Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________________________
`
`KOIOS PHARMACEUTICALS LLC
`
`
`Petitioner
`
`v.
`
`MEDAC GESELLSCHAFT FÜR KLINISCHE
`SPEZIALPRÄPARATE MBH
`
`
`Patent Owner
`
`___________________________________
`
`Inter Partes Review Case No. IPR2016-01370
`Patent Number 8,664,231
`
`
`
`
`
`
`
`DECLARATION OF BRIAN GUMMOW IN SUPPORT OF
`PATENT OWNER’S RESPONSE
`
`I, Brian Gummow, make
`
`the
`
`following Declaration pursuant
`
`to
`
`28 U.S.C. § 1746:
`
`1.
`
`2.
`
`I am an Associate at Ropes & Gray LLP.
`
`I provide this Declaration in connection with the above-identified
`
`Inter Partes Review proceeding that is being requested at the United States Patent
`
`1
`
`Medac Exhibit 2058
`Koios Pharmaceuticals v. Medac
`IPR2016-01370
`Page 00001
`
`
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________________________
`
`KOIOS PHARMACEUTICALS LLC
`
`
`Petitioner
`
`v.
`
`MEDAC GESELLSCHAFT FÜR KLINISCHE
`SPEZIALPRÄPARATE MBH
`
`
`Patent Owner
`
`___________________________________
`
`Inter Partes Review Case No. IPR2016-01370
`Patent Number 8,664,231
`
`
`
`
`
`
`
`DECLARATION OF BRIAN GUMMOW IN SUPPORT OF
`PATENT OWNER’S RESPONSE
`
`I, Brian Gummow, make
`
`the
`
`following Declaration pursuant
`
`to
`
`28 U.S.C. § 1746:
`
`1.
`
`2.
`
`I am an Associate at Ropes & Gray LLP.
`
`I provide this Declaration in connection with the above-identified
`
`Inter Partes Review proceeding that is being requested at the United States Patent
`
`1
`
`Medac Exhibit 2058
`Koios Pharmaceuticals v. Medac
`IPR2016-01370
`Page 00001
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`and Trademark Office. Unless otherwise stated, the facts stated in this Declaration
`
`are based on my personal knowledge.
`
`1.
`
`Exhibit 2013 hereto is a true and correct copy of an article
`
`entitled “The Use of Methotrexate in Rheumatoid Arthritis,” published by
`
`Seminars in Arthritis and Rheumatism, which was downloaded by Ropes & Gray
`
`Librarian Dan Braun, at my request from http://www.sciencedirect.com/science/
`
`article/pii/S0049017204001556 on May 31, 2016. Page numbers and an exhibit
`
`label have been added to the bottom of this document but no other alterations have
`
`been made.
`
`2.
`
`Exhibit 2014 hereto is a true and correct copy of an article
`
`entitled “Pharmacokinetics and pharmacodynamics of methotrexate in non-
`
`neoplastic diseases,” published by Clinical Pharmacokinetics, which was
`
`downloaded by Ropes & Gray Librarian Ying Zhang, at my request from
`
`http://link.springer.com/article/10.2165/00003088-200342020-00003 on May 24,
`
`2016. Page numbers and an exhibit label have been added to the bottom of this
`
`document but no other alterations have been made.
`
`3.
`
`Exhibit 2015 hereto is a true and correct copy of Drugs@FDA
`
`database
`
`entry
`
`for Mexate, which
`
`I
`
`accessed
`
`and printed
`
`from
`
`http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Searc
`
`h.DrugDetails on May 22, 2016, and which his a record of the FDA to which all
`
`2
`
`Page 00002
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`parties have access. Page numbers and an exhibit label have been added to the
`
`bottom of this document but no other alterations have been made.
`
`4.
`
`Exhibit 2016 hereto is a true and correct copy of an article
`
`entitled “Head-to-head, randomised, crossover study of oral versus subcutaneous
`
`methotrexate in patients with rheumatoid arthritis,” published by Annals of the
`
`Rheumatic Diseases, which I downloaded from http://www.ncbi.nlm.nih.gov/pmc/
`
`articles/PMC4112421/pdf/annrheumdis-2014-205228.pdf on June 1, 2016, and
`
`which is a record of the NIH to which all parties have access. Page numbers and
`
`an exhibit label have been added to the bottom of this document but no other
`
`alterations have been made.
`
`5.
