Case 1:18-cv-00924-CFC-SRF Document 78 Filed 01/23/19 Page 1 of 109 PageID #:
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`10319
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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,
`
`
`
`Plaintiffs,
`
`v.
`
`AMGEN, INC.
`
`Defendant.
`
`
`
`
`
`Case No. 18-CV-00924-CFC
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`
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`
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`STIPULATION AND PROPOSED ORDER
`REGARDING SECOND AMENDED COMPLAINT
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`WHEREAS, on June 21, 2018, Plaintiffs Genentech, Inc. and City of Hope (collectively,
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`“Plaintiffs”) filed the above-captioned action against Defendant Amgen, Inc. (“Amgen”);
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`WHEREAS, on November 7, 2018, pursuant to this Court’s scheduling order (D.I. 44),
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`Plaintiffs sent Amgen a letter (the “Claim Narrowing Letter”) identifying allowed claims 10 and
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`11 of U.S. App. No. 14/073,659 (“the ’659 application”) as among the narrowed set of patents
`
`and claims to be litigated in this case once issued by the United States Patent Office;
`
`WHEREAS, on December 25, 2018 the United States Patent Office issued U.S. Patent
`
`No. 10,160,811 (“the ’811 patent”) from the ’659 application,
`
`WHEREAS, claims 6 and 7 of the ’811 patent correspond to claims 10 and 11 of the ’659
`
`application;
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`WHEREAS, pursuant to 42 U.S.C. § 262(l)(7), Plaintiffs have supplemented their list of
`
`patents pursuant to 42 U.S.C. § 262(l)(3)(A) to include the ’811 patent;
`
`WHEREAS, U.S. Patent No. 8,425,908 (“the ’908 patent”), originally asserted against
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`Amgen, has since expired and Amgen’s biosimilar product was not approved by the FDA for
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`PUBLIC VERSION FILED: January 23, 2019
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`10320
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`marketing in the United States prior to the expiration of the ’908 patent;
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`WHEREAS, Plaintiffs seek leave to amend the complaint in this action to (1) add a count
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`of infringement of the ’811 patent and (2) remove a count of infringement of the ’908 patent, and
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`Amgen does not oppose such amendment;
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`
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`NOW, THEREFORE, IT IS HEREBY STIPULATED AND AGREED, by and between
`
`the undersigned parties and subject to the Court’s approval, that pursuant to Fed. R. Civ. P. 15(a)
`
`and D. Del. L.R. 15.1, and in the interests of judicial efficiency, the proposed second amended
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`pleading attached hereto as Exhibit A, which adds a count of infringement of the ’811 patent and
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`removes a count of infringement of the ’908 patent, shall be docketed, along with all exhibits
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`thereto, by Plaintiffs, promptly following approval of this Stipulation by the Court, as the second
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`amended pleading and shall be deemed served upon docketing. A form of the second amended
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`pleading indicating in what respect it differs from the pleading which it amends is attached as
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`Exhibit B. Pursuant to the Court’s scheduling order (D.I. 44) and the Plaintiffs’ Claim
`
`Narrowing Letter, the claims of the ’811 patent to be litigated in this case are claims 6 and 7.
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`
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`Dated: January 11, 2019
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`
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`
`
`/s/ Daniel M. Silver
`Michael P. Kelly (#2295)
`Daniel M. Silver (#4758)
`MCCARTER &ENGLISH, LLP
`Renaissance Centre
`405 North King Street, 8th Floor
`Wilmington, DE 19801
`(302) 984-6300
`mkelly@mccarter.com
`dsilver@mccarter.com
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`/s/ Eve H. Ormerod
`Neal C. Belgam (No. 2721)
`Eve H. Ormerod (No. 5369)
`SMITH KATZENSTEIN & JENKINS LLP
`1000 West Street, Suite 1501
`Wilmington, DE 19801
`(302) 652-8400
`nbelgam@skjlaw.com
`eormerod@skjlaw.com
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`Case 1:18-cv-00924-CFC-SRF Document 78 Filed 01/23/19 Page 3 of 109 PageID #:
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`10321
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`OF COUNSEL:
`
`Michelle Rhyu
`Susan Krumplitsch
`Daniel Knauss
`COOLEY, LLP
`3175 Hanover Street
`Palo Alto, CA 94304-1130
`P 650-843-5287
`skrumplitsch@cooley.com
`mrhyu@cooley.com
`dknauss@cooley.com
`
`Orion Armon
`COOLEY, LLP
`380 Interlocken Crescent, Suite 900
`Broomfield, CO 80021-8023
`(720) 566-4119
`oarmon@cooley.com
`
`Eamonn Gardner
`COOLEY, LLP
`4401 Eastgate Mall
`San Diego, CA 92121-1909
`(858) 550-6086
`egardner@cooley.com
`
`Nancy Gettel
`Thomas Lavery, IV
`AMGEN, INC.
