Case 1:17-cv-01672-GMS Document 28 Filed 04/24/18 Page 1 of 108 PageID #: 2891
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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 Counterclaim
`Defendants,
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`PFIZER INC.
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`Defendant and Counterclaim
`Plaintiff.
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`C.A. No. 17-1672-GMS
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`DEFENDANT PFIZER INC.’S FIRST AMENDED ANSWER,
`AFFIRMATIVE DEFENSES, AND COUNTERCLAIMS
`TO PLAINTIFFS’ FIRST AMENDED COMPLAINT
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`Defendant and Counterclaim-Plaintiff Pfizer Inc. (“Pfizer”), by and through its attorneys,
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`hereby submits this First Amended Answer, Affirmative Defenses, and Counterclaims to the
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`First Amended Complaint filed by Plaintiffs Genentech, Inc. and City of Hope (collectively,
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`“Genentech” or “Plaintiffs”) on March 28, 2018 (the “First Amended Complaint”). (D.I. 23.)
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`ANSWER TO FIRST 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 First Amended Complaint. Pfizer denies all allegations in the First 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 and/or
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`ambiguous, Pfizer denies said allegations. Pfizer denies that Genentech is entitled to the relief
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`requested or any other relief. Pfizer responds to the First Amended Complaint as follows:
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`NATURE OF THE CASE
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`1.
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`Admitted in part; denied in part. Pfizer admits that breast cancer is a disease
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`affecting women in the United States. Pfizer lacks knowledge or information sufficient to form a
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`belief as to the truth or falsity of the remaining allegations of Paragraph 1 and, therefore, denies
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`the same.
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`2.
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`Pfizer lacks knowledge or information sufficient to form a belief as to the truth of
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`the allegations of Paragraph 2 and, therefore, denies the same.
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`3.
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`Admitted in part; denied in part. Pfizer admits that Herceptin® contains
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`trastuzumab, which is an antibody. Pfizer lacks knowledge or information sufficient to form a
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`belief as to the truth of the allegations of Paragraph 3 and, therefore, denies the same.
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`4.
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`Pfizer admits that the sources cited in Paragraph 4 include the quoted language.
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`Pfizer lacks knowledge or information sufficient to form a belief as to the truth of the other
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`allegations of Paragraph 4 and, therefore, denies the same.
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`5.
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`Pfizer admits that Herceptin® was approved by the FDA in 1998. Pfizer lacks
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`knowledge or information sufficient to form a belief as to the truth or falsity of the remaining
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`allegations of Paragraph 5 and, therefore, denies the same.
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`6.
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`Pfizer lacks knowledge or information sufficient to form a belief as to the truth of
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`the allegations of Paragraph 6 and, therefore, denies the same.
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`7.
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`Pfizer admits that it is seeking FDA approval of a biosimilar version of
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`Herceptin® called PF-05280014. Pfizer admits that it is relying in part on data concerning
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`Genentech’s U.S.-licensed Herceptin® product. Also, Pfizer admits to proposing a draft label for
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`PF-05280014 consistent with that of Genentech’s U.S.-licensed Herceptin® product, including all
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`indications for which U.S.-licensed Herceptin® is currently approved. Pfizer otherwise denies
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`the allegations of Paragraph 7.
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`8.
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`Pfizer admits that in 2010, Congress passed the Biologics Price Competition and
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`Innovation Act (“BPCIA”). Pfizer admits that pursuant to the BPCIA, biosimilar applicants and
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`reference product sponsors exchange the biosimilar application submitted to the FDA for
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`approval, and a list and description of patents that the reference product sponsor believes a claim
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`of patent infringement could reasonably be asserted by the reference product sponsor. See 42
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`U.S.C. §262(1). Also, Pfizer admits that on November 17, 2017, consistent with the BPCIA and
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`pursuant to 42 U.S.C. §262(1)(8)(A), Pfizer provided notice to Genentech of its intent to begin
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`commercial marketing of its trastuzumab biosimilar, PF-05280014, as described in BLA No.
