Attorney Docket No.
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`110670-0010-651
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________________________
`
`FRONTIER THERAPEUTICS, LLC
`
`
`Petitioner
`
`v.
`
`MEDAC GESELLSCHAFT FÜR KLINISCHE
`SPEZIALPRÄPARATE MBH
`
`
`Patent Owner
`
`___________________________________
`
`Inter Partes Review Case No. IPR2016-00649
`Patent Number 8,664,231
`
`
`
`
`
`
`
`DECLARATION OF BRIAN GUMMOW IN SUPPORT OF PATENT
`OWNER’S PRELIMINARY 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
`Frontier Therapeutics v. Medac
`IPR2016-00649
`Page 00001
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`110670-0010-651
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________________________
`
`FRONTIER THERAPEUTICS, LLC
`
`
`Petitioner
`
`v.
`
`MEDAC GESELLSCHAFT FÜR KLINISCHE
`SPEZIALPRÄPARATE MBH
`
`
`Patent Owner
`
`___________________________________
`
`Inter Partes Review Case No. IPR2016-00649
`Patent Number 8,664,231
`
`
`
`
`
`
`
`DECLARATION OF BRIAN GUMMOW IN SUPPORT OF PATENT
`OWNER’S PRELIMINARY 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
`Frontier Therapeutics v. Medac
`IPR2016-00649
`Page 00001
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`and Trademark Office. Unless otherwise stated, the facts stated in this Declaration
`
`Attorney Docket No.
`110670-0010-651
`
`
`
`
`are based on my personal knowledge.
`
`3.
`
`Exhibit 2001 hereto is a true and correct copy of a January 8, 2016
`
`letter from Frontier Therapeutics to Medac Pharma, Inc., which I understand was
`
`received by Ms. Terri Shoemaker, President and CEO of Medac Pharma, Inc. on
`
`January 8, 2016. Page numbers and an exhibit label have been added to the bottom
`
`of this document but no other alterations have been made.
`
`4.
`
`Exhibit 2002 hereto is a true and correct copy of the State of
`
`Washington’s Secretary of State’s Corporations Division – Registration Data
`
`Search entry for Frontier Therapeutics LLC, which I accessed and printed from
`
`http://www.sos.wa.gov/corps/search_detail.aspx?ubi=603566537 on May 24,
`
`2016, and which is 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.
`
`5.
`
`Exhibit 2003 hereto is a true and correct copy of the State of
`
`Washington’s Secretary of State’s Corporations Division – Registration Data
`
`Search entry for Jason Paul Greer Enterprises Limited Liability Company, which I
`
`accessed
`
`and
`
`printed
`
`from
`
`http://www.sos.wa.gov/corps/search_detail.aspx?ubi=603185788 on May 24,
`
`2
`
`
`Page 00002
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`2016, and which is a record to which all parties have access. Page numbers and an
`
`Attorney Docket No.
`110670-0010-651
`
`
`
`
`exhibit label have been added to the bottom of this document but no other
`
`alterations have been made.
`
`6.
`
`Exhibit 2004 hereto is a true and correct copy of the State of
`
`Washington Business Licensing Service entry for Jason Paul Greer Enterprises
`
`Limited Liability Company, which was accessed and printed by Ropes & Gray
`
`librarian
`
`David
`
`Kolpin
`
`at
`
`my
`
`request
`
`from
`
`http://washington.intercreditreport.com/company/jason-paul-greer-enterprises-
`
`limited-liability-company-603185788 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.
`
`7.
`
`Exhibit 2005 hereto is a true and correct copy of the Whois Data
`
`entry for frontiertherapeuticsnw.com, which I accessed and printed from
`
`http://www.whoismind.com/whois/frontiertherapeuticsnw.com.html on June 1,
`
`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 2006 hereto is a true and correct copy of Dr. Weinblatt’s
`
`Declaration from IPR2014-01091, which I downloaded from the Patent Trial and
`
`Appeal
`
`Board’s
`
`Patent
`
`Review
`
`Processing
`
`System
`
`3
`
`
`Page 00003
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`(https://ptabtrials.uspto.gov/prweb/PRServlet/HcI5xOSeX_yQRYZAnTXXCg%5
`
`Attorney Docket No.
