Page 1
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`-------------------------------x
`WEST-WARD PHARMACEUTICALS
`INTERNATIONAL LIMITED,
`
` Case No.
` Petitioner, IPR2017-01592
` IPR2018-00507
`
` Patent No.
` 8,410,131
`V.
`
`NOVARTIS PHARMACEUTICALS
`CORPORATION,
`
` Patent Owner.
`-------------------------------x
`
` TELEPHONIC HEARING
` September 12, 2018
`
`Reported by:
`Tiffany Valentine
`Job No. 147868
`
`TSG Reporting - Worldwide 877-702-9580
`
`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
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 1 of 46
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`-------------------------------x
`WEST-WARD PHARMACEUTICALS
`INTERNATIONAL LIMITED,
`
` Case No.
` Petitioner, IPR2017-01592
` IPR2018-00507
`
` Patent No.
` 8,410,131
`V.
`
`NOVARTIS PHARMACEUTICALS
`CORPORATION,
`
` Patent Owner.
`-------------------------------x
`
` TELEPHONIC HEARING
` September 12, 2018
`
`Reported by:
`Tiffany Valentine
`Job No. 147868
`
`TSG Reporting - Worldwide 877-702-9580
`
`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
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 1 of 46
`
`
`
`Page 2
`
` Wednesday, September 12, 2018
` 3:01 p.m.
`
` PTAB Telephonic Hearing, held Before
`Administrative Patent Judges Robert A. Pollock,
`Sheridan K. Snedden and Jacqueline T. Harlow,
`held before Tiffany Valentine, a Court Reporter
`and Notary Public within and for the State of
`New York.
`
`TSG Reporting - Worldwide 877-702-9580
`
`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
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 2 of 46
`
`
`
`Page 3
`
`A P P E A R A N C E S
`GOODWIN PROCTER
`Attorneys for Petitioner
` 620 Eighth Avenue
` New York, New York 10018
`BY: MICHAEL COTTLER, ESQ.
` KEITH ZULLOW, ESQ.
`
`FITZPATRICK, CELLA, HARPER & SCINTO
`Attorneys for Patent Owner
` 1290 Avenue of the Americas
` New York, New York 10104-3800
`BY: CHRISTINA SCHWARZ, ESQ.
` NICHOLAS KALLAS, ESQ.
`
`TSG Reporting - Worldwide 877-702-9580
`
`1 2
`
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 3 of 46
`
`
`
`Page 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
`
` TELEPHONIC PROCEEDINGS
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`Good afternoon. This is the prehearing
`conference for IPR2017-01529, which is
`joined with IPR2018-00507.
` I am Judge Pollock. On the line
`with me are Judges Snedden and Harlow.
` Who is on the line for Petitioner
`Breckenridge?
` MR. COTTLER: Good afternoon, your
`Honor. This is Michael Cottler from
`Goodwin Procter on behalf of the Petitioner
`West-Ward.
` Petitioner Breckenridge has settled
`out of the IPR proceeding. They were lead
`Petitioner. With Breckenridge leaving,
`West-Ward stepped into their shoes.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`Thank you, Mr. Cottler.
` MR. COTTLER: You're welcome. With
`me also is Keith Zullow, who is lead
`counsel for West-Ward.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`Who is on the line for Patent Owner?
` MS. SCHWARZ: Good afternoon. This
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 4 of 46
`
`
`
`Page 5
`
`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
`
` TELEPHONIC PROCEEDINGS
`is Christina Schwarz and Nicholas Kallas
`for Novartis.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`Good afternoon. Is there a court reporter
`on the line?
` (Court Reporter responds to the
`Judge.)
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`Who retained the court reporter?
` MS. SCHWARZ: Patent Owner, your
`Honor.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`Please submit the transcript as an exhibit
`as soon as it is ready. It will serve as a
`record of this conference.
` MS. SCHWARZ: Sure. We will do
`that.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`We will several issues today.
` Petitioner seeks to address whether
`'131 patent can claim priority to February
`19, 2001 or February 18, 2002. And Patent
`Owner seeks to address the antedation of
`Luan, Exhibit 1005. And Petitioner has
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 5 of 46
`
`
`
`Page 6
`
`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
`
` TELEPHONIC PROCEEDINGS
`requested excluding the declaration of
`Dr. Komanduri, exhibit 2080.