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1799
`P 805-447-1000
`ngettel@amgen.com
`tlavery@amgen.com
`
`Attorneys for Defendant Amgen, Inc.
`
`OF COUNSEL:
`
`William F. Lee
`Lisa J. Pirozzolo
`Emily R. Whelan
`Kevin S. Prussia
`Andrew J. Danford
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`(627) 526-6000
`william.lee@wilmerhale.com
`lisa.pirozzolo@wilmerhale.com
`emily.whelan@wilmerhale.com
`kevin.prussia@wilmerhale.com
`andrew.danford@wilmerhale.com
`
`Robert J. Gunther Jr.
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, NY 10007
`(212) 230-8800
`robert.gunther@wilmerhale.com
`
`Daralyn J. Durie
`Adam R. Brausa
`DURIE TANGRI LLP
`217 Leidesdorff St.
`San Francisco, CA 94111
`(415) 362-6666
`ddurie@durietangri.com
`abrausa@durietangri.com
`
`Attorneys for Plaintiffs
`Genentech, Inc. and City of Hope
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`
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`10322
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`SO ORDERED this ______ day of ____________, 2019.
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`____________________________________
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`United States District Judge
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`10323
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`EXHIBIT A
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`

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`Case 1:18-cv-00924-CFC-SRF Document 78 Filed 01/23/19 Page 6 of 109 PageID #:
`10324
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`
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`GENENTECH, INC. and CITY OF HOPE,
`
`Plaintiffs,
`
`C.A. No. 18-924-CFC
`
`v.
`
`AMGEN INC.,
`
`Defendant.
`
`
`
`
`
`
`SECOND AMENDED COMPLAINT
`
`Plaintiffs Genentech, Inc. (“Genentech”) and City of Hope (collectively, “Plaintiffs”)
`
`bring this Second Amended Complaint for declaratory and injunctive relief against Defendant
`
`Amgen Inc. (“Amgen”) to address Amgen’s infringement of patents relating to Genentech’s
`
`groundbreaking breast cancer drug Herceptin®.
`
`NATURE OF THE CASE
`
`1.
`
`
`
`Breast cancer is a serious disease affecting over 2.8 million women in the United
`
`States. Approximately 20-25% of those women suffer from “HER2-positive” breast cancer.
`
`This is a particularly aggressive form of the disease characterized by overexpression of human
`
`epidermal growth factor receptor 2 (i.e., “HER2”) proteins due to excessive HER2 gene
`
`amplification.
`
`2.
`
`
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`In the early 1990s, a diagnosis of HER2-positive breast cancer was effectively a
`
`death sentence: patients had an average life expectancy of only 18 months. The quality of life
`
`for those patients was markedly poor—the disease rapidly metastasized (i.e., spread to other
`
`parts of the body). The only available treatments were invasive and disfiguring surgery and
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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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`3.
`
`
`
`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
`
`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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`4.
`
`
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`Although the scientific community was initially skeptical that such an antibody-
`
`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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`5.
`
`
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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
`
`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
`
`with out-of-pocket prescription-related expenses. All told, Genentech has spent over two
`
`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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`6.
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`
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`Genentech’s groundbreaking work developing Herceptin® was the result of years
`
`of research from a group of talented scientists. The United States Patent and Trademark Office
`
`recognized that innovative work by granting Genentech numerous patents claiming Herceptin®,
`
`its manufacture, and its use. And as one of the pioneers in the biotechnology field, Genentech
`
`collaborated with scientists at research institutions such as the City of Hope to make foundational
`
`inventions, such as efficient techniques for making antibodies that can be used as drugs.
