`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
`
`AMNEAL PHARMACEUTICALS LLC
`and
`AMNEAL PHARMACEUTICALS OF NEW YORK, LLC,
`Petitioners,
`V.
`INC.
`ALLERGAN,
`Patent Owner
`
`Case: IPR2018-00608
`U.S. Patent No. 9,161,926
`
`NORRIS MCLAUGHLIN, P.A.
`400 CROSSING BOULEVARD - 8TH FLOOR
`BRIDGEWATER, NEW JERSEY
`08807
`NOVEMBER 20, 2018
`10:03 A.M.
`
`ORAL DEPOSITION OF
`BOZENA B. MICHNIAK-KOHN, PH.D., FAAPS, M.R.PHARM.S.
`
`REPORTED BY:
`DEBRA SAPIO LYONS, RDR, CRR, CRC, CCR, CLR, CPE
`
`DIGITAL EVIDENCE GROUP
`1730 M Street, NW, Suite 812
`Washington, D.C. 20036
`(202) 232-0646
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`1 of 241
`
`Almirall EXHIBIT 2053
`Amneal v. Almirall
`IPR2018-00608
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 2
`
`1
`
`2
`
`November 20, 2018
`
`Oral deposition of Bozena B.
`
`3 Michniak-Kohn, Ph.D., FAAPS, M.R.Pharm.S.,
`
`4
`
`5
`
`6
`
`7
`
`held at the offices of Norris McLaughlin,
`
`P.A., 400 Crossing Boulevard - 8th Floor,
`
`Bridgewater, New Jersey 08807, before Debra
`
`Sapio Lyons, a Registered Diplomat Reporter, a
`
`s Certified Realtime Reporter, a Certified
`
`Realtime Captioner, a Certified LiveNote
`
`Reporter, an Approved Reporter of the United
`
`States District Court for the Eastern District
`
`of Pennsylvania, a Certified Court Reporter of
`
`the State of New Jersey, a Notary Public of
`
`the States of New Jersey, New York and the
`
`Commonwealth of Pennsylvania.
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`2 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 3
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`APPEARANCES:
`
`STERNE KESSLER GOLDSTEIN FOX
`
`BY:
`
`ADAM C. LAROCK, ESQUIRE
`
`DENNIES VARUGHESE, PHARM.D,
`
`ESQUIRE
`
`1100 New York Ave. N.W., Suite 600
`
`Washington, D.C. 20005
`
`202.772.8794
`
`202.772.8805
`
`alarock@sternekessler.com
`
`dvarughe@sternekessler.com
`
`Attorneys for Petitioners
`
`FENWICK & WEST LLP
`
`BY:
`
`ELIZABETH B. HAGAN, PH.D., ESQUIRE
`
`1191 Second Avenue, 10th Floor
`
`Washington, D.C. 98101
`
`206.389.4587
`
`ehagan@fenwick.com
`
`Attorneys for Patent Owner
`
`ALSO PRESENT:
`
`LARS TAAVOLA, ESQUIRE
`
`Senior Patent Counsel, Global Intellectual
`
`Property
`
`Amneal Pharmaceuticals
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`3 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 4
`
`1
`
`2 WITNESS
`
`I N D E X
`
`PAGE
`
`9
`
`PAGE
`
`8
`
`Bozena B. Michniak-Kohn, Ph.D., FAAPS,
`
`M.R.Pharm.S.
`
`EXAMINATION
`
`BY MS. HAGAN
`
`E X H I B I T S
`
`NUMBER
`
`DESCRIPTION
`
`Exhibit Michniak-Kohn 1, Declaration
`
`of Bozena B. Michniak-Kohn Ph.D.