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`761081, as early as 180 days from the date of the notice. The remaining allegations of Paragraph
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`8 contain conclusions of law for which no response is required. To the extent an answer is
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`required, Pfizer denies the remaining allegations of Paragraph 8.
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`9.
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`Admitted in part; denied in part. Pfizer admits only that Plaintiffs brought this
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`action for infringement pursuant to 35 U.S.C. § 271(e)(2). Pfizer admits only that Plaintiffs seek
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`a declaratory judgment pursuant to 42 U.S.C. § 262(l)(9) and 28 U.S.C. § 2201 that the
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`manufacture, use, offer to sell, sale, or importation into the United States of the Pfizer aBLA
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`product would infringe the 20 patents in dispute in this case, to which they are not entitled.
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`Pfizer also admits only that Plaintiffs seek a preliminary and/or permanent injunction pursuant to
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`42 U.S.C. § 262(l)(8)(B) barring Pfizer’s manufacture, use, offer to sell, sale, or importation of
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`its biosimilar product prior to the expiration of those patents, to which they are not entitled.
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`Pfizer lacks sufficient knowledge or information to form a belief as to the truth of the last
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`sentence of paragraph 9 concerning Plaintiffs’ future plans based on an event that has not
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`occurred, and therefore denies the same.
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`THE PARTIES
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`On information and belief, admitted.
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`On information and belief, Pfizer admits that Genentech was founded in 1976.
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`10.
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`11.
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`Pfizer lacks knowledge or information sufficient to form a belief as to the truth of the allegations
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`of Paragraph 11 and, therefore, denies the same.
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`12.
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`13.
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`On information and belief, admitted.
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`On information and belief, Pfizer admits that City of Hope was founded in 1913.
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`Pfizer lacks knowledge or information sufficient to form a belief as to the truth of the allegations
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`of 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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`Pfizer admits that it is seeking licensure in the United States pursuant to 42 U.S.C.
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`§ 262(k) for the importation, commercial manufacture, offer to sell, sale and/or use of the drug
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`product (“Pfizer Product”) described in Pfizer’s BLA No. 761081 (“Pfizer’s BLA”), which is a
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`biological drug. Pfizer admits that the BLA Product will be distributed in the United States,
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`including the State of Delaware, but not before the date provided to Genentech in Pfizer’s
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`statement pursuant to 42 U.S.C. § 262(l)(3)(B). Pfizer otherwise denies the allegations of
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`Paragraph 15.
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`JURISDICTION AND VENUE
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`16.
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`Pfizer admits that the First Amended Complaint purports to bring an action under
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`the BPCIA, 42 U.S.C. § 262(l) and the Patent Laws of the United States, Title 35, United State
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`Code, and the Declaratory Judgment Act, 28 U.S.C. §§ 2201-2202. Pfizer denies that Genentech
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`is entitled to any relief in this action. The remaining allegations of Paragraph 16 contain
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`conclusions of law for which no response is required. To the extent an answer is required, Pfizer
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`denies the remaining allegations of Paragraph 16.
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`17.
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`Pfizer does not contest venue for purposes of this action only. Pfizer admits that
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`Pfizer is incorporated in Delaware. The remaining allegations of Paragraph 17 contain
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`conclusions of law for which no response is required. To the extent an answer is required, Pfizer
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`denies the remaining allegations of Paragraph 17.
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`18.
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`Pfizer admits that it is a corporation incorporated in Delaware. Pfizer admits that
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`it has filed Biologics License Application No. 761081 with the FDA seeking approval to market
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`the Pfizer product described therein. Pfizer does not contest personal jurisdiction for purposes of
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`this action only. The remaining allegations of Paragraph 18 contain conclusions of law for
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`which no response is required. To the extent an answer is required, Pfizer denies the remaining
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`allegations of Paragraph 18.
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`THE PARTIES’ EXCHANGES UNDER THE BPCIA
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`19.
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`Pfizer admits that it submitted BLA No. 761081 to the FDA seeking approval for
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`the commercial manufacture, use, offer for sale, or sale of the product described therein, a
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`biosimilar version of Herceptin® called PF-05280014. Upon information and belief, Pfizer
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`admits that trastuzumab is subject to BLA No. 103792 to Genentech.