`110670-0010-651
`
`
`
`
`B%5B*/!STANDARD?) on May 17, 2016, and which is 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 2007 hereto is a true and correct copy of a redline
`
`comparison of Dr. Gershwin’s Declaration (Ex. 1012) and Dr. Weinblatt’s
`
`Declaration from IPR2014-01091, which I generated on May 17, 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 2008 hereto is a true and correct copy of a search of the
`
`National Center
`
`for Biotechnology
`
`Information’s PubMed database for
`
`“Gershwin” and “methotrexate,” which
`
`I accessed and printed
`
`from
`
`https://www.ncbi.nlm.nih.gov/pubmed on May 22, 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.
`
`11.
`
`Exhibit 2009 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
`
`4
`
`
`Page 00004
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`Librarian
`
`Dan
`
`
`
`
`Attorney Docket No.
`110670-0010-651
`
`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.
`
`12.
`
`Exhibit 2010 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.
`
`13.
`
`Exhibit 2011 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
`
`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.
`
`14. Exhibit 2012 hereto is a true and correct copy of an article entitled
`
`“Parenteral methotrexate should be given before biological therapy,” published by
`
`5
`
`
`Page 00005
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`Rheumatology,
`
`which
`
`
`
`
`I
`
`Attorney Docket No.
`110670-0010-651
`
`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.
`
`15. Exhibit 2014 hereto is a true and correct copy of an article entitled
`
`“Improving Tolerance and Bioavailability of Methotrexate by Switching from Oral
`
`to Subcutaneous Route of Administration,” published by Rheumatology, which
`
`was downloaded by Ropes & Gray Librarian Derrik Albertelli, at my request from
`
`http://rheumatology.oxfordjournals.org/content/44/suppl_1/i145.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.
`
`16. Exhibit 2015 hereto is a true and correct copy of an article entitled
`
`“Pharmacokinetics of Subcutaneous Methotrexate,” published by the Journal of
`
`Clinical Oncology, which was downloaded by Ropes & Gray Librarian Derrik
`
`Albertelli,
`
`at
`
`my
`
`request
`
`from
`
`http://jco.ascopubs.org/content/6/12/1882.full.pdf+html on June 1, 2016. Page
`
`numbers and an exhibit label have been added to the bottom of this document but
`
`no other alterations have been made.
`
`6
`
`
`Page 00006
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`17.
`
`
`
`
`Attorney Docket No.
`110670-0010-651
`
`Exhibit 2016 hereto is a true and correct copy of an article entitled
`
`“Head-to-head, randomized, 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.
`
`18.
`
`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
`
`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.
`
`19.
`
`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
`
`7
`
`
`Page 00007
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`numbers and an exhibit label have been added to the bottom of this document but
`
`Attorney Docket No.
`110670-0010-651
`
`
`
`
`no other alterations have been made.
`
`20.
`
`Exhibit 2021 hereto is a true and correct copy of a letter from
`
`SICOR Pharmaceuticals, Inc. entitled “ANDA Suitability Petition,” 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.
`
`21.
`
`Exhibit 2022 hereto is a true and correct copy of an article entitled
`
`“Current Perspectives on Pain Upon Injection of Drugs,” published by the 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.
`
`22.
`
`Exhibit 2024 hereto is a true and correct copy of book chapters
`
`entitled “Drug Administration” and “Life Span: Children,” published by Wolters
`
`Kluwer Health | Lippincott Williams & Wilkinson, in the book Drug Therapy in
`
`8
`
`
`Page 00008
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`Nursing, which was photocopied from the University of Wisconsin Library by
`
`Attorney Docket No.
`110670-0010-651
`
`
`
`
`WTS Article Delivery 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.
`
`23.
