Case 1:19-cv-00638-CFC Document 1 Filed 04/05/19 Page 1 of 70 PageID #: 1
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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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`v.
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`PFIZER INC.,
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`Plaintiffs,
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`Defendant.
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`Case No.
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`JURY TRIAL DEMANDED
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`COMPLAINT FOR PATENT INFRINGEMENT AND DECLARATORY JUDGMENT
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`Plaintiffs Genentech, Inc. (“Genentech”) and City of Hope (collectively, “Plaintiffs”)
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`bring this Complaint for monetary, declaratory, and injunctive relief against Defendant Pfizer
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`Inc. (“Pfizer”) to address Pfizer’s infringement of 22 patents relating to Genentech’s
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`revolutionary cancer therapy, Avastin®.
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`NATURE OF THE CASE
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`1.
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`Avastin® contains a genetically engineered antibody, bevacizumab, that inhibits
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`the proliferation of blood vessels necessary for cancerous tumors to grow. The Food and Drug
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`Administration (“FDA”) first approved Avastin® in 2004. Based on extensive clinical testing by
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`Genentech, Avastin® is now approved for use in treating metastatic colon cancer, lung cancer,
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`glioblastoma, ovarian cancer, and cervical cancer. It is one of the top selling medicines in the
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`United States and a critical source of research and development funding for Genentech.
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`2.
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`Enacted in 2010 as part of the Affordable Care Act, the Biologics Price
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`Competition and Innovation Act (“BPCIA”) provides for abbreviated regulatory approval for
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`biosimilars by letting applicants rely on the extensive clinical testing previously conducted by
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`the innovator company that developed the medicine the applicant wants to copy.
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`3.
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`Biologic medicines are complex and complicated to manufacture. As a result,
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`biologics often have extensive patent portfolios associated with them. Avastin® is no exception.
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`Genentech’s innovative work in developing bevacizumab has been recognized by the United
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`States Patent and Trademark Office (“USPTO”) with dozens of patents covering the antibody
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`itself, methods for its therapeutic use, and processes for the manufacture of therapeutic
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`antibodies.
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`4.
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`Recognizing the need to protect the patent rights of innovator companies like
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`Genentech, Congress included provisions in the BPCIA to ensure that innovator companies have
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`adequate opportunity to study the proposed biosimilars and the complex manufacturing
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`processes used to make them, and where appropriate, to assert infringement before competing
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`biosimilars come to market. This process, often called the “patent dance,” starts when the FDA
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`accepts an application for review, and is supposed to run in parallel with the FDA’s review
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`process. The “patent dance” allows parties to narrow or eliminate disputes over infringement
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`prior to approval and ensures the innovator has received enough information about the proposed
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`biosimilar to determine if the proposed biosimilar infringes or will infringe any of the
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`innovator’s patents, as well as to seek a preliminary injunction should an applicant who receives
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`approval attempt to launch at risk.
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`5.
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`The statutory protections for Genentech in this case kicked in when the FDA
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`notified Pfizer that its Abbreviated Biologic License Application, or “aBLA,” had been accepted
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`for review. That FDA notification gave Pfizer 20 days to provide Genentech with “a copy of the
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`application submitted to [the FDA] under subsection (k), and such other information that
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`describes the process or processes used to manufacture the biological product that is the subject
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`of such application.” 42 U.S.C. § 262(l)(2)(A) (emphasis added); see also id. § 262(l)(3)(A).
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`6.
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`Pfizer’s compliance with this requirement is critical to protecting Genentech’s
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`statutory rights. The BPCIA gives Genentech just 60 days after receiving this information to
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`review it before serving Pfizer with a list of patents Genentech believes “could reasonably be
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`asserted” against the manufacture, use, sale, offer for sale, or importation of Pfizer’s proposed
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`biosimilar. 42 U.S.C. § 262(l)(3)(A). The early disclosure requirements also serve to facilitate
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`informed and orderly preliminary injunction proceedings, should that become necessary, after
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`FDA licensure, but before the biosimilar product is commercialized.
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`7.
