Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 1 of 47 PageID #: 1983
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF HOPE,
`
`Plaintiffs and Counterclaim
`Defendants,
`
`v.
`
`PFIZER INC.,
`
`Defendant and Counterclaim
`Plaintiff.
`
`
`Civil Action No. 17-1672-GMS
`
`
`
`FIRST AMENDED COMPLAINT
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`
`
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`Plaintiffs Genentech, Inc. (“Genentech”) and City of Hope bring this First Amended
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`Complaint for declaratory and injunctive relief against Defendant Pfizer Inc. to address Pfizer’s
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`infringement of 20 patents relating to Genentech’s groundbreaking breast cancer drug
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`Herceptin®.
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`NATURE OF THE CASE
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`
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`Breast cancer is a serious disease affecting over 2.8 million women in the United
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`States. Approximately 20-25% of those women suffer from “HER2-positive” breast cancer.
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`This is a particularly aggressive form of the disease characterized by overexpression of human
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`epidermal growth factor receptor 2 (i.e., “HER2”) proteins due to excessive HER2 gene
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`amplification.
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`
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`In the early 1990s, a diagnosis of HER2-positive breast cancer was effectively a
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`death sentence: patients had an average life expectancy of only 18 months. The quality of life
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`for those patients was markedly poor—the disease rapidly metastasized (i.e., spread to other
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`parts of the body). The only available treatments were invasive and disfiguring surgery and
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`1
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`

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`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 2 of 47 PageID #: 1984
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`chemotherapeutic drugs with harsh side effects, and those treatments added little to the patient’s
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`life span.
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`
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`The treatment of HER2-positive breast cancer, and the lives of millions of women
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`suffering from the disease, changed dramatically with Genentech’s development of Herceptin®.
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`Herceptin® was the first drug of its kind—an antibody called trastuzumab that specifically
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`targeted the biological mechanism that makes HER2-positive breast cancer such an aggressive
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`form of the disease.
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`
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`Although the scientific community was initially skeptical that such an antibody-
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`based therapy could work, Genentech’s specific methods of using Herceptin® proved remarkably
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`effective. Indeed, after Genentech revealed the results of its clinical studies, the scientific
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`community hailed Herceptin® as “the beginning of a whole new wave of biological drugs that
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`modulate the causes of cancer”1 and a sign that “the whole field of cancer research has turned a
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`corner.”2
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`
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`Since FDA approval of Herceptin® in 1998, Genentech has worked diligently to
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`develop new methods of using Herceptin®—including improved dosing schedules and broader
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`indications—to expand access to therapy and improve the quality of life for millions of patients
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`worldwide. This research has greatly expanded the number of patients who are able to benefit
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`from Herceptin®. To further expand access to this lifesaving drug, Genentech also provides
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`Herceptin® free of charge to patients who are uninsured or cannot afford treatment and assists
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`with out-of-pocket prescription-related expenses. All told, Genentech has spent over two
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`decades, and billions of dollars, developing Herceptin® into the life-saving drug it is today.
`
`
`1 Gina Kolata and Lawrence M. Fisher, Drugs to Fight Breast Cancer Near Approval, NEW
`YORK TIMES (FRONT PAGE) (Sept. 3, 1998).
`2 Robert Langreth, Breast-Cancer Drug Is Backed by FDA Panel, Wall Street J. (Sept. 3, 1998).
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`2
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`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 3 of 47 PageID #: 1985
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`
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`Genentech’s groundbreaking work developing Herceptin® was the result of years
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`of research from a group of talented scientists. The United States Patent and Trademark Office
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`recognized that innovative work by granting Genentech numerous patents claiming Herceptin®,
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`its manufacture, and its use. And as one of the pioneers in the biotechnology field, Genentech
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`collaborated with scientists at research institutions such as the City of Hope to make foundational
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`inventions, such as efficient techniques for making antibodies that can be used as drugs.
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`
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`Seeking to profit from the success of Plaintiffs’ innovations, Pfizer is seeking
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`FDA approval of a biosimilar version of Herceptin® called PF-05280014. PF-05280014 is a
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`copycat product for which Pfizer is seeking the same label indications and usage as Herceptin®.
