Case No. IPR2018-01403
`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 REBECCA CONAGHAN
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`
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`
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`Biogen Exhibit 2098
`Mylan v. Biogen
`IPR 2018-01403
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`Page 1 of 8
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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 REBECCA CONAGHAN
`
`
`
`
`
`
`
`
`
`Biogen Exhibit 2098
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 8
`
`
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`
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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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`Personal Background and Introduction ........................................................... 1
`I.
`II. My Role in the Phase II Trial .......................................................................... 2
`III. Conclusion ....................................................................................................... 5
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`Page 2 of 8
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`I, Rebecca Conaghan, 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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`provide the following testimony:
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`I.
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`Personal Background and Introduction
`I am a Regulatory Affairs Manager for Biogen Idec Ltd. in Maidenhead,
`1.
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`United Kingdom. I have worked for Biogen for approximately 15 years as a
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`permanent employee or a contractor in various clinical trial and regulatory roles. I
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`attended school at the King’s College of London, where I obtained my Msc in
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`Human and Applied Physiology, and the University of St. Andrews, where I
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`obtained by BSc Honors in Physiology.
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`2.
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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 Biogen’s U.S. Patent No.
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`8,399,514 (“the ’514 patent”).
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`3.
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`I also understand that Mylan has submitted the following exhibits in
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`that proceeding:
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`• Ex. 1007: L. Kappos et al., Efficacy of a Novel Oral Single-
`Agent Fumarate, BG0012, in Patients with Relapsing-Remitting
`Multiple Sclerosis: Results of a Phase 2 Study, 253 (Supp. 2) J.
`Neurol. II27, O108 (2006)
`
`• Ex. 1046: L. Kappos et al., Efficacy of a Novel Oral Single-
`Agent Fumarate, BG0012, in Patients with Relapsing-Remitting
`Multiple Sclerosis: Results of a Phase II Study, 253 (16th
`Meeting of the European Neurological Society, May 20, 2006)
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`1
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`Page 3 of 8
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`Case No. IPR2018-01403
`U.S. Patent No. 8,399,514
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`• Ex. 1016: NewsRoom document, Oral Compound BG-12
`Achieves Primary Endpoint in Phase II Study of Relapsing-
`Remitting Multiple Sclerosis; Treatment with BG-12 Led to
`Statistically Significant Reductions in MRI Measures (May 30,
`2006)
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`I provide this declaration based on my personal knowledge and my role
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`4.
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`in the Phase II trial of BG-12 for the treatment of multiple sclerosis (MS).
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`II. My Role in the Phase II Trial
`I was Biogen’s Clinical Trial Manager of its Phase II trial of BG-12 in
`5.
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`patients with MS. I worked as part of the team to set up all aspects of the clinical
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`trial, including chairing weekly meetings of the Study Management Team (SMT),
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`which were attended by Biogen’s Medical Director for the MS BG-12 program, Dr.
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`Gilmore O’Neill, the lead statistician, Minhua Yang, and others. At the weekly SMT
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`meetings, members would update Dr. O’Neill and members of the SMT on the status
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`of the various activities involved in executing a clinical trial. I was also involved in
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`numerous other activities, including setting up the labs and selecting and managing
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`the external vendors including the contract research organization (CRO). In my role
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`as Clinical Trial Manager, I worked closely with Dr. O’Neill, Minhua Yang, and
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`others on the SMT. I also interacted with the individuals and groups outside Biogen,
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`including Clinical Investigators, who came together to execute the Phase II clinical
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`trial.
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`2
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`Page 4 of 8
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`6.
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`I was present from the very beginning of the BG-12 MS program, when
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`Case No. IPR2018-01403
`U.S. Patent No. 8,399,514
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`Dr. O’Neill presented his clinical trial concept at a meeting of the Clinical Trial
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`Review Board (CTRB). See Ex. 2088. As shown in the meeting minutes, Dr.
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`O’Neill presented four dosing regimens, the first and second of which included the
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`dose of 480 mg/day of DMF, which is the dose approved for Biogen’s MS treatment
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`Tecfidera®. Id. The decision was made to go forward with his third proposed dosing
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`option—120 mg/day, 360 mg/day, and 720 mg/day. Once the protocol was
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`finalized, we quickly got to work undertaking the numerous activities required for a
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`Phase II trial, including setting up our initial Clinical Investigators meeting in
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`Versailles, France. See Ex. 2089.
