`
` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` MYLAN PHARMACEUTICALS, INC., )
` )
` Petitioner, )
` )
` vs. ) No. IPR2016-00710
` )
` GENENTECH, INC., and CITY OF )
` HOPE, )
` )
` Patent Owners. )
`
` The deposition of JULIE DAVIS, taken
`before JO ANN LOSOYA, C.S.R., pursuant to the
`provisions to Title 37 CFR Section 42.53, at 20
`North Wacker Drive, Chicago, Illinois commencing at
`8:00 a.m. on March 7, 2017.
`
`1
`
`2
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Mylan v. Genentech
`IPR2016-00710
`Merck Ex. 1121, Pg. 1
`
`
`
`1
`2
`
`3
`
`4
`
`5
`
`6
`7
`
`8
`
`9
`
`1 0
`1 1
`1 2
`1 3
`
`1 4
`
`1 5
`
`1 6
`1 7
`
`1 8
`
`1 9
`
`2 0
`2 1
`
`2 2
`
`2 3
`2 4
`
`2 5
`
`Page 2
`
`P R E S E N T :
`
`F O R P E T I T I O N E R :
`
` R A K O C Z Y , M O L I N O , M A Z Z O C H I , S I W I K , L L P
` M R . H E I N Z J . S A L M E N
` 6 W e s t H u b b a r d S t r e e t
` C h i c a g o , I l l i n o i s 6 0 6 5 4
` ( 3 1 2 ) 2 2 2 - 7 5 0 4
` h s a l m e n @ r m m s l e g a l . c o m
` Q U I N N E M A N U E L U R Q U H A R T & S U L L I V A N L L P
` M S . A M A N D A A N T O N S
` 5 0 0 W e s t M a d i s o n S t r e e t
` S u i t e 2 4 5 0
` C h i c a g o , I l l i n o i s 6 0 6 6 1
` ( 3 1 2 ) 7 0 5 - 7 4 0 9
` a m a n d a a n t o n s @ q u i n n e m a n u e l . c o m
`
`F O R P A T E N T O W N E R :
` D U R I E T A N G R I
` M R . D A V I D M c G O W A N
` 2 1 7 L e i d e s d o r f f S t r e e t
` [ ! A D D R E S S - B 3 ]
` S a n F r a n c i s c o , C a l i f o r n i a 9 4 1 1 1
` ( 4 1 5 ) 3 6 2 - 6 6 6 6
` d m c g o w a n @ d u r i e t a n g r i . c o m
` W I L M E R H A L E
` M R . J E F F R E Y A . D E N N H A R D T
` 7 W o r l d T r a d e C e n t e r
` 2 5 0 G r e e n w i c h S t r e e t
` N e w Y o r k , N e w Y o r k 1 0 0 0 7
` ( 2 1 2 ) 2 9 5 - 6 2 9 3
` j e f f r e y . d e n n h a r d t @ w i l m e r h a l e . c o m
`
`A L S O P R E S E N T :
`
` M R . M Y L E S D . K A L U Z N A , D A V I S & H O S F I E L D
`
`R E P O R T E D B Y : J O A N N L O S O Y A
`L I C E N S E # : 0 8 4 - 0 0 2 4 3 7
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 2
`
`
`
`Page 3
`
` EXAMINATION
`
` Witness Page Line
`
` JULIE DAVIS
`
` By Mr. Salmen 4 7
`
` By Mr. McGowan 156 13
`
` ***************
`
` E X H I B I T S
`
` DESCRIPTION PAGE
`
`EXHIBIT 1082 Notice of Deposition 5
`
`EXHIBIT 1083 Petition for Inter Partes 9
`
` Review
`
`EXHIBIT 1084 Kathryn Calame PHD 36
`
` deposition
`
`EXHIBIT 1085 U.S. patent No. 4740470 103
`
`EXHIBIT 1086 U.S. patent No. 4237224 103
`
`EXHIBIT 1087 U.S. patent No. 4468464 103
`
`EXHIBIT 1088 The Story of the Cohen-Boyer 104
`
` Patents.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6 7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 3
`
`
`
`Page 4
`
` (Witness sworn at 8:01 a.m.)
`
` WHEREUPON:
`
` JULIE DAVIS,
`
` called as a witness herein, having been first duly
`
` sworn, was examined and testified as follows:
`
` E X A M I N A T I O N
`
` BY MR. SALMEN:
`
` Q. Good morning.
