throbber
August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`1
`
` 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,
` Petitioners,
` v.
` BIOGEN MA INC.,
` Patent Owner.
` ______________________________________
`
` Case No. IPR2015-01993
` Patent 8,399,514 B2
`
` DEPOSITION of RICHARD A. RUDICK, M.D., a witness
`called by counsel for the Petitioner, taken pursuant to
`the Federal Rules of Civil Procedure before Katherine A.
`Tevnan, RPR, CSR No. 129093 and Notary Public in and for
`the Commonwealth of Massachusetts, at the Offices of
`Finnegan, Henderson, Farabow, Garrett & Dunner, on
`Monday, August 29, 2016, commencing at 10:54 a.m.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 1 of 113
`
`Coalition Exhibit 1053
`Coalition v. Biogen
`IPR2015-01993
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`2
`
`APPEARANCES:
`
` CARMICHAEL IP, PLLC
` (By Carol A. Spiegel, Esq.)
` 8000 Towers Crescent Drive, 13th Floor
` Tysons Corner, Virginia 22182
` 703-646-9249]
` carol@carmichaelip.com
` for the Petitioner.
`
` FINNEGAN, HENERSON, FARABOW, GARRETT & DUNNER, LLP
` (By Michael J. Flibbert, Esq.)
` 901 New York Avenue, NW
` Washington, DC 20001-4413
` 202-408-4000
` michael.flibbert@finnegan.com
` and
` (By Shana K. Cyr, PH.D.)
` Two Freedom Square
` 11955 Freedom Drive
` Reston, Virginia 20190-5675
` Patent 8,399,514 B2
`
`ALSO PRESENT: Wendy Plotkin (Biogen)
`
`1
`
`2 3
`
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 2 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
` I N D E X
`Deposition of: Direct Cross Redirect Recross
`RICHARD A. RUDICK, M.D.
` By Ms. Spiegel 4
`
`3
`
` E X H I B I T S
`No. Page
`
`1
`2
`3
`4
`
`5 6 7
`
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 3 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`4
`
` P R O C E E D I N G S
` MS. SPIEGEL: Good morning, Dr. Rudick. I
`am with Carmichael IP law firm and I am going to be
`asking you a series of questions today. All I ask is
`that you answer to the best of your ability. If there
`is anything about my question that you don't understand,
`just let me know and I will try to rephrase it or
`restate it to the best of my ability.
` If you need a break, any time, that's fine.
`This is not a marathon. The only thing I ask is if a
`question is on the table, please complete your answer
`before we break.
` And, as you know, a court reporter is
`transcribing everything we say, so it is important that
`you give verbal answers as opposed to a nod. And that
`neither one of us speak over each other. Is that okay?
` THE WITNESS: Fine.
` RICHARD A. RUDICK, M.D.
`
`a witness called for examination by counsel for the
`Petitioner, being first duly sworn, was examined and
`testified as follows:
`
` DIRECT EXAMINATION
`BY MS. SPIEGEL:
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 4 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`5
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` Q. Would you state your full name for the record,
`please?
` A. Richard Allen Rudick.
` Q. Do you understand that your testimony is being
`given under oath today?
` A. I do.
` Q. I may be referring to the patent at issue here by
`its last three digits, the '514 patent. Would you
`understand the abbreviation?
` A. Yes.
` Q. I might also refer to the interoffice proceeding
`that we are involved in as an IPR. Would that be okay?
` A. Yes.
` Q. I will probably say "MS" instead of "multiple
`sclerosis". Is that okay?
` A. Yes.
` Q. I will probably refer to Gadolinium as capital G,
`little D, and pronounce it as Gd, would that be okay?
` A. Gadolinium, yes. Gd would be fine.
` Q. Is there any reason you can't give full and
`truthful testimony today?
` A. No.
` Q. Are you taking any medications that would impair
`your ability to testify today?
` A. No.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 5 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`6
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` Q. Have you provided any declarations in any other
`patent matters other than the one that you submitted in
`the application that became the '514 patent?
` A. Could you specify which one you are referring to
`so I can answer that question?
