Case 1:17-cv-13507-RMB-KMW Document 1 Filed 12/21/17 Page 1 of 117 PageID: 1
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`Keith J. Miller, Esq.
`ROBINSON MILLER LLC
`One Newark Center, 19th Floor
`Newark, NJ 07102
`Telephone: (973) 690-5400
`kmiller@rwmlegal.com
`
`Attorneys for Plaintiffs Genentech, Inc.,
`Biogen, Inc., and City of Hope
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`
`
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`IN THE UNITED STATES DISTRICT COURT
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`FOR THE DISTRICT OF NEW JERSEY
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`Case No.
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`
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`COMPLAINT FOR: PATENT
`INFRINGEMENT; DECLARATORY
`RELIEF
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`DEMAND FOR JURY TRIAL
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`GENENTECH, INC., a Delaware corporation,
`BIOGEN, INC., a Delaware corporation, and
`CITY OF HOPE, a California not-for-profit
`organization,
`
` Plaintiffs,
`
` v.
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`SANDOZ, INC., a Colorado corporation,
`SANDOZ INTERNATIONAL GMBH, a
`German corporation, and SANDOZ GMBH,
`an Austrian corporation,
`
` Defendants.
`
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`Pursuant to Local Civil Rule 10.1, the address of Plaintiff Genentech, Inc. (“Genentech”)
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`is 1 DNA Way, South San Francisco, California, 94080. The address of Plaintiff Biogen, Inc.
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`(“Biogen”) is 225 Binney Street, Cambridge, Massachusetts, 02142. The address of Plaintiff City
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`of Hope is 1500 East Duarte Road, Duarte, California, 91010. The address of Defendant Sandoz,
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`Inc. is One Health Plaza, East Hanover, New Jersey, 07936, with another address at 100 College
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`Road West, Princeton, New Jersey, 08540. The address of Defendant Sandoz International
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`GmbH is Industriestrasse 25, 83607 Holzkirchen, Germany. The address of Defendant Sandoz
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`GmbH is Biochemiestrasse 10, 6250 Kundl, Austria.
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`Plaintiffs Genentech, Biogen, and City of Hope (collectively, “Plaintiffs”) by their
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`undersigned attorneys, for their Complaint against Defendants allege as follows:
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`NATURE OF THIS ACTION
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`1.
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`This is an action for patent infringement arising under 28 U.S.C. § 1331 and the
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`United States Patent Act, 35 U.S.C. § 100 et seq., including 35 U.S.C. § 271(e)(2), and an action
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`under the Declaratory Judgment Act, 28 U.S.C. §§ 2201-2202, seeking a declaratory judgment of
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`patent infringement.
`2.
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`The claims for patent infringement brought in this action are necessitated by
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`Defendants’ stated intent to import, market, and sell in New Jersey and throughout the United
`States a copy of Genentech and Biogen’s groundbreaking medicinal product, Rituxan®, which
`aids millions of patients in their fight against debilitating and life-threatening diseases, including
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`blood cancers such as Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia, as well
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`as Rheumatoid Arthritis and Vasculitis, which are chronic and painful autoimmune diseases.
`First approved in 1997, Rituxan® is proven to improve both the length and quality of life for
`patients with these and other diseases and has been recognized internationally for its pioneering
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`effect on patients’ lives and medicine in general.
`3.
`
`Such benefits and success did not come quickly or easily. Genentech and Biogen
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`invested many years of work and many hundreds of millions of dollars into developing and
`testing Rituxan® and ensuring that the product is both safe and effective. Those investments
`include, inter alia, years of laborious and expensive clinical trials that were required before
`medical professionals could use Rituxan® to help their patients—clinical trials on which the U.S.
`Food and Drug Administration (“FDA”) relied in making Rituxan® the first monoclonal antibody
`approved for therapeutic use in fighting cancer in the United States.
`4.
`In contrast, Defendants have piggybacked on Plaintiffs’ investments and success
`and seek to profit from a copied version of Rituxan®. Claiming that their copycat product is
`“biosimilar” to Rituxan®, Defendants have not borne the expense of conducting their own
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`clinical trials—instead relying on Genentech and Biogen’s costly and time-consuming
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`proprietary clinical trials—and have applied to the FDA for approval to market and sell that
`product for the very same therapeutic uses as Rituxan®.
`5.
