10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 1
`
` UNITED STATES DISTRICT COURT
` DISTRICT OF NEW JERSEY
`________________________________
`HORIZON PHARMA, INC. and POZEN, )
`INC., )
` Plaintiffs. )
` )
`v. )
` )
`DR. REDDY'S LABORATORIES, INC. )
`and DR REDDY'S LABORATORIES, )
`LTD., )
` Defendants. )
`________________________________)
`
` *** HIGHLY CONFIDENTIAL ***
`
` October 10, 2014
` New York, New York
` Videotaped deposition of DR. MARK SOSTEK, taken at
`the offices of Morgan Lewis, 1701 Market Street,
`Philadelphia, Pennsylvania, 19103, on Friday, October 10,
`2014, at 8:13 a.m., before Anthony Armstrong, a Realtime
`Systems Administrator, Certified Realtime Reporter,
`Certified Court Reporter and Notary Public of the State of
`New York.
`
`---------------------------------------------------
` DIGITAL EVIDENCE GROUP
` 1726 M Street NW, Suite 1010
` Washington, DC 20036
` (202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 1 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 2
`
`A P P E A R A N C E S:
`
`BUDD LARNER, P.C.
`150 John F. Kennedy Parkway
`Short Hills, New Jersey 07078
`BY: DMITRY V. SHELHOFF, Ph.D., ESQ.,
`(973)379-4800
`dshelhoff@buddlarner.com
`Attorneys for Dr. Reddy's Laboratories
`
`COVINGTON & BURLING, LLP
`1201 Pennsylvania Avenue, NW
`Washington, D.C. 20004
`BY: EDWARD H. RIPPEY, ESQ.,
`(202)662-5171
`erippey@cov.com
`BY: ASHLEY KWON, ESQ.,
`(202)662-5873
`akwon@cov.com
`BY: P. ANTHONY LOPEZ, ESQ., appearing telephonically
`(202)662-5431
`rlopez@cov.com
`Attorneys for AstraZeneca
`
`1
`
`2 3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 2 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 3
`
`A P P E A R A N C E S (Cont'd)
`
`PERKINS COIE
`One East Main Street, Suite 201
`Madison, Wisconsin 53703
`BY: MELODY K. GLAZER, ESQ.,
`(608)663-7485
`mglazer@perkinscoie.com
`Attorneys for Mylan
`
`COOLEY, LLP
`3175 Hanover Street
`Palo Alto, California 94304
`BY: RICARDO RODRIGUEZ, ESQ.,
`(650)843-5046
`rr@cooley.com
`Attorneys for Plaintiffs Horizon Pharma
`
`KNOBBE MARTENS OLSON & BEAR, LLP
`1717 Pennsylvania Avenue, NW, Suite 900
`Washington, D.C. 20006
`BY: STEVEN A. MADDOX, ESQ., appearing telephonically
`(202)640-6400
`steve.maddox@knobbe.com
`
`1
`
`2 3
`
`4
`5
`6
`7
`8
`9
`10
`11
`
`12
`13
`14
`15
`16
`17
`
`18
`19
`20
`21
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 3 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 4
`
` I N D E X
`WITNESS DIRECT
`DR. MARK SOSTEK By Mr. Shelhoff 8
` By Ms. Glazer 230
`
` E X H I B I T S
`NUMBER DESCRIPTION PAGE
`DEFENDANTS
`1 Mark Sostek's LinkedIn profile 8
`2 Email from Lori Kreamer 11
`3 Email from Larsson Birgitta to Peter Wallach and 24
` others
`4 US Patent No. 6,356,184 25
`5 US Patent 6,613,354 29
`6 US Patent No. 8,557,285 35
`7 US Patent Application Publication No. US 37
` 2010/0062064
`8 Frequently Asked Questions about PN40020 72
`9 Publication by Christopher J. Hawkey and others 79
`10 US Patent No. 5,601,843 85
`11 ClincialTrials.gov screenshot 91
`12 Multi-page document AZV00000068 to AZV00000154 95
`13 US Patent 5,204,11 98
`14 Document titled Pozen Inc. PN Opportunity 99
`15 May 17, 2006 Pozen New York minutes 114
`16 May 16, 2006 site visit to Pozen headquarters 115
`17 Email chain 126
`18 June 2, 2006 email from Kerstin Rahss to several 144
` people
`19 Document by Lapenna entitled Antioxidant 148
` Properties of Omeprazole
`20 1986 reference by Clissold 151
`21 1988 reference by Koji Takeuchi 152
`22 October 1995 Japanese Journal of Pharmacology 153
`23 1990 reference by T.K. Daneshmend 153
`24 Horizon's Citizen Petition dated February 3, 156
` 2014
`
`1
`
`2
`3
`
`45
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`20
`21
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 4 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 5
`
` E X H I B I T S (Cont'd)
