Richard Auchus , M.D., Ph.D.
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`April 10, 2017
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`Page 1
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` UNITED STATES PATENT AND TRADEMARK OFFICE
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` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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` --------------------------------------
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` MYLAN PHARMACEUTICALS INC,
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`Petitioner,
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` v.
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` JANSSEN ONCOLOGY, INC.,
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`Patent Owner.
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` Case No. IPR2016-01332
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` U.S. Patent No. 8,822,438
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`1 2
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`3
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`4
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`5
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`6
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` WOCKHARDT BIO AG,
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`11
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`12
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`13
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`14
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`15
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`Petitioner,
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` v.
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` JANSSEN ONCOLOGY, INC.,
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`Patent Owner.
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` Case IPR2016-01582
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`16
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` U.S. Patent No. 8.822,438 B2
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`17
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`18
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`20
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`21
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`22
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`23
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`24
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`25
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`787 Seventh Avenue
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`New York, New York
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`9:08 a.m.
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`HIGHLY CONFIDENTIAL
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`VIDEOTAPED DEPOSITION OF
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`RICHARD J. AUCHUS, M.D., Ph.D.
`
`APRIL 10, 2017
`
`VERITEXT LEGAL SOLUTIONS
`202-803-8830
`
`WCK1121
`Wockhardt Bio AG v. Janssen Oncology, Inc.
`IPR2016-01582
`
`1
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`

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`Richard Auchus , M.D., Ph.D.
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`April 10, 2017
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`Page 2
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`Page 4
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`1 2
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` E X A M I N A T I O N S
`3 Witness Page
`4 Richard Auchus, M.D., Ph.D.
` By Mr. Beel 7
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` E X H I B I T S
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`5 6
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`7
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` Mylan
`8 Exhibit Description Page
`9 Exh 1090 Janssen's Patent Owner 34
` Response
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`10
`11
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`12
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`13
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` PRIOR MARKED EXHIBITS
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` Exhibit Description Page
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` Mylan 1001 U.S. Patent No. 26
`14 8,822,438
`15 Janssen Auchus declaration 30
` 2040
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`16
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`17
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` Mylan 1026 Auchus 2001 paper 37
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` Mylan 1025 Excerpt from 54
`18 Harrison's "Principles
` of Internal Medicine
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`19
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`20
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`21
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` Mylan 1003 O'Donnell paper 63
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` Mylan 1023 Attard 2005 84
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` Mylan 1005 U.S. Patent Number 86
`22 5,604,213
`23 Mylan 1002 Declaration of Marc B. 87
` Garnick M.D.
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` HIGHLY CONFIDENTIAL VIDEOTAPED
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`1 2 3 4
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`5 OF RICHARD J. AUCHUS, M.D.. Ph.D., a Witness
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`6 herein, taken by Petitioners, at the
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`7 offices of Sidley Austin LLP, 787 Seventh
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`8 Avenue, New York, New York, on Monday
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`9 April 10, 2017, before Debra Stevens, a
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`10 Certified Realtime and Registered
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`11 Professional Reporter and Notary Public of
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`12 the State of New York
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` A P P E A R A N C E S:
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`13
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`14
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`15
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`16
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`17
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`18
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`19
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`20
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`21
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`22
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`23
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`24
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`25
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`1 2
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`3 4
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` PERKINS COIE LLP
` Attorneys for Petitioner Mylan
`5 Pharmaceuticals Inc.
` 700 Thirteenth Street, N.W., Suite 600
`6 Washington, DC 20005-3960
`7 BY: BRYAN BEEL, ESQ.
` bbeel@perkinscoie.com
`8 (Portland office)
`9 BRANDON M. WHITE, ESQ.
` bmwhite@perkinscoie.com
`
`10
`11
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` STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C
`12 Attorneys for Petitioner
` Wockhardt Bio AG
`13 1100 New York Ave. NW, Suite 600
` Washington DC 20005
`
`14
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` BY: CHRISTOPHER M. GALLO, ESQ.
`15 cgallo@skgf.com
`16
`17
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` SIDLEY AUSTIN LLP
`18 Attorneys for Patent Owner Mylan
` Pharmaceuticals Inc.