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`On September 7, 2018, Genentech provided a list of “other information” that was
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`relevant to its patent assessment, tying each request to the patents implicated. But Pfizer ignored
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`this targeted request and took the position that producing only portions of its aBLA alone was
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`sufficient under the statute.
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`8.
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`On September 14, 2018, Pfizer produced to Genentech what it later admitted to be
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`only portions of the aBLA it submitted to the FDA. Pfizer did not produce any information or
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`documents (other than what was contained in its incomplete aBLA production) Genentech had
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`specifically requested in its September 7, 2018 letter.
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`9.
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`On September 17, 2018, Genentech sent a letter documenting failures in Pfizer’s
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`purported 42 U.S.C. § 262(l)(2)(A) production, and offering to discuss a mutually agreed upon
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`extension of Pfizer’s deadline so that it could satisfy its obligations under the BPCIA.
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`10.
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`On September 19, 2018, Pfizer responded by claiming its September 14, 2018
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`production satisfied its statutory obligations, and refused to provide a copy of its aBLA in the
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`form it was provided to the FDA or to produce any of the “other information that describes the
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`process or processes used to manufacture the biological product that is the subject of such
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`application” required by 42 U.S.C. § 262(l)(2)(A).
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`11.
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`Over the next two months, the parties exchanged correspondence regarding the
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`deficiencies in Pfizer’s production, but Pfizer did not agree to supplement its production or
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`otherwise provide the information it was required to produce under the BPCIA prior to the
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`deadline for Genentech to serve its list of patents pursuant to 42 U.S.C. § 262(l)(3)(A).
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`12.
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`Despite not having all the information to which it was entitled under the BPCIA
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`to evaluate whether Pfizer’s manufacture and sale of its proposed biosimilar Avastin® product
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`(“Pfizer’s aBLA product”, “its aBLA Product”)
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`1
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` would infringe Genentech’s patents, on
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`November 13, 2018, Genentech proceeded to serve a list of 31 patents pursuant to 42 U.S.C.
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`1 References herein to Pfizer’s aBLA product are to the drug substance and/or the drug product.
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`§ 262(l)(3)(A).
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`13.
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`On December 21, 2018, Pfizer served disclosures purporting to comply with 42
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`U.S.C. § 262(l)(3)(B). On January 18, 2019, pursuant to 42 U.S.C. § 262(l)(8)(A), before
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`Genentech’s contentions pursuant to 42 U.S.C. § 262(l)(3)(C) would have been due, Pfizer
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`provided notice to Genentech of its intent to begin commercial marketing of its aBLA product as
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`early as July 17, 2019 (180 days from the date of the notice).
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`14.
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`On February 19, 2019, and pursuant to 42 U.S.C. § 262(l)(3)(C), Genentech
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`provided Pfizer with its detailed statement asserting that the manufacture, use, sale, offer for sale,
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`or importation of Pfizer’s aBLA product would infringe 23 patents (its “(3)(C) Statement”).
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`Genentech’s statement included, with respect to 17 patents, the factual and legal basis of its
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`opinion that those patents will be infringed by the commercial marketing of Pfizer’s aBLA
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`product, on a claim-by-claim basis, as well as providing a response to Pfizer’s December 21,
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`2018 statement concerning validity and enforceability for those patents. Pursuant to 42 U.S.C.
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`§ 262(l)(3)(C), Genentech was not obligated, and did not, provide infringement or validity
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`contentions with respect to patents for which Pfizer did not provide non-infringement or
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`invalidity contentions in its statement, pursuant to 42 U.S.C. § 262(l)(3)(B).
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`15.
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`On March 6, 2019, Pfizer sent a letter to Genentech stating that Pfizer accepted
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`and agreed that the 17 patents for which Genentech provided infringement contentions in its
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`(3)(C) Statement would be the subject matter of an action for patent infringement pursuant to 42
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`U.S.C. § 262(l)(6), and thus the negotiations under 42 U.S.C. § 262(l)(4)(A) were concluded.