`
`7.
`
`
`
`Seeking to profit from the success of Plaintiffs’ innovations, Amgen is seeking
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`FDA approval of a biosimilar version of Herceptin® called ABP 980. ABP 980 is a copycat
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`product for which Amgen is seeking the same label indications and usage as Herceptin®. In fact,
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`Amgen is relying upon Genentech’s own studies demonstrating the safety and efficacy of
`
`Herceptin® to obtain approval of its biosimilar product.
`
`8.
`
`
`
`In 2010, Congress provided a pathway for resolving patent disputes relating to
`
`biosimilar products through the Biologics Price Competition and Innovation Act (“BPCIA”).
`
`Amgen initially purported to follow the process outlined in the BPCIA, which requires biosimilar
`
`applicants and innovator companies to exchange certain information concerning the biosimilar
`
`product and the patents that may be infringed by the manufacture and sale of the biosimilar
`
`product. See 42 U.S.C. § 262(l).
`
`9.
`
`
`
`Plaintiffs thus bring this action for infringement pursuant to 35 U.S.C. § 271(e)(2)
`
`based upon Amgen’s submission of its aBLA for ABP 980. Plaintiffs also seek a declaratory
`
`judgment pursuant to 42 U.S.C. § 262(l)(9) and 28 U.S.C. § 2201 that the manufacture, use, offer
`
`to sell, sale, or importation into the United States of Amgen’s biosimilar product would infringe
`
`the patents described below. Pursuant to 35 U.S.C. § 271(e)(4)(B), 42 U.S.C. § 262(l)(8)(B), 35
`
`U.S.C. § 271(a), (b), and/or 35 U.S.C. § 283, Plaintiffs also seek a preliminary and/or permanent
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`injunction barring Amgen’s manufacture, use, offer to sell, sale, or importation of its biosimilar
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`product prior to the expiration of those patents. In the event that Amgen imports, manufactures,
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`or launches its biosimilar product, and/or otherwise practices the patented inventions in the
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`United States prior to the expiration of those patents, Plaintiffs also seek monetary damages,
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`including lost profits, and any further relief as this Court may deem just and proper.
`
`PARTIES
`
`10.
`
`
`
`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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`11.
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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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`12.
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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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`13.
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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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`14.
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`
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`Upon information and belief, Defendant Amgen 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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`One Amgen Center Drive, Thousand Oaks, California 91320.
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`15.
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`
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`Amgen 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, ABP 980
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`(“Amgen’s aBLA product”). Upon information and belief, Amgen’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
`
`16.
`
`
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`This action arises under the BPCIA, 42 U.S.C. § 262(l) and the Patent Laws of the
`
`United States, Title 35, United States Code, and the Declaratory Judgment Act, 28 U.S.C.
`
`§§ 2201-2202. This Court has subject matter jurisdiction pursuant to 28 U.S.C. §§ 1331, 1332,
`
`and 1338.
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`17.
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`
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`Venue is proper with respect to Amgen in this Court pursuant to 28 U.S.C.
`
`§§ 1391 and 1400(b) because Amgen is incorporated in Delaware.
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`18.
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`
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`This Court has personal jurisdiction over Amgen because it is incorporated in
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`Delaware. In addition, among other things, Amgen has filed an Abbreviated Biologics License
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`Application (“aBLA”) for ABP 980 with the FDA seeking approval to market it, which reliably
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`indicates that it will market its proposed biosimilar product in Delaware if approved.
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`THE PARTIES’ EXCHANGES UNDER THE BPCIA
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`19.
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`
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`On July 31, 2017, Amgen announced that it had submitted an aBLA for ABP 980
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`to the FDA seeking approval for the commercial manufacture, use, offer for sale, or sale of the
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`Amgen aBLA product, a biosimilar version of trastuzumab, which is subject to BLA No. 103792
`
`to Genentech.3
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`20.
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`
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`The FDA accepted Amgen’s aBLA for review
`
`.
`
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`3 http://www.amgen.com/media/news-releases/2017/07/amgen-and-allergan-submit-biosimilar-
`biologics-license-application-for-abp-980-to-us-food-and-drug-administration/
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`21.
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`On October 16, 2017, Amgen provided Genentech with a copy of Amgen’s
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`aBLA, which included a small amount of manufacturing information.
