·1· · · · · IN THE UNITED STATES DISTRICT COURT
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`·2· · · · · · · FOR THE DISTRICT OF DELAWARE
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`·3· · · · · · Civil Action No. 1:15CV00079-GMS
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`·4
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`·5· ·PFIZER INC., AND UCB PHARMA GMBH,· ·)
`· · · · · · · · · ·Plaintiffs,· · · · · ·)
`·6· · · · · · · · · · · · · · · · · · · ·)
`· · · · · · · vs.· · · · · · · · · · · · )
`·7· · · · · · · · · · · · · · · · · · · ·)
`· · · · · · · · · · · · · · · · · · · · ·)
`·8· ·MYLAN PHARMACEUTICALS, INC.,· · )
`· · · · · · · · · ·Defendant· · · · · · ·)
`·9
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`10
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`11
`· · · · · · · ·DEPOSITION OF HANS MAAG, Sc.D.
`12
`· · · · · · · · · TUESDAY, AUGUST 16, 2016
`13
`· · · · · · · · · · ·9:51 AM - 5:18 PM
`14
`· · · · · · · · · · · WHITE & CASE LLP
`15
`· · · · · · · · · · · 75 STATE STREET
`16
`· · · · · · · · · ·BOSTON, MASSACHUSETTS
`17
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`18
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`19
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`20
`· · ·Reported by:· Sandra A. Deschaine, CSR, RPR, CLR
`21· · · · · · · · ·CRA
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`22
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`23
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`24
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`25· ·Job 133305
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 1
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`·2· · · · · · · FOR THE DISTRICT OF DELAWARE
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`·3· · · · · · Civil Action No. 1:15CV00079-GMS
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`·4
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`·5· ·PFIZER INC., AND UCB PHARMA GMBH,· ·)
`· · · · · · · · · ·Plaintiffs,· · · · · ·)
`·6· · · · · · · · · · · · · · · · · · · ·)
`· · · · · · · vs.· · · · · · · · · · · · )
`·7· · · · · · · · · · · · · · · · · · · ·)
`· · · · · · · · · · · · · · · · · · · · ·)
`·8· ·MYLAN PHARMACEUTICALS, INC.,· · )
`· · · · · · · · · ·Defendant· · · · · · ·)
`·9
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`10
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`11
`· · · · · · · ·DEPOSITION OF HANS MAAG, Sc.D.
`12
`· · · · · · · · · TUESDAY, AUGUST 16, 2016
`13
`· · · · · · · · · · ·9:51 AM - 5:18 PM
`14
`· · · · · · · · · · · WHITE & CASE LLP
`15
`· · · · · · · · · · · 75 STATE STREET
`16
`· · · · · · · · · ·BOSTON, MASSACHUSETTS
`17
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`18
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`19
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`20
`· · ·Reported by:· Sandra A. Deschaine, CSR, RPR, CLR
`21· · · · · · · · ·CRA
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`22
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`23
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`24
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`25· ·Job 133305
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 1
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`·1· ·APPEARANCES:
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`·2
`· · ·ON BEHALF OF THE DEFENDANT:
`·3
`· · ·KILPATRICK, TOWNSEND & STOCKTON LLP
`·4
`· · · · · D. Clay Holloway, Esquire
`·5
`· · · · · 1100 Peachtree Street NE, Suite 2800
`·6
`· · · · · Atlanta, Georgia 30309-4528
`·7
`· · · · · T. 404.815.6537
`·8
`· · · · · dholloway@kilpatricktownsend.com
`·9
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`10
`· · ·ON BEHALF OF THE PLAINTIFFS:
`11
`· · ·WHITE & CASE LLP
`12
`· · · · · Robert Counihan, Esquire
`13
`· · · · · 1155 Avenue of the Americas
`14
`· · · · · New York, New York· 10036-2787
`15
`· · · · · T. 212.819.8255
`16
`· · · · · rcounihan@whitecase.com
`17
`· · · · · T. 336.725.6444· F. 336.724.4755
`18
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`19· ·Also Present:· Craig Newman
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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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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 2
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`·1· · · · · · · · · · · ·I N D E X
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`·2· ·-------------------------------------------------
`· · ·WITNESSES:· · · · · · · · · · · · · · · · ·PAGE
`·3· ·-------------------------------------------------
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`·4· ·Hans Maag
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`·5· · ·By Mr. Holloway· · · · · · · · · · · · · · 6
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`·6
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`·7· ·-------------------------------------------------
`· · ·EXHIBITS:· · · · DESCRIPTION· · · · · · · · PAGE
`·8· ·-------------------------------------------------
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`·9· ·MAAG EXHIBITS
`
`10· ·Exhibit 1, Opening Expert Report of
`· · · · · · · · Hans Maag,· Sc.D.· · · · · · · · · 5
`11
`· · ·Exhibit 2, Rebuttal Expert Report of
`12· · · · · · · Hans Maag,· Sc.D.· · · · · · · · · 5
`
`13· ·Exhibit 3, Rebuttal Expert Report of
`· · · · · · · · William R. Roush· · · · · · · · · 16
`14
`· · ·Exhibit 4, U.S. Patent 6,858,650· · · · · · ·36
`15
`· · ·Exhibit 5, U.S. Patent 7,384,980· · · · · · ·41
`16
`· · ·Exhibit 6, U.S. Patent 7,855,230· · · · · · ·43
`17
`· · ·Exhibit 7, U.S. Patent 7,895,772· · · · · · ·46
`18
`· · ·Exhibit 8, U.S. Patent 8,338,478· · · · · · ·47
`19
`· · ·Exhibit 9, Bates Nos. MYLB_FESO_00026903,
`20· · · · · · · ·through 6913· · · · · · · · · · · 79
`