`25 A 2010 reference by J.L Goldstein 157
`26 Document entitled Highlights of Prescribing 194
` Information
`27 FDA's response to Horizon's Citizen Petition 197
`28 Excerpt from AstraZeneca's claim construction 201
` presentation
`29 US Patent 6,926,907 214
`30 Article by C. Blandizzi, MD, 1999 220
`31 A reference by Goksel Sener-Muratoglu, 2001 221
`32 Document titled Gastroenterology 221
`33 A reference by S.J. Konturek, 1983 222
`34 A reference by S.J. Konturek, 1984 223
`35 Document entitled Omeprazole Provides Protection 224
` Against Experimentally Induced Gastric Mucosal
` Lesions
`36 A paper by Ohara, 1988 224
`37 Document pertaining to May 9-15, 1987 88th 225
` Annual Meeting of the AGA
`38 Program of the Annual Meeting of the AGA 226
`39 US Patent No. 5,954,124 227
`40 A reference by Yamamoto, 1984 227
`41 Amendment C and Response to Final Office Action 256
`42 Phase 1 study that AstraZeneca conducted 267
`43 US Patent Application Publication - Plachetka 277
`44 May 22, 2006 email from Mark Sostek to Joy 312
` Cmorik
`45 November 10, 2008 email from Carol Bjorkheden 319
`
`1
`
`2
`3
`
`4
`
`5
`6
`7
`
`8
`9
`
`10
`11
`
`12
`13
`14
`
`15
`
`16
`17
`18
`19
`20
`21
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 5 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 6
` THE VIDEOGRAPHER: This is Tape No. 1
` of the video deposition of Mark Sostek,
` taken by the defense, in the matter of
` Horizon Pharma Incorporated, et al. versus
` Dr. Reddy's Laboratories Incorporated, et
` al., in the District Court of Trenton, New
` Jersey, Case No. 3:11-02317 (JAP)(DEA) and
` 3:13-00091 (JAP)(DEA).
` This deposition is being held at 1701
` Market Street, Philadelphia, Pennsylvania
` 19103, on October 10th, 2014.
` The time on the video screen is
` 8:13 a.m.
` My name is Brian Boyd. I am a legal
` videographer from Digital Evidence Group.
` The court reporter is Anthony
` Armstrong, in association with Digital
` Evidence Group.
` Will counsel please introduce
` themselves for the record.
` MR. SHELHOFF: Dmitry Shelhoff from
` Budd Larner on behalf of Dr. Reddy's
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 6 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 7
`
` Laboratories.
` MS. GLAZER: Melody Glazer from
` Perkins Coie on behalf of the Mylan
` defendant.
` MR. RODRIGUEZ: Ricardo Rodriguez
` from Cooley LLP on behalf of Horizon.
` MS. KWON: Ashley Kwon from Covington
` & Burling on behalf of AZ.
` MR. RIPPEY: Ed Rippey, Covington &
` Burling, on behalf of AZ.
` THE VIDEOGRAPHER: Is there anyone on
` the conference call that needed to identify
` themselves?
` MS. KWON: Hi. We're ready to begin.
` So if the folks on the line could introduce
` themselves.
` MR. LOPEZ: Tony Lopez from Covington
` & Burling.
` MR. MADDOX: Steve Maddox from Knobbe
` Martens.
` THE VIDEOGRAPHER: And will the court
` reporter please swear in the witness.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 7 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 8
`D R. M A R K S O S T E K, a witness, having first been
` duly sworn, testified as follows:
`DIRECT EXAMINATION
`BY MR. SHELHOFF:
` Q. Good morning, Dr. Sostek. I'm Dmitry
` Shelhoff. I'll be taking your deposition.
` MR. SHELHOFF: Let's mark Exhibit
` No. 1, Mark Sostek LinkedIn profile.
` (Whereupon, Exhibit No. 1 was
` marked for identification.)
` ************
`BY MR. SHELHOFF:
` Q. So, Dr. Sostek, in front of you is
` your LinkedIn profile.
` Is that something that's been prepared
` by you?
` A. Yes.
` Q. And does it accurately reflect your
` background and professional experience?
` A. Yes.
` Q. Are there any updates that need to be
` made here, or it's accurate?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 8 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 9
`
` A. It's accurate.
` Q. So how many years in total have you
` worked for AstraZeneca?