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`22.
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`
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`On November 3, 2017, Amgen provided Genentech with additional
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`manufacturing information regarding Amgen’s aBLA product.
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`23.
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`Genentech responded on November 20, 2017, to identify deficiencies in Amgen’s
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`production of manufacturing information and request specific information concerning the
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`manufacture of Amgen’s biosimilar product. Amgen provided additional manufacturing
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`information on December 1, 2017, and December 4, 2017, but did not satisfy its disclosure
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`obligations. Genentech then responded on December 15, 2017, to explain that Amgen’s
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`production was deficient in that it failed to provide all of the requested information in
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`contravention of 42 U.S.C. § 262(l)(2).
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`24.
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`
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`Amgen did not disclose all of the information relevant to establishing whether the
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`manufacture of Amgen’s aBLA product will infringe each of the patents identified on
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`Genentech’s operative list pursuant to 42 U.S.C. § 262(l)(3)(A), despite Genentech’s request that
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`Amgen provide sufficient “other information that describes the process or processes used to
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`manufacture” as required by 42 U.S.C. § 262(l)(A). Amgen’s failure to provide sufficient
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`information under those circumstances justifies Genentech’s contention that manufacturing
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`Amgen’s aBLA product will infringe such patents.
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`25.
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`
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`Despite Amgen’s non-compliance (and without waiving Genentech’s objection to
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`such non-compliance), Genentech provided its operative list of 36 patents pursuant to 42 U.S.C.
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`§ 262(l)(3)(A) on December 15, 2017.
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`26.
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`
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`Amgen replied on December 20, 2017, to assert its position that it had complied
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`with its disclosure obligations based on Amgen’s earlier production of its aBLA and two
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`manufacturing documents.
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`27.
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`
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`Genentech responded on December 27, 2017, to reiterate that Amgen’s
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`production was insufficient to provide Genentech with a complete understanding of Amgen’s
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`trastuzumab manufacturing process.
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`28.
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`29.
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`Amgen replied on February 1, 2018, with an additional supplemental production.
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`On February 6, 2018, Genentech supplemented its § 262(l)(3)(A) list to include a
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`newly issued manufacturing patent: U.S. Patent No. 9,868,760.
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`30.
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`
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`On February 13, 2018, Amgen purported to provide its detailed statement
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`concerning non-infringement and invalidity pursuant to 42 U.S.C. § 262(l)(3)(B) (“Amgen’s 3B
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`Statement”). Amgen’s 3B Statement was deficient in numerous ways. For example, it—like
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`Amgen’s document productions—failed to fully describe Amgen’s manufacturing process, such
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`that Genentech was unable to evaluate many of Amgen’s non-infringement arguments.
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`31.
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`
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`On
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`, and
`
`, Amgen produced
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`additional documents regarding
`
`
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` These supplemental productions still failed to fully describe Amgen’s
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`manufacturing process.
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`32.
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`
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`On April 13, 2018, and subject to its objections, Genentech provided its response
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`to Amgen’s 3C Statement pursuant to 42 U.S.C. § 262(l)(3)(C) (“Genentech’s 3C Statement”).
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`Genentech included responses to Amgen’s non-infringement and invalidity statements for each
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`of the patents addressed in Amgen’s 3B Statement and maintained that ABP 980 will infringe at
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`least 18 Genentech patents. With its 3C Statement, Genentech proposed that Amgen agree that
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`all 18 of these patents be included in a first-phase infringement action under § 262(l)(6).
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`33.
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`
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`On
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`, and
`
`, Amgen produced additional documents
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`regarding
`
`. These
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`supplemental productions still failed to fully describe Amgen’s manufacturing process.
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`34.
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`
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`After Genentech served its 3C Statement, the parties initiated negotiations under
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`§ 262(l)(4). On May 23, 2018, Genentech and Amgen agreed that the 37 patents addressed in the
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`exhibits to Genentech’s 3C Statement shall be the subject of an action for patent infringement
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`under § 262(l)(6).
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`35.
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`
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`In light of the parties’ agreement, § 262(l)(6)(A) required Genentech to bring an
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`action for patent infringement with respect to each of the 37 patents that were part of the parties’
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`agreement. This action is Genentech’s action pursuant to § 262(l)(6)(A).