` Q. Well, we'll just do it this way. I am going to
`start by handing a copy of a document premarked as
`Biogen Exhibit 2044. This is the declaration that I am
`going to be referring to today. Just take a quick look
`at it and confirm that this is the declaration that you
`submitted in this IPR proceeding?
` A. Yes, this is it.
` Q. Can you confirm that it is your signature on page
`35 of 36, and I am talking about the little numbers in
`the lower left-hand corner (indicating)?
` A. Yes, that is my signature.
` Q. Looking at your declaration, are you aware of any
`errors or mistakes in your declaration?
` A. No, I am not.
` Q. Did you review your declaration before signing
`it?
` A. Yes.
` Q. I am handing you a copy of a document premarked
`as Biogen Exhibit 2045, which is the curriculum vitae
`that was attached to your declaration. Looking at your
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 6 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`7
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`CV, are you aware of any errors or mistakes in your CV?
` A. No, I am not.
` Q. If you look at page 16 of 36 of your declaration,
`I am going to be looking at paragraph 32. In there you
`refer to a declaration you wrote in July of 2012 that
`was submitted to the patent office as part of the
`application that became the '514 patent. Do you see
`that?
` A. Are you referring to paragraph 32? Because I am
`not seeing it there.
` Q. I am referring to paragraph 33.
` A. Oh, okay. 33.
` Q. On page 16 of 36?
` A. Okay.
` Q. It is about halfway down.
` A. Yes. Yes. I see that.
` Q. So my previous question about, have you provided
`any declarations in any other patent matters other than
`the one you submitted to the U.S. Patent Office during
`prosecution of the application that became the '514
`patent. That's the declaration I am referring to.
` A. I understand. In addition to the July 2012
`declaration on this matter, I have done one other
`declaration in a separate patent matter related Biogen.
` Q. Is the separate patent matter related to
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 7 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`8
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`Tecfidera or BG-12?
` A. No.
` Q. Have you provided any expert reports in any
`patent matters other than what you have done for the
`Biogen?
` A. No.
` Q. Have you done expert reports for any matters
`other than patent matters?
` A. Yes.
` Q. Could you give me a general description of what
`they were?
` A. I participated as an expert witness for the
`lawyers of a woman who was suing her employer for
`discrimination and I was providing testimony regarding
`her MS.
` Q. Just a general description was fine.
` Have you ever been deposed before?
` A. Yes.
` Q. When?
` A. I would have to consult my calendar, but maybe
`one year ago.
` Q. What kind of case was that?
` A. This was the other patent matter that I
`mentioned.
` Q. Did you prepare for your deposition today?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 8 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`9
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` A. Yes.
` Q. What did you do to prepare?
` A. I met with these attorneys (indicating) to learn
`about the matter at hand. I prepared my declaration and
`the appendix material, identified the appendix material.
`I read through the appendix material. And I read
`carefully through my declaration.
` Q. Do you recall reviewing anything other than those
`documents you just referred to?
` A. There are two documents that are not listed in
`the appendix that I looked at. One is the '514 patent
`and the other is a publication by Kappos and Lancet on a
`Phase 2 study of Tecfidera. Other than that, no.
` Q. When you say that you spoke with counsel, you are
`talking of the counsel present at this deposition?
` A. Correct.
` Q. Did you meet with anyone else besides counsel or
`was anyone else besides counsel present when you
`prepared for the deposition?
` A. No.
` Q. How long did you meet with counsel to prepare for
`the deposition?
` A. I would have to look back at my calendar, but I
`would give an estimate of eight hours.
` Q. Do you have any questions before we begin?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 9 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`10
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` A. No.
` Q. You received a Bachelor of Science in Zoology
`from Ohio University in Athens, Ohio; is that correct?
` A. Yes.
` Q. You received an M.D. degree from Case Western
`Reserve University School Of Medicine in Cleveland,
`Ohio; is that correct?
` A. Correct.
` Q. Do you specialize in neurology?
` A. Yes.
` Q. Are you an expert in the field of immunology?
` A. I would consider myself an expert.
` Q. On what basis?
` A. On the research work that I have done over the
`years. I don't have a formal degree in immunology but I
`have enough knowledge to understand much of it and
`conduct research on it.
` Q. Are you an expert in the field of cell biology?
` A. No.
` Q. Are you an expert in the field of molecular
`biology?