`19 787 Seventh Avenue
` New York, New York 10019
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`20
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` BY: BINDU DONOVAN, ESQ.
`21 bdonovan@sidley.com
`22 ALYSSA B. MONSEN, ESQ.
` amonsen@sidley.com
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`23
`24 ALSO PRESENT: Deverell Write, Video
`25 * * *
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` Exh 2131 Van den Akker paper 101
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`24
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`25
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`Page 3
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`Page 5
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`1 2
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` VIDEOGRAPHER: We are on the
`3 record. Please note that the
`4 microphones are sensitive and may pick
`5 up whispering and private
`6 conversations.
`7 My name is Deverell Write,
`8 representing Veritext Legal Solutions.
`9 Today's date is April 10, 2017. The
`10 time on the video monitor is
`11 approximately 9:11 a.m. This
`12 deposition is being held at the
`13 offices of Sidley Austin, located at
`14 787 Seventh Avenue, New York, New
`15 York.
`16 The caption of this case, Mylan
`17 Pharmaceuticals Incorporated vs.
`18 Janssen Oncology Incorporated, Case
`19 Number IPR2016-01332; also, Wockhardt
`20 Bio AG vs. Janssen Oncology
`21 Incorporated, Case Number
`22 IPR2016-01582. These cases are filed
`23 in the U.S. Patent and Trademark
`24 Office before the Patent Trial and
`25 Appeal Board. The name of the witness
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`VERITEXT LEGAL SOLUTIONS
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`2 (Pages 2 - 5)
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`2
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`

`Richard Auchus , M.D., Ph.D.
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`April 10, 2017
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`Page 6
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`Page 8
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`2 hour or so.
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`3 A. Okay.
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` is Dr. Richard J. Auchus.
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`1 2
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`3 At this time will counsel please
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`4 state appearances?
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`4 Q. Is there any reason that you
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`5 MR. BEEL: Bryan Beel for Mylan
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`5 cannot give complete and truthful
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`6 Pharmaceuticals. With me is my
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`7 colleague Brandon White.
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`8 MR. GALLO: Christopher Gallo,
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`6 testimony today?
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`7 A. No, there is not.
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`8 Q. Okay. Thanks.
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`9 Sterne, Kessler Goldstein & Fox,
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`9 Do you have an understanding of
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`10 representing Petitioner Wockhardt.
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`10 what this proceeding is related to?
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`11 MS. DONOVAN: Bindu Donovan from
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`11 A. Yes, I do.
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`12 Sidley Austin LLP, representing
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`12 Q. Can you tell me what that
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`13 Janssen Oncology Inc. With me is my
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`13 understanding is?
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`14 colleague Alyssa Monsen.
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`15 Whereupon,
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`14 A. So, Janssen holds a patent for
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`15 the use of one of their medications in a
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`16 R I C H A R D J. A U C H U S,
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`16 specific way, and this is a challenge to
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`17 having been first duly sworn/affirmed,
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`17 that patent.
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`18 was examined and testified as follows:
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`18 Q. Do you understand that it is a
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`19 MR. BEEL: Ms. Donovan, I was
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`19 proceeding under the U.S. Patent and
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`20 going to begin by showing Dr. Auchus
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`20 Trademark Office as opposed to District
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`21 his Deposition Notice. Can we just
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`21 Court?
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`22 stipulate that he is here pursuant to
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`22 A. Yes, I do.
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`23 the Notice?
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`24 MS. DONOVAN: Yes.
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`23 Q. Have you been deposed before?
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`24 A. A few months ago was the first
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`25 MR. BEEL: Thank you very much.
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`25 time.
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`Page 7
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`Page 9
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`2 EXAMINATION BY
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`3 MR. BEEL:
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`2 Q. What case was that?
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`3 A. That was the case of the same
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`4 Q. Good morning, Dr. Auchus.
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`4 patent with a different company
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`5 A. Good morning.
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`5 challenging it.
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`6 Q. Let me begin with just a few
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`6 Q. Do you recall the company?
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`7 comments. We are here today to discuss
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`7 A. I believe it was Amerigen.
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`8 your declaration that you drafted and
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`8 Q. Thank you.