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`20.
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`21.
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`22.
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`Admitted.
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`Admitted.
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`Pfizer admits that on September 5, 2017, Pfizer provided Genentech with a
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`complete copy of Pfizer’s BLA, in compliance with § 262(l)(2)(A). Indeed, Pfizer’s BLA
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`contains over two-hundred and fifty thousand pages of information on Pfizer’s Product and the
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`processes to manufacture it. The produced information completely “describe[d] the process or
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`processes used to manufacture the biological product that is the subject of such application” as
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`contemplated by the BPCIA. Pfizer otherwise denies the allegations of Paragraph 22.
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`23.
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`Pfizer admits that it received a letter from Genentech dated October 19, 2017,
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`alleging that “the documents that Pfizer has produced so far do not appear to fully describe the
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`PF-05280014 manufacturing processes.” Pfizer admits that Genentech identified several
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`categories of information for which it requested production of the information or identification of
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`where the information may be found in Pfizer’s BLA. Pfizer admits that it responded to
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`Genentech in a letter dated November 1, 2017, which identified for each of Genentech’s
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`categories the sections of Pfizer’s BLA that contain related information. Although the
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`production of Pfizer’s BLA satisfied 42 U.S.C. § 262(l)(2), Pfizer admits that it produced some
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`additional documents in response to some of Genentech’s categories in the spirit of cooperation.
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`Pfizer admits that Genentech responded on November 3, 2017 with allegations that Pfizer’s
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`November 1, 2017 production was deficient in contravention of 42 U.S.C. § 262(l)(2). Pfizer
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`otherwise denies the allegations of Paragraph 23.
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`24.
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`The documents that Pfizer produced to Genentech demonstrate that Genentech
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`had no reasonable basis to assert certain patents that it listed purportedly pursuant to 42 U.S.C. §
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`262(l)(3)(A). Pfizer admits that Genentech requested additional information purportedly
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`pursuant to 42 U.S.C. § 262(l)(2)(A). Pfizer otherwise denies the allegations of Paragraph 24.
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`25.
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`Pfizer admits that Genentech provided a list of patents purportedly pursuant to 42
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`U.S.C. 262(l)(3)(A) on November 3, 2017 (“Genentech’s 3A List”). Pfizer otherwise denies the
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`allegations of Paragraph 25.
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`26.
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`Pfizer admits that on November 17, 2017, it notified Genentech pursuant to 42
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`U.S.C. § 262(l)(8)(A) that it intends to commence commercial marketing of PF-05280014 in the
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`United States as early as 180 days from the date of the notice. Pfizer also admits that Genentech
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`filed the original complaint in this action on November 17, 2017. Pfizer admits that Exhibit A
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`purports to be a copy of Pfizer’s notice of commercial marketing.
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`27.
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`Pfizer admits that on January 2, 2018, pursuant to and in compliance with 42
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`U.S.C. § 262(l)(3)(B), Pfizer provided its detailed statement, spanning over six hundred pages,
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`that describes on a claim by claim basis, the factual and legal basis for its opinion that each of the
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`patents listed by Genentech is invalid, unenforceable, and/or will not be infringed by the
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`biological product that is the subject of Pfizer’s BLA (“Pfizer’s 3B Statement”). Pfizer
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`otherwise denies the allegations of Paragraph 27.
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`28.
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`Pfizer admits that on March 2, 2018, Genentech purported to provide its response
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`to Pfizer’s 3B Statement pursuant to 42 U.S.C. § 262(l)(3)(C) (“Genentech’s 3C Statement”).
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`Pfizer also admits Genentech purported to include responses to Pfizer’s non-infringement and
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`invalidity statements for 18 of the 38 patents addressed in Pfizer’s 3B Statement. Pfizer admits
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`that Genentech proposed agreeing that all patents in Genentech’s 3C Statement and two patents
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`included on Genentech’s 3A List be included in this infringement action. Pfizer otherwise
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`denies the allegations of Paragraph 28.
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`PFIZER’S aBLA PRODUCT
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`29.
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`Pfizer admits that the sources cited in Paragraph 29 include the quoted language.