`Irrespective of whether they are able to secure FDA approval for their copy of
`Rituxan®, however, Defendants do not have the right to infringe Plaintiffs’ patents. As stated
`herein, Defendants’ intended activities would unquestionably infringe many of those patents,
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`none of which Plaintiffs have licensed to Defendants and all of which are valid and enforceable.
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`Plaintiffs bring this action to stop that infringement.
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`PARTIES
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`6.
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`Plaintiff Genentech, Inc. is a corporation organized and existing under the laws of
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`the State of Delaware, having its principal place of business at 1 DNA Way, South San Francisco,
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`California, 94080.
`7.
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`Plaintiff Biogen, Inc. is a corporation organized and existing under the laws of the
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`State of Delaware, having its principal place of business at 225 Binney Street, Cambridge,
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`Massachusetts, 02142.
`8.
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`Plaintiff City of Hope is a California not-for-profit organization, having its principal
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`place of business at 1500 East Duarte Road, Duarte, California, 91010.
`9.
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`Genentech and Biogen, two pioneers of the biotechnology industry, have been
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`discovering, developing, manufacturing, and commercializing innovative therapies to address
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`significant unmet medical needs for more than 40 years. Collectively, they manufacture and
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`commercialize products for a variety of medical conditions, including numerous types of cancer,
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`Rheumatoid Arthritis, Multiple Sclerosis, and many other serious conditions. Genentech and
`Biogen developed and jointly market Rituxan®, the revolutionary antibody-based medicine at
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`issue in this case.1
`
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`1 Genentech initially collaborated with IDEC Pharmaceuticals, which subsequently
`merged with Biogen (forming Biogen-Idec) and later adopted the name Biogen. We use
`“Biogen” herein for simplicity.
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`10.
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`Founded in 1913, City of Hope is a leading research hospital that incorporates
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`cutting-edge research into patient care for cancer, diabetes, and other serious diseases.
`11.
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`Plaintiffs regularly seek patents on inventions originating from their research and
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`development activities, and each has been issued numerous patents relating to its proprietary
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`technology. Among those patents are several that claim, inter alia, the manufacture and use of
`Rituxan®.
`12.
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`Plaintiffs are informed and believe, and on that basis allege, that Defendant
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`Sandoz, Inc. is a corporation organized and existing under the laws of the State of Colorado,
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`having offices at One Health Plaza, East Hanover, New Jersey, 07936, and its principal place of
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`business at 100 College Road West, Princeton, New Jersey, 08540.
`13.
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`Plaintiffs are informed and believe, and on that basis allege, that Defendant
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`Sandoz International GmbH is a corporation organized and existing under the laws of the Federal
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`Republic of Germany, having its principal place of business at Industriestrasse 25, 83607
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`Holzkirchen, Germany.
`14.
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`Plaintiffs are informed and believe, and on that basis allege, that Defendant
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`Sandoz GmbH is a corporation organized and existing under the laws of the Republic of Austria,
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`having its principal place of business at Biochemiestrasse 10, 6250 Kundl, Austria.
`15.
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`Plaintiffs are informed and believe, and on that basis allege, that Sandoz, Inc.,
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`Sandoz International GmbH, and Sandoz GmbH (collectively, “Sandoz”) operate within a
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`division of Novartis, one of the largest pharmaceutical companies in the world, and are almost
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`entirely dedicated to the development of generic and “biosimilar” products.
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`JURISDICTION AND VENUE
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`16.
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`This action arises under the Patent Laws of the United States of America,
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`35 U.S.C. § 1 et seq. This Court has federal question jurisdiction under 28 U.S.C. §§ 1331,
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`1338(a), 2201(a), and 2202 because this is a civil action arising under the Patent Act.
`17.
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`Venue is proper in this District under 28 U.S.C. §§ 1391(b), (c) and 1400(b),
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`including because Sandoz, Inc. has committed acts of infringement in and has a regular and
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`established place of business in New Jersey.
`A.
`18.
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`
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`Sandoz, Inc.
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`Plaintiffs are informed and believe, and on that basis allege, that this Court has
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`personal jurisdiction over Sandoz, Inc. because Sandoz, Inc. has availed itself of the legal
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`protections of the State of New Jersey by, among other things, maintaining its principal place of
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`business in New Jersey, registering to do business in New Jersey, and conducting operations
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`related to the manufacturing, importing, marketing, and/or selling of pharmaceutical drug
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`products in New Jersey.
