Case 1:18-cv-00924-CFC Document 347 Filed 09/04/19 Page 1 of 372 PageID #: 26400
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`GENENTECH, INC.,
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`Plaintiff,
`
`v.
`
`AMGEN INC.,
`
`Defendant.
`
`
`
`
`C.A. No. 18-924-CFC
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`JURY TRIAL DEMANDED
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`
`
`THIRD AMENDED COMPLAINT
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`Plaintiff Genentech, Inc. (“Genentech”) brings this Third Amended Complaint against
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`Defendant Amgen Inc. (“Amgen”) to address Amgen’s infringement of patents relating to
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`Genentech’s groundbreaking breast cancer drug Herceptin®.
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`NATURE OF THE CASE
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`1.
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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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`2.
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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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`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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`Case 1:18-cv-00924-CFC Document 347 Filed 09/04/19 Page 2 of 372 PageID #: 26401
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`3.
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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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`4.
`
`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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`5.
`
`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
`
`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.
`
`6.
`
`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
`
`
`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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`Case 1:18-cv-00924-CFC Document 347 Filed 09/04/19 Page 3 of 372 PageID #: 26402
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`recognized that innovative work by granting Genentech numerous patents claiming Herceptin®,
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`its manufacture, and its use.
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`7.
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`Seeking to profit from the success of Genentech’s innovations, Amgen sought
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`FDA approval of a biosimilar version of Herceptin® called ABP 980 (trastuzumab-anns). The
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`FDA approved ABP 980, which Amgen markets under the tradename Kanjinti, on June 13, 2019
`
`for the same label indications and usage as Herceptin®. In fact, Amgen relied 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.
`
`Genentech thus brings this action for infringement pursuant to 35 U.S.C.
`
`§ 271(e)(2) based upon Amgen’s submission of its Abbreviated Biologics License Application
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`(“aBLA”) for ABP 980. Genentech also seeks a judgment of infringement under 35 U.S.C. §
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`271(a), (b), and (g) that Amgen’s manufacture, use, offer to sell, sale, or importation into the
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`United States of Amgen’s biosimilar product has infringed the patents described below.
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`Genentech also seeks a declaratory judgment pursuant to 42 U.S.C. § 262(l)(9) and 28 U.S.C.
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`§ 2201 that the manufacture, use, offer to sell, sale, or importation into the United States of
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`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), (g), and/or 35 U.S.C. § 283,
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`Genentech also seeks a preliminary and/or permanent injunction barring Amgen’s manufacture,
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`use, offer to sell, sale, or importation of its biosimilar product prior to the expiration of those
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`patents. Genentech also seeks monetary damages, including lost profits and/or a reasonable
`
`royalty, for Amgen’s infringement of Genentech’s patents, and any further relief as this Court
`
`may deem just and proper.
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`PARTIES
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`10.
`
`Plaintiff Genentech is a corporation organized and existing under the laws of the
`
`State of Delaware with its corporate headquarters at 1 DNA Way, South San Francisco,
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`California 94080.
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`11.
`
`Genentech was founded in 1976 and for four decades has been at the forefront of
`
`innovation in the field of therapeutic biotechnology. Today, Genentech employs a large number
`
`of researchers, scientists, and post-doctoral staff members who routinely publish in top peer-
`
`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
`
`attacks, strokes, rheumatoid arthritis, and respiratory diseases.
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`12.
`
`Upon information and belief, Defendant Amgen is a company organized and
`
`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.
`
`13.
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`Amgen is, among other things, engaged in the development of biologic drugs,
`
`including a biosimilar version of Genentech’s Herceptin® product, ABP 980 (“Amgen’s aBLA
`
`product”). Upon information and belief, Amgen’s aBLA product is or will be distributed and
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`sold in the State of Delaware and throughout the United States.
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`Case 1:18-cv-00924-CFC Document 347 Filed 09/04/19 Page 5 of 372 PageID #: 26404
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`JURISDICTION AND VENUE
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`14.
`
`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.
`
`15.
`
`Venue is proper with respect to Amgen in this Court pursuant to 28 U.S.C.
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`§§ 1391 and 1400(b) because Amgen is incorporated in Delaware.
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`16.
`
`This Court has personal jurisdiction over Amgen because it is incorporated in
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`Delaware. In addition, among other things, Amgen has been approved by the FDA to market its
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`aBLA product and has announced that its aBLA product is now available to customers in the
`
`United States, including in Delaware.