`
`FAAPS, M.R.Pharm.S. bearing Bates
`
`Numbers AMN1002
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`Exhibit Michniak-Kohn 2, Curriculum
`
`8
`
`Vitae B. Michniak-Kohn January 2018
`
`bearing Bates Numbers AMN1003,
`
`Exhibit Michniak-Kohn 3, United
`
`30
`
`States Patent Number 9,161,926 B2,
`
`bearing Bates Numbers AMN1001
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`4 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`EXHIBITS (Continued)
`
`NUMBER
`
`DESCRIPTION
`
`Exhibit Michniak-Kohn 4,
`
`PAGE
`
`41
`
`Page 5
`
`International Publication Number
`
`WO 2009/061298 Al bearing Bates
`
`Numbers AMN1004
`
`Exhibit Michniak-Kohn 5, Pub. Number
`
`44
`
`U.S. 2006/0204526 Al, United States
`
`Patent Application Publication,
`
`Lathrop, et al., bearing Bates
`
`Numbers AMN1006
`
`Exhibit Michniak-Kohn 6, document
`
`56
`
`titled Diethylene glycol monoethyl
`
`ether:
`
`an emerging solvent in
`
`topical dermatology products by
`
`David W. Osborne, Ph.D., bearing
`
`Bates Numbers AMN1009
`
`Exhibit Michniak-Kohn 7,
`
`84
`
`International Publication Number
`
`WO 2010/072958 A2 bearing Bates
`
`Numbers AMN1005
`
`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 2018
`
`202-232-0646
`
`5 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`EXHIBITS (Continued)
`
`NUMBER
`
`DESCRIPTION
`
`Exhibit Michniak-Kohn 8,
`
`PAGE
`
`189
`
`Page 6
`
`United States Patent Application
`
`Publication Guo, et al., Publication
`
`Number U.S. 2007/0190019 Al bearing
`
`Bates Numbers AMN1013
`
`Exhibit Michniak-Kohn 9, multipage
`
`194
`
`article entitled Characterization and
`
`Stability of Emulsion Gels Based on
`
`Acrylamide/Sodium Acryloyldimethyl
`
`Taurate Copolymer by Giuila
`
`Bonacucina, et al., bearing Bates
`
`Numbers AMN1015,
`
`Exhibit Michniak-Kohn 10, multipage
`
`208
`
`Pharmaceutical Bulletin entitled
`
`Lubrizol Pharmaceutical Bulletin 21
`
`bearing Bates Numbers AMN1021
`
`Exhibit Michniak-Kohn 11, document
`
`218
`
`titled Seppic SepineoTM P 600. The
`
`3-in-1 polymer for pharmacy bearing
`
`Bates Numbers AMN1026
`
`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 2018
`
`202-232-0646
`
`6 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 7
`
`EXHIBITS (Continued)
`
`NUMBER
`
`DESCRIPTION
`
`Exhibit Michniak-Kohn 12,
`
`PAGE
`
`223
`
`United States Patent, Orsoni, et al.,
`
`Patent Number U.S. 7,820,186 B2
`
`bearing Bates Numbers AMN1011
`
`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 2018
`
`202-232-0646
`
`7 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 8
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`(Exhibit Michniak-Kohn 1,
`
`Declaration of Bozena B. Michniak-Kohn
`
`Ph.D. FAAPS, M.R.Pharm.S. bearing Bates
`
`Numbers AMN1002, is marked for
`
`identification.)
`
`(Exhibit Michniak-Kohn 2,
`
`Curriculum Vitae B. Michniak-Kohn
`
`January 2018 bearing Bates Numbers
`
`AMN1003, is marked for identification.)
`
`BOZENA B. MICHNIAK-KOHN, PH.D.,
`
`FAAPS, M.R.PHARM.S., having been first
`
`duly sworn, was examined and testified
`
`as follows:
`
`MS. HAGAN: Good morning.
`
`I'm
`
`Elizabeth Hagan for Fenwick -- of
`
`Fenwick & West for parent owner
`
`Almirall, LLC.
`
`MR. LaROCK:
`
`I'm Adam LaRock from
`
`Sterne, Kessler law firm for
`
`Petitioners. With me is also Dennies
`
`Varughese from Sterne, Kessler and
`
`Lars Taavola from Amneal.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`8 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 9
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`s
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`EXAMINATION
`
`BY MS. HAGAN:
`
`Q.
`
`A.
`
`Q.
`
`Good morning.
