Transcript of the Testimony of Benjamin
`Greenberg
`
`Date: October 28, 2019
`
`Case: Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`Ace-Federal Reporters, Inc.
`Phone: 202-347-3700
`Fax: 202-737-3638
`Email: info@acefederal.com
`Internet: www.acefederal.com
`
`Biogen Exhibit 2231
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 256
`
`
`Greenberg
`
`Date: October 28, 2019
`
`Case: Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`Ace-Federal Reporters, Inc.
`Phone: 202-347-3700
`Fax: 202-737-3638
`Email: info@acefederal.com
`Internet: www.acefederal.com
`
`Biogen Exhibit 2231
`Mylan v. Biogen
`IPR 2018-01403
`
`Page 1 of 256
`
`
`
`Page 2 of 256
`
`Page 2 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 1
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`MYLAN PHARMACEUTICALS INC.,
` PETITIONER, CASE NO. IPR2018-01403
` vs.
`BIOGEN MA, INC.,
` PATENT OWNER.
`* * * * * * * * * * * * * * * * * * * * * * * * * * *
` VIDEOTAPED ORAL DEPOSITION OF
` BENJAMIN M. GREENBERG, M.D.
` OCTOBER 28, 2019
` VIDEOTAPED ORAL DEPOSITION OF BENJAMIN M. GREENBERG,
`M.D., produced as a witness and duly sworn, was taken
`in the above-styled and numbered cause on OCTOBER 28,
`2019, from 9:15 a.m. until 2:45 p.m., before Suzanne
`Kelly, CSR Number 1260, in and for the State of Texas,
`reported by stenographic method at the offices of
`Perkins Coie, L.L.P., located at 500 North Akard
`Street, Suite 3300, Dallas, Texas, pursuant to Federal
`Rules of Civil Procedure and the provisions stated on
`the record, if any.
` Reported by: Suzanne Kelly, CSR, RDR, CRR
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 3 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 2
`1
`
` APPEARANCES
`
` FOR PETITIONER MYLAN PHARMACEUTICALS, INC.:
` Courtney M. Prochnow, Ph.D., Esq.
` -and-
` Shannon Bloodworth, Esq.
` PERKINS COIE L.L.P.
` 633 West 5th Street
` Suite 5850
` Los Angeles, California 90071
` e-mail: cprochnow@perkinscoie.com
` sbloodworth@perkinscoie.com
`
` FOR PETITIONER SAWAI:
` Martin S. Masar III, Esq.
` KATTEN MUCHIN ROSENMAN L.L.P.
` 525 West Monroe Street
` Chicago, Illinois 60661
` Phone: 312.902.5200
` e-mail: martin.masar@katten.com
`
`
`2 3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 4 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 3
`
` FOR PATENT OWNER BIOGEN MA:
` Mark J. Feldstein, Esq.
` -and-
` Michael R. Galgano, Esq.
` FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER L.L.P.
` 901 NW New York Avenue, NW
` Washington, D.C. 20001
` Phone: 202.408.4000
` e-mail: mark.feldstein@finnegan.com
` michael.galgano@finnegan.com
` ALSO PRESENT:
` Joe Willis, Videographer
` Matthew Greiner, Esq. (via telephone)
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 5 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 4
`1
`
` INDEX
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` Page
`
`No.
`
` BENJAMIN M. GREENBERG, M.D.