`
`THE PARTIES’ EXCHANGES UNDER THE BPCIA
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`17.
`
`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
`
`18.
`
`19.
`
`The FDA accepted Amgen’s aBLA for review on September 26, 2017.
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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.
`
`20.
`
`On November 3, 2017, Amgen provided Genentech with additional
`
`manufacturing information regarding Amgen’s aBLA product.
`
`
`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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`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
`
`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
`
`contravention of 42 U.S.C. § 262(l)(2).
`
`22.
`
`Amgen did not disclose all of the information relevant to establishing whether the
`
`manufacture of Amgen’s aBLA product will infringe each of the patents identified on
`
`Genentech’s operative list pursuant to 42 U.S.C. § 262(l)(3)(A), despite Genentech’s request that
`
`Amgen provide sufficient “other information that describes the process or processes used to
`
`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.
`
`23.
`
`Despite Amgen’s non-compliance (and without waiving Genentech’s objection to
`
`such non-compliance), Genentech provided its operative list of 36 patents pursuant to 42 U.S.C.
`
`§ 262(l)(3)(A) on December 15, 2017.
`
`24.
`
`Amgen replied on December 20, 2017, to assert its position that it had complied
`
`with its disclosure obligations based on Amgen’s earlier production of its aBLA and two
`
`manufacturing documents.
`
`25.
`
`Genentech responded on December 27, 2017, to reiterate that Amgen’s
`
`production was insufficient to provide Genentech with a complete understanding of Amgen’s
`
`trastuzumab manufacturing process.
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`Case 1:18-cv-00924-CFC Document 347 Filed 09/04/19 Page 7 of 372 PageID #: 26406
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`26.
`
`27.
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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.
`
`28.
`
`On February 13, 2018, Amgen purported to provide its detailed statement
`
`concerning non-infringement and invalidity pursuant to 42 U.S.C. § 262(l)(3)(B) (“Amgen’s 3B
`
`Statement”). Amgen’s 3B Statement was deficient in numerous ways. For example, it—like
`
`Amgen’s document productions—failed to fully describe Amgen’s manufacturing process, such
`
`that Genentech was unable to evaluate many of Amgen’s non-infringement arguments.
`
`29.
`
`On February 27, 2018, March 12, 2018, and April 13, 2018, Amgen produced
`
`additional documents regarding Amgen’s correspondence with the FDA regarding its aBLA
`
`submission. These supplemental productions still failed to fully describe Amgen’s
`
`manufacturing process.
`
`30.
`
`On April 13, 2018, and subject to its objections, Genentech provided its response
`
`to Amgen’s 3C Statement pursuant to 42 U.S.C. § 262(l)(3)(C) (“Genentech’s 3C Statement”).
`
`Genentech included responses to Amgen’s non-infringement and invalidity statements for each
`
`of the patents addressed in Amgen’s 3B Statement and maintained that ABP 980 will infringe at
`
`least 18 Genentech patents. With its 3C Statement, Genentech proposed that Amgen agree that
`
`all 18 of these patents be included in a first-phase infringement action under § 262(l)(6).
`
`31.
`
`On April 25, 2018, and April 30, 2018, Amgen produced additional documents
`
`regarding Amgen’s correspondence with the FDA regarding its aBLA submission. These
`
`supplemental productions still failed to fully describe Amgen’s manufacturing process.
`
`32.
`
`After Genentech served its 3C Statement, the parties initiated negotiations under
`
`§ 262(l)(4). On May 23, 2018, Genentech and Amgen agreed that the 37 patents addressed in the
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`Case 1:18-cv-00924-CFC Document 347 Filed 09/04/19 Page 8 of 372 PageID #: 26407
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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).
`
`33.
`
`In light of the parties’ agreement, § 262(l)(6)(A) required Genentech to bring an
`
`action for patent infringement with respect to each of the 37 patents that were part of the parties’
`
`agreement. This action is Genentech’s action pursuant to § 262(l)(6)(A).
`
`34.
`
`On May 15, 2018, while the parties’ negotiations pursuant to § 262(l)(4) were
`
`underway, Amgen purported to notify Genentech pursuant to 42 U.S.C. § 262(l)(8)(A) that it
`
`intends to commence commercial marketing of ABP 980 in the United States no earlier than 180
`
`from May 15, 2018 (i.e., October 28, 2018).
`
`35.