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`9 submitted in our inter partes review
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`9 That was your only prior
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`10 proceedings. I want to talk to you about
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`10 deposition you said?
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`11 certain topics in the declaration, but can
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`11 A. That was my only prior
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`12 we please be sure not to speak over each
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`12 deposition.
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`13 other? I will ask questions and if you
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`13 Q. Have you ever testified at
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`14 can respond after I finish?
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`14 trial?
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`15 A. Okay.
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`15 A. I was -- I testified at a
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`16 Q. And I would ask that you please
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`16 court-martial when I was in the Air Force.
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`17 answer the question unless Ms. Donovan
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`17 Q. Never in District Court
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`18 requests that you not answer.
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`18 proceedings?
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`19 A. Okay.
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`19 A. No. And I have also been
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`20 Q. If at any time you need a break,
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`20 involved with Court of Arbitrations board.
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`21 can you please let me know, but not when a
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`21 Q. That sounds potentially more
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`22 question is pending? Please finish your
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`22 interesting --
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`23 answer?
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`24 A. Right.
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`23 A. You might imagine what that was
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`24 about.
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`25 Q. Generally we break about every
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`25 Q. Yes, I can imagine. We'll talk
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`VERITEXT LEGAL SOLUTIONS
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`3
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`Richard Auchus , M.D., Ph.D.
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`April 10, 2017
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`2 a little about your professional
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`2 Q. What kind of basic research do
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`Page 10
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`Page 12
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`3 background.
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`3 you do?
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`4 Do you treat patients regularly?
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`4 A. I do basic research on steroid
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`5 A. Yes, I do.
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`5 biosynthesis and metabolism.
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`6 Q. Do you have a hospital
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`6 Q. Is that like laboratory-based
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`7 appointment?
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`8 A. I work at the University of
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`7 research?
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`8 A. Yes.
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`9 Michigan. Our healthcare system recently
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`9 Q. Do you know how many people are
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`10 changed its name to Michigan Medicine.
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`10 in your laboratory?
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`11 And that's the only clinical practice that
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`11 A. Currently, one, two, three,
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`12 I do is within that umbrella.
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`12 four, five -- if you count undergraduates,
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`13 Q. How many patients do you have
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`13 that's six.
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`14 regularly?
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`14 Q. Have you ever participated as an
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`15 A. That's a hard question to
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`15 investigator in clinical trials?
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`16 answer, but I will give you some ways of
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`16 A. Yes --
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`17 calculating that. I have one or two
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`17 MS. DONOVAN: Objection to the
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`18 half-day clinics a week and I probably
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`18 form of the question.
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`19 have about 100 or 200 patients that I
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`19 A. Yes, I have.
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`20 manage, but I only see them usually once
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`20 Q. And can you describe those
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`21 every six months or so.
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`22 I also do in-hospital
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`21 trials?
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`22 A. So, we have done Phase I trials
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`23 consultation services for two weeks or so
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`23 of either abiraterone acetate or a drug
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`24 every year, and I also staff our
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`24 called NBI-77860, for treating
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`25 Endocrinology Fellows Continuity of Care
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`25 21-hydroxylase deficiency. Actually, we
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`Page 11
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`Page 13
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`2 Clinic, and those patients I share
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`2 also have a trial of a drug called ATR-101
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`3 responsibility with the Fellow and with
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`3 for 21-hydroxylase deficiency.
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`4 other attending physicians.
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`4 We are studying drugs for the
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`5 Q. What appointment do you have
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`5 treatment of Cushing's syndrome. We also
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`6 that fills the rest of your time? Do you
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`6 do a lot of studies that aren't
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`7 have a university appointment?
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`7 interventional studies but are biomarker
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`8 A. Right. So, I am a professor of
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`8 studies in these diseases, where we
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`9 internal medicine, endocrinology and
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`9 collect samples and measure steroid
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`10 metabolism and professor of pharmacology
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`10 hormones that are the sort of traditional
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`11 at the University of Michigan. So my
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`11 ones but also non-traditional ones, to
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`12 activities include the patient care,
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`12 look for better disease markers.
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`13 running the fellowship program,
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`13 That's not all, but that is kind
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`14 research -- both clinical and basic -- and
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`14 of the main things we have been doing.