`19.
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`Plaintiffs are further informed and believe, and on that basis allege, that this Court
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`has personal jurisdiction over Sandoz, Inc. because Sandoz, Inc. has purposefully directed
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`activities at the State of New Jersey and this litigation relates to or arises out of those activities.
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`In particular, Plaintiffs are informed and believe, and on that basis allege, that Sandoz, Inc. has
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`taken the costly, significant step of filing an Abbreviated Biologic License Application
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`(“aBLA”) with the FDA seeking FDA approval of the proposed biosimilar product Rixathon
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`(also referred to by the development code “GP2013”) for the express purposes of marketing,
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`distributing, and selling Rixathon/GP2013 in New Jersey and throughout the United States.
`20.
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`Plaintiffs are informed and believe, and on that basis allege, that if and when the
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`FDA approves that aBLA for Rixathon/GP2013, Sandoz, Inc. intends to import, market,
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`distribute, and sell Rixathon/GP2013 in New Jersey and throughout the United States.
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`Moreover, Plaintiffs are informed and believe, and on that basis allege, that Sandoz, Inc. intends
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`to coordinate the importation, marketing, distribution, and sale of Rixathon/GP2013 from New
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`Jersey, where its United States leadership team is based.
`21.
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`Plaintiffs are further informed and believe, and on that basis allege, that Sandoz,
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`Inc. has previously submitted to the jurisdiction of this Court and availed itself of the legal
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`protections of the State of New Jersey by asserting claims and not contesting jurisdiction in the
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`United States District Court for the District of New Jersey. See, e.g., Sandoz Inc. v. Daiichi
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`Sankyo, Inc., et al., No. 16-cv-00994 (D.N.J. Feb. 22, 2016); Immunex Corp., et al. v. Sandoz
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`Inc., et al., No. 16-cv-1118, Answer, ¶ 19 (D.N.J. Mar. 21, 2016).
`B.
`22.
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`
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`Sandoz International GmbH
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`Plaintiffs are informed and believe, and on that basis allege, that Sandoz
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`International GmbH has engaged in the foregoing contacts with New Jersey directly and through
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`one or more agent and/or alter ego subsidiaries, including by controlling and directing the
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`conduct of Sandoz, Inc. and by establishing and operating Sandoz, Inc. in order to undertake
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`activities that, if not for Sandoz, Inc., Sandoz International GmbH would have to undertake
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`itself.
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`23.
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`Plaintiffs are informed and believe, and on that basis allege, that Sandoz
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`International GmbH and its subsidiaries, including Sandoz, Inc., operate within a division of
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`Novartis organized around the manufacture, distribution, marketing, and sale of pharmaceuticals,
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`and particularly generic and biosimilar pharmaceuticals.
`24.
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`Plaintiffs are informed and believe, and on that basis allege, that Sandoz operates
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`and holds itself out to the world as one company that, despite its global operations, maintains
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`unitary administration, values, policies, history, and strategy. Indeed, on
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`its website
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`www.sandoz.com, which is copyrighted by “Sandoz International GmbH” and “intended for a
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`global audience,” Sandoz publicly describes itself as a “single global brand.” And, according to
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`the website of Sandoz’s United States operations (headquartered in New Jersey), “the Sandoz
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`brand has been transformed into a global leader in generic pharmaceuticals and biosimilars.
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`Today, as a division of the Novartis Group, we offer approximately 1,000 molecules covering a
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`broad range of therapeutic areas. In 2015, our products reached more than 500 million patients
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`and we aspire to reach one billion.” https://www.us.sandoz.com/about-us/who-we-are/sandoz-
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`brand. As yet another example of that unitary administration, on information and belief, Sandoz
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`aggregates and reports (through Novartis) its financial performance on a global, division-wide
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`basis, with individual entities not reporting separate financial data or making separate financial
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`reports to governmental authorities.
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`25.
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`Plaintiffs are further informed and believe, and on that basis allege, that Sandoz
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`International GmbH exercises control over the Sandoz division and over the Sandoz
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`subsidiaries—including Sandoz, Inc. and with respect to biosimilars—through a global Sandoz
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`Executive Committee. That committee, led by “Division Head” Richard Francis, includes Peter
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`Goldschmidt, whom Sandoz International GmbH lists as the “President of Sandoz US and Head
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`of
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`North
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`America.”