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`In fact, Pfizer is relying upon Genentech’s own studies demonstrating the safety and efficacy of
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`Herceptin® to obtain approval of its biosimilar product.
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`
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`In 2010, Congress provided a pathway for resolving patent disputes relating to
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`biosimilar products through the Biologics Price Competition and Innovation Act (“BPCIA”).
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`Pfizer initially purported to follow the process outlined in the BPCIA, which requires biosimilar
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`applicants and innovator companies exchange certain information concerning the biosimilar
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`product and the patents that may be infringed by the manufacture and sale of the biosimilar
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`product. See 42 U.S.C. § 262(l). However, before completing the process required by the
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`statute, Pfizer purported to provide Genentech with a notice pursuant to 42 U.S.C. § 262(l)(8)(A)
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`on November 17, 2017, that it intends to market PF-05280014 in the United States. That notice
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`of commercial marketing allows Plaintiffs to bring an immediate action for injunctive and
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`declaratory relief concerning the patents that would be infringed by the manufacture and sale of
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`Pfizer’s biosimilar product.
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`3
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`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 4 of 47 PageID #: 1986
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`
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`Plaintiffs thus bring this action for infringement pursuant to 35 U.S.C. § 271(e)(2)
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`based upon Pfizer’s submission of its aBLA for PF-05280014. Plaintiffs also seek a declaratory
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`judgment pursuant to 42 U.S.C. § 262(l)(9) and 28 U.S.C. § 2201 that the manufacture, use, offer
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`to sell, sale, or importation into the United States of the Pfizer aBLA product would infringe the
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`20 patents described below. Pursuant to 42 U.S.C. § 262(l)(8)(B), Plaintiffs also seek a
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`preliminary and/or permanent injunction barring Pfizer’s manufacture, use, offer to sell, sale, or
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`importation of its biosimilar product prior to the expiration of those patents. In the event that
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`Pfizer imports or launches its biosimilar product and/or otherwise practice the patented
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`inventions in the United States prior to the expiration of those patents, Plaintiffs also seek
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`monetary damages, including lost profits, and any further relief as this Court may deem just and
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`proper.
`
`PARTIES
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`
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`Plaintiff Genentech is a corporation organized and existing under the laws of the
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`State of Delaware with its corporate headquarters at 1 DNA Way, South San Francisco,
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`California 94080.
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`
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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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`
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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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`4
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`

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`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 5 of 47 PageID #: 1987
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`
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`Founded in 1913, the 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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`
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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 located at
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`235 East 42nd Street, New York, NY 10017.
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`
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`Pfizer Inc. is, among other things, engaged in the development of biologic drugs,
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`including a proposed biosimilar version of Genentech’s Herceptin® product, PF-05280014
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`(“Pfizer’s aBLA product”). Upon information and belief, Pfizer’s aBLA product will be
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`distributed and sold in the State of Delaware and throughout the United States.
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`JURISDICTION AND VENUE
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`
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`This action arises under the BPCIA, 42 U.S.C. § 262(l) and the Patent Laws of the
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`United States, Title 35, United States Code, and the Declaratory Judgment Act, 28 U.S.C.
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`§§ 2201-2202. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331 and
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`1338.
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`
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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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`
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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 an Abbreviated Biologics License
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`Application (“aBLA”) No. 761081 with the FDA seeking approval to market its aBLA product,
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`which reliably indicates that it will market its proposed biosimilar product in Delaware if
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`approved.
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`5
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`

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`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 6 of 47 PageID #: 1988
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`THE PARTIES’ EXCHANGES UNDER THE BPCIA
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`
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`Pfizer submitted aBLA number 761081 to the FDA seeking approval for the
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`commercial manufacture, use, offer for sale, or sale of the Pfizer aBLA product, a biosimilar
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`version of trastuzumab, which is subject to BLA No. 103792 to Genentech, Inc.
