throbber
Attorney Docket No.
`
`IPR2016-01370
`U.S. Patent No. 8,664,231
`110670-0009-651
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`___________________________________
`
`KOIOS PHAMRACEUTICALS 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 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 2010
`Koios v. Medac
`IPR2016-01370
`Page 00001
`
`

`
`IPR2016-01370
`U.S. Patent No. 8,664,231
`
`and Trademark Office. Unless otherwise stated, the facts stated in this Declaration
`
`Attorney Docket No.
`110670-0009-651
`
`
`
`
`are based on my personal knowledge.
`
`3.
`
`Exhibit 2001 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.
`
`4.
`
`Exhibit 2002 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.
`
`5.
`
`Exhibit 2003 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
`
`2
`
`
`Page 00002
`
`

`
`IPR2016-01370
`U.S. Patent No. 8,664,231
`
`Albertelli,
`
`at
`
`
`
`
`my
`
`Attorney Docket No.
`110670-0009-651
`
`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.
`
`Exhibit 2004 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.
`
`7.
`
`Exhibit 2005 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
`
`Nursing, which was photocopied from the University of Wisconsin Library by
`
`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.
`
`3
`
`
`Page 00003
`
`

`
`IPR2016-01370
`U.S. Patent No. 8,664,231
`
`8.
`
`
`
`
`Attorney Docket No.
`110670-0009-651
`
`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
`
`Methotrexate in Patients with Rheumatoid Arthritis,” published and released by
`
`Business Wire
`
`on April
`
`17,
`
`2014, which
`
`I
`
`downloaded
`
`from
`
`http://www.businesswire.com/news/home/20140417005273/en/Drug-Exposure-
`
`Limitations-Oral-Methotrexate-Doses-Greater-Equal on November 8, 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.
`
`9.
`
`Exhibit 2009 hereto is a press release by Koios Pharmaceuticals LLC
`
`entitled, “Koios Pharmaceuticals Files Challenge to High-Cost Drug’s Patent”
`
`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.
`
`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
`
`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.
`
`4
`
`
`Page 00004
`
`

`
`IPR2016-01370
`U.S. Patent No. 8,664,231
`
`
`
`
`
`Attorney Docket No.
`110670-0009-651
`
`I declare under penalty of perjury that the foregoing is true and correct.
`
`Executed this 10 day of November, 2016, at New York, NY.
`
`Brian Gummow
`
`5
`
`
`Page 00005

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