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`The 17 patents listed in Pfizer’s letter are: U.S. Patent Nos. 6,407,213; 6,610,516; 7,060,269;
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`7,169,901; 7,390,660; 7,485,704; 7,622,115; 7,807,799; 7,846,336; 8,314,225; 8,512,983;
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`8,574,869; 9,441,035; 9,714,293; 9,795,672; 9,884,904; and 10,010,611. Pfizer stated that 42
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`U.S.C. § 262(l)(6)(A) required Genentech to file an action for patent infringement within 30 days
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`of Pfizer’s March 6, 2019 letter.
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`16.
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`Pursuant to the BPCIA, once the subsection (k) applicant and the reference
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`product sponsor have agreed upon the patents that will be included in a patent infringement
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`lawsuit, the reference product sponsor is to file an action for patent infringement of those patents
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`in the appropriate venue of its choosing. 42 U.S.C. § 262(l)(6)(A). In addition, once the
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`subsection (k) applicant has provided notice of commercial marketing, pursuant to 42
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`U.S.C. § 262(l)(8), the reference product sponsor is permitted to file an action for declaratory
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`judgment of patent infringement in the appropriate venue of its choosing. Plaintiffs therefore
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`bring this action for infringement, declaratory judgment, an injunction, and any additional
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`appropriate relief. Specifically, Plaintiffs seek an order declaring that Pfizer’s actions are
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`contrary to the BPCIA and that the manufacture, use, offer for sale, sale, and/or importation of
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`Pfizer’s proposed biologic product infringes Plaintiffs’ intellectual property rights, and an order
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`enjoining Pfizer from infringing the Asserted Patents (as listed below), including by offering to
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`sell or selling its aBLA product until after the expiration of the last-to-expire of the Asserted
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`Patents.
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`PARTIES
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`17.
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`Plaintiff Genentech, Inc. is a corporation organized and existing under the laws of
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`the State of Delaware with its corporate headquarters at 1 DNA Way, South San Francisco,
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`California 94080.
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`18.
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`Genentech was founded in 1976 and for four decades has been at the forefront of
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`innovation in the field of therapeutic biotechnology. Today, Genentech employs a large number
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`of researchers, scientists and post-doctoral staff members who routinely publish in top peer-
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`reviewed journals and are among the leaders in total citations to their work by researchers.
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`Genentech currently markets numerous approved pharmaceutical and biologic drugs for a range
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`of serious or life-threatening medical conditions, including various forms of cancer, heart
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`attacks, strokes, rheumatoid arthritis, and respiratory diseases.
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`19.
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`Plaintiff City of Hope is a California not-for-profit organization, with its principal
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`place of business at 1500 East Duarte Road, Duarte, California 91010.
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`20.
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`Founded in 1913, City of Hope is a leading research hospital that incorporates
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`cutting-edge research into patient care for cancer, diabetes, and other serious diseases.
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`21.
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`Upon information and belief, Defendant Pfizer Inc. is a company organized and
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`existing under the laws of the State of Delaware with its principal place of business at 235 East
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`42nd Street, New York, NY 10017.
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`22.
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`Pfizer Inc. is, among other things, engaged in the development of biologic drugs,
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`including Pfizer’s aBLA product. Pfizer’s aBLA product will be distributed and sold in the State
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`of Delaware and throughout the United States.
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`JURISDICTION AND VENUE
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`23.
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`This action arises under the BPCIA, 42 U.S.C. § 262(l), and the Patent Laws of
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`the United States, Title 35, United States Code. This Court has subject matter jurisdiction,
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`pursuant to 28 U.S.C. §§ 1331 and 1338.
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`24.
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`Venue is proper with respect to Pfizer Inc. in this Court, pursuant to 28 U.S.C.
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`§ 1400(b) because Pfizer is incorporated in Delaware.
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`25.
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`This Court has personal jurisdiction over Pfizer because it is incorporated in
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`Delaware. In addition, among other things, Pfizer has filed aBLA No. 761099 with the FDA
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`seeking approval to market its aBLA product, which reliably indicates that it will market its
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`proposed biosimilar product in Delaware if approved.
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`FACTUAL BASIS FOR RELIEF
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`26.