`
` A. Good morning.
`
` Q. This is the deposition of Ms. Julie
`
` Davis. It is being taken in the matter of the inter
`
` partes review case number IPR2016-00710 between
`
` Mylan Pharmaceuticals, Inc., and Genentech, Inc., et
`
` al.
`
` This deposition is being taken
`
` pursuant to Title 37 CFR Section 42.53 and the
`
` agreement of the parties at Ms. Davis's office, 20
`
` North Wacker Drive, Suite 215021, Chicago, Illinois,
`
` 606064.
`
` My name is Heinz Salmen. I'll be
`
` questioning the witness today on behalf of the
`
` petitioner, Mylan.
`
` I'll ask if anyone else in the room
`
` wants to identify themselves.
`
` MR. MCGOWAN: David McGowan, Durie Tangri
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 4
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 5
`
` for patent owners.
`
` MR. DENNHARDT: Jeff Dennhadt for patent
`
` owner.
`
` MR. KALUZNA: Myles Kaluzna from Davis &
`
` Hosfield.
`
` MS. ANTONS: Amanda Antons from Quinn
`
` Emanuel on behalf of Merck.
`
` MR. SALMEN: I'm going to hand you a few
`
` exhibits. This has been marked Petitioner's
`
` Exhibit 1082.
`
` (Deposition Exhibit 1082 was
`
` marked for identification.)
`
` BY MR. SALMEN:
`
` Q. Ms. Davis, do you recognize this exhibit?
`
` A. I do.
`
` Q. It's your understanding that you're being
`
` deposed pursuant to this notice and the agreement of
`
` the parties on the IPR?
`
` A. Yes.
`
` Q. Ms. Davis, I handed you a copy of a
`
` Genentech Exhibit 2033.
`
` Do you recognize this?
`
` A. I do.
`
` Q. Could you identify it for the record
`
` please?
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`888-391-3376
`
`Merck Ex. 1121, Pg. 5
`
`
`
` A. This appears to be a copy of my
`
` declaration submitted to the IPR in this matter.
`
` Q. Ms. Davis, is there a copy of your CV in
`
`Page 6
`
` that exhibit?
`
` A. There is.
`
` Q. And it's at Exhibit 1 of Genentech
`
` Exhibit 2033?
`
` A. That's correct.
`
` Q. Ms. Davis, what is your area of
`
` expertise?
`
` A. I think of my area of expertise, as it
`
` relates to this matter anyway, the issues related to
`
` damages and other related matters for intellectual
`
` property litigation.
`
` Q. Can you be more specific when you say
`
` "related matters to intellectual property"?
`
` A. I think of this particular declaration as
`
` a related matter. The issue of the commercial
`
` success is related, in part, to damages. It's also
`
` related to the liability aspects of the case.
`
` Q. Would you include licensing in the
`
` related matters to the litigation?
`
` A. Yes.
`
` Q. You are not a biologist, correct?
`
` A. I am not.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 6
`
`
`
`Page 7
`
` Q. You are not an expert in biological
`
` sciences?
`
` A. I am not.
`
` Q. You are not an expert in molecular
`
` biology?
`
` A. I am not.
`
` Q. You are not an expert in protein
`
` biochemistry?
`
` A. That's correct.
`
` Q. Not an expert in protein structure or
`
` function?
`
` A. I am not.
`
` Q. Not an expert in antibody production?
`
` A. That's correct.
`
` Q. You couldn't give me an industry
`
` definition of a protein or a polypeptide today,
`
` could you?
`
` A. No, not one that would sound scientific.
`
` Q. You're also not an expert in immunology,
`
` correct?
`
` A. I am not.
`
` Q. You have never worked in an immunology
`
` lab?
`
` A. I have not.
`
` Q. You have never cultured a cell?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 7
`
`
`
`Page 8
`
` A. I have not.
`
` Q. You never transected DNA into a cell?
`
` A. That's correct.
`
` Q. You never expressed a recombinant protein
`
` from a cultured cell?
`
` A. I have not.
`
` Q. You never expressed an immunoglobulin or
`
` an antibody from a culture cell?
`
` A. I have not.
`
` Q. Would you agree that you are not an
`
` expert in the scientific act of the Cabilly patents?
`
` A. I would agree with you.
