throbber
DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`1
`
`·1· · · · · · UNITED STATES PATENT AND TRADEMARK OFFICE
`
`·2· · · · · · BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`·3· ·------------------------------------
`
`·4· ·MYLAN PHARMACEUTICALS, INC. AND
`· · ·DR. REDDY'S LABORATORIES, INC.
`·5
`· · · · · · · · · · · ·Petitioners,
`·6
`· · ·v.· · · · · · · · · · · · · · · · · ·Case IPR2018-00272
`·7· · · · · · · · · · · · · · · · · · · · Patent 9,393,208 B2
`· · ·HORIZON PHARMA USA, INC.
`·8· ·AND NUVO PHARMACEUTICALS (IRELAND)
`· · ·DESIGNATED ACTIVITY COMPANY,
`·9
`· · · · · · · · · · · ·Patent Owners.
`10
`· · ·------------------------------------
`11
`
`12
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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· · · · ·VIDEOTAPED DEPOSITION UPON ORAL EXAMINATION
`· · · · · · · · · · OF DAVID A. JOHNSON, M.D.
`18· · · · · · · TAKEN ON BEHALF OF THE PETITIONERS
`
`19· · · · · · · · · · · Norfolk, Virginia
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`20· · · · · · · · · · · · May 3, 2019
`
`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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`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.com
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 1
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`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`2
`
`·1· ·Appearances:
`
`·2· · · · · · PERKINS COIE, LLP
`· · · · · · · By: MARIA A. STUBBINGS, ESQUIRE
`·3· · · · · · · · 700 13th Street, NW
`· · · · · · · · · Suite 600
`·4· · · · · · · · Washington, DC 20005-3960
`· · · · · · · · · (202)654-1742
`·5· · · · · · · · MStubbings@perkinscoie.com
`· · · · · · · · · Counsel for the Petitioners
`·6
`· · · · · · · COOLEY, LLP
`·7· · · · · · By: ELLEN A. SCORDINO, ESQUIRE
`· · · · · · · · · 500 Boylston Street
`·8· · · · · · · · Boston, MA 02116
`· · · · · · · · · (617)937-2492
`·9· · · · · · · · escordino@cooley.com
`· · · · · · · · · Counsel for the Patent Owner
`10· · · · · · · · Horizon Pharma USA, Inc.
`
`11· · · · · · BAKER BOTTS, LLP
`· · · · · · · By: JEFFREY S. GRITTON, ESQUIRE
`12· · · · · · · · 98 San Jacinto Boulevard
`· · · · · · · · · Suite 1500
`13· · · · · · · · Austin, TX 78701-4078
`· · · · · · · · · (512)322-2624
`14· · · · · · · · jeff.gritton@bakerbotts.com
`· · · · · · · · · Counsel for the Patent Owner
`15· · · · · · · · Nuvo Pharmaceuticals (Ireland)
`· · · · · · · · · Designated Activity Company
`16
`
`17
`
`18· · · · · · · · Also present:· Josh Bridges, Videographer
`
`19
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`20
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`21
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`22
`
`23
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`24
`
`25
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.com
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 2
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`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`3
`
`·1· · · · · · · · · · ·I N D E X
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`·2· ·WITNESS· · · · · · · · · · ·EXAMINATION BY· · · ·PAGE
`
`·3· ·David A. Johnson, M.D.· · · Ms. Stubbings· · · · · 5
`
`·4
`
`·5
`
`·6
`
`·7
`
`·8· · · · · · · · · ·E X H I B I T S
`
`·9· ·NO.· · · · · · · ·DESCRIPTION· · · · · · · · · · PAGE
`
`10· ·Exhibit 1· · · · ·Declaration of Dr. Johnson· · · 68
`
`11· ·Exhibit 1064· · · PDR 2000 excerpt· · · · · · · · 77
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`12
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`13
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`14
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`15
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`16
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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
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 3
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`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`4
`
`·1· · · · · · · · Videotaped deposition upon oral
`
`·2· ·examination of DAVID A. JOHNSON, M.D., taken on behalf
`
`·3· ·of the Petitioners, before Penny C. Wile, RPR, RMR, CRR,
`
`·4· ·a Notary Public for the Commonwealth of Virginia at
`
`·5· ·large, taken pursuant to notice, commencing at 9:16 a.m.
`
`·6· ·on May 3, 2019, at the Norfolk Marriott Waterside, 235
`
`·7· ·East Main Street, Norfolk, Virginia, 23510.