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`The BPCIA provides a mechanism to obtain FDA approval for a biological
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`product that is “biosimilar” to a previously licensed “reference product” such as Avastin®. 42
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`U.S.C. § 262(k). Biosimilars must be “highly similar to the reference product notwithstanding
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`minor differences in clinically inactive components,” with “no clinically meaningful differences
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`between the biological product and the reference product in terms of the safety, purity, and
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`potency of the product.” 42 U.S.C. § 262(i)(2)(A)-(B). In addition, a biosimilar must use the
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`same mechanism of action as the reference product for the conditions of use prescribed,
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`recommended, or suggested in the reference product’s FDA approved label. See 42 U.S.C.
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`§ 262(k)(2)(A)(i)(II). The route of administration, dosage form, and strength of a biosimilar
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`must also be the same as those of the reference product. See 42 U.S.C. § 262(k)(2)(A)(i)(I).
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`27.
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`The BPCIA reduces the time and expense otherwise required to gain FDA
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`approval by letting an applicant rely on most of the clinical testing used to establish the safety
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`and efficacy of the reference product. The statute also includes extensive provisions to ensure
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`the reference product sponsor (i.e., the innovator) has an opportunity to assess the proposed
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`product and the manufacturing processes used to make it, to determine the extent to which there
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`is threatened infringement of the innovator’s patent rights, and if necessary, to vindicate those
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`rights before the biosimilar product comes to market.
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`28.
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`Genentech, the reference product sponsor of Avastin®, invested many years of
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`effort into the design and development of Avastin® and received numerous patents rewarding
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`this research. In addition, as an industry leader with many biologic products besides Avastin®,
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`Genentech has an extensive patent portfolio covering various innovations generally applicable to
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`the antibody manufacturing process.
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`THE ASSERTED PATENTS
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`29.
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`As a result of Pfizer’s conduct, Genentech has been forced to assess Pfizer’s
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`infringement based on incomplete information. Nevertheless, Genentech served on November
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`13, 2018 a list of 31 patents that Genentech believed could reasonably be asserted against the
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`manufacture, use, sale, offer for sale, or import into the United States of Pfizer’s aBLA product.
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`See 42 U.S.C. § 262(l)(3)(A).
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`30.
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`Pfizer notified Genentech of its contentions, pursuant to 42 U.S.C. § 262(l)(3)(B),
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`with respect to these patents on December 21, 2018.
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`31.
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`On January 18, 2019, before Genentech’s contentions, pursuant to 42 U.S.C.
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`§ 262(l)(3)(C) would have been due, Pfizer provided Genentech notice pursuant to 42 U.S.C.
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`§ 262(l)(8)(A) of its intent to begin commercial marketing of its aBLA product as early as July
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`17, 2019 (180 days from the date of the notice).
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`32.
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`Genentech asserted through the “patent dance” that the following patents, among
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`others, have been infringed and will be infringed by the manufacture, use, sale, or offer for sale
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`of Pfizer’s aBLA product. The patents-in-suit (“the Asserted Patents”) on which Plaintiffs now
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`bring claims are:
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`US Patent No.
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`Issue Date
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`First Named Inventor
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`EX A -- 6,054,297
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`Apr. 25, 2000
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`Carter
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`EX B -- 6,121,428
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`Sept. 19, 2000
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`Blank
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`EX C -- 6,331,415
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`Dec. 18, 2001
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`Cabilly
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`EX D -- 6,407,213
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`Jun. 18, 2002
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`Carter
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`EX E -- 6,610,516
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`Aug. 26, 2003
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`Andersen
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`EX F -- 6,884,879
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`Apr. 26, 2005
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`EX G – 7,060,269
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`Jun. 13, 2006
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`EX H -- 7,169,901
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`Jan. 30, 2007
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`Baca
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`Baca
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`Baca
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`US Patent No.
