Daryl S. Paulson, Ph.D., M.B.A. - February 19, 2016
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` U N I T E D S T A T E S P A T E N T A N D T R A D E M A R K O F F I C E
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` B E F O R E T H E P A T E N T T R I A L A N D A P P E A L B O A R D
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`_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
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`I N N O P H A R M A L I C E N S I N G , I N C . , )
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`I N N O P H A R M A L I C E N S I N G L L C , )
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`I N N O P H A R M A I N C . , I N N O P H A R M A L L C )
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`M Y L A N P H A R M A C E U T I C A L S I N C . a n d )
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`M Y L A N I N C . , )
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` P e t i t i o n e r , ) C a s e N o .
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` v s . ) I P R 2 0 1 5 - 0 0 9 0 2
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`S E N J U P H A R M A C E U T I C A L C O . , L T D . , )
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`B A U S C H & L O M B , I N C . , a n d B A U S C H )
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`& L O M B P H A R M A H O L D I N G S C O R P . , )
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` P a t e n t O w n e r . )
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` * * * C A P T I O N C O N T I N U E D * * * )
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`_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ )
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` V i d e o t a p e d D e p o s i t i o n o f :
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` D A R Y L S . P A U L S O N , P h . D . , M . B . A .
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` F e b r u a r y 1 9 , 2 0 1 6
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
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`

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`Daryl S. Paulson, Ph.D., M.B.A. - February 19, 2016
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`Page 2
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`2 (Pages 2 to 5)
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`Page 4
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` A P P E A R A N C E S
`
` On behalf of Senju Pharmaceutical Co.,
` Ltd., Bausch & Lomb Incorporated and
` Bausch & Lomb Pharma Holdings Corp.:
` BRYAN C. DINER, ESQUIRE
` Finnegan Henderson Farabow
` Garrett & Dunner, LLP
` 901 New York Avenue, N.W.
` Washington, D.C. 20001-4413
` 202-408-4000 (P) 202-408-4400 (F)
` bryan.diner@finnegan.com
`
` On behalf of Lupin Limited and Lupin
` Pharmaceuticals, Inc.:
` NATASHA E. DAUGHTREY, ESQUIRE
` Goodwin Procter LLP
` The New York Times Building
` 620 Eighth Avenue
` New York, New York 10018
` 212-813-8800 (P) 212-355-3333 (F)
` ndaughtrey@goodwinprocter.com
`
`1
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` IN THE UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF NEW JERSEY
`
`________________________________
` )
`SENJU PHARMACEUTICAL CO., LTD., )
`BAUSCH & LOMB INCORPORATED, and )
`BAUSCH & LOMB PHARMA HOLDINGS ) C.A. Nos.
`CORP., ) 1:14-cv-00667
` ) 1:14-cv-04149
` Plaintiffs, ) 1:14-cv-05144
` )
` vs. )
` )
`LUPIN LIMITED and LUPIN )
`PHARMACEUTICALS, INC., )
` )
` Defendants. )
` )
` vs. )
` )
`INNOPHARMA LICENSING, INC., ) C.A. Nos.
`INNOPHARMA LICENSING, LLC, ) 1:14-cv-06893
`INNOPHARMA, INC., and ) 1:15-cv-03240
`INNOPHARMA, LLC, )
` )
` Defendants. )
` )
`________________________________)
`
` Videotaped Deposition of:
` DARYL S. PAULSON, Ph.D., M.B.A.
` February 19, 2016
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`1 A P P E A R A N C E S (Continued)
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`2 3
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` On behalf of InnoPharma Licensing, Inc.,
`4 InnoPharma Licensing LLC, InnoPharma Inc.,
`5 InnoPharma LLC, Mylan Pharmaceuticals Inc.,
`6 and Mylan Inc.:
`7 H. JAMES ABE, REGISTERED PATENT ATTORNEY
`8 Alston & Bird LLP
`9 333 South Hope Street, 16th Floor
`10 Los Angeles, California 90071
`11 213-576-1000 (P) 213-576-1100 (F)
`12 james.abe@alston.com
`13
`14 - and -
`15
`16 JOSEPH M. JANUSZ, ESQUIRE
`17 Alston & Bird LLP
`18 Bank of America Plaza
`19 101 South Tryon Street, Suite 4000
`20 Charlotte, North Carolina 28280-4000
`21 704-444-1000 (P) 704-444-1738 (F)
`22 joe.janusz@alston.com
`
`1 2
`
` The Videotaped Deposition of DARYL S.
`3 PAULSON, Ph.D., M.B.A., was taken on Friday,
`4 February 19, 2016, commencing at 10:07 a.m. at the
`5 law offices of Finnegan Henderson Farabow Garrett
`6 & Dunner, LLP, 901 New York Avenue, N.W.,
`7 Washington, D.C., before Cappy Hallock, Registered
`8 Professional Reporter, Certified Realtime
`9 Reporter, Certified Livenote Reporter, and Notary
`10 Public in and for the District of Columbia.
`11
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`21 Videographer:
`22 TJ O'Toole, CLVS
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
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`Page 2
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`

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`Daryl S. Paulson, Ph.D., M.B.A. - February 19, 2016
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`3 (Pages 6 to 9)
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`Page 8
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` E X H I B I T S (Continued)
`
`PAULSON PAGE
`Exhibit 11 Expert Reply Report of Daryl 218
` Paulson, Senju v. Lupin v.
` InnoPharma
`Exhibit 12 Media Production and Growth 225
` Testing Data Sheet,
` PROL0340406-0425
`Exhibit 13 2-14-16 TSA/SDA Equivalence 232
` Evaluation, PROL0340429
`Exhibit 14 EP General Notices 241
`Exhibit 15 Media/Diluent Tracking Form 256
` for Study No. 151142-203,
` PROL0340403-0405
` -o0o-
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` I N D E X
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`Page 6
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` Deposition of Daryl S. Paulson, Ph.D., M.B.A.
` February 19, 2016
`
`EXAMINATION BY: PAGE
` Mr. Abe (IPR) 12
` Mr. Diner 161
` Mr. Abe 173
` Mr.Abe (District Court) 192
` Ms. Daughtrey 260
` -o0o-
`
` E X H I B I T S
`
`PAULSON PAGE
`Exhibit 1 U.S. Patent No. 8,669,290, 28
` InnoPharma EX1001 01-09
`Exhibit 2 European Pharmacopoeia, Seventh 33
` Edition, Volume 1,
` LUPIN068837-8854
`
`Page 7
`
`Page 9
`
` E X H I B I T S (Continued)
`
`PAULSON PAGE
`Exhibit 3 Declaration of Daryl Paulson, 51
` Senju Exhibit 2128,
` IPR2015-00902, Pages 1-20
`Exhibit 4 Supplemental Expert Report of 61
` Daryl Paulson, Senju Exhibit
` 2257, IPR2015-00902, Pages 1-31
`Exhibit 5 1-7-16 letter, Dragotoiu to 64
` Myers, Senju Exhibit 2249,
` IPR2015-00902, Pages 1-65
`Exhibit 6 Addendum 4, Senju Exhibit 2250, 128
` PROL0337854-7869
`Exhibit 7 Expert Report of Daryl Paulson, 192
` Senju v. InnoPharma
`Exhibit 8 Expert Report of Daryl Paulson, 205
` Senju v. Lupin
`Exhibit 9 1-7-16 letter, Dragotoiu to 209
` Myers, PROL0337789-7853
`Exhibit 10 1-7-16 letter, Dragotoiu to 214
` Myers, PROL0337789-7853
`
`1 P R O C E E D I N G S
`2 - - - - - -
`3 THE VIDEO OPERATOR: All right, stand by.
`4 On the record with Disc Number 1 of the
`5 video deposition of Daryl Paulson, taken by the
`6 defendant in the matter of Senju Pharmaceutical
`7 Company Limited, et al. versus Lupin Limited, et
`8 al., being heard before the United States District
`9 Court for the District of New Jersey, Civil Action
`10 Number 1:14-cv-00667-JBS-KMW and in the matter of
`11 InnoPharma Licensing, Incorporated, et al. versus
`12 Senju Pharmaceuticals Company Limited, et al.
`13 being heard before the Patent Trial and Appeal
`14 Board of the United States Patent & Trademark
`15 Office, Case Number IPR2015-00902.
`16 This deposition is being held at the Law
`17 Offices of Finnegan Henderson, located at 901 New
`18 York Avenue Northwest in Washington, D.C. on
`19 February 19th, 2016 at approximately 10:08 a.m.
`20 My name is TJ O'Toole. I am the
`21 Certified Legal Video Specialist. The court
`22 reporter is Cappy Hallock. We are both here
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
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`Page 3
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`

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`Daryl S. Paulson, Ph.D., M.B.A. - February 19, 2016
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`Page 10
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`1 representing GregoryEdwards LLC.
`2 Will counsel please introduce themselves
`3 and indicate which parties they represent.
`4 MR. ABE: James Abe for the InnoPharma
`5 defendants and Petitioner InnoPharma.
`6 Natasha Daughtrey from Goodwin & Procter
`7 on behalf of Lupin Limited.
`8 MR. JANUSZ: Joe Janusz with Alston &
`9 Bird also on behalf of the InnoPharma defendants.
`10 MR. DINER: Brian Diner of Finnegan
`11 Henderson representing plaintiff Senju, et al. in
`12 the District Court and Patent Owner Senju in the
`13 PTAB proceeding.
`14 THE VIDEO OPERATOR: Thank you.
`15 Will the court reporter please swear in
`16 the witness.
`17 WHEREUPON,
`18 DARYL S. PAULSON, Ph.D., M.A., M.S., M.B.A.,
`19 A Witness called for examination, having
`20 been first duly sworn, was examined and testified
`21 as follows:
`22
`
`4 (Pages 10 to 13)
`
`Page 12
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`1 understanding.
`2 EXAMINATION
`3 BY MR. ABE:
`4
`
` Q Q Good morning, Dr. Paulson.
`
` Q Q
`5
`
` A A Good morning.
`
` A A
`6
`
` Q Q Have you ever been deposed before?
`
` Q Q
`7
`
` A A Yes, I have.
`
` A A
`8
`
` Q Q Okay. Well, let me go over the ground
`
` Q Q
`9 rules just quickly to refresh you of how this will
`10 work.
`11 I represent the InnoPharma entities and I
`12 will be asking questions of you today. When I ask
`13 a question I will expect you to answer it. Your
`14 counsel might object, but I will still expect you
`15 to answer it unless your counsel instructs you not
`16 to answer. Is that okay?
`17
`
` A A It's okay.
`
` A A
`18
`
` Q Q If you don't understand a question that
`
` Q Q
`19 I'm asking, please let me know and I will try to
`20 clarify, but if you answer it I will assume you
`21 understood my question. Is that okay?
`22
`
` A A Yes.
`
` A A
`
`Page 11
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`Page 13
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`1 MR. ABE: Before I go into the
`2 questioning, I just want to note I think it is
`3 clear from the case caption that was stated --
`4 THE WITNESS: Could you people speak up
`5 so I can hear you?
`6 MR. ABE: Sure. I'm sorry about that.
`7 -- that we are conducting a consolidated
`8 deposition pursuant to an agreement that the
`9 parties reached by e-mail this morning. And under
`10 the conditions in that e-mail and including that
`11 the plaintiffs Patent Owner will not object to the
`12 IPR testimony by the witness given during this
`13 consolidated deposition from being used in the
`14 District Court litigation in a manner consistent
`15 with the Federal Rules of Civil Procedure and the
`16 Federal Rules of Evidence.
`17 MR. DINER: I am just going to interject
`18 that the agreement that has been struck between
`19 the parties is that no party will object --
`20 MR. ABE: Both parties.
`21 MR. DINER: So it's bilateral?
`22 MR. ABE: Right. That's my
`
`1 MR. DINER: James, if I can just
`2 interject, Dr. Paulson is a Vietnam War veteran,
`3 and he does have a hearing deficiency so you may
`4 see him lean into you --
`5 THE WITNESS: Yeah.
`6 MR. DINER: -- to try to hear you better.
`7 THE WITNESS: Yes, so speak up.
`8 THE VIDEO OPERATOR: Excuse me, counsel,
`9 can we go off the record for a moment?
`10 MR. ABE: Of course.
`11 THE VIDEO OPERATOR: The time is
`12 10:12:05. Off the record.
`13 (Discussion off the record.)
`14 (Recess taken - 10:12 a.m.)
`15 (After recess - 10:20 p.m.)
`16 THE VIDEO OPERATOR: Stand by.
`17 On the record, the time is 10:20:06.
`18 BY MR. ABE:
`19
`
` Q Q Dr. Paulson, is there any reason you
`
` Q Q
`20 can't testify truthfully today?
`21
`
` A A No, there isn't.
`
` A A
`22
`
` Q Q You're not taking any medication that
`
` Q Q
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
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`Page 4
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`

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`Daryl S. Paulson, Ph.D., M.B.A. - February 19, 2016
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`Page 14
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`might affect your ability to testify truthfully?
`
` A A No.
`
` A A
`
` Q Q Okay, thank you.
`
` Q Q
` You mentioned you have been deposed
`before. How many times?
`
` A A One time.
`
` A A
`
` Q Q When was that?
`
` Q Q
`
` A A Two years ago.
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` A A
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` Q Q Do you recall what case it was?
`
` Q Q
`
` A A Yes. It was a BioScience case versus
`
` A A
`another woman who was suing the company, and I
`defended as a key employee.
`
` Q Q So you were not testifying as an expert
`
` Q Q
`in that case?
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` A A No.
`
` A A
`
` Q Q And it had nothing to do with
`
` Q Q
`preservative efficacy or --
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` A A No, nothing at all. Nothing at all.
`
` A A
`
` Q Q Dr. Paulson, you have several degrees.
`
` Q Q
`And you have a Ph.D. in microbiology, I believe?
`
` A A I have a Ph.D. in microbiology and
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` A A
`psychology where I combined them at Saybrook.
`
`5 (Pages 14 to 17)
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`Page 16
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`1
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` A A Yes, we do.
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` A A
`2
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` Q Q Do you personally?
`
` Q Q
`3
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` A A Occasionally I'm involved in them.
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` A A
`4
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` Q Q What is your involvement?
`
` Q Q
`5
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` A A If there is problems they always ask me
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` A A
`6 to help solve them.
`7
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` Q Q What kind of problems?
`
` Q Q
`8 MR. DINER: Objection, vague.
`9
`
` Q Q You can answer.
`
` Q Q
`10
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` A A It could be any problem.
`
` A A
`11
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` Q Q For example, if a procedure was not
`
` Q Q
`12 followed during a test protocol?
`13 MR. DINER: Objection. There is no
`14 question in that.
`15 MR. ABE: Let me rephrase it.
`16
`
` Q Q Would one of the problems be if a person
`
` Q Q
`17 didn't properly follow the procedures and they
`18 come to you, for example, whether that -- strike
`19 that.
`20 Do you have standard operating procedures
`21 at the company --
`22
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` A A Yes, we do.
`
` A A
`
`Page 15
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`Page 17
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`1
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` Q Q And that was in 1992?
`
` Q Q
`2
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` A A Yes.
`
` A A
`3
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` Q Q Is it accurate to say it's a Ph.D. in
`
` Q Q
`4 human science?
`5
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` A A Well, that's what they call it. That's
`
` A A
`6 what they call it at Saybrook.
`7
`
` Q Q Okay.
`
` Q Q
`8 And how long have you had the company, is
`9 it biolife --
`10
`
` A A BioScience Labs.
`
` A A
`11
`
` Q Q BioScience Labs?
`
` Q Q
`12
`
` A A 25 years.
`
` A A
`13
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` Q Q Is it okay if I refer to it as BSL?
`
` Q Q
`14
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` A A BSLI, BSL.
`
` A A
`15
`
` Q Q Thank you.
`
` Q Q
`16 Dr. Paulson, do you conduct the
`17 preservative efficacy testing in the ordinary
`18 course of your business, you personally?
`19 MR. DINER: Objection, vague. Compound.
`20 You may answer.
`21
`
` A A Yes, we do.
`
` A A
`22
`
` Q Q Your company does?
`
` Q Q
`
`1 MR. DINER: Just let him finish his
`2 question before you answer. Otherwise the record
`3 is not going to be clear, and it's going to wreak
`4 havoc on the poor court reporter.
`5
`
` Q Q Do you have a procedure for how to handle
`
` Q Q
`6 deviations?
`7 MR. DINER: Objection, vague.
`8
`
` Q Q You can answer.
`
` Q Q
`9
`
` A A Yes, we do.
`
` A A
`10
`
` Q Q Do you know what the general procedure is
`
` Q Q
`11 for handling deviations?
`12 MR. DINER: Objection, vague. In which
`13 context are you referring to?
`14 MR. ABE: He says he has a standard
`15 operating procedure so I just want to know what,
`16 generally, it says.
`17
`
` A A Quality assurance has methods in place
`
` A A
`18 right now.
`19
`
` Q Q Okay.
`
` Q Q
`20 I earlier asked have you done
`21 preservative efficacy testing in your regular
`22 course of business, and you said you -- if there
`
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`Page 5
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`

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`Daryl S. Paulson, Ph.D., M.B.A. - February 19, 2016
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`Page 18
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`was a problem they would ask you to solve them.
` Do you actually conduct any of the
`testings in the labs?
`
` A A I have.
`
` A A
`
` Q Q When was the last time you've done the
`
` Q Q
`testing personally?
`
` A A The complete study? Probably four, five
`
` A A
`years ago.
`
` Q Q And this is referring to preservative
`
` Q Q
`efficacy testing?
`
` A A Yes.
`
` A A
`
` Q Q And that would include -- well, strike
`
` Q Q
`that.
` The last time you did that, was that the
`EP preservative efficacy testing?
`
` A A I don't remember.
`
` A A
`
` Q Q At your lab, BSL, do you regularly
`
` Q Q
`conduct what is called a European Pharmacopeia
`preservative efficacy testing?
` MR. DINER: Objection, asked and
`answered.
`
` Q Q You can answer.
`
` Q Q
`
`6 (Pages 18 to 21)
`
`Page 20
`
`1 is that right?
`2
`
` A A Yes, it is.
`
` A A
`3
`
` Q Q And one of the employees that conducts
`
` Q Q
`4 the EP criteria testing is by the name of
`5 Mr. Dan -- I'm sorry, I'm blanking on his name --
`6 Dragoo --
`7
`
` A A Dragotoiu.
`
` A A
`8
`
` Q Q Dragoo --
`
` Q Q
`9
`
` A A Dragotoiu.
`
` A A
`10
`
` Q Q Dragotoiu. Sorry. Thank you.
`
` Q Q
`11 Do you work with him regularly?
`12 MR. DINER: I'm sorry, can you repeat
`13 that question? I didn't hear that. I'm sorry.
`14
`
` Q Q Do you work with Mr. Dragotoiu regularly?
`
` Q Q
`15
`
` A A Yes, I do.
`
` A A
`16
`
` Q Q How long has he worked for you, or for
`
` Q Q
`17 BSL?
`18
`
` A A Him? Probably eight years.
`
` A A
`19
`
` Q Q And when BSL conducts EP -- strike that.
`
` Q Q
`20 When BSL conducts preservative efficacy
`21 testing in accordance with the EP, is it always
`22 Mr. Dragotoiu who conducts the testing?
`
`Page 19
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`Page 21
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`1
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` A A We conduct those as well as Europeans.
`
` A A
`2 We conduct them all. It depends on what the
`3 customer wants.
`4
`
` Q Q How frequently does one of your customers
`
` Q Q
`5 ask you to do a testing in accordance with the EP?
`6 MR. DINER: Objection, calls for
`7 speculation.
`8
`
` Q Q You can answer.
`
` Q Q
`9
`
` A A Oh, probably six of them a year.
`
` A A
`10
`
` Q Q In accordance with the EP criteria?
`
` Q Q
`11 THE REPORTER: I'm sorry?
`12 MR. DINER: When you answer, you have to
`13 answer yes or no --
`14
`
` A A Yes.
`
` A A
`15 THE WITNESS: Okay.
`16 MR. DINER: You can't make a visual sign
`17 or a grunt or something.
`18 THE WITNESS: Okay.
`19 MR. ABE: Thank you.
`20 MR. DINER: And also let him finish his
`21 question before you jump in with an answer.
`22
`
` Q Q At BSL you have many employees, I assume;
`
` Q Q
`
`1
`
` A A No, sir.
`
` A A
`2
`
` Q Q Who is it?
`
` Q Q
`3
`
` A A There is various people in the in vitro
`
` A A
`4 lab that can do it.
`5
`
` Q Q Can you tell me a general number of how
`
` Q Q
`6 many people would conduct it on a, say --
`7
`
` A A Three.
`
` A A
`8
`
` Q Q Three people?
`
` Q Q
`9 And one of them is Mr. Dragotoiu?
`10
`
` A A Yes, it is.
`
` A A
`11
`
` Q Q Okay.
`
` Q Q
`12 The EP criteria requires testing of
`13 four -- well, strike that.
`14 Now, in this proceeding you provided some
`15 testimony regarding the EP criteria, correct?
`16
`
` A A Correct.
`
` A A
`17
`
` Q Q And in that you were required to test, I
`
` Q Q
`18 believe, four microorganisms; is that right?
`19 MR. DINER: Objection to the form of the
`20 question. Assumes facts not in evidence.
`21
`
` Q Q You can answer.
`
` Q Q
`22
`
` A A Yes, we did.
`
` A A
`
`GregoryEdwards, LLC | Worldwide Court Reporting
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`
`Page 6
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`

`
`Daryl S. Paulson, Ph.D., M.B.A. - February 19, 2016
`
`Page 22
`
`1
`
` Q Q Can you state the four microorganisms?
`
` Q Q
`2
`
` A A Pseudomonas aeruginosa, Staph aureus.
`
` A A
`3 Candida albicans, Aspergillus brasiliensis.
`4
`
` Q Q Can you tell me which one of these are a
`
` Q Q
`5 type of bacteria?
`6
`
` A A The Staph and the Pseudomonas. The Staph
`
` A A
`7 is gram-positive, Psuedomonas is gram-negative,
`8 and the other two are fungi.
`9
`
` Q Q Are any of these, can be categorized as
`
` Q Q
`10 also a yeast?
`11
`
` A A Candida albicans.
`
` A A
`12
`
` Q Q Now, when you conduct preservative
`
` Q Q
`13 efficacy testing, one of the steps is to grow
`14 these bacteria or fungus; is that right?
`15 Let's start with a bacteria. Can you
`16 just generally describe for me how the growing
`17 process occurs?
`18 MR. DINER: Objection. Are we speaking
`19 in terms of European Pharmacopeia or any criteria?
`20 MR. ABE: EP.
`21 MR. DINER: Do you have a document to
`22 show him? It's not a memory contest.
`
`7 (Pages 22 to 25)
`
`Page 24
`
`1 MR. DINER: Objection, vague. Compound.
`2
`
` A A Explain what you -- I don't see what
`
` A A
`3 you're getting at.
`4
`
` Q Q Right.
`
` Q Q
`5 So when do you write a protocol?
`6
`
` A A When a proposal has been accepted.
`
` A A
`7
`
` Q Q By proposal what do you mean?
`
` Q Q
`8
`
` A A Well, when a company asks us to do a job,
`
` A A
`9 we send out a proposal. When they say it's all
`10 right by signing the proposal, then we write a
`11 protocol.
`12
`
` Q Q And who determines whether that protocol
`
` Q Q
`13 is acceptable?
`14
`
` A A What do you mean, who determines?
`
` A A
`15
`
` Q Q So somebody at BSL writes the protocol,
`
` Q Q
`16 is that correct, and you submit that to -- was
`17 that a yes? Sorry. BSL writes the protocol?
`18
`
` A A Um-hmm.
`
` A A
`19
`
` Q Q Yes, and I believe you said you submit
`
` Q Q
`20 that to the, I guess I will refer to it, the
`21 customer?
`22
`
` A A Right.
`
` A A
`
`Page 23
`
`Page 25
`
`1
`
` Q Q Do you have any general understanding?
`
` Q Q
`2
`
` A A I would like to look at a document.
`
` A A
`3
`
` Q Q You would like to see that. Okay.
`
` Q Q
`4 Now, of the four microorganisms we just
`5 talked about, which one of these are molds or form
`6 molds?
`7 MR. DINER: Objection, vague.
`8
`
` A A Aspergillus brasiliensis.
`
` A A
`9
`
` Q Q Have you heard of the term GLP?
`
` Q Q
`10
`
` A A Yes, I have.
`
` A A
`11
`
` Q Q It stands for good laboratory practices;
`
` Q Q
`12 is that correct?
`13
`
` A A That's correct.
`
` A A
`14
`
` Q Q Generally speaking, what does that
`
` Q Q
`15 entail? What are sort of the requirements for
`16 that?
`17
`
` A A Quality assurance is involved. All the
`
` A A
`18 records are kept. There is a protocol written.
`19 All that.
`20
`
` Q Q When there is a protocol written, you
`
` Q Q
`21 just said, is there any kind of validation or
`22 qualification procedure that goes with that?
`
`1
`
` Q Q And the customer determines whether that
`
` Q Q
`2 is acceptable or not?
`3
`
` A A Right.
`
` A A
`4
`
` Q Q Is there any testing to verify that
`
` Q Q
`5 protocol is appropriate for the purpose?
`6 MR. DINER: Objection, vague.
`7
`
` A A I don't understand what you're referring
`
` A A
`8 to.
`9
`
` Q Q Which part did you not understand?
`
` Q Q
`10
`
` A A The last part.
`
` A A
`11
`
` Q Q The purpose.
`
` Q Q
`12 Does BSL conduct any testing to verify
`13 that the protocol will accomplish what is
`14 intended?
`15
`
` A A Right.
`
` A A
`16
`
` Q Q What is done to verify that?
`
` Q Q
`17
`
` A A The testing.
`
` A A
`18
`
` Q Q In accordance with the protocol that was
`
` Q Q
`19 written, correct?
`20 Is that a yes?
`21
`
` A A Yes.
`
` A A
`22
`
` Q Q So what type of documents do you refer to
`
` Q Q
`
`GregoryEdwards, LLC | Worldwide Court Reporting
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`
`Page 7
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`

`
`Daryl S. Paulson, Ph.D., M.B.A. - February 19, 2016
`
`Page 26
`
`1 if you're writing a protocol for testing?
`2 MR. DINER: Objection, vague. What
`3 context are we talking about?
`4
`
` Q Q You can answer it.
`
` Q Q
`5
`
` A A What are we talking about?
`
` A A
`6
`
` Q Q So if I ask you to write a protocol with
`
` Q Q
`7 respect to a certain preservative efficacy
`8 testing, is there a document that you might refer
`9 to?
`10
`
` A A Yes.
`
` A A
`11
`
` Q Q What is it?
`
` Q Q
`12
`
` A A The EU guidelines.
`
` A A
`13
`
` Q Q The EU guidelines?
`
` Q Q
`14
`
` A A Um-hmm.
`
` A A
`15
`
` Q Q Is that the same as the, what I have been
`
` Q Q
`16 referring to as the EP as in European
`17 Pharmacopeia?
`18 MR. DINER: Objection, vague.
`19
`
` Q Q Is that a yes?
`
` Q Q
`20
`
` A A Yes. Yes.
`
` A A
`21
`
` Q Q And you would determine whether the
`
` Q Q
`22 product meets the EP criteria in accordance with
`
`8 (Pages 26 to 29)
`
`Page 28
`
`1 that is in accordance with the European
`2 Pharmacopeia you would have to refer to the
`3 European Pharmacopeia document; is that a fair
`4 statement?
`5 MR. DINER: Objection, incomplete
`6 hypothetical.
`7
`
` Q Q You can answer.
`
` Q Q
`8
`
` A A It depends -- what this study involved
`
` A A
`9 was the patent. We had to -- we had to go into
`10 that patent section and do it as it was written in
`11 there.
`12 MR. ABE: Let me hand over to you what
`13 has been marked as Exhibit 1001 in the IPR
`14 proceeding, and I believe it's IPR2015-00902.
`15 We will also mark it as Paulson
`16 Exhibit 1.
`17 (Paulson Deposition Exhibit No. 1 was
`18 marked for identification.)
`19 BY MR. ABE:
`20
`
` Q Q And for the record, this is United States
`
` Q Q
`21 Patent 8,669,290.
`22 Doctor, is it okay if I refer to this as
`
`Page 27
`
`Page 29
`
`1 that document you referred to --
`2 MR. DINER: Objection --
`3
`
` Q Q -- in which case you call the EU; is that
`
` Q Q
`4 right?
`5 MR. DINER: Objection, vague. Compound.
`6 Assumes facts not in evidence.
`7
`
` Q Q You can answer.
`
` Q Q
`8
`
` A A It's a pharmacopeia document, European
`
` A A
`9 Pharmacopeia.
`10
`
` Q Q So you defer to the European
`
` Q Q
`11 Pharmacopeia?
`12 MR. DINER: Objection, mischaracterizes
`13 his prior testimony.
`14
`
` Q Q So when you would -- strike that.
`
` Q Q
`15 When you prepare a protocol, for example,
`16 in accordance with the European Pharmacopeia, why
`17 do you refer to the European Pharmacopeia
`18 document?
`19 MR. DINER: Objection, incomplete
`20 hypothetical.
`21
`
` A A I don't understand.
`
` A A
`22
`
` Q Q Is it true that to develop a protocol
`
` Q Q
`
`1 the '290 patent?
`2
`
` A A Yes, it is.
`
` A A
`3
`
` Q Q Have you seen this patent before?
`
` Q Q
`4
`
` A A Yes, I have.
`
` A A
`5
`
` Q Q On the cover page, if I could direct your
`
` Q Q
`6 attention to the left side towards the middle
`7 where you see a (30) -- can you see that?
`8 Do you see that? Yes?
`9 Where it says Foreign Application
`10 Priority Data, do you understand what that means?
`11 MR. DINER: Objection, outside the scope
`12 of the deposition. Calls for a legal
`13 interpretation.
`14
`
` Q Q Do you have an understanding?
`
` Q Q
`15
`
` A A No, I don't.
`
` A A
`16
`
` Q Q Now, under that it says January 21st,
`
` Q Q
`17 2003. Do you see that?
`18 Well, I will represent to you that that
`19 was when the first patent application relating to
`20 this '290 patent was filed in Japan. And, doctor,
`21 you've conducted some testing or BSL has conducted
`22 some testing in relation to your testimony that is
`
`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
`
`Page 8
`
`

`
`Daryl S. Paulson, Ph.D., M.B.A. - February 19, 2016
`
`Page 30
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`the subject of today's deposition, correct?
`
` A A Correct.
`
` A A
`
` Q Q And if I recall correctly, you conducted
`
` Q Q
`the testing in accordance with the European
`Pharmacopeia 7.0?
` MR. DINER: Objection, vague.
`
` Q Q Is that right?
`
` Q Q
` MR. DINER: Mischaracterizes prior
`testimony.
`
` A A We used the patent to tell us -- we used
`
` A A
`the patent and that would tell us which time
`points to use.
`
` Q Q In that case, in or -- strike that.
`
` Q Q
` On January 21st, 2003, which version of
`the European Pharmacopeia would have been in
`place?
`
` A A I don't know.
`
` A A
`
` Q Q You don't know. Could it have been the
`
` Q Q
`Version 4 of the EP?
` MR. DINER: Objection, calls for
`speculation. Asked and answered.
`
` Q Q You can answer.
`
` Q Q
`
`9 (Pages 30 to 33)
`
`Page 32
`
`1
`
` Q Q Okay.
`
` Q Q
`2 On Column 9 of the '290 patent around
`3 Row 54 you see the word, "EP-Criteria A."
`4 Do you see that?
`5
`
` A A Yes.
`
` A A
`6
`
` Q Q So you did not follow the testing with
`
` Q Q
`7 respect to that section? And I'm referring to
`8 Column 9 around Row 54 through 61 -- sorry, yes,
`9 54 through 61.
`10 MR. DINER: Objection, vague. Asked and
`11 answered.
`12
`
` Q Q You can answer.
`
` Q Q
`13
`
` A A No. We followed EP criteria B.
`
` A A
`14
`
` Q Q When you say EP criteria B, do you mean
`
` Q Q
`15 the EP criteria B as described right underneath
`16 that at Column 9, Row 63 and through 67?
`17
`
` A A It also covers it on the right-hand side.
`
` A A
`18
`
` Q Q Thank you.
`
` Q Q
`19 So is that a yes, you followed --
`20
`
` A A Yes, we followed the total EP -- EP
`
` A A
`21 criteria B.
`22
`
` Q Q Earlier I think you -- so you -- strike
`
` Q Q
`
`Page 31
`
`Page 33
`
`1
`
` A A Could be.
`
` A A
`2
`
` Q Q So can you turn to page -- sorry,
`
` Q Q
`3 Column 9. That's Page 7 of the Exhibit 1. Is
`4 this the general page that you have been referring
`5 to as -- strike that.
`6 You said you conducted the testing in
`7 accordance with the patent. Is this page the
`8 relevant page for that?
`9
`
` A A Yes.
`
` A A
`10
`
` Q Q Okay. So when you conducted the testing
`
` Q Q
`11 you did follow the European preservative -- sorry,
`12 EP -- let me start that over.
`13 So when you conducted the testing you
`14 followed the EP preservative efficacy testing,
`15 correct?
`16 MR. DINER: Objection, mischaracterizes
`17 his prior testimony.
`18
`
` Q Q You can answer.
`
` Q Q
`19
`
` A A We followed it, but we followed EP
`
` A A
`20 criteria B.
`21
`
` Q Q So you did not follow EP criteria A?
`
` Q Q
`22
`
` A A No, we didn't.
`
` A A
`
`1 that.
`2 In your preservative efficacy testing you
`3 followed the time points in the patent; is that
`4 correct?
`5
`
` A A Of EP criteria B.
`
` A A
`6
`
` Q Q Of EP criteria B. Thank you.
`
` Q Q
`7 So the time points that you tested, that
`8 was in accordance with the '290 patent and not the
`9 EP criteria B; is that correct?
`10 MR. DINER: Objection,