`
`Good morning.
`
`Thank you for coming.
`
`I
`
`understand that you have some issues regarding
`
`sitting and standing, so we'll work out as
`
`best we can and try to keep you comfortable
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Thank you.
`
`-- throughout the process.
`
`I appreciate it.
`
`Absolutely.
`
`Can you, please, state your full
`
`name?
`
`A.
`
`Bozena, B middle initial,
`
`17 Michniak-Kohn.
`
`18
`
`19
`
`20
`
`21
`
`22
`
`Q.
`
`A.
`
`And where do you live?
`
`25 Riverview Avenue in
`
`Piscataway, New Jersey 08854.
`
`Q.
`
`A.
`
`How are you employed?
`
`I am employed by Rutgers
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`9 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`1 University full time.
`
`I'm a full professor
`
`Page 10
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`there with tenure in the Ernest Mario School
`
`of Pharmacy on Busch Campus.
`
`Q.
`
`And what is the address of the
`
`office where you work?
`
`A.
`
`145 Bevier -- that's
`
`B-E-V-I-E-R -- Road, Piscataway, New Jersey
`
`08854.
`
`Q.
`
`Have you ever testified in any
`
`type of a proceeding?
`
`A.
`
`Q.
`
`Yes,
`
`I have.
`
`Have you had your deposition
`
`taken before?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Many times
`
`All right.
`
`yes.
`
`So you're quite familiar with
`
`this process then, but just to get this out of
`
`the way, I'm going to be asking you questions
`
`and hopefully getting answers from you. Our
`
`questions -- my questions and your answers
`
`22 will be transcribed by the court reporter.
`
`I
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`10 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`1 will try not to speak when you are speaking;
`
`Page 11
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`and I ask that you also try not to speak when
`
`I am speaking. All right?
`
`A.
`
`Q.
`
`Understood.
`
`Great.
`
`Did you do anything to prepare
`
`for the deposition today?
`
`A.
`
`Yes,
`
`I did. And before I answer
`
`that totally, I have some corrections as well
`
`that -- that were picked up.
`
`Q.
`
`A.
`
`Okay.
`
`In my first report, Paragraph 61
`
`on Page 33 and Paragraph 90 on Page 56 there
`
`is a reference missing.
`
`Q.
`
`I'm sorry. When you say your
`
`"first report," are you referring to the
`
`declaration you submitted on behalf of Amneal
`
`in this IPR?
`
`A.
`
`Yes, because I submitted two
`
`declarations, so it's the first declaration.
`
`Q.
`
`You submitted -- what is your
`
`second declaration?
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`11 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`1
`
`A.
`
`There's a second declaration as
`
`2 well.
`
`Page 12
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`MR. LaROCK: There was a -- there
`
`was a supplemental declaration to --
`
`THE WITNESS: A supplemental.
`
`That's the correct term.
`
`MR. LaROCK:
`
`-- moot some
`
`objections that your prior counsel made.
`
`MS. HAGAN: When was that
`
`submitted?
`
`MR. LaROCK: September.
`
`MS. HAGAN:
`
`Do you know the
`
`exhibit number?
`
`MR. LaROCK: No, they aren't
`
`filed. They're just served.
`
`MS. HAGAN: And to whom were they
`
`served?
`
`MR. LaROCK: Scott Kamholz of
`
`Covington --
`
`MS. HAGAN: Okay.
`
`MR. LaROCK:
`
`-- patent owner's
`
`counsel.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`12 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 13
`
`MS. HAGAN: Right. We don't have
`
`that. Would you, please, provide that
`
`to us?
`
`MR. LaROCK: Sure. We can see
`
`what we can do.
`
`MS. HAGAN:
`
`Thank you.
`
`BY MS. HAGAN:
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`So your first report or -(cid:173)
`
`Declaration.
`
`-- declaration you said Page 33?
`
`Yes, Page 33, Paragraph 61.
`
`Hold on just a moment, please.
`
`So Page 33 I have the end of
`
`Paragraph 57 and Paragraph 58.
`
`A.