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`Issue Date
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`First Named Inventor
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`EX I -- 7,390,660
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`Jun. 24, 2008
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`Behrendt
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`EX J -- 7,485,704
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`Feb. 3, 2009
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`Fahrner
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`EX K -- 7,622,115
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`Nov. 24, 2009
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`Fyfe
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`EX L -- 7,807,799
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`Oct. 5, 2010
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`Fahrner
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`EX M -- 7,846,336
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`Dec. 7, 2010
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`Burg
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`EX N -- 7,923,221
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`Apr. 12, 2011
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`Cabilly
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`EX O -- 8,314,225
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`Nov. 20, 2012
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`Goepfert
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`EX P -- 8,512,983
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`Aug. 20, 2013
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`Gawlitzek
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`EX Q -- 8,574,869
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`Nov. 5, 2013
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`Kao
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`EX R -- 9,441,035
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`Sept. 13, 2016
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`Carvalhal
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`EX S -- 9,714,293
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`Jul. 25, 2017
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`Gawlitzek
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`EX T -- 9,795,672
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`Oct. 24, 2017
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`Fyfe
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`EX U -- 9,884,904
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`Feb. 6, 2018
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`Binder
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`EX V -- 10,010,611
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`Jul. 3, 2018
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`Gokarn
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`33.
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`Genentech is the owner of all rights, title, and interest in the Asserted Patents,
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`with the following exceptions: Genentech and City of Hope are co-owners of U.S. Patent Nos.
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`6,331,415 (Exhibit C) and 7,923,221 (Exhibit N). Hoffmann-La Roche, Inc. is the owner of U.S.
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`Patent Nos. 7,390,660 (Exhibit I), 7,846,336 (Exhibit M), 8,314,225 (Exhibit O), and 9,884,904
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`(Exhibit U); Genentech is the exclusive licensee of these patents with the sole right to enforce
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`these patents pursuant to a Patent Licensing Agreement between Genentech and Hoffmann-La
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`Roche, Inc. dated January 13, 2017, as amended.
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`COUNT ONE
`(Infringement of the ’297 Patent)
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`34.
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`35.
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`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
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`United States Patent No. 6,054,297 (“the ’297 patent”) (Exhibit A hereto) was
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`duly and legally issued on April 25, 2000.
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`36.
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`Although the ’297 patent expired on February 26, 2018, prior to expiry Pfizer
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`infringed the ’297 patent in violation of 35 U.S.C. § 271(a) at least by making and/or using its
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`aBLA product in the United States.
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`37.
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`Based on Plaintiffs’ current knowledge, which is informed by material Pfizer
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`provided during the BPCIA “patent dance” to date, Pfizer’s pre-expiration manufacture and/or
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`use of its aBLA product infringed at least claim 1 of the ’297 patent.
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`38.
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`Based on information and belief, including information about the amount of
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`Pfizer’s aBLA product Pfizer manufactured before the expiration of the ’297 patent, Pfizer’s pre-
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`expiration manufacture and/or use of its aBLA product was not protected by the “safe harbor”
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`provision of 35 U.S.C. § 271(e)(1).
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`39.
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`If its aBLA is approved by the FDA, Pfizer intends to offer for sale or sell its
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`aBLA product, some manufacture of which predated the expiry of the ’297 patent and infringed
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`the ’297 patent.
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`40.
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`Pfizer’s infringement of the ’297 patent was willful for reasons including the fact
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`that Pfizer is and has been aware of the ’297 patent and its scope prior to making and/or using its
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`aBLA product in the United States. Pfizer has knowledge of and is aware of the ’297 patent at
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`least because the ’297 patent is cited in U.S. Patent No. 7,449,616 to which Pfizer is listed as an
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`assignee. Additionally, Pfizer has had knowledge of and has been aware of the ’297 patent since
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`at least as early as Genentech’s disclosure of this patent to Pfizer on November 3, 2017, pursuant
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`to 42 U.S.C. § 262(l)(3)(A) and related to Pfizer’s proposed biosimilar Herceptin® product.
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`41.
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`As a consequence of Pfizer’s infringement of the ’297 patent, Plaintiffs have
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`suffered damages in an amount not yet determined, but no less than a reasonable royalty.
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`42.
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`Pfizer’s willful, wanton, and deliberate infringement of the ’297 patent justifies an
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`award to Plaintiffs of increased damages, pursuant to 35 U.S.C. § 284, and attorneys’ fees and
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`costs incurred, pursuant to 35 U.S.C. § 285.