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`
`
`
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`The FDA accepted Pfizer’s aBLA for review on August 21, 2017.
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`On August 28, 2017, Pfizer’s outside counsel sent a letter to Genentech regarding
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`the provision of a copy of Pfizer’s aBLA for PF-05280014.
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`
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`On September 5, 2017, Pfizer provided Genentech with a copy of Pfizer’s aBLA,
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`which included a small amount of manufacturing information.
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`
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`Genentech responded on October 19, 2017 to identify deficiencies in Pfizer’s
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`production of manufacturing information and request specific information concerning the
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`manufacture of Pfizer’s biosimilar product. Pfizer provided some additional manufacturing
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`information on November 1, 2017, but did not satisfy its disclosure obligations. Genentech then
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`responded on November 3, 2017 to explain that Pfizer’s November 1, 2017 production was
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`deficient in that it failed to provide all of the requested information in contravention of 42 U.S.C.
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`§ 262(l)(2).
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`
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`Pfizer did not disclose all of the information relevant to establishing whether the
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`manufacture of Pfizer’s aBLA product will infringe each of the patents identified on Genentech’s
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`operative list pursuant to 42 U.S.C. § 262(l)(3)(A), despite Genentech’s request that Pfizer
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`provide “other information that describes the process or processes used to manufacture” as
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`required by 42 U.S.C. § 262(l)(A). Pfizer’s failure to provide sufficient information under those
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`circumstances justifies Genentech’s contention that manufacturing Pfizer’s aBLA product will
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`infringe such patents.
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`6
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`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 7 of 47 PageID #: 1989
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`
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`Despite Pfizer’s non-compliance (and without waiving Genentech’s objection to
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`such non-compliance), Genentech provided its operative list of patents pursuant to 42 U.S.C. §
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`262(l)(3)(A) on November 3, 2017 (“Genentech’s 3A List”).
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`
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`On November 17, 2017, Pfizer notified Genentech pursuant to 42 U.S.C.
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`§ 262(l)(8)(A) that it intends to commence commercial marketing of PF-05280014 in the United
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`States. See Exhibit A. Genentech filed the original complaint in this action later that day.
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`
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`On January 2, 2018, Pfizer purported to provide its detailed statement concerning
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`non-infringement and invalidity pursuant to 42 U.S.C. § 262(l)(3)(B) for 38 of the 40 patents on
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`Genentech’s 3A List (“Pfizer’s 3B Statement”). Pfizer’s 3B Statement was deficient in
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`numerous ways. For example, it—like Pfizer’s document production—failed to fully describe
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`Pfizer’s manufacturing process, such that Genentech was unable to evaluate many of Pfizer’s
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`non-infringement arguments.
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`
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`Nonetheless, and subject to its objections, Genentech provided its response to
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`Pfizer’s 3C Statement on March 2, 2018, pursuant to 42 U.S.C. § 262(l)(3)(C) (“Genentech’s 3C
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`Statement”). Genentech included responses to Pfizer’s non-infringement and invalidity
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`statements for 18 of the 38 patents addressed in Pfizer’s 3B Statement. With its 3C Statement,
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`Genentech proposed that Pfizer agree that all patents addressed in Genentech’s 3C Statement and
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`the two patents included on Genentech’s 3A List but not include addressed on their merits in
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`Pfizer’s 3B Statement be included in this infringement action.
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`PFIZER’S aBLA PRODUCT
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`
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`Pfizer has publicly states that its aBLA product is biosimilar to Herceptin®. For
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`example, Pfizer has issued press releases claiming that PF-05280014 is “a potential biosimilar to
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`7
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`

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`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 8 of 47 PageID #: 1990
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`Herceptin®”3 and an “investigational trastuzumab biosimilar,”4 and it has announced the results
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`of a Pfizer study that purports to conclude that “there were no clinically meaningful differences
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`between PF-05280014 and Herceptin.”5 Given Pfizer’s claim of biosimilarity, Pfizer’s aBLA
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`product must “utilize the same mechanism or mechanisms of action [as Herceptin®] for the
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`condition or conditions of use prescribed, recommended, or suggested in the proposed labeling.”
