throbber
IPR2016-00649
`U.S. Patent No. 8,664,231
`
`
`
`
`
`Attorney Docket No.
`110670-0010-651
`
`Patent Owner’s Updated Exhibit List – November 22, 2016
`
`January 8, 2016 Letter from Jason Greer to Terri Shoemaker re
`Rasuvo™ and Orange Book-Listed U.S. Patent No. 8,664,231
`WA Secretary of State Registration Detail for Frontier Therapeutics,
`LLC, available at
`http://www.sos.wa.gov/corps/search_detail.aspx?ubi=603566537
`WA Secretary of State Registration Detail for Jason Paul Greer
`Enterprises LLC, available at
`http://www.sos.wa.gov/corps/search_detail.aspx?ubi=603185788
`State of Washington Business Licensing Service entry for Jason Paul
`Greer Enterprises Limited Liability Company, available at
`http://bls.dor.wa.gov/LicenseSearch/lqsLicenseDetail.aspx?RefID=1084
`904, last visited May 24, 2016
`Whois Data for Frontiertherapeuticsnw.com, available at
`http://www.whoismind.com/whois/frontiertherapeuticsnw.com.html, last
`visited June 1, 2016
`Declaration of Dr. Michael E. Weinblatt, dated June 17 2014
`Redline comparison of Gershwin Declaration and Weinblatt Declaration
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`U.S. Patent No. 8,480,631
`Breslin, et al., “Improving Tolerance and Bioavailability of
`Methotrexate by Switching from Oral to Subcutaneous Route of
`Administration,” Rheumatology 388 (2005)
`Balis, et al., “Pharmacokinetics of Subcutaneous Methotrexate,” Journal
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`
`2001
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`2002
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`2003
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`2004
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`2005
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`2006
`2007
`2008
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`2009
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`2010
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`2011
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`2012
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`2013
`2014
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`2015
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`

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`2016
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`2017
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`2018
`2019
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`2020
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`2021
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`2022
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`2023
`2024
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`2025
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`
`Schiff, et al., “Head-to-head, randomized, crossover study of oral versus
`subcutaneous methotrexate in patients with rheumatoid arthritis,” Ann
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`Antares Pharma Press Release, “Antares Pharma Announces the
`Publication of a Head-to-Head, Randomized, Crossover Study of Oral
`versus Subcutaneous Methotrexate in Patients with Rheumatoid
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`Expert Declaration of Elena Massarotti, MD., dated Nov. 14, 2014
`Goodman and Gilman’s The Pharmacological Basis of Therapeutics, 7th
`Ed, 1985
`2007 CDC Guidelines for Isolation Precautions: Preventing
`Transmission of Infectious Agents in Healthcare Settings
`SICOR Pharmaceuticals ANDA Suitability Petition Methotrexate
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`Pavy S. et al., “Methotrexate therapy for rheumatoid arthritis: clinical
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`Declaration of Maria Salgado in Support of Patent Owner’s Preliminary
`Response
`Declaration of Michael P. Duffey in Support of Patent Owner’s
`Preliminary Response
`Expert Declaration of Dr. Sean Nicholson
`MTX Information with Strength (MEDAC-NJ 0002040)
`
`-2-
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`2041
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`Ashburn, T. et al., “Drug Repositioning: Identifying and Developing
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`Beyer, V. et al., “Recent Trends in Systemic Psoriasis Treatment
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`United States: An Observational Longitudinal Study,” Journal of
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`Selection and Use of Essential Medicines (2010)
`Greenapple, R., “Trends in Biologic Therapies for Rheumatoid
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`Vol. 58, No. 1, pp. 15-25 (2008)
`Kalb, R. et al., “Methotrexate and Psoriasis: 2009 National Psoriasis
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`Dermatology, Vol. 60, No. 5, pp. 824-837 (2009)
`Kurd, S. et al., “The Prevalence of Previously Diagnosed and Undiagnosed
`Psoriasis in US Adults,” Journal of the American Academy of
`Dermatology, Vol. 60, Issue 2, pp. 218-224 (2009)
`Menter, A. et al., “Guidelines of Care for the Management of Psoriasis
`and Psoriatic Arthritis: Section 4,” Journal of the American Academy of
`Dermatology, Vol. 61, No. 3, pp. 451-485 (2009)
`Michaud, K. et al., “Direct Medical Costs and Their Predictors in Patients
`with Rheumatoid Arthritis,” Arthritis & Rheumatism, Vol. 48, No. 10,
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`Mount, C. et al., “Rheumatoid Arthritis Market,” Nature Reviews Drug
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`Paul, S. et al., “How to Improve R&D Productivity: The Pharmaceutical
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`
`-3-
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`Oxford Handbook of The Economics of the Biopharmaceutical Industry,
`Oxford University Press, pp. 21-46 (2012)
`Eisenberg, R., “Patents and Regulatory Exclusivity,” in P. Danzon, and
`S. Nicholson (eds), The Oxford Handbook of The Economics of the
`Biopharmaceutical Industry, Oxford University Press, pp. 167-198
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`and S. Nicholson (eds), The Oxford Handbook of the Economics of the
`Biopharmaceutical Industry, Oxford University Press, pp. 100-142
`(2012)
`Omitted
`“October 2006 ASP Pricing File - Updated 12/19/07,” Centers for
`Medicare and Medicaid Services,
`http://www.cms.gov/apps/ama/license.asp?file=/McrPartBDrugAvgSalesP
`rice/downloads /oct06asphcpcs.zip
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`Medicaid Services,
`http://www.cms.gov/apps/ama/license.asp?file=/McrPartBDrugAvgSalesPri
`ce/downloads /2014-October-ASP-Pricing-File.zip
`Declaration of Brian Gummow in Support of Patent Owner’s Preliminary
`Response
`
`
`
`-4-
`
`