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`7.
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`As with all clinical trials, there were of course many individuals
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`involved in the clinical trial, both inside and outside Biogen. All of us who worked
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`on the Phase II project, both inside and outside Biogen, did so under the direction
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`and supervision of Dr. O’Neill and the members of Biogen’s SMT who were acting
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`at his direction. For example, each trial site had a designated Principal Investigator
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`or Investigators who were responsible for overseeing the site, executing the
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`approved study protocol, and receiving monitors who regularly visited the site to
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`ensure the protocol was being adhered to. Dr. Ludwig Kappos was designated
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`“Coordinating Investigator.” A Scientific Advisory Committee was also formed to
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`provide scientific and medical advice for the study and oversee its progress.
`3
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`Page 5 of 8
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`Together, we all worked to execute and carry out the Phase II trial under the guidance
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`Case No. IPR2018-01403
`U.S. Patent No. 8,399,514
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`and direction of Dr. O’Neill.
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`8.
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`During February 2005, I took maternity leave. I returned in June
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`2006—in a contractor role for 5 months and returned again in April 2009. I have
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`been working at Biogen since 2009 in a contractor position and then as a permanent
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`employee. Despite my absence from Biogen during the time when Exhibits 1007,
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`1046, and 1016 were being prepared, I can affirm that those exhibits all relate to the
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`Phase II clinical trial led by Dr. O’Neill. The subject matter in Exhibits 1007, 1046,
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`and 1016 is solely the work of Dr. O’Neill and those who worked on the Phase II
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`clinical trial under his direction and supervision.
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`9.
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`I understand that an issue in this legal proceeding relates to whose work
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`is described in Exhibits 1007, 1046, and 1016. I can attest that, although multiple
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`authors are listed on Exhibits 1007 and 1046, the work described in them and in
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`Exhibit 1016 is the work of Dr. O’Neill, and those who worked on the Phase II BG-
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`12 MS study at his direction. The Scientific Advisory Committee determined as a
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`group in September 2004 the individuals who would be listed as authors. See Ex.
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`2092. Everyone agreed that the entire Scientific Advisory Committee would be
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`named; Biogen’s study medical director (Dr. O’Neill) and lead statistician would be
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`named; the members of the MRI Reading Centre would be included due to their role
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`in data processing; and the top 3 highest enrollers would be included as well. Id. As
`4
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`Case No. IPR2018-01403
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`US. Patent No. 8,399,514
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`the designated Coordinating Investigator for the study, Dr. Kappos was listed as the
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`first author, which is the common practice. The multiple authors on Exhibits 1007
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`and 1046 are a testament to the many people who assisted in executing the Phase II
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`clinical trial protocol. All those involved in executing Biogen’s Phase II clinical trial
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`did so under the guidance and direction ofDr, O’Neill.
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`111. Conclusion
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`10.
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`I declare that all statements made herein ofmy 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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`1 1.
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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, 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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`Ie/Maj/ LOICI
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`Page 7 of 8
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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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`1007
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`1016
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`1046
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`2088
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`2089
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`2092
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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)
`L. Kappos et al., Efficacy of a Novel Oral Single-Agent
`Fumarate, BG0012,
`in Patients with Relapsing-
`Remitting Multiple Sclerosis: Results of a Phase 2 Study,
`253 (Supp. 2) J. Neurol. II27, O108 (2006)
`NewsRoom document, Oral Compound BG-12 Achieves
`Primary Endpoint in Phase II Study of Relapsing-
`Remitting Multiple Sclerosis; Treatment with BG-12 Led
`to Statistically Significant Reductions in MRI Measures
`(May 30, 2006)
`L. Kappos et al., Efficacy of a Novel Oral Single-Agent
`Fumarate, BG0012, in Patients with Relapsing-Remitting
`Multiple Sclerosis: Results of a Phase II Study, 253 (16th
`Meeting of the European Neurological Society, May 20, 2006)
`Clinical Trial Review Board Agenda Item Meeting Minutes
`(February 19, 2004)
`Email from Rebecca Conaghan and Gilmore O’Neill, M.D.
`(August 16, 2004)
`Email from Gilmore O’Neill, M.D. with Attachment (February
`1, 2006)
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`Page 8 of 8
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