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`42 U.S.C. § 262(k)(2)(A)(i)(II).
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`
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`Under 35 U.S.C. § 271(e)(2)(C), Pfizer has committed a statutory act of patent
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`infringement with respect to patents identified by Genentech under 42 U.S.C. § 262(l)(3),
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`through the submission of its aBLA application for PF-05280014.
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`GENENTECH’S ASSERTED PATENTS
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`
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`Genentech has spent over two decades and significant resources developing
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`Herceptin®, and the USPTO has awarded to Genentech numerous patents on innovations
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`resulting from this massive undertaking. These patents cover the antibody trastuzumab, along
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`with its manufacture and use.
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`
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`Upon information and belief, Pfizer’s aBLA product will infringe at least the
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`following patents, which Genentech has asserted in this lawsuit: U.S. Patent No. 6,331,415, U.S.
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`Patent No. 7,923,221, U.S. Patent No. 6,407,213, U.S. Patent No. 7,846,441, U.S. Patent No.
`
`7,892,549, U.S. Patent No. 6,627,196, U.S. Patent No. 7,371,379, U.S. Patent No. 6,339,142,
`
`
`3 https://www.pfizer.com/news/press-release/press-release-
`detail/pfizer_announces_positive_top_line_results_from_the_pivotal_comparative_reflections_b
`3271002_study_for_pf_05280014_a_potential_biosimilar_to_herceptin_1_trastuzumab
`4 https://investors.pfizer.com/investor-news/press-release-details/2017/Pfizer-Presents-Positive-
`Pivotal-Data-for-PF-05280014-an-Investigational-Biosimilar-to-Herceptin-trastuzumab-at-the-
`European-Society-for-Medical-Oncology-ESMO-2017-Congress/default.aspx
`5 Id.
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`8
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`

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`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 9 of 47 PageID #: 1991
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`U.S. Patent No. 9,249,218, U.S. Patent No. 8,574,869, U.S. Patent No. 7,485,704, U.S. Patent
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`No. 7,807,799, U.S. Patent No. 7,993,834, U.S. Patent No. 8,076,066, U.S. Patent No.
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`8,425,908, U.S. Patent No. 8,440,402, U.S. Patent No. 6,121,428, U.S. Patent No. 6,242,177,
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`U.S. Patent No. 6,610,516, and U.S. Patent No. 8,314,225.
`
`The Cabilly Patents
`
`
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`U.S. Patent Nos. 6,331,415 and 7,923,221 (collectively, the “Cabilly Patents”)
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`describe and claim a process for producing monoclonal antibodies, such as Herceptin®, from
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`recombinant DNA. This effective and efficient process applies a novel co-expression technique
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`to produce antibody heavy and light chains in a single host cell, and has given rise to an entire
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`industry of therapeutic monoclonal antibodies.
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`
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`U.S. Patent No. 6,331,415 (“the ’415 patent”), titled “Methods of Producing
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`Immunoglobulins, Vectors and Transformed Host Cells for Use Therein,” was duly and legally
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`issued by the Patent Office on December 18, 2001. A true and correct copy of the ’415 patent is
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`attached as Exhibit B. Genentech and the City of Hope are the owners by assignment of the ’415
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`patent.
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`
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`U.S. Patent No. 7,923,221 (“the ’221 patent”), titled “Methods of Making
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`Antibody Heavy and Light Chains Having Specificity for a Desired Antigen,” was duly and
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`legally issued by the Patent Office on April 12, 2011. A true and correct copy of the ’221 patent
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`is attached as Exhibit C. Genentech and the City of Hope are the owners by assignment of the
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`’221 patent.
