Case 1:18-cv-11553-RMB-KMW Document 1 Filed 07/11/18 Page 1 of 90 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
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`Attorneys for Plaintiffs Genentech, Inc.,
`Biogen, Inc., Hoffmann-La Roche Inc., and City of
`Hope
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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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`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,
`HOFFMANN-LA ROCHE INC., a New
`Jersey corporation, and CITY OF HOPE, a
`California not-for-profit organization,
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` Plaintiffs,
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` v.
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`CELLTRION, INC., a Korean corporation,
`CELLTRION HEALTHCARE CO., LTD., a
`Korean corporation, TEVA
`PHARMACEUTICALS USA, INC., a
`Delaware corporation, and TEVA
`PHARMACEUTICALS INTERNATIONAL
`GmbH, a Swiss corporation,
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` 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 Plaintiff Hoffmann-
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`La Roche Inc. (“Roche”) is 150 Clove Road, Little Falls, New Jersey, 07424. The address of
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`Defendant Celltrion, Inc. (“Celltrion”) is 23, Academy-ro, Yeonsu-gu, Incheon, Korea. The
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`address of Defendant Celltrion Healthcare, Co. Ltd. (“Celltrion Healthcare”) is 23, Academy-ro,
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`Yeonsu-gu, Incheon, Korea. The address of Defendant Teva Pharmaceuticals USA, Inc. (“Teva”)
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`is 1090 Horsham Road, North Wales, PA 19454-1090. The address of Defendant Teva
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`Pharmaceuticals International GmbH (“TPIG”) is Schlüsselstrasse 12, Jona (SG) 8645,
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`Switzerland.
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`Plaintiffs Genentech, Biogen, Roche, and City of Hope (individually or collectively,
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`“Plaintiffs”) by their undersigned attorneys, for their Complaint against Celltrion, Celltrion
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`Healthcare, Teva, and TPIG (individually or collectively, “Defendants”) allege as follows:
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`NATURE OF THIS ACTION
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`1.
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`Plaintiffs file this new lawsuit for patent infringement under the Biologics Price
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`Competition and Innovation Act (“BPCIA”) (codified at 42 U.S.C. § 262) because Celltrion is
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`taking the position that it has complied with the requirements of the BPCIA’s so-called “patent
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`dance” set forth at § 262(l)(2)-(l)(6). Plaintiffs’ claims mirror those asserted in Genentech, Inc. et
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`al. v. Celltrion, Inc. et al., No. 18-cv-00574-RMB-KMW (D.N.J.), currently pending before this
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`Court (“574 Celltrion Action” or “the related action”).
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`2.
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`On June 6, 2018, months after Celltrion repudiated the requirements of the BPCIA,
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`and one month after Celltrion’s declaratory judgment action in the Northern District of California
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`was dismissed by Judge Jeffrey White on the ground that Celltrion had failed to comply with its
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`statutory obligations under the BPCIA, see Celltrion, Inc. v. Genentech, Inc., 2018 WL 2448254
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`(N.D. Cal. May 9, 2018), Celltrion improperly attempted to resurrect the patent dance. In
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`particular, Celltrion notified Genentech of the number of patents it believed should be the subject
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`of a patent infringement action under § 262(l)(5)(A) on June 6, 2018 and demanded that the parties
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`exchange lists “of the patents each believes should be the subject of an action for patent
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`infringement under 42 U.S.C. § 262(l)(6).” Out of an abundance of caution, while reserving all
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`rights and waiving none, Genentech objected and sent a responsive letter on June 11, 2018.
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`3.
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`Celltrion asserts that the parties exchanged patent lists under § 262(l)(5)(B) on June
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`11, 2018. If Celltrion is correct that it was permitted to resurrect the patent dance and that the June
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`11, 2018 exchange completes and satisfies the BPCIA requirements under § 262(l)(5), then the
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`next step in the patent dance would require Genentech to have brought an action for infringement
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`not later than 30 days after such exchange, which is today, July 11, 2018. See 42 U.S.C. § 262(l)(6).
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`4.
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`Wary of filing a new lawsuit, particularly given the harsh penalties (e.g., loss of
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`right to lost profits or injunctive relief) that could apply to a patent owner under 35 U.S.C.