`
`Exhibit 2017 hereto is a true and correct copy of an article
`
`entitled “Parenteral methotrexate should be given before biological therapy,”
`
`published
`
`by
`
`Rheumatology,
`
`which
`
`I
`
`downloaded
`
`from
`
`http://rheumatology.oxfordjournals.org/content/42/8/1009.full.pdf+html on May
`
`31, 2016. Page numbers and an exhibit label have been added to the bottom of this
`
`document but no other alterations have been made.
`
`6.
`
`Exhibit 2019 hereto is a true and correct copy of a book chapter
`
`entitled “Antiproliferative Agents and Drugs Used for Immunosuppression,”
`
`published by Macmillan Publishing Company, in the book Goodman and Gilman’s
`
`The Pharmacological Basis of Therapeutics, Seventh Edition, which was
`
`3
`
`Page 00003
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`photocopied from the University of Minnesota Library at my request on June 2,
`
`2016. Page numbers and an exhibit label have been added to the bottom of this
`
`document but no other alterations have been made.
`
`7.
`
`Exhibit 2020 hereto is a true and correct copy of an article
`
`entitled “2007 Guidelines for Isolation Precautions: Preventing Transmission of
`
`Infectious Agents in Healthcare Settings,” published by Centers for Disease
`
`Control
`
`and
`
`Prevention,
`
`which
`
`I
`
`downloaded
`
`from
`
`http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf on May 24, 2016. Page
`
`numbers and an exhibit label have been added to the bottom of this document but
`
`no other alterations have been made.
`
`8.
`
`Exhibit 2021 hereto is a true and correct copy of a letter from
`
`SICOR Pharmaceuticals, Inc. entitled “ANDA Suitability Petition Methotrxate
`
`Injections, USP (100 mg/mL),” published by the Food and Drug Administration,
`
`which
`
`I
`
`downloaded
`
`from
`
`http://www.fda.gov/ohrms/dockets/dockets/06p0177/06p-0177-cp00001-01-
`
`vol1.pdf on May 24, 2016, and which his a record to which all parties have access.
`
`Page numbers and an exhibit label have been added to the bottom of this document
`
`but no other alterations have been made.
`
`9.
`
`Exhibit 2022 hereto is a true and correct copy of an article
`
`entitled “Current Perspectives on Pain Upon Injection of Drugs,” published by the
`
`4
`
`Page 00004
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`Journal of Pharmaceutical Sciences, which was downloaded by Ropes & Gray
`
`Librarian
`
`Dan
`
`Braun,
`
`at
`
`my
`
`request
`
`from
`
`http://www.sciencedirect.com/science/article/pii/S0022354915505923 on May 26,
`
`2016. Page numbers and an exhibit label have been added to the bottom of this
`
`document but no other alterations have been made.
`
`10.
`
`Exhibit 2024 hereto is a true and correct copy of “Clinical
`
`Guidelines, Extravasation,” West Suffolk Hospitals, http://www.wsh.nhs.uk/
`
`AboutUs/FOI/FOIRequestsAndResponses/Attachments/1033(i).pdf (July 2011),
`
`which was downloaded at my request on June 7, 2017. An exhibit label on the first
`
`page and page numbers on all pages have been added to the bottom of this
`
`document but no other alterations have been made.
`
`11.
`
`Exhibit 2025 hereto is a true and correct copy of “Vesicant
`
`Extravasation: Myths and Realities” Oncology Nursing Forum, Vol. 22, No 1
`
`https://www.researchgate.net/publication/15489710_Vesicant_extravasation_myths_
`
`and_realities (January 1995), which I downloaded on June 8, 2017. An exhibit
`
`label on the first page and page numbers on all pages have been added to the
`
`bottom of this document but no other alterations have been made.
`
`12.
`
`Exhibit 2028 hereto
`
`is a
`
`true and correct copy of
`
`“Extravasation guidelines 2007, Guidelines Implementation Toolkit,” which I
`
`downloaded
`
`from
`
`5
`
`Page 00005
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`http://www.cancernurse.eu/documents/EONSClinicalGuidelinesSection6-en.pdf on
`
`June 8, 2017. Page numbers and an exhibit label have been added to the bottom of
`
`this document but no other alterations have been made.
`
`13.