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`The remaining allegations of Paragraph 29 contain conclusions of law for which no response is
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`required.
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`30.
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`Admitted in part; denied in part. Pfizer admits that a justiciable case or
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`controversy exists between the parties, but denies that any act of infringement has occurred.
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`GENENTECH’S ASSERTED PATENTS
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`31.
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`Pfizer lacks knowledge or information sufficient to form a belief as to the truth of
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`the allegations of Paragraph 31 and, therefore, denies the same.
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`32.
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`Admitted in part; denied in part. Pfizer admits that Genentech has asserted that
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`Pfizer’s BLA product will infringe the patents cited in Paragraph 32. Pfizer denies the remaining
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`allegations of Paragraph 32.
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`The Cabilly Patents
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`33.
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`Pfizer admits that U.S. Patent Nos. 6,331,415 and 7,923,221 purport to relate to
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`processes for producing an immunoglobulin. Pfizer lacks knowledge or information sufficient to
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`form a belief as to the truth of the remaining allegations of Paragraph 33 and, therefore, denies
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`the same.
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`34.
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`Pfizer admits that U.S. Patent No. 6,331,415 is titled “Methods of Producing
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`Immunoglobulins, Vectors and Transformed Host Cells for Use Therein,” and was issued on
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`December 18, 2001 by the Patent Office. Pfizer admits that what purports to be a copy of the
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`’415 patent is attached to the First Amended Complaint as Exhibit B. Pfizer admits that U.S.
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`Patent No. 6,331,415, on its face, is assigned to Genentech, Inc. Pfizer lacks knowledge or
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`information sufficient to form a belief as to the truth of the remaining allegations of Paragraph 34
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`and, therefore, denies the same.
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`35.
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`Pfizer admits that U.S. Patent No. 7,923,221 is titled “Methods of Making
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`Antibody Heavy and Light Chains Having Specificity for a Desired Antigen,” and was issued on
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`April 12, 2011 by the Patent Office. Pfizer admits that what purports to be a copy of the ’221
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`patent is attached to the First Amended Complaint as Exhibit C. Pfizer admits that U.S. Patent
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`No. 7,923,221, on its face, is assigned to Genentech, Inc. and City of Hope. Pfizer lacks
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`knowledge or information sufficient to form a belief as to the truth of the remaining allegations
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`of Paragraph 35 and, therefore, denies the same.
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`The ’213 Patent
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`36.
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`Pfizer admits that U.S. Patent No. 6,407,213 purports to relate to methods for the
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`preparation and use of variant antibodies. Pfizer lacks knowledge or information sufficient to
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`form a belief as to the truth of the remaining allegations of Paragraph 36 and, therefore, denies
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`the same.
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`37.
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`Pfizer admits that U.S. Patent No. 6,407,213 is titled “Method for Making
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`Humanized Antibodies,” and was issued on June 18, 2002 by the Patent Office. Pfizer admits
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`that what purports to be a copy of the ’213 patent is attached to the First Amended Complaint as
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`Exhibit D. Pfizer admits that U.S. Patent No. 6,407,213 is assigned on its face to Genentech,
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`Inc. Pfizer lacks knowledge or information sufficient to form a belief as to the truth of the
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`remaining allegations of Paragraph 37 and, therefore, denies the same.
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`The Combination Chemotherapy Patents
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`38.
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`Pfizer admits that U.S. Patent No. 7,846,441 purports to relate to the treatment of
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`disorders characterized by the overexpression of ErbB2. Pfizer lacks knowledge or information
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`sufficient to form a belief as to the truth of the remaining allegations of Paragraph 38 and,
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`therefore, denies the same.
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`39.
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`Pfizer admits that U.S. Patent No. 7,846,441 is titled “Treatment with Anti-ErbB2
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`Antibodies,” and was issued on December 7, 2010 by the Patent Office. Pfizer admits that what
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`purports to be a copy of the ’441 patent is attached to the First Amended Complaint as Exhibit E.
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`Pfizer admits that U.S. Patent No. 7,846,441, on its face, is assigned to Genentech, Inc. Pfizer
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`lacks knowledge or information sufficient to form a belief as to the truth of the remaining
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`allegations of Paragraph 39 and, therefore, denies the same.