` Each party has 15 minutes to present
`its case and may reserve five minutes at
`that time for rebuttal. Opposing party
`also has 15 minutes argument time but may
`not reserve time.
` Oral argument in this case is
`scheduled for September 19. Parties are
`free to revisit today's topics at that
`time.
` Let's start with Petitioner.
`Counsel, you have 15 minutes to present
`your case with respect to the priority
`claims of the '131 patent.
` Would you like to reserve five
`minutes of that time for rebuttal?
` MR. COTTLER: Yes, your Honor. And
`hopefully this won't take ten minutes
`either. I think it will be pretty brief.
`Feel free to stop me at any time to ask any
`questions.
` Just so it's clear, all of our
`arguments are on the papers, but I will try
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 6 of 46
`
`
`
`Page 7
`
`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
`
` TELEPHONIC PROCEEDINGS
`to give a brief summary of opposition as to
`why the challenged claims of the '131
`patent are not entitled priority to the
`British, the two British applications, the
`first of which was filed and published
`2001.
` The claim one of the '131 patent is
`directed to the inhibition of tumors of the
`solid excretory system. The information in
`the specification of these priority
`applications does not reasonably convey to
`a person skilled in the art that the
`patentee was in possession of a method of
`inhibiting the full scope of that genus of
`tumor.
` Novartis heavily relies on the two
`excerpts of the British application to
`support its position regarding priority.
` The first exhibit is 1012, that is
`the February, 2001, application. And the
`paragraph that I am referring to is at the
`bottom of page 005. And that's where the
`specification provides information
`regarding solid tumors. And the relevant
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 7 of 46
`
`
`
`Page 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
`
` TELEPHONIC PROCEEDINGS
`language is first found three lines down,
`the phrase renal cell carcinomas.
` And then there is a second phrase
`that is relied upon by Novartis starting
`with genitourinary cancer, e.g., cervical,
`uterine, ovarian, prostate or bladder
`cancer.
` Neither one of those excerpts
`provides written support for the full scope
`of claim one. As of the relevant date,
`excretory system tumors were understood to
`refer to tumors in the urinary tract, which
`include kidneys, ureter, bladder and
`urethra.
` As of that same timeframe,
`ordinarily just urinary cancer is
`understood as covered by excretory system
`tumors. But the question here is whether
`the phrase genitourinary cancer gives
`Novartis priority as to the genus of solid
`excretory system tumors. The answer is, it
`does not.
` While the application does refer to
`genitourinary cancer, including the
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 8 of 46
`
`
`
`Page 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
`
` TELEPHONIC PROCEEDINGS
`bladder, that would not include benign
`tumors, which are not cancerous.
` What's more important is that the
`listing of genitourinary cancers does not
`include -- it's listed separately from RCC,
`which is a type of kidney cancer. And to a
`person skilled in the art -- and to a
`person skilled in the art, RCC would
`ordinarily be included within the scope of
`genitourinary cancers.
` So the fact that the applicant here
`has categorized RCC separately from this
`scope of genitourinary cancers suggests the
`patentee here has used different naming
`conventions such that genitourinary cancer
`does not include the genus of excretory
`system tumors.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`Mr. Cottler, this argument about priorities
`is only relevant to Luan as prior art in
`this case, correct?
` MR. COTTLER: With respect to the
`references being relied upon forming a
`bases for the grounds, that is correct,
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 9 of 46
`
`
`
`Page 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
`
` TELEPHONIC PROCEEDINGS
`your Honor.
` There are some additional references
`that the Petitioner or there were some --
`there were additional references that
`Petitioner relied upon in the petition with
`respect to the state of the art, that are
`102(a) art.
` And those references would not be
`prior art if Novartis could claim priority
`to the earlier application.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`All right. And now if we were to find, as
`you suggest, that Novartis is not entitled
`to the earlier priority date, could we
`nevertheless find the Patent Owner still
`antedates Luan?
` MR. COTTLER: It is our position,
`your Honor, that Novartis cannot antedate
`Luan. Even assuming that Novartis cannot
`claim priority to the earlier application,
`it's Petitioner's position that the law
`that Patent Owner cites in its response,
`does not support its position that the
`information in the priority application
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 10 of 46
`
`
`
`Page 11
`
`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
`
` TELEPHONIC PROCEEDINGS
`antedates the disclosures of Luan.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`Okay. I hope Patent Owner can shed some
`more light on this position too.