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`15 other academic activities.
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`15 Q. You mentioned a Phase I trial
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`16 Q. What kind of clinical research
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`16 with abiraterone acetate. When did that
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`17 do you do?
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`17 occur?
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`18 A. Well, it's clinical research on,
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`18 A. That paper -- so that started
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`19 generally, endocrine diseases. The focus
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`19 right after I moved to Michigan in 2011,
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`20 would be on disorders of the adrenal
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`20 and that probably ran until 2013. I
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`21 cortex, congenital adrenal hyperplasia,
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`21 believe the results were published in
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`22 Cushing's syndrome, primary aldosteronism
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`22 2014.
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`23 are the main diseases we study. We also
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`23 Q. Can you describe the subject
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`24 do some other things mainly in
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`24 matter of that clinical trial?
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`25 collaboration with my colleagues.
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`25 A. So, patients with 21-hydroxylase
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`VERITEXT LEGAL SOLUTIONS
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`4
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`Richard Auchus , M.D., Ph.D.
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`April 10, 2017
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`Page 14
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`Page 16
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`2 deficiency have cortisol deficiency and
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`2 primary hyperaldosteronism?
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`3 they make too much testosterone. And so
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`3 A. So, there is a long and involved
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`4 the traditional treatment has been to
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`4 evaluation to determine what the source of
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`5 suppress -- both replace the cortisol
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`5 aldosterone is. And then if it's only one
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`6 deficiency and suppress the testosterone
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`6 side, only one adrenal gland that's the
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`7 with glucocorticoids, and that requires
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`7 source, we tend to treat that with
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`8 doses that are above physiologic and lead
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`8 surgery.
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`9 to complications.
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`9 I don't do the surgery. I refer
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`10 So, we reduce the dose of
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`10 them to our surgeons. And that usually
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`11 glucocorticoids to a physiologic level,
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`11 cures the problem and then we don't have a
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`12 allow the testosterone to rise, and then
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`12 long-term relationship.
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`13 try to block the testosterone synthesis
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`13 If it's both adrenal glands that
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`14 with abiraterone. And it was a small
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`14 are making aldosterone in excess, we don't
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`15 study of six participants, two different
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`15 do a bilateral surgery because that would
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`16 dose levels, six days each.
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`16 render the patient adrenal insufficient.
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`17 Q. What was the purpose of the
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`17 So, we treat that medically with drugs
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`18 study if it only lasted six days?
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`18 like spironalactone, eplerenone, sometimes
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`19 A. It was a proof-of-concept study
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`19 amiloride, and in combination with other
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`20 with the intention of then doing a larger
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`20 blood pressure medicines.
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`21 study in children, which is going -- which
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`21 Q. Has any of your research
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`22 is now funded by the NIH. So, that's on
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`22 involved prostate cancer patients?
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`23 the books for later this year.
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`23 MS. DONOVAN: Object to the form
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`24 Q. What do you mean by "proof of
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`24 of the question. You may answer.
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`25 concept"?
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`25 Q. Clinical research. Sorry.
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`Page 15
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`Page 17
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`2 MS. DONOVAN: Object to form.
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`2 A. So, my clinical research, no. I
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`3 You may answer.
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`3 have collaborators that do prostate cancer
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`4 A. A study that is large enough to
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`4 research that do use patient-derived
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`5 show that the idea has validity and that
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`5 samples or do have ongoing patient
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`6 would allow you to then -- would then
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`6 management.
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`7 encourage one to do a larger study that
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`7 But we do basic research that
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`8 would be more definitive.
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`8 dovetails with that on steroid metabolism.
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`9 Q. You said those results were
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`9 So, I have a number of papers with
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`10 published in 2014?
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`10 prostate cancer collaborators,
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`11 A. I believe that is the year, yes.
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`11 particularly Dr. Sharifi at the Cleveland
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`12 Q. Roughly. Okay.
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`12 clinic, where we do a combination of
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`13 Have you treated prostate cancer
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`13 human, mouse, tissue culture, in vivo
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`14 patients in a clinical setting?
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`14 biochemistry. And we work more on the
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`15 MS. DONOVAN: I object to the
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`15 chemical synthesis and in vitro
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`16 form of the question. You may answer.