` A. I'm starting my 14th year.
` Q. And what's your area of expertise at
` AstraZeneca?
` MR. RIPPEY: Objection to the form.
`BY MR. SHELHOFF:
` Q. What do you do at AstraZeneca?
` A. I am in clinical research.
` Q. And you were in clinical research
` when you started?
` A. That's correct.
` Q. And you continue to be in clinical
` research?
` A. That's correct.
` Q. Were you involved in
` Omeprazole-Prilosec development?
` A. No.
` Q. Were you involved in
` Esomeprazole-Nexium development?
` MR. RIPPEY: Objection to the form.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 9 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 10
` A. Do you mean prior to its approval in
` the United States?
` Q. Yes.
` A. No.
` Q. Were you involved in
` Esomeprazole-Nexium development after its
` approval in the United States?
` A. Yes.
` Q. What is known as post-approval
` status?
` A. Yes. And other indications of their
` formulations.
` Q. Did you have any involvement with
` different formulations of esomeprazole?
` A. Yes.
` Q. Have you ever seen the patents at
` issue in this case, the '907 patent and the '285
` patent?
` MR. RIPPEY: Objection to the form.
`BY MR. SHELHOFF:
` Q. Have you seen the '907 patent?
` A. I do not know the patents by their
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 10 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 11
`
` number.
` Q. Okay. Have you seen Pozen's patent?
` MR. RIPPEY: Objection to the form.
` A. I would have to see the specific
` patents you are talking about to answer the
` question.
` Q. Were you involved in European
` proceedings on the Vimovo patents?
` MR. RIPPEY: Objection to form.
` Vague and ambiguous.
` A. Yes. I'm not sure exactly what you
` mean by involved.
` Q. Okay.
` MR. SHELHOFF: So marking Exhibit 2,
` e-mail from Lori Kreamer to multiple people
` at Pozen.
` (Whereupon, Exhibit No. 2 was
` marked for identification.)
` ************
`BY MR. SHELHOFF:
` Q. Dr. Sostek, I think your microphone
` might have fallen off a little bit. You might
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 11 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 12
`
` want to adjust it.
` THE WITNESS: Can you hear me now
` okay?
` THE VIDEOGRAPHER: Yes.
` THE WITNESS: Okay. Thank you.
`BY MR. SHELHOFF:
` Q. So if you look at the bottom of this
` document, I think it's congratulatory e-mail. It
` mentions your name thanking you for support in
` crafting the winning arguments in European
` proceedings. It also says patent team.
` Does this refresh your recollection?
` A. Yes.
` Q. So now that it does, were you
` involved in the Vimovo patent in Europe?
` A. I probably worked with the patent
` attorney Jackie -- Jackie Cohen to help prepare
` for the proceedings that were held in Europe,
` although I did not personally attend those
` proceedings.
` Q. Jackie Cohen is AstraZeneca's inhouse
` attorney -- patent attorney?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 12 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 13
` A. I don't believe she -- she works at
` AstraZeneca now. She was at the time.
` Q. But in-house at AstraZeneca?
` A. Yes.
` Q. Here in the United States?
` A. Yes.
` Q. How would you define a person of
` ordinary skill in the art in this case?
` MR. RIPPEY: Objection to form. It
` calls for a legal conclusion.
`BY MR. SHELHOFF:
` Q. Okay. Do you consider yourself to be
` a person of ordinary skill in the art?
` MR. RIPPEY: Same objection. Calls
` for a legal conclusion.
` MR. SHELHOFF: I'll rephrase.
`BY MR. SHELHOFF:
` Q. Do you understand what I mean when I
` say or make a reference to person of ordinary
` skill in the art?
` A. I'm sorry. I'm having a problem sort
` of understanding your sort of articulation.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 13 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 14
` Could you speak a little slower? I didn't catch
` some of the words.
` Q. Do you understand when I make
` reference to a person of ordinary skill in the
` art?
` MR. RIPPEY: Same objection.
` A. I do not understand that from a legal
` perspective, no.
`BY MR. SHELHOFF:
` Q. Well, what about your colleagues;
` what kind of people are involved in your work?
` What kind of degrees do they have?
` MR. RIPPEY: Objection to form.
` Calls for speculation.
`BY MR. SHELHOFF:
` Q. What degree do you have?
` A. A bachelor of arts and a medical
` degree.
` Q. And also do you have Ph.D.'s which
` work with you?
` A. Yes.
` Q. So when did you first hear about
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 14 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 15
`
` Pozen Inc.?
` A. My recollection is sometime in 2006.