`
`Exhibit 2029 hereto is a true and correct copy of an article
`
`entitled “Methotrexate therapy for rheumatoid arthritis: clinical practice guidelines
`
`based on published evidence and expert opinion,” published by Joint Bone Spine,
`
`which
`
`I
`
`downloaded
`
`from
`
`https://www.researchgate.net/profile/
`
`Arnaud_Constantin/publication/7153532_Methotrexate_therapy_for_rheumatoid_a
`
`rthritis_clinical_practice_guidelines_based_on_published_evidence_and_expert_o
`
`pinion/links/54af9d4a0cf2b48e8ed67782.pdf on May 11, 2016. Page numbers and
`
`an exhibit label have been added to the bottom of this document but no other
`
`alterations have been made.
`
`14.
`
`Exhibit 2031 hereto is a true and correct copy of “Occurrence
`
`and Impact of Unanticipated Variation in Intravenous Methotrexate Dosing” The
`
`Annals of Pharmacotherapy (May 2006), which was obtained by a Ropes & Gray
`
`Librarian at my request on June 2, 2017. Page numbers and an exhibit label have
`
`been added to the bottom of this document but no other alterations have been
`
`made.
`
`15.
`
`I understand Exhibit 2033 hereto is a true and correct copy of
`
`an extract of the Symphony Health Pharmaceutical Audit Suite (PHAST) search
`
`6
`
`Page 00006
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`for third-party national physician level prescription data reported by dispensing
`
`pharmacies in the U.S. for the treatment of rheumatoid arthritis, including all forms
`
`of methotrexate and biologic treatments from January 2007 to April 2016. It is
`
`also my understanding that Medac Pharma, Inc. produces such reports monthly in
`
`the ordinary course of business. Page numbers and an exhibit label have been
`
`added to the bottom of this document but no other alterations have been made.
`
`16.
`
`Exhibit 2034 hereto is a true and correct copy of an article
`
`entitled “Drug Repositioning: Identifying and Developing New Uses for Existing
`
`Drugs,” published by Nature Reviews Drug Discovery, which was downloaded by
`
`Ropes & Gray Librarian Derrik Albertelli,
`
`at my
`
`request
`
`from
`
`http://www.nature.com/nrd/journal/v3/n8/pdf/nrd1468.pdf on May 27, 2016. Page
`
`numbers and an exhibit label have been added to the bottom of this document but
`
`no other alterations have been made.
`
`17.
`
`Exhibit 2035 hereto is a true and correct copy of an article
`
`entitled “Adherence in the Treatment of Psoriasis: A Systematic Review,”
`
`published by Dermatology, which was downloaded by Ropes & Gray Librarian
`
`Derrik Albertelli,
`
`at my
`
`request
`
`from http://www.karger.com/Article/
`
`Abstract/329026 on May 27, 2016. Page numbers and an exhibit label have been
`
`added to the bottom of this document but no other alterations have been made.
`
`7
`
`Page 00007
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`18.
`Exhibit 2036 hereto is a true and correct copy of an article
`
`entitled “Medication Adherence in Patients With Rheumatoid Arthritis: A Critical
`
`Appraisal of the Existing Literature,” published by Expert Review of Clinical
`
`Immunology, which was downloaded by Ropes & Gray Librarian Derrik
`
`Albertelli,
`
`at my
`
`request
`
`from
`
`http://www.tandfonline.com/doi/full/
`
`10.1586/eci.12.23 on May 27, 2016. Page numbers and an exhibit label have been
`
`added to the bottom of this document but no other alterations have been made.
`
`19.
`
`Exhibit 2037 hereto is a true and correct copy of an article
`
`entitled “Recent Trends in Systemic Psoriasis Treatment Costs,” published by
`
`Archives of Dermatology, which was downloaded by Ropes & Gray Librarian
`
`Derrik Albertelli, at my
`
`request
`
`from http://archderm.jamanetwork.com/
`
`article.aspx?articleid=420949 on May 27, 2016. Page numbers and an exhibit
`
`label have been added to the bottom of this document but no other alterations have
`
`been made.
`
`20.
`
`Exhibit 2038 hereto is a true and correct copy of an article
`
`entitled “Biologics Utilization for Rheumatoid Arthritis in the United States: An
`
`Observational Longitudinal Study,” published by Journal of Medical Marketing,
`
`which was downloaded by Ropes & Gray Librarian Derrik Albertelli, at my
`
`request from http://mmj.sagepub.com/content/13/2/74.full.pdf+html on May 27,
`
`8
`
`Page 00008
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`2016. Page numbers and an exhibit label have been added to the bottom of this
`
`document but no other alterations have been made.