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`36.
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`
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`On
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`
`, Amgen purported to notify Genentech pursuant to 42 U.S.C. § 262(l)(8)(A) that it
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`intends to commence commercial marketing of ABP 980 in the United States no earlier than 180
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`from
`
` (i.e.,
`
`).
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`37.
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`
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`On June 21, 2018, Plaintiffs sued Amgen for infringement of all 37 patents that
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`the parties agreed to litigate during their § 262(l)(4) negotiations. On July 19, 2018, Plaintiffs
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`and Amgen stipulated to dismiss with prejudice all claims for infringement of U.S. Patent Nos.
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`6,242,177, 6,489,447, 6,586,206, 6,870,034, 7,449,184, 7,501,122, 8,044,017, 8,314,225,
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`8,357,301, 8,460,895, 8,691,232, 8,710,196, 8,771,988, 9,047,438, 9,080,183, 9,428,766,
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`9,487,809, 9,493,744, and 9,868,760 relating to ABP 980, subject to certain conditions.
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`38.
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`In a letter dated November 7, 2018, pursuant to the Court’s scheduling order (D.I.
`
`44), Genentech identified to Amgen a narrowed list of 10 patents which it intended to assert
`
`against Amgen in this litigation. In the same letter, Genentech notified Amgen that it intended to
`
`assert infringement of claims 10 and 11 of U.S. App. No. 14/073,659 (“the ’659 application”)
`
`once issued by the U.S. Patent Office. On December 25, 2018, the ’659 application issued as
`
`U.S. Patent No. 10,160,811 (“the ’811 patent”). Claims 6 and 7 of the ’811 patent as issued
`
`correspond to claims 10 and 11 of the ’659 application. Genentech further supplemented its
`
`supplemented its § 262(l)(3)(A) list to include the ’811 patent.
`
`AMGEN’S aBLA PRODUCT
`
`39.
`
`
`
`Amgen has publicly stated that its aBLA product is biosimilar to Herceptin®. For
`
`example, Amgen has issued press releases claiming that ABP 980 is “a biosimilar candidate to
`
`Herceptin®” and “ABP 980 is a biosimilar candidate to trastuzumab,”4 and it has announced the
`
`results of an Amgen study that purports to conclude that “[e]fficacy, safety and immunogenicity
`
`data support ABP 980 as a trastuzumab biosimilar.”5
`
`40.
`
`
`
`Given Amgen’s claim of biosimilarity, Amgen’s aBLA product must “utilize the
`
`same mechanism or mechanisms of action [as Herceptin®] for the condition or conditions of use
`
`prescribed, recommended, or suggested in the proposed labeling.” 42 U.S.C.
`
`§ 262(k)(2)(A)(i)(II).
`
`
`4 http://www.amgen.com/media/news-releases/2017/07/amgen-and-allergan-submit-biosimilar-
`biologics-license-application-for-abp-980-to-us-food-and-drug-administration/
`5 https://www.amgen.com/media/news-releases/2017/09/amgen-and-allergan-present-phase-3-
`data-on-biosimilar-trastuzumab-candidate-abp-980-at-the-european-society-for-medical-
`oncology-2017-congress/
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`41.
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`
`
`Under 35 U.S.C. § 271(e)(2)(C), Amgen has committed a statutory act of patent
`
`infringement with respect to patents identified by Genentech under 42 U.S.C. § 262(l)(3),
`
`through the submission of its aBLA application for ABP 980.
`
`GENENTECH’S ASSERTED PATENTS
`
`42.
`
`
`
`Genentech has spent over two decades and significant resources developing
`
`Herceptin®, and the USPTO has awarded to Genentech numerous patents on innovations
`
`resulting from this massive undertaking. These patents cover the antibody trastuzumab, along
`
`with its manufacture and use.
`
`43.
`
`
`
`Upon information and belief, Amgen’s aBLA product will infringe at least the
`
`following patents, which Genentech has asserted in this lawsuit: U.S. Patent No. 6,331,415, U.S.