`
`On June 21, 2018, Genentech and City of Hope (collectively, “Plaintiffs”) sued
`
`Amgen for infringement of all 37 patents that the parties agreed to litigate during their
`
`§ 262(l)(4) negotiations. On July 19, 2018, Plaintiffs and Amgen stipulated to dismiss with
`
`prejudice all claims for infringement of U.S. Patent Nos. 6,242,177, 6,489,447, 6,586,206,
`
`6,870,034, 7,449,184, 7,501,122, 8,044,017, 8,314,225, 8,357,301, 8,460,895, 8,691,232,
`
`8,710,196, 8,771,988, 9,047,438, 9,080,183, 9,428,766, 9,487,809, 9,493,744, and 9,868,760
`
`relating to ABP 980, subject to certain conditions.
`
`36.
`
`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
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`U.S. Patent No. 10,160,811 (“the ’811 patent”). Claims 6 and 7 of the ’811 patent as issued
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`correspond to claims 10 and 11 of the ’659 application. Genentech further supplemented its
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`§ 262(l)(3)(A) list to include the ’811 patent.
`
`37.
`
`On July 23, 2019, Plaintiffs and Amgen stipulated to dismiss with prejudice all
`
`claims for infringement of U.S. Patent Nos. 6,331,415, 7,923,221, 6,407,213, 6,417,335,
`
`9,249,218, 6,121,428, and 6,620,918 relating to ABP 980. City of Hope was dismissed as a
`
`plaintiff to this case through that stipulation. That stipulation was so-ordered by the Court on
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`July 24, 2019. D.I. 325
`
`38.
`
`On August 2, 2019, Genentech and Amgen stipulated to a judgment of non-
`
`infringement of U.S. Patent Nos. 8,512,983 and 9,714,293 under the Court’s claim construction
`
`of “a glutamine-free production culture medium,” while preserving Genentech’s ability to
`
`challenge that claim construction on appeal. That stipulation was so-ordered by the Court on
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`August 20, 2019. D.I. 340.
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`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
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`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
`
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`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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`prescribed, recommended, or suggested in the proposed labeling.” 42 U.S.C.
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`§ 262(k)(2)(A)(i)(II).
`
`41.
`
`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.
`
`42.
`
`43.
`
`On June 13, 2019, Amgen’s aBLA product was approved by the FDA.
`
`On July 18, 2019, Amgen issued a press release announcing that “KANJINTI™
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`(trastuzumab-anns), a biosimilar to Herceptin® (trastuzumab), [is] now available in the United
`
`States (U.S.).”6
`
`44.
`
`Since making its aBLA product available to customers in the United States,
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`Amgen has stated that it “has received confirmation from its customers that they have begun
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`administering Kanjinti® to cancer patients.”7
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`GENENTECH’S ASSERTED PATENTS
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`45.
`
`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.
`
`46.
`
`Upon information and belief, Amgen’s aBLA product infringes or will infringe at
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`least the following patents, which Genentech has asserted in this lawsuit: 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,
`
`
`6 http://investors.amgen.com/news-releases/news-release-details/amgen-and-allergans-mvasitm-
`bevacizumab-awwb-and-kanjintitm
`7 Second Declaration of Robert Jacobson in Support of Amgen Inc.’s Opposition to Genentech,
`Inc.’s Emergency Motion for an Injunction Pending Appeal, Genentech, Inc. v. Amgen Inc., No.
`19-2156 (Fed. Cir.), ECF No. 28 (July 29, 2019).
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`Case 1:18-cv-00924-CFC Document 347 Filed 09/04/19 Page 11 of 372 PageID #: 26410
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`U.S. Patent No. 10,160,811, U.S. Patent No. 8,574,869, U.S. Patent No. 7,993,834, U.S. Patent
`
`No. 8,076,066, and U.S. Patent No. 8,440,402.
`
`The Combination Chemotherapy Patents
`
`47.
`
`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
`
`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
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`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
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`avoided the serious cardiotoxicity associated with Herceptin® in combination with anthracycline
`
`derivatives that unexpectedly presented during the Herceptin® clinical trials.
`
`48.
`
`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 A. Genentech is the owner by assignment of the ’441 patent.
`
`49.
`
`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.
`
`50.
`
`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 B. Genentech is the owner by assignment of the ’549 patent.
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`Case 1:18-cv-00924-CFC Document 347 Filed 09/04/19 Page 12 of 372 PageID #: 26411
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`The Method of Administration Patents
`
`51.
`
`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’
`
`quality of life by providing the same life-saving effects of Herceptin® while allowing patients to
`
`receive treatment less frequently.
`
`52.