`
` Q. You're familiar with the legal term,
`
` person of ordinary skill in the art, correct?
`
` A. Yes.
`
` Q. And in the over 300 cases that you have
`
` consulted on, you have come across the legal term
`
` person of ordinary skill in the art, correct?
`
` A. I have.
`
` Q. You have seen definitions -- in each of
`
` those cases, you have seen a definition for a person
`
` of ordinary skill in the art, correct?
`
` A. In most cases, I would have seen that,
`
` perhaps all.
`
` Q. And you understand in each of those cases
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 8
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 9
`
` that the definition for a person of ordinary skill
`
` in the art is specific to the patent at issue in
`
` each one of those cases, correct?
`
` A. I would expect that to be true, but I
`
` don't know what the legal requirements would be.
`
` Q. Ms. Davis, I'm going to hand you what I
`
` have marked Petitioner's Exhibit 1083.
`
` (Deposition Exhibit 1083 was
`
` marked for identification.)
`
` BY MR. SALMEN:
`
` Q. Ms. Davis, have you seen this exhibit
`
` before?
`
` A. Yes, I have.
`
` Q. Can you identify it for the record,
`
` please?
`
` A. I understand this to be the petition for
`
` the IPR related to this patent.
`
` Q. This is the petition that Mylan
`
` submitted, correct?
`
` A. That's my understanding.
`
` Q. If you turn to Page 17 of this petition,
`
` you see there's a definition for person of ordinary
`
` skill in the art?
`
` A. I do.
`
` Q. Have you read that definition before?
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 9
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 10
`
` A. Yes.
`
` Q. Would you agree to your understanding --
`
` Strike that.
`
` To your understanding, has Genentech
`
` disputed this definition?
`
` A. I have reviewed Genentech's response to
`
` this request, but I do not recall anything specific
`
` about what it said related to the person of ordinary
`
` skill in the art.
`
` Q. Okay. I'll represent to you that
`
` Genentech has not disputed this definition.
`
` Now, reading this definition, do you
`
` agree that you are not considered a person of
`
` ordinary skill in the art with respect to the
`
` Cabilly patents?
`
` MR. MCGOWAN: Objection to form.
`
` BY THE WITNESS:
`
` A. I would agree that I'm not a person of
`
` ordinary skill in the art as it is defined here.
`
` Q. And person of ordinary skill in the art
`
` with respect to the Cabilly patents, you agree that
`
` you are not a person of ordinary skill in the art in
`
` that regard, correct?
`
` A. I would agree.
`
` Q. Now, I'd like to ask you some questions
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 10
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 11
`
` about your declaration. So, feel free to look at
`
` your declaration, and if you need any other
`
` documents that I haven't given you, feel free to ask
`
` me. I have got three boxes worth of documents here.
`
` So if we can first turn to Page 9,
`
` Paragraph 24 of your declaration. And in this
`
` section, you provide your claimed understanding of
`
` the Cabilly patents, correct?
`
` A. I do.
`
` Q. Did you read the Cabilly patents?
`
` A. Yes.
`
` Q. And just so we're on the same page, I'm
`
` sorry, when I refer to the Cabilly patents, I'm
`
` going to use the same nomenclature that you use in
`
` your declaration. Is that acceptable?
`
` A. I'll understand that.
`
` Q. You reviewed the claims of each of the
`
` Cabilly patents?
`
` A. Yes.
`
` Q. You reviewed the examples?
`
` A. I don't remember any specifics about the
`
` examples, but I did read the three Cabilly patents
`
` front to back.
`
` Q. Did you compare the claims of each of the
`
` Cabilly patents?
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 11
`
`
`
`Page 12
`
` A. No. That would be outside my expertise.
`
` Q. Did you compare the specifications to
`
` determine if there was anything different between
`
` each of the Cabilly patents?
`
` A. I did not.
`
` Q. Now, if we could look at Paragraph 26
`
` here. And the first statement in Paragraph 26 is
`
` the Cabilly II patent is a continuation of Cabilly
`
` I. Do you see that?
`
` A. I do.
`
` Q. Why was that important to your opinion?
`
` A. I have simply provided this as background
`
` information.
`
` Q. Okay. So, you understand that -- you
`
` understand what a continuation application is?
`
` A. Generally speaking, yes.
`
` Q. All right. What does it mean to you that
`
` Cabilly II is a continuation of Cabilly I?