` Please continue, Mr. Cottler.
` MR. COTTLER: Okay. And we were
`talking about priority and moved on to
`antedation, I can provide more of
`explanation as to the this side of the law
`in Patent Owner's response does not support
`that antedation argument or I can wait
`until Patent Owner addresses it.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`You're welcome to use your time as you see
`fit.
` MR. COTTLER: Okay. So I will go to
`back to priority then and we will wait to
`see what Patent Owner argument is.
` So getting back to the distinction
`between genitourinary cancer and RCC, as I
`said before, a person of skill in the art
`would understand that because RCC is
`separated from genitourinary cancer,
`genitourinary cancer would not include the
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 11 of 46
`
`
`
`Page 12
`
`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
`
` TELEPHONIC PROCEEDINGS
`full scope of the genus of excretory system
`tumors.
` Additionally, there is no data in
`the specification to support the idea that
`the only two examples of excretory system
`tumors here in the specification, which are
`the bladder and RCC, whether those two
`examples would be representative of the
`full scope of the genus of excretory system
`tumors.
` In fact, Patent Owner argues in this
`proceeding that the science surrounding
`these drugs and tumors was quite complex.
`And so the absence of any data in this
`priority application, bolsters the argument
`that simply providing the two examples of
`excretory system tumors would not provide
`support that's representative as a full
`scope of solid excretory system tumors in
`claim one.
` As for claim two, claim two simply
`limits the tumor of claim one to one that
`is advanced. The narrowing of claim two
`does not fix the written description
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 12 of 46
`
`
`
`Page 13
`
`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
`
` TELEPHONIC PROCEEDINGS
`problem I just described for claim one,
`because the scope of the types of solid
`excretory system tumors has not changed.
` On claim three, that does limit the
`scope of tumors of claim one to a kidney
`tumor. So while that claim is narrower
`than claim one with respect to the scope of
`the types of excretory tumors, there's
`still no priority with respect to that
`claim as well.
` There is no dispute that a kidney
`tumor is also a genus of tumors. One
`species of that genus is RCC. A kidney
`tumor can be benign or non-cancerous --
`sorry, benign or cancerous. And RCC is of
`the cancerous type.
` RCC is the only example in the
`specification of the priority application.
`And there are no examples of any other
`types of cancerous tumors and no examples
`of any benign kidney tumors.
` While it is true that RCC is the
`most prevalent, or was understood to be the
`most prevalent type of kidney tumor at that
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 13 of 46
`
`
`
`Page 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
`
` TELEPHONIC PROCEEDINGS
`relevant timeframe, the RCC is not
`representative of the other types of tumors
`that fall in the scope of kidney tumors.
` As I said before, Novartis argues
`that the science here is too complex and
`there is no data in this specification to
`suggest that inhibiting the growth -- that
`whether a drug can inhibit the growth of
`RCC is representative as to whether the
`same drug could inhibit the growth of any
`other kind of kidney tumor.
` Second, the reference to
`genitourinary cancers in the specification
`in the priority application does not
`support the idea that patentee was in
`possession the full scope of kidney tumors.
` As I said before, genitourinary
`cancer at the relevant timeframe was
`ordinarily understood to include kidney
`tumors. But the way that the patentee
`drafted the specifications suggests that
`the genitourinary cancers did not include
`all excretory system tumors, of which is
`one type --
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 14 of 46
`
`
`
`Page 15
`
`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
`
` TELEPHONIC PROCEEDINGS
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`I think ten minutes is up.
` MR. COTTLER: Okay. Thank you.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`Who is speaking for Patent Owner, Novartis?
` MS. SCHWARZ: Christina Schwarz,
`your Honor.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`Ms. Schwarz, you have 15 minutes.
` MS. SCHWARZ: Thank you, your Honor.
`So before getting into the substance, I
`just want to clarify one issue: In the
`e-mail to the Board about the conference as
`well as at the beginning of the conference,
`I think the Board identified the priority
`issue as whether the '131 patent is
`entitled to claim priority to February 19,
`2001 or February 18, 2002. But that second
`date is not correct. It actually should be
`October 17, 2001.