`
`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 C. Genentech is the
`
`owner by assignment of the ’196 patent.
`
`53.
`
`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 D. Genentech is the owner by
`
`assignment of the ’379 patent.
`
`54.
`
`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 E. Genentech is the owner by
`
`assignment of the ’811 patent.
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`Case 1:18-cv-00924-CFC Document 347 Filed 09/04/19 Page 13 of 372 PageID #: 26412
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`HER2 Diagnostic Patents
`
`55.
`
`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.
`
`56.
`
`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 F. Genentech is the owner by assignment
`
`of the ’834 patent.
`
`57.
`
`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 G. Genentech is the owner by assignment of the ’066
`
`patent.
`
`58.
`
`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
`
`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 H. Genentech is the owner by assignment of the ’402 patent.
`
`The Kao Patent
`
`59.
`
`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
`
`− 13 −
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`

`

`Case 1:18-cv-00924-CFC Document 347 Filed 09/04/19 Page 14 of 372 PageID #: 26413
`
`by the Patent Office on November 5, 2013. A true and correct copy of the ’869 patent is
`
`attached as Exhibit I. Genentech is the owner by assignment of the ’869 patent.
`
`COUNT I
`INFRINGEMENT OF U.S. PATENT NO. 7,846,441
`
`60.
`
`61.
`
`Genentech incorporates by reference paragraphs 1-59 as if fully set forth herein.
`
`Upon review of publicly available information and/or information provided by
`
`Amgen pursuant to 42 U.S.C. § 262(l)(2), Genentech believes that a claim of patent
`
`infringement, either literally or under the doctrine of equivalents, could reasonably be asserted
`
`by Genentech if a person not licensed by Genentech engaged in the making, using, offering to
`
`sell, selling, or importing into the United States of ABP 980 prior to the expiration of the ’441
`
`patent. Genentech included the ’441 patent in its disclosure of patents pursuant to 42 U.S.C.
`
`§ 262(l)(3)(A). Genentech also provided Amgen with a detailed statement that describes, on a
`
`claim-by-claim basis, the factual and legal basis of its opinion that the ’441 patent will be
`
`infringed by the commercial marketing of ABP 980, pursuant to 42 U.S.C.§ 262(l)(3)(C).
`
`62.
`
`Amgen submitted its aBLA to obtain approval to engage in the commercial
`
`manufacture, use, or sale of ABP 980 before the expiration of the ’441 patent. Amgen has
`
`therefore committed a technical act of infringement of one or more claims of the ’441 patent
`
`under 35 U.S.C. § 271(e)(2)(C)(i).
`
`63.
`
`Likewise, based on publicly available information and/or information provided by
`
`Amgen pursuant to 42 U.S.C. § 262(l)(2), Amgen has infringed or will infringe the ’441 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 ABP 980 drug
`
`substance and its ABP 980 drug product, as explained in Genentech’s 3C Statement. Such
`
`− 14 −
`
`

`

`Case 1:18-cv-00924-CFC Document 347 Filed 09/04/19 Page 15 of 372 PageID #: 26414
`
`infringement either has occurred or is imminent because, among other things, Amgen has
`
`announced that its aBLA product is now available in the United States.
`
`64.
`
`Pursuant to 42 U.S.C. § 262(l)(9)(A) and 28 U.S.C. § 2201, Genentech is entitled
`
`to a declaratory judgment that Amgen’s manufacture, importation, sale, offer for sale, use, and
`
`promotion of the use of the ABP 980 drug substance and Amgen’s ABP 980 drug product has
`
`infringed or will infringe the ’441 patent pursuant to 35 U.S.C. §§ 271(a), (b), and/or (g).
`
`65.
`
`Amgen has knowledge of and is aware of the ’441 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. Amgen’s infringement of the ’441 patent is willful.
`
`66.
`
`By obtaining FDA approval of a package insert having directions that instruct
`
`patients to administer and/or use and medical practitioners to prescribe and/or administer the
`
`Amgen aBLA product, Amgen has an affirmative intent to actively induce infringement by
`
`others of one or more claims of the ’441 patent, either literally or under the doctrine of
`
`equivalents.
`
`67.
`
`Upon information and belief, Amgen is aware, has knowledge, and/or is willfully
`
`blind to the fact that patients will administer and/or use and medical practitioners will prescribe
`
`and/or administer the Amgen aBLA product according to Amgen’s package insert and, therefore,
`
`will directly infringe at least one claim of the ’441 patent, either literally or under the doctrine of
`
`equivalents.