`
`Patent No. 7,923,221, U.S. Patent No. 6,407,213, U.S. Patent No. 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. 10,160,811,
`
`U.S. Patent No. 6,417,335, U.S. Patent No. 9,249,218, U.S. Patent No. 8,574,869, U.S. Patent
`
`No. 6,620,918, U.S. Patent No. 7,993,834, U.S. Patent No. 8,076,066, U.S. Patent No. 8,440,402,
`
`U.S. Patent No. 6,121,428, U.S. Patent No. 8,512,983, and U.S. Patent No. 9,714,293.
`
`The Cabilly Patents
`
`44.
`
`
`
`U.S. Patent Nos. 6,331,415 and 7,923,221 (collectively, the “Cabilly Patents”)
`
`describe and claim a process for producing monoclonal antibodies, such as Herceptin®, from
`
`recombinant DNA. This effective and efficient process applies a novel co-expression technique
`
`to produce antibody heavy and light chains in a single host cell, and has given rise to an entire
`
`industry of therapeutic monoclonal antibodies.
`
`45.
`
`
`
`U.S. Patent No. 6,331,415 (“the ’415 patent”), titled “Methods of Producing
`
`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
`
`attached as Exhibit A. Genentech and the City of Hope are the owners by assignment of the ’415
`
`patent.
`
`46.
`
`
`
`U.S. Patent No. 7,923,221 (“the ’221 patent”), titled “Methods of Making
`
`Antibody Heavy and Light Chains Having Specificity for a Desired Antigen,” was duly and
`
`legally issued by the Patent Office on April 12, 2011. A true and correct copy of the ’221 patent
`
`is attached as Exhibit B. Genentech and the City of Hope are the owners by assignment of the
`
`’221 patent.
`
`The ’213 Patent
`
`47.
`
`
`
`U.S. Patent No. 6,407,213 (“the ’213 patent”) claims the Herceptin® antibody
`
`itself, along with other humanized monoclonal antibodies. The inventors of the ’213 patent
`
`discovered that by grafting the key parts of a mouse antibody onto a human antibody consensus
`
`sequence, they could create antibodies that were both tolerated by the immune system and
`
`effective to treat diseases like HER2-positive breast cancer. The techniques described in the
`
`’213 patent allowed scientists to efficiently design antibodies for specific disease targets by
`
`modifying mouse antibodies produced in the laboratory in specific ways so that they are
`
`compatible with a human immune system.
`
`48.
`
`
`
`The ’213 patent, titled “Method for Making Humanized Antibodies,” was duly
`
`and legally issued by the Patent Office on June 18, 2002. A true and correct copy of the ’213
`
`patent is attached as Exhibit C. Genentech is the owner by assignment of the ’213 patent.
`
`The Combination Chemotherapy Patents
`
`49.
`
`
`
`U.S. Patent No. 7,846,441 (“the ’441 patent”), claims the administration of
`
`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
`
`disease progression without overall increase in severe adverse events. This specific method of
`
`treatment unexpectedly resulted in a significant improvement in patient outcomes. It nearly
`
`doubled the time until disease progression compared to treatment using a taxoid alone, and it also
`
`avoided the serious cardiotoxicity associated with Herceptin® in combination with anthracycline
`
`derivatives that unexpectedly presented during the Herceptin® clinical trials.
`
`50.
`
`
`
`The ’441 patent, titled “Treatment with Anti-ErbB2 Antibodies,” was duly and
`
`legally issued by the Patent Office on December 7, 2010. A true and correct copy of the ’441
`
`patent is attached as Exhibit D. Genentech is the owner by assignment of the ’441 patent.
`
`51.
`
`
`
`U.S. Patent No. 7,892,549 (“the ’549 patent”) is a continuation to the ’441 patent
`
`that claims a method of treating a patient with HER2-positive breast cancer by administering
`
`Herceptin® in combination with a taxoid and a further growth inhibitory agent or further
`
`therapeutic agent.
`
`52.
`
`
`
`The ’549 patent, titled “Treatment with Anti-ErbB2 Antibodies,” was duly and
`
`legally issued by the Patent Office on February 22, 2011. A true and correct copy of the ’549
`
`patent is attached as Exhibit E. Genentech is the owner by assignment of the ’549 patent.
`
`The Method of Administration Patents
`
`53.