` A. No.
` Q. Are you an expert in the field of statistics?
` A. I don't have formal training or a degree in
`statistics but I have some working knowledge of
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 10 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`11
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`statistics based on my research over the years.
` Q. Are you an expert in the field of pharmacology?
` A. No.
` Q. Are you an expert in the field of regulatory
`affairs for drug development?
` A. No.
` Q. Do you have any experience designing protocols
`for clinical trials?
` A. Yes.
` Q. Would you explain, please.
` A. I could give two examples, if that would be
`useful.
` Q. Certainly.
` A. I participated as one of the two principal
`investigators in designing a study of interferon beta 1A
`for multiple sclerosis. This was in the late 1980's.
`This study was eventually funded by the National
`Institutes of Health. And was in relapsing forms of
`multiple sclerosis. This was partially supported by
`Biogen at the time and this led to an application for
`licensing of what became known as Avonex, a treatment
`for multiple sclerosis.
` I was also involved in the design of studies of a
`drug called natalizumab, also for relapsing multiple
`sclerosis. This led to regulatory approval of what
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 11 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`12
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`became known as Tysabri for MS.
` Q. When you say you were involved in the design of
`these clinical trials, could you explain to me a little
`bit more about what design elements you provided, that
`is, for example, type of study group, the randomization,
`the dose selection? Would you give me a general idea,
`please, of what elements of the clinical trial you
`designed?
` A. Well, for the original Avonex study, the first
`one I mentioned, I was the co-principal investigator
`along with a doctor named Lawrence Jacobs who was in
`Buffalo, New York. I had just moved to the Cleveland
`clinic. So I was in Cleveland, he was in Buffalo and we
`wrote the entire protocol, determining every aspect of
`the protocol from the test article, which was interferon
`beta 1A, to the dose of the test article, the dosing
`regimen, the patient population, the outcome measures,
`the design of the study. That was such determined by
`myself and Dr. Jacobs.
` Q. Do you have any experience in preparing or
`submitting an investigational new drug application to
`the United States Food and Drug Administration?
` A. I don't, no.
` Q. In paragraph 6 of your declaration, it would be
`on page 3 of 36, in the second sentence you talk about
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 12 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`13
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`an investigator-initiated clinical trial. What is an
`investigator-initiated clinical trial?
` A. This is a study that was initiated as it says or
`started by the investigators as opposed to a company.
`So this particular study, as I mentioned, Dr. Jacobs and
`I wrote the protocol, designed and wrote the protocol
`and applied to the NIH for funding. So that's
`considered investigator-initiated.
` Q. Did you receive support from Biogen for that
`trial?
` A. Yes, we did.
` Q. What type of support?
` A. The proposed protocol for the -- from the NIH
`didn't anticipate some of the safety monitoring that
`would be needed for an application to the NIH, so after
`that grant was made, meaning after the funding was
`allocated by the NIH, we approached Biogen for support
`and specifically we requested that Biogen file and hold
`the IND and assist with monitoring the study. And in
`the process Biogen requested that we add certain
`laboratory monitoring that would be needed for
`submission for the FDA.
` Q. Do you happen to recall what dose of Avonex has
`been approved by the FDA and by what means of
`administration?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 13 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`14
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` A. Yes. 30 micrograms by intramuscular
`administration once weekly.
` Q. Have you or a person under your direct
`supervision ever administered Avonex at other than the
`FDA-approved dosage at the time of administration?
` A. Yes. After the Avonex study was completed, I
`participated in two subsequent studies that tested a
`different dose and compared it with 30.
` Q. You also stated that you received support from
`Biogen over the years, can you just give me a general
`outline of what that support was?
` A. I believe I have commented on that in the
`declaration. If you give me one moment.
` Q. Take your time. All the time you need.
` A. So on page 4 of 36 in paragraph 7 I cited two
`grants from Biogen, one for $70,000. That was from 1993
`to 1995. And it was to study immuno effects of Avonex.
`And another from 1994 to 2001 for $624,900, which was to
`study the long-term effects of Avonex in the patients
`who were in the NIH study.
` Q. You mentioned another drug, natalizumab. If you
`would correct my pronunciation, please?