`
` A. I think of that, as a layperson, as being
`
` a patent that is related as a member of the same
`
` family, so to speak, as the Cabilly I patent. They
`
` arose out of a common application process.
`
` Q. You understand that as a continuation
`
` patent, the invention claimed in Cabilly II had to
`
` be fully disclosed in the Cabilly I specification?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 12
`
`
`
`Page 13
`
` MR. MCGOWAN: Objection to the extent it
`
` calls for a legal conclusion.
`
` BY THE WITNESS:
`
` A. I don't have any particular understanding
`
` as to what the legal requirements are on that.
`
` Q. I'm not asking for the legal
`
` requirements, Ms. Davis. I'm asking for your
`
` understanding.
`
` You characterized Cabilly II as a
`
` continuation of Cabilly I in your declaration. So
`
` I'm asking you whether or not you understand that as
`
` a continuation patent, the invention claimed in
`
` Cabilly II had to be disclosed in Cabilly I?
`
` A. No. That information is outside my
`
` expertise. I don't have any understanding on
`
` whether that's a necessary requirement or not.
`
` Q. All right. You didn't consider that in
`
` forming your opinions with respect to your
`
` understanding of the Cabilly patents, correct?
`
` A. I did not.
`
` Q. Do you understand that as a continuation
`
` patent, Cabilly II was not allowed to contain any
`
` new information over Cabilly I?
`
` A. I don't have an understanding regarding
`
` those requirements.
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 13
`
`
`
`Page 14
`
` Q. You didn't consider that in forming your
`
` opinions or your understanding of the Cabilly
`
` patents, correct?
`
` A. That is correct.
`
` Q. Now, you make a similar comment in
`
` Paragraph 28. You state, "Cabilly III is a
`
` continuation of Cabilly II."
`
` Do you see that?
`
` A. I do.
`
` Q. I'll ask you the same question.
`
` Do you understand that as a
`
` continuation patent, the invention claimed in
`
` Cabilly III had to be fully disclosed in Cabilly I?
`
` A. I don't have any specific understanding
`
` of that.
`
` Q. And you did not consider that in forming
`
` your opinion regarding what your understanding of
`
` the Cabilly patents are, correct?
`
` A. That is correct.
`
` Q. Now, I'd like to look at Paragraph 27
`
` here, please.
`
` Here you state your understanding
`
` that, "Cabilly I specifies a method for producing
`
` chimeric heavy or light chains of an antibody."
`
` Do you see that?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 14
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 15
`
` A. I do.
`
` Q. And you cite -- at the end of that
`
` sentence, you have a footnote 28, which cites to the
`
` '567 patent, and that's the Cabilly I, correct?
`
` A. Yes.
`
` Q. You do not have technical expertise to
`
` give me a definition of a chimeric heavy chain or
`
` light chain of an antibody, correct?
`
` A. I do not have that technical expertise.
`
` Q. You are just quoting language from the
`
` patent there, correct?
`
` A. Generally speaking, yes, as well as my
`
` overall understanding.
`
` Q. You cannot tell me how a person of
`
` ordinary skill in the art would interpret that claim
`
` term?
`
` A. I cannot.
`
` Q. You then state, "Cabilly II specifies
`
` vectors, host cells, and methods used to express
`
` both heavy and light chains (co-expression) in a
`
` single host cell to produce an antibody or antibody
`
` fragment."
`
` Do you see that?
`
` A. I do.
`
` Q. You do not have the technical expertise
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 15
`
`
`
`Page 16
`
` to tell me what that means, correct?
`
` A. I do not have.
`
` Q. Again, you're just quoting language from
`
` the patent, correct?
`
` MR. MCGOWAN: I'll ask you to let the
`
` witness complete her answer.
`
` BY THE WITNESS:
`
` A. I was just about complete.
`
` I do not have that technical
`
` expertise. In that particular situation, I was
`
` quoting the patent as well as my understanding based
`
` upon the other materials I have reviewed in this
`
` case.
`
` Q. I'm sorry if I interrupted you.
`
` So, you recite the language in the
`
` patent, but you cannot give me a person of ordinary
`
` skill in the art's definition of those technical
`
` terms, correct?
`
` A. I am not a person of ordinary skill in
`
` the art, so I could not give you a technical
`
` description.