` Q. And how did you hear about Pozen
` in 2006?
` A. I believe that someone within the
` organization came to me and told me that
` AstraZeneca had had some preliminary discussions
` with the company Pozen about an inlicensing
` opportunity for a product that Pozen was -- or a
` formulation that they were developing.
` Q. And what do you mean when you say
` "inlicensing opportunity"?
` A. When -- when another company outside
` of AstraZeneca is working on a drug or a
` formulation, it's an opportunity to work with
` that company to form a partnership to jointly
` develop a drug to bring it to market.
` Q. In your experience prior to this
` Pozen inlicensing opportunity and after, did you
` have any other situations where inlicensing
` opportunities arose?
` A. Yes.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 15 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 16
` Q. So the fact that Pozen approached
` AstraZeneca with this --
` THE REPORTER: I'm sorry. I didn't
` catch that, sir.
`BY MR. SHELHOFF:
` Q. The fact that Pozen approached Astra
` was not in your mind unusual?
` MR. RIPPEY: Objection to the form.
` Q. You may answer.
` A. I do not know if Pozen approached
` AstraZeneca or if AstraZeneca approached Pozen.
` Q. So when you were told about this
` inlicensing opportunity, what did you do?
` A. Well, I was asked if I would be
` willing to get involved with it and take a trip
` down to Chapel Hill and participate in what's
` called due diligence as the clinical
` representative for AstraZeneca to assess the
` product.
` Q. And Chapel Hill, that's in North
` Carolina? That's where Pozen's headquarters are
` located?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 16 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 17
`
` A. Yes.
` Q. Were you asked at the time to review
` any patents that Pozen's people were inventors
` on?
` A. No.
` Q. And when you went to Pozen's
` headquarters, did they show you any of Pozen's
` patents?
` A. Not me, no.
` Q. Did they show it to any members of
` your team?
` A. I don't know that. I do not know.
` Q. Do you -- do you recall whom did you
` travel with?
` A. It's eight years ago. I remember
` some of the -- some of them. And there were
` two -- two trips, but I can't remember all.
` Q. Do you recall how many people went on
` the first trip?
` A. The first trip I believe it was
` myself and someone named Dave Magner, and there
` may have been one other person. But I think it
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 17 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 18
`
` was just Dave Magner and myself.
` And then the second trip was a larger
` group. And I -- it was probably -- I can't recall
` everyone in that group.
` Q. Does Dave Magner still works at
` AstraZeneca?
` A. No.
` Q. Do you recall when he left?
` A. Not the date or the year. It was
` quite a while ago.
` Q. What was his -- what was his title
` and responsibility in 2006?
` MR. RIPPEY: Objection to the form.
` A. I don't remember what his title was.
` He was in the gastrointestinal therapeutic area.
` And he was a project leader.
` Q. Was he a medical doctor?
` A. No.
` Q. Was he a Ph.D.?
` A. I'm not sure. His area of expertise
` was as a statistician.
` Q. Was he a biostatistician?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 18 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 19
` A. He was. That was his training.
` Q. Who chose him to go with you on that
` first trip?
` A. I do not --
` MR. RIPPEY: Objection to the form.
` THE WITNESS: Sorry.
` MR. RIPPEY: Go ahead.
`BY MR. SHELHOFF:
` Q. Did you suggest him to go?
` A. No.
` Q. And during the second trip when you
` had a larger group, do you recall how many people
` were in that group?
` A. I'm going to say between probably six
` and nine.
` Q. And just speaking about the type of
` people who went, can you just characterize like
` the groups of, you know, business people,
` management? That sort of thing.
` MR. RIPPEY: Objection to the form.
` A. Sure. It was a cross-functional
` group. There was a rheumatologist; there would
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 19 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 20
` have been someone from manufacturing or what
` we -- what manufacturing; there would have been a
` statistician; I believe there was someone expert
` in patents, perhaps a patent attorney; there
` would -- was a clinical pharmacologist.
` Those are the ones that I specifically
` recall. There may have been others.
` Q. Was there a formulation expert among
` those?
` A. Yes. Actually, I believe somebody
` named Tommy Anderson was also at that meeting.
` MR. RIPPEY: I want to object to the
` form of the question.
`BY MR. SHELHOFF:
` Q. Tommy Anderson, was he at the time at
` AstraZeneca's US headquarters?
` A. No.
` Q. Did he come from Sweden?
` A. Yes.
` Q. This cross-functional team, did it
` contain people both from the US and from Sweden?
` A. Yes.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 20 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 21
` Q. Was there anybody else besides Tony
` Anderson from Sweden who was there?