`
` Examination by Mr. Feldstein........ 14
`
`
`
` EXHIBITS
`
` NO. DESCRIPTION PAGE
`
` Exhibit 1002 A copy of a 132-page 15
`
` document entitled,
`
` "Expert Declaration of
`
` John R. Corboy, M.D., in
`
` Support of Petition for
`
` Inter Parties Review of
`
` U.S. Patent No. 8,399,514"
`
` Exhibit 1003 A copy of a 226-page 15
`
` document entitled,
`
` "Expert Declaration of
`
` Leslie Z. Benet, Ph.D.,
`
` in Support of Petition
`
` for Inter Parties Review
`
` of U.S. Patent No. 8,399,514"
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 6 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
` EXHIBITS
`
`October 28, 2019
`
`Page 5
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
` NO. DESCRIPTION PAGE
`
` Exhibit 1018 A copy of a seven-page 203
`
` document entitled,
`
` "Oral fumaric acid
`
` esters for the treatment
`
` of active multiple
`
` sclerosis: An open-label,
`
` baseline-controlled
`
` pilot study
`
` Exhibit 1028 A copy of a five-page 158
`
` document entitled,
`
` "Treatment of psoriasis
`
` with fumaric acid
`
` esters: Results of a
`
` prospective multicentre
`
` study
`
` Exhibit 1046 A copy of a 27-page 39
`
` document entitled, "Declaration of
`
` Katherine.. Dawson,
`
` M.D., Under 37 CFR 1.132"
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 7 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 6
`1
`
` EXHIBITS
`
` NO. DESCRIPTION PAGE
`
` Exhibit 1119 A copy of a three-page 78
`
` document entitled,
`
` "Gadolinium enhanced
`
` MRI predicts clinical
`
` and MRI disease activity
`
` in relapsing-remitting
`
` multiple sclerosis"
`
` Exhibit 1121 A copy of a 178-page 15
`
` document entitled,
`
` "Reply Declaration of
`
` Benjamin M. Greenberg,
`
` M.D., in Support of
`
` Petitioner's Reply to
`
` Patent Owner's Response"
`
` Exhibit 2073 A copy of a 178-page 144
`
` document entitled,
`
` "Oral Fingolimod (FTY720)
`
` for Relapsing Multiple
`
` Sclerosis"
`
`2
`
`3 4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 8 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 7
`
` INDEX (Continued)
`
` EXHIBITS (Continued)
`
`
`
` NO. DESCRIPTION PAGE
`
` Exhibit 2218 A copy of an 11-page 21
`
` document entitled,
`
` "Addressing the
`
` Challenges in Risk
`
` Assessment and Risk
`
` Management in Multiple
`
` Sclerosis"
`
` Exhibit 2219 A copy of a three-page 69
`
` document entitled,
`
` "Gadolinium enhanced
`
` MRI predicts clinical
`
` and MRI disease activity
`
` in relapsing-remitting
`
` multiple sclerosis"
`
` Exhibit 2220 A copy of a one-page 95
`
` document entitled,
`
` "Koudriavtseva 1997 (Ex. 1119)"
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 9 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 8
`1
`
` EXHIBITS
`
` NO. DESCRIPTION PAGE
`
` Exhibit 2221 A copy of an eight-page 119
`
` document entitled,
`
` "Serial Gadolinium-enhanced
`
` Magnetic Resonance Imaging
`
` Scans in Patients with
`
` Early, Relapsing-Remitting
`
` Multiple Sclerosis:
`
` Implications for Clinical
`
` Trials and Natural History"
`
` Exhibit 2222 A copy of an nine-page 119
`
` document entitled,
`
` "Using Gadolinium-enhanced
`
` Magnetic Resonance Imaging
`
` Lesions to Monitor Disease
`
` Activity in Multiple
`
` Sclerosis"
`
`2
`
`3 4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 10 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
` INDEX (Continued)
`
` EXHIBITS (Continued)
`
`Page 9
`
`
`
` NO. DESCRIPTION PAGE
`
` Exhibit 2223 A copy of an 26-page 136
`
` document entitled,
`
` "Pharmacology and
`
` Therapeutics Principles
`
` to Practice"
`
` Exhibit 2224 A copy of an seven-page 139
`
` document entitled,
`
` "Future Research
`
` Directions in Multiple
`
` Sclerosis Therapies"
`
` Exhibit 2225 A copy of an 16-page 146
`
` document entitled,
`
` "Current and emerging
`
` therapies in multiple
`
` Sclerosis: A
`
` systematic review"
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 11 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 10
` EXHIBITS
`1
`
` NO. DESCRIPTION PAGE
`
` Exhibit 2226 A copy of an 13-page 148
`
` document entitled,
`
` "B-Cell Depletion with
`
` Rituximab in
`
` Relapsing-Remitting
`
` Multiple Sclerosis"
`
` Exhibit 2227 A copy of a 15-page 174
`
` document entitled,
`
` "Modulation of immune
`
` function occurs within
`
` hours of therapy
`
` initiation for
`
` multiple sclerosis"
`
` Exhibit 2228 A copy of a two-page 219
`
` document entitled,
`
` "Dr. Lindsey's
`
` Multiple Sclerosis
`
` Website ECTRIMS Sept
`
` 2009"
`
`2
`
`3 4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 12 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 11
`
` INDEX (Continued)
` EXHIBITS (Continued)
`
` NO. DESCRIPTION PAGE
`
` Exhibit 2229 A copy of a two-page 221
` document entitled,
` "Dr. Lindsey's
` Multiple Sclerosis
` Website ECTRIMS 2011"
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 13 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 12
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` P R O C E E D I N G S
` THE VIDEOGRAPHER: We are now on
`the record. Please note that the microphones are
`sensitive and may pick up whispering and private
`conversations. Please turn off cell phones or
`place them away from the microphones as they may
`interfere with the deposition audio. Recording
`will continue until parties agree to go off the
`record.
