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` UNITED STATES PATENT AND TRADEMARK OFFICE
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` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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` CASE IPR 2016-01332
`
` Patent 8,822,438
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` ______________________________
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` MYLAN PHARMACEUTICALS, INC. )
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` Petitioner )
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` vs. )
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` JANSSEN ONCOLOGY, INC., )
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` Patent Owner )
`
` ______________________________
`
` Videotaped Deposition of Ivan T. Hofmann
`
` Washington, D.C.
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` April 26, 2017
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` 9:01 a.m.
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` Reported by: Bonnie L. Russo
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` Job No. 2600768
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` Veritext Legal Solutions
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`21
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` Mid-Atlantic Region
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` 1250 Eye Street NW - Suite 350
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`22
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` Washington, D.C. 20005
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`JANSSEN EXHIBIT 2187
`Mylan v. Janssen IPR2016-01332
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`

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`Page 2
`1 Videotaped Deposition of Ivan T. Hofmann held
`2 at:
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`1 C O N T E N T S
`2 EXAMINATION OF IVAN T. HOFMANN PAGE
`3 BY MR. ZEGGER 5
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`Page 4
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` EXHIBITS
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` PREVIOUSLY MARKED EXHIBITS
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` Exhibit 1012 USPTO Response
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`45
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`6
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`7
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`8
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` Exhibit 1015 Notice of Allowance
`9 and Fee(S) Due
`10 Exhibit 1016 Notice of Allowance
` and Fee(S) Due
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`11
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` Exhibit 1017 Declaration of
`12 Ivan T. Hofmann, CPA/CFF,CLP
`13 Exhibit 1134 Reply Declaration of
` Ivan T. Hofmann
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`14
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` Exhibit 1136 Deposition of
`15 Christopher A. Vellturo, Ph.D.
` 4-5-17
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`16
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` Exhibit 2157 Affidavit of
`17 Christopher Butler
`18
`19
`20
`21 (Exhibits included with transcript.)
`22
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`Page 3
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`Page 5
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`1 P R O C E E D I N G S
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`2 3
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` THE VIDEOGRAPHER: We are going on
`4 the record.
`5 The time now is 9:01.
`6 This marks the beginning of Disk No.
`7 1 for the videotaped deposition testimony of
`8 Ivan T. Hofmann in the matter of Mylan
`9 Pharmaceuticals, Inc., et al, versus Janssen
`10 Oncology, Inc. This case is pending in the
`11 United States Patent and Trademark Office, Case
`12 No. IPR 2016-01332. Today's date is April 26,
`13 2017.
`14 This deposition is being taken at
`15 700 13th Street, Northwest, Washington, D.C.
`16 Will all attorneys present please
`17 identify themselves and who they represent.
`18 MR. ZEGGER: I'm Paul Zegger with
`19 the firm Sidley Austin for the patent owner,
`20 Janssen Oncology, Inc.
`21 MR. SWANSON: Robert Swanson from
`22 Perkins Coie for the petitioner Mylan.
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`2 (Pages 2 - 5)
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`3 4 5 6
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` Perkins Coie
`7 700 13th Street, N.W.
`8 Washington, D.C.
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
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`1 Pursuant to Notice, when were present on behalf
`2 of the respective parties:
`3 APPEARANCES:
`4 On behalf of the Petitioner:
`5 PERKINS COIE
` ROBERT D. SWANSON, Esq.
`6 BRANDON M. WHITE, Esq.
` 600 13th Street, N.W.
`7 Washington, D.C. 20005
` 202-654-1729
`8 rswanson@perkinscoie.com
` bmwhite@perkinscoie.com
`
`9
`
`10
`
` On behalf of the Co-Petitioners:
`
` WINSTON & STRAWN, LLP
`11 SHARON LIN, Esq.
` 1700 K Street, N.W.
`12 Washington, D.C. 20006
` 202-282-5756
`13 slin@winston.com
`14 On behalf of the Patent Owner:
`15 SIDLEY AUSTIN, LLP
` PAUL J. ZEGGER, Esq.
`16 1501 K Street, N.W.
` Washington, D.C. 20005
`17 202-736-8060
` pzegger@sidley.com
`
`18
`19 Also Present:
` Michael Gay, Videographer
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`20
`21
`22
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`Page 8
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`1 MR. WHITE: Brandon White from
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`2 Perkins Coie for the Mylan petitioner.