`
` Q. Do you agree with me then that your
`
` understanding of the Cabilly patents as you describe
`
` them here in Paragraphs 24 through 29 came from
`
` somewhere else or someone else?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 16
`
`
`
` A. As opposed to my own expertise, is that
`
`Page 17
`
` what you are asking?
`
` Q. Yes.
`
` A. Yes, I would agree with you that that
`
` information is outside my technical expertise. So I
`
` had to rely on other sources for that.
`
` Q. I asked you earlier if you compared the
`
` claims of the various Cabilly patents, and you said
`
` you did not; is that correct?
`
` A. That is correct.
`
` Q. So, you do not have an independent
`
` technical understanding of what the differences
`
` between those claimed inventions of the Cabilly
`
` patents are, correct?
`
` A. I do not.
`
` Q. Likewise, you do not have the knowledge
`
` or experience to tell me how a person of ordinary
`
` skill in the art would understand the differences
`
` between those claimed inventions of the Cabilly
`
` patents, correct?
`
` A. I do not have the background of someone
`
` of ordinary skill in the art, therefore, I would not
`
` be able to provide that technical insight.
`
` Q. Now, one last point on this second here.
`
` At the end of Paragraph 27, you conclude stating,
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 17
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` "the claims of the Cabilly I patent do not require
`
`Page 18
`
` co-expression."
`
` Do you see that?
`
` A. Yes.
`
` Q. We agreed or you represented earlier in
`
` this section that the Cabilly II patent is a
`
` continuation of Cabilly I, correct?
`
` A. That's my understanding.
`
` Q. And you don't -- you do not have an
`
` understanding of whether or not the Cabilly I patent
`
` would have had to disclose co-expression in a single
`
` cell, correct?
`
` A. I do not have any background to
`
` understand the requirements about that.
`
` Q. You didn't investigate the Cabilly I
`
` specification to determine whether or not the
`
` Cabilly I patent actually disclosed heavy and light
`
` chains co-expressed in a single host cell?
`
` A. No. That's outside my expertise.
`
` Q. If we can move onto the next section in
`
` your declaration. You titled this "benefits
`
` provided by the Cabilly patents."
`
` Do you see that?
`
` A. I do.
`
` Q. And here, again, you state "I understand
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 18
`
`
`
`Page 19
`
` the inventions of the Cabilly patents."
`
` Do you see that?
`
` A. I do.
`
` Q. As we agreed, you do not have your own
`
` independent technical understanding of the
`
` inventions of the Cabilly patents, correct?
`
` A. I do not have a technical background. So
`
` I do not have a technical understanding other than
`
` what I have been informed.
`
` Q. And we agree that you have no technical
`
` expertise in the art of the Cabilly patents,
`
` correct?
`
` A. We agreed on that.
`
` Q. We also agreed that your technical
`
` understanding comes from somewhere or someone else,
`
` correct?
`
` A. That's correct.
`
` Q. So here, in this section, you rely on Dr.
`
` Carlo Croce, Genentech's hired expert?
`
` A. I do rely on Dr. Croce.
`
` Q. Here in Paragraphs 30 and 31, the only
`
` expert evidence you rely on is Dr. Croce's opinions,
`
` correct?
`
` A. In these two paragraphs, that is correct.
`
` Q. Did you review Dr. Croce's entire report
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 19
`
`
`
`Page 20
`
` or just the paragraph you cite in your declaration?
`
` A. I have read his entire report.
`
` Q. How did you identify the relevant
`
` paragraphs that you cite in your declaration?
`
` A. I was looking for information that dealt
`
` with the benefits provided by the Cabilly patents.
`
` This is what I located in his report.
`
` Q. And you located that in Paragraph 26 of
`
` his report?
`
` A. If you are referring to footnote 37,
`
` that's correct. I cite other paragraphs later on.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 20
`
`
`
`Page 21
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 21
`
`
`
`Page 22
`
`1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 22
`
`
`
`Page 23
`
`
`
`1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 23
`
`
`
`Page 24
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`h
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`:
`
`
`
`
`
`
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 24
`
`
`
`Page 25
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 25
`
`
`
`Page 26
`
`1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 26
`
`
`
`Page 27
`
`
`
`
`
`1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 27
`
`
`
`Page 28
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 28
`
`
`
`Page 29
`
`1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 29
`
`
`
`Page 30
`
`
`
`1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 30
`
`
`
`Page 31
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`.