`
`So it's paragraph -- end of
`
`Paragraph 61.
`
`Q.
`
`Hold on just a minute and let me
`
`give you a copy of your declaration.
`
`A.
`
`Q.
`
`Please.
`
`So before we get started, I've
`
`handed you two documents marked as
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22 Michniak-Kohn Exhibit 1 --
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`13 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`MR. LaROCK: Do you have a copy?
`
`Page 14
`
`BY MS. HAGAN:
`
`Q.
`
`-- and Michniak-Kohn Exhibit 2.
`
`MS. HAGAN: Absolutely. And
`
`here's another one.
`
`MR. VARUGHESE: Oh, thanks.
`
`MS. HAGAN: And the stapler was
`
`not that fantastic on the second one -(cid:173)
`
`MR. LaROCK: Oh.
`
`MS. HAGAN:
`
`-- so there may be
`
`some loose pages for the CV.
`
`Could we, please, get a copy of
`
`the second declaration at break?
`
`MR. LaROCK: Yeah, we can see
`
`what we can do, but you should have
`
`gotten everything from prior counsel
`
`before coming to the deposition today.
`
`MS. HAGAN: Great. But if you
`
`can look for it, and I assume that you
`
`have a copy somewhere, can get it to us
`
`in some format, that's fine.
`
`MR. LaROCK:
`
`I don't actually
`
`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 2018
`
`202-232-0646
`
`14 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 15
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`have a copy, nor a printer here since
`
`we're not at our offices, so we'll see
`
`what we can do.
`
`MS. HAGAN: Electronic would be
`
`great. Okay.
`
`MR. LaROCK: Okay.
`
`MS. HAGAN: Thanks.
`
`THE WITNESS:
`
`So it's
`
`Paragraph 61 on Page 36.
`
`BY MS. HAGAN:
`
`Q.
`
`A.
`
`Q.
`
`A.
`
`Okay.
`
`My apologies.
`
`I said 33.
`
`All right.
`
`It's 36. And if we look at
`
`Line 1, 2, 3, 4 -- Line 5 there is a reference
`
`AMNl 010
`
`Q.
`
`A.
`
`Uh-huh.
`
`that stays, but what is
`
`19 missing there in addition is the Guo, G-U-O,
`
`20
`
`21
`
`22
`
`reference, and the Guo reference number is
`
`1013. And the same occurred on Paragraph 90.
`
`Q.
`
`I'm sorry. Do you have a pin
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`15 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 16
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`cite for that or just Guo generally?
`
`A.
`
`I just -- sorry.
`
`I just said it.
`
`It is AMN1013 is Guo.
`
`Q.
`
`Was there any particular page
`
`that you were citing to in that Guo reference
`
`for this citation?
`
`A.
`
`No, it was -- it was the
`
`reference. That refers to -- any page that
`
`refers to Sepineo in Guo.
`
`I don't remember
`
`unless I look at Guo.
`
`Q.
`
`So you don't have a specific page
`
`cite?
`
`yeah.
`
`A.
`
`I don't have a specific page,
`
`Q.
`
`Thank you.
`
`Okay. And the second one?
`
`A.
`
`Paragraph 90, and I believe that
`
`is on Page 56 or starts on Page 56, and on
`
`Page 57 we see (AMN1010, 1), to that we need
`
`to, again, add the Guo reference.
`
`Q.
`
`And, again, no specific page
`
`cite
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`16 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 17
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`A.
`
`Q.
`
`No specific.
`
`within the Guo reference?
`
`All right. Are there any other
`
`clarifications you would like to make before
`
`we get started?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`That was all.
`
`Okay.
`
`Thank you.
`
`You have a Ph.D. in pharmacology;
`
`is that correct?
`
`A.
`
`Q.
`
`Yes,
`
`I do.
`
`And you earned your Ph.D. in 1980
`
`from DeMontfort University in Leicester,
`
`England; is that correct?
`
`A.
`
`Q.
`
`That is correct.
`
`You are also a licensed member of
`
`the Royal Pharmaceutical Society of Great
`
`18 Britain; correct?
