Case 1:18-cv-01363-CFC Document 1 Filed 09/04/18 Page 1 of 54 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`GENENTECH, INC. and CITY OF HOPE,
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`Plaintiffs,
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`v.
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`Civil Action No. ___________
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`SAMSUNG BIOEPIS CO., LTD.,
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`Defendant.
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`COMPLAINT
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`Plaintiffs Genentech, Inc. (“Genentech”) and City of Hope (collectively, “Plaintiffs”)
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`bring this Complaint for declaratory and injunctive relief against Defendant Samsung Bioepis
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`Co., Ltd. (“Bioepis”) to address Bioepis’s infringement of 21 patents relating to Genentech’s
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`groundbreaking breast cancer drug Herceptin®.
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`NATURE OF THE CASE
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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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`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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`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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`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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`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.
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`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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`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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`Seeking to profit from the success of Plaintiffs’ innovations, Bioepis is seeking
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`FDA approval of a biosimilar version of Herceptin® called SB3. SB3 is a copycat product for
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`which Bioepis is seeking the same label indications and usage as Herceptin®. In fact, Bioepis is
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`relying upon Genentech’s own studies demonstrating the safety and efficacy of Herceptin® to
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`obtain approval of its biosimilar product.
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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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`See 42 U.S.C. § 262(l). Bioepis has declined to follow the process outlined in the BPCIA, which
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`requires biosimilar applicants and innovator companies to exchange certain information
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`concerning the biosimilar product and the patents that may be infringed by the manufacture and
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`sale of the biosimilar product. Bioepis and Genentech have, however, exchanged limited
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`information to narrow the scope of the patent disputes involving SB3.
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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 Bioepis’s submission of its aBLA for SB3. 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 Bioepis’s biosimilar product would infringe
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`the 21 patents described below. Pursuant to 35 U.S.C. § 271(e)(4)(B), 35 U.S.C. § 271(a), (b),
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`and/or 35 U.S.C. § 283, Plaintiffs also seek a preliminary and/or permanent injunction barring
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`Bioepis’s manufacture, use, offer to sell, sale, or importation of its biosimilar product prior to the
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`expiration of those patents. In the event that Bioepis imports, manufactures, or launches its
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`biosimilar product, and/or otherwise practices the patented inventions in the United States prior
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`to the expiration of those patents, Plaintiffs also seek monetary damages, including lost profits,
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`and any further relief as this Court may deem just and proper.
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`PARTIES
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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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`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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`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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`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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`Upon information and belief, Defendant Bioepis is a company organized and
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`existing under the laws of the Republic of Korea with its principal place of business located at
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`107, Cheomdan-daero, Yeonsu-gu, Incheon, Republic of Korea.
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`Bioepis is a biopharmaceutical company that is, among other things, engaged in
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`the development of biologic drugs, including a proposed biosimilar version of Genentech’s
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`Herceptin® product, SB3 (“Bioepis’s aBLA product”). Upon information and belief, Bioepis
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`intends to market and distribute such biopharmaceutical products in the United States, including
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`through its distributor and commercialization partner Merck & Co., Inc. Upon information and
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`belief, Bioepis’s aBLA product will be distributed and sold in the State of Delaware and
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`throughout the United States.
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`JURISDICTION AND VENUE
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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, 1332,
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`and 1338.
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`Venue is proper with respect to Bioepis, a Korean company, in this Court
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`pursuant to 28 U.S.C. § 1391(c)(3).
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`This Court has personal jurisdiction over Bioepis because it has filed an
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`Abbreviated Biologics License Application (“aBLA”) for SB3 with the FDA seeking approval to
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`market its aBLA product, which reliably indicates that it will market its proposed biosimilar
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`product in Delaware if approved. Alternatively, this Court has personal jurisdiction over Bioepis
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`pursuant to Federal Rule of Civil Procedure 4(k)(2).
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`THE PARTIES’ PRE-SUIT EXCHANGES
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`On December 20, 2017, Bioepis announced that it had submitted, and FDA had
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`accepted for review, an aBLA for SB3 to the FDA seeking approval for the commercial
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`manufacture, use, offer for sale, or sale of the Bioepis aBLA product, a biosimilar version of
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`trastuzumab, which is subject to BLA No. 103792 to Genentech.3
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`Under 42 U.S.C. § 262(l)(2), Bioepis was required to provide Genentech with a
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`copy of its aBLA and such other information that describes the process or processes used to
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`manufacture its aBLA product within 20 days of FDA’s acceptance of its aBLA for review (i.e.,
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`no later than January 9, 2018).
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`On December 27, 2017, Genentech wrote to Bioepis to request a copy of its aBLA
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`and to identify exemplary categories of additional information about the process or processes
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`used to manufacture its aBLA product necessary to evaluate whether its aBLA product would
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`infringe Genentech’s patents.
