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`#: 37331
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`#: 37331
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`#: 37332
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`#: 37333
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`#: 37334
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`#: 37335
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`#: 37336
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`#: 37337
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`#: 37338
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 9 of 70 PageID
`#: 37339
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 10 of 70 PageID
`#: 37340
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 11 of 70 PageID
`#: 37341
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 12 of 70 PageID
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 13 of 70 PageID
`#: 37343
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 14 of 70 PageID
`#: 37344
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 15 of 70 PageID
`#: 37345
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 16 of 70 PageID
`Case 3:14-cv-04741-RS Document 56 Filed 02/05/15 Page 1 of 30
`#: 37346
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`SIDLEY AUSTIN LLP
`Vernon M. Winters (SBN 130128)
`555 California Street, Suite 2000
`San Francisco, CA 94104-1503
`Telephone: (415) 772-1200
`Facsimile: (415) 772-7400
`vwinters@sidley.com
`PAUL, WEISS, RIFKIND, WHARTON & GARRISON LLP
`Nicholas Groombridge (pro hac vice)
`Eric Alan Stone (pro hac vice)
`Jennifer H. Wu (pro hac vice)
`Jennifer Gordon
`Peter Sandel (pro hac vice)
`Michael T. Wu (pro hac vice)
`1285 Avenue of the Americas
`New York, NY 10019-6064
`Telephone: (212) 373-3000
`Facsimile: (212) 757-3990
`ngroombridge@paulweiss.com
`
`AMGEN INC.
`Wendy A. Whiteford (SBN 150283)
`Lois M. Kwasigroch (SBN 130159)
`One Amgen Center Drive
`Thousand Oaks, CA 91320-1789
`Telephone: (805) 447-1000
`Facsimile: (805) 447-1010
`wendy@amgen.com
`
`Attorneys for Plaintiffs Amgen Inc.
`and Amgen Manufacturing, Limited
`
`UNITED STATES DISTRICT COURT
`NORTHERN DISTRICT OF CALIFORNIA
`
`AMGEN INC. and
`AMGEN MANUFACTURING, LIMITED,
`
`vs.
`
`Plaintiffs,
`
`SANDOZ INC., SANDOZ
`INTERNATIONAL GMBH, and
`SANDOZ GMBH,
`
`Case No. 3:14-cv-04741-RS
`
`NOTICE OF MOTION AND MOTION
`BY AMGEN FOR A PRELIMINARY
`INJUNCTION
`
`Date:
`Time:
`Location:
`
`March 2, 2015
`1:30 PM
`Courtroom 3, 17th Floor
`
`Defendants.
`
`AMGEN’S MOTION FOR A PRELIMINARY INJUNCTION
`
`Case No. 3:14-cv-04741-RS
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`1 2 3 4 5 6 7 8 9
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 17 of 70 PageID
`Case 3:14-cv-04741-RS Document 56 Filed 02/05/15 Page 23 of 30
`#: 37347
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`
`
`Irreparable Harm to Research and Development
`1.
`Amgen—unlike Sandoz—is an innovator. It invests substantially to develop novel,
`
`potentially life-saving products through primary research and development. Revenue for that
`
`research comes from Amgen’s commercial products, including Neupogen® and Neulasta®.
`
`That research will be immediately and irreversibly harmed if Sandoz’s biosimilar filgrastim
`
`draws sales from Amgen’s products. See Philipson Report ¶¶ 20-59, 83-101. The missed
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`opportunities in research or development of a product could not be remedied later by an
`
`injunction or an award of damages. In addition, Sandoz’s entry into the market could cause
`
`Amgen to have to lay off the highly skilled research and development scientists whose projects
`
`would now go unfunded. This is irreparable harm: “[D]amage caused by a loss in personnel
`
`and the impact this would have on [a] company are indeed significant and unquantifiable.”
`
`AstraZeneca LP v. Apotex, Inc., 623 F. Supp. 2d 579, 612 (D.N.J. 2009), supplemented, 623 F.
`
`Supp. 2d 615 (D.N.J. 2009) and aff’d, 633 F.3d 1042 (Fed. Cir. 2010).
`
`In the preliminary injunction context, the law must guard against that outcome. In Bio-
`
`Technology Gen. Corp. v. Genentech, Inc., the Federal Circuit affirmed the finding of
`
`irreparable harm based in part on Genentech’s being “required to reduce its research and
`
`development activities” and because of the loss of revenue that would occur absent an
`
`injunction. 80 F.3d 1553, 1566 (Fed. Cir. 1996). Another court noted that “a significant
`
`disruption or loss of research that otherwise would have been sponsored or completed by
`
`[plaintiff] as well as a scaling back of investment in research and development which otherwise
`
`would not have occurred” are losses that cannot be “adequately compensated by a monetary
`
`payment.” Eli Lilly & Co. v. Teva Pharm. USA, Inc., 609 F. Supp. 2d 786, 812 (S.D. Ind.