`
`The ’213 Patent
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`
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`U.S. Patent No. 6,407,213 (“the ’213 patent”) claims the Herceptin® antibody
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`itself, along with other humanized monoclonal antibodies. The inventors of the ’213 patent
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`discovered that by grafting the key parts of a mouse antibody onto a human antibody consensus
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`9
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`

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`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 10 of 47 PageID #: 1992
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`sequence, they could create antibodies that were both tolerated by the immune system and
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`effective to treat diseases like HER2-positive breast cancer. The techniques described in the
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`’213 patent allowed scientists to efficiently design antibodies for specific disease targets by
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`modifying mouse antibodies produced in the laboratory in specific ways so that they are
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`compatible with a human immune system.
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`
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`The ’213 patent, titled “Method for Making Humanized Antibodies,” was duly
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`and legally issued by the Patent Office on June 18, 2002. A true and correct copy of the ’213
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`patent is attached as Exhibit D. Genentech is the owner by assignment of the ’213 patent.
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`The Combination Chemotherapy Patents
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`
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`U.S. Patent No. 7,846,441 (“the ’441 patent”) claims the administration of
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`Herceptin® in combination with a chemotherapy agent known as a taxoid, in the absence of an
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`anthracycline derivative (another chemotherapy agent) in an amount effective to extend time to
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`disease progression without overall increase in severe adverse events. This specific method of
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`treatment unexpectedly resulted in a significant improvement in patient outcomes. It nearly
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`doubled the time until disease progression compared to treatment using a taxoid alone, and it also
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`avoided the serious cardiotoxicity associated with Herceptin® in combination with anthracycline
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`derivatives that unexpectedly presented during the Herceptin® clinical trials.
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`
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`The ’441 patent, titled “Treatment with Anti-ErbB2 Antibodies,” was duly and
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`legally issued by the Patent Office on December 7, 2010. A true and correct copy of the ’441
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`patent is attached as Exhibit E. Genentech is the owner by assignment of the ’441 patent.
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`
`
` U.S. Patent No. 7,892,549 (“the ’549 patent”) is a continuation to the ’441 patent
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`that claims a method of treating a patient with HER2-positive breast cancer by administering
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`Herceptin® in combination with a taxoid and a further growth inhibitory agent or further
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`therapeutic agent.
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`10
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`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 11 of 47 PageID #: 1993
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`
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`The ’549 patent, titled “Treatment with Anti-ErbB2 Antibodies,” was duly and
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`legally issued by the Patent Office on February 22, 2011. A true and correct copy of the ’549
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`patent is attached as Exhibit F. Genentech is the owner by assignment of the ’549 patent.
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`
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`U.S. Patent No. 8,425,908 (“the ’908 patent”), claims priority to the same
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`provisional application as the ’441 and ’549 patents. The ’908 patent claims a method of treating
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`a patient with HER2-positive gastric cancer by administering Herceptin® in combination with
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`chemotherapy and in the absence of an anthracycline derivative.
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`
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`The ’908 patent, titled “Treatment with Anti-ErbB2 Antibodies,” was duly and
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`legally issued by the Patent Office on April 23, 2013. A true and correct copy of the ’908 patent
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`is attached as Exhibit G. Genentech is the owner by assignment of the ’908 patent.
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`The Method of Administration Patents
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`
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`U.S. Patent Nos. 6,627,196 and 7,371,379 (collectively, the “Method of
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`Administration Patents”) cover the most common administration method for Herceptin®: an
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`initial dose of 8 mg/kg, followed by 6 mg/kg doses once every three weeks. Herceptin® was
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`initially approved for administration on a weekly regimen, but Genentech discovered that the
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`drug could be dosed only once every three weeks without reducing safety or effectiveness. The
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`discovery of three-weekly dosing has had a marked impact on patients’ quality of life by
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`providing the same life-saving effects of Herceptin® while allowing patients to receive treatment
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`less frequently.
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`
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`U.S. Patent No. 6,627,196 (“the ’196 patent”), titled “Dosages for Treatment with
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`Anti-ErbB2 Antibodies,” was duly and legally issued by the Patent Office on September 30,
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`2003. A true and correct copy of the ’196 patent is attached as Exhibit H. Genentech is the
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`owner by assignment of the ’196 patent.