`
`·8· · · · · · · · · · ·-· · -· · -
`
`·9· · · · · · · · THE VIDEOGRAPHER:· This is tape number one
`
`10· ·to the videotaped deposition of David A. Johnson, M.D.
`
`11· ·in the matter of Mylan Pharmaceuticals, Incorporated
`
`12· ·versus Horizon Pharma USA, being heard before the U.S.
`
`13· ·Patent and Trademark Office, File No. IPR2018-00272.
`
`14· · · · · · · · This deposition is being held at 235 East
`
`15· ·Main Street, Norfolk, Virginia on 5/3/2019.· The time is
`
`16· ·currently 9:16 a.m.
`
`17· · · · · · · · My name is Josh Bridges, and I'm the
`
`18· ·videographer.· The court reporter is Penny Wile.
`
`19· · · · · · · · Counsel, will you please introduce
`
`20· ·yourselves for the record and affiliations, and the
`
`21· ·witness will be sworn?
`
`22· · · · · · · · MS. STUBBINGS:· Maria Stubbings from
`
`23· ·Perkins Coie, representing Mylan.
`
`24· · · · · · · · MS. SCORDINO:· Ellen Scordino from Cooley,
`
`25· ·LLP, representing Horizon and the witness.
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
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`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 4
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`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`5
`
`·1· · · · · · · · MR. GRITTON:· Jeff Gritton from Baker
`
`·2· ·Botts, LLP, representing Nuvo.
`
`·3· · · · · · · · THE VIDEOGRAPHER:· Thank you.
`
`·4· · · · · · · · Please swear the witness.
`
`·5· · · · · · · · THE WITNESS:· I didn't hear what you said.
`
`·6
`
`·7· · · · · · · · DAVID A. JOHNSON, M.D. was sworn and
`
`·8· ·deposed on behalf of the Petitioner as follows:
`
`·9· · · · · · · · · · ·EXAMINATION
`
`10· ·BY MS. STUBBINGS:
`
`11· · · · · Q.· · Good morning, Dr. Johnson.
`
`12· · · · · A.· · Good morning.
`
`13· · · · · Q.· · So I know you've done this a few times
`
`14· ·before, so I'm going to go over a few ground rules, but
`
`15· ·I don't think we need to really go over anything in
`
`16· ·great detail.
`
`17· · · · · · · · So just a few things.· If you don't
`
`18· ·understand any of my questions, please let me know.
`
`19· ·Feel free to ask me to clarify, and I'll make an attempt
`
`20· ·to do so.· If you don't let me know that you don't
`
`21· ·understand a question that I ask, I'm going to assume
`
`22· ·that you do understand it.· Is that okay?
`
`23· · · · · A.· · Yes.
`
`24· · · · · Q.· · If you need a break at any time, just let
`
`25· ·me know and we can take a break.· I'll try to take
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 5
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`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`6
`
`·1· ·breaks every hour or so.· But if you -- if you need one,
`
`·2· ·we can certainly take one.· I'll just have you answer
`
`·3· ·whatever question that is pending, and then we can take
`
`·4· ·a break.
`
`·5· · · · · · · · And, then, just make sure to speak clearly
`
`·6· ·for the court reporter, especially, you know, in giving
`
`·7· ·affirmative yes and no answers instead of uh-huh or
`
`·8· ·uh-uh.· And, then, try not to speak in front of each
`
`·9· ·other.
`
`10· · · · · · · · That's it.· I think we can get started.
`
`11· · · · · · · · So I'm going to mark an exhibit, your
`
`12· ·declaration.· Did you -- oh, we did not.· Okay.
`
`13· · · · · · · · (Off-the-record discussion)
`
`14· ·BY MS. STUBBINGS:
`
`15· · · · · Q.· · So this -- yeah.· This -- this has already
`
`16· ·been marked Exhibit -- Patent Owners Exhibit 2026 in the
`
`17· ·proceeding.
`
`18· · · · · · · · MS. STUBBINGS:· Copies for you.· Here you
`
`19· ·go.
`
`20· · · · · · · · MS. SCORDINO:· Thank you.
`
`21· ·BY MS. STUBBINGS:
`
`22· · · · · Q.· · One for you, Dr. Johnson.
`
`23· · · · · · · · Dr. Johnson, do you recognize this
`
`24· ·document?