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`https://www.sandoz.com/about-us/who-we-are/sandoz-leadership.
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`Mr. Goldschmidt also headlines the “Sandoz US Leadership,” which is “responsible for
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`overseeing the business operations of Sandoz in the US,” and also holds the position of
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`President, Sandoz, Inc. https://www.us.sandoz.com/about-us/who-we-are/sandoz-us-leadership.
`26.
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`Plaintiffs are further informed and believe, and on that basis allege, that through
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`this global Sandoz Executive Committee, Sandoz International GmbH exercises control and
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`makes and approves significant decisions concerning the manufacture, distribution, marketing,
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`and sale of biosimilars in the United States, including of Sandoz’s proposed Rixathon/GP2013
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`product. On information and belief, the acts of Sandoz, Inc. complained of herein thus were and
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`will be done, in part, for the benefit of Sandoz International GmbH.
`27.
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`For example, on information and belief, Sandoz International GmbH coordinated
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`and directed Sandoz, Inc. to act as its agent in preparing and filing Sandoz’s aBLA for
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`Rixathon/GP2013 and Sandoz International GmbH is actively involved in planning Sandoz,
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`Inc.’s planned importation, marketing, and sale of Rixathon/GP2013. In a press release dated
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`September 12, 2017, issued from Sandoz International GmbH’s Holzkirchen, Germany
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`headquarters, Sandoz announced that the “US Food and Drug Administration (FDA) has
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`accepted
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`its
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`Biologics
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`License Application
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`(BLA)”
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`for
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`Rixathon/GP2013.
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`https://www.sandoz.com/news/media-releases/sandoz-proposed-biosimilar-rituximab-accepted-
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`review-fda. That press release included the following quote from Mark Levick, MD PhD (listed
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`as the Global Head of Development, Biopharmaceuticals at Sandoz): “With the FDA acceptance
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`of our regulatory submission for proposed biosimilar rituximab, we plan to deliver patients a
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`high-quality Sandoz biosimilar that, following approval, could help drive healthcare savings and
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`increase competition, while freeing up resources for and supporting patient access in other areas
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`of cancer care including innovative therapies.” Id. On information and belief, Dr. Levick is a
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`Sandoz Senior Vice President based in Sandoz International GmbH’s Holzkirchen, Germany
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`headquarters.
`28.
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`In addition, Plaintiffs are informed and believe, and on that basis allege, that
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`Novartis applied for and obtained a registration for at least one trademark with the United States
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`Patent and Trademark Office for the word “Rixathon,” which trademark (i) Novartis holds in the
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`name of Sandoz International GmbH, (ii) Sandoz International GmbH intends to use in
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`commerce in the United States, and (iii) through which Sandoz International GmbH has availed
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`itself of the benefits of United States law.
`29.
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`Plaintiffs are informed and believe, and on that basis allege, that Sandoz
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`International GmbH has previously submitted to the jurisdiction of this Court and availed itself
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`of the legal protections of the State of New Jersey by asserting affirmative defenses and not
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`contesting jurisdiction in the United States District Court for the District of New Jersey. See, e.g.,
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`Immunex Corp., et al. v. Sandoz Inc., et al., No. 16-cv-1118, Answer, ¶ 30 (D.N.J. Sept. 21,
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`2016).
`30.
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`In the alternative, Plaintiffs are further informed and believe, and on that basis
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`allege, that this Court has personal jurisdiction over Sandoz International GmbH pursuant to
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`Federal Rule of Civil Procedure 4(k)(2) because Sandoz International GmbH has extensive
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`contacts with the United States, including but not limited to the above-described contacts, is not
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`subject to jurisdiction in any particular state, and exercising jurisdiction over Sandoz
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`International GmbH is consistent with the laws of the United States and the United States
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`Constitution.
`C.
`31.
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`
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`Sandoz GmbH
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`Plaintiffs are informed and believe, and on that basis allege, that Sandoz GmbH is
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`part of the Sandoz-branded Novartis division discussed above and a Sandoz entity specifically
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`involved in the manufacturing and distribution of biosimilar pharmaceuticals, including of the
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`proposed Rixathon/GP2013 biosimilar at issue in this action.
`32.