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`11
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`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 12 of 47 PageID #: 1994
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`
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`U.S. Patent No. 7,371,379 (“the ’379 patent”), titled “Dosages for Treatment with
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`Anti-ErbB2 Antibodies,” was duly and legally issued by the Patent Office on May 13, 2008. A
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`true and correct copy of the ’379 patent is attached as Exhibit I. Genentech is the owner by
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`assignment of the ’379 patent.
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`The Acidic Variants Patents
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`
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`U.S. Patent Nos. 6,339,142 and 9,249,218 (collectively, the “Acidic Variants
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`Patents”) cover compositions with reduced amounts of more acidic structural variants of
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`trastuzumab (“acidic variants”) and chromatographic processes for removing these acidic
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`variants during purification. Some trastuzumab acidic variants have lower potency than
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`trastuzumab itself. The Acidic Variants Patents describe and claim chromatographic processes
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`and compositions that ensure the Herceptin® drug product is uniformly pure and effective.
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`
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`U.S. Patent No. 6,339,142 (“the ’142 patent”), titled “Protein Purification,” was
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`duly and legally issued by the Patent Office on January 15, 2002. A true and correct copy of the
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`’142 patent is attached as Exhibit J. Genentech is the owner by assignment of the ’142 patent.
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`
`
`U.S. Patent No. 9,249,218 (“the ’218 patent”), titled “Protein Purification,” was
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`duly and legally issued by the Patent Office on February 2, 2016. A true and correct copy of the
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`’218 patent is attached as Exhibit K. Genentech is the owner by assignment of the ’218 patent.
`
`HER2 Diagnostic Patents
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`
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`U.S. Patent Nos. 7,993,834; 8,076,066 and 8,440,402 claim novel techniques for
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`identifying patients who might benefit from trastuzumab therapy using gene amplification
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`techniques even where immunohistochemistry techniques suggest that the patient may not
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`overexpress HER2.
`
`
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`U.S. Patent No. 7,993,834 (“the ’834 patent”), 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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`12
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`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 13 of 47 PageID #: 1995
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`Therapy,” was duly and legally issued by the Patent Office on August 9, 2011. A true and
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`correct copy of the ’834 patent is attached as Exhibit L. Genentech is the owner by assignment
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`of the ’834 patent.
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`
`
`U.S. Patent No. 8,076,066 (“the ’066 patent”), titled “Gene Detection Assay for
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`Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy,” was
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`duly and legally issued by the Patent Office on December 13, 2011. A true and correct copy of
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`the ’066 patent is attached as Exhibit M. Genentech is the owner by assignment of the ’066
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`patent.
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`
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`U.S. Patent No. 8,440,402 (“the ’402 patent”), titled “Gene Detection Assay for
`
`Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy,” was
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`duly and legally issued by the Patent Office on May 14, 2013. A true and correct copy of the
`
`’402 patent is attached as Exhibit N. Genentech is the owner by assignment of the ’402 patent.
`
`Cell Culture, Purification, and Antibody Manufacturing Patents
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`
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`U.S. Patent Nos. 6,242,177, 6,610,516, 8,574,869, 6,121,428, 7,485,704,
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`7,807,799, and 8,314,225, claim novel techniques developed by Genentech relating to various
`
`aspects of cell culture, purification, and antibody purification.
`
`
`
`U.S. Patent No. 7,485,704 (“the ’704 patent”), titled “Reducing Protein A
`
`Leaching During Protein A Affinity Chromatography,” was duly and legally issued by the Patent
`
`Office on February 3, 2009. A true and correct copy of the ’704 patent is attached as Exhibit O.
`
`Genentech is the owner by assignment of the ’704 patent.
`
`
`
`U.S. Patent No. 7,807,799 (“the ’799 patent”), titled “Reducing Protein A
`
`Leaching During Protein A Affinity Chromatography,” was duly and legally issued by the Patent
`
`Office on October 5, 2010. A true and correct copy of the ’799 patent is attached as Exhibit P.
`
`Genentech is the owner by assignment of the ’799 patent.