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`3 MS. LIN: Sharon Lin from Winston &
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`4 Strawn for the co-petitioners, Activist, Teva,
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`5 West-Ward, DRL and Amneal.
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`6 THE VIDEOGRAPHER: My name is
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`7 Michael Gay, I'm with Golkow Technologies. Our
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`8 court reporter today is Bonnie Russo also with
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`9 Golkow Technologies and will now swear in our
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`10 witness.
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`11 IVAN T. HOFMANN,
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`12 being first duly sworn, to tell the truth, the
`
`13 whole truth and nothing but the truth,
`
`14 testified as follows:
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`15 EXAMINATION BY COUNSEL FOR THE PATENT OWNER
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`16 BY MR. ZEGGER:
`
`17 Q. Mr. Hofmann, do you dispute that
`
`18 Zytiga has had over $4 billion in sales since
`
`19 it was launched?
`
`20 A. I think the gross sales have been on
`
`21 the order of what your question suggests
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`22 according to IMS data.
`
`1 that armamentarium.
`2 Q. What drugs, other than Xtandi, do
`3 you understand compete in the market for mCRPC?
`4 MR. SWANSON: Objection. Vague.
`5 THE WITNESS: Well, I mean, I think
`6 that that is the primary competitor these days.
`7 I think that there are other products that are
`8 used, like I said, that are listed within a
`9 variety of Janssen documents. There's
`10 different sets of competing products that are
`11 looked at at different times but they include a
`12 variety of products.
`13 BY MR. ZEGGER:
`14 Q. Is there a relevant market for
`15 purposes of evaluating commercial success, the
`16 mCRPC market?
`17 A. Well, I think we talked about this
`18 last time we met. I think that there are
`19 different ways that one can look at the
`20 competing products and I think that certainly
`21 MRCPC [sic] is one way to look at it but I
`22 think that that is a narrow focus.
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`Page 7
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`1 Q. What is Zytiga prescribed for?
`2 A. Well, I think it's labeled for
`3 metastatic castrate resistant prostate cancer
`4 both pre and post chemotherapy.
`5 Q. And that's sometimes referred to as
`6 mCRPC in short; is that right?
`7 A. Yes, sir.
`8 Q. What drugs does Zytiga compete with
`9 based on your understanding?
`10 A. Well, I think, you know, broadly, it
`11 competes with a variety of drugs for the
`12 treatment of prostate cancer including Xtandi
`13 as well as others.
`14 Q. Well, does it -- does Zytiga compete
`15 with all prostate cancer drugs?
`16 A. I think -- I think as I understand
`17 it, and again, I am not a clinician but as I
`18 understand it, people with -- who present with
`19 prostate cancer go in and out of different
`20 therapies and at different times, yes. People
`21 look at the armamentarium of what is available
`22 to treat prostate cancer and Zytiga is part of
`
`Page 9
`1 I think as I said in my answer a few
`2 moments ago, there is reasons to look at
`3 broader competing products and broader -- you
`4 know, really what we are talking about is the
`5 patients that present with prostate cancer and
`6 there are different ways to deal with that.
`7 Q. Have you seen any evidence that
`8 Zytiga is prescribed for conditions other than
`9 mCRPC?
`10 A. I am not sure I have seen specific
`11 documents that address that one way or the
`12 other.
`13 Q. In your reply declaration, do you
`14 set forth Zytiga's market share in the mCRPC
`15 market?
`16 A. Among others. Well, when you say my
`17 "declaration," I have issued two declarations.
`18 I talk about the market share relative to a
`19 variety of competitive data sets.
`20 Q. Well, you mentioned your
`21 declarations.
`22 Let me put before you what has been
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`Page 12
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`1 identified as Mylan Exhibit 1017.
`2 Is that your opening declaration in
`3 this IPR proceeding?
`4 A. That's my opening declaration. Just
`5 looked at the cover page but...
`6 Q. We discussed that at your prior
`7 deposition.
`8 A. We did, yes.
`9 Q. Let me put before you what has been
`10 identified as Mylan Exhibit 1134.
`11 Is that your reply declaration in
`12 this matter?
`13 A. It appears to be, yes.
`14 Q. Is that your signature on Page 25?
`15 A. Yeah, it looks like a
`16 black-and-white version, but yeah.
`17 Q. Signed on April 19 of this year,
`18 2017?