`
`21.
`
`Exhibit 2039 hereto is a true and correct copy of an article
`
`entitled “Review of Disease - Modifying Anti Rheumatic Drugs in Paediatric
`
`Rheumatic Disease,” published by the 18th Expert Committee on the Selection
`
`and Use of Essential Medicines, which was downloaded by Ropes & Gray
`
`Librarian Derrik Albertelli,
`
`at my
`
`request
`
`from http://www.who.int/
`
`selection_medicines/committees/expert/18/applications/Child_DMARD.pdf
`
`on
`
`May 27, 2016. Page numbers and an exhibit label have been added to the bottom
`
`of this document but no other alterations have been made.
`
`22.
`
`Exhibit 2040 hereto is a true and correct copy of an article
`
`entitled “Trends in Biologic Therapies for Rheumatoid Arthritis: Results from a
`
`Survey of Payers and Providers,” published by American Health & Drug Benefits,
`
`which was downloaded by Ropes & Gray Librarian Derrik Albertelli, at my
`
`request from http://www.ahdbonline.com/issues/2012/march-april-2012-vol-5-no-
`
`2/962-feature-962 on May 27, 2016. Page numbers and an exhibit label have been
`
`added to the bottom of this document but no other alterations have been made.
`
`23.
`
`Exhibit 2041 hereto is a true and correct copy of an article
`
`entitled “Estimates of the Prevalence of Arthritis and Other Rheumatic Conditions
`
`in the United States,” published by Arthritis and Rheumatism, which was
`
`9
`
`Page 00009
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`downloaded by Ropes & Gray Librarian Derrik Albertelli, at my request from
`
`http://onlinelibrary.wiley.com/doi/10.1002/art.23177/epdf on May 27, 2016. Page
`
`numbers and an exhibit label have been added to the bottom of this document but
`
`no other alterations have been made.
`
`24.
`
`Exhibit 2042 hereto is a true and correct copy of an article
`
`entitled “Methotrexate and Psoriasis: 2009 National Psoriasis Foundation
`
`Consensus Conference,” published by the Journal of American Academy of
`
`Dermatology, which was downloaded by Ropes & Gray Librarian Derrik
`
`Albertelli, at my request from http://www.jaad.org/article/S0190-9622(08)02482-
`
`1/pdf on May 27, 2016. Page numbers and an exhibit label have been added to the
`
`bottom of this document but no other alterations have been made.
`
`25.
`
`Exhibit 2043 hereto is a true and correct copy of an article
`
`entitled “The Prevalence of Previously Diagnosed and Undiagnosed Psoriasis in US
`
`Adults,” published by the Journal of American Academy of Dermatology, which
`
`was downloaded by Ropes & Gray Librarian Derrik Albertelli, at my request from
`
`http://www.jaad.org/article/S0190-9622(08)01201-2/pdf on May 27, 2016. Page
`
`numbers and an exhibit label have been added to the bottom of this document but
`
`no other alterations have been made.
`
`26.
`
`Exhibit 2044 hereto is a true and correct copy of an article
`
`entitled “Guidelines of Care for the Management of Psoriasis and Psoriatic Arthritis:
`
`10
`
`Page 00010
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`Section 4,” published by the Journal of American Academy of Dermatology, which
`
`was downloaded by Ropes & Gray Librarian Derrik Albertelli, at my request from
`
`http://www.jaad.org/article/S0190-9622(09)00390-9/pdf on May 27, 2016. Page
`
`numbers and an exhibit label have been added to the bottom of this document but
`
`no other alterations have been made.
`
`27.
`
`Exhibit 2045 hereto is a true and correct copy of an article
`
`entitled “Direct Medical Costs and Their Predictors in Patients with Rheumatoid
`
`Arthritis,” published by Arthritis & Rheumatism, which was downloaded by
`
`Ropes & Gray Librarian Derrik Albertelli,
`
`at my
`
`request
`
`from
`
`http://onlinelibrary.wiley.com/doi/10.1002/art.11439/epdf on May 27, 2016. Page
`
`numbers and an exhibit label have been added to the bottom of this document but
`
`no other alterations have been made.
`
`28.