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`43.
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`Plaintiffs will suffer irreparable injury if Pfizer offers to sell or sells its aBLA
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`product whose manufacture infringed the ’297 patent. Unless Pfizer is enjoined from offering to
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`sell or selling this product, Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate
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`remedy at law.
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`COUNT TWO
`(Infringement of the ’428 Patent)
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`44.
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`45.
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`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
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`United States Patent No. 6,121,428 (“the ’428 patent”) (Exhibit B hereto) was
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`duly and legally issued on September 19, 2000.
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`46.
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`Although the ’428 patent expired on June 12, 2018, prior to expiry Pfizer
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`infringed the ’428 patent in violation of 35 U.S.C. § 271(a) at least by making and/or using its
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`aBLA product in the United States.
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`47.
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`Based on Plaintiffs’ current knowledge, which is informed by material Pfizer
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`provided during the BPCIA “patent dance” to date, Pfizer’s pre-expiration manufacture and/or
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`use of its aBLA product infringed at least claim 16 of the ’428 patent.
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`48.
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`Based on information and belief, including information about the amount of
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`Pfizer’s aBLA product Pfizer manufactured before the expiration of the ’428 patent, Pfizer’s pre-
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`expiration manufacture and/or use of its aBLA product was not protected by the “safe harbor”
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`provision of 35 U.S.C. § 271(e)(1).
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`49.
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`If its aBLA is approved by the FDA, Pfizer intends to offer for sale or sell its
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`aBLA product, some manufacture of which predated the expiry of the ’428 patent and infringed
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`the ’428 patent.
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`50.
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`Pfizer’s infringement of the ’428 patent was willful for reasons including the fact
`
`that Pfizer is and has been aware of the ’428 patent and its scope prior to making and/or using its
`
`aBLA product in the United States. Pfizer has had knowledge of and has been aware of the ’428
`
`patent since at least as early as Genentech’s disclosure of this patent to Pfizer on November 3,
`
`2017, pursuant to 42 U.S.C. § 262(l)(3)(A) and related to Pfizer’s proposed biosimilar
`
`Herceptin® product.
`
`51.
`
`As a consequence of Pfizer’s infringement of the ’428 patent, Plaintiffs have
`
`suffered damages in an amount not yet determined, but no less than a reasonable royalty.
`
`52.
`
`Pfizer’s willful, wanton, and deliberate infringement of the ’428 patent justifies an
`
`award to Plaintiffs of increased damages, pursuant to 35 U.S.C. § 284, and attorneys’ fees and
`
`costs incurred, pursuant to35 U.S.C. § 285.
`
`53.
`
`Plaintiffs will suffer irreparable injury if Pfizer offers to sell or sells its aBLA
`
`product whose manufacture infringed the ’428 patent. Unless Pfizer is enjoined from offering to
`
`sell or selling this product, Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate
`
`remedy at law.
`
`COUNT THREE
`(Infringement of the ’415 Patent)
`
`54.
`
`55.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
`
`United States Patent No. 6,331,415 (“the ’415 patent”) (Exhibit C hereto) was
`
`duly and legally issued on December 18, 2001.
`
`56.
`
`Although the ’415 patent expired on December 18, 2018, prior to expiry Pfizer
`
`infringed the ’415 patent in violation of 35 U.S.C. § 271(a) at least by making and/or using its
`
`aBLA product in the United States.
`
`57.
`
`Based on Plaintiffs’ current knowledge, which is informed by material Pfizer
`
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`
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`provided during the BPCIA “patent dance” to date, Pfizer’s pre-expiration manufacture and/or
`
`use of its aBLA product infringed at least claim 1 of the ’415 patent.
`
`58.
`
`Based on information and belief, including information about the amount of
`
`Pfizer’s aBLA product Pfizer manufactured before the expiration of the ’415 patent, Pfizer’s pre-
`
`expiration manufacture and/or use of its aBLA product was not protected by the “safe harbor”
`
`provision of 35 U.S.C. § 271(e)(1).