`21· ·Exhibit 10, Deposition Transcript of
`· · · · · · · · ·Hans Maag, 4/17/15· · · · · · · ·91
`22
`· · ·Exhibit 11, Bates Nos. MYLB_FESO_00026891· ·163
`23
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`24
`
`25· ·(Exhibits continued)
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 3
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`·1· · · · · · · · · · · ·I N D E X
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`·2
`· · ·-------------------------------------------------
`·3· ·EXHIBITS:· · · · DESCRIPTION· · · · · · · · PAGE
`· · ·-------------------------------------------------
`·4
`· · ·MAAG EXHIBITS
`·5
`· · ·Exhibit 12, Bates Nos. MYLB_FESO_00026934
`·6· · · · · · · ·through 271119· · · · · · · · · 178
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`·7· ·Exhibit 13, Bates Nos. PFE00528017 through
`· · · · · · · · ·8070· · · · · · · · · · · · · · 195
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`·9
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`10
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`11
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`25
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 4
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`
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`·1· ·(Exhibit 1, Opening Expert Report of Hans Maag,
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`·2· · Sc.D., marked for identification.)
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`·3· ·(Exhibit 2, Rebuttal Expert Report of Hans Maag,
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`·4· · Sc.D.,· marked for identification.)
`
`·5· · · · · · · · THE VIDEOGRAPHER:· This is the
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`·6· · · · · beginning of Disk Number 1 in the
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`·7· · · · · deposition of Hans Maag in the matter of
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`·8· · · · · Pfizer, Inc., and UCB Pharma GmbH versus
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`·9· · · · · Mylan Pharmaceuticals, Inc.· The case
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`10· · · · · number is Civil Action 1:15-CV-00079-GMS.
`
`11· · · · · · · · This has been filed in the United
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`12· · · · · States District Court for the District of
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`13· · · · · Delaware.· Today's date is August 16, 2016,
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`14· · · · · and the time on the monitor is 9:51.· My
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`15· · · · · name is Craig Newman, and I'm the
`
`16· · · · · videographer.· The court reporter is Sandy
`
`17· · · · · Deschaine.· We are both with Huseby Global
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`18· · · · · Litigation.
`
`19· · · · · · · · At this point, would counsel please
`
`20· · · · · introduce yourselves, after which the court
`
`21· · · · · reporter will swear in the deponent.
`
`22· · · · · · · · MR. HOLLOWAY:· Clay Holloway with
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`23· · · · · Kilpatrick Townsend & Stockton for Mylan.
`
`24· · · · · · · · MR. COUNIHAN:· Robert Counihan from
`
`25· · · · · White & Case on behalf of Plaintiffs and
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 5
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`
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`·1· · · · · the witness.
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`·2· · · · · · · · HANS MAAG, Deponent, having first
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`·3· ·been satisfactorily identified by the production
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`·4· ·of his Oregon driver's license and duly sworn by
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`·5· ·the Notary Public, was examined and testified as
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`·6· ·follows:
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`·7· · · · · · · · · · · EXAMINATION
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`·8· ·BY MR. HOLLOWAY:
`
`·9· · · · · Q.· · Good morning, Dr. Maag.· How are
`
`10· ·you?
`
`11· · · · · A.· · I'm fine.· How are you?
`
`12· · · · · Q.· · Good.· I understand you've been
`
`13· ·deposed several times before?
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`14· · · · · A.· · A few times, yes.
`
`15· · · · · Q.· · Okay.· So I won't go through all the
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`16· ·rigamarole.· My biggest thing would be, I'll try
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`17· ·to not interrupt your answers by starting a new
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`18· ·question until you're done.· If I do, please let
`
`19· ·me know so I can stop talking and you keep giving
`
`20· ·your answers.· If you'll wait for me to complete
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`21· ·my question before you start answering, that will
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`22· ·help us go along a little bit better.
`
`23· · · · · · · · Is that okay?
`
`24· · · · · A.· · Fine.
`
`25· · · · · Q.· · Are you aware of any reason today
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 6
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`
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`·1· ·that you might not be able to give truthful and
`
`·2· ·accurate testimony?
`
`·3· · · · · A.· · I have no reason to doubt that I
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`·4· ·would not be able to --
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`·5· · · · · Q.· · Okay.· Thank you.
`
`·6· · · · · A.· · -- due to the deposition.
`
`·7· · · · · Q.· · And you've provided two reports in
`
`·8· ·this case; correct?