`
`19
`
`20
`
`21
`
`22
`
`A.
`
`Q.
`
`A.
`
`That is correct.
`
`What does that mean?
`
`That means that I am a registered
`
`pharmacist and able to, even currently because
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`17 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 18
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`I've kept up my license, it's the equivalent
`
`of the United States licensure of the
`
`boards -- State Board of Pharmacy that allows
`
`a pharmacy-educated person to practice the art
`
`of pharmacy.
`
`Q.
`
`So you are allowed to be a
`
`dispensing pharmacist in Great Britain
`
`according to that licensure?
`
`A.
`
`Q.
`
`That is correct.
`
`Is there anything that you need
`
`to do for maintenance of that license?
`
`A.
`
`Yes.
`
`In fact, I have to provide
`
`always the continuing education; and the fact
`
`that I publish, in fact, counts for continuing
`
`education, that I'm in the science anyway
`
`already counts.
`
`Q.
`
`And as part of your current
`
`employment at Rutgers, you are the Director of
`
`the Laboratory for Drug Delivery at New Jersey
`
`Center for Biomaterials; is that correct?
`
`A.
`
`Q.
`
`That is correct.
`
`And you've been in that position
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`18 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 19
`
`1
`
`2
`
`3
`
`from around September of 2000 to the present?
`
`A.
`
`Q.
`
`That is correct.
`
`And you are also the Founder and
`
`4 Director of the Center For Dermal Research at
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`the NJCBM; is that correct?
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Yes, that is correct
`
`And --
`
`-- at Rutgers, uh-huh.
`
`Does the NJCBM stand for the New
`
`Jersey Center for Biomaterials?
`
`A.
`
`Q.
`
`It does.
`
`What would you say is the
`
`authoritative text on current trends in
`
`research on topical pharmaceutical
`
`compositions?
`
`BY MS. HAGAN:
`
`MR. LaROCK: Objection to form.
`
`Q.
`
`A.
`
`You may answer if you have one.
`
`I think basically there are many
`
`texts from Marcel Dekker series that talks
`
`about percutaneous absorption and formulation.
`
`And there's a whole series of books that cover
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`19 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 20
`
`1
`
`2
`
`3
`
`4
`
`that topic. There are what are called kind of
`
`pharmaceutical encyclopedias that cover more,
`
`obviously, than just topical, that cover all
`
`aspects of formulation such as Remington's,
`
`5 Ansel, and Stoklosa that we use to teach
`
`6
`
`7
`
`s
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`students from, and many, many others.
`
`And, of course, there's a lot of
`
`publications because formulation is a science
`
`and an art, so people try things that may be
`
`not in the books and then publish.
`
`So that
`
`all gathered, there -- there's a lot of
`
`information out and available.
`
`Q.
`
`So if I was a formulator and
`
`trying to keep up with the current trends in
`
`research, are there any particular journals
`
`that you would point me to?
`
`MR. LaROCK: Objection to form.
`
`THE WITNESS: Well, formulation
`
`can come up in many types of journals
`
`from many disciplines --
`
`BY MS. HAGAN:
`
`Q.
`
`Let's --
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`20 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 21
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`A.
`
`Q.
`
`so --
`
`stick to topical
`
`pharmaceutical compositions.
`
`A.
`
`Q.
`
`A.
`
`Indeed, that would still apply.
`
`Great.
`
`Because I'm thinking there are
`
`what are known as material science journals as
`
`s well as pharmaceutical journals that --
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`polymer journals that cover different -- you
`
`know, wide aspects and aren't necessarily just
`
`pharmaceutical journals by definition that can
`
`cover formulation aspects. You know, somebody
`
`may have discovered a new polymer that has
`
`topical applications, and that may appear in
`
`what would be known in colloquial terms in a
`
`polymer journal.
`
`So there are many, in other
`
`words.
`
`Q.
`
`I've handed you a document marked
`
`as Exhibit 1 titled, "Declaration of Bozena B.