`
`68.
`
`Upon information and belief, Amgen knows or should know that it will aid and
`
`abet another’s direct infringement of at least one of the claims of the ’441 patent, either literally
`
`or under the doctrine of equivalents, by at least Amgen’s package insert for the Amgen aBLA
`
`product.
`
`− 15 −
`
`

`

`Case 1:18-cv-00924-CFC Document 347 Filed 09/04/19 Page 16 of 372 PageID #: 26415
`
`69.
`
`Pursuant to 35 U.S.C. § 284, Genentech is entitled to damages, including lost
`
`profits and/or a reasonable royalty, for Amgen’s infringement of the ’441 patent.
`
`70.
`
`Genentech has suffered or will suffer irreparable injury for which damages are an
`
`inadequate remedy unless Amgen is enjoined from infringing the claims of the ’441 patent.
`
`Genentech has no adequate remedy at law.
`
`71.
`
`Genentech is entitled to an injunction pursuant to at least 35 U.S.C.
`
`§ 271(e)(4)(B), 42 U.S.C. § 262(l)(8)(B), 35 U.S.C. § 271(a), (b), (g), and/or 35 U.S.C. § 283
`
`preventing Amgen from the commercial manufacture, use, offer to sell, or sale within the United
`
`States of the Amgen aBLA product.
`
`COUNT II
`INFRINGEMENT OF U.S. PATENT NO. 7,892,549
`
`72.
`
`73.
`
`Genentech incorporates by reference paragraphs 1-59 as if fully set forth herein.
`
`Upon review of publicly available information and/or information provided by
`
`Amgen pursuant to 42 U.S.C. § 262(l)(2), Genentech believes that a claim of patent
`
`infringement, either literally or under the doctrine of equivalents, could reasonably be asserted
`
`by Genentech if a person not licensed by Genentech engaged in the making, using, offering to
`
`sell, selling, or importing into the United States of ABP 980 prior to the expiration of the ’549
`
`patent. Genentech included the ’549 patent in its disclosure of patents pursuant to 42 U.S.C.
`
`§ 262(l)(3)(A). Genentech also provided Amgen with a detailed statement that describes, on a
`
`claim-by-claim basis, the factual and legal basis of its opinion that the ’549 patent will be
`
`infringed by the commercial marketing of ABP 980, pursuant to 42 U.S.C.§ 262(l)(3)(C).
`
`74.
`
`Amgen submitted its aBLA to obtain approval to engage in the commercial
`
`manufacture, use, or sale of ABP 980 before the expiration of the ’549 patent. Amgen has
`
`− 16 −
`
`

`

`Case 1:18-cv-00924-CFC Document 347 Filed 09/04/19 Page 17 of 372 PageID #: 26416
`
`therefore committed a technical act of infringement of one or more claims of the ’549 patent
`
`under 35 U.S.C. § 271(e)(2)(C)(i).
`
`75.
`
`Likewise, based on publicly available information and/or information provided by
`
`Amgen pursuant to 42 U.S.C. § 262(l)(2), Amgen has infringed or will infringe the ’549 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 ABP 980 drug
`
`substance and its ABP 980 drug product, as explained in Genentech’s 3C Statement. Such
`
`infringement either has occurred or is imminent because, among other things, Amgen has
`
`announced that its aBLA product is now available in the United States.
`
`76.
`
`Pursuant to 42 U.S.C. § 262(l)(9)(A) and 28 U.S.C. § 2201, Genentech is entitled
`
`to a declaratory judgment that Amgen’s manufacture, importation, sale, offer for sale, use, and
`
`promotion of the use of the ABP 980 drug substance and Amgen’s ABP 980 drug product has
`
`infringed or will infringe the ’549 patent pursuant to 35 U.S.C. §§ 271(a), (b), and/or (g).
`
`77.
`
`Amgen has knowledge of and is aware of the ’549 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. Amgen’s infringement of the ’549 patent is willful.
`
`78.
`
`By obtaining FDA approval of a package insert having directions that instruct
`
`patients to administer and/or use and medical practitioners to prescribe and/or administer the
`
`Amgen aBLA product, Amgen has an affirmative intent to actively induce infringement by
`
`others of one or more claims of the ’549 patent, either literally or under the doctrine of
`
`equivalents.
`
`79.
`
`Upon information and belief, Amgen is aware, has knowledge, and/or is willfully
`
`blind to the fact that patients will administer and/or use and medical practitioners will prescribe
`
`− 17