19 Page 17 of 94 PageID #: 9119
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`24, 2008, and that what purports to be a copy of the ’660 patent is attached to the Amended
`
`Complaint as Exhibit P. Bioepis lacks knowledge or information sufficient to form a belief about
`
`the truth of the allegations in the last sentence of Paragraph 62 and, therefore, denies the same.
`
`Paragraph 62 otherwise contains Plaintiffs’ characterization of their claims, applicable law and
`
`regulations, and/or legal conclusions, to which no response is required. To the extent that a
`
`response is required, Bioepis denies the allegations.
`
`63.
`
`Bioepis admits that the ’704 patent is titled “Reducing Protein A Leaching During
`
`Protein A Affinity Chromatography,” that the United States Patent and Trademark Office issued
`
`the ’704 patent on February 3, 2009, and that what purports to be