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`On January 8, 2018, Bioepis provided Genentech with redacted versions of four
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`subsections of its aBLA, which represented a tiny fraction of its entire aBLA. Bioepis therefore
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`failed to comply with its obligations under 42 U.S.C. § 262(l)(2)(A) to provide Genentech with,
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`among other things, its aBLA within twenty days of the FDA’s acceptance of its aBLA.
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`On January 12, 2018, Genentech wrote to Bioepis about its failure to comply with
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`§ 262(l)(2)(A) and to reiterate its request for at least an unredacted copy of Bioepis’s complete
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`aBLA.
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`3 http://www.samsungbioepis.com/en/newsroom/detail/Samsung-Bioepis-SB3-Trastuzumab-
`Biosimilar-Candidate.html.
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`During January and February 2018, Genentech and Bioepis engaged in further
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`correspondence regarding Bioepis’s failure to provide Genentech with its aBLA as required by
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`42 U.S.C. § 262(l)(2)(A).
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`On February 15, 2018, and February 20, 2018, Bioepis provided Genentech with
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`additional subsections of its aBLA. These subsections still represented only a small fraction of
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`Bioepis’s entire aBLA.
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`On March 1, 2018, Genentech agreed to provide Bioepis with a list of patents for
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`which it believed a claim of patent infringement could reasonably be asserted based on
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`Genentech’s review of the limited set of aBLA documents that Bioepis produced. Genentech
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`reiterated its objections about Bioepis’s failure to comply with the requirements of
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`§ 262(l)(2)(A) and noted that its provision of this patent list would not waive those objections.
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`After its review of Bioepis’s limited production of aBLA subsections, Genentech
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`wrote to Bioepis on March 30, 2018, to identify deficiencies in Bioepis’s production of
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`manufacturing information and request specific information concerning the manufacture of
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`Bioepis’s biosimilar product. Bioepis responded on April 16, 2018 and refused to produce any
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`additional aBLA subsections or information about its aBLA product.
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`Despite Bioepis’s non-compliance (and without waiving Genentech’s objection to
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`such non-compliance), Genentech provided a list of patents for which it believed a claim of
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`patent infringement could reasonably be asserted on April 23, 2018 (“Genentech’s Apr. 23, 2018
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`List”), and informed Bioepis that it was not prepared to license any of the listed patents to
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`Bioepis. Genentech expressly reserved its rights to supplement or revise this list in light of any
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`additional information provided by Bioepis, and it noted that Bioepis’s failure to comply with its
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`disclosure obligations under § 262(l)(2) caused Bioepis to forfeit any rights under the BPCIA
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`that were contingent upon its compliance with those obligations.
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`Bioepis did not disclose all of the information relevant to establishing whether the
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`manufacture of Bioepis’s aBLA product will infringe each of the patents identified on
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`Genentech’s Apr. 23, 2018 list, despite Genentech’s request that Bioepis provide sufficient
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`“other information that describes the process or processes used to manufacture” as required by
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`42 U.S.C. § 262(l)(A). Bioepis’s failure to provide sufficient information under those
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`circumstances supports Genentech’s contention that manufacturing Bioepis’s aBLA product will
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`infringe such patents.
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`On June 22, 2018, Bioepis responded to Genentech’s Apr. 23, 2018 List by
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`providing a statement purporting to describe the factual and legal bases for its opinion that the
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`patents on Genentech’s Apr. 23, 2018 List are not infringed, invalid, and/or unenforceable
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`(“Bioepis’s June 22, 2018 Statement”). Bioepis’s June 22, 2018 Statement contains numerous
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`deficiencies. For example, it—like Bioepis’s document productions—failed to fully describe
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`Bioepis’s manufacturing process, such that Genentech was unable to evaluate many of Bioepis’s
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`non-infringement arguments.
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`On August 17, 2018, and subject to its objections, Genentech provided its
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`response to Bioepis’s June 22, 2018 Statement (“Genentech’s Aug. 17, 2018 Response”).
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`Genentech included responses to Bioepis’s non-infringement and invalidity statements for each
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`of the patents addressed in Bioepis’s June 22, 2018 Statement and maintained that SB3 will
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`infringe at least 21 Genentech patents. With its Aug. 17, 2018 Response, Genentech proposed
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`that Bioepis agree that all 21 of these patents be included in an infringement action concerning
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`SB3. Bioepis responded to Genentech’s proposal on August 23, 2018, and the parties engaged in
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`further discussions regarding the patents to be asserted in this litigation.
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`On September 3, 2018, Bioepis agreed to litigate each of the 21 patents addressed
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`in Genentech’s Aug. 17, 2018 Response.