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`40.
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`Pfizer admits that U.S. Patent No. 7,892,549 is a continuation of U.S. Patent No.
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`7,846,441 and purports to relate to the treatment of disorders characterized by the overexpression
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`of ErbB2. Pfizer lacks knowledge or information sufficient to form a belief as to the truth of the
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`remaining allegations of Paragraph 40 and, therefore, denies the same.
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`41.
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`Pfizer admits that U.S. Patent No. 7,892,549 is titled “Treatment with Anti-ErbB2
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`Antibodies,” and was issued on February 22, 2011 by the Patent Office. Pfizer admits that what
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`purports to be a copy of the ’549 patent is attached to the First Amended Complaint as Exhibit F.
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`Pfizer admits that U.S. Patent No. 7,892,549, on its face, is assigned to Genentech, Inc. Pfizer
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`lacks knowledge or information sufficient to form a belief as to the truth of the remaining
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`allegations of Paragraph 41 and, therefore, denies the same.
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`42.
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`Pfizer admits that U.S. Patent Nos. 8,425,908, 7,846,441, and 7,892,549 identify
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`Provisional Application No. 60/069,346 on the face of the patent as a related U.S. application.
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`Pfizer admits that U.S. Patent No. 8,425,908 purports to relate to the treatment of disorders
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`characterized by the overexpression of ErbB2. Pfizer lacks knowledge or information sufficient
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`to form a belief as to the truth of the remaining allegations of Paragraph 42 and, therefore, denies
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`the same.
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`43.
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`Pfizer admits that U.S. Patent No. 8,425,908 is titled “Treatment with Anti-ErbB2
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`Antibodies,” and was issued on April 23, 2013 by the Patent Office. Pfizer admits that what
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`purports to be a copy of the ’908 patent is attached to the First Amended Complaint as Exhibit G.
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`Pfizer admits that U.S. Patent No. 8,425,908, on its face, is assigned to Genentech, Inc. Pfizer
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`lacks knowledge or information sufficient to form a belief as to the truth of the remaining
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`allegations of Paragraph 43 and, therefore, denies the same.
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`The Method of Administration Patents
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`44.
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`Pfizer admits that U.S. Patent Nos. 6,627,196 and 7,371,379 purport to relate to
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`the treatment of disorders characterized by the overexpression of ErbB2. Pfizer lacks knowledge
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`or information sufficient to form a belief as to the truth of the remaining allegations of Paragraph
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`44 and, therefore, denies the same.
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`45.
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`Pfizer admits that U.S. Patent No. 6,627,196 is titled “Dosages for Treatment with
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`Anti-ErbB2 Antibodies,” and was issued on September 30, 2003 by the Patent Office. Pfizer
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`admits that what purports to be a copy of the ’196 patent is attached to the First Amended
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`Complaint as Exhibit H. Pfizer admits that U.S. Patent No. 6,627,196, on its face, is assigned to
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`Genentech, Inc. Pfizer lacks knowledge or information sufficient to form a belief as to the truth
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`of the remaining allegations of Paragraph 45 and, therefore, denies the same.
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`46.
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`Pfizer admits that U.S. Patent No. 7,371,379 is titled “Dosages for Treatment with
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`Anti-ErbB2 Antibodies,” and was issued on May 13, 2008 by the Patent Office. Pfizer admits
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`that what purports to be a copy of the ’379 patent is attached to the First Amended Complaint as
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`Exhibit I. Pfizer admits that U.S. Patent No. 7,371,379, on its face, is assigned to Genentech,
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`Inc. Pfizer lacks knowledge or information sufficient to form a belief as to the truth of the
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`remaining allegations of Paragraph 46 and, therefore, denies the same.
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`The Acidic Variants Patents
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`47.
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`Pfizer admits that U.S. Patent Nos. 6,339,142 and 9,249,218 purport to relate to
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`methods for purifying a polypeptide by ion exchange chromatography. Pfizer lacks knowledge
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`or information sufficient to form a belief as to the truth of the remaining allegations of Paragraph
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`47 and, therefore, denies the same.