`
`25· · · · · A.· · Just give me a second.· This is --
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 6
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`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`7
`
`·1· · · · · Q.· · Sure.· Yeah.· Feel free to review it.
`
`·2· · · · · A.· · I do.
`
`·3· · · · · Q.· · Is this your declaration in IPR2018-272 on
`
`·4· ·Patent No. 9,393,208?
`
`·5· · · · · A.· · Yes.
`
`·6· · · · · Q.· · And over the course of today if I refer to
`
`·7· ·Patent No. two-zero-eight or two-oh-eight, do you
`
`·8· ·understand that I'm referring to Patent No. 9,393,208?
`
`·9· · · · · A.· · I do.
`
`10· · · · · Q.· · Great.· Thanks.
`
`11· · · · · · · · Could you please turn to -- I'm going to
`
`12· ·use the page numbers in the right-hand corner of the
`
`13· ·document, not the ones in the middle.· So if you can
`
`14· ·turn to page 41 of 128.
`
`15· · · · · · · · Can you just confirm for me that is your
`
`16· ·signature on page 41?
`
`17· · · · · A.· · It is.
`
`18· · · · · Q.· · Great.
`
`19· · · · · · · · Can you please turn to paragraph 56 of
`
`20· ·your report?
`
`21· · · · · A.· · What -- what page?
`
`22· · · · · Q.· · Oh.· Let me see.
`
`23· · · · · · · · 26.
`
`24· · · · · A.· · I have it.
`
`25· · · · · Q.· · Okay.· So in paragraph 56 you represent
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
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`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 7
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`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`8
`
`·1· ·that you have reviewed and agree with expert declaration
`
`·2· ·of Dr. Taft submitted in this proceeding.
`
`·3· · · · · · · · Did you have any conversations with
`
`·4· ·Dr. Taft?
`
`·5· · · · · A.· · No.
`
`·6· · · · · Q.· · Okay.· So you didn't speak with him on the
`
`·7· ·phone or in-person?
`
`·8· · · · · A.· · No.
`
`·9· · · · · Q.· · Okay.· So for this paragraph you just read
`
`10· ·Dr. Taft's opinions?
`
`11· · · · · · · · MS. SCORDINO:· Objection.· Vague.
`
`12· · · · · · · · THE WITNESS:· I -- I reviewed it.
`
`13· ·BY MS. STUBBINGS:
`
`14· · · · · Q.· · Okay.· Thank you.
`
`15· · · · · · · · Can you please turn to paragraph 21?· I'll
`
`16· ·get you a page number.
`
`17· · · · · · · · Page number 8.· And feel free to read all
`
`18· ·of paragraph 21.
`
`19· · · · · A.· · I have it.
`
`20· · · · · Q.· · So on paragraph 21 I'm looking
`
`21· ·particularly at the sentence that spans over into page
`
`22· ·9.· So you say, Here, I understand that conception and
`
`23· ·actual reduction to practice was ach -- were achieved by
`
`24· ·June 25th, 2007.
`
`25· · · · · · · · What is the basis for that understanding?
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 8
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`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`9
`
`·1· · · · · A.· · It's outlined in discussion by my
`
`·2· ·conversation and information provided by the legal
`
`·3· ·principles relating to the opinions in my expert
`
`·4· ·declaration.
`
`·5· · · · · Q.· · Okay.· So is it accurate to say that you
`
`·6· ·believe the conception and re -- reduction to practice
`
`·7· ·was achieved by June 25th, 2007 because of the clinical
`
`·8· ·study disclosing the claimed invention of the '208
`
`·9· ·patent?
`
`10· · · · · · · · MS. SCORDINO:· Objection to form.
`
`11· · · · · · · · THE WITNESS:· I understand that the -- the
`
`12· ·patent's entitled to the earliest priority date by which
`
`13· ·the invention is disclosed therein and conceived of and
`
`14· ·reduced to practice.
`
`15· ·BY MS. STUBBINGS:
`
`16· · · · · Q.· · Do you have any other basis to opine that
`
`17· ·the '208 patent is entitled to a priority date of June
`
`18· ·25th, 2007, other than the clinical study you mentioned
`
`19· ·in paragraph 21 of your report?
`
`20· · · · · · · · MS. SCORDINO:· Objection to form.
`
`21· · · · · · · · THE WITNESS:· If you can point me to
`
`22· ·someplace where I declare that in my declaration, I'll
`
`23· ·be happy to review that again.