`
`Exhibit 2046 hereto is a true and correct copy of an article
`
`entitled “Rheumatoid Arthritis Market,” published by Nature Reviews Drug
`
`Discovery, which was downloaded by Ropes & Gray Librarian Derrik Albertelli,
`
`at my request from http://www.nature.com/nrd/journal/v4/n1/full/nrd1611.html on
`
`May 27, 2016. Page numbers and an exhibit label have been added to the bottom
`
`of this document but no other alterations have been made.
`
`29.
`
`Exhibit 2047 hereto is a true and correct copy of an article
`
`entitled “How to Improve R&D Productivity: The Pharmaceutical Industry’s Grand
`
`11
`
`Page 00011
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`Challenge,” published by Nature Reviews Drug Discovery, which was downloaded
`
`by Ropes & Gray Librarian Derrik Albertelli, at my
`
`request
`
`from
`
`http://www.nature.com/nrd/journal/v9/n3/pdf/nrd3078.pdf on May 27, 2016. Page
`
`numbers and an exhibit label have been added to the bottom of this document but
`
`no other alterations have been made.
`
`30.
`
`Exhibit 2048 hereto is a true and correct copy of an article
`
`entitled “Psoriasis Prevalence Among Adults in the United States,” published by the
`
`Journal of the American Academy of Dermatology, which was downloaded by
`
`Ropes & Gray Librarian Derrik Albertelli,
`
`at my
`
`request
`
`from
`
`http://www.jaad.org/article/S0190-9622(13)01268-1/pdf on May 27, 2016. Page
`
`numbers and an exhibit label have been added to the bottom of this document but
`
`no other alterations have been made.
`
`31.
`
`Exhibit 2049 hereto is a true and correct copy of an article
`
`entitled “American College of Rheumatology 2008 Recommendations for the Use of
`
`Nonbiologic and Biologic Disease-Modifying Antirheumatic Drugs in Rheumatoid
`
`Arthritis,” published by Arthritis & Rheumatology (Arthritis Care & Research),
`
`which was downloaded by Ropes & Gray Librarian Derrik Albertelli, at my
`
`request from http://onlinelibrary.wiley.com/doi/10.1002/art.23721/epdf on May 27,
`
`2016. Page numbers and an exhibit label have been added to the bottom of this
`
`document but no other alterations have been made.
`
`12
`
`Page 00012
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`32.
`Exhibit 2050 hereto is a true and correct copy of an article
`
`entitled “Systemic Therapy of Psoriasis Using Methotrexate,” published by Skin
`
`Therapy Letter, which was photocopied from the National Library of Medicine at
`
`my request on May 31, 2016. Page numbers and an exhibit label have been added
`
`to the bottom of this document but no other alterations have been made.
`
`33.
`
`Exhibit 2051 hereto is a true and correct copy of an article
`
`entitled “Pharmacy Benefit Plans and Prescription Drug Spending,” published by the
`
`Journal of the American Medical Association, which was downloaded by Ropes
`
`& Gray
`
`Librarian Derrik Albertelli,
`
`at my
`
`request
`
`from
`
`http://jama.jamanetwork.com/article.aspx?articleid=195366 on May 27, 2016.
`
`Page numbers and an exhibit label have been added to the bottom of this document
`
`but no other alterations have been made.
`
`34.
`
`Exhibit 2052 hereto is a true and correct copy of a book chapter
`
`entitled “R&D Costs and Returns to New Drug Development: A Review of the
`
`Evidence,” published by the Oxford University Press, in the book The Oxford
`
`Handbook of The Economics of the Biopharmaceutical Industry, which was
`
`photocopied from the Library of Congress at my request on May 31, 2016. Page
`
`numbers and an exhibit label have been added to the bottom of this document but
`
`no other alterations have been made.
`
`13
`
`Page 00013
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`35.
`Exhibit 2053 hereto is a true and correct copy of a book chapter
`
`entitled “Patents and Regulatory Exclusivity,” published by the Oxford University
`
`Press,
`
`in
`
`the book The Oxford Handbook of The Economics of
`
`the
`
`Biopharmaceutical Industry, which was photocopied from the Library of Congress
`
`at my request on May 31, 2016. Page numbers and an exhibit label have been
`
`added to the bottom of this document but no other alterations have been made.
`
`36.
`
`Exhibit 2054 hereto is a true and correct copy of a book chapter
`
`entitled “The Regulations of Medical Products,” published by the Oxford University
`
`Press,
`
`in
`
`the book The Oxford Handbook of The Economics of
`
`the
`
`Biopharmaceutical Industry, which was photocopied from the Library of Congress
`
`at my request on May 31, 2016. Page numbers and an exhibit label have been
`
`added to the bottom of this document but no other alterations have been made.