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`16 biochemistry, and he does more of the
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`17 A. I don't treat patients for
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`17 animal and human experiments.
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`18 prostate cancer. I do treat patients who
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`18 Q. You are familiar with the drug
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`19 happen to have prostate cancer, for other
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`19 abiraterone acetate?
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`20 endocrine diseases. For example, I have
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`20 A. Yes, I am.
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`21 one patient with prostate cancer and
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`21 MS. DONOVAN: Objection to the
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`22 primary aldosteronism. I manage the
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`22 form of the question.
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`23 primary aldosteronism. I don't treat the
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`23 Just allow him to finish his
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`24 primary cancer. Somebody else does that.
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`24 question, allow me to object, and then
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`25 Q. How do you treat the patient for
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`25 you may answer.
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`VERITEXT LEGAL SOLUTIONS
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`5
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`Richard Auchus , M.D., Ph.D.
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`April 10, 2017
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`2 THE WITNESS: Right.
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`3
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`Q. When did you first become aware
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`4 of the drug?
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`5
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`A. Let's see. So, that was -- I
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`6 can't give you the exact time. It was
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`7 probably around 2007.
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`8
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`Q. Why did you learn of it in
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`9 around 2007?
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`VERITEXT LEGAL SOLUTIONS
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`Richard Auchus , M.D., Ph.D.
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`April 10, 2017
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`2 objection. You may continue.
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`3 MR. WHITE: We disagree with the
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`4 accusations --
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`5 MS. DONOVAN: You may disagree.
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`6 You may continue.
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`7 MR. WHITE: Nothing but
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`8 open-ended questions that the witness
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`9 has answered.
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`10 MS. DONOVAN: You may continue.
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`11 BY MR. BEEL:
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`12 Q. Have you played a role in
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`13 developing any other anti-prostate cancer
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`14 drugs?
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`15 MS. DONOVAN: Object to the form
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`16 of the question.
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`17 A. I have consulted for other
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`18 companies. None of those drugs has made
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`19 it to market.
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`20 Q. About how many others?
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`21 A. I can think of three for sure.
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`22 Q. Were any of those other drugs
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`23 inhibitors of cytochrome P450?
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`24 A. I am not sure that my
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`25 confidentiality agreements with those
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`Page 23
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`2 companies will allow me to disclose that
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`3 information.
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`4 Q. Can you answer yes or no?
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`5 MS. DONOVAN: You may answer
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`6 MS. DONOVAN: And I designate
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`6 that yes or no.
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`7 this transcript highly confidential.
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`7 A. Yes.
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`8 MR. BEEL: One more question
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`8 MS. DONOVAN: Without naming the
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`9 companies.
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`10 THE WITNESS: All right.
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`11 Q. Were you involved with any
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`12 clinical trials involving abiraterone
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`13 acetate?
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`14 MS. DONOVAN: Object to the form
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`15 of the question. Asked and answered.
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`16 A. The previous -- the trial on
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`17 21-hydroxylase deficiency we discussed
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`18 previously is the only one.
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`9 then.
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`10
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`
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`19 MS. DONOVAN: We reserve all
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`19 Q. That is the only one you said?
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`20 rights with regard to misuse of our
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`20 A. Yes.
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`21 confidential information that is
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`21 I will point out that that
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`22 misused in the litigation in the IPR.
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`22 preparation was different than the
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`23 MR. WHITE: There has been no
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`23 preparation that is commercially used.
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`24 misuse --
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`24 The preparation that we used for that
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`25 MS. DONOVAN: I maintain my
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`25 trial is not commercially available.
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`VERITEXT LEGAL SOLUTIONS
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`7 (Pages 22 - 25)
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`7
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`Richard Auchus , M.D., Ph.D.
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`April 10, 2017
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`Page 26
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`Page 28
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`2
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`Q. What do you mean by
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`2 issues related to patent claims.
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`3 "preparation"?
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`3 Q. If you turn back to what is page
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`4
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`A. The form of the drug that was
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`4 11 of the patent on the bottom right-hand
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`5 administered to the patients.