` A. I can't recall.
` Q. And you mentioned -- you mentioned
` the statistician which went along.
` Was that again Dave Magner?
` A. No. I believe it was someone named
` Clara Hwang. H-W-A-N-G.
` Q. You also mentioned the patent expert
` or attorney.
` Do you recall his name?
` MR. RIPPEY: Same objection to form.
` A. I don't recall if it was a man or a
` woman, and I can't remember his or her name.
`BY MR. SHELHOFF:
` Q. And you also mentioned clinical
` pharmacology person.
` Do you recall who that was?
` A. I'm sorry, I can't remember the name.
` Q. With respect to the clinical type of
` person, were you the only one who would fit that
` profile who went there?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 21 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 22
` A. No. There was myself and there was
` some -- I was providing gastroenterology and sort
` of acid -- acid suppression expertise. There was
` another physician whose name was Richard Leff,
` L-E-F-F. He was a rheumatologist who worked at
` AstraZeneca.
` Q. So you went there as a
` gastroenterologist?
` A. I went there as someone with
` experience and -- experience and knowledge about
` esomeprazole and about gastric ulcers and about
` the protection against NSAID-induced ulcers.
` Q. By NSAID, you mean non-steroidal
` inflammatory drugs?
` A. Non-steroidal inflammatory drugs,
` yes.
` Q. So you say you were an expert with
` respect to esomeprazole.
` Why don't you mention omeprazole?
` A. Well, I had direct experience working
` on esomeprazole. I believe that I did and still
` do have a very good knowledge base about
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 22 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 23
` omeprazole, but my experience at the company was
` more with esomeprazole.
` Q. And esomeprazole is capital S- an
` antimer of omeprazole, correct?
` THE REPORTER: I'm sorry, sir?
`BY MR. SHELHOFF:
` Q. Esomeprazole is capital S- an anti
` mir of Omeprazole?
` A. I don't think it's capital. It's
` a -- it's a small case S. An anti mer of
` omeprazole, yeah.
` Q. Prior to 2006, was AstraZeneca
` working on any combination formulations between
` an NSAID and omeprazole or esomeprazole?
` MR. RIPPEY: Objection to form.
` A. To the best of my knowledge, I don't
` think they were working on combination forms.
`BY MR. SHELHOFF:
` Q. Did AstraZeneca have any patents
` prior to 2001 with respect to combination
` formulations containing a proton pump inhibitor
` and an NSAID?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 23 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 24
` MR. RIPPEY: Objection to the form.
` A. I don't know.
` (Whereupon, Exhibit No. 3 was
` marked for identification.)
` ************
` MR. SHELHOFF: Marking as Exhibit 3.
`BY MR. SHELHOFF:
` Q. An e-mail from Larsson Birgitta to
` Peter Wallach and other people, dated
` September 14th, 2005, AZV00389162 to
` AZV00389163.
` MR. RIPPEY: Could I please have a
` copy of that?
` MS. GLAZER: Do you have one more?
`BY MR. SHELHOFF:
` Q. Do you know who Larsson Birgitta is?
` A. Yes.
` Q. Who is she?
` A. I believe she's a patent attorney who
` was located in Sweden and worked for AstraZeneca.
` She was a senior patent attorney for AstraZeneca
` out of Sweden.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 24 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 25
` Q. Was she -- was she the one who went
` with you on that second trip to Pozen?
` A. I don't believe so.
` Q. So as you can see in this e-mail,
` they mention a couple of AstraZeneca's patent.
` One is US Patent 6365184, and the other one is US
` Patent No. 6613354.
` I'm going to show you those patents.
` (Whereupon, Exhibit No. 4 was
` marked for identification.)
` ************
` MR. SHELHOFF: Marking as Exhibit 4
` US Patent No. 6,365,184.
`BY MR. SHELHOFF:
` Q. Have you ever seen this patent?
` A. No.
` Q. Do you know who Helen Depui is?
` A. No.
` Q. Do you know who Per Lundberg is?
` A. Yes.
` Q. Who is he?
` A. He's a scientist who had worked on
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2014
`
`202-232-0646
`
`Page 25 of 337
`
`Patent Owner Ex. 2031
`Mylan v. Pozen
`IPR2017-01995
`
`

`

`10/10/2014
`
`Horizon Pharma, Inc., et al. v. Dr. Reddy's Laboratories Inc., et al.
`Highly Confidential
`
`Dr. Mark Sostek
`
`Page 26
` omeprazole for a long time in Sweden, and he was
` a clinical resea