Case No. IPR2018-01403
`U.S. Patent No. 8,399,514
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner.
`____________________________________________
`
`Case IPR2018-01403
`Patent 8,399,514 B2
`____________________________________________
`
`DECLARATION OF MATVEY LUKASHEV, PH.D.
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`Biogen Exhibit 2100
`Mylan v. Biogen
`IPR 2018-01403
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`Page 1 of 6
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`U.S. Patent No. 8,399,514
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________
`
`
`MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`BIOGEN MA INC.,
`Patent Owner.
`____________________________________________
`
`Case IPR2018-01403
`Patent 8,399,514 B2
`____________________________________________
`
`DECLARATION OF MATVEY LUKASHEV, PH.D.
`
`
`
`
`
`
`
`
`
`Biogen Exhibit 2100
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 6
`
`
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`
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`Case No. IPR2018-01403
`U.S. Patent No. 8,399,514
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`Table of Contents
`
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`I.
`Personal Background and Introduction ........................................................... 1
`Inventorship of the ’514 Patent Claims ........................................................... 2
`II.
`III. Conclusion ....................................................................................................... 3
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`i
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`Page 2 of 6
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`I, Matvey Lukashev, have personal knowledge of the facts stated herein and
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`Case No. IPR2018-01403
`U.S. Patent No. 8,399,514
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`
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`provide the following testimony:
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`I.
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`Personal Background and Introduction
`I am the Senior Director of Translational Research at the ALS
`1.
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`Therapy Development Institute in Boston, Massachusetts. I received my Ph.D.
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`from the Russian Academy of Medical Sciences and did my postdoctoral training
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`at Johns Hopkins and the University of California, San Francisco. My career has
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`focused on drug development in the fields of neurology, oncology, immunology,
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`and fibrosis.
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`2.
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`Prior to working at the ALS Therapy Development Institute, I was
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`employed as a scientist by Biogen for nearly 15 years, from 1998 through 2012.
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`During that time, I worked on a drug candidate called BG-12, now known as
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`Tecfidera® and prescribed for the treatment of multiple sclerosis. As a result of my
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`work on BG-12 and described in more detail below, I am a named co-inventor,
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`together with Dr. Gilmore O’Neill, on Biogen’s U.S. Patent No. 8,399,514 (“the
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`’514 patent”).
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`3.
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`I understand that the U.S. Patent and Trademark Office has instituted
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`an Inter Partes Review, IPR2018-01403, involving the ’514 patent.
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`4.
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`I provide this declaration based on my personal knowledge and my
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`role in the subject matter of the ’514 patent.
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`1
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`Page 3 of 6
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`II.
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`Case No. IPR2018-01403
`U.S. Patent No. 8,399,514
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`Inventorship of the ’514 Patent Claims
`5. My work at Biogen on the BG-12 project related to mechanism of
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`action analysis and biomarker discovery, for which I was a research lead. Through
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`this work, I discovered that dimethyl fumarate interacts with Keap1, the key
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`regulator of the Nrf2 pathway. Examples 1-3 in the ’514 patent describe some of
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`the work that I supervised in understanding this mechanism of action.
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`6.
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`I am not a clinician and was not involved in the clinical aspects of the
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`BG-12 MS program. I was not involved in the selection of doses to be used in
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`clinical trials, which is not my expertise, nor was I involved in the portions of the
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`’514 patent dealing with clinical treatment of disease. My focus and expertise is
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`on the research and discovery side of pharmaceutical drug development rather than
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`the clinical side.
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`7.
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`I have reviewed the claims of the ’514 patent. Dr. O’Neill is solely
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`responsible for discovering the subject matter of claims 1-16 and 20, which are
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`directed to methods of treating MS by administering about 480 mg per day of
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`dimethyl fumarate, monomethyl fumarate, or a combination thereof. Both Dr.
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`O’Neill and I are jointly responsible for the subject matter of claims 17-19, which
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`are directed to those methods, as well as the increased expression level of NQO1
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`when dimethyl fumarate is administered to a patient, the latter part of which was
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`my contribution.
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`2
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`Page 4 of 6
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`Case No. lPR2018-01403
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`US. Patent No. 8,399,514
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`III. Conclusion
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`8.
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`I declare that all statements made herein of my knowledge are true, and
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`that all statements made on information and belief are believed to be true, and that
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`these statements were made with the knowledge that willful false statements and the
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`like so made are punishable by fine or imprisonment, or both, under Section 1001 of
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`Title 18 of the United States Code.
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`9.
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`In signing this declaration, I understand that the declaration will be filed
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`as evidence in a contested case before the Patent Trial and Appeal Board of the
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`United States Patent and Trademark Office. I acknowledge that I may be subject to
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`cross examination in the case and that cross examination will take place within the
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`United States. If cross examination is required of me,
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`I will appear for cross
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`examination within the United States during the time allotted for cross examination.
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`DATE:
`95. 225 '20/67
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`By: M MflM/
`Matvey Lukashev
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`Page 5 of 6
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`Case No. IPR2018-01403
`U.S. Patent No. 8,399,514
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`Exhibit
`1001
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`APPENDIX A
`
`
`Description
`U.S. Patent No. 8,399,514, Treatment for Multiple Sclerosis
`(filed Feb. 13, 2012) (issued Mar. 19, 2013)
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`Page 6 of 6
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