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`48.
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`Pfizer admits that U.S. Patent No. 6,339,142 is titled “Protein Purification,” and
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`was issued on January 15, 2002 by the Patent Office. Pfizer admits that what purports to be a
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`copy of the ’142 patent is attached to the First Amended Complaint as Exhibit J. Pfizer admits
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`that U.S. Patent No. 6,339,142, on its face, is assigned to Genentech, Inc. Pfizer lacks
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`knowledge or information sufficient to form a belief as to the truth of the remaining allegations
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`of Paragraph 48 and, therefore, denies the same.
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`49.
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`Pfizer admits that U.S. Patent No. 9,249,218 is titled “Protein Purification,” and
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`was issued on February 2, 2016 by the Patent Office. Pfizer admits that what purports to be a
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`copy of the ’218 patent is attached to the First Amended Complaint as Exhibit K. Pfizer admits
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`that U.S. Patent No. 9,249,218, on its face, is assigned to Genentech, Inc. Pfizer lacks
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`knowledge or information sufficient to form a belief as to the truth of the remaining allegations
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`of Paragraph 49 and, therefore, denies the same.
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`HER2 Diagnostic Patents
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`50.
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`Pfizer admits that U.S. Patent Nos. 7,993,834, 8,076,066, and 8,440,402 purport
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`to relate to the treatment of cancers characterized by the overexpression of a tumor antigen.
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`Pfizer lacks knowledge or information sufficient to form a belief as to the truth of the remaining
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`allegations of Paragraph 50 and, therefore, denies the same.
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`51.
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`Pfizer admits that U.S. Patent No. 7,993,834 is titled “Detection of ErbB2 Gene
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`Amplification to Increase the Likelihood of the Effectiveness of ErbB2 Antibody Breast Cancer
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`Therapy,” and was issued on August 9, 2011 by the Patent Office. Pfizer admits that what
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`purports to be a copy of the ’834 patent is attached to the First Amended Complaint as Exhibit L.
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`Pfizer admits that U.S. Patent No. 7,993,834, on its face, is assigned to Genentech, Inc. Pfizer
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`lacks knowledge or information sufficient to form a belief as to the truth of the remaining
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`allegations of Paragraph 51 and, therefore, denies the same.
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`52.
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`Pfizer admits that U.S. Patent No. 8,076,066 is titled “Gene Detection Assay for
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`Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy,” and
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`was issued on December 13, 2011 by the Patent Office. Pfizer admits that what purports to be a
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`copy of the ’066 patent is attached to the First Amended Complaint as Exhibit M. Pfizer admits
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`that U.S. Patent No. 8,076,066, on its face, is assigned to Genentech, Inc. Pfizer lacks
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`knowledge or information sufficient to form a belief as to the truth of the remaining allegations
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`of Paragraph 52 and, therefore, denies the same.
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`53.
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`Pfizer admits that U.S. Patent No. 8,440,402 is titled “Gene Detection Assay for
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`Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy,” and
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`was issued on May 14, 2013 by the Patent Office. Pfizer admits that what purports to be a copy
`
`of the ’402 patent is attached to the First Amended Complaint as Exhibit N. Pfizer admits that
`
`U.S. Patent No. 8,440,402, on its face, is assigned to Genentech, Inc. Pfizer lacks knowledge or
`
`information sufficient to form a belief as to the truth of the remaining allegations of Paragraph 53
`
`and, therefore, denies the same.
`
`Cell Culture, Purification, and Antibody Manufacturing Patents
`
`54.
`
`Pfizer admits only that U.S. Patent Nos. 6,242,177, 6,610,516, 8,574,869,
`
`6,121,428, 7,485,704, 7,807,799 and 8,314,225 purport to relate to various subject matter. Pfizer
`
`lacks knowledge or information sufficient to form a belief as to the truth of the remaining
`
`allegations of Paragraph 54 and, therefore, denies the same.
`
`55.