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`BIOEPIS’S aBLA PRODUCT
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`Bioepis has publicly stated that its aBLA product is biosimilar to Herceptin®. For
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`example, Bioepis has issued a press release claiming that SB3 is “a biosimilar candidate
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`referencing Herceptin®” and describing SB3 as a “Trastuzumab Biosimilar Candidate.”4
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`Given Bioepis’s claim of biosimilarity, Bioepis’s aBLA product must “utilize the
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`same mechanism or mechanisms of action [as Herceptin®] for the condition or conditions of use
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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).
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`Under 35 U.S.C. § 271(e)(2)(C), Bioepis has committed a statutory act of patent
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`infringement with respect to the each patent asserted in this action because Bioepis submitted an
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`application seeking approval of a biological product for which each such patent could have been
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`identified by Genentech pursuant to 42 U.S.C. § 262(l)(3)(A)(i) had Bioepis provided the
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`application and information required under 42 U.S.C. § 262(l)(2)(A) and because Genentech
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`identified each such patent on its Apr. 28, 2018 List based on its review of the limited
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`information that Bioepis produced to Genentech.
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`4 http://www.samsungbioepis.com/en/newsroom/detail/Samsung-Bioepis-SB3-Trastuzumab-
`Biosimilar-Candidate.html.
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`GENENTECH’S ASSERTED PATENTS
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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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`Upon information and belief, Bioepis’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.
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`7,892,549, U.S. Patent No. 6,627,196, U.S. Patent No. 7,371,379, U.S. Patent No. 6,339,142,
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`U.S. Patent No. 6,417,335, U.S. Patent No. 9,249,218, U.S. Patent No. 8,574,869, U.S. Patent
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`No. 7,993,834, U.S. Patent No. 8,076,066, U.S. Patent No. 8,425,908, U.S. Patent No. 8,440,402,
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`U.S. Patent No. 6,610,516, U.S. Patent No. 7,390,660, U.S. Patent No. 7,485,704, U.S. Patent
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`No. 7,807,799, U.S. Patent No. 8,512,983, and U.S. Patent No. 9,714,293.
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`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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`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 A. Genentech and the City of Hope are the owners by assignment of the ’415
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`patent.
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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 B. Genentech and the City of Hope are the owners by assignment of the
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`’221 patent.
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`The ’213 Patent
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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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`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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`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 C. Genentech is the owner by assignment of the ’213 patent.
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`The Combination Chemotherapy Patents
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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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`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 D. 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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`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 E. Genentech is the owner by assignment of the ’549 patent.
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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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`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 F. Genentech is the owner by assignment of the ’908 patent.
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`The Method of Administration Patents
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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”) generally cover the most common administration method for
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`Herceptin®: an initial dose of 8 mg/kg, followed by 6 mg/kg doses once every three weeks.
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`Herceptin® was initially approved for administration on a weekly regimen, but Genentech
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`discovered that the drug could be dosed only once every three weeks without reducing safety or
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`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
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`receive treatment less frequently.
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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 G. Genentech is the
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`owner by assignment of the ’196 patent.
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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 H. 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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`U.S. Patent Nos. 6,339,142, 6,417,335, and 9,249,218 (collectively, the “Acidic
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`Variants 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 I. Genentech is the owner by assignment of the ’142 patent.
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`U.S. Patent No. 6,417,335 (“the ’335 patent”), titled “Protein Purification,” was
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`duly and legally issued by the Patent Office on July 9, 2002. A true and correct copy of the ’335
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`patent is attached as Exhibit J. Genentech is the owner by assignment of the ’335 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.
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`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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`
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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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`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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`
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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
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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 May 14, 2013. A true and correct copy of the
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`’402 patent is attached as Exhibit N. Genentech is the owner by assignment of the ’402 patent.
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`Cell Culture, Purification, and Antibody Manufacturing Patents
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`
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`U.S. Patent Nos. 6,610,516, 7,390,660, 7,485,704, 7,807,799, 8,512,983,
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`8,574,869, and 9,714,293, and claim novel techniques developed by Genentech relating to
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`various aspects of cell culture, purification, and antibody purification.
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`
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`U.S. Patent No. 6,610,516 (“the ’516 patent”), titled “Cell Culture Process,” was
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`duly and legally issued by the Patent Office on August 26, 2003. A true and correct copy of the
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`’516 patent is attached as Exhibit O. Genentech is the owner by assignment of the ’516 patent.
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`
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`U.S. Patent No. 7,390,660 (“the ’660 patent”), titled “Methods for Growing
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`Mammalian Cells In Vitro,” was duly and legally issued by the Patent Office on June 24, 2008.
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`A true and correct copy of the ’660 patent is attached as Exhibit P. The ’660 patent is assigned
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`to Hoffmann La-Roche Inc., and Genentech, Inc. is the exclusive licensee with the sole right to
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`enforce the ’660 patent.