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`§ 271(e)(6) if an action for infringement of certain patents is dismissed without prejudice or not
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`prosecuted to judgment in good faith, Genentech met and conferred with Celltrion and asked for
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`clarification on whether Celltrion’s position was that the BPCIA required Genentech to file a new
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`lawsuit even though Genentech has already asserted its patents against Celltrion in the related
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`action. Celltrion refused to engage. Rather, Celltrion responded that it was leaving it to Genentech
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`to figure out whether any further action under the BPCIA was required. Genentech raised this issue
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`with this Court in a June 22, 2018 letter filed in the related action.
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`5.
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`Solely out of an abundance of caution, Genentech now files this new lawsuit for
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`patent infringement against Celltrion. Genentech has designated this new lawsuit as related to the
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`574 Celltrion Action and will promptly file a motion to consolidate this new lawsuit with the 574
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`Celltrion Action in the event Celltrion declines to stipulate to such consolidation. This new action
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`for patent infringement arises under 28 U.S.C. § 1331 and the United States Patent Act, 35 U.S.C.
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`§ 100 et seq., including 35 U.S.C. § 271(e)(2), and an action under the Declaratory Judgment Act,
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`28 U.S.C. §§ 2201-2202, seeking a declaratory judgment of patent infringement.
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`6.
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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
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`States a copy of Genentech and Biogen’s groundbreaking medicinal product, Rituxan®, which aids
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`millions of patients in their fight against debilitating and life-threatening diseases, including blood
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`cancers such as Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia, as well as
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`Rheumatoid Arthritis and Vasculitis, which are chronic and painful autoimmune diseases. First
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`approved in 1997, Rituxan® is proven to improve both the length and quality of life for patients
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`with these and other diseases and has been recognized internationally for its pioneering effect on
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`patients’ lives and medicine in general.
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`7.
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`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
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`Rituxan® and ensuring that the product is both safe and effective. Those investments include, inter
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`alia, years of laborious and expensive clinical trials that were required before medical
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`professionals could use Rituxan® to help their patients—clinical trials on which the U.S. Food and
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`Drug Administration (“FDA”) relied in making Rituxan® the first monoclonal antibody approved
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`for therapeutic use in fighting cancer in the United States.
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`8.
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`In contrast, Defendants have piggybacked on Plaintiffs’ investments and success
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`and seek to profit from a copied version of Rituxan®. Claiming that their copycat product is
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`“biosimilar” to Rituxan®, Defendants have not borne the expense of conducting their own clinical
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`trials—instead relying on Genentech and Biogen’s costly and time-consuming proprietary clinical
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`trials—and have applied to the FDA for approval to market and sell that product.
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`9.
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`Irrespective of whether they are able to secure FDA approval for its copy of
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`Rituxan®, however, Defendants do not have the right to infringe Plaintiffs’ patents. Defendants’
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`intended activities would unquestionably infringe many of those patents, none of which Plaintiffs
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`have licensed to Defendants and all of which are valid and enforceable. Plaintiffs bring this action
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`to stop that infringement.
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`PARTIES
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`10.
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`Plaintiff Genentech, 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 1 DNA Way, South San Francisco,
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`California, 94080.
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`11.
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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.
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`12.
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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.
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`13.
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`Plaintiff Hoffmann-La Roche Inc. is a corporation organized and existing under the
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`laws of the State of New Jersey, having its principal place of business at 150 Clove Road, Little
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`Falls, New Jersey, 07424.
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`14.
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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
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`developed and jointly market Rituxan®, the revolutionary antibody-based medicine at issue in this
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`case.1
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`15.
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`Founded in 1913, City of Hope is a leading research hospital that incorporates cutting-
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`edge research into patient care for cancer, diabetes, and other serious diseases.
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`16.
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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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`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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`technology. Among those patents are several that claim, inter alia, the manufacture and use of
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`Rituxan®.
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`17.
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`Plaintiffs are informed and believe, and on that basis allege, that Defendant
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`Celltrion, Inc. is a corporation organized and existing under the laws of the Republic of Korea,
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`having its principal place of business at 23 Academy-ro, Yeonsu-gu, Incheon, 406-840, South
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`Korea. Plaintiffs are further informed and believe, and on that basis allege, that Celltrion is a
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`pharmaceutical company that develops claimed “biosimilars” of biological medicines and, either
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`by itself or through subsidiaries and/or partners, markets and distributes such products around the
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`world, including in the United States.