`
`24· ·BY MS. STUBBINGS:
`
`25· · · · · Q.· · Sure.
`
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 9
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`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`10
`
`·1· · · · · · · · I just wanted to -- I know in paragraph 21
`
`·2· ·you mentioned the clinical study.· And I just wanted to
`
`·3· ·understand whether that's the only -- the only facts
`
`·4· ·that you -- that you're relying on to opine that the
`
`·5· ·'208 patent is entitled to a priority date of June 25th,
`
`·6· ·2007.· Is that correct?
`
`·7· · · · · A.· · Well, I understand that the patent's
`
`·8· ·entitled to the earliest priority, as stated in my
`
`·9· ·declaration.
`
`10· · · · · Q.· · Okay.· I'm going to give you another
`
`11· ·exhibit.· This exhibit is marked Mylan Pharms, Inc.
`
`12· ·Exhibit 1001.
`
`13· · · · · · · · Dr. Johnson, do you recognize this
`
`14· ·exhibit?
`
`15· · · · · A.· · I do.
`
`16· · · · · Q.· · What is it?
`
`17· · · · · A.· · The '208 patent.
`
`18· · · · · Q.· · Okay.· And do you see -- if you look at
`
`19· ·the first column on the first page, so page 1 of the
`
`20· ·'208 patent, it's the line starting at number 60.· So
`
`21· ·there is a number 60 on the left-hand side, all the way
`
`22· ·on the left-hand side of the page in parentheses.
`
`23· · · · · A.· · I have it.
`
`24· · · · · Q.· · And the '208 patent represents that the
`
`25· ·provisional application to which it claims priority --
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 10
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`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`11
`
`·1· ·Provisional Application No. 61-095,584 was filed on
`
`·2· ·September 9th, 2008.· Is that right?
`
`·3· · · · · · · · MS. SCORDINO:· Objection.· Outside the
`
`·4· ·scope.· Calls for a legal conclusion.
`
`·5· · · · · · · · THE WITNESS:· Line 60 says, Provisional
`
`·6· ·Application No. 61/095,584 filed on September 9, 2008.
`
`·7· ·BY MS. STUBBINGS:
`
`·8· · · · · Q.· · So in paragraph 21 of your expert
`
`·9· ·declaration you are giving the opinion that the '208
`
`10· ·patent is entitled to a priority date earlier than
`
`11· ·September 9th, 2008, right?
`
`12· · · · · A.· · Well, I stated I understand that a patent
`
`13· ·is entitled to the earliest priority date to which
`
`14· ·it's -- the invention is disclosed therein or conceived
`
`15· ·and put into -- reduced to practice.
`
`16· · · · · Q.· · Okay.· And June 25th, 2007 is earlier than
`
`17· ·September 9th, 2008, right?
`
`18· · · · · A.· · I'm sorry?· I don't understand what your
`
`19· ·question is.
`
`20· · · · · Q.· · Sorry.
`
`21· · · · · · · · June 25th, 2007, the date mentioned in
`
`22· ·paragraph 21 of your expert declaration, is earlier than
`
`23· ·September 9th, 2008, the date listed on the face of the
`
`24· ·'208 patent; is that correct?
`
`25· · · · · · · · MS. SCORDINO:· Objection to form.
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
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`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 11
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`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`12
`
`·1· · · · · · · · THE WITNESS:· As a calendar reference, the
`
`·2· ·answer is June 25th is different than the -- the other
`
`·3· ·date that you just mentioned, by calendar.
`
`·4· ·BY MS. STUBBINGS:
`
`·5· · · · · Q.· · And your opinion that the '208 patent is
`
`·6· ·entitled to a priority date of June 25th, 2007 is based
`
`·7· ·on the clinical study -- completion date for the
`
`·8· ·clinical study disclosing the claimed invention of the
`
`·9· ·'208 patent, right?
`
`10· · · · · · · · MS. SCORDINO:· Objection to form.· Asked
`
`11· ·and answered.
`
`12· · · · · · · · THE WITNESS:· As I said in my declaration,
`
`13· ·I understand that the patent is entitled to the earliest
`
`14· ·priority date by the -- which the invention was
`
`15· ·disclosed therein, was conceived of and reduced to
`
`16· ·practice.