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`Plaintiffs are informed and believe, and on that basis allege, that Sandoz
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`manufactures biosimilars at three locations in Europe, two of which are operated by Sandoz
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`GmbH in Austria. Plaintiffs are further informed and believe, and on that basis allege, that
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`Sandoz manufactures Rixathon/GP2013 at one or both of those Sandoz GmbH facilities and that
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`any Rixathon/GP2013 imported into the United States by Sandoz will originate at one of those
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`Sandoz GmbH facilities.
`33.
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`Plaintiffs are informed and believe, and on that basis allege, that Sandoz GmbH
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`collaborates with Sandoz, Inc. to, at a minimum, develop, manufacture, and seek approval for
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`proposed biosimilars, including Rixathon/GP2013. Title 42 U.S.C. § 262(k)(2)(A)(v) requires
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`that any application for a proposed biosimilar product “shall include” information demonstrating
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`that “the facility in which the biological product is manufactured, processed, packed, or held
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`meets standards designed to assure that the biological product continues to be safe, pure, and
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`potent.” On information and belief, the facility at which Sandoz manufactures Rixathon/GP2013
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`is operated by Sandoz GmbH and Sandoz GmbH collaborated with Sandoz, Inc. in the
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`determination of the necessary requirements for that facility and the preparation of the requisite
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`aBLA submitted by Sandoz, Inc., discussed above, pursuant to which Sandoz intends to import,
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`market, offer for sale, and sell Rixathon/GP2013 in New Jersey and throughout the United
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`States.
`34.
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`Plaintiffs are further informed and believe, and on that basis allege, that the acts
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`of Sandoz, Inc. complained of herein were and will be done, in part, for the benefit of Sandoz
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`GmbH, which manufactures and exports the Rixathon/GP2013 product that is the subject of this
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`action.
`35.
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`Plaintiffs are informed and believe, and on that basis allege, that Sandoz GmbH
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`has previously submitted to the jurisdiction of this Court and availed itself of the legal
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`protections of the State of New Jersey by asserting affirmative defenses and not contesting
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`jurisdiction in the United States District Court for the District of New Jersey. See, e.g., Immunex
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`Corp., et al. v. Sandoz Inc., et al., No. 16-cv-1118, Answer, ¶ 38 (D.N.J. Oct. 28, 2016).
`36.
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`In the alternative, Plaintiffs are further informed and believe, and on that basis
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`allege, that this Court has personal jurisdiction over Sandoz GmbH pursuant to Federal Rule of
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`Civil Procedure 4(k)(2) because Sandoz GmbH has extensive contacts with the United States,
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`including but not limited to the above-described contacts, is not subject to jurisdiction in any
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`particular state, and exercising jurisdiction over Sandoz GmbH is consistent with the laws of the
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`United States and the United States Constitution.
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`BACKGROUND FACTS
`This case relates to the pioneering product Rituxan® and the duly-issued United
`37.
`States patents that cover the manufacture and use of that product. Rituxan® was the first
`monoclonal antibody approved by the FDA for therapeutic use in fighting cancer and is one of
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`the most successful medicinal products in the world.
`38.
`Plaintiffs are informed and believe, and on that basis allege, that (i) Sandoz is
`engaged in the development of a proposed biosimilar copy of Rituxan®, Rixathon/GP2013,
`(ii) the aBLA filed by Sandoz seeking FDA approval for Rixathon/GP2013 has named Rituxan®
`as the reference product that Rixathon/GP2013 is intended to copy, and (iii) the FDA has
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`accepted Sandoz’s aBLA for review.
`39.
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`Plaintiffs are informed and believe, and on that basis allege, that upon FDA
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`approval Sandoz intends to import, market, distribute, offer to sell, and sell Rixathon/GP2013 in
`New Jersey and throughout the United States as an alleged biosimilar substitute for Rituxan®.
`40.
`As alleged herein, the manufacture, importation, use, offer for sale, and/or sale of
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`Rixathon/GP2013 infringes one or more patents owned or licensed by Plaintiffs, who therefore
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`bring this patent action to address Sandoz’s infringement and to protect the intellectual property
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`into which they have invested innumerable resources, investments which have redounded to the
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`benefit of the public and medicine in general.
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`GENENTECH AND BIOGEN’S RITUXAN® PRODUCT
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`41.
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`Antibodies are produced by cells of the immune system and are an important
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`component in the immune system’s fight against foreign invaders, such as bacteria, viruses, and
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`other microbes and pathogens. In particular, antibodies can bind (attach) to a specific molecular
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`structure that can be present on such foreign invaders or can be present on the body’s own cells.