` A. Natalizumab.
` Q. What kind of drug is that? I mean, you said
`Avonex was an interferon. What kind of drug is this?
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 14 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`15
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` A. Natalizumab is a monoclonal antibody.
` Q. Do you happen to recall how it is administered
`and at what dosage, what dose?
` A. Natalizumab is administered at 300 milligram,
`once monthly, intravenously.
` Q. To the best of your knowledge have you or any
`person under your direct supervision administered
`Natalizumab at other than the FDA-approved dose at the
`time of administration?
` A. No. We treated hundreds of patients under my
`direction. We adhere to the FDA-approved dosage.
` Q. You have used the term pivotal to describe
`clinical studies in your declaration. If you need to
`refresh your memory, it would be in paragraph 6 and
`paragraph 5. My question for you is, what does pivotal
`mean?
` A. I don't know if pivotal actually has a formal
`definition but I used it synonymously with registration
`study or Phase 3 study.
` Q. To mean what? That it was a Phase 3 study?
` A. Yes. I used it as a synonymous term to Phase 3
`or registration study.
` Q. Have you ever heard of a product called Rebif,
`R-E-B-I-F?
` A. Yes.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 15 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`16
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
` Q. Do you know what that is?
` A. Yes.
` Q. Can you tell me?
` A. Rebif?
` Q. Yes.
` A. Rebif is a form of recombinant interferon beta
`1A.
` Q. It is used for what indication?
` A. It is used for relapsing forms of MS.
` Q. If you know, could you tell me how it is
`administered and at what dose?
` A. I don't recall the exact dosage. I would have to
`look that up.
` Q. That's fine.
` A. I do know it is administered by subcutaneous
`injection three times each week.
` Q. Have you ever prescribed Rebif?
` A. Rebif?
` Q. Sorry.
` A. Yes, I have.
` Q. To the best of your knowledge have you or anyone
`under your supervision ever administered Rebif at other
`than the FDA-approved label dose at the time of
`administration?
` A. Yes. I am aware of that.
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 16 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`17
` Q. Could you give me a general explanation of that?
` A. Sure. At the full dose of Rebif patients often
`have side effects characterized as flu-like symptoms and
`generally it is common practice to start at half a dose
`and gradually increase the dose to the full dose over
`two weeks or three weeks or a month. That would be
`typical practice for Rebif.
` Q. You have used MRI to diagnose and treat patients
`with MS for quite some time. Can you give me just a
`rough idea for how long you have been using MRI as a
`diagnostic and treatment tool?
` A. Yes. I remember exactly how long. In 1985 my
`institution which was University of Rochester got the
`MRI machine. I started using it to start diagnosing MS
`immediately.
` Q. In paragraph 25 of your declaration, that's on
`page 12 of 36 at the top, you say that "MRI scans are
`generally used to detect damaged areas of the nerve
`(lesions or scars) to aid in the diagnosis" of MS. Do
`all patients with MS have abnormal MRI scans?
` A. For all practical purposes, yes.
` Q. What do you mean for all practical purposes?
` A. MRI is used in the diagnostic criteria for MS.
`So patients who meet the diagnostic criteria have
`abnormal MRI scans.
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 17 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`18
` Q. According to paragraph 6 of your declaration, you
`have participated in clinical trials and in clinical
`research protocols in the field of MS, translational
`research, outcome measures, magnetic resonance imaging
`(MRI), clinical trials and biomarkers. Now that's
`bridges pages 3 to 4 of your declaration. It is
`paragraph 6 and it is the part that bridges pages 3 to 4
`of your dec.
` A. Yes, I see that.
` Q. What's the difference between a clinical trial
`and a clinical research protocol?
` A. Clinical trial is more, a more narrow. It is one
`type of clinical research protocols. Clinical research
`protocols could include observational studies of the
`natural history of a condition, health economics
`research, aspects of the condition. That's a very broad
`term. Clinical trials means you are testing and
`interventioned.
` Q. What is translational research?
` A. As I have used the term, there are many
`definitions of this, but as I have used the term, it is
`taking basic research, knowledge or findings, and
`testing them in the patients to determine the clinical
`relevance of the research finding.