`
`·9· · · · · A.· · That's correct.
`
`10· · · · · Q.· · You did an Opening Report and a
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`11· ·Rebuttal Report?
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`12· · · · · A.· · Yes.
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`13· · · · · Q.· · And I understand from looking at the
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`14· ·materials reviewed attached to your report, that
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`15· ·you reviewed the reports of several other people;
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`16· ·is that correct?
`
`17· · · · · A.· · I have reviewed the reports as
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`18· ·detailed in my opening and Rebuttal Report.
`
`19· · · · · Q.· · Have you reviewed the Rebuttal
`
`20· ·Report of Dr. Roush in this case?
`
`21· · · · · · · · MR. COUNIHAN:· Roush.
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`22· · · · · · · · MR. HOLLOWAY:· Roush.
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`23· · · · · A.· · Not that I recall.
`
`24· · · · · Q.· · Did you review -- do you know what
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`25· ·an IPR is?
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 7
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`
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`·1· · · · · A.· · No, I don't know the abbreviation.
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`·2· · · · · Q.· · Do you know what an inter partes
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`·3· ·review is?
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`·4· · · · · A.· · I think it's best if you explain it
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`·5· ·to me.
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`·6· · · · · Q.· · Okay.· Let's try it a little
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`·7· ·differently.
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`·8· · · · · A.· · Since it's a technical term.
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`·9· · · · · · · · MR. HOLLOWAY:· Let's mark as Exhibit
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`10· · · · · 1 the Open Report of Hans Maag, and as
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`11· · · · · Exhibit 2, the Rebuttal Report of Hans
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`12· · · · · Maag.
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`13· · · · · · · · THE WITNESS:· In reviewing the
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`14· · · · · Rebuttal Report, we found a few very minor,
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`15· · · · · basically typos.· And one typo is in
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`16· · · · · paragraph 97.
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`17· ·BY MR. HOLLOWAY:
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`18· · · · · A.· · Hold on one second.
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`19· · · · · · · · MR. COUNIHAN:· Let Mr. Holloway do
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`20· · · · · what he's going to do with each, and --
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`21· · · · · · · · THE WITNESS:· Okay.
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`22· · · · · · · · MR. COUNIHAN:· Then he can ask you
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`23· · · · · that.· Is that okay?
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`24· · · · · · · · MR. HOLLOWAY:· Yeah, that's
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`25· · · · · absolutely fine.· We'll get there in one
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 8
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`
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`·1· · · · · second.
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`·2· ·BY MR. HOLLOWAY:
`
`·3· · · · · Q.· · If you take in your Opening Report
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`·4· ·-- I'm sorry, your Rebuttal Report.· So Exhibit
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`·5· ·2, if you turn to your rebuttal, at the back is
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`·6· ·Exhibit D which is a list of things you
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`·7· ·considered.
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`·8· · · · · · · · MR. COUNIHAN:· Give him one second.
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`·9· · · · · · · · MR. HOLLOWAY:· Yeah.
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`10· · · · · · · · MR. COUNIHAN:· D as in dog?
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`11· · · · · · · · MR. HOLLOWAY:· D as in dog.
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`12· ·BY MR. HOLLOWAY:
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`13· · · · · Q.· · And if you'll go to the second page
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`14· ·of materials considered, the bottom of the
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`15· ·column, starting at about line seven up from the
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`16· ·bottom, you'll see Petition for Inter Partes
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`17· ·Review of U.S. Patent No. 7,855,230.
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`18· · · · · · · · Do you see that?
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`19· · · · · A.· · I do see that.
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`20· · · · · Q.· · Okay.· Does that refresh your
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`21· ·recollection that you reviewed materials involved
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`22· ·in the inter partes review?
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`23· · · · · A.· · That refreshes my memory, yes.
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`24· · · · · Q.· · Okay.· If you go down to the second
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`25· ·to the last line in that column, you'll see
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 9
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`·1· ·Patent Owner Preliminary Response to Petition for
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`·2· ·Inter Partes Review for the '650.
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`·3· · · · · · · · Do you see that?
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`·4· · · · · A.· · I do see that.
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`·5· · · · · Q.· · Okay.· Do you recall reviewing the
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`·6· ·preliminary response that's identified on that
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`·7· ·page?
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`·8· · · · · A.· · I certainly would like to review the
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`·9· ·document.
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`10· · · · · Q.· · Sitting here right now, you don't
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`11· ·recall looking at it?
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`12· · · · · A.· · I do not recall specifics.
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`13· · · · · Q.· · Do you recall if there was a
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`14· ·declaration of Dr. Roush that was part of that?
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`15· · · · · · · · MR. COUNIHAN:· Roush.· And the only
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`16· · · · · reason I'm correcting because he used to
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`17· · · · · work at Roche.
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`18· · · · · · · · MR. HOLLOWAY:· Got it.· Dr. Roush.
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`19· · · · · A.· · I would like to review the document.
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`20· · · · · Q.· · Sitting here now, you don't recall
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`21· ·whether or not you reviewed Dr. --
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`22· · · · · A.· · I reviewed so --
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`23· · · · · Q.· · Dr. Roush.
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`24· · · · · A.· · -- many documents, but to recall
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`25· ·specifically, it's very difficult for me.
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 10
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`·1· · · · · Q.· · Okay.· I'll let you walk through the
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`·2· ·edits to your report in just one second.· I'm not
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`·3· ·going to forget.
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`·4· · · · · · · · Did you work at all on the inter
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`·5· ·partes review that we just talked about in those
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`·6· ·documents?
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`·7· · · · · A.· · I do not recall.
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`·8· · · · · Q.· · Okay.· Are you providing any advice
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`·9· ·or information as part of your engagement that
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`10· ·goes into the inter partes review?
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`11· · · · · · · · MR. COUNIHAN:· Objection.
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`12· · · · · · · · MR. HOLLOWAY:· I don't like that
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`13· · · · · question either.· Let me start over.
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`14· ·BY MR. HOLLOWAY:
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`15· · · · · Q.· · Are you engaged by White & Case or
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`16· ·by Pfizer and UCB?
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`17· · · · · A.· · I don't think I fully understand
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`18· ·your question.
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`19· · · · · Q.· · Who hired you to work on these
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`20· ·matters?· Was it White & Case or Pfizer and UCB?
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`21· · · · · A.· · I have an agreement with White &
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`22· ·Case.
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`23· · · · · Q.· · As part of your agreement with White
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`24· ·& Case, have you done any work on the inter
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`25· ·partes reviews that are in the documents that we
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 11
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`·1· ·just referenced?
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`·2· · · · · A.· · I do not believe so.
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`·3· · · · · Q.· · Okay.· You said a second ago that in
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`·4· ·looking over your reports and getting ready for
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`·5· ·your deposition in the Rebuttal Report you
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`·6· ·identified a couple typos?
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`·7· · · · · A.· · Yes.
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`·8· · · · · Q.· · You want to walk through those for
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`·9· ·me?
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`10· · · · · A.· · So these are very minor things.· In
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`11· ·paragraph 97, in the graph, the third bar is
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`12· ·mislabeled.· It should be HO-/O and small i
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`13· ·b-u-t.
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`14· · · · · Q.· · And that's fesoterodine, correct?
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`15· · · · · A.· · That's fesoterodine.
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`16· · · · · Q.· · Okay.
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`17· · · · · A.· · The other one is a very obvious
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`18· ·typo.· It's in the bottom of paragraph 107. I
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`19· ·don't think there are Caco-2 call layers.· It
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`20· ·should be cell layers.· It should be obvious.
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`21· · · · · · · · And in paragraph 116 the percent
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`22· ·measured in the dog plasma should be 29 percent
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`23· ·and not 27 percent.· It is correct in my Opening
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`24· ·Report.
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`25· · · · · Q.· · Okay.· Is that it?
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 12
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`·1· ·A.· · That's it.
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`·2· · · · ·MR. COUNIHAN:· And then, you know --
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`·3· · · · ·MR. HOLLOWAY:· The exhibit, yeah.
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`·4· · · · ·MR. COUNIHAN:· Yeah.
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`·5· · · · ·MR. HOLLOWAY:· We're good.
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`·6· · · · ·MR. COUNIHAN:· And so I see it's not
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`·7· ·in this, but if he needs it at some
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`·8· ·point.
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`·9· · · · ·MR. HOLLOWAY:· It's attached to the
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`10· ·Opening Report.
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`11· · · · ·MR. COUNIHAN:· Oh, is it?
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`12· · · · ·MR. HOLLOWAY:· Is it that?
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`13· · · · ·MR. COUNIHAN:· No, it has --
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`14· · · · ·MR. HOLLOWAY:· It has the same
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`15· ·listing.
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`16· · · · ·MR. COUNIHAN:· There's a diagram on
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`17· ·the front.
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`18· · · · ·MR. HOLLOWAY:· Yeah.· Yeah.· Okay.
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`19· ·If we need that, we'll get it.
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`20· · · · ·MR. COUNIHAN:· So you know what
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`21· ·we're talking about, that exhibit we talked
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`22· ·about.· All right.· Yeah.· So if you need
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`23· ·it at some point --
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`24· · · · ·MR. HOLLOWAY:· Just let me know.
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`25· · · · ·MR. COUNIHAN:· -- just ask for it.
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 13
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`·1· · · · · Okay.
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`·2· ·BY MR. HOLLOWAY:
`
`·3· · · · · Q.· · Could you explain to me, in your
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`·4· ·words, what you view your testimony in this case
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`·5· ·to be?
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`·6· · · · · A.· · My testimony is to aid the court in
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`·7· ·the understanding of the -- what I will call
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`·8· ·scientific matter.
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`·9· · · · · Q.· · And specifically within that, it
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`10· ·looks like you're talking about two subjects.
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`11· ·The first subject is whether a person of ordinary
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`12· ·skill in the art would have looked at 5-HMT as a
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`13· ·potential lead compound.· And then the second
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`14· ·part seems to be whether a person of ordinary
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`15· ·skill in the art would have been motivated to do
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`16· ·certain modifications to that compound.
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`17· · · · · · · · Would you agree with that?
`
`18· · · · · A.· · I think it's correct that the --
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`19· ·part of my testimony is to indicate how likely a
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`20· ·person of ordinary skill will be to investigate a
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`21· ·derivative of tolteradine in the broader sense,
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`22· ·and then to how likely it would be or how
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`23· ·logically it would be for a person of ordinary
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`24· ·skill to make certain modifications to the
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`25· ·molecule.
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 14
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`·1· · · · · · · · In addition, I think my testimony is
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`·2· ·also directed, once a person of ordinary skill
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`·3· ·would advance along these lines, how unexpected
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`·4· ·certain properties of the compounds in question
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`·5· ·are.
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`·6· · · · · Q.· · Are you planning on giving opinions
`
`·7· ·that, for example, Claim 1 of the '650 Patent is
`
`·8· ·not obvious?
`
`·9· · · · · A.· · Well, I think Claim 1s are always
`
`10· ·very broad, and I think the question to me is, as
`
`11· ·a scientist, it's much more relevant to focus on
`
`12· ·a compound then on a broad claim, because that's
`
`13· ·a very -- to me that's a legal question.
`
`14· · · · · Q.· · Let me try my question a little
`
`15· ·differently.
`
`16· · · · · · · · For example, I don't see in your
`
`17· ·reports you going through the asserted claims
`
`18· ·that Pfizer has asserted against Mylan, and
`
`19· ·saying, for example, I don't agree that Claim 1
`
`20· ·is not obvious, or I don't agree that Claim 2 is
`
`21· ·not obvious.
`
`22· · · · · · · · Do you agree that you don't conduct
`
`23· ·that kind of analysis in your reports?
`
`24· · · · · · · · MR. COUNIHAN:· Objection.
`
`25· · · · · A.· · As my report state, I focused on
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 15
`
`
`
`·1· ·fesoterodine, and did not focus on basically the
`
`·2· ·different claims or a claim construction.
`
`·3· · · · · · · · MR. HOLLOWAY:· Let's mark as Exhibit
`
`·4· · · · · 3 the Rebuttal Expert Report of William R.
`
`·5· · · · · Roush.
`
`·6· ·(Exhibit 3, Rebuttal Expert Report of William R.
`
`·7· · Roush, marked for identification.)
`
`·8· · · · · Q.· · And I believe you testified you
`
`·9· ·haven't seen this before; correct?
`
`10· · · · · A.· · Well, I testified that I do not
`
`11· ·recall.
`
`12· · · · · Q.· · Okay.· Have you seen this before?
`
`13· · · · · A.· · I do not believe so.
`
`14· · · · · Q.· · Okay.· So if you turn to the table
`
`15· ·of contents.· It's at the front.· And go down to
`
`16· ·heading number Roman VIII.
`
`17· · · · · · · · Do you see that?
`
`18· · · · · A.· · Yes.
`
`19· · · · · Q.· · And it says, "The asserted claims of
`
`20· ·the '650 Patent are not invalid for obvious
`
`21· ·[sic]."
`
`22· · · · · · · · Do you see that?
`
`23· · · · · A.· · Yep.
`
`24· · · · · Q.· · And then it goes down, and for each
`
`25· ·claim in the patents there's a separate entry
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 16
`
`
`
`·1· ·that says, "This claim is not invalid for
`
`·2· ·obviousness."
`
`·3· · · · · · · · Do you see that?
`
`·4· · · · · A.· · I do see it.
`
`·5· · · · · Q.· · You don't have a similar type of
`
`·6· ·statements or analyses in your reports, do you?
`
`·7· · · · · · · · MR. COUNIHAN:· I'm sorry.
`
`·8· · · · · A.· · I do not.
`
`·9· · · · · · · · MR. COUNIHAN:· I'm sorry.· I just
`
`10· · · · · object because he said he didn't -- he's
`
`11· · · · · making that based on what the TOC says and
`
`12· · · · · not looking at the actual sections.
`
`13· · · · · · · · MR. HOLLOWAY:· Okay.
`
`14· · · · · Q.· · Let's turn to page 70.
`
`15· · · · · · · · MR. COUNIHAN:· I don't know if you
`
`16· · · · · want to look at it.
`
`17· ·BY MR. HOLLOWAY:
`
`18· · · · · Q.· · Do you see the subheading A, Claim 1
`
`19· ·of the '650 Patent is not valid for obviousness?
`
`20· · · · · A.· · Yes, I do see it.
`
`21· · · · · Q.· · You see that?
`
`22· · · · · A.· · Yep.
`
`23· · · · · Q.· · And you see it's followed by
`
`24· ·paragraphs 201 through 209, all talking about
`
`25· ·Claim 1 of the '650 Patent?
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 17
`
`
`
`·1· · · · · A.· · I do see that.
`
`·2· · · · · Q.· · In your report, do you have a
`
`·3· ·similar set of analyses where you go claim by
`
`·4· ·claim and provide reasons for why each individual
`
`·5· ·claim is not obvious?
`
`·6· · · · · A.· · As you know from my reports, I
`
`·7· ·had -- do not have a similar analyses by claim.
`
`·8· ·However, when I look at the statements, I have
`
`·9· ·similar or identical arguments.· I just don't
`
`10· ·have it in -- divided up by claim.
`
`11· · · · · Q.· · So going back to your reports, your
`
`12· ·opening and Rebuttal Reports, your Rebuttal
`
`13· ·Report, for example, is based on your review of
`
`14· ·the literature and the inferences described in
`
`15· ·Dr. Janero, and Dr. McDuff's, and Dr. Carson's
`
`16· ·reports.
`
`17· · · · · · · · Would you agree with that?
`
`18· · · · · A.· · It is -- as I reference in this
`
`19· ·report, it's based on my knowledge in the field,
`
`20· ·the review of the literature, and Dr. Janero's
`
`21· ·report.
`
`22· · · · · Q.· · Let's start with your Opening
`
`23· ·Report.· Would you agree with me that your
`
`24· ·Opening Report is focused on the science behind
`
`25· ·prodrug design and the unexpected, as you put it,
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 18
`
`
`
`·1· ·properties of fesoterodine?
`
`·2· · · · · A.· · I would, in general terms, agree
`
`·3· ·it -- that deals with product design and it deals
`
`·4· ·with the properties of fesoterodine.
`
`·5· · · · · Q.· · And I believe you said that part of
`
`·6· ·what went into your reports is information that
`
`·7· ·comes from your own experience.
`
`·8· · · · · · · · Did your own experience help you
`
`·9· ·define the person of ordinary skill in the art?
`
`10· · · · · A.· · I would agree with that because I
`
`11· ·think having worked in exactly this field at the
`
`12· ·same time as some of the work was done at
`
`13· ·Schwarz, I think that the person of ordinary
`
`14· ·skill should have an understanding of the
`
`15· ·physiology of overactive bladder conditions.
`
`16· · · · · Q.· · And you would agree with me that the
`
`17· ·person of ordinary skill in the art has access to
`
`18· ·all of the literature concerning antimuscarinics
`
`19· ·used to treat overactive bladder?
`
`20· · · · · A.· · A person of ordinary skill should
`
`21· ·have access to the relevant literate in this case
`
`22· ·in terms of overactive bladder.
`
`23· · · · · Q.· · Would you agree that relevant
`
`24· ·literature for a person of ordinary skill in the
`
`25· ·art includes all of the literature related to
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 19
`
`
`
`·1· ·antimuscarinics in the field of overactive
`
`·2· ·bladder?
`
`·3· · · · · A.· · I think that's a very absolute
`
`·4· ·statement.· I don't think any person can know all
`
`·5· ·the literature.· We may have theoretically access
`
`·6· ·to all the literature, but if a person knows
`
`·7· ·everything, is, in my opinion, really impossible.
`
`·8· · · · · Q.· · You understand that a person of
`
`·9· ·ordinary skill in the art, as we're using the
`
`10· ·term today, is an artificial construct?
`
`11· · · · · A.· · I know that.
`
`12· · · · · Q.· · And part of that artificial
`
`13· ·construct is that they are presumed to know
`
`14· ·everything?
`
`15· · · · · A.· · Okay.
`
`16· · · · · Q.· · Do you agree with that?
`
`17· · · · · A.· · I think if you state that's the
`
`18· ·definition, it's the definition.
`
`19· · · · · Q.· · Are you working under a different
`
`20· ·definition?
`
`21· · · · · A.· · I understand that the person is
`
`22· ·supposed to know everything, yeah.
`
`23· · · · · Q.· · Would you agree that in the design
`
`24· ·of a pharmaceutical industry is concerned with,
`
`25· ·obviously, the efficacy of a product?
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 20
`
`
`
`·1· · · · · · · · MR. COUNIHAN:· Objection.· Could you
`
`·2· · · · · say it again?· I just didn't understand the
`
`·3· · · · · question.
`
`·4· ·BY MR. HOLLOWAY:
`
`·5· · · · · Q.· · Would you agree that in the design
`
`·6· ·of a pharmaceutical, the industry is obviously
`
`·7· ·concerned with the efficacy of a product?
`
`·8· · · · · A.· · Well, the industry is concerned with
`
`·9· ·the safety and the efficacy of the products.
`
`10· · · · · Q.· · Okay.· So if we put them together,
`
`11· ·are you happy with that, the industry is
`
`12· ·concerned with the safety and efficacy of a
`
`13· ·product?
`
`14· · · · · A.· · I would agree with that.
`
`15· · · · · Q.· · See, I thought Robert was going to
`
`16· ·be mad.· It was a compound question, so.
`
`17· · · · · · · · Would you also agree that in the
`
`18· ·design of a pharmaceutical, the industry is not
`
`19· ·only concerned with the safety and efficacy of
`
`20· ·the product but the ability to protect it
`
`21· ·commercially?
`
`22· · · · · · · · MR. COUNIHAN:· Objection.
`
`23· · · · · A.· · Well, the industry can only afford
`
`24· ·the research going into the identification and
`
`25· ·development of a potential drug if they have a
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 21
`
`
`
`·1· ·reasonable access to a return on their
`
`·2· ·investment.
`
`·3· · · · · Q.· · And one of the ways that the return
`
`·4· ·on investment is realized is that a company, for
`
`·5· ·example, Pfizer, would be the only one allowed to
`
`·6· ·market that discovered and safe and effective
`
`·7· ·product?
`
`·8· · · · · A.· · Well, in the -- certainly in the
`
`·9· ·Western World, the pharmaceutical companies are
`
`10· ·granted an exclusivity period through the
`
`11· ·patents.
`
`12· · · · · Q.· · And I'm sticking with your
`
`13· ·experience and knowledge in the pharmaceutical
`
`14· ·industry.
`
`15· · · · · · · · Would you agree that there's a
`
`16· ·desire to have the most efficient number of
`
`17· ·metabolic pathway steps when you're trying to
`
`18· ·deliver an effective and safe product?
`
`19· · · · · · · · MR. COUNIHAN:· Do you need that one
`
`20· · · · · said again?
`
`21· · · · · A.· · I think this is a confusing
`
`22· ·question.
`
`23· · · · · Q.· · Okay.
`
`24· · · · · A.· · I mean, the goal is to have a safe
`
`25· ·and effective medication and that is the
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 22
`
`
`
`·1· ·overriding guidance in this field.
`
`·2· · · · · Q.· · Okay.· So we're trying to have a
`
`·3· ·safe and effective medication, right, we can
`
`·4· ·assume that?
`
`·5· · · · · A.· · Right.
`
`·6· · · · · Q.· · When you're designing a drug and its
`
`·7· ·delivery, isn't there a motivation to have the
`
`·8· ·least number of metabolic pathway steps involved
`
`·9· ·in the delivery of that drug product?
`
`10· · · · · A.· · Well, I think, as I stated, the only
`
`11· ·question is safe and effective.· How many
`
`12· ·metabolic steps or if the metabolites are all
`
`13· ·inactive, who cares.
`
`14· · · · · Q.· · Okay.
`
`15· · · · · A.· · I mean, you have to look at the
`
`16· ·specific situation.· You can't answer this
`
`17· ·question in a general way.
`
`18· · · · · Q.· · So if I'm -- if I've discovered an
`
`19· ·active ingredient and it's effective and safe, I
`
`20· ·want to deliver that to the target organ or
`
`21· ·system within the body, would it be ideal if I
`
`22· ·could just deliver that compound to the organ or
`
`23· ·system, just straightaway as it is?
`
`24· · · · · A.· · Well, I mean, as I stated, it
`
`25· ·depends on the situation.· The goal is safe and
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 23
`
`
`
`·1· ·effective.· How many steps there are in getting
`
`·2· ·to the organ or how it gets eliminated is of
`
`·3· ·secondary importance.
`
`·4· · · · · Q.· · Assuming -- Go ahead.· ·I'm sorry.
`
`·5· · · · · A.· · The more metabolic steps you have,
`
`·6· ·maybe your clearance is much faster, but it
`
`·7· ·always needs to be determined experimentally.
`
`·8· · · · · Q.· · Okay.· So let's take a step back.
`
`·9· · · · · · · · I have a compound that I know has
`
`10· ·specific activity at an organ or system.
`
`11· · · · · · · · You with me so far?
`
`12· · · · · A.· · Yes.
`
`13· · · · · Q.· · Okay.· And I know that compound is
`
`14· ·effective in doing something when it gets to that
`
`15· ·organ and system.· Okay?
`
`16· · · · · A.· · Okay.
`
`17· · · · · Q.· · And I know that compound is safe.
`
`18· ·Like by itself that compound is safe in the human
`
`19· ·body when it's administered.· Okay?
`
`20· · · · · A.· · Okay.
`
`21· · · · · Q.· · So assuming all of those things,
`
`22· ·wouldn't the ideal delivery of that compound to
`
`23· ·the organ or system be direct?· Nothing has to
`
`24· ·happen to that molecule in order to get to the
`
`25· ·organ and system other than the patient takes it.
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 24
`
`
`
`·1· · · · · · · · Would you agree with that?
`
`·2· · · · · A.· · Well, you basically state the
`
`·3· ·situation which rarely ever occurs.· I think what
`
`·4· ·you want to do is just put the compound very task
`
`·5· ·to act and no other systems in the body see or do
`
`·6· ·anything to the compound, and I don't know of a
`
`·7· ·situation, except if you inject it, for instance,
`
`·8· ·directly into the organ, how you do that.
`
`·9· · · · · Q.· · Again, I said it was an ideal,
`
`10· ·right?· So, understandably, it's not always the
`
`11· ·case that the compound that is going to be doing
`
`12· ·the activity at a system or organ can be
`
`13· ·administered in a form exactly as it's supposed
`
`14· ·to work straightaway.
`
`15· · · · · · · · You would agree with that?
`
`16· · · · · A.· · I mean, the situations you have is
`
`17· ·that in most cases the drug gets distributed
`
`18· ·through the system and circulation to all organs.