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`A structure to which an antibody binds is called an “antigen.” By binding to specific antigens,
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`antibodies help the immune system identify and attack the foreign invaders.
`42.
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`Although the human body creates antibodies for various antigens naturally, for
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`several decades scientists have successfully engineered in laboratories antibodies capable of
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`binding to a predetermined antigen, such that the antibodies can be used to develop therapeutic
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`products that target specific medical conditions in humans.
`43.
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`In the early 1990s, after many years of research, IDEC Pharmaceuticals (which
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`subsequently merged with Biogen) first created the antibody rituximab (then known as IDEC-
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`C2B8). Researchers at IDEC Pharmaceuticals created rituximab in the laboratory to bind to the
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`human CD20 antigen, a protein expressed on the surface of immune cells called B-cells. By
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`binding to the CD20 antigen, rituximab helps to fight diseases caused or exacerbated by B-cells,
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`including several forms of B-cell cancer.
`44.
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`Rituximab is a “chimeric” antibody, meaning that part of its structure is derived
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`from human genetic sequence and part is derived from mouse genetic sequence. Creating this
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`hybrid antibody and studying it in the laboratory, however, was only the beginning of the years-
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`long process required to create an effective yet safe human therapeutic.
`45.
`
`Following the creation of rituximab, IDEC Pharmaceuticals, Genentech, and
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`F. Hoffmann-La Roche AG, in a tri-company collaboration, spent many years and many
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`hundreds of millions of dollars on scientific studies and clinical trials to develop that therapeutic,
`which is marketed under the trade name Rituxan® in the United States and MabThera® abroad.
`They also dedicated enormous time and resources to establish the safety and efficacy of
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`Rituxan®, to investigate numerous ways to use Rituxan® to treat different diseases, and to
`determine how to manufacture Rituxan® in sufficient quantity and purity for administration to
`humans. For example, Rituxan® aids millions of patients in their fight against debilitating and
`life-threatening diseases, including Non-Hodgkin’s Lymphomas (NHLs), Chronic Lymphocytic
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`Leukemia (CLL), both of which are blood cancers, as well as Rheumatoid Arthritis (RA), and
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`Vasculitis, both chronic and painful autoimmune diseases. Genentech and Biogen continue to
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`dedicate significant time and resources to their ongoing efforts to maximize the effectiveness and
`use of Rituxan® to benefit patients across the world.
`46.
`Because of its effectiveness against several diseases, including several forms of
`cancer, Rituxan®/MabThera® has been an enormous commercial success, generating over
`$7 billion in worldwide revenue in 2016 alone.
`The innovative work dedicated to creating and developing Rituxan® has been
`47.
`recognized repeatedly by the medical and scientific communities. For example, Rituxan® is on
`the World Health Organization’s List of Essential Medicines (a well-recognized publication that
`identifies essential medicines for priority diseases) and Plaintiffs have been honored with the
`Trailblazers Award from the Cure for Lymphoma Foundation and with the Peter McCuen Cancer
`Research Award for their groundbreaking research and development of Rituxan®.
`THE BPCIA PATHWAY FOR BIOSIMILAR APPROVAL
`
`48.
`
`In 1984, Congress created an abbreviated regulatory pathway for the approval of
`
`generic small-molecule drugs through the passage of the Hatch-Waxman Act. Small molecule
`
`drugs are made from chemicals synthesized in a laboratory and contain both a relatively small
`
`number of atoms and a specific, known chemical structure. For example, the active ingredient in
`
`aspirin, acetylsalicylic acid, has only 21 atoms. Its chemical makeup and structure is easy to
`
`identify and characterize, and it is relatively simple to copy, develop, and manufacture.
`Biologic agents, like the rituximab antibody in Rituxan®, are much larger and
`49.
`more complex molecules, and are not produced by chemical synthesis in a laboratory. Rather,
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`they are produced in, and purified from, specially modified living cells, making them extremely
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`difficult to develop and manufacture. Whereas the small-molecule acetylsalicylic acid has only
`
`21 atoms, a complex antibody biologic like rituximab contains about 20,000 atoms. Accordingly,
`the efforts and investment needed to develop a therapeutic antibody like Rituxan® are
`significantly greater than for a small-molecule drug like aspirin.
`50.