`
`17· ·BY MS. STUBBINGS:
`
`18· · · · · Q.· · Okay.· Was the '208 -- the invention
`
`19· ·claimed in the '208 patent diligently reduced to
`
`20· ·practice?
`
`21· · · · · · · · MS. SCORDINO:· Objection to form.· Outside
`
`22· ·the scope.
`
`23· · · · · · · · THE WITNESS:· If you can point me to a
`
`24· ·point in my declaration that I discussed it, I'd be
`
`25· ·happy to review that comment.
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 12
`
`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`13
`
`·1· ·BY MS. STUBBINGS:
`
`·2· · · · · Q.· · Sure.
`
`·3· · · · · · · · And I'll just -- I mean, you are free to
`
`·4· ·check for yourself.· I did not see any discussion of
`
`·5· ·diligence in your report.· I just want to make sure I'm
`
`·6· ·not missing anything.· But feel free to refer to your
`
`·7· ·report.
`
`·8· · · · · · · · But is it correct that you did not offer
`
`·9· ·any opinions on whether the '208 patent was diligently
`
`10· ·reduced to practice?
`
`11· · · · · · · · MS. SCORDINO:· Objection to form.
`
`12· · · · · · · · THE WITNESS:· And, again, if you can point
`
`13· ·that to me in my declaration, I'd be happy to review
`
`14· ·that.
`
`15· ·BY MS. STUBBINGS:
`
`16· · · · · Q.· · All right.· Did you review any documents
`
`17· ·to come to your opinion that the conception and actual
`
`18· ·reduction to practice of the '208 patented invention
`
`19· ·were achieved by June 25th, 2007?
`
`20· · · · · A.· · The documents that I reviewed are in my
`
`21· ·declaration.· And I'd be happy to review that comment
`
`22· ·if -- if you can point me to where I say that in my
`
`23· ·declaration.
`
`24· · · · · Q.· · Sure.
`
`25· · · · · · · · You don't actually cite to any documents
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 13
`
`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`14
`
`·1· ·in paragraph 21 of your report, right?
`
`·2· · · · · · · · MS. SCORDINO:· Objection to form.
`
`·3· · · · · · · · THE WITNESS:· 21 stands as it's stated.
`
`·4· ·BY MS. STUBBINGS:
`
`·5· · · · · Q.· · Okay.· So paragraph 21 does not cite to
`
`·6· ·any documents; is that right?
`
`·7· · · · · · · · MS. SCORDINO:· Objection to form.· Lacks
`
`·8· ·foundation.
`
`·9· · · · · · · · THE WITNESS:· Again, I -- my -- that's
`
`10· ·left to your interpretation.· My -- my comments are very
`
`11· ·clear in the -- in point number 21.
`
`12· ·BY MS. STUBBINGS:
`
`13· · · · · Q.· · Sure.
`
`14· · · · · · · · And I'm just asking you to confirm things
`
`15· ·in your report.· So I don't -- I don't want to give any
`
`16· ·testimony here today.· So I'm just trying to get you to
`
`17· ·confirm what -- what my reading of certain things are.
`
`18· · · · · · · · What clinical study are you referring to
`
`19· ·in paragraph 21 of your report?
`
`20· · · · · A.· · Point to me where you -- where I cited
`
`21· ·the -- the clinical study.
`
`22· · · · · Q.· · Sure.
`
`23· · · · · · · · The -- the last sentence of paragraph 21,
`
`24· ·that starts on page 8 and goes over to page 9, that
`
`25· ·says, Here, I understand that conception and actual
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
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`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 14
`
`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`15
`
`·1· ·reduction to practice were achieved by June 25th, 2007
`
`·2· ·when the clinical study disclosed -- disclosing the
`
`·3· ·claimed invention of the '208 patent was completed.
`
`·4· · · · · · · · What clinical study are you referring to
`
`·5· ·there?
`
`·6· · · · · A.· · The study of the '208 patent.
`
`·7· · · · · Q.· · The two-zero-eight patent?
`
`·8· · · · · A.· · The -- the study aimed at disclosing the
`
`·9· ·invention of the 2008 patent.
`
`10· · · · · Q.· · Okay.· And what clinical study was that?
`
`11· · · · · · · · MS. SCORDINO:· Objection.· This isn't a
`
`12· ·memory test.· Do you want him to come up with a number?
`
`13· · · · · · · · MS. STUBBINGS:· We can move on.
`
`14· ·BY MS. STUBBINGS:
`
`15· · · · · Q.· · Can you turn to paragraph 57 of your
`
`16· ·report?