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`2070
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`“Antares Pharma Announces Availability of Otrexup™ (Methotrexate)
`Injection for Subcutaneous Use to Treat Rheumatoid Arthritis (RA) and
`psoriasis in adults, and polyarticular idiopathic arthritis (pJIA) in
`Children,” Antares Pharma Press Release, dated Jan. 15, 2014
`“Supply of a Cancer Drug May Run Out Within Weeks,” New York
`Times, dated Feb. 10, 2012
`“About Rasuvo™,” Medac Pharma,
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`“Antares Pharma’s (ATRS) CEO Paul Wotton on Q1 2014 Results -
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`on-the-upcoming-otrexuplaunch
`“Antares; My View of How Otrexup™ and Medac's New Product
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`12, 2014, http.//smithonstocks.com/antares-my-view-of-how-otrexup-and-
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`guide/search-byclass.php?drugclass=DMARDs
`“DMARDs for Juvenile Idiopathic Arthritis: A Review of the Research
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`Sept. 26, 2011,
`http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0016454/
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`drugs/disease-modifying-drugs/drug-guide-dmards.php
`“FDA Approval Letter: Otrexup™,” Drugs@FDA, Oct. 11, 2013,
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig2s
`000Approv.pdf
`“FDA Approval Letter: Rasuvo™,” Drugs@FDA, July 10, 2014,
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`000Approv.pdf
`“FDA OKs a New Methotrexate Injection Device,” Arthritis
`Foundation, Aug. 15, 2014, http://www.arthritistoday.org/news/new-
`methotrexate-autoinjector-349.php
`
`-5-
`
`

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`000Admincorres.pdf
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`(PDUFA),” U.S. Food and Drug Administration,
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`sAssistance/ucm069943.htm
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`bl.pdf
`
`“Highlights of Prescribing Information: RASUVO™,”
`Drugs@FDA, July 2014,
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205776s00
`0lbl.pdf
`“How Medicare Prescription Drug Plans and Medicare Advantage
`Plans with Prescription Drug Coverage (MA-PDs) Use Pharmacies,
`Formularies, & Common Coverage Rules,” Department of Health &
`Human Services, October 2015,
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`OTREXUP™ PDUFA; Maintains Buy,” StreetInsiden.com, Oct. 8,
`2013,
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`+on+Antares+Pharma+%28ATRS%29+20%25+into+OTREXUP+PDU
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`“Juvenile Idiopathic Arthritis (JIA),” NYU Langone Medical Center
`Division of Pediatric Rheumatology,
`http://pediatrics.med.nyu.edu/rheumatology/patient-care/juvenile-
`idiopathic-arthritis-jia
`
`
`
`-6-
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`
`“Memorandum Report: Comparison of First-Quarter 2012 Average Sales
`Prices and Average Manufacturer Prices: Impact on Medicare
`Reimbursement for Third Quarter 2012, OEI-03-12-00730,”
`Department of Health and Human Services, Dec. 12, 2012,
`https://oig.hhs.gov/oei/reports/oei-03-12-00730.pdf
`“Methotrexate Fact Sheet,” American College of Rheumatology,
`May 2012,
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`otrexate.pdf
`“Prescription Drug Trends,” Kaiser Family Foundation, Fact Sheet
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`“Psoriasis Treatments with Next Generation Vitamin D Analogs,”
`Wisconsin Alumni Research Foundation, http://www.warf.org/for-
`industry/vitamin-d/psoriasis/psoriasis.cmsx
`“Questions and Answers about Juvenile Arthritis,” National
`Institute of Arthritis and Musculoskeletal and Skin Diseases, Aug.
`2013, http://www.niams.nih.gov/Health Info/Juv Arthritis/#1
`“Rheumatoid Arthritis Signs and Symptoms,” Johns Hopkins
`Arthritis Center, http://www.hopkinsarthritis.org/arthritis-
`info/rheumatoid-arthritis/ra-symptoms/
`“State and County QuickFacts,” United States Census
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`FDA Orange Book Data File Patent.txt
`FDA Orange Book Data File Products.txt
`FDA Orange Book Data File Exclusivity.txt
`Compilation of Drug Labels
`Settlement Agreement [Confidential]
`
`
`
`-7-

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