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`5 corner, do you understand that the
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`6 MS. DONOVAN: Again, I am going
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`6 numbered paragraphs in the right-hand
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`7 to caution the witness not to disclose
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`7 column are patent claims?
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`8 confidential information related to
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`8 A. Yes, I do.
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`9 unpublished clinical trials.
`
`10 You may continue.
`
`9 Q. Have you seen these patent
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`10 claims before?
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`11 MR. BEEL: I will hand you an
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`11 MS. DONOVAN: You may answer
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`12 exhibit that has been previously
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`12 that yes or no.
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`13 marked Mylan Pharm Inc. Exhibit 1001,
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`13 A. I have seen them, yes.
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`14 U.S. Patent Number 8,822,438.
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`14 Q. We'll refer to Claim 1. It says
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`15
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`16
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`A. Okay.
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`15 "A method for the treatment of a prostate
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`Q. Have you seen this patent
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`16 cancer in a human comprising administering
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`17 before?
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`A. Yes, I have.
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`18
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`19
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`17 to said human a therapeutically effective
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`18 amount of abiraterone acetate or a
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`Q. When was the first time that you
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`19 pharmaceutically acceptable salt thereof
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`20 saw it?
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`20 and a therapeutically effective amount of
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`21
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`A.
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`I am not -- I honestly don't
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`21 prednisone."
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`22 remember. I am going to guess that it was
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`22 Did I read that correctly?
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`23 somewhere about two years ago.
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`23 A. Yes; I agree with that.
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`24
`
`Q. Why did you see it about two
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`24 Q. Have you seen this claim before?
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`25 MS. DONOVAN: You may answer
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`25 years ago? Do you recall?
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`Page 27
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`Page 29
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`2 MS. DONOVAN: Objection to the
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`2 that yes or no.
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`3 question on the grounds of attorney
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`4 client privilege. I caution the
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`3
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`4
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`A. Yes.
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`Q. Do you understand what is
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`5 witness not to disclose privileged
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`5 claimed there?
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`6 communications. You may answer the
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`6 MS. DONOVAN: Object to the form
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`7 question generally.
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`7 of the question. The witness is not a
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`8
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`A.
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`It was in relationship to my
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`8 lawyer, and I object on the grounds of
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`9 current serving as an expert witness.
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`9 relevance and outside the scope of the
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`10 I was going to say, I might have
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`10 declaration.
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`11 seen it at some other point but I don't
`
`11 You may answer if you can
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`12 really recall that.
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`12 understand the question.
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`13 Q. Did you provide any consulting
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`13
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`A. To the extent that any non-legal
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`14 services regarding the subject matter of
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`14 person can understand it, I do understand
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`15 the application before it was issued as a
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`15 it.
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`16 patent?
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`16
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`Q.
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`In your layman's understanding,
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`17 MS. DONOVAN: You may answer
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`17 how do you understand Claim 1?
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`18 that question yes or no.
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`18 MS. DONOVAN: Object to the form
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`19 A. No.
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`19 of the question. Again, same
`
`20 Q. Do you know what patent claims
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`20 objection.
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`21 are?
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`21 A. It appears to be a claim for the
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`22 A. I do not -- I am not a patent
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`22 treatment of prostate cancer using the
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`23 lawyer. I do understand the general
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`23 stated medications as -- in the manner
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`24 concept, but I am certainly not highly
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`24 described.
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`25 versed in the specifics of the legal
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`25 Q. Do you understand that this is
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`VERITEXT LEGAL SOLUTIONS
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`8 (Pages 26 - 29)
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`8
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`Richard Auchus , M.D., Ph.D.
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`April 10, 2017
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`Page 30
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`Page 32
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`2 the patent that is at issue in these
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`3 proceedings?
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`4 MS. DONOVAN: You may answer
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`5 that yes or no.
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`6 A. Yes.
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`2
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`3
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`4
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`5
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`A. Because it was relevant.
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`Q. How was it relevant?
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`MS. DONOVAN: Same objection.
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`A.
`
`If I am not mistaken,
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`6 Dr. Garnick provided a declaration on your
`
`7 Q. I would like to refer you to
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`7 behalf.
`
`8 your declaration, I will not hand it to
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`8
`
`Q. Why did you review the
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`9 you since it looks like you already have a
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`9 declaration of Scott R. Serels, M.D.?