`
`2009). Irreparable harm has also been found in the context of a permanent injunction when “a
`
`reduction of revenue would subsequently impact [a pharmaceutical company’s] ability to
`
`allocate its resources to product development.” Pozen Inc. v. Par Pharm., Inc., 800 F. Supp. 2d
`
`789, 824 (E.D. Tex. 2011) aff’d, 696 F.3d 1151 (Fed. Cir. 2012).
`
`19
`AMGEN’S MOTION FOR A PRELIMINARY INJUNCTION
`
`Case No. 3:14-cv-04741-RS
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 18 of 70 PageID
`#: 37348
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`(cid:53)(cid:40)(cid:39)(cid:36)(cid:38)(cid:55)(cid:40)(cid:39)(cid:3)(cid:44)(cid:49)(cid:3)
`(cid:44)(cid:55)(cid:54)(cid:3)(cid:40)(cid:49)(cid:55)(cid:44)(cid:53)(cid:40)(cid:55)(cid:60)
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 19 of 70 PageID
`#: 37349
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`EXHIBIT 78
`
`
`
`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 20 of 70 PageID
`What Are "Biologics" Questions and Answers
`#: 37350
`
`What Are "Biologics" Questions and
`Answers
`
`What is a biological product?
`
`Biological products include a wide range of products such as vaccines, blood and blood components, allergenics,
`Biological products include a wide range of products such as vaccines, blood and blood components, allergenics,
`somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars,
`somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.
`proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and
`tissues. Biologics are isolated from a variety of natural sources - human, animal, or microorganism - and may be
`produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for
`example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions
`for which no other treatments are available.
`
`How do biological products differ from conventional drugs?
`
`In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are complex
`mixtures that are not easily identified or characterized. Biological products, including those manufactured by
`biotechnology, tend to be heat sensitive and susceptible to microbial contamination. Therefore, it is necessary to
`use aseptic principles from initial manufacturing steps, which is also in contrast to most conventional drugs.
`
`Biological products often represent the cutting-edge of biomedical research and, in time, may offer the most
`effective means to treat a variety of medical illnesses and conditions that presently have no other treatments
`available.
`
`Contact FDA
`
`(800) 835-4709
`(301) 827-1800
`ocod@fda.hhs.gov (mailto:ocod@fda.hhs.gov)
`
`Consumer Affairs Branch (CBER)
`Division of Communication and Consumer Affairs
`Office of Communication, Outreach and Development
`Food and Drug Administration
`1401 Rockville Pike
`Suite 200N/HFM-47
`Rockville, MD 20852-1448
`
`Resources for You
`
`Consumers (Biologics) (/BiologicsBloodVaccines/ResourcesforYou/Consumers/default.htm)
`Healthcare Providers (Biologics) (/BiologicsBloodVaccines/ResourcesforYou/HealthcareProviders/default.htm)
`
`https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cber/ucm133077.htm
`
`1/2
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`
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 21 of 70 PageID
`What Are "Biologics" Questions and Answers
`#: 37351
`
`Industry (Biologics) (/BiologicsBloodVaccines/ResourcesforYou/Industry/default.htm)
`About the Center for Biologics Evaluation and Research (CBER)
`(/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/default.htm)
`
`More in About the Center for Biologics Evaluation and Research
`(/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/default.htm)
`
`CBER Offices & Divisions (/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm122875.htm)
`
`CBER Vision & Mission (/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm122878.htm)
`
`CBER Reports (/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm122880.htm)
`
`CBER Ombudsman (/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm122881.htm)
`
`CBER Product Jurisdiction (/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm471141.htm)
`
`https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cber/ucm133077.htm
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`2/2
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`
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 22 of 70 PageID
`#: 37352
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`EXHIBIT 79
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 23 of 70 PageID
`#: 37353
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 24 of 70 PageID
`#: 37354
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 25 of 70 PageID
`#: 37355
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 26 of 70 PageID
`#: 37356
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 27 of 70 PageID
`#: 37357
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 28 of 70 PageID
`#: 37358
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`EXHIBIT 80
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 29 of 70 PageID
`#: 37359
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 30 of 70 PageID
`#: 37360
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 31 of 70 PageID
`#: 37361
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 32 of 70 PageID
`#: 37362
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 33 of 70 PageID
`#: 37363
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 34 of 70 PageID
`#: 37364
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 35 of 70 PageID
`#: 37365
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 36 of 70 PageID
`#: 37366
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 37 of 70 PageID
`#: 37367
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 38 of 70 PageID
`#: 37368
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`#: 37369
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`#: 37370
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`#: 37371
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`#: 37373
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 47 of 70 PageID
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`#: 37379
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`#: 37380
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 55 of 70 PageID
`#: 37385
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 56 of 70 PageID
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 58 of 70 PageID
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`#: 37389
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`#: 37390
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 62 of 70 PageID
`#: 37392
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 63 of 70 PageID
`#: 37393
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 66 of 70 PageID
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 67 of 70 PageID
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 68 of 70 PageID
`#: 37398
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 69 of 70 PageID
`#: 37399
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`Case 1:18-cv-00924-CFC-SRF Document 563-6 Filed 11/09/20 Page 70 of 70 PageID
`#: 37400
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