`
`17· · · · · A.· · What page is that?
`
`18· · · · · Q.· · Let me get it for you.
`
`19· · · · · · · · Page 26.
`
`20· · · · · · · · So in section B of your declaration, in
`
`21· ·paragraphs 57 through 62, you're giving the opinion that
`
`22· ·the '285 patent is not prior art to claims 1 through 7
`
`23· ·of the '208 patent, right?
`
`24· · · · · A.· · I'm stating what I understand from counsel
`
`25· ·as the reference.
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
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`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 15
`
`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`16
`
`·1· · · · · Q.· · Okay.· And I don't want to know what
`
`·2· ·counsel told you, so please don't disclose any -- any
`
`·3· ·substantive discussions with counsel.
`
`·4· · · · · · · · But aside from your discussions with
`
`·5· ·counsel, do you have any independent understanding of
`
`·6· ·whether the '285 patent is prior art to the '208 patent?
`
`·7· · · · · · · · MS. SCORDINO:· Objection to form.
`
`·8· · · · · · · · THE WITNESS:· Well, I think it would be --
`
`·9· ·it would be irresponsible for me to formulate an opinion
`
`10· ·without understanding from counsel since this is a legal
`
`11· ·proceeding.
`
`12· ·BY MS. STUBBINGS:
`
`13· · · · · Q.· · Okay.· Can you describe what you did,
`
`14· ·aside from your discussions with counsel, to formulate
`
`15· ·your opinion that the '285 patent is not prior art to
`
`16· ·the '208 patent?
`
`17· · · · · A.· · Sure.· If you'd point to me in my
`
`18· ·declaration my preparation statements, I'd be happy to
`
`19· ·review that with you.
`
`20· · · · · Q.· · Sure.· I believe that's in paragraphs 57
`
`21· ·through 62 of the report where we are now.
`
`22· · · · · A.· · Well, the understanding as outlined in the
`
`23· ·declaration is -- is quite clear as far as the documents
`
`24· ·that were reviewed.
`
`25· · · · · Q.· · Okay.· Can you walk me through what you
`
`800.211.DEPO (3376)
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`EsquireSolutions.com
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`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 16
`
`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`17
`
`·1· ·did to come to that understanding?
`
`·2· · · · · A.· · To review the patents and having
`
`·3· ·discussion with -- with counsel and understanding.
`
`·4· · · · · Q.· · Okay.· In paragraph 61 you state, In my
`
`·5· ·opinion, the claimed subject matter at issue in the '208
`
`·6· ·patent is comparable to the underlying subject matter
`
`·7· ·asserted as prior art in the '285 patent.
`
`·8· · · · · · · · What do you mean by "comparable"?
`
`·9· · · · · A.· · That's the word that came to mind.· That's
`
`10· ·what, in my mind, solidifies the statement.
`
`11· · · · · Q.· · Do you mean that the '285 patent is
`
`12· ·similar to the '208 patent?
`
`13· · · · · A.· · What I said was comparable.
`
`14· · · · · Q.· · Okay.· Can you give any -- any more
`
`15· ·description of what you mean by comparable?
`
`16· · · · · A.· · That's the best description that I can
`
`17· ·provide right now.
`
`18· · · · · Q.· · Okay.· So what I'm trying to get at is
`
`19· ·when I think of the word comparable, me personally, it
`
`20· ·seems like it could have multiple definitions.· It could
`
`21· ·mean that two patents, for example, are similar or it
`
`22· ·can mean these two documents can just be compared
`
`23· ·irrespective of whether they're similar or not.
`
`24· · · · · · · · When you say that the '285 patent is
`
`25· ·comparable to the '208 patent, do you mean that they're
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 17
`
`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`18
`
`·1· ·similar or do you simply mean that you're comparing
`
`·2· ·them?
`
`·3· · · · · A.· · Well, in due respect to your opinion, and
`
`·4· ·I respect that, in my opinion they're comparable.
`
`·5· · · · · Q.· · Which comparable do you mean?
`
`·6· · · · · · · · MS. SCORDINO:· Objection to form.
`
`·7· · · · · · · · THE WITNESS:· The word -- the word
`
`·8· ·comparable is -- is the best description that I can have
`
`·9· ·and formulate in the way I would -- I would look at
`
`10· ·this.