`
`13
`
`

`

`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 14 of 47 PageID #: 1996
`
`
`
`U.S. Patent No. 6,242,177 (“the ’177 patent”), titled “Methods and Compositions
`
`for Secretion of Heterologous Polypeptides,” was duly and legally issued by the Patent Office on
`
`June 5, 2001. A true and correct copy of the ’177 patent is attached as Exhibit Q. Genentech is
`
`the owner by assignment of the ’177 patent.
`
`
`
`U.S. Patent No. 6,610,516 (“the ’516 patent”), titled “Cell Culture Process,” was
`
`duly and legally issued by the Patent Office on August 26, 2003. A true and correct copy of the
`
`’516 patent is attached as Exhibit R. Genentech is the owner by assignment of the ’516 patent.
`
`
`
`U.S. Patent No. 8,574,869 (“the ’869 patent”), titled “Prevention of Disulfide
`
`Bond Reduction During Recombinant Production of Polypeptides,” was duly and legally issued
`
`by the Patent Office on November 5, 2013. A true and correct copy of the ’869 patent is
`
`attached as Exhibit S. Genentech is the owner by assignment of the ’869 patent.
`
`
`
`U.S. Patent No. 8,314,225 (“the ’225 patent”), titled “Heavy Chain Mutant
`
`Leading to Improved Immunoglobulin Production,” was duly and legally issued by the Patent
`
`Office on November 20, 2012. A true and correct copy of the ’225 patent is attached as Exhibit
`
`T. The ’225 patent is assigned to Hoffmann-La Roche, Inc., and Genentech is the exclusive
`
`licensee with the right to enforce the ’225 patent.
`
`
`
`U.S. Patent No. 6,121,428 (“the ’428 patent”), titled “Protein Recovery,” was
`
`duly and legally issued by the Patent Office on September 19, 2000. A true and correct copy of
`
`the ’428 patent is attached as Exhibit U. Genentech is the owner by assignment of the ’428
`
`patent.
`
`COUNT I
`INFRINGEMENT OF U.S. PATENT NO. 6,331,415
`
`
`
`Plaintiffs incorporate by reference paragraphs 1-61 as if fully set forth herein.
`
`14
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`

`

`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 15 of 47 PageID #: 1997
`
`
`
`Genentech included the ’415 patent in its disclosure of patents pursuant to 42
`
`U.S.C. § 262(l)(3)(A). On November 17, 2017, Pfizer chose to file a notice of commercial
`
`marketing. See Exhibit A.
`
`
`
`Based on publicly available information and/or information provided by Pfizer
`
`pursuant to 42 U.S.C. § 262(l)(2), Genentech reasonably believes that Pfizer’s submission of the
`
`aBLA to obtain approval to engage in the commercial manufacture, use, offer to sell, or sale of
`
`the Pfizer aBLA product prior to the expiration of the ’415 patent is a technical act of
`
`infringement of one or more claims of the ’415 patent under 35 U.S.C. § 271(e)(2)(C)(i), either
`
`literally or under the doctrine of equivalents. Genentech has provided detailed, claim-by-claim
`
`infringement contentions to Celltrion pursuant to 42 U.S.C.§ 262(l)(3)(C).
`
`
`
`Likewise, based on publicly available information and/or information provided by
`
`Pfizer pursuant to 42 U.S.C. § 262(l)(2), Plaintiffs reasonably believe that Pfizer will infringe the
`
`’415 patent in violation of 35 U.S.C. §§ 271(a), (b), and/or (g) as a result of its activities relating
`
`to the manufacture, importation, sale, offer for sale, use, and promotion of the use of the PF-
`
`05280014 drug substance and its proposed PF-05280014 drug product, as explained in
`
`Genentech’s 3C Statement. Pursuant to 42 U.S.C. § 262(l)(9)(A) and 28 U.S.C. § 2201,
`
`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 Defendants’
`
`proposed PF-05280014 drug product will infringe the ’415 patent pursuant to 35 U.S.C. §§
`
`271(a), (b), and/or (g).