`
`20 Michniak-Kohn, Ph.D., FAAPS, M.R.Pharm.S" and
`
`21
`
`22
`
`bearing the label AMN1002 in the lower right
`
`corner of the first page.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`21 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 22
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`Do you recognize this document?
`
`A.
`
`Q.
`
`Yes,
`
`I do.
`
`Is it the first declaration you
`
`submitted on behalf of Amneal in this matter?
`
`A.
`
`Q.
`
`Yes, it is.
`
`And is it the document to which
`
`you were giving corrections earlier?
`
`A.
`
`Q.
`
`That is correct.
`
`I've also handed you a document
`
`that's been marked as Exhibit 2 with the words
`
`"Curriculum Vitae" and "Name: Bozena
`
`'Bo' B.
`
`Michniak-Kohn" at the top and the label
`
`AMN1003 in the lower right corner of the first
`
`page.
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`Do you recognize this document?
`
`Yes,
`
`I do.
`
`What is it?
`
`It's my CV as of January 2018.
`
`I assume that you may have a - -
`
`more recent publications than are listed in
`
`that CV; is that correct?
`
`A.
`
`That is probably correct, yes.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`22 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 23
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`Q.
`
`With that exception, are there
`
`any other changes or updates to the CV from
`
`January 2018 to now?
`
`A.
`
`Well, there's probably more
`
`abstracts, posters, presentations during the
`
`year, perhaps some organizational awards or
`
`updates, funding updates probably because
`
`s we're nearly at the end of -- of the year, so
`
`9
`
`those sections probably need updating. You
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`know, postdoctoral experiences, appointments
`
`are probably the same.
`
`Q.
`
`So the
`
`your current
`
`appointments are the same as here?
`
`A.
`
`Q.
`
`Yes, they are.
`
`Okay. On Page 3 of your CV you
`
`list "Research Interests and Experience."
`
`Do you see that?
`
`Yes.
`
`And you include, "Optimization of
`
`A.
`
`Q.
`
`topical, transdermal and transmucosal drug
`
`delivery"; is that correct?
`
`A.
`
`That is correct.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`23 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 24
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`s
`
`9
`
`10
`
`11
`
`Q.
`
`What do you mean here by
`
`"optimization"?
`
`A.
`
`I use that word to kind of cover
`
`the broad scope of the type of work that we
`
`do. That may span from starting with a new
`
`drug that may not have been applied
`
`topically -- for example, or act
`
`another
`
`active -- when I say "active," a
`
`non-pharmaceutical, for example vitamins or
`
`other sometimes personal care or even cosmetic
`
`agents in some cases -- through to coming up
`
`12 with the formulation, the testing of
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`formulations to answer questions like:
`
`"Is
`
`the active going into the skin and where it's
`
`going into the skin?"
`
`We also, you know, optimize a
`
`particular formulation in the sense that we
`
`start with one version and then look at other
`
`ingredients, other excipients, the influence
`
`of what we're doing.
`
`I mean, I'm talking very
`
`generally. Obviously it's project specific.
`
`But I tried to use language that was broad
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`24 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 25
`
`1
`
`2
`
`3
`
`enough to cover the types of things we do.
`
`Q.
`
`Understood. And if we turn to
`
`your declaration, Exhibit -- what's been
`
`4 marked as Exhibit 1, and looking at
`
`5
`
`6
`
`7
`
`s
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`Paragraph 6 of your declaration, which begins
`
`on page -- is on Page 4, your declaration
`
`states that you are "an expert in the field of
`
`topical pharmaceutical compositions and
`
`transdermal drug delivery systems"; is that
`
`correct?
`
`A.
`
`Q.
`
`That is correct.
`
`And what do you mean here by "the
`
`field of topical pharmaceutical compositions"?
`
`A.
`
`Pharmaceutical compositions of
`
`various excipients and also actives that are
`
`applied to the skin with the intention of
`
`either delivering to the skin or across the
`
`skin for transdermal drug delivery systems.
`
`And I've spent 40 years now looking and
`
`researching in that area.
`
`Q.
`
`And when you say here
`
`"pharmaceutical," what does that mean,
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`25 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`particularly in this instance?
