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`IPR2016-01370
`U.S. Patent No. 8,664,231
`110670-0009-651
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`___________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`___________________________________
`
`KOIOS PHAMRACEUTICALS LLC
`
`
`Petitioner
`
`v.
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`MEDAC GESELLSCHAFT FÜR KLINISCHE
`SPEZIALPRÄPARATE MBH
`
`
`Patent Owner
`
`___________________________________
`
`Inter Partes Review Case No. IPR2016-01370
`Patent Number 8,664,231
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`
`
`
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`
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`DECLARATION OF BRIAN GUMMOW IN SUPPORT OF PATENT
`OWNER’S PRELIMINARY RESPONSE
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`I, Brian Gummow, make
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`the
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`following Declaration pursuant
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`to
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`28 U.S.C. § 1746:
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`1.
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`2.
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`I am an Associate at Ropes & Gray LLP.
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`I provide this Declaration in connection with the above-identified
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`Inter Partes Review proceeding that is being requested at the United States Patent
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`1
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`
`Medac Exhibit 2010
`Koios v. Medac
`IPR2016-01370
`Page 00001
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`and Trademark Office. Unless otherwise stated, the facts stated in this Declaration
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`Attorney Docket No.
`110670-0009-651
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`
`
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`are based on my personal knowledge.
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`3.
`
`Exhibit 2001 hereto is a true and correct copy of an article entitled
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`“Bioavailability of oral vs. subcutaneous low-dose methotrexate in patients with
`
`Crohn’s disease,” published by Alimentary Pharmacology & Therapeutics, which I
`
`downloaded
`
`from
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`http://onlinelibrary.wiley.com/doi/10.1046/j.1365-
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`2036.2003.01614.x/pdf on May 22, 2016. Page numbers and an exhibit label have
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`been added to the bottom of this document but no other alterations have been
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`made.
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`4.
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`Exhibit 2002 hereto is a true and correct copy of an article entitled
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`“Improving Tolerance and Bioavailability of Methotrexate by Switching from Oral
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`to Subcutaneous Route of Administration,” published by Rheumatology, which
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`was downloaded by Ropes & Gray Librarian Derrik Albertelli, at my request from
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`http://rheumatology.oxfordjournals.org/content/44/suppl_1/i145.full.pdf+html on
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`May 31, 2016. Page numbers and an exhibit label have been added to the bottom
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`of this document but no other alterations have been made.
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`5.
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`Exhibit 2003 hereto is a true and correct copy of an article entitled
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`“Pharmacokinetics of Subcutaneous Methotrexate,” published by the Journal of
`
`Clinical Oncology, which was downloaded by Ropes & Gray Librarian Derrik
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`2
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`Page 00002
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`Albertelli,
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`at
`
`
`
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`my
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`Attorney Docket No.
`110670-0009-651
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`request
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`from
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`http://jco.ascopubs.org/content/6/12/1882.full.pdf+html on June 1, 2016. Page
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`numbers and an exhibit label have been added to the bottom of this document but
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`no other alterations have been made.
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`6.
`
`Exhibit 2004 hereto is a true and correct copy of a book chapter
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`entitled “Human: Veterinary Technology Cross Over,” published by Springer, in
`
`the book Long Acting Animal Health Drug Products: Fundamentals and
`
`Applications,
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`which
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`was
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`downloaded
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`from
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`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
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`exhibit label have been added to the bottom of this document but no other
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`alterations have been made.
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`7.
`
`Exhibit 2005 hereto is a true and correct copy of book chapters
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`entitled “Drug Administration” and “Life Span: Children,” published by Wolters
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`Kluwer Health | Lippincott Williams & Wilkinson, in the book Drug Therapy in
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`Nursing, which was photocopied from the University of Wisconsin Library by
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`WTS Article Delivery at my request on May 31, 2016. Page numbers and an
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`exhibit label have been added to the bottom of this document but no other
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`alterations have been made.
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`3
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`Page 00003
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`8.
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`
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`Attorney Docket No.
`110670-0009-651
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`Exhibit 2006 hereto is a true and correct copy of a press release by
`
`Antares Pharma entitled, “Antares Pharma Announces the Publication of a Head-
`
`to-Head, Randomized, Crossover Study of Oral Versus Subcutaneous
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`Methotrexate in Patients with Rheumatoid Arthritis,” published and released by
`
`Business Wire
`
`on April
`
`17,
`
`2014, which
`
`I
`
`downloaded
`
`from
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`http://www.businesswire.com/news/home/20140417005273/en/Drug-Exposure-
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`Limitations-Oral-Methotrexate-Doses-Greater-Equal on November 8, 2016. An
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`exhibit label on the first page and page numbers on all pages have been added to
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`the bottom of this document but no other alterations have been made.
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`9.
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`Exhibit 2009 hereto is a press release by Koios Pharmaceuticals LLC
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`entitled, “Koios Pharmaceuticals Files Challenge to High-Cost Drug’s Patent”
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`published and released by Business Wire on July 20, 2016, which I downloaded
`
`from
`
`http://www.businesswire.com/news/home/20160720006500/en/Koios-
`
`Pharmaceuticals-Files-Challenge-High-Cost-Drug’s-Patent on October 29, 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.
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`10.
`
`I have been informed that willfully false statements are punishable by
`
`fine or imprisonment, or both. I make this declaration of my own personal
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`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.
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`4
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`Page 00004
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`IPR2016-01370
`U.S. Patent No. 8,664,231
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`
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`Attorney Docket No.
`110670-0009-651
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`I declare under penalty of perjury that the foregoing is true and correct.
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`Executed this 10 day of November, 2016, at New York, NY.
`
`Brian Gummow
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`5
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`Page 00005