`
`
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 31
`
`
`
`Page 32
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 32
`
`
`
`Page 33
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 33
`
`
`
`Page 34
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` Q. Did you review Dr. Jefferson Foote's
`
` declaration?
`
` A. Yes, that sounds familiar.
`
` Q. In the Mylan IPR, did you review Dr.
`
` Kathryn Calame's declaration?
`
` A. No, I do not believe I have seen her
`
` declaration.
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 34
`
`
`
`Page 35
`
` Q. Did you review Dr. Foote's or did you
`
` review any of the deposition testimony of any of the
`
` experts from the Sanofi or the Mylan IPR matters?
`
` A. I have not reviewed any deposition
`
` testimony related to the Mylan IPR matter. I do not
`
` recall specifically what deposition testimony I
`
` reviewed in connection with the Sanofi matters and
`
` whether those depositions would have been designated
`
` for both the district court action as well as the
`
` declaration.
`
` Q. Did you review any of the materials from
`
` the Cabilly II patent reexamination?
`
` A. Unless they were marked as exhibits to
`
` deposition testimony or included within expert
`
` reports, I do not believe I have reviewed any of
`
` those.
`
` Q. Do you recall reviewing the declaration
`
` of Dr. Walton?
`
` A. What is Dr. Walton's first name?
`
` Q. Doctor E. Fenton Walton.
`
` A. That name is familiar.
`
` Q. Do you recall reviewing his declaration?
`
` A. Not specifically.
`
` Q. Do you recall reviewing the declaration
`
` of Timothy Harris?
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 35
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 36
`
` A. That name is not currently ringing any
`
` bells. So I don't know if I have reviewed Dr.
`
` Harris's declaration or not.
`
` Q. Is there a reason why you didn't review
`
` Dr. Calame's deposition testimony this IPR
`
` proceeding?
`
` A. When was this deposition testimony?
`
` MR. SALMEN: November.
`
` MR. MCGOWAN: Deposition?
`
` (Deposition Exhibit 1084 was
`
` marked for identification.)
`
` BY MR. SALMEN:
`
` Q. Ms. Davis, I've handed you what has been
`
` marked as Petitioner's Exhibit 1084. This is the
`
` transcript of Kathryn Calame, PhD, date November 18,
`
` 2016. Case Mylan Pharmaceuticals Inc. V Genentech
`
` Inc. and City of Hope.
`
` Do you see that?
`
` A. I do.
`
` Q. You have never reviewed this deposition
`
` transcript, correct?
`
` A. I have not.
`
` Q. Okay. And just so, we're all on the same
`
` page, your declaration was signed December 22, 2016,
`
` correct?
`
`www.veritext.com
`
`Veritext Legal Solutions
`
`888-391-3376
`
`Merck Ex. 1121, Pg. 36
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Page 37
`
` A. Right.
`
` Q. Roughly a month after Dr. Calame's
`
` deposition?
`
` A. Roughly.
`
` Q. You did not consider any of this
`
` testimony in forming your understanding of the
`
` Cabilly patents?
`
` A. I did not.
`
` Q. Take a look at some of Dr. Calame's
`
` testimony. If you turn to -- it's a condensed
`
` transcript. I'm going to refer to the small numbers
`
` in the corners.
`
` Page 242, are you there?
`
` A. I am.
`
` Q. Dr. Calame was asked a question:
`
` "And did the Cabilly '415 patent
`
` teach the person of ordinary
`
` skill in the art in any example
`
` how to prepare any antibodies
`
` fully assembled in the host
`
` cell?
`
` "Answer. No."
`
` Do you see that?
`
` A. I do.
`
` MR. MCGOWAN: Subject to the objection.
`
`www.veritext.com
`
`888-391-3376
`
`Veritext Legal Solutions
`
`Merck Ex. 1121, Pg. 37
`
`
`
`1
`
`2
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
` BY MR. SALMEN:
`
` Q. You did not consider that testimony in
`
` forming your understanding of the Cabilly patents,
`
`Page 38
`
` correct.
`
` A. I did not.
`
` Q. If we look at Page 243 to 244, beginning
`
` at line 13 -- I'm sorry. Dr. Calame was asked:
`
` "Did the Cabilly '415 patent
`
` provide any experimental results
`
` in which two different
`
`