`
`
`
`U.S. Patent Nos. 6,627,196, 7,371,379, and 10,160,811 (collectively, the “Method
`
`of Administration Patents”) generally cover the most common administration method for
`
`Herceptin®: an initial dose of 8 mg/kg, followed by 6 mg/kg doses once every three weeks.
`
`Herceptin® was initially approved for administration on a weekly regimen, but Genentech
`
`discovered that the drug could be dosed only once every three weeks without reducing safety or
`
`effectiveness. The discovery of three-weekly dosing has had a marked impact on patients’
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`quality of life by providing the same life-saving effects of Herceptin® while allowing patients to
`
`receive treatment less frequently.
`
`54.
`
`
`
`U.S. Patent No. 6,627,196 (“’196 patent”), titled “Dosages for Treatment with
`
`Anti-ErbB2 Antibodies,” was duly and legally issued by the Patent Office on September 30,
`
`2003. A true and correct copy of the ’196 patent is attached as Exhibit G. Genentech is the
`
`owner by assignment of the ’196 patent.
`
`55.
`
`
`
`U.S. Patent No. 7,371,379 (“the ’379 patent”), titled “Dosages for Treatment with
`
`Anti-ErbB2 Antibodies,” was duly and legally issued by the Patent Office on May 13, 2008. A
`
`true and correct copy of the ’379 patent is attached as Exhibit H. Genentech is the owner by
`
`assignment of the ’379 patent.
`
`56.
`
`
`
`U.S. Patent No. 10,160,811 (“the ’811 patent”), titled “Treatment with Anti-
`
`ErbB2 Antibodies,” was duly and legally issued by the Patent Office on December 25, 2018. A
`
`true and correct copy of the ’811 patent is attached as Exhibit F. Genentech is the owner by
`
`assignment of the ’811 patent.
`
`The Acidic Variants Patents
`
`57.
`
`
`
`U.S. Patent Nos. 6,417,335 and 9,249,218 (collectively, the “Acidic Variants
`
`Patents”) cover compositions with reduced amounts of more acidic structural variants of
`
`trastuzumab (“acidic variants”) and chromatographic processes for removing these acidic
`
`variants during purification. Some trastuzumab acidic variants have lower potency than
`
`trastuzumab itself. The Acidic Variants Patents describe and claim chromatographic processes
`
`and compositions that ensure the Herceptin® drug product is uniformly pure and effective.
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`58.
`
`
`
`U.S. Patent No. 6,417,335 (“the ’335 patent”), titled “Protein Purification,” was
`
`duly and legally issued by the Patent Office on July 9, 2002. A true and correct copy of the ’335
`
`patent is attached as Exhibit I. Genentech is the owner by assignment of the ’335 patent.
`
`59.
`
`
`
`U.S. Patent No. 9,249,218 (“the ’218 patent”), titled “Protein Purification,” was
`
`duly and legally issued by the Patent Office on February 2, 2016. A true and correct copy of the
`
`’218 patent is attached as Exhibit J. Genentech is the owner by assignment of the ’218 patent.
`
`HER2 Diagnostic Patents
`
`60.
`
`
`
`U.S. Patent Nos. 7,993,834, 8,076,066, and 8,440,402 claim novel techniques for
`
`identifying patients who might benefit from trastuzumab therapy using gene amplification
`
`techniques even where immunohistochemistry techniques suggest that the patient may not
`
`overexpress HER2.
`
`61.
`
`
`
`U.S. Patent No. 7,993,834 (“the ’834 patent”), titled “Detection of ErbB2 Gene
`
`Amplification to Increase the Likelihood of the Effectiveness of ErbB2 Antibody Breast Cancer
`
`Therapy,” was duly and legally issued by the Patent Office on August 9, 2011. A true and
`
`correct copy of the ’834 patent is attached as Exhibit K. Genentech is the owner by assignment
`
`of the ’834 patent.
`
`62.
`
`
`
`U.S. Patent No. 8,076,066 (“the ’066 patent”), titled “Gene Detection Assay for
`
`Improving the Likelihood of an Effective Response to a HER2 Antibody Cancer Therapy,” was
`
`duly and legally issued by the Patent Office on December 13, 2011. A true and correct copy of
`
`the ’066 patent is attached as Exhibit L. Genentech is the owner by assignment of the ’066
`
`patent.
`
`63.
`
`
`
`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