`19 A. I did.
`20 Q. And does Paragraph 4 and Attachment
`21 A1 contain a complete list of materials you
`22 considered in connection with your reply
`
`1 time off the top of my head.
`2 Q. Do you have an approximate
`3 estimation?
`4 A. It would be dozens of hours but I
`5 don't have a specific time, no.
`6 Q. Looking at your reply declaration,
`7 is there anything in there that would indicate
`8 what you think the market share is for Zytiga
`9 in the mCRPC market?
`10 MR. SWANSON: Object to form.
`11 THE WITNESS: Well, I think between
`12 my two declarations, I do discuss market share
`13 with various data sets. I mean, part of the
`14 critique I have of Dr. Vellturo is that he
`15 discusses a very narrow market and when one
`16 looks at it relative to patients who present at
`17 various stages of prostate cancer, one gets
`18 different market shares based on available data
`19 sets.
`20 BY MR. ZEGGER:
`21 Q. Well, do you set forth in either of
`22 your declarations, the initial one or the reply
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`Page 11
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`Page 13
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`1 declaration?
`2 MR. SWANSON: Objection. Form.
`3 THE WITNESS: I think that A1 in
`4 Paragraph 4 lists the documents that I cite
`5 herein. I think as we talked about at my last
`6 deposition, I have also been tracking other
`7 parallel IPRs and I reviewed materials that
`8 were included in those IPRs.
`9 BY MR. ZEGGER:
`10 Q. What IPRs have you been tracking?
`11 A. The Amerigen IPR and then the
`12 Wockhardt IPR.
`13 Q. Have you read the expert
`14 declarations of McDuff and Stoner in the
`15 Amerigen and Wockhardt IPRs?
`16 MR. SWANSON: Object to form.
`17 THE WITNESS: I have.
`18 BY MR. ZEGGER:
`19 Q. How much time did you spend on the
`20 present matter since your deposition on
`21 February 7th, 2017?
`22 A. I don't have a precise amount of
`
`1 one, what you think the market share is for
`2 Zytiga in the relevant market?
`3 MR. SWANSON: Object to form.
`4 THE WITNESS: Well, I think that,
`5 you know, as a backdrop, I mean my role here is
`6 to look at what Vellturo puts forth. I think I
`7 have provided some greater context than
`8 Vellturo provides with respect to market share,
`9 but I haven't asserted commercial success. I
`10 haven't asserted market share in the way that
`11 he has.
`12 I think that the market share
`13 metrics that I provide in my opening
`14 declaration and then reiterated in my reply
`15 declaration provide, you know, greater context
`16 to the performance of Zytiga relative to other
`17 available treatments for prostate cancer.
`18 BY MR. ZEGGER:
`19 Q. Do you see your role in the present
`20 matter as critiquing Dr. Vellturo?
`21 MR. SWANSON: Object. Vague.
`22 THE WITNESS: Well, I mean, I think
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`1 my role was to -- as I explain in my opening
`2 declaration as well as my rebuttal declaration,
`3 that my role was to respond to Dr. Vellturo's
`4 assertions. In my opening declaration, it was
`5 to respond to the assertions made by Janssen
`6 with respect to alleged commercial success and
`7 nexus.
`8 I don't think that my role was
`9 limited to critiques of Dr. Vellturo. I think
`10 it was looking at the record and the assertions
`11 made by the patent holder with respect to
`12 claimed commercial success and nexus relative
`13 to the performance of Zytiga.
`14 BY MR. ZEGGER:
`15 Q. Well, did you undertake on your own
`16 to independently figure out what the market
`17 share is for Zytiga in the relevant market?
`18 MR. SWANSON: Object to form.
`19 THE WITNESS: I mean, that is
`20 certainly part of the information that I -- I
`21 considered. I looked at what Janssen asserted
`22 in their prosecution of the patent. I looked
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`Page 16
`1 Q. Other than the ones that Vellturo
`2 presented in his report?
`3 MR. SWANSON: Object to form.
`4 THE WITNESS: I don't think I did do
`5 any sort of alternative mathematical
`6 calculation the way that I did in my opening
`7 declaration relative to the data sets that were
`8 provided to the USPTO.
`9 BY MR. ZEGGER:
`10 Q. In your opening report, did you set
`11 forth your understanding of the legal standards
`12 relative to commercial success?