`
`37.
`
`Exhibit 2055 hereto is a true and correct copy of “Use of
`
`Plasma Pharmacokinetics to Predict and Prevent Methotrexate Toxicity,” New
`
`England
`
`Journal
`
`of
`
`Medicine,
`
`http://www.nejm.org/doi/full/10.1056/NEJM197709222971203 (September 1977),
`
`which I downloaded on request on June 8, 2017. Page numbers and an exhibit
`
`label have been added to the bottom of this document but no other alterations have
`
`been made.
`
`14
`
`Page 00014
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`
`
`Attorney Docket No.
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`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`38.
`Exhibit 2059 hereto is a true and correct copy of a press release
`
`by Antares Pharma entitled, “Antares Pharma Announces Availability of Otrexup
`
`(Methotrexate) Injection for Subcutaneour Use to Treat Rheumatoid Arthritis (RA)
`
`and Psoriasis in Adults, and Polyarticular Idiopathic Arthritis (pJIA) in Children,”
`
`published Jan. 15, 2014, which was downloaded at my request from
`
`http://www.antarespharma.com/files/1613/8979/5540/OTREXUP_Availability_Re
`
`lease.pdf on May 31, 2016. An exhibit label on the first page and page numbers on
`
`all pages have been added to the bottom of this document but no other alterations
`
`have been made.
`
`39.
`
`Exhibit 2060 hereto is a true and correct copy of an article by
`
`Gardiner Harris entitled, “Supply of a Cancer Drug May Run Out Within Weeks,”
`
`published Feb. 10, 2012 by The New York Times, which was downloaded at my
`
`request
`
`from
`
`http://www.nytimes.com/2012/02/11/health/policy/supply-of-
`
`methotrexate-a-cancer-drug-may-run-out-soon.html?_r=0 on May 31, 2016. An
`
`exhibit label on the first page and page numbers on all pages have been added to
`
`the bottom of this document but no other alterations have been made.
`
`40.
`
`Exhibit 2061 hereto is a true and correct copy of “About
`
`Rasuvo™,” Medac Pharma, which was downloaded at my request from
`
`http://www.rasuvo.com/patients/background on May 31, 2016. An exhibit label on
`
`15
`
`Page 00015
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`the first page and page numbers on all pages have been added to the bottom of this
`
`document but no other alterations have been made.
`
`41.
`
`Exhibit 2062 hereto is a true and correct copy of “Antares
`
`Pharma’s (ATRS) CEO Paul Wotton on Q1 2014 Results - Earnings Call
`
`Transcript,” Seeking Alpha, May 9, 2014, which was downloaded at my request
`
`from
`
`http://seekingalpha.com/article/2206743-antarespharmas-atrs-ceo-paul-
`
`wotton-on-q1-2014-results-earnings-call-transcript?part=single on May 31, 2016.
`
`An exhibit label on the first page and page numbers on all pages have been added
`
`to the bottom of this document but no other alterations have been made.
`
`42. Exhibit 2063 hereto is a true and correct copy of an article, “Antares:
`
`Thoughts on the Upcoming OtrexupTM Launch,” Seeking Alpha, Nov, 8, 2013,
`
`which was downloaded at my
`
`request
`
`from http://seekingalpha.com/
`
`article/1822102-antares-thoughts-on-the-upcoming-otrexup-launch on May 31,
`
`2016. An exhibit label on the first page and page numbers on all pages have been
`
`added to the bottom of this document but no other alterations have been made.
`
`43. Exhibit 2064 hereto is a true and correct copy of an article by Larry
`
`Smith entitled, “Antares; My View of How Otrexup™ and Medac’s New Product
`
`Rasuvo™ May Compete (ATRS, Buy, $2.54),” SmithOnStocks, July 12, 2014,
`
`which was downloaded at my request from http://smithonstocks.com/antares-my-
`
`view-of-how-otrexup-and-medacs-new-product-rasuvo-may-compete-atrs-buy-2-
`
`16
`
`Page 00016
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`54/ on May 31, 2016. An exhibit label on the first page and page numbers on all
`
`pages have been added to the bottom of this document but no other alterations have
`
`been made.
`
`44.