` This is the deposition of Dr.
`Benjamin Greenberg, M.D. in the matter of Mylan
`Pharmaceuticals, Inc. versus Biogen MA Inc.; Case
`Number IPR-2018-01403 in the United States Patent
`and Trademark Office.
` The deposition is being taken at
`500 North Akard Street in Dallas, Texas. The
`time is approximately 9:15 a.m. The date is
`October 28th, 2019. The Court Reporter is
`Suzanne Kelly with -- in association with Ace
`Federal Reporters. I am the video operator, Joe
`Willis; and I represent the Ace Federal
`Reporters.
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 14 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 13
`
` Will counsel please identify
`yourselves and state your affiliation for the
`record?
` MR. GALGANO: Michael Galgano of
`Finnegan, on behalf of Biogen.
` MR. FELDSTEIN: Mark Feldstein from
`Finnegan, Henderson, also on behalf of patent
`owner Biogen.
` MS. PROCHNOW: Courtney Prochnow
`from Perkins Coie on behalf of Mylan
`Pharmaceuticals, Inc.
` MS. BLOODWORTH: Shannon
`Bloodworth, also from Perkins Coie, also on
`behalf of Mylan.
` MR. MASAR: Martin Masar from
`Katten Muchin Rosenman on behalf of the select
`petitioners.
` MS. BLOODWORTH: And Matt can you
`introduce yourself, please.
` MR. GREINER: Yes, Matthew Greiner,
`in-house counsel for Mylan.
` THE VIDEOGRAPHER: Will the court
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 15 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 14
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`reporter please swear in the witness so that we
`may begin?
` THE REPORTER: If you would please
`raise your right hand, I will administer the
`witness's oath to you.
` THE WITNESS: (Complies.)
` THE COURT REPORTER: Do you
`solemnly swear or affirm that the testimony which
`you will give in this case will be the truth, the
`whole truth, and nothing but the truth, so help
`you God?
` THE WITNESS: I do.
` BENJAMIN GREENBERG, M.D.,
` having sworn to testify the truth, the whole
`truth, and nothing but the truth testifies on his
` oath as follows:
` EXAMINATION
`BY MR. FELDSTEIN:
` Q. Morning, Doctor. How are you?
` A. Well, thank you.
` Q. Good. I see you brought some documents
`with you. What did you bring?
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 16 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 15
` A. Three documents. The reply that -- my
`reply to the declaration in this case in support
`of the Petitioner's reply to patent owner's
`response.
` The expert declaration of John R.
`Corboy.
` And the expert declaration of
`Leslie Z. Benet.
` (Deposition Exhibit Number 1003 is
`marked.)
`BY MR. FELDSTEIN:
` Q. And do you mind -- would you just mind
`reading them with the exhibit numbers of what
`those three documents are so we have those for
`the record?
` A. My reply declaration is Exhibit 1121.
` Q. So, Doctor, did you write Exhibit 1121,
`your declaration in the case?
` MS. PROCHNOW: Objection; form.
` THE WITNESS: Yes.
`BY MR. FELDSTEIN:
` Q. Okay. And Dr. Corboy's report,
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 17 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 16
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`Exhibit 1002, did you write that?
` A. No.
` Q. Could you turn in Exhibit 1002 to
`Paragraph 8? Can you read Paragraph 80 from 1002
`into the record?