` Q. In paragraph 7 of your declaration, and I am
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 18 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`19
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`looking at the top of page 5 of 36, you said that you
`transitioned to Biogen in 2014. Do you see that
`sentence? What do you mean by "transitioned"?
` A. That's a long way of saying I switched to Biogen.
` Q. What's the full name of your employer?
` A. Biogen.
` Q. When did you start working at Biogen?
` A. I believe it was May 8, 2014.
` Q. What is your job title and your job
`responsibilities at Biogen?
` A. I am a vice president of development sciences and
`my job responsibility is director of a group called the
`Value-Based Medicine Group.
` Q. Are your job responsibilities limited to multiple
`sclerosis?
` A. Yes.
` Q. Where did you work prior to being hired at
`Biogen?
` A. I worked at the Cleveland Clinic Foundation.
` Q. At page 4 of your CV, about 4/5 of the way toward
`the bottom, you say you were on the Biogen Idec,
`SURPASS, all in capital letters, Advisory Board from
`2009 to 2011. What is the SURPASS Advisory Board and
`what did it do?
` A. SURPASS was a study that was started but never
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 19 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`20
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`completed. The purpose of the study was to determine
`the best treatment for patients who had MS disease
`activity despite one of the disease-modifying therapies.
`I was chairman of the advisory committee which was a
`group of doctors that was advising Biogen on the study.
` Q. Did the study involve Tecfidera or BG-12?
` A. No.
` Q. On pages 6 to 7 of your CV you list a number of
`research grants in which you participated. Can you give
`me an idea of which ones were supported by Biogen?
` A. I will need to look through this, if you give me
`a moment.
` Q. Sure.
` A. None of the grants on page 6 were supported by
`Biogen either partially or fully.
` Q. Okay.
` A. On page 7 of 70, the fifth one down was supported
`in relatively small part by Biogen. That was the Avonex
`Phase 3 pivotal trial. The dollar amount listed there
`was the NIH budget.
` The grant halfway down listed as $70,000 was to
`study immune effects of interferon. This was supported
`entirely by Biogen. By the way, all of the support on
`all of these grants, none of this went to me. This all
`went to my institution. The institution used it to pay
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 20 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`21
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`the expenses on the research grants that I directed.
` The next one down, $624,900 was supported
`entirely by Biogen to do a follow-up study from the
`original Avonex patients. Nothing else on page --
`sorry?
` Q. This might continue to page 8.
` A. Nothing else on page 7 was supported by Biogen.
` Page 8, nothing on page 8 was supported by
`Biogen.
` Q. Do you recall how many times you were principal
`investigator of a Biogen-sponsored project or clinical
`trial?
` A. I believe it would be two. One was, I was the
`coordinating investigator or chairman of the advisory
`committee for the SENTINEL trial which was one of two
`natalizumab studies. That trial was designed by and
`supported entirely by Biogen and I was the chairman of
`the advisory committee of the academic investigators.
` The second would be the follow-up study of the
`original Avonex patients in which I directed the recall
`of those patients and the reassessment roughly eight
`years following the original clinical trial. Those were
`the two studies that I recall being the lead
`investigator.
` Now, in addition, I was the lead academic
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 21 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`22
`investigator for the SURPASS trial but that really never
`got off the ground. So that trial never actually
`enrolled patients or completed.
` Q. Still looking at your CV, on page 10 to 16, you
`have listed selected presentations. Presentation number
`30, presentation number 36, presentation number 60 and
`presentation number 67 took place out of the country,
`Sweden, Canada, Australia. My question for you is: Did
`Biogen pay your expenses in whole or in part to give
`these presentations? Again, that's presentation 30?
` A. I would need to go back and look at my records.
`I can comment on each of them individually. 30, I don't
`really know because this was a symposium at the ECTRMS
`meeting which is an annual meeting for multiple
`sclerosis that occurs in Europe. I ordinarily would pay
`may own expenses but I might participate in an
`educational symposium while there. I can't answer 30.
` Q. How about 36?
` A. 36, this was a meeting where Biogen would have
`covered my expenses. What was the next one?
` Q. 60.
` A. This is also a meeting where Biogen would have
`covered my expenses.
` Q. The last one was 67?