`
`11· ·BY MS. STUBBINGS:
`
`12· · · · · Q.· · Is it your opinion that the claims of the
`
`13· ·'285 patent are similar to the claims of the '208
`
`14· ·patent?
`
`15· · · · · A.· · I believe I used the word comparable.
`
`16· · · · · Q.· · Okay.· So are the claims of the '285
`
`17· ·patent comparable to the claims of the '208 patent?
`
`18· · · · · A.· · In my opinion, the claimed subject matter
`
`19· ·at issue in the '208 is comparable to the underlying
`
`20· ·subject matter asserted as prior art in the '285 patent.
`
`21· · · · · Q.· · Is the claimed subject matter at issue in
`
`22· ·the '208 patent comparable to the '907 patent?
`
`23· · · · · A.· · If you point me to where I discuss the
`
`24· ·'907 patent as far as my opinion, I'd be happy to review
`
`25· ·that with you.
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
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`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 18
`
`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`19
`
`·1· · · · · Q.· · Are the '208 patent and the '285 patent
`
`·2· ·different in any way?
`
`·3· · · · · · · · MS. SCORDINO:· Objection to form.
`
`·4· · · · · · · · THE WITNESS:· I didn't hear the --
`
`·5· ·BY MS. STUBBINGS:
`
`·6· · · · · Q.· · Sorry.
`
`·7· · · · · · · · Are the '208 patent and the '285 patent
`
`·8· ·different in any way?
`
`·9· · · · · A.· · In my opinion, the claimed subject matter
`
`10· ·in the '208 is comparable to the underlying subject
`
`11· ·matter asserted in the prior art of the '285 patent.
`
`12· · · · · Q.· · Sure.
`
`13· · · · · · · · And so does that mean, on the flip side,
`
`14· ·your opinion is that you -- they are not different?
`
`15· · · · · A.· · You'd have to point to where I -- that is
`
`16· ·declared in my -- in my statements here.· I'd be happy
`
`17· ·to review that with you.
`
`18· · · · · Q.· · Sure.
`
`19· · · · · · · · I think the only -- the only paragraph
`
`20· ·that discusses the comparability of these two patents is
`
`21· ·in paragraph 61, so I'm just focusing on that.
`
`22· · · · · · · · But I want to know that since your opinion
`
`23· ·is that the two patents are comparable or the subject
`
`24· ·matter is comparable, does that mean you do not believe
`
`25· ·that the two patents are different?
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
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`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 19
`
`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`20
`
`·1· · · · · · · · MS. SCORDINO:· Objection to form.
`
`·2· · · · · · · · THE WITNESS:· In my opinion, the claimed
`
`·3· ·subject matter at issue is the '208 patent is comparable
`
`·4· ·to the underlying subject matter asserted as prior art
`
`·5· ·in the '285 patent.
`
`·6· ·BY MS. STUBBINGS:
`
`·7· · · · · Q.· · Okay.· We can come back to that.
`
`·8· · · · · · · · Actually, one more question on that.· Why
`
`·9· ·did you include this statement in your declaration?
`
`10· · · · · A.· · Which statement?
`
`11· · · · · Q.· · That the claimed subject matter at issue
`
`12· ·in the '208 patent is comparable to the underlying
`
`13· ·subject matter asserted as prior art in the '285 patent.
`
`14· · · · · A.· · I'd have to go back and consider at the
`
`15· ·time why -- why -- why I did that.· It made sense at the
`
`16· ·time.
`
`17· · · · · Q.· · What do you mean by "it made sense at the
`
`18· ·time"?
`
`19· · · · · A.· · Well, in discussion with the understanding
`
`20· ·with counsel and the -- the review of the documents,
`
`21· ·that was my opinion.
`
`22· · · · · Q.· · I'm going to hand you another exhibit.
`
`23· ·Dr. Johnson, this exhibit is Mylan Pharms, Inc. Exhibit
`
`24· ·1005.· Here you go.
`
`25· · · · · · · · Dr. Johnson, do you recognize this
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 20
`
`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`21
`
`·1· ·exhibit?
`
`·2· · · · · A.· · I do.
`
`·3· · · · · Q.· · What is it?
`
`·4· · · · · A.· · As abbreviated, the '285 patent.
`
`·5· · · · · Q.· · Sure.