`13 MR. SWANSON: Object to form.
`14 THE WITNESS: I did. Sorry.
`15 BY MR. ZEGGER:
`16 Q. And did you apply those same legal
`17 standards in connection with your reply
`18 declaration?
`19 MR. SWANSON: Object to form.
`20 THE WITNESS: I did.
`21 BY MR. ZEGGER:
`22 Q. Did you have an understanding as to
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`Page 15
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`1 at what Dr. Vellturo put forth in his
`2 declaration and I analyzed the relative
`3 performance of Zytiga as explained in my two
`4 declarations.
`5 BY MR. ZEGGER:
`6 Q. Well, for example, do you have
`7 anything in your reply declaration that would
`8 indicate what the Zytiga market share was for
`9 2016?
`10 MR. SWANSON: Object to form.
`11 THE WITNESS: I don't know that I
`12 specifically address 2016 in the data set other
`13 than if it's in the Vellturo data set. I think
`14 that, you know, again, my response and reply
`15 was in reference to the patent prosecution
`16 files as well as the assertion filed by
`17 Vellturo.
`18 BY MR. ZEGGER:
`19 Q. Are you offering any alternative
`20 numbers for Zytiga's market share for 2016?
`21 MR. SWANSON: Object to form.
`22 BY MR. ZEGGER:
`
`Page 17
`1 whether there are circumstances under which a
`2 nexus between commercial success and a patent
`3 is presumed?
`4 MR. SWANSON: Objection. Vague.
`5 THE WITNESS: I mean, I am not a
`6 legal expert. I am not providing legal
`7 opinions. I understand there has been some,
`8 you know, that there are legal arguments and
`9 aspects of that. I think my opinions are laid
`10 out as explained in my two declarations.
`11 BY MR. ZEGGER:
`12 Q. Well, did you consider whether a
`13 nexus should be presumed in this case?
`14 A. Yeah, I think that -- relative to
`15 whether it's presumed or not, my opinions stand
`16 on their own. The fact is that the existence
`17 of the blocking patent, the existence of all
`18 the evidence that shows a lack of nexus
`19 relative to the patent-in-suit and the
`20 marketplace performance of Zytiga, regardless
`21 of whether there is a presumed nexus stands.
`22 But I will leave the presumption issue to
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`1 lawyers to argue about.
`2 Q. Well, is it fair to say then that
`3 the existence or nonexistence of a presumption
`4 of nexus didn't figure in your analysis?
`5 MR. SWANSON: Object to form.
`6 THE WITNESS: I wouldn't say it that
`7 way. I would say it -- that the evidence that
`8 I looked at through my economic lens, it's
`9 clear that there is both the existence of the
`10 blocking patent as well as the lack of nexus,
`11 whether or not one -- whether or not one
`12 assumes a presumption of nexus that indicates a
`13 lack of nexus or a lack of showing of nexus
`14 with respect to the performance of Zytiga.
`15 BY MR. ZEGGER:
`16 Q. You mentioned a blocking patent.
`17 Are you referring -- is that your term for the
`18 '213 patent?
`19 A. Yeah. I mean, yes, it's a term I
`20 use but I think conceptually, it's the fed
`21 circuit's term with respect to what a blocking
`22 patent is.
`
`1 BY MR. ZEGGER:
`2 Q. Well, let's take it step by step.
`3 First, is it your understanding that
`4 a company -- BTG was the owner of the '213
`5 patent?
`6 A. Yes.
`7 Q. You are also aware that BTG at
`8 various times tried to license that patent, the
`9 '213 patent to others?
`10 A. Well, I mean, it's a little bit
`11 obscure. You know, Dr. Vellturo I think cited
`12 to the Wayback Machine and some older website
`13 references. They are looking to partner and/or
`14 out-license at -- in the late '90s. It seems
`15 to be so. But ultimately, it was the exclusive
`16 license with Cougar in 2004 that moved the
`17 product forward.
`18 Q. You mentioned the Wayback. Did you
`19 actually look at the exhibit indicating the BTG
`20 website from 2002?
`21 A. I did.
`22 Q. Let me show you Janssen Exhibit
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`Page 19
`1 Q. Were you aware that the owner of the
`2 '213 patent was actively seeking to license the
`3 '213 patent at various times?
`4 MR. SWANSON: Objection. Vague.