` That's because February 18, 2002 is
`the PCT filing date of the application that
`led to the '131 patent, not the priority
`date. And the Petitioner here has never
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 15 of 46
`
`
`
`Page 16
`
`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
`
` TELEPHONIC PROCEEDINGS
`challenged the February 18, 2002 nor could
`they because that would be a 112 argument.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`Okay. So October 17, 2001 is the target
`date we're looking at?
` MR. COTTLER: No, I am sorry. That
`is not correct.
` The question in this case is what
`the relevant date for determining what is
`prior art. And the dispute is whether it's
`February, 2001, if Novartis can claim
`priority to the earlier application or
`whether it was February, 2002, if it can
`not claim priority to the earlier
`application.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`You can bring that up in your rebuttal
`time.
` MR. COTTLER: Okay, thank you.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
` MS. SCHWARZ: I think we are all on
`the same page here, might just be semantic
`issue. The two priority dates are February
`19, 2001 or October 17, 2001.
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 16 of 46
`
`
`
`Page 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
`
` TELEPHONIC PROCEEDINGS
` If patent owner is not entitled to
`claim priority to either of those dates,
`then the appropriate date is February 18,
`2002.
` Now Patent Owner relied on the same
`disclosures in the February, 2001, and
`October, 2001, priority application, so the
`Board doesn't need to separately consider
`those two dates.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`Okay.
` MS. SCHWARZ: So with respect to
`priority, there's really only one disputed
`issue, and that's whether the GB '072
`priority application discloses the claimed
`tumor types; solid excretory system tumors
`and solid kidney tumors. And the answer to
`that question is yes, because GB '072
`expressly discloses genitourinary tumors.
` That is a category that has two
`subgenera, one of which is urinary
`excretory system tumors, which are the
`claimed solid excretory system tumors.
` Also GB '072 expressly discloses
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 17 of 46
`
`
`
`Page 18
`
`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
`
` TELEPHONIC PROCEEDINGS
`renal cell carcinoma, prostate and bladder
`tumors, each of which is an example of
`solid excretory system tumor.
` So as Mr. Cottler indicated GB '072,
`on page two, discloses everolimus inhibits
`the growth of solid tumors including the
`genitourinary tumors. And the Petitioner's
`expert, Dr. Pantuck, agreed at deposition
`that in 2001, the genitourinary organs were
`understood to include just two categories
`of organs; the reproductive system organs
`and the urinary excretory system organs.
` That is in exhibit 2027, page 65,
`lines two to eight. I will --
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`What was the citation again?
` MS. SCHWARZ: 2027 at page 65, lines
`two to eight.
` I will focus on the urinary
`excretory system organs here.
` Dr. Pantuck agreed at deposition,
`and counsel for Petitioner just agreed as
`well, that the organs of the urinary
`excretory system were known. So there is a
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 18 of 46
`
`
`
`Page 19
`
`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
`
` TELEPHONIC PROCEEDINGS
`bladder, kidney, renal pelvis, ureter,
`urethra and prostate. That is in the
`record in the exhibit 2027 at page 65,
`lines eight to 18 and exhibit 2092 at
`paragraph 106.
` Dr. Pantuck also agreed at
`deposition that tumors arising from the
`urinary excretory system were known. And
`that is in exhibit 2027 at page 234, lines
`five to 21.
` So Dr. Pantuck has admitted that the
`term genitourinary would have been
`understood to disclose two categories of
`organs; one of which is the urinary
`excretory system organs.
` He also admitted that the urinary
`excretory system organs were known and that
`tumors arising from those organs were
`known.
` There is no dispute here that solid
`excretory system tumors as claimed in the
`'131 patent refer to tumors that arise from
`cells of the urinary excretory system.
`That was set forth in the Institution
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 19 of 46
`
`
`
`Page 20
`
`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
`
` TELEPHONIC PROCEEDINGS
`Decision at page ten, and the Petitioner
`agreed at page six of the reply, Paper 39.
` So for these reasons, the reference
`to genitourinary tumors GB '072 on its own,
`clearly constitutes an adequate written
`description of solid excretory system
`tumors.
` But in addition to disclosing
`genitourinary, GB '072 also specifically
`discloses the three most common types of
`solid excretory system tumors; RCC, or
`renal cell carcinoma, prostate tumors and
`bladder tumors. The combination of these
`disclosures meets the written description
`requirement for solid excretory system
`tumors.