`
`Pfizer admits that U.S. Patent No. 7,485,704 is titled “Reducing Protein A
`
`Leaching During Protein A Affinity Chromatography,” and was issued on February 3, 2009 by
`
`the Patent Office. Pfizer admits that what purports to be a copy of the ’704 patent is attached to
`
`the First Amended Complaint as Exhibit O. Pfizer admits that U.S. Patent No. 7,485,704, on its
`
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`Case 1:17-cv-01672-GMS Document 28 Filed 04/24/18 Page 14 of 108 PageID #: 2904
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`face, is assigned to Genentech, Inc. Pfizer lacks knowledge or information sufficient to form a
`
`belief as to the truth of the remaining allegations of Paragraph 55 and, therefore, denies the same.
`
`56.
`
`Pfizer admits that U.S. Patent No. 7,807,799 is titled “Reducing Protein A
`
`Leaching During Protein A Affinity Chromatography,” and was issued on October 5, 2010 by
`
`the Patent Office. Pfizer admits that what purports to be a copy of the ’799 patent is attached to
`
`the First Amended Complaint as Exhibit P. Pfizer admits that U.S. Patent No. 7,807,799, on its
`
`face, is assigned to Genentech, Inc. Pfizer lacks knowledge or information sufficient to form a
`
`belief as to the truth of the remaining allegations of Paragraph 56 and, therefore, denies the same.
`
`57.
`
`Pfizer admits that U.S. Patent No. 6,242,177 is titled “Methods and Compositions
`
`for Secretion of Heterologous Polypeptides,” and was issued on June 5, 2001 by the Patent
`
`Office. Pfizer admits that what purports to be a copy of the ’177 patent is attached to the First
`
`Amended Complaint as Exhibit Q. Pfizer admits that U.S. Patent No. 6,242,177, on its face, is
`
`assigned to Genentech, Inc. Pfizer lacks knowledge or information sufficient to form a belief as
`
`to the truth of the remaining allegations of Paragraph 57 and, therefore, denies the same.
`
`58.
`
`Pfizer admits that U.S. Patent No. 6,610,516 is titled “Cell Culture Process,” and
`
`was issued on August 26, 2003 by the Patent Office. Pfizer admits that what purports to be a
`
`copy of the ’516 patent is attached to the First Amended Complaint as Exhibit R. Pfizer admits
`
`that U.S. Patent No. 6,610,516, on its face, is assigned to Genentech, Inc. Pfizer lacks
`
`knowledge or information sufficient to form a belief as to the truth of the remaining allegations
`
`of Paragraph 58 and, therefore, denies the same.
`
`59.
`
`Pfizer admits that U.S. Patent No. 8,574,869 titled “Prevention of Disulfide Bond
`
`Reduction During Recombinant Production of Polypeptides,” and was issued on November 5,
`
`2013 by the Patent Office. Pfizer admits that what purports to be a copy of the ’869 patent is
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`Case 1:17-cv-01672-GMS Document 28 Filed 04/24/18 Page 15 of 108 PageID #: 2905
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`attached to the First Amended Complaint as Exhibit S. Pfizer admits that U.S. Patent No.
`
`8,574,869, on its face, is assigned to Genentech, Inc. Pfizer lacks knowledge or information
`
`sufficient to form a belief as to the truth of the remaining allegations of Paragraph 59 and,
`
`therefore, denies the same.
`
`60.
`
`Pfizer admits that U.S. Patent No. 8,314,225 titled “Heavy Chain Mutant Leading
`
`to Improved Immunoglobulin Production,” and was issued on November 20, 2012 by the Patent
`
`Office. Pfizer admits that what purports to be a copy of the ’225 patent is attached to the First
`
`Amended Complaint as Exhibit T. Pfizer admits that U.S. Patent No. 8,314,225 is assigned on
`
`its face to Hoffmann-La Roche Inc. Pfizer lacks knowledge or information sufficient to form a
`
`belief as to the truth of the remaining allegations of Paragraph 60 and, therefore, denies the same.
`
`61.