`
`Exhibit 2066 hereto is a true and correct copy of a publication
`
`“DMARDs for Juvenile Idiopathic Arthritis: A Review of the Research for Parents
`
`and Caregivers,” John M Eisenberg Center for Clinical Decisions and
`
`Communications Science, Baylor College of Medicine, dated Sept. 26, 2011,
`
`which was downloaded at my request from http://www.ncbi.nlm.nih.gov/
`
`pubmedhealth/PMH0016454/ on May 31, 2016, and which is a record of the U.S.
`
`National Institutes of Health to which all parties have access. An exhibit label on
`
`the first page and page numbers on all pages have been added to the bottom of this
`
`document but no other alterations have been made.
`
`45. Exhibit 2068 hereto is a true and correct copy of “FDA Approval
`
`Letter: Otrexup™,” Drugs@FDA, dated Oct. 11, 2013, which was
`
`downloaded
`
`at my
`
`request
`
`from
`
`http://www.accessdata.fda.gov/
`
`drugsatfda_docs/nda/2013/204824Orig2s000Approv.pdf on May 31, 2016, and
`
`which is a record of the U.S. Food and Drug Adminstration (“FDA”) to which all
`
`parties have access. An exhibit label on the first page and page numbers on all
`
`pages have been added to the bottom of this document but no other alterations have
`
`been made.
`
`17
`
`Page 00017
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`46.
`Exhibit 2069 hereto is a true and correct copy of “FDA
`
`Approval Letter: Rasuvo™,” Drugs@FDA, July 10, 2014, which was
`
`downloaded
`
`at my
`
`request
`
`from
`
`http://www.accessdata.fda.gov/
`
`drugsatfda_docs/nda/2014/205776Orig1s000Approv.pdf on May 31, 2016, and
`
`which is a record of the FDA to which all parties have access. An exhibit label on
`
`the first page and page numbers on all pages have been added to the bottom of this
`
`document but no other alterations have been made.
`
`47.
`
`Exhibit 2070 hereto is a true and correct copy of an article by
`
`Linda Rath entitled, “FDA OKs a New Methotrexate Injection Device,”
`
`Arthritis Foundation, Aug. 15, 2014, which was downloaded at my request
`
`from http://www.arthritistoday.org/news/new-methotrexate-autoinjector-349.php on
`
`May 31, 2016. An exhibit label on the first page and page numbers on all pages
`
`have been added to the bottom of this document but no other alterations have been
`
`made.
`
`48. Exhibit 2071 hereto is a true and correct copy of “FDA Summary
`
`Review:
`
`Otrexup™,”
`
`Drugs@FDA,
`
`Oct.
`
`15,
`
`2013,
`
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204824Orig1s000Admin
`
`corres.pdf which was downloaded at my request on May 31, 2016, and which is a
`
`record of the FDA to which all parties have access. An exhibit label on the first
`
`18
`
`Page 00018
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`page and page numbers on all pages have been added to the bottom of this
`
`document but no other alterations have been made.
`
`49.
`
`Exhibit 2072 hereto is a true and correct copy of “Frequently
`
`Asked Questions on Prescription Drug User Fees (PDUFA),” U.S. Food and Drug
`
`Administration,
`
`http://www.fda.gov/Drugs/DevelopmentApprovalProcess/
`
`SmallBusinessAssistance/ucm069943.htm which was downloaded at my request
`
`on May 31, 2016, and which is a record of the FDA to which all parties have
`
`access. An exhibit label on the first page and page numbers on all pages have been
`
`added to the bottom of this document but no other alterations have been made.
`
`50. Exhibit 2073 hereto is a true and correct copy of “Guidance for
`
`Industry: Applications Covered by Section 505(b)(2),”U.S. Food and Drug
`
`Administration, Oct. 1999, http://www.fda.gov/downloads/Drugs/.../Guidances/
`
`ucm079345.pdf which was downloaded at my request on May 31, 2016, and which
`
`is a record of the FDA to which all parties have access. An exhibit label on the
`
`first page and page numbers on all pages have been added to the bottom of this
`
`document but no other alterations have been made.
`
`51.
`
`Exhibit 2074 hereto is a true and correct copy of “Highlights
`
`of Prescribing Information: OXTREXUP™,” Drugs@FDA, Nov. 2014,
`
`http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204824s003lbl.pdf
`
`which was downloaded at my request on May 31, 2016, and which is a record of
`
`19
`
`Page 00019
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`the FDA to which all parties have access. An exhibit label on the first page and
`
`page numbers on all pages have been added to the bottom of this document but no
`
`other alterations have been made.