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`18.
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`Plaintiffs are informed and believe, and on that basis allege, that Defendant
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`Celltrion Healthcare, Co. Ltd. is a corporation organized and existing under the laws of the
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`Republic of Korea, having its principal place of business at 23 Academy-ro, Yeonsu-gu, Incheon,
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`406-840, South Korea. Plaintiffs are further informed and believe, and on that basis allege, that
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`Celltrion Healthcare is a pharmaceutical company that develops claimed “biosimilars” of
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`biological medicines and, either by itself or through subsidiaries and/or partners, markets and
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`distributes such products around the world, including in the United States.
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`19.
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`Plaintiffs are informed and believe, and on that basis allege, that Defendant Teva
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`Pharmaceuticals USA, Inc. is a corporation organized and existing under the laws of the State of
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`Delaware, having its principal place of business at 1090 Horsham Road, North Wales,
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`Pennsylvania, 19454-1090. Plaintiffs are further informed and believe, and on that basis allege,
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`that Teva Pharmaceuticals USA, Inc. is a pharmaceutical company that, inter alia, develops
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`claimed “biosimilars” of biological medicines and, either by itself or through subsidiaries and/or
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`partners, markets and distributes such products around the world, including in the United States.
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`20.
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`Plaintiffs are informed and believe, and on that basis allege, that Defendant Teva
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`Pharmaceuticals International GmbH is a limited liability company organized and existing under
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`the laws of Switzerland, having its principal place of business at Schlüsselstrasse 12, Jona (SG)
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`8645, Switzerland. Plaintiffs are further informed and believe, and on that basis allege, that Teva
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`Pharmaceuticals International GmbH is a pharmaceutical company that develops claimed
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`“biosimilars” of biological medicines and, either by itself or through subsidiaries and/or partners,
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`markets and distributes such products around the world, including in the United States.
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`JURISDICTION AND VENUE
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`21.
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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.
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`22.
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`Venue is proper in this District under 28 U.S.C. §§ 1391(b) and (c) and 1400(b),
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`including because Defendants are subject to this Court’s personal jurisdiction, Defendants have
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`and/or will commit acts of infringement in this district, Celltrion, Inc., Celltrion Healthcare, Co.
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`Ltd., and Teva Pharmaceuticals International GmbH do not reside in the United States, and Teva
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`Pharmaceuticals USA, Inc. has regular and established places of business located in New Jersey.
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`A. Celltrion, Inc.
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`23.
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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 Celltrion because Celltrion has purposefully directed activities at the
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`State of New Jersey and this litigation relates to or arises out of those activities. In particular,
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`Plaintiffs are informed and believe, and on that basis allege, that Celltrion has taken the costly,
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`significant step of filing an Abbreviated Biologic License Application (“aBLA”) with the United
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`States Food and Drug Administration (“FDA”) seeking FDA approval of the proposed biosimilar
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`product “Truxima” (also known under the development code “CT-P10”) for the express purposes
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`of marketing, distributing, and selling Truxima/CT-P10 in New Jersey and throughout the United
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`States.
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`24.
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`Plaintiffs are informed and believe, and on that basis allege, that Celltrion and
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`Celltrion Healthcare have entered into a commercial, contractual relationship with Teva and TPIG
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`for the purpose of marketing, distributing, and selling Truxima/CT-P10 in New Jersey and
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`throughout the United States and Canada.
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`25.
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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 Celltrion’s aBLA for Truxima/CT-P10, Defendants will market, distribute, and sell
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`Truxima/CT-P10 in New Jersey and throughout the United States.
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`26.
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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 Celltrion pursuant to Federal Rule of Civil
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`Procedure 4(k)(2) because Celltrion has extensive contacts with the United States, including but
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`not limited to the above-described contacts, is not subject to jurisdiction in any particular state,
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`and exercising jurisdiction over Celltrion is consistent with the laws of the United States and the
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`United States Constitution.
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`27.