`
`Pfizer admits that U.S. Patent No. 6,121,428 titled “Protein Recovery,” and was
`
`issued on September 19, 2000 by the Patent Office. Pfizer admits that what purports to be a copy
`
`of the ’428 patent is attached to the First Amended Complaint as Exhibit U. Pfizer admits that
`
`U.S. Patent No. 6,121,428, on its face, is assigned to Genentech, Inc. Pfizer lacks knowledge or
`
`information sufficient to form a belief as to the truth of the remaining allegations of Paragraph 61
`
`and, therefore, denies the same.
`
`COUNT I
`INFRINGEMENT OF U.S. PATENT NO. 6,331,415
`
`62.
`
`Pfizer incorporates by reference its answers to Paragraphs 1-61 as if fully set forth
`
`herein.
`
`63.
`
`Pfizer admits that Genentech included the ’415 patent in the list of patents
`
`provided on November 3, 2017. Pfizer admits that on November 17, 2017, Pfizer provided
`
`notice to Genentech of its intent to begin commercial marketing of its trastuzumab biosimilar,
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`Case 1:17-cv-01672-GMS Document 28 Filed 04/24/18 Page 16 of 108 PageID #: 2906
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`PF-05280014, as described in BLA No. 761081, as early as 180 days from the date of the notice.
`
`Pfizer admits that Exhibit A purports to be a copy of Pfizer’s notice of commercial marketing.
`
`64.
`
`Pfizer denies any allegation of infringement based on the submission of Pfizer’s
`
`BLA. Pfizer lacks knowledge or information sufficient to form a belief as to the truth of the
`
`remaining allegations of Paragraph 64 and, therefore, denies the same.
`
`65.
`
`Pfizer denies any allegation of infringement based on Pfizer’s activities relating to
`
`the manufacture, importation, sale, offer for sale, use, and/or promotion of the use of the PF-
`
`05280014 drug substance and its proposed PF-05280014 drug product. Pfizer also denies that
`
`Plaintiffs are entitled to a declaratory judgment that Pfizer’s manufacture, importation, sale, offer
`
`for sale, use, and promotion of the use of the PF-05280014 drug substance and Pfizer’s proposed
`
`PF-05280014 drug product will infringe the ’415 patent pursuant to 35 U.S.C. §§ 271(a), (b),
`
`and/or (g). Pfizer lacks knowledge or information sufficient to form a belief as to the truth of the
`
`remaining allegations of Paragraph 65 and, therefore, denies the same.
`
`66.
`
`Pfizer has knowledge of and is aware of U.S. Patent No. 6,331,415. Pfizer
`
`otherwise denies the allegations of Paragraph 66.
`
`67.
`
`68.
`
`Denied.
`
`Denied.
`
`COUNT II
`INFRINGEMENT OF U.S. PATENT NO. 7,923,221
`
`69.
`
`Pfizer incorporates by reference its answers to Paragraphs 1-68 as if fully set forth
`
`herein.
`
`70.
`
`Pfizer admits that Genentech included the ’221 patent in its list of patents
`
`provided on November 3, 2017. Pfizer admits that on November 17, 2017, Pfizer provided
`
`notice to Genentech of its intent to begin commercial marketing of its trastuzumab biosimilar,
`
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`Case 1:17-cv-01672-GMS Document 28 Filed 04/24/18 Page 17 of 108 PageID #: 2907
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`PF-05280014, as described in BLA No. 761081, as early as 180 days from the date of the notice.
`
`Pfizer admits that Exhibit A purports to be a copy of Pfizer’s notice of commercial marketing.
`
`71.
`
`Pfizer denies any allegation of infringement based on the submission of Pfizer’s
`
`BLA. Pfizer admits that on March 2, 2018, Genentech provided to Pfizer its 3C Statement
`
`pursuant to 42 U.S.C.§ 262(l)(3)(C). Pfizer lacks knowledge or information sufficient to form a
`
`belief as to the truth of the remaining allegations of Paragraph 71 and, therefore, denies the same.
`
`72.
`
`Pfizer denies any allegation of infringement based on Pfizer’s activities relating to
`
`the manufacture, importation, sale, offer for sale, use, and/or promotion of the use of the PF-
`
`05280014 drug substance and its proposed PF-05280014 drug product. Pfizer also denies that
`
`Plaintiffs are entitled to a declaratory judgment t