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`10 copy, Janssen Exhibit 2040.
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`10 MS. DONOVAN: Again I caution
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`11 Bindu, do you have your own
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`12 copy?
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`11 the witness not to reveal
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`12 attorney-client privileged
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`13 MS. DONOVAN: I do, thank you.
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`13 communication.
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`14 Q. Dr. Auchus, when is the last
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`14
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`A.
`
`If I am not mistaken Dr. Serels
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`15 time you reviewed your declaration?
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`15 provided a declaration for Amerigen.
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`16 A. Last night.
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`16
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`Q.
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`Is Amerigen party to these
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`17 Q. Do you have any changes that you
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`17 proceedings to your understanding?
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`18 wish to make to the declaration?
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`18 MS. DONOVAN: You may answer.
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`19 A. No, I do not.
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`19
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`A. So, Amerigen has a parallel set
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`20 Q. If you could go back to the
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`20 of proceedings related to this topic.
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`21 Appendix A which is on page 33, please?
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`21
`
`Q.
`
`Is it your understanding that
`
`22 Is this a list of the materials that you
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`22 Dr. Serels provided testimony on Mylan's
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`23 reviewed in preparing your declaration?
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`23 behalf?
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`24 A. I did -- yes. I did incorporate
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`24
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`A. Not that I am aware.
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`Q. Did you review Mylan's Petition
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`25 these materials.
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`25
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`Page 31
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`Page 33
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`2
`
`Q. Did you review and incorporate
`
`2 For Inter Partes Review in these
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`3 any other materials that aren't listed?
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`3 proceedings?
`
`4 A. So, I think you have to realize
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`4 MS. DONOVAN: Again I caution
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`5 that I have been working in this field my
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`5 the witness not to disclose privileged
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`6 whole career, and sometime -- you know, my
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`6 communications. You may answer if you
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`7 previous understanding of the literature,
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`7 recall.
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`8 which incorporates hundreds of papers,
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`8
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`A.
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`I did not -- I did not read that
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`9 gets drawn into this.
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`9 document.
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`10 Although I didn't specifically
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`10
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`Q. Did you look at it? You said
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`11 reread those papers for this, it's
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`11 you did not read the document. What do
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`12 sometimes difficult to distinguish where
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`12 you mean by that?
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`13 all the information is coming from in
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`13
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`A.
`
`I can't entirely remember if I
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`14 one's mind. But these were the primary
`
`14 saw it. But if I did, I did not read it
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`15 sources involved with generating the
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`15 in detail.
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`16 declaration.
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`16
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`Q. Do you recall the extent to
`
`17 Q. The third item down says
`
`17 which you reviewed it?
`
`18 Declaration of Marc B. Garnick, M.D. Why
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`18
`
`A. So if I reviewed it, it was very
`
`19 did you review Dr. Garnick's declaration?
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`19 cursory.
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`20 MS. DONOVAN: Object to the form
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`20
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`Q. Were you looking for anything in
`
`21 of the question. I caution the
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`21 particular when you reviewed it?
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`22 witness not to disclose any
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`23 attorney-client privileged
`
`22
`
`23
`
`A. No.
`
`Q. What did you take away from your
`
`24 communication. You may answer the
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`24 review if anything?
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`25 question generally.
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`25 MS. DONOVAN: Object on the
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`VERITEXT LEGAL SOLUTIONS
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`9
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`

`Richard Auchus , M.D., Ph.D.
`
`April 10, 2017
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`Page 34
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`Page 36
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`2 grounds of form, as vague. You may
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`2 not an attorney. And so -- but the -- as
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`3 answer.
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`3 a cartoon to, without being too
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`4 A. It was very similar to the
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`4 complicated, explain the pathways, this is
`
`5 Amerigen case.
`
`5 sufficient. Of course, it's not
`
`6 Q. Did you review Janssen's Patent
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`6 100 percent reflective of what goes on in
`
`7 Owner Response in these proceedings?
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`7 the totality of human biology, but that's
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`8 A. No, I did not.
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`8 very difficult to explain in a
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`9 Q. I am going to hand you a copy of
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`9 two-dimensional figure.