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`
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`U.S. Patent No. 7,485,704 (“the ’704 patent”), titled “Reducing Protein A
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`Leaching During Protein A Affinity Chromatography,” was duly and legally issued by the Patent
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`Office on February 3, 2009. A true and correct copy of the ’704 patent is attached as Exhibit Q.
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`Genentech is the owner by assignment of the ’704 patent.
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`U.S. Patent No. 7,807,799 (“the ’799 patent”), titled “Reducing Protein A
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`Leaching During Protein A Affinity Chromatography,” was duly and legally issued by the Patent
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`Office on October 5, 2010. A true and correct copy of the ’799 patent is attached as Exhibit R.
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`Genentech is the owner by assignment of the ’799 patent.
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`
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`U.S. Patent No. 8,512,983 (“the ’983 patent”), titled “Production of Proteins in
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`Glutamine-Free Cell Culture Media,” was duly and legally issued by the Patent Office on August
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`20, 2013. A true and correct copy of the ’983 patent is attached as Exhibit S. Genentech is the
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`owner by assignment of the ’983 patent.
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`
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`U.S. Patent No. 8,574,869 (“the ’869 patent”), titled “Prevention of Disulfide
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`Bond Reduction During Recombinant Production of Polypeptides,” was duly and legally issued
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`by the Patent Office on November 5, 2013. A true and correct copy of the ’869 patent is
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`attached as Exhibit T. Genentech is the owner by assignment of the ’869 patent.
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`
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`U.S. Patent No. 9,714,293 (“the ’293 patent”), titled “Production of Proteins in
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`Glutamine-Free Cell Culture Media,” was duly and legally issued by the Patent Office on July
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`25, 2017. A true and correct copy of the ’293 patent is attached as Exhibit U. Genentech is the
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`owner by assignment of the ’293 patent.
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`COUNT I
`INFRINGEMENT OF U.S. PATENT NO. 6,331,415
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`Plaintiffs incorporate by reference paragraphs 1-67 as if fully set forth herein.
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`Bioepis failed to provide Genentech with its aBLA and other information that
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`describes the process or processes used to manufacture SB3, as required by 42 U.S.C.
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`§ 262(l)(2)(A). Based on the information currently available to Genentech, the ’415 patent could
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`have been identified pursuant to 42 U.S.C. § 262(l)(3)(A)(i) had Bioepis provided this required
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`information. Alternatively, to the extent that Bioepis contends that the list of patents that
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`Genentech provided to Bioepis on April 23, 2018, constitutes a list pursuant to 42 U.S.C.
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`§ 262(l)(3)(A), Genentech identified the ’415 patent on that list.
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`
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`Based on publicly available information and/or information provided by Bioepis
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`pursuant to 42 U.S.C. § 262(l)(2), Genentech reasonably believes that Bioepis’s submission of
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`the aBLA to obtain approval to engage in the commercial manufacture, use, offer to sell, or sale
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`of the Bioepis aBLA product prior to the expiration of the ’415 patent is a technical act of
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`infringement of one or more claims of the ’415 patent under 35 U.S.C. § 271(e)(2)(C)(i), either
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`literally or under the doctrine of equivalents. Genentech provided detailed, claim-by-claim
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`infringement contentions to Bioepis in its Aug. 17, 2018 Response.
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`
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`Likewise, based on publicly available information and/or information provided by
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`Bioepis pursuant to 42 U.S.C. § 262(l)(2), Genentech reasonably believes that Bioepis will
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`infringe the ’415 patent in violation of 35 U.S.C. §§ 271(a), (b), and/or (g) as a result of its
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`activities relating to the manufacture, importation, sale, offer for sale, use, and promotion of the
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`use of the SB3 drug substance and its proposed SB3 drug product, as explained in Genentech’s
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`Aug. 17, 2018 Response. Pursuant to 42 U.S.C. § 262(l)(9)(A) and 28 U.S.C. § 2201, Genentech
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`is entitled to a declaratory judgment that Bioepis’s manufacture, importation, sale, offer for sale,
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`use, and promotion of the use of the SB3 drug substance and Bioepis’s proposed SB3 drug
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`product will infringe the ’415 patent pursuant to 35 U.S.C. §§ 271(a), (b), and/or (g).
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`Bioepis has knowledge of and is aware of the ’415 patent, including due to
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`Genentech’s Apr. 23, 2018 List and the filing of this Complaint. Bioepis’s infringement of the
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`’415 patent is willful.
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`Plaintiffs will suffer irreparable injury for which damages are an inadequate
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`remedy unless Bioepis is enjoined from infringing the claims of the ’415 patent. Plaintiffs have
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`Case 1:18-cv-01363-CFC D