`5 THE WITNESS: So I think that that
`6 is -- we know that BTG had the '213 patent and
`7 I think you are talking about a very long
`8 period of time. I think that Dr. Vellturo in
`9 his opening or in other IPRs didn't argue that.
`10 He did in his rebuttal report to my declaration
`11 that BTG was in fact seeking to out-license the
`12 '213 patent.
`13 Having said that, as I explain in my
`14 reply declaration, I considered that and it's
`15 very clear that there remains economic
`16 disincentives for pursuing various uses of
`17 abiraterone for the periods of time that we are
`18 talking about, and then in particular from 2004
`19 forward, when the Cougar exclusive license was
`20 in place, you know, the blocking patent sits in
`21 the place that it sits as described in the
`22 entirety of my declarations.
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`Page 21
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`1 2157.
`2 Do you recall reviewing this
`3 document?
`4 A. Yeah, just -- just quickly flipping
`5 through it, yes, I think so.
`6 Q. Is it your understanding that in the
`7 -- at least in the 2002 time frame, BTG was
`8 seeking licensees for the '213 patent?
`9 A. It's certainly published. I mean,
`10 it seems that according to this document, that
`11 there was an interest in partnering with
`12 respect to the '213 patent.
`13 Q. Are you also aware that BTG did
`14 enter into a relationship with a company called
`15 Boehringer regarding abiraterone?
`16 MR. SWANSON: Objection. Vague.
`17 THE WITNESS: So, yes. I think this
`18 predates 2002. In 1996, they entered into a
`19 partnership arrangement with BI.
`20 BY MR. ZEGGER:
`21 Q. Could you look at Paragraph 8 of
`22 your reply declaration.
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`1 In that paragraph, you state: "In
`2 my opinion, the performance of Zytiga fails to
`3 provide objective indicia of nonobviousness of
`4 the asserted claims of the '483 patent because
`5 no other company had the ability to
`6 commercialize a product containing abiraterone
`7 acetate in the U.S. as a result of the blocking
`8 nature," and then you mention the '213 patent;
`9 is that right?
`10 A. You said '483? I think you mean
`11 '438.
`12 Q. '438 patent.
`13 A. But otherwise, I think you read my,
`14 you know, sentence there, summarized the tail
`15 end of it.
`16 Q. Well, is it correct that no other
`17 company had the ability to commercialize a
`18 product containing abiraterone acetate because
`19 of the '213 patent?
`20 MR. SWANSON: Object to form.
`21 THE WITNESS: In terms of
`22 commercialization, yes. I think that there is
`
`1 correct?
`2 MR. SWANSON: Object to form.
`3 Vague.
`4 THE WITNESS: I mean, there is a big
`5 gap between Exhibit 2157, which is kind of
`6 discussing the availability of the '213 patent
`7 and actually executing a deal. I am not aware
`8 of any other deal. BTG had the exclusive
`9 rights once Boehringer or BI, you know, ceased
`10 the relationship with respect to the patent.
`11 BY MR. ZEGGER:
`12 Q. Well, in 2002, when BTG was
`13 advertising the availability of a license under
`14 the '213 patent, can you name a single company
`15 that that was blocked from commercializing a
`16 product containing abiraterone acetate?
`17 MR. SWANSON: Object to form.
`18 THE WITNESS: Well, sure. I mean,
`19 every company that didn't have the rights that
`20 the '213 patent granted to BTG were prevented,
`21 were economically disincentivized without an
`22 arrangement with BTG.
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`Page 23
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`Page 25
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`1 a significant economic disincentive that is
`2 presented by the existence of the '213 compound
`3 patent with respect to abiraterone acetate.
`4 BY MR. ZEGGER:
`5 Q. Well, when you say that no other
`6 company had the ability to commercialize a
`7 product containing abiraterone, are you
`8 referring to Boehringer?
`9 MR. SWANSON: Object to form.
`10 BY MR. ZEGGER:
`11 Q. Let me ask it -- maybe I can clarify
`12 my question.
`13 Are you suggesting that Boehringer
`14 was prevented from commercializing or
`15 attempting to commercialize a product
`16 containing abiraterone acetate?
`17 A. No. I mean in the early period,
`18 before they ceased the relationship, they had
`19 rights to do so.