`
`In contrast to the abbreviated regulatory pathway for generic small-molecule
`
`medicines provided in the Hatch-Waxman Act, no abbreviated pathway for approval of follow-
`
`on biologic products existed until the enactment in 2010 of the Biologics Price Competition and
`
`Innovation Act (“BPCIA”) (codified at 42 U.S.C. § 262) as part of the Patient Protection and
`
`Affordable Care Act. As a result, before the enactment of the BPCIA, the only way to obtain
`
`FDA approval of a biologic product was through an original Biologic License Application
`
`(“BLA”) supported by a full complement of pre-clinical and clinical study data. Genentech and
`
`Biogen underwent that long, laborious, and expensive process to obtain FDA approval for
`Rituxan®.
`51.
`
`The BPCIA’s abbreviated pathway for biologic products requires a determination
`
`that the proposed product is “biosimilar” to a previously licensed “reference product.” 42 U.S.C.
`
`§ 262(k). The BPCIA defines a “biosimilar” as a biological product that is (1) “highly similar to
`
`the reference product notwithstanding minor differences in clinically inactive components” and
`
`(2) has “no clinically meaningful differences between the biological product and the reference
`
`product in terms of the safety, purity, and potency of the product.” 42 U.S.C. §§ 262(i)(2)(A),
`
`(B).
`
`52.
`
`The BPCIA defines a “reference product” to be a “single biological product
`
`licensed under subsection (a) against which a biological product is evaluated in an application
`submitted under subsection (k).” 42 U.S.C. § 262(i)(4). Here, Rituxan® is the reference product
`and Rixathon/GP2013 is the proposed biosimilar.
`53.
`
`Under the BPCIA, biosimilar applicants are permitted to make use of the
`
`reference product sponsor’s proprietary safety and efficacy data and the FDA’s prior
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`determinations as to the safety, purity, and potency of the already-approved reference product. A
`
`biosimilar applicant must identify a single reference product that has already been approved by
`
`the FDA and submit to the FDA “publicly-available information regarding the Secretary’s
`
`previous determination that the reference product is safe, pure, and potent.” 42 U.S.C.
`
`§ 262(k)(2)(A)(iii)(I).
`54.
`
`Consequently, the abbreviated regulatory pathway created by the BPCIA allows a
`
`biosimilar applicant like Sandoz to avoid the time, expense, and risks of original research and
`
`development—as well as the need to conduct a full complement of pre-clinical and clinical
`
`testing—required for the submission of an original BLA. The abbreviated pathway thus permits a
`
`biosimilar applicant like Sandoz to gain approval to commercialize its biological product much
`
`more quickly than if it had undertaken the significant activities required for submission of an
`
`original BLA.
`
`SANDOZ’S DEVELOPMENT OF RIXATHON
`
`55.
`
`Plaintiffs are informed and believe, and on that basis allege, that on a date prior to
`
`September 12, 2017, Sandoz submitted to the FDA an aBLA for Rixathon/GP2013. On
`
`September 12, 2017, Sandoz issued a press release announcing that the FDA had accepted that
`
`aBLA for review. https://www.sandoz.com/news/media-releases/sandoz-proposed-biosimilar-
`
`rituximab-accepted-review-fda. More specifically, that press release stated that the FDA had
`
`“accepted [Sandoz’s] Biologics License Application (BLA) … for a proposed biosimilar to the
`reference medicine, Rituxan® (rituximab).” Id.
`In addition, that same press release acknowledged that “Rituxan® is used to treat
`56.
`blood cancers including non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell
`
`lymphoma) and chronic lymphocytic leukemia, as well as immunological diseases such as
`
`rheumatoid arthritis.” Id. These are diseases for which Rixathon was recently approved in
`
`Europe (as a biosimilar of rituximab marketed outside the United States under the trade name
`MabThera®). https://www.novartis.com/news/media-releases/sandoz-receives-approval-europe-
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`rixathonr-biosimilar-rituximab-treat-blood. Plaintiffs are informed and believe, and on that basis
`
`allege, that Sandoz is seeking FDA approval to treat those same diseases, i.e., those same
`
`“indications,” in the United States, thereby seeking FDA approval for a proposed biosimilar
`copying Rituxan® while intending to market that proposed biosimilar as a substitute treatment for
`the same medicinal purposes.
`THE BPCIA’S DISPUTE RESOLUTION PROCEDURES
`
`57.
`
`Although the BPCIA provides for an abbreviated regulato