`
`59.
`
`If its aBLA is approved by the FDA, Pfizer intends to offer for sale or sell its
`
`aBLA product, some manufacture of which predated the expiry of the ’415 patent and infringed
`
`the ’415 patent.
`
`60.
`
`Pfizer has knowledge of and is aware of the ’415 patent at least because the ’415
`
`patent is cited in Pfizer’s U.S. Patent No. 7,449,616 to which Pfizer is listed as an assignee.
`
`Additionally, Pfizer has had knowledge of and has been aware of the ’415 patent since at least as
`
`early as Genentech’s disclosure of this patent to Pfizer on November 3, 2017, pursuant to 42
`
`U.S.C. § 262(l)(3)(A) and related to Pfizer’s proposed biosimilar Herceptin® product.
`
`61.
`
`As a consequence of Pfizer’s infringement of the ’415 patent, Plaintiffs have
`
`suffered damages in an amount not yet determined, but no less than a reasonable royalty.
`
`62.
`
`Pfizer’s willful, wanton, and deliberate infringement of the ’415 patent justifies an
`
`award to Plaintiffs of increased damages, pursuant to 35 U.S.C. § 284, and attorneys’ fees and
`
`costs, pursuant to under 35 U.S.C. § 285.
`
`63.
`
`Plaintiffs will suffer irreparable injury if Pfizer offers to sell or sells its aBLA
`
`product whose manufacture infringed the ’415 patent. Unless Pfizer is enjoined from offering to
`
`sell or selling this product, Plaintiffs will suffer irreparable injury. Plaintiffs have no adequate
`
`remedy at law.
`
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`
`
`64.
`
`65.
`
`COUNT FOUR
`(Infringement of the ’213 Patent)
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
`
`United States Patent No. 6,407,213 (“the ’213 patent”) (Exhibit D hereto) was
`
`duly and legally issued on June 18, 2002.
`
`66.
`
`The ’213 patent was among the patents Pfizer agreed on March 6, 2019 should be
`
`included in a suit for patent infringement under the BPCIA.
`
`67.
`
`Pfizer has infringed the ’213 patent in violation of 35 U.S.C. § 271(a) at least by
`
`making and/or using its aBLA product in the United States.
`
`68.
`
`Based on Plaintiffs’ current knowledge, which is informed by material Pfizer
`
`provided during the BPCIA “patent dance” to date, Pfizer’s manufacture and/or use of its aBLA
`
`product infringed at least claim 65 of the ’213 patent.
`
`69.
`
`Based on information and belief, including information about the amount of
`
`Pfizer’s aBLA product Pfizer manufactured, Pfizer’s manufacture and/or use of its aBLA
`
`product was not protected by the “safe harbor” provision of 35 U.S.C. § 271(e)(1).
`
`70.
`
`Upon information and belief, Pfizer submitted aBLA No. 761099 to the FDA
`
`seeking approval to engage in the commercial manufacture, use, offer for sale, and sale of a
`
`biosimilar version of Avastin® before expiration of the ’213 patent. Pfizer knows and intends
`
`that its offer for sale and/or sale of its aBLA product in the United States will infringe the ’269
`
`patent.
`
`71.
`
`The submission of Pfizer’s aBLA to the FDA to obtain approval to engage in the
`
`commercial manufacture, use, offer for sale, and/or sale, or import into the United States of
`
`Pfizer’s aBLA product before the expiration of the ’213 patent is an act of infringement of one or
`
`more claims of the ’213 patent, pursuant to 35 U.S.C. § 271(e)(2)(C).
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`
`
`72.
`
`Pfizer knew, understood, and believed that the ’213 patent was infringed by
`
`Pfizer’s aBLA product and by its submission of aBLA No. 761099 to the FDA.
`
`73.
`
`Pfizer’s infringement of the ’213 patent was and is willful for reasons including
`
`the fact that Genentech listed the ’213 patent on its November 13, 2018 list, pursuant to 42
`
`U.S.C. § 262(l)(3)(A).
`
`74.