`20 Q. All right. And at least in the 2002
`21 time period, other companies could have availed
`22 themselves of a license under the '213 patent,
`
`1 Of course, as I explain in my
`2 report, in 2004, there is an exclusive
`3 agreement with Cougar and then -- of most
`4 import here is that when we are talking about
`5 the patent-in-suit, you are looking at a
`6 priority date of 2006 and the performance
`7 thereafter and certainly during the entirety of
`8 that period, the blocking patent and exclusive
`9 relationship with Cougar and Janssen existed.
`10 BY MR. ZEGGER:
`11 Q. Well, I am trying to focus on the
`12 time period around 2002. Can we focus on that?
`13 A. Sure.
`14 MR. SWANSON: Objection. Vague.
`15 BY MR. ZEGGER:
`16 Q. And we're agreed that BTG was
`17 letting it be known to the world that they were
`18 willing to license the '213 patent, correct?
`19 MR. SWANSON: Object to form.
`20 THE WITNESS: I mean, I think as I
`21 explained at my last deposition, you know,
`22 people do out-license and when people can reach
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`1 terms that are amicable, that can be the case.
`2 I think BTG and the disclosures that existed
`3 with respect to abiraterone acetate in the 2002
`4 time frame invited offers, but there was no
`5 owner of the rights to abiraterone acetate
`6 other than BTG in 2002.
`7 BY MR. ZEGGER:
`8 Q. Well, in short, BTG could have
`9 chosen to exclude others from developing an
`10 abiraterone acetate product or licensed the
`11 rights to others and it chose the latter,
`12 correct?
`13 MR. SWANSON: Object to form.
`14 THE WITNESS: Right. But -- well,
`15 let me be careful there. One has to be mindful
`16 that what we are talking about in terms of
`17 whether there is potential objective indicia of
`18 nonobviousness is whether there is this level
`19 playing field where other parties would have
`20 motivation to conceive of the alleged invention
`21 of the patent-in-suit, and the reality is that
`22 it does appear that BTG in the 2002 time frame
`
`1 BY MR. ZEGGER:
`2 Q. Right. But the actual history
`3 includes the time period from when the '213
`4 patent issued in 1997 through the licensing of
`5 Cougar in 2004, correct?
`6 MR. SWANSON: Objection to form.
`7 BY MR. ZEGGER:
`8 Q. That is part of the licensing
`9 history?
`10 A. Yeah, and beyond, sure.
`11 Q. So focusing on the period between
`12 1997 and 2004, Boehringer had rights and rights
`13 were offered to others by BTG, correct?
`14 MR. SWANSON: Objection. Vague.
`15 THE WITNESS: I mean, I think that
`16 we have seen some evidence that -- yes, we know
`17 that Boehringer had rights. Those ceased at
`18 some point, I think in 1999, and thereafter,
`19 there is some black holes with respect to what
`20 was going on with respect to abiraterone
`21 acetate, but there are some documents that have
`22 now been cited that suggests that BTG was at
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`Page 27
`1 was inviting partners but they were inviting a
`2 partner. It wasn't that they were inviting
`3 dozens of partners to commercialize various
`4 abiraterone acetate products, and that is
`5 really the problem with what Dr. Vellturo
`6 asserts, and what we see in reality is that as
`7 this played out in 2004, there was an exclusive
`8 license with Cougar or Janssen and that
`9 manifested itself in what became the
`10 commercialized product Zytiga, and there was
`11 really no motivation for anyone else to
`12 commercialize and conceive of the alleged
`13 invention of the patent-in-suit given that
`14 landscape and history and timeline.
`15 BY MR. ZEGGER:
`16 Q. Well, you are talking about the time
`17 period after Cougar was granted the exclusive
`18 license, in other words, in 2004 onward?
`19 MR. SWANSON: Objection. Vague.
`20 Mischaracterizes.
`21 THE WITNESS: Well, I think what I
`22 am talking about is the actual history.
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`Page 29
`
`1 least expressing interest in partnering with
`2 one.
`3 But again, that partnering would be
`4 presumably limited and ultimately, we know that
`5 that partnering manifested itself with respect
`6 to Cougar in 2004.
`7 BY MR. ZEGGER:
`8 Q. Going back to Paragraph 8 of your
`9 reply declaration, you say that: "No other
`10 company had the ability to commercialize a
`11 product containing abiraterone acetate as a
`12 result of the '213 patent."
`13 In that phrase, who are you
`14 referring to by "no other company?"