` A. Paragraph 80 reads: "Nieboer 1990,"
`spelled, N-i-e-b-o-e-r, 1990, is an article
`titled: Fumaric acid therapy in psoriasis, a
`double-blind comparison between fumaric acid
`compound therapy and monotherapy with
`dimethylfumaric acid ester, Exhibit 1017 at 2.
`Nieboer 1990 was publicly available prior to the
`priority date of the 514 patent.
` Q. Can you turn to Paragraph 82 of your
`declaration, Exhibit 1121? And if you'd read
`Paragraph 82 of Exhibit 1121 for the record?
` A. Paragraph 82 reads: Nieboer 1990 is an
`article titled "Fumaric Acid Therapy in
`Psoriasis, a double-blind comparison between
`fumaric acid compound therapy and monotherapy
`with dimethylfumaric acid ester."
` Nieboer -- excuse
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 18 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 17
`
`me -- Exhibit 1017 at 2. Nieboer 1990 was
`publicly available prior to the priority date of
`the 514 patent.
` Q. And that Paragraph 82 from your
`declaration, Exhibit 1121 is word-for-word
`verbatim, the same as Dr. Corboy's 1002,
`Paragraph 80; correct?
` A. Yes.
` Q. And then if you look at Paragraph 81 of
`Exhibit 1002, you don't need to read that into
`the record, but would you just read it -- look at
`it.
` And can you look at Paragraph 83 of
`your declaration of 1121 and confirm that other
`than the fact that in your Paragraph 83, there is
`an additional sentence interposed in the middle,
`otherwise, it's word-for-word verbatim, copy of
`Dr. Corboy's Exhibit 11, Paragraph 81 of Exhibit
`1002?
` A. So 83 and 81 have the same language
`except the changes that you noted.
` Q. The one additional paragraph -- one
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 19 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 18
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`additional sentence that you added?
` MS. PROCHNOW: Objection; form.
` THE WITNESS: Yes. There is an
`additional sentence.
`BY MR. FELDSTEIN:
` Q. And the Footnote, Footnote 2, that comes
`off of Dr. Corboy's Paragraph 81 and your
`Paragraph 83, those are identical, verbatim, as
`well? Correct?
` A. Those are identical.
` Q. And then in Exhibit 1002 Dr. Corboy's
`declaration, Paragraph 82, that's word-for-word
`verbatim, the same as your Paragraph 84 in
`Exhibit 1121; correct?
` A. It is.
` Q. And so did you, in fact, write both
`paragraphs, Paragraphs 83, 82 of Dr. Corboy's
`declaration and Paragraphs 82 through 84 of your
`declaration, 1121?
` MS. PROCHNOW: Objection; form.
` THE WITNESS: I was not involved in
`the preparation of Dr. Corboy's declaration.
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 20 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 19
`
`BY MR. FELDSTEIN:
` Q. Okay. But you didn't -- you didn't
`write the statements in Paragraphs 82 of Dr.
`Corboy's declaration that were then copied into
`your declaration. Correct?
` MS. PROCHNOW: Objection; form.
` THE WITNESS: So my process for
`forming a declaration was to go through the
`literature and create the paragraphs and then
`work to edit and make it succinct. How these are
`identical, I can't speak to how Dr. Corboy's are.
`BY MR. FELDSTEIN:
` Q. But you are testifying that you actually
`drafted, yourself, from scratch, Paragraphs 82 to
`84 of your declaration, Exhibit 1121, and just by
`chance it turned out to be verbatim the same as
`Dr. Corboy's?
` MS. PROCHNOW: Objection; form.
` THE WITNESS: I don't believe
`that's what I said. In terms of the drafting,
`putting things together, and -- I'd have to think
`back in terms of where these words fell into the
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 21 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 20
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`sequence for mine, but I can't speak to Dr.
`Corboy's.
`BY MR. FELDSTEIN:
` Q. For use, you testified you drafted 82,
`Paragraphs 82 through 84 of your declaration a,
`Exhibit 1121 from scratch?
` MS. PROCHNOW: Objection; form.
` THE WITNESS: I don't recall if I
`typed it out from scratch or made it from notes
`and put it together.
`BY MR. FELDSTEIN:
` Q. Okay. And, Dr. Greenberg, you testified
`in the related district court case with same 514
`patent at issue here; correct?