`
`As a consequence of Pfizer’s infringement of the ’213 patent, Plaintiffs have
`
`suffered damages in an amount not yet determined, but no less than a reasonable royalty.
`
`75.
`
`Pfizer’s willful, wanton, and deliberate infringement of the ’213 patent justifies an
`
`award to Plaintiffs of increased damages, pursuant to 35 U.S.C. § 284, and attorneys’ fees and
`
`costs incurred, pursuant to 35 U.S.C. § 285.
`
`76.
`
`As a result of Pfizer’s infringement of the ’213 patent, Plaintiffs will suffer
`
`irreparable injury. Unless Pfizer is enjoined from infringing the ’213 patent, Plaintiffs will suffer
`
`additional irreparable injury. Plaintiffs have no adequate remedy at law.
`
`COUNT FIVE
`(Declaratory Judgment of Infringement of the ’213 Patent)
`
`77.
`
`78.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
`
`Pfizer’s future manufacture of its aBLA product will infringe one or more claims
`
`of the ’213 patent, pursuant to 35 U.S.C. § 271(a).
`
`79.
`
`Pfizer’s past manufacture of its aBLA product infringed one or more method
`
`claims of the ’213 patent.
`
`80.
`
`Based on information and belief, including information about the amount of
`
`Pfizer’s aBLA product Pfizer manufactured, Pfizer’s manufacture and/or use of its aBLA
`
`product was not protected by the “safe harbor” provision of 35 U.S.C. § 271(e)(1).
`
`81.
`
`Pfizer’s future sale of its aBLA product that was or will be manufactured using a
`
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`
`
`method or methods claimed by the ’213 patent will infringe one or more claims of the ’213
`
`patent under 35 U.S.C. § 271(g).
`
`82.
`
`Pfizer knows, understands, and believes that the ’213 patent is infringed by
`
`Pfizer’s aBLA product and by Pfizer’s submission of aBLA No. 761099 to the FDA.
`
`83.
`
`Pfizer’s infringement of the ’213 patent was and will be willful, for reasons
`
`including the fact that Genentech listed the ’213 patent on its November 13, 2018 list, pursuant
`
`to 42 U.S.C. § 262(l)(3)(A).
`
`84.
`
`Unless Pfizer is enjoined from infringing the ’213 patent, including by selling its
`
`aBLA product made by processes patented by the ’213 patent, Plaintiffs will suffer irreparable
`
`injury. Plaintiffs have no adequate remedy at law.
`
`85.
`
`Pfizer provided notice to Genentech of its intent to begin commercial marketing
`
`of its aBLA product as early as July 17, 2019.
`
`86.
`
`Accordingly, there is a real, immediate, substantial, and continuing case or
`
`controversy between Genentech and Pfizer regarding whether Pfizer’s past manufacture
`
`infringed the ’213 patents and whether its future manufacture and/or sale of its aBLA product
`
`will infringe the ’213 patent.
`
`87.
`
`Genentech is entitled to a judgment that Pfizer’s past manufacture and its future
`
`manufacture and/or sale of its aBLA product will infringe the ’213 patent, and that that
`
`infringement will cause Plaintiffs to suffer irreparable injury.
`
`COUNT SIX
`(Infringement of the ’516 Patent)
`
`88.
`
`89.
`
`Plaintiffs incorporate each of the preceding paragraphs as if fully set forth herein.
`
`United States Patent No. 6,610,516 (“the ’516 patent”) (Exhibit E hereto) was
`
`duly and legally issued on August 26, 2003.
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`
`
`90.
`
`The ’516 patent was among the patents Pfizer agreed on March 6, 2019 should be
`
`included in a suit for patent infringement under the BPCIA.
`
`91.
`
`Pfizer has infringed the ’516 patent in violation of 35 U.S.C. § 271(a) at least by
`
`making its aBLA product in the United States.
`
`92.
`
`Based on Plaintiffs’ current knowledge, which is informed by material Pfizer
`
`provided during the BPCIA “patent dance” to date, Pfizer’s manufacture of its aBLA product
`
`infringed at least claim 1 of the ’516 patent.
`
`93.
`
`Based on information an