`
`·6· · · · · · · · And so just for housekeeping, Mylan
`
`·7· ·Pharms, Inc. Exhibit 1005, the top right corner states
`
`·8· ·that it is Patent No. 8,557,285.· And if I refer to this
`
`·9· ·patent over the course of the day as the '285 patent,
`
`10· ·you understand that I'm referring to this document,
`
`11· ·right?
`
`12· · · · · A.· · Yes.
`
`13· · · · · Q.· · Okay.· Thanks.
`
`14· · · · · · · · And to confirm, this is the patent that
`
`15· ·you believe is not prior art to the '208 patent, right?
`
`16· · · · · A.· · This is the '285 patent that's subject to
`
`17· ·my -- my declaration.
`
`18· · · · · Q.· · Okay.· Did you offer your opinions in this
`
`19· ·inter partes review proceeding under the assumption that
`
`20· ·the '285 patent is not prior art to the '208 patent?
`
`21· · · · · · · · MS. SCORDINO:· Objection to form.
`
`22· · · · · · · · THE WITNESS:· I'm not sure I understand
`
`23· ·the question.
`
`24· ·BY MS. STUBBINGS:
`
`25· · · · · Q.· · So for the opinions you gave on whether
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
`
`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 21
`
`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`22
`
`·1· ·the '208 patent is valid, did you offer those opinions
`
`·2· ·with the assumption that the '285 patent is not prior
`
`·3· ·art to the '205 -- '208 patent?
`
`·4· · · · · · · · MS. SCORDINO:· Objection to form.
`
`·5· · · · · · · · THE WITNESS:· Well, my opinion, the '285
`
`·6· ·patent didn't qual -- does not qualify as prior art by
`
`·7· ·another for there is a common inventor with
`
`·8· ·Dr. Plachetka in the subject matter of the '285 patent
`
`·9· ·and the claimed subject matter asserting the claims of
`
`10· ·the '208 patent.
`
`11· ·BY MS. STUBBINGS:
`
`12· · · · · Q.· · Let's turn back to Exhibit 1005, the '285
`
`13· ·patent.· Would you please turn to page 10 of Exhibit
`
`14· ·1005?· And if you look at column 1, I am looking at the
`
`15· ·paragraph that starts on line, I think, 48 of the first
`
`16· ·column.
`
`17· · · · · A.· · 48 of the first column?
`
`18· · · · · Q.· · Yeah.· The paragraph starts, In general.
`
`19· ·Are you there?
`
`20· · · · · A.· · I have it.
`
`21· · · · · Q.· · Great.
`
`22· · · · · · · · So the '285 patent discloses that
`
`23· ·proton-pump inhibitors are thought to be more protective
`
`24· ·during chronic administration events than short --
`
`25· ·shorter acting agents such as H2-receptor antagonists;
`
`800.211.DEPO (3376)
`800.211.DEPO (3376)
`EsquireSolutions.com
`EsquireSolutions.comYVer1f
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`MYLAN PHARMS. INC. EXHIBIT 1085 PAGE 22
`
`

`

`DAVID A. JOHNSON M.D.
`DAVID A. JOHNSON M.D.
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`MYLAN PHARMACEUTICALS vs HORIZON PHARMA
`
`May 03, 2019
`May 03, 2019
`23
`
`·1· ·is that right?
`
`·2· · · · · A.· · In general.
`
`·3· · · · · Q.· · Okay.· And to support that statement the
`
`·4· ·'285 patent cites two articles from 1998, right?
`
`·5· · · · · A.· · Correct.
`
`·6· · · · · · · · MS. STUBBINGS:· And just for the court
`
`·7· ·reporter, when I say NSAIDs -- you've got that -- it's
`
`·8· ·N-S-A-I-D.
`
`·9· ·BY MS. STUBBINGS:
`
`10· · · · · Q.· · And if you look at -- Dr. Johnson, if you
`
`11· ·look at column 2 of page 10, I'm looking at the
`
`12· ·paragraph around line 26 that starts, Recognizing the
`
`13· ·potential benefits.
`
`14· · · · · A.· · I have it.
`
`15· · · · · Q.· · Great.
`
`16· · · · · · · · And feel free to review that paragraph.
`
`17· ·But do you agree that the '285 patent discloses that
`
`18· ·others in the art recognize the potential benefits of
`
`19· ·proton-pump inhibitors, or PPIs, for the prevention of
`
`20· ·NSAID-induced gastroduodenal damage and have disclosed
`
`21· ·strategies for combining PPIs and NSAIDs

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