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`10 Janssen's Patent Owner Response in these
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`10 I struggle with this all the
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`11 proceedings. I think we need to mark this
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`11 time in writing textbooks and review
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`12 one, Exhibit 1090.
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`12 chapters, that we have not yet figured out
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`13 (So marked for identification as
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`13 a good way to explain everything that
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`14 Exhibit 1090.)
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`14 happens on a single piece of paper without
`
`15 Q. Can I have you turn to page 14
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`15 getting too complicated and confusing
`
`16 of the Response, please. If you turn your
`
`16 people. So, it's not perfect, but it
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`17 attention to Figure 1, which says
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`18 "Abiraterone Acetate Selective
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`17 makes the point that the authors are
`
`18 trying to make.
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`19 Inhibition"? Based on your experience and
`
`19 Q. Would it have been difficult to
`
`20 your expertise, do you see any errors in
`
`20 accurately represent the reactions
`
`21 this figure?
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`21 catalyzed by the enzyme?
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`22 MS. DONOVAN: Object to the form
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`22 MS. DONOVAN: Object to the form
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`23 of the question. You may answer.
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`23 of the question on grounds of
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`24 A. This is a cartoon; and as many
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`24 relevance.
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`25 cartoons of steroid genesis, it's very
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`25 A. So, those three reactions shown
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`2 difficult to explain the totality of what
`
`2 are the major reactions. To add the other
`
`3 happens with a single figure.
`
`3 12 or so, yes, would have been difficult.
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`Page 35
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`Page 37
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`4 I would see that the purpose of
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`4 Q. I guess I was asking
`
`5 this figure is to explain the fundamental
`
`5 specifically about the
`
`6 difference between abiraterone and
`
`6 17 alpha-hydroxylase. Would it have been
`
`7 ketoconazole; that abiraterone inhibits
`
`7 difficult to accurately represent the
`
`8 one enzyme and ketoconazole inhibits three
`
`8 reactions it catalyzes?
`
`9 enzymes. I believe that's the only
`
`9 MS. DONOVAN: Objection to form,
`
`10 purpose of this figure.
`
`10 and misleading. Again, I object on
`
`11 Q. Does Figure 1 accurately
`
`11 the grounds of relevance and outside
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`12 represent the reactions that are catalyzed
`
`12 the scope of the Petition and on the
`
`13 by CYP17, 17 alpha-hydroxylase?
`
`13 grounds that the witness testified he
`
`14 MS. DONOVAN: Object to the form
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`14 has not reviewed the Response and
`
`15 of the question on the grounds it's
`
`15 doesn't know the context in which this
`
`16 outside of the declaration and the
`
`16 was written.
`
`17 Petition, and object on the grounds of
`
`17 You may respond if you
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`18 the form of the question as well.
`
`18 understand the question.
`
`19 A. So, I want to first state
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`19 A. What other aspects of the 17
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`20 that --
`
`20 hydroxylase reaction are you referring to?
`
`21 MS. DONOVAN: You are welcome to
`
`21 Q. I am handing you what has been
`
`22 review the document.
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`22 labeled for identification as Mylan Pharm
`
`23 THE WITNESS: I understand.
`
`23 Exhibit 1026. I believe you will
`
`24 A. I didn't know there was such a
`
`24 recognize this as a prior publication of
`
`25 thing as Patent Owner's response. I am
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`25 yours.
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`VERITEXT LEGAL SOLUTIONS
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`10 (Pages 34 - 37)
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`10
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`

`

`Richard Auchus , M.D., Ph.D.
`
`April 10, 2017
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`1 HIGHLY CONFIDENTIAL - R. AUCHUS, M.D.
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`Page 38
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`Page 40
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`2 If you please, turn to page 2,
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`2 A. Right. So, if -- so you are
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`3 which is the paper's page 102. Do you see
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`3 asking if the fact that there isn't a
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`4 that there is a reaction between
`
`4 separate label identifying the enzyme that
`
`5 progesterone and 17OH progesterone on your
`
`5 converts progesterone to 17 hydroxy
`
`6 figure?
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`7 A. Yes.
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`6 progesterone is an inaccuracy. And if the
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`7 authors intended to imply that CYP17 does
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`8