UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE DRUGS V LLC;
`
`HAYMAN CREDES MASTER FUND, L.P.;
`
`HAYMAN ORANGE FUND SPC — PORTFOLIO A;
`
`HAYMAN CAPITAL MASTER FUND, L.P.;
`
`HAYMAN CAPITAL MANAGEMENT, L.P.;
`
`HAYMAN OFFSHORE MANAGEMENT, INC.;
`
`HAYMAN INVESTMENTS, LLC;
`
`NXN PARTNERS, LLC;
`
`IP NAVIGATION GROUP, LLC;
`
`J KYLE BASS, and ERICH SPANGENBERG,
`
`Petitioner,
`
`V.
`
`BIOGEN MA INC.,
`Patent Owner.
`
`Case IPR2015—0I993
`
`Patent 8,399,514 B2
`
`DECLARATION OF GILMORE O’NEILL, M.D.
`
`Page 1 of 5
`
`Biogen Exhibit 2014
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`COALITION FOR AFFORDABLE DRUGS V LLC;
`
`HAYMAN CREDES MASTER FUND, L.P.;
`
`HAYMAN ORANGE FUND SPC — PORTFOLIO A;
`
`HAYMAN CAPITAL MASTER FUND, L.P.;
`
`HAYMAN CAPITAL MANAGEMENT, L.P.;
`
`HAYMAN OFFSHORE MANAGEMENT, INC.;
`
`HAYMAN INVESTMENTS, LLC;
`
`NXN PARTNERS, LLC;
`
`IP NAVIGATION GROUP, LLC;
`
`J KYLE BASS, and ERICH SPANGENBERG,
`
`Petitioner,
`
`V.
`
`BIOGEN MA INC.,
`Patent Owner.
`
`Case IPR2015—0I993
`
`Patent 8,399,514 B2
`
`DECLARATION OF GILMORE O’NEILL, M.D.
`
`Page 1 of 5
`
`Biogen Exhibit 2014
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`U.S. Patent No. 8,399,514
`Case:
`IPR2015—O1993
`
`I, Gilmore O’Neill, have personal knowledge of the facts stated herein and
`
`provide the following testimony:
`
`Personal Background and Introduction
`
`1.
`
`I am currently Senior Vice President, Drug Innovation Units at
`
`Biogen and have held this position since October 2015. In this position, I am
`
`responsible for leading multi-disciplinary groups accountable for research and
`
`development in Pain, Immunology, Hemophilia and Rare Diseases, and Gene and
`
`Cell therapeutics.
`
`2.
`
`I received my medical degree from University College Dublin in 1988
`
`and completed residencies and fellowship training in internal medicine,
`
`pulmonology and neuropathology in 1993 at Beaumont Hospital, Dublin. I
`
`completed my residency in Neurology at Massachusetts General Hospital in 1997
`
`and was Chief Resident from 1996 to 1997 during that time. I also received a
`
`Master of Medical Science degree from Harvard Medical School in 1999. I am a
`
`Clinical Instructor in Neurology at Harvard Medical School and a Neurologist at
`
`Massachusetts General Hospital and have held those positions since 1997. I joined
`
`Biogen in 2003 as Associate Director, Medical Research and, through my work at
`
`the company over approximately the past 12 years, am now Senior Vice President,
`
`Drug Innovation Units.
`
`Page 2 of 5
`
`
`
`US. Patent No. 8,399,514
`
`Case: IPR20l5-01993
`
`3.
`
`I understand that the U.S. Patent and Trademark Office has instituted
`
`an Inter Parres Review (“IPR”) proceeding involving Biogen’s U.S. Patent No.
`
`8,399,514 (“the ’5 14 patent”).
`
`I am a named co—inventor on the ’5 14 patent based
`
`on my contribution to the claimed subject matter.
`
`4.
`
`I understand that Biogen submitted Ex. 2005, a poster entitled “A
`
`Randomized, Placebo-Controlled Phase 2 Trial of a Novel Oral Fumarate,
`
`BG00012, in Patients With Relapsing—Remitting Multiple Sclerosis” presented at
`
`the 15th Meeting of the European Neurological Society on June 18-22, 2005, in
`
`support of its Patent Owner Preliminary Response. I am a co-author on that poster
`
`(Ex. 2005), which I have reviewed.
`
`5.
`
`I provide this declaration based on my personal knowledge of Ex.
`
`2005.
`
`I am not being compensated to provide this declaration, nor will I receive
`
`any compensation based on a favorable outcome for Biogen in this proceeding.
`
`Ex. 2005 is a True Copy of the Poster Presentation Made in June 2005
`
`6.
`
`I attended the 15th Meeting of the European Neurological Society held
`
`in Vienna, Austria from June 18-22, 2005. I believe that Ex. 2005 is a true and
`
`accurate copy of the poster that was presented at that meeting.
`
`7.
`
`At Biogen, I led the MS Clinical Development Team’s (“CDT”)
`
`efforts to design a Clinical Development Plan for the MS indication and to design a
`
`Phase 2 proof—of—concept clinical trial using BG-00012, an orally administered
`
`Page 3 of 5
`
`
`
`U.S. Patent No. 8,399,514
`Case: IPR20l5—0l993
`
`pharmaceutical composition containing dimethyl fumarate (“DMF”) as the sole
`
`active agent and one or more pharmaceutically acceptable excipients, to treat MS
`
`patients.
`
`8.
`
`I was the principal lead on Biogen’s Phase 2 study, the clinical design
`
`of which is summarized in Ex. 2005. I confirm, based on my personal knowledge,
`
`that the active dosage units of DMF used in that study contained 120 mg of DMF
`
`per capsule. The study did not use capsules containing 240 mg of DMF. Thus, for
`
`example, patients in the 720 mg/day group took two l20 mg DMF capsules three
`
`times a day as shown in Table 1 of Ex. 2005.
`
`III. Conclusion
`
`9.
`
`I declare that all statements made herein of my own knowledge are
`
`true and that all statements made on information and belief are believed to be true,
`
`and, further, that these statements are made with knowledge that willful false
`
`statements and the like are punishable by fine or imprisonment, or both, under
`
`Section 1001 of Title 18 of the United States Code and may jeopardize the
`
`patentability of Biogen’s U.S. Patent No. 8,399,514.
`
`10.
`
`In signing this declaration, I understand that the declaration may be
`
`filed as evidence in a contested case before the Patent Trial and Appeal Board of
`
`the United States Pate11t and Trademark Office. I acknowledge that I may be
`
`subject to cross—eXamination in the case and that cross—examir1ation will take place
`
`Page 4 of 5
`
`
`
`U.S. Patent No. 8,399,514
`
`Case: IPR2015-01993
`
`within the United States. If cross—examinati0n is required of me, I will appear for
`
`cross—examinati0n within the United States during the time allotted f01'c1'oss—
`
`examination.
`
`Dated: April 14,2016
`
`__
`‘
`./
`(1 k [“ Vfik" 9*’
`’
`/i. Q ,
`GiII1’101'e O’Nei11, MD.
`
`\
`
`Page 5 of 5
`
`
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