` A. Yes.
` Q. And that was in June of this year;
`correct?
` A. That sounds correct.
` Q. And you testified in that case?
` A. Yes.
` Q. And all of your answers there were
`truthful?
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 22 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 21
`
` A. All of the answers I give are on
`truthful to the best of my knowledge, yes.
` MR. FELDSTEIN: Okay. Do you have
`a copy of Dr. Greenberg's declaration?
` MS. BLOODWORTH: I'll just take
`one. Scribble factor.
` MR. FELDSTEIN: I didn't throw it.
` MS. BLOODWORTH: That's okay. No.
`This table is crazy big.
`BY MR. FELDSTEIN:
` Q. I am going to mark as Exhibit 2218,
`paper, first author Frohman, F-r-o-h-m-a-n, from
`March, 2012.
` MS. PROCHNOW: And we are going to
`object to this -- the use of this exhibit.
`BY MR. FELDSTEIN:
` Q. Can you can you identify Exhibit 2218,
`Doctor?
` A. Exhibit 2218 is titled addressing the
`challenges and risk assessment and risk
`management in multiple sclerosis.
` Q. Is it a paper you wrote?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 23 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 22
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` A. It's a paper that I am a co-author on.
`One of four authors and it's a report out of a
`meeting that occurred.
` Q. So you are co-authoring Exhibit 2218?
` A. Yes.
` Q. Can you turn -- well, actually, on the
`first page, the very first paragraph, can read
`the last sentence of the first paragraph into the
`record?
` A. "After experiencing a, quote, honeymoon
`period relative to the low-risk associated with
`the interferon glatiramer acetate injection
`therapy, patients with MS and physicians were
`forced to determine what amount of risk they
`would be willing to endure in order to achieve
`substantially optimized disease-modifying effects
`(both clinical and radiographic.)"
` Q. And what are disease-modifying effects
`in that context?
` MS. PROCHNOW: Objection; form.
` THE WITNESS: Disease-modifying
`effects are relative to therapies that change the
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 24 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 23
`
`course of multiple sclerosis.
`BY MR. FELDSTEIN:
` Q. What are examples of disease-modifying
`effects?
` A. Disease-modifying effect examples
`include a reduction in MRI activity, a reduction
`in clinical activity.
` Q. Clinical would be what, for example?
` A. Clinical activity includes reduction
`both in the number of relapses and in the
`progression of disability.
` Q. So MRI effects are non-clinical
`effects --
` MS. PROCHNOW: Objection; form.
`BY MR. FELDSTEIN:
` Q. -- the way you separated them?
` A. An MRI readout is considered a
`paraclinical test. It is related and a hallmark
`of, and is associated with, clinical events, but
`it is not a clinical event.
` Q. Does it mean, then -- does optimizing
`disease-modifying effects mean trying to maximize
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 25 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 24
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`effects on MRI and clinical outcomes?
` MS. PROCHNOW: Objection; form.
` THE WITNESS: I'm not sure I
`understand your question.
`BY MR. FELDSTEIN:
` Q. In the sentence that you had read into
`the record on Exhibit 2218, it referred to
`substantially optimized disease-modifying effects
`in order -- back up a second -- it's -- refers
`to in order to achieve substantially optimized
`disease-modifying effects. Does substantially
`optimized in that context mean that you are
`trying to do the most possible to effect the MRI
`in the clinical outcomes?
` MS. PROCHNOW: Objection; form.
` THE WITNESS: I think what this
`sentence is referring to is, when talking about
`substantially optimized is that goal of reducing
`the amount of clinical and MRI activity to the
`most you can.
`BY MR. FELDSTEIN:
` Q. And if you could turn to the sentence
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 26 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 25
`that bridges Pages 7 and 8 of Exhibit 2218, I'm
`using the original pagination of the article.
`Can you read that sentence into the record?
` A. "Beyond suppression of relapses,
`however, there are many goals in MS therapy, the
`most important of which is the maintenance of
`both physical and intellectual function in our
`patients over decades."
` Q. And is that part of the substantially
`optimized diseased-modifying effects that are the
`goal that you are referring to?
` MS. PROCHNOW: Objection; form.