` A. 67, yes, this was a meeting where Biogen would
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 22 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`23
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`have covered my travel expenses.
` Q. Do you own stock in Biogen?
` A. Yes.
` Q. Do you own stock futures in Biogen?
` A. No.
` MS. SPIEGEL: Is this a good place to take a
`break, or would you like to keep going?
` MR. FLIBBERT: Take a short break, if you
`want.
` (Recess taken)
`BY MS. SPIEGEL:
` Q. Your CV lists a number of publications that you
`authored or coauthored over the years. It goes from
`about page 16 to 36 in your CV. In some of these
`publications you are listed as the first author and in
`others as the last author and then there is the in-
`between author. Could you tell me if you know what the
`significance is as to the placement of your name as
`author?
` A. The first author and the last author have the
`most significance in terms of directing the project.
`The middle author is generally -- imply a contribution
`to the work in some way or to the writing of the paper
`or editing of the paper.
` Q. In paragraph 15 of your declaration, that's
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 23 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`24
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`bridging pages 7 to 8, you say that you have been
`engaged as an expert consultant for pharmaceutical
`companies including Biogen and a number of other
`agencies. Do you see that?
` A. Yes.
` Q. Were any of these expert consults related to
`Tecfidera or BG-12?
` A. No.
` Q. In paragraph 24 of your declaration, that would
`be on page 11, you state that "The progress and severity
`of MS in an individual are also unpredictable". Do you
`see that?
` A. Yes.
` Q. Then you go on to talk about relapsing-remitting
`MS, which is abbreviated RRMS, secondary progressive MS
`with the abbreviation SPMS, and primary progressive MS
`with the abbreviation PPMS. Do you see that?
` A. I do.
` Q. Could you briefly tell me how RRMS, SPMS and PPMS
`are related? Are these different diseases?
` A. The vast majority of people who have MS
`experience what we call relapses. These are attacks of
`MS with symptoms. The attack then subsides over a few
`weeks and the patient recovers to some extent. Then
`this could come back with another attack. Those are
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 24 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`25
`relapses and remissions. This affects up to 90 percent
`of people with MS. Over the years this typically
`happens when a person is 30 years old or 35 years old.
`Over the years and decades the relapses become less
`common, less frequent. And as a person ages into their
`60's and 70's they can sometimes get progressively worse
`without any more relapses. That is then called
`secondary progressive MS. That's the same person and
`same disease, just two different stages of the
`condition.
` The distinction between those two categories is
`very indistinct. Sometimes difficult to know exactly
`when a person has switched to the secondary category.
`My opinion is the progressive MS is the same disease but
`it has a different pattern. It is a minority of cases,
`maybe 10 percent, then in that particular category the
`patient never does experience one of these attacks or
`relapses. But usually a little later in life, in the
`40's or 50's, there is a gradual walking problem. The
`MRI scan and spinal fluid which you get by lumbar
`puncture is exactly the same as MS. So my opinion is it
`is the same condition but with a slightly different
`pattern.
` Q. Are you aware of any other patterns or categories
`of MS?
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`202-220-4158
`
`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
`
`Page 25 of 113
`
`

`
`August 29, 2016 Deposition of Richard A. Rudick
`Patent 8,399,514 B2
`
`26
` A. There was a category that was called progressive
`relapsing, which was the second type I mentioned, but
`then the person would have an attack. That category was
`eliminated in the most recent classification
`publication. Those were the only three categories.
` Q. Is it possible to have a benign form of MS?
` A. Well, I think this does relate to what I said in
`paragraph 24 about the variability of MS. So within
`these categories, like relapsing and progressive, there
`is also variability in how bad the disease is. So there
`are patients that have very mild MS and don't become
`disabled. Some doctors call that benign MS. I don't
`care for the term myself.
` Other people with MS get severely disabled just
`in a few years and go into a wheelchair or even a
`nursing home. Some people will call that malignant MS.
`This just refers to the extreme variability between
`people and how bad the disease is.
` Q. Is MS a disease found only in humans?
` A. Yes, it is. It is a human disease.
` Q. Is MS strictly a disease of adults say 18 to 20
`or older or do children get MS as well?
` A. Children can get MS much less commonly.
` Q. Would you expect that a metho

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket