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 MARIA SALGADO IN SUPPORT OF PATENT
`OWNER’S PRELIMINARY RESPONSE
`
`I, Maria Salgado, make
`
`the
`
`following Declaration pursuant
`
`to
`
`28 U.S.C. § 1746:
`
`1.
`
`2.
`
`I am a Principal at Cornerstone Research.
`
`I provide this Declaration in connection with the above-identified
`
`Inter Partes Review proceeding that is being requested at the United States Patent
`
`Medac Exhibit 2030
`Koios Pharmaceuticals v. Medac
`IPR2016-01370
`Page 00001
`
`
`
`___________________________________
`
`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 MARIA SALGADO IN SUPPORT OF PATENT
`OWNER’S PRELIMINARY RESPONSE
`
`I, Maria Salgado, make
`
`the
`
`following Declaration pursuant
`
`to
`
`28 U.S.C. § 1746:
`
`1.
`
`2.
`
`I am a Principal at Cornerstone Research.
`
`I provide this Declaration in connection with the above-identified
`
`Inter Partes Review proceeding that is being requested at the United States Patent
`
`Medac Exhibit 2030
`Koios Pharmaceuticals v. Medac
`IPR2016-01370
`Page 00001
`
`
`
`and Trademark Office. Unless otherwise stated, the facts stated in this Declaration
`
`are based on my personal knowledge.
`
`3.
`
`Exhibit 2026 hereto is a document compiled from the Drugs@FDA
`
`Data
`
`Files,
`
`available
`
`on
`
`http://www.fda.gov/Drugs/InformationOnDrugs/ucm079750.htm. Page numbers
`
`and an exhibit label have been added to the bottom of this document but no other
`
`alterations have been made.
`
`4.
`
`Exhibit 2027 hereto is a true and correct copy of the November 20,
`
`2014
`
`results
`
`of
`
`searching
`
`“methotrexate”
`
`on
`
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/, which was a record of the
`
`FDA. Page numbers and an exhibit label have been added to the bottom of this
`
`document but no other alterations have been made.
`
`5.
`
`Exhibit 2056 hereto is a true and correct PDF of the excel file
`
`“October 2006 ASP Pricing File - Updated 12/19/07,” which I downloaded
`
`from
`
`http://www.cms.gov/apps/ama/license.asp?file=/McrPartBDrugAvgSalesPrice/downl
`
`oads /oct06asphcpcs.zip, which was data provided by Centers for Medicare and
`
`Medicaid Services, and which I downloaded on November 19, 2014. Page
`
`Page 00002
`
`
`
`numbers and an exhibit label have been added to the bottom of this document, and
`
`the excel file was converted to PDF, but no other alterations have been made.
`
`6.
`
`Exhibit 2057 hereto is a true and correct PDF of the excel file
`
`“October 2014 ASP Pricing File 09/12/14,” which I downloaded from
`
`http://www.cms.gov/apps/ama/license.asp?file=/McrPartBDrugAvgSalesPrice/downloa
`
`ds /2014-October-ASP-Pricing-File.zip, and which was data provided by Centers
`
`for Medicare and Medicaid Services. Page numbers and an exhibit label have
`
`been added to the bottom of this document, and the excel file was converted to
`
`PDF, but no other alterations have been made.
`
`7.
`
`Exhibit 2065 hereto is a true and correct copy of an article entitled
`
`“Arthritis Today Drug Guide”, published by the Arthritis Foundation, which I
`
`downloaded
`
`from
`
`http://www.arthritistoday.org/arthritis-
`
`treatment/medications/drug-guide/search-by-class.php?drugclass=DMARDs
`
`on November 18, 2014. Page numbers and an exhibit label have been added to the
`
`bottom of this document but no other alterations have been made.
`
`8.
`
`Exhibit 2067 hereto is a true and correct copy of an article entitled
`
`“Drug Guide: DMARDs”, published by the Arthritis Foundation, which I
`
`downloaded
`
`from
`
`http://www.arthritistoday.org/arthritis-
`
`treatment/medications/types-of-drugs/disease-modifying-drugs/drug-guide-
`
`Page 00003
`
`
`
`dmards.php on November 18, 2014. Page numbers and an exhibit label have been
`
`added to the bottom of this document but no other alterations have been made.
`
`9.