`
`52.
`
`Exhibit 2075 hereto is a true and correct copy of “Highlights
`
`of Prescribing
`
`Information: RASUVO™,” Drugs@FDA, July 2014,
`
`https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205776s000lbl.pdf
`
`which was downloaded at my request on May 31, 2016, and which is a record of
`
`the FDA to which all parties have access. An exhibit label on the first page and
`
`page numbers on all pages have been added to the bottom of this document but no
`
`other alterations have been made.
`
`53. Exhibit 2076 hereto is a true and correct copy of a publication
`
`entitled, “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,
`
`https://www.medicare.gov/Publications/Pubs/pdf/11136.pdf
`
`which was downloaded at my request on May 31, 2016, and which is a record of
`
`the FDA to which all parties have access. An exhibit label on the first page and
`
`page numbers on all pages have been added to the bottom of this document but no
`
`other alterations have been made.
`
`20
`
`Page 00020
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`54.
`Exhibit 2077 hereto is a true and correct copy of “Jefferies
`
`Boosts PT on Antares Pharma (ATRS) 20% into OTREXUP™ PDUFA;
`
`Maintains
`
`Buy,”
`
`StreetInsiden.com,
`
`Oct.
`
`8,
`
`2013,
`
`http://www.streetinsider.com/Analyst+Comments/Jefferies+Boosts+PT+on+Antar
`
`es+Pharma+%28ATRS%29+20%25+into+OTREXUP+PDUFA%3B+Maintains+
`
`Buy/8758127.html which was downloaded at my request on May 31, 2016. An
`
`exhibit label on the first page and page numbers on all pages have been added to
`
`the bottom of this document but no other alterations have been made.
`
`55.
`
`Exhibit 2079 hereto
`
`is a
`
`true and correct copy of a
`
`“Memorandum Report: Comparison of First-Quarter 2012 Average Sales Prices
`
`and Average Manufacturer Prices: Impact on Medicare Reimbursement for Third
`
`Quarter 2012, OOEI-03-12-00730,” Department of Health and Human Services,
`
`Dec. 12, 2012, https://oig.hhs.gov/oei/reports/oei-03-12-00730.pdf which was
`
`downloaded at my request on May 31, 2016, and which is a record of U.S.
`
`Department of Health and Human Services which all parties have access. An
`
`exhibit label on the first page and page numbers on all pages have been added to
`
`the bottom of this document but no other alterations have been made.
`
`56. Exhibit 2081 hereto is a true and correct copy of “Prescription Drug
`
`Trends,” Kaiser Family Foundation, Fact Sheet #3057-30, Oct. 2004,
`
`http://www.cigna.com/pdf/Prescription-Drug-Trends-Oct2004.pdf which was
`
`21
`
`Page 00021
`
`
`
`Attorney Docket No.
`
`IPR2016-01370
`110670-0009-651
`
`U.S. Patent No. 8,664,231
`downloaded at my request on May 31, 2016. An exhibit label on the first page and
`
`page numbers on all pages have been added to the bottom of this document but no
`
`other alterations have been made.
`
`57. Exhibit 2082 hereto is a true and correct copy of “Psoriasis Treatments
`
`with Next Generation Vitamin D Analogs,” Wisconsin Alumni Research
`
`Foundation,
`
`http://www.warf.org/for-industry/vitamin-d/psoriasis/
`
`psoriasis.cmsx which was downloaded at my request on May 31, 2016. An
`
`exhibit label on the first page and page numbers on all pages have been added to
`
`the bottom of this document but no other alterations have been made.
`
`58.
`
`Exhibit 2084 hereto is a true and correct copy of “Rheumatoid
`
`Arthritis Signs
`
`and Symptoms,”
`
`Johns Hopkins Arthritis Center,
`
`http://www.hopkinsarthritis.org/arthritis-info/rheumatoid-arthritis/ra-symptoms/
`
`which was downloaded at my request on May 31, 2016. An exhibit label on the
`
`first page and page numbers on all pages have been added to the bottom of this
`
`document but no other alterations have been made.
`
`59.
`
`Exhibit 2090 hereto is a true and correct copy of “Use of Oral
`
`and Subcutaneous Methotrexate in Rheumatoid Arthr
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