`
`Exhibit 2025 hereto is a true and correct copy of a book chapter
`
`entitled “Human: Veterinary Technology Cross Over,” published by Springer, in
`
`the book Long Acting Animal Health Drug Products: Fundamentals and
`
`Applications,
`
`which
`
`was
`
`downloaded
`
`from
`
`http://link.springer.com/chapter/10.1007/978-1-4614-4439-8_16 at my request by
`
`Ropes & Gray librarian Michele Prevost on May 23, 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 2028 hereto is a true and correct copy of an article
`
`entitled “Bioavailability of oral vs. subcutaneous low-dose methotrexate in patients
`
`with Crohn’s disease,” published by Alimentary Pharmacology & Therapeutics,
`
`which I downloaded from http://onlinelibrary.wiley.com/doi/10.1046/j.1365-
`
`2036.2003.01614.x/pdf on May 22, 2016. Page numbers and an exhibit label have
`
`been added to the bottom of this document but no other alterations have been
`
`made.
`
`9
`
`
`Page 00009
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`25.
`
`
`
`
`Attorney Docket No.
`110670-0010-651
`
`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_Met
`
`hotrexate_therapy_for_rheumatoid_arthritis_clinical_practice_guidelines_based_o
`
`n_published_evidence_and_expert_opinion/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.
`
`26.
`
`I understand Exhibit 2033 hereto is a true and correct copy of an
`
`extract of the Symphony Health Pharmaceutical Audit Suite (PHAST) search 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.
`
`27. 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
`
`10
`
`
`Page 00010
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`Ropes & Gray Librarian Derrik Albertelli,
`
`
`
`
`Attorney Docket No.
`110670-0010-651
`
`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.
`
`28.
`
`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.
`
`29.
`
`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.
`
`11
`
`
`Page 00011
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`30.
`
`
`
`
`Attorney Docket No.
`110670-0010-651
`
`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.
`
`31.
`
`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,
`
`2016. Page numbers and an exhibit label have been added to the bottom of this
`
`document but no other alterations have been made.
`
`32.
`
`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_
`
`12
`
`
`Page 00012
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`DMARD.pdf on May 27, 2016. Page numbers and an exhibit label have been
`
`Attorney Docket No.
`110670-0010-651
`
`
`
`
`added to the bottom of this document but no other alterations have been made.
`
`33.
`
`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.
`
`34.
`
`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
`
`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.
`
`35.
`
`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
`
`13
`
`
`Page 00013
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`Dermatology, which was downloaded by Ropes & Gray Librarian Derrik
`
`Attorney Docket No.
`110670-0010-651
`
`
`
`
`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.
`
`36.
`
`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.
`
`37.
`
`Exhibit 2044 hereto is a true and correct copy of an article
`
`entitled “Guidelines of Care for the Management of Psoriasis and Psoriatic Arthritis:
`
`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.
`
`14
`
`
`Page 00014
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`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`38.
`
`
`
`
`Attorney Docket No.
`110670-0010-651
`
`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.
`
`39.
`
`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.
`
`40.
`
`Exhibit 2047 hereto is a true and correct copy of an article
`
`entitled “How to Improve R&D Productivity: The Pharmaceutical Industry’s Grand
`
`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.
`
`15
`
`
`Page 00015
`
`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`41.
`
`
`
`
`Attorney Docket No.
`110670-0010-651
`
`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.
`
`42.
`
`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.
`
`43.
`
`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.
`
`16
`
`
`Page 00016
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`
`
`IPR2016-00649
`U.S. Patent No. 8,664,231
`
`44.
`
`
`
`
`Attorney Docket No.
`110670-0010-651
`
`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.
`
`45.
`
`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.
`
`46.
`
`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.
`
`17
`
`
`Page 00017
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`
`
`IPR2016—00649
`
`U.S. Patent No. 8,664,231
`
`Attorney Docket No.
`
`110670—0010—651
`
`47.
`
`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
`
`Biop/qarmaceutical 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.
`
`48.
`
`I have been informed that willfully false
`
`statements
`
`are
`
`punishable by fine or imprisonment, or both.
`
`I make this declaration of my own
`
`personal knowledge, and all statements are true. If called to testify as to the truth
`
`of the matters stated herein, I could and would testify competently.
`
`I declare under penalty of perjury that the foregoing is true and correct._
`
`Executed this 2 day of June, 2016, at New York, NY.
`
`,,\_~
`
`/6
`
`Brian Gummow
`
`18
`
`Page 00013
`
`Page 00018
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