`15 A. I mean, I guess as I explain in the
`16 entirety of my declaration, the '213 patent
`17 existed and continued to exist through 2016, so
`18 no company other than those with rights to the
`19 '213 patent would be included in no other
`20 company.
`21 Q. Right. So "no other company" in
`22 your Paragraph 8 would not include Boehringer
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`Page 32
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`1 or Cougar, correct?
`2 MR. SWANSON: Objection.
`3 Mischaracterizes.
`4 THE WITNESS: During the period of
`5 time that the '213 patent, those -- I mean,
`6 Boehringer ceased its right at the early stage
`7 and Cougar gained rights at a different stage,
`8 but yeah, I mean, it's limited to no other
`9 company, and when we say, "limited to," we are
`10 talking about pretty much every other company
`11 in the periods of time that BI and Cougar had
`12 rights, that's correct.
`13 BY MR. ZEGGER:
`14 Q. And no other company wouldn't
`15 include those companies who had an opportunity
`16 to license the '213 patent, but for whatever
`17 reason declined, correct?
`18 MR. SWANSON: Object to form.
`19 THE WITNESS: Well, I think that is
`20 overly simplistic. I think that the reality
`21 is, you know, what -- again, one has to ground
`22 oneself in what we are looking at in terms of
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`Page 31
`1 potential objective indicia of nonobviousness
`2 as reflected through commercial success.
`3 The reality is the '213 patent
`4 exists. It is a compound patent. It claims
`5 abiraterone acetate and I think that other
`6 companies who sit with limited resources
`7 figuring out how to deploy said resources would
`8 sit -- whether it is in 1997 or 1999 or 2002 or
`9 2004 or 2000 thereafter.
`10 Recognizing that the '213 patent
`11 exists and one would have to either partner or
`12 gain licenses or, you know, have certain
`13 economic disincentives with respect to pursuing
`14 the abiraterone acetate compound and then
`15 certainly from 2004 forward where Cougar and
`16 Janssen gained exclusive rights to the molecule
`17 abiraterone acetate which well predates the
`18 claimed priority date of the patent-in-suit,
`19 significant economic disincentives would exist
`20 as to figuring out how to tinker with
`21 abiraterone acetate in a way that could be
`22 potentially commercialized.
`
`1 BY MR. ZEGGER:
`2 Q. Let's look at different periods of
`3 time.
`4 First, are you aware of any blocking
`5 rights in the period prior to the issuance of
`6 the '213 patent in 1997?
`7 A. Well, I think we touched on this a
`8 little bit at my last deposition. I think that
`9 some level of deterrence exists from the
`10 publication of the application for what matured
`11 into the '213 patent. I mean, because you are
`12 kind of telegraphing to the world that you have
`13 a priority date to a claimed invention, so
`14 there is some deterrence.
`15 Of course, that deterrence is
`16 greater because uncertainties with respect to
`17 what matures into actually published claims or
`18 issued claims doesn't exist until the '213
`19 patent, in fact, issued.
`20 Q. So do you have any understanding as
`21 to whether BTG had the right to block anyone
`22 prior to the issuance of the '213 patent in
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`Page 33
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`1 1997?
`2 MR. SWANSON: Objection. Vague.
`3 THE WITNESS: Yeah, I think -- I
`4 think legal recourse is limited to
`5 post-issuance. I think that legal recourse and
`6 again, I am not a lawyer, but is slightly
`7 different than economic disincentives. I think
`8 that economic disincentives can be created when
`9 one publishes to the world that they have
`10 conceived of an alleged, you know, invention
`11 that they are claiming priority dates and
`12 priority rights to, and that can deter -- if I
`13 am, I don't know, Pfizer, I might say I'm not
`14 going to pursue this particular molecule
`15 because I understand that BTG has published
`16 that they have done research and claimed
`17 priority with respect to this particular
`18 molecule.
`19 BY MR. ZEGGER:
`20 Q. Well, as an economic matter, do you
`21 see any difference between a company like BTG
`22 telling the world, we have a '213 patent and we
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`1 are going to enforce that against anyone who
`2 tries to make abiraterone acetate products
`3 compared to BTG saying, we have a '213 patent
`4 and we are willing to license others under this
`5 patent?
`6 MR. SWANSON: Object to form.
`7 THE WITNESS: Can you read that back
`8 or repeat that. That was kind of long.
`9 BY MR. ZE