`
`
`
`Pfizer has knowledge of and is aware of the ’415 patent, including due to
`
`Genentech’s disclosure of patents pursuant to 42 U.S.C. § 262(l)(3)(A) and the filing of this
`
`Complaint. Pfizer’s infringement of the ’415 patent is willful.
`
`15
`
`

`

`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 16 of 47 PageID #: 1998
`
`
`
`Plaintiffs will suffer irreparable injury for which damages are an inadequate
`
`remedy unless Pfizer is enjoined from infringing the claims of the ’415 patent. Plaintiffs have no
`
`adequate remedy at law.
`
`
`
`Plaintiffs are entitled to an injunction pursuant to at least 35 U.S.C. §
`
`271(e)(4)(B), 42 U.S.C. § 262(l)(8)(B), and/or 35 U.S.C. §§ 271(a), (b), and/or (g) preventing
`
`Pfizer from the commercial manufacture, use, offer to sell, or sale within the United States of the
`
`Pfizer aBLA product.
`
`COUNT II
`INFRINGEMENT OF U.S. PATENT NO. 7,923,221
`
`
`
`
`
`Plaintiffs incorporate by reference paragraphs 1-68 as if fully set forth herein.
`
`Genentech included the ’221 patent in its disclosure of patents pursuant to 42
`
`U.S.C. § 262(l)(3)(A). On November 17, 2017, Pfizer chose to file a notice of commercial
`
`marketing. See Exhibit A.
`
`
`
`Based on publicly available information and/or information provided by Pfizer
`
`pursuant to 42 U.S.C. § 262(l)(2), Genentech reasonably believes that Pfizer’s submission of the
`
`aBLA to obtain approval to engage in the commercial manufacture, use, offer to sell, or sale of
`
`the Pfizer aBLA product prior to the expiration of the ’221 patent is a technical act of
`
`infringement of one or more claims of the ’221 patent under 35 U.S.C. § 271(e)(2)(C)(i), either
`
`literally or under the doctrine of equivalents. Genentech has provided detailed, claim-by-claim
`
`infringement contentions to Pfizer pursuant to 42 U.S.C.§ 262(l)(3)(C).
`
`
`
`Likewise, based on publicly available information and/or information provided by
`
`Pfizer pursuant to 42 U.S.C. § 262(l)(2), Plaintiffs reasonably believe that Pfizer will infringe the
`
`’221 patent in violation of 35 U.S.C. §§ 271(a), (b), and/or (g) as a result of its activities relating
`
`to the manufacture, importation, sale, offer for sale, use, and promotion of the use of the PF-
`
`16
`
`

`

`Case 1:17-cv-01672-GMS Document 23 Filed 03/28/18 Page 17 of 47 PageID #: 1999
`
`05280014 drug substance and its proposed PF-05280014 drug product, as explained in
`
`Genentech’s 3C Statement. Pursuant to 42 U.S.C. § 262(l)(9)(A) and 28 U.S.C. § 2201,
`
`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 ’221 patent pursuant to 35 U.S.C. §§ 271(a), (b),
`
`and/or (g).
`
`
`
`Pfizer has knowledge of and is aware of the ’221 patent, including due to
`
`Genentech’s disclosure of patents pursuant to 42 U.S.C. § 262(l)(3)(A) and the filing of this
`
`Complaint. Pfizer’s infringement of the ’221 patent is willful.
`
`
`
`Plaintiffs will suffer irreparable injury for which damages are an inadequate
`
`remedy unless Pfizer is enjoined from infringing the claims of the ’221 patent. Plaintiffs have no
`
`adequate remedy at law.
`
`
`
`Plaintiffs are entitled to an injunction pursuant to at least 35 U.S.C. §
`
`271(e)(4)(B), 42 U.S.C. § 262(l)(8)(B), and/or 35 U.S.C. §§ 271(a), (b), and/or (g)preventing
`
`Pfizer from the commercial manufacture, use, offer to sell, or sale within the United States of the
`
`Pfizer aBLA product.
`
`COUNT III
`INFRINGEMENT OF U.S. PATENT NO