`
`Page 26
`
`MR. LaROCK: Objection to form.
`
`THE WITNESS: We look at, as I
`
`already kind of alluded to in -- a few
`
`minutes ago, that we look at drugs,
`
`either pharmaceutical, over-the-counter
`
`or new -- new compounds, that are
`
`intended ultimately for patient use.
`
`And I also look at what I would
`
`classify as personal care actives. And
`
`occasionally, this is not the main focus
`
`of what we do, some cosmetic actives.
`
`In other words, non-pharmaceutical or at
`
`concentrations that are
`
`non-pharmaceuticals.
`
`BY MS. HAGAN:
`
`Q.
`
`You, when you just gave that
`
`answer, you listed both pharmaceutical and
`
`over-the-counter.
`
`Do those have different meanings
`
`or is over-the-counter a subset of
`
`pharmaceutical?
`
`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 2018
`
`202-232-0646
`
`26 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 27
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`s
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`A.
`
`That would be a sub --
`
`pharmaceutical would cover both, so
`
`prescription and non-prescription,
`
`over-the-counter pharmaceutical. Things that
`
`are approved by the FDA for patient use.
`
`Q.
`
`Thank you.
`
`The same paragraph says that you
`
`have, and you just alluded to, a lot of
`
`experience, 37 to 40 years of experience of
`
`designing and testing novel formulations for
`
`topical and transdermal drug delivery systems;
`
`correct?
`
`A.
`
`Q.
`
`Correct.
`
`Have you ever designed any
`
`topical pharmaceutical formulations that were
`
`improvements upon an existing FDA-approved
`
`topical pharmaceutical formulation?
`
`A.
`
`Q.
`
`Yes,
`
`I have.
`
`When you have done that, is there
`
`any particular place where you start when you
`
`formulate or design a formulation that's an
`
`improvement upon an FDA-approved formulation?
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`27 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 28
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`s
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`A.
`
`It de --
`
`MR. LaROCK: Objection to form.
`
`THE WITNESS:
`
`It depends very
`
`much on the project and what the -- what
`
`the objective is and what the drug is.
`
`BY MS. HAGAN
`
`Q.
`
`If your goal was improved
`
`efficacy with the same active agent or active
`
`ingredient, would that affect where you start?
`
`MR. LaROCK: Objection to form.
`
`THE WITNESS: Again, it would
`
`depend on what drug this is, what the
`
`previous dosage form is, and what the
`
`objective of the changed formulation is.
`
`BY MS. HAGAN:
`
`Q.
`
`Would you consider the previous
`
`FDA-approved formulation when developing an
`
`improved formulation?
`
`MR. LaROCK: Objection to form.
`
`THE WITNESS: Again, it would
`
`depend on what the study entails and
`
`what you mean by consideration.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`28 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 29
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`s
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`I mean, would I know about it?
`
`I -- I would, but how -- how useful is
`
`that information would be, again, it
`
`would depend on the case.
`
`BY MS. HAGAN:
`
`Q.
`
`In Paragraph 13 you include a
`
`table of documents. And the statement at the
`
`top of that table says, "In formulating my
`
`opinion, I have considered all documents cited
`
`herein, including the following."
`
`Is this table a complete list of
`
`documents that you considered in formulating
`
`the opinion expressed in this declaration?
`
`A.
`
`Q.
`
`Yes, of the exhibits, yes, it is.
`
`Is there anything outside of
`
`those exhibits that you considered in
`
`formulating the opinion expressed in this
`
`declaration?
`
`A.
`
`Apart from my own knowledge and
`
`skill, no.
`
`Q.
`
`And if you go back to Page 3
`
`I'm sorry, Paragraph 3 which is on Page 3, you
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`29 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 30
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`state that, "In preparing this declaration, I
`
`have reviewed the '926 Patent" -- and that's
`
`AMN1001 -- "and considered each of the
`
`documents cited therein."
`
`MS. HAGAN: And, actually, to
`
`make things easier, I'm going to ask
`
`that an exhibit be marked here.