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`For example, Plaintiffs are informed and believe, and on that basis allege, that
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`Celltrion has purposefully established commercial relationships and business dealings with several
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`pharmaceutical companies in the United States, including Teva, Teva subsidiaries, Hospira, Inc.,
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`and Pfizer Inc. (“Pfizer”). In addition to Celltrion’s aforementioned contractual relationship with
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`Teva to market, distribute, and sell Truxima/CT-P10, Celltrion and Pfizer are, on information and
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`belief, currently marketing the biosimilar Inflectra® in New Jersey and throughout the United
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`States.
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`28.
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`In addition, Plaintiffs are informed and believe, and on that basis allege, that
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`Celltrion has availed itself of the benefits of United States law by applying for and obtaining
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`registrations for at least one trademark with the United States Patent and Trademark Office
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`(“PTO”) for the word “Truxima,” which trademark Celltrion has declared its intent to use in
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`commerce in the United States.
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`29.
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`Celltrion has further availed itself of the benefits of United States law by filing with
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`the PTO at least ten (10) inter partes review petitions challenging Plaintiffs’ patents relating to the
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`pioneering biological drug at issue in this case, Rituxan®.
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`B. Celltrion Healthcare, Co. Ltd.
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`30.
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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 Celltrion Healthcare because Celltrion Healthcare has purposefully
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`directed activities at the State of New Jersey and this litigation relates to or arises out of those
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`activities. In particular, Plaintiffs are informed and believe, and on that basis allege, that Celltrion
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`Healthcare has assisted Celltrion to aid Celltrion in filing an aBLA with the FDA seeking FDA
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`approval of the proposed biosimilar product Truxima for the express purposes of marketing,
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`distributing, and selling Truxima/CT-P10 in New Jersey and throughout the United States.
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`Celltrion Healthcare and Celltrion share the same principal place of business and, on information
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`and belief, Celltrion Healthcare markets, sells, and distributes products developed by Celltrion.
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`31.
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`Plaintiffs are informed and believe, and on that basis allege, that Celltrion and
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`Celltrion Healthcare have entered into a commercial, contractual relationship with Teva and TPIG
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`for the purpose of marketing, distributing, and selling Truxima/CT-P10 in New Jersey and
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`throughout the United States and Canada.
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`32.
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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 Celltrion’s aBLA for Truxima/CT-P10, Defendants will market, distribute, and sell
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`Truxima/CT-P10 in New Jersey and throughout the United States.
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`33.
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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 Celltrion Healthcare pursuant to Federal Rule
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`of Civil Procedure 4(k)(2) because Celltrion Healthcare has extensive contacts with the United
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`States, including but not limited to the above-described contacts, is not subject to jurisdiction in
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`any particular state, and exercising jurisdiction over Celltrion Healthcare is consistent with the
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`laws of the United States and the United States Constitution.
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`C. Teva Pharmaceuticals USA, Inc.
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`34.
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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 Teva because Teva has purposefully directed activities at the State of
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`New Jersey and this litigation relates to or arises out of those activities. For example, Plaintiffs are
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`informed and believe, and on that basis allege, that (1) Teva is registered to do business in New
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`Jersey under Entity Identification Number 0100250184 and has appointed a registered agent in
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`New Jersey, Corporate Creations Network Inc., 811 Church Road #105, Cherry Hill, NJ 08002;
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`(2) Teva is registered with the New Jersey Department of Health as a drug manufacturer and
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`wholesaler under Registration Numbers 5000583 and 5003436; (3) Teva manufactures and
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`distributes brand and generic drugs for sale and use throughout the United States, including in New
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`Jersey; (4) Teva has regular and established places of business in New Jersey, where it has
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`employees and from which it services customers in New Jersey, located at least at 8 Gloria Lane,
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`Fairfield, New Jersey 07004; 400 Chestnut Ridge Rd, Woodcliff Lake, NJ 07677; 208 Passaic
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`Avenue, Fairfield, New Jersey 07004; and 200 Elmora Avenue, Elizabeth, New Jersey 07202; and
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`(5) Teva has additional facilities in New Jersey at least in Elizabeth, Newark, Ewing, Parsippany,
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`and Woodcliff Lake, from which it engages in sales.
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`35.