` THE WITNESS: I think what this
`sentence is talking about is taking a broad,
`wholistic view of goals in treating MS patients,
`and so optimized therapy, the goal of MS therapy
`is to prevent changes on MRI, prevent relapses,
`and when talking about disability, this sentence
`points out both physical and intellectual
`function over the long-term of our patients.
`BY MR. FELDSTEIN:
` Q. And is there some particular challenge
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 27 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 26
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`to maintaining both physical and intellectual
`function over the long-term or decades as your
`article says?
` MS. PROCHNOW: Objection; form.
` THE WITNESS: I don't think this
`article says there is a challenge. I think it
`talks about a goal. And when looking at
`individuals, we have achieved success in many
`individuals in terms of achieving this goal, but
`based on the heterogeneity of the patient
`population, we haven't cured the disease yet for
`100 percent of the population. So this sentence
`talks about the goals, not about --
`BY MR. FELDSTEIN:
` Q. No, I apologize. I may have not asked
`the question clearly. I wasn't asking if this
`article refers -- explains what the challenges
`are, refers to challenges. I am just asking you
`separately from the article what, if any,
`challenges there are to maintaining both physical
`and intellectual function in your patients over
`decades.
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 28 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 27
`
` MS. PROCHNOW: Objection; form.
` THE WITNESS: So I think speaking
`broadly about the challenge of treating patients,
`it's about matching patients up with the right
`therapy for them, given the number of options we
`have and have had for a long time, trying to find
`that match that works for each patient.
`BY MR. FELDSTEIN:
` Q. How do you go about finding that match
`just generally?
` MS. PROCHNOW: Objection; form.
` THE WITNESS: Today, in my clinic,
`it's a -- what's called a shared decision-making
`model with patients where we discuss the
`advantages and disadvantages of different drugs,
`the risks, benefits, the impact on lifestyle,
`third-party payer issues, a very holistic
`approach to having each patient share in the
`process of deciding which therapy they want to
`start with.
` And then we monitor their response.
`BY MR. FELDSTEIN:
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 29 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 28
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
` Q. What are you monitoring for in their
`response just generally once you begin therapy?
` MS. PROCHNOW: Objection; form.
` THE WITNESS: So in general, we
`monitor patients for evidence of efficacy. We
`monitor them clinically and with MRI.
` And we also monitor their lifestyle
`and the impact on their life and monitor both for
`benefit as well as side effects.
` And then depending on the drug,
`there are different prescribed safety monitoring
`programs, some mandated by the government and the
`FDA, and some that we do out of course.
`BY MR. FELDSTEIN:
` Q. And if a therapy is deemed efficacious,
`do you normally maintain that therapy, sort of in
`a status quo? If it's working, keep it?
` MS. PROCHNOW: Objection; form.
` THE WITNESS: So there have been
`situations where even if a therapy seems to be
`efficacious, patients have switched for a variety
`of reasons, our goal is to have an efficacious
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 30 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 29
`
`therapy that checks all the boxes a patient
`desires relative to their view of the therapy, as
`well.
`BY MR. FELDSTEIN:
` Q. And while I appreciate you probably have
`an example of a patient who has done every
`possible different choice, is it generally true
`that if a therapy is working you maintain that
`therapy?
` MS. PROCHNOW: Objection; form.
` THE WITNESS: I think in -- it's
`fair to say, in general, we want to maintain
`patients on effective therapies. But the number
`of examples are beyond one-offs where patients
`are switching for a variety of reasons. So, I
`mean, it's a very individualized discussion.
`BY MR. FELDSTEIN:
` Q. If a therapy is not working, what do you
`do?
` A. So, if we see evidence of the therapies
`not working, we have conversations with the
`patient around adherence and making sure they are
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`866-928-6509
`
`Ace-Federal Reporters, Inc.
`
`202-347-3700
`
`Page 31 of 256
`
`
`
`Benjamin Greenberg
`
`Mylan Pharmaceuticals Inc. v. Biogen MA, Inc.
`
`October 28, 2019
`
`Page 30
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`actually taking the medication. We have
`conversations about access, making sure they are
`actually getting the medication. And then we
`have a discussion relative to the context of that
`individual patient as to whether or not they
`should consider a switch.
` Q. And, I can hand you paper, but, I don't
`know
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
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.
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.
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