`
`(Exhibit Michniak-Kohn 3, United
`
`States Patent Number 9,161,926 B2,
`
`bearing Bates Numbers AMN1001, is marked
`
`for identification.)
`
`BY MS. HAGAN:
`
`Q.
`
`So you've been handed an exhibit
`
`14 marked Exhibit 3, and at the top it says,
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`"United States Patent Warner et al. Patent
`
`Number U.S. 9,161,926 B2. And at the bottom
`
`right corner its says AMN1001.
`
`Do you recognize this document?
`
`Yes,
`
`I do.
`
`Is this the '926 Patent that you
`
`A.
`
`Q.
`
`are referring to in your declaration?
`
`A.
`
`Yes, this is that patent.
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`30 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Q.
`
`Okay. Thank you.
`
`So going back to Paragraph 3 of
`
`Page 31
`
`your declaration, it says you reviewed the
`
`'926 Patent and considered each of the
`
`documents cited therein; correct?
`
`A.
`
`Q.
`
`That is correct.
`
`What documents cited in the
`
`'926 Patent did you consider?
`
`A.
`
`(Reviewing document.)
`
`So we have the -- on the patent,
`
`56 the References Cited, for example, the
`
`Osborne, Patent Number 5,863,560 is the
`
`equivalent on my Page 7 of the declaration
`
`document or Exhibit Number 1016, which we're
`
`calling the Osborne II reference.
`
`We then see in Column 2, Lathrop
`
`et al., 2006/0204526 Al, and that is my
`
`Exhibit Number 1007, and it's called in
`
`in
`
`quotes "Lathrop" reference on my Page 7 of the
`
`declaration.
`
`Q.
`
`Did you consider the other --
`
`MR. LaROCK:
`
`She wasn't done,
`
`I
`
`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 2018
`
`202-232-0646
`
`31 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Page 32
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`don't think.
`
`THE WITNESS: No, because I'm -(cid:173)
`
`I'm looking at Morris, and I know I had
`
`a Morris reference, but I don't recall
`
`the patent number.
`
`Morris, here you are.
`
`'781, yes.
`
`So Column 2 of the '926 Patent refers to
`
`2010/0029781 Al by Morris. And Morris
`
`is in my exhibits Number 1008 called and
`
`referred to as the Morris reference.
`
`There may be others, but those
`
`are the ones I recognize right now.
`
`BY MS. HAGAN:
`
`Q.
`
`Okay. Do you recall whether you
`
`considered the other two Osborne patents
`
`listed on Page 1 of Exhibit 3? That would be
`
`Patent 6,060,085 or Patent 6,620,435.
`
`MR. LaROCK: Objection to form.
`
`THE WITNESS: They are not listed
`
`in my exhibits that I considered, I
`
`don't think.
`
`BY MS. HAGAN:
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence Group C'rt 2018
`
`202-232-0646
`
`32 of 241
`
`
`
`11/20/2018
`
`Amneal, et al. v. Allergan, Inc.
`
`Bozena B. Michniak-Kohn
`
`Q.
`
`I agree they're not listed there.
`
`But do you recall whether you
`
`Page 33
`
`considered them?
`
`MR. LaROCK: Objection to form.
`
`THE WITNESS:
`
`I don't think so.
`
`BY MS. HAGAN:
`
`Q.
`
`Thank you.
`
`Okay. Turning to Paragraph 17 of
`
`your declaration, you state, "In my opinion a
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`POSA" -- P-O-S-A -- "would work as part of a
`
`11 multi-disciplinary team."
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`And you -- POSA here, I believe,
`
`refers to person of ordinary skill in the art;
`
`is that correct?
`
`A.
`
`Q.
`
`correctly?
`
`A.
`
`Q.
`
`That is correct.
`
`Did I read that statement
`
`You did.
`
`Why in your opinion would a POSA
`
`work as part of a multi-disciplinary team?
`
`A.
`
`Because in Paragraph 18 if we
`
`look at the definition of a hypothetical POSA
`
`www.DigitalEvidenceGroup.com
`
`Digital Evidence G