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`Plaintiffs are informed and believe, and on that basis allege, that Celltrion and
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`Celltrion Healthcare have entered into a commercial, contractual relationship with Teva and TPIG
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`for the purpose of marketing, distributing, and selling Truxima/CT-P10 in New Jersey and
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`throughout the United States and Canada.
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`36.
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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 Celltrion’s aBLA for Truxima/CT-P10, Defendants will market, distribute, and sell
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`Truxima/CT-P10 in New Jersey and throughout the United States.
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`37.
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`Plaintiffs are informed and believe, and on that basis allege, that Teva has been
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`sued and has litigated in the District of New Jersey, in connection with which it has repeatedly
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`submitted to the jurisdiction of this Court and has availed itself of the legal protections of the State
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`of New Jersey by asserting claims or counterclaims involving pharmaceutical drug patent disputes
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`in this Judicial District in at least the following cases in the past year alone: Teva Pharms. USA,
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`Inc., et al. v. Sandoz Inc., et al., Civil Action No. 17-275; Teva Pharms. USA, Inc., et al. v. Dr.
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`Reddy’s Laboratories, Ltd., et al., Civil Action No. 17-517; BTG Int’l Ltd., et al. v. Teva Pharms.
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`USA, Inc., et al., Civil Action No. 17-6435; Adapt Pharma Operations Ltd., et al. v. Teva Pharms.
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`USA, Inc., et al., Civil Action No. 17-5100; Celgene Corp. v. Par Pharm., Inc., et al., Civil Action
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`No. 17-3159; Adapt Pharma Operations Ltd., et al. v. Teva Pharms. USA, Inc., et al., Civil Action
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`No. 17-2877; Adapt Pharma Operations Ltd., et al. v. Teva Pharms. USA, Inc., et al., Civil Action
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`No. 17-864; Mitsubishi Tanabe Pharma Corp., et al. v. MSN Labs. Private Ltd., et al., Civil Action
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`No. 17-5302; Astrazeneca Pharms. LP, et al. v. Teva Pharms. USA, Inc., Civil Action No. 17-
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`2448.
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`D. Teva Pharmaceuticals International GmbH
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`38.
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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 TPIG because TPIG has purposefully directed activities at the State of
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`New Jersey and this litigation relates to or arises out of those activities.
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`39.
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`In particular, Plaintiffs are informed and believe, and on that basis allege, that
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`Celltrion and Celltrion Healthcare have entered into a commercial, contractual relationship with
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`Teva and TPIG for the purpose of marketing, distributing, and selling Truxima/CT-P10 in New
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`Jersey and throughout the United States and Canada.
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`40.
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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 Celltrion’s aBLA for Truxima/CT-P10, Defendants will market, distribute, and sell
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`Truxima/CT-P10 in New Jersey and throughout the United States.
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`41.
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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 TPIG pursuant to Federal Rule of Civil
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`Procedure 4(k)(2) because TPIG has extensive contacts with the United States, including but not
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`limited to the above-described commercial contract, is not subject to jurisdiction in any particular
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`state, and exercising jurisdiction over TPIG is consistent with the laws of the United States and
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`the United States Constitution.
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`BACKGROUND FACTS
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`42.
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`This case relates to the pioneering product Rituxan® and the duly-issued United
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`States patents that cover the manufacture and use of that product. Rituxan® was the first
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`monoclonal antibody approved by the FDA for therapeutic use in fighting cancer and is one of the
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`most successful medicinal products in the world.
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`43.
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`Plaintiffs are informed and believe, and on that basis allege, that (i) Defendants are
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`engaged in the development of a proposed biosimilar copy of Rituxan®, Truxima/CT-P10, (ii) the
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`aBLA filed by Celltrion seeking FDA approval for Truxima/CT-P10 has named Rituxan® as the
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`reference product that Truxima/CT-P10 is intended to copy, and (iii) the FDA has accepted
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`Celltrion’s aBLA for review.
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`44.
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`Plaintiffs are informed and believe, and on that basis allege, that upon FDA
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`approval Defendants intend to market, distribute, and sell Truxima/CT-P10 in New Jersey and
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`throughout the United States as an alleged biosimilar substitute for Rituxan®.
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`45.
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`As alleged herein, the manufacture, importation, use, offer for sale, and/or sale of
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`Truxima/CT-P10 infringes one or more patents owned by Plaintiffs, who therefore bring this patent
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`action to address Defendants’ infringement and to protect the intellectual property into which they
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`have invested innumerable resources, investments which have redounded to the benefit of the
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`public and medicine in general.
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`GENENTECH AND BIOGEN’S RITUXAN® PRODUCT
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`46.
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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.
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`47.
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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.
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`48.
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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.
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`49.
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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.
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`50.
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`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 hundreds
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`of millions of dollars on scientific studies and clinical trials to develop that therapeutic, which is
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`marketed under the trade name Rituxan® in the United States and MabThera® abroad. They also
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`dedicated enormous time and resources to establish the safety and efficacy of Rituxan®, to
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`investigate numerous ways to use Rituxan® to treat different diseases, and to determine how to
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`manufacture Rituxan® in sufficient quantity and purity for administration to humans. For example,
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`Rituxan® aids millions of patients in their fight against debilitating and life-threatening diseases,
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`including Non-Hodgkin’s Lymphomas (NHLs) and Chronic Lymphocytic Leukemia (CLL), both
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`of which are blood cancers, as well as Rheumatoid Arthritis (RA) and Vasculitis, both chronic and
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`painful autoimmune diseases. Genentech and Biogen continue to dedicate significant time and
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`resources to their ongoing efforts to maximize the effectiveness and use of Rituxan® to benefit
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`patients across the world.
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`51.
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`Because of its effectiveness against several diseases, including several forms of
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`cancer, Rituxan®/MabThera® has been an enormous commercial success, generating over $7
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`billion in worldwide revenue in 2016 alone.
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`52.
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`The innovative work dedicated to creating and developing Rituxan® has been
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`recognized repeatedly by the medical and scientific communities. For example, Rituxan® is on the
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`World Health Organization’s List of Essential Medicines (a well-recognized publication that
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`identifies essential medicines for priority diseases) and Plaintiffs have been honored with the
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`Trailblazers Award from the Cure for Lymphoma Foundation and with the Peter McCuen Cancer
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`Research Award for their groundbreaking research and development of Rituxan®.
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`THE BPCIA PATHWAY FOR BIOSIMILAR APPROVAL
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`53.
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`In 1984, Congress created an abbreviated regulatory pathway for the approval of
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`generic small-molecule drugs through the passage of the Hatch-Waxman Act. Small molecule
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`drugs are made from chemicals synthesized in a laboratory and contain both a relatively small
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`number of atoms and a specific, known chemical structure. For example, the active ingredient in
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`aspirin, acetylsalicylic acid, has only 21 atoms. Its chemical makeup and structure is easy to
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`identify and characterize, and it is relatively simple to copy, develop, and manufacture.
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`54.
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`Biologic agents, like the rituximab antibody in Rituxan®, are much larger and more
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`complex molecules, and are not produced by chemical synthesis in a laboratory. Rather, they are
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`produced in, and purified from, specially modified living cells, making them extremely difficult
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`to develop and manufacture. Whereas the small-molecule acetylsalicylic acid has only 21 atoms,
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`a complex antibody biologic like rituximab contains about 20,000 atoms. Accordingly, the efforts
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`and investment needed to develop a therapeutic antibody like Rituxan® are significantly greater
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`than for a small-molecule drug like aspirin.
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`55.
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`In contrast to the abbreviated regulatory pathway for generic small-molecule
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`medicines provided in the Hatch-Waxman Act, no abbreviated pathway for approval of follow-on
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`biologic products existed until the enactment in 2010 of the Biologics Price Competition and
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`Innovation Act (“BPCIA”) (codified at 42 U.S.C. § 262) as part of the Patient Protection and
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`Affordable Care Act. As a result, before the enactment of the BPCIA, the only way to obtain FDA
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`approval of a biologic product was through an original Biologic License Application (“BLA”)
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`supported by a full complement of pre-clinical and clinical study data. Genentech and Biogen
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`underwent that long, laborious, and expensive process to obtain FDA approval for Rituxan®.
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`56.
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`The BPCIA’s abbreviated pathway for biologic products requires a determination
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`that the proposed product is “biosimilar” to a previously licensed “reference product.” 42 U.S.C.
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`§ 262(k). The BPCIA defines a “biosimilar” as a biological product that is (1) “highly similar to
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