`
`Exhibit 2078 hereto is a true and correct copy of an article entitled
`
`“Juvenile Idiopathic Arthritis (JIA),” published by the Department of Pediatrics
`
`Division
`
`of
`
`Pediatric Rheumatology, which
`
`I
`
`downloaded
`
`from
`
`http://pediatrics.med.nyu.edu/rheumatology/patient-care/juvenile-idiopathic-
`
`arthritis-jia on November 18, 2014. Page numbers and an exhibit label have been
`
`added to the bottom of this document but no other alterations have been made.
`
`10. Exhibit 2080 hereto is a true and correct copy of a Methotrexate Fact
`
`Sheet, published by the American College of Rheumatology in May 2012, and
`
`which
`
`I
`
`downloaded
`
`from
`
`https://www.rheumatology.org/practice/clinical/patients/medications/methotrexate.
`
`pdf, on November 18, 2014. Page numbers and an exhibit label have been added
`
`to the bottom of this document but no other alterations have been made.
`
`11. Ex. 2083 hereto is a true and correct copy of an article entitled
`
`“Questions and Answers about Juvenile Arthritis,” National Institute of Arthritis
`
`and Musculoskeletal and Skin Diseases, 8/13, which I downloaded on November
`
`18, 2014 from http://www.niams.nih.gov/Health_Info/Juv_Arthritis/#1 and which
`
`was a record of the National Institute of Arthritis and Musculoskeletal and Skin
`
`Page 00004
`
`
`
`Diseases (NIH). Page numbers and an exhibit label have been added to the bottom
`
`of this document but no other alterations have been made.
`
`12. Ex. 2085 hereto is a true and correct copy of an article entitled “State
`
`and County QuickFacts,” which I downloaded on November 18, 2014 from
`
`http://quickfacts.census.gov/qfd/states/00000.html, and which was a record of
`
`United States Census Bureau. Page numbers and an exhibit label have been
`
`added to the bottom of this document but no other alterations have been made.
`
`13. Exhibit 2086 hereto is a true and correct PDF of a .txt file entitled
`
`“patent.txt,” which I downloaded from the FDA’s Orange Book Data Files
`
`website,
`
`http://www.fda.gov/Drugs/InformationOnDrugs/ucm129689.htm,
`
`on
`
`October 17, 2014, which was a record of the FDA. Page numbers and an exhibit
`
`label have been added to the bottom of this document, and the text file was
`
`converted to PDF, but no other alterations have been made.
`
`14. Exhibit 2087 hereto is a true and correct PDF of a .txt file entitled
`
`“products.txt,” which I downloaded from the FDA’s Orange Book Data Files
`
`website,
`
`http://www.fda.gov/Drugs/InformationOnDrugs/ucm129689.htm,
`
`on
`
`October 17, 2014. Page numbers and an exhibit label have been added to the
`
`bottom of this document, and the text file was converted to PDF, but no other
`
`alterations have been made.
`
`Page 00005
`
`
`
`15. Exhibit 2088 hereto is a true and correct PDF of a .txt file entitled
`
`“exclusivity.txt,” which I downloaded from the FDA’s Orange Book Data Files
`
`website,
`
`http://www.fda.gov/Drugs/InformationOnDrugs/ucm129689.htm,
`
`on
`
`October 17, 2014, which was a record of the FDA. Page numbers and an exhibit
`
`label have been added to the bottom of this document, and the text file was
`
`converted to PDF, but no other alterations have been made.
`
`16. Exhibit 2089 hereto is a true and collect compilation of drug labels,
`
`which I downloaded from https://www.accessdata.fda.gov/scripts/cder/drugsatfda/
`
`on November 2014, and which was a record of the FDA. Page numbers and an
`
`exhibit label have been added to the bottom of this document but no other
`
`alterations have been made.
`
`17.
`
`I created the information referenced as “Fingertip Formulary” in the
`
`Exhibits to the Expert Declaration of Sean Nicholson (Dated 6/2/2016) by crawling
`
`various webpages found at www.fingertipformulary.com/. This was done by
`
`creating a computer code that was able to collect information from tens of
`
`thousands of pages of the Fingertip Formulary website.
`
`18.
`
`I have been informed that willfully false statements are punishable by
`
`fine or imprisonment, or both. I make this declaration of my own personal
`
`Page 00006
`
`
`
`IPR2016-00649
`
`US. Patent No. 8,664,231
`
`Attorney Docket No.
`
`110670-0010-651
`
`knowledge, and I believe 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 2nd day of June, 2016, at San Francisco, CA.
`
`’_ (bM/Lf/fij :
`
`Maria Salgado
`
`Page 00007
`
`Page 00007
`
`
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