`
`19· ·And so it's usually not possible to get a
`
`20· ·compound directly to the organ where you would
`
`21· ·like to have the effect.
`
`22· · · · · Q.· · I think you and I are focusing on
`
`23· ·different parts of this.· Okay.
`
`24· · · · · · · · So I understand that when I give in
`
`25· ·a compound, so, for example, I give an --
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 25
`
`
`
`·1· · · · · · · · THE REPORTER:· Hold on, Counsel.
`
`·2· · · · · · · · "So I understand that when I give
`
`·3· · · · · compound" -- I didn't hear it.
`
`·4· · · · · Q.· · And it's administered orally and
`
`·5· ·absorbed into the blood system, it's circulated
`
`·6· ·throughout the blood system; right?
`
`·7· · · · · A.· · That's correct.
`
`·8· · · · · Q.· · So what I'm referring to more is,
`
`·9· ·let's say that the compound that is being
`
`10· ·administered can be administered in exactly the
`
`11· ·same form as it needs to be whenever it reaches
`
`12· ·the target system or organ.
`
`13· · · · · · · · Are you following me now?
`
`14· · · · · A.· · Yeah, I think what you are
`
`15· ·describing is something of a ideal situation
`
`16· ·which, in my mind, never occurs.
`
`17· · · · · Q.· · So there are no compounds available
`
`18· ·on the market that function when they're -- for
`
`19· ·example, absorbed into the bloodstream and
`
`20· ·distributed throughout the body, there are no
`
`21· ·compounds that are in the same form as they were
`
`22· ·when I administered them to the patient?
`
`23· · · · · A.· · There are cases like this, yes.
`
`24· · · · · Q.· · Okay.
`
`25· · · · · A.· · There are.
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 26
`
`
`
`·1· · · · · Q.· · Okay.· So they do exist where --
`
`·2· · · · · A.· · They do exist, but they have effects
`
`·3· ·on all different organs.
`
`·4· · · · · Q.· · Okay.· Yeah, I think we're focusing
`
`·5· ·on different parts.
`
`·6· · · · · A.· · And so I realize we are not on the
`
`·7· ·same page.
`
`·8· · · · · Q.· · Okay.· So I'm talking about the
`
`·9· ·molecule itself.· I get that when it goes to --
`
`10· ·when I ingest a molecule, so, for example, what
`
`11· ·we're dealing with here are the overactive
`
`12· ·bladder drugs.· I understand that the same
`
`13· ·compound that has an effect on the bladder can
`
`14· ·have an effect on somewhere else like the
`
`15· ·salivary glands.
`
`16· · · · · · · · We're in agreement there; right?
`
`17· · · · · A.· · Yes.
`
`18· · · · · Q.· · Okay.· What I'm talking about is
`
`19· ·what the body may or may not have to do to the
`
`20· ·molecule once it's ingested.· Okay.· So the same
`
`21· ·compound that has effect on the bladder may have
`
`22· ·an effect on the salivary glands that I may or
`
`23· ·may not care about.· That's not the part I'm
`
`24· ·talking about.· I'm saying that compound that
`
`25· ·does have that effect, did it have to be
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 27
`
`
`
`·1· ·metabolized by the body or otherwise worked on
`
`·2· ·and become different from the time that I
`
`·3· ·administered it until it got to its active form.
`
`·4· · · · · · · · Are you following what I'm saying
`
`·5· ·now?
`
`·6· · · · · A.· · Yep.
`
`·7· · · · · Q.· · Okay.· In an ideal case, the body
`
`·8· ·doesn't have to do anything to the molecule;
`
`·9· ·right?
`
`10· · · · · A.· · Yeah.· I mean, to me it's an
`
`11· ·irrelevant point.
`
`12· · · · · Q.· · Okay.· And the reason --
`
`13· · · · · A.· · Because you need to get a safe and
`
`14· ·effective compound, if it goes through first past
`
`15· ·metabolism and the liver and so on.· That is an
`
`16· ·unimportant question to me.
`
`17· · · · · Q.· · But I do care -- in the
`
`18· ·pharmaceutical industry, I do have to care about
`
`19· ·each of those steps because at each step I have
`
`20· ·the possibility of changing the safety and
`
`21· ·efficacy of the dosed product; correct?
`
`22· · · · · A.· · Yeah.· I mean, when you develop a
`
`23· ·drug, you need to understand its disposition, its
`
`24· ·elimination and all the steps which are going on
`
`25· ·in metabolism.· And the goal is to have a safe
`
`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1074A - Page 28
`
`
`
`·1· ·and effective medication.· How you achieve that
`
`·2· ·is secondary.
`
`·3· · · · · Q.· · Okay.· So because the goal is safety
`
`·4· ·and efficacy, the number of steps, say the number
`
`·5· ·of metabolic steps necessary to take the dosed
`
`·6· ·compound and turn it into the active compound
`
`·7· ·that does its job, in your opinion that is a
`
`·8· ·secondary piece of information?
`
`·9· · · · · A.· · The goal has always to be a safe and
`
`10· ·effective medication.· How you achieve it is, I
`
`1
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