` I will turn now to the solid kidney
`tumor claim. In GB '072 also provides
`adequate written description support for
`those claimed tumors. One of ordinary
`skill understands that GB '072's express
`disclosure of genitourinary tumors in
`combination with its express exemplary
`disclosure of its most common type of
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 20 of 46
`
`
`
`Page 21
`
`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
`
` TELEPHONIC PROCEEDINGS
`kidney tumor, describes the claim solid
`kidney tumors.
` To be clear, the Patent Owner is not
`relying on the disclosure of RCC alone for
`written description support of solid kidney
`tumors, but rather on the combination of
`disclosure of genitourinary and the
`specific example RCC.
` As I explained earlier, the term
`genitourinary would be understood to
`include two subgenera; one of which is
`solid excretory system tumors. Solid
`excretory tumors are a small class of
`tumors and there is no dispute that kidney
`tumors fall within that small class.
` The case law supports the disclosure
`of a small genus is disclosure of the
`species within that genus and that's what
`we have here.
` Now the Institution Decision did not
`specifically address whether GB '072's
`disclosure of genitourinary tumors provided
`adequate written description support for
`the '131 claim. The Petitioner's only
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 21 of 46
`
`
`
`Page 22
`
`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
`
` TELEPHONIC PROCEEDINGS
`reply to that disclosure is that GB '072
`specifically defined genitourinary to
`exclude renal cell carcinoma.
` But that argument, which we heard
`for Petitioner today, is unsupported
`attorney argument raised for the first time
`in the reply, which failed to establish
`what GB '072 reasonably conveys to one of
`ordinary skill in the art. It also failed
`to allow the Petitioner to bear its burden
`of persuasion on priority.
` The Petitioner does not point at any
`part of the GB '072 that excludes RCC from
`genitourinary tumors. Rather, one of
`ordinary skill would expect that
`genitourinary was being used in its
`ordinary sense. And the Petitioner's
`expert admitted at deposition that one of
`skill would know that kidney tumors, which
`include RCC, are genitourinary tumors.
` The Federal Circuit has made clear
`that inventors are not required to list
`every detail of their invention in the
`specification because one of ordinary skill
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 22 of 46
`
`
`
`Page 23
`
`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
`
` TELEPHONIC PROCEEDINGS
`comes to the patent with knowledge of what
`has come before. Here because the
`Petitioners admit one of ordinary skill
`would understand the term genitourinary
`tumors to include the claim solid excretory
`tumors and solid kidney tumors, there could
`be no dispute that GB '072 satisfies the
`written description requirement and the
`'131 patent is entitled to claim priority
`to the February, 2001, date of GB '072.
` Now the Petitioner also suggested
`that preclinical and clinical data was
`required to meet the written description
`requirement. But this argument, raised for
`the first time in reply, is pure attorney
`argument and it's not supported by any
`expert testimony.
` It also misses the point. The issue
`for written description is whether one of
`ordinary skill would have understood that
`the inventors were in possession of the
`invention. Here based on the disclosure of
`genitourinary cancer and the three specific
`examples of solid urinary excretory system
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 23 of 46
`
`
`
`Page 24
`
`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
`
` TELEPHONIC PROCEEDINGS
`tumors, the written description requirement
`was clearly satisfied.
` The Petitioner also argued that RCC
`was not representative of all kidney
`tumors. Again, that is a new argument in
`reply that's totally unsupported in the
`reply by any expert testimony. And the
`Patent Owner here is not relying on RCC
`alone as support for the kidney tumor
`claim.
` Petitioner also mentioned that
`genitourinary does not include or does not
`cover benign tumors. Again, that is a new
`argument that's never been raised in the
`petition or the reply.
` And as Dr. Pantuck admitted, for
`each type of tumor disclosed in GB '072,
`both malignant and benign tumors were
`envisaged. And that is exhibit 2027 at
`Page 273, line 20, to Page 274, line two.
` Then one final point on the
`antedating and priority issues -- we will
`discuss antedating later on in this call,
`but those are two separate issues. And
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 24 of 46
`
`
`
`Page 25
`
`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
`
` TELEPHONIC PROCEEDINGS
`even if Patent Owner were not to prevail on
`priority, Patent Owner could still antedate
`Luan. As we will explain, Petitioner never
`addressed antedating issues including the
`cases that Patent Owner relied on for
`antedating in its reply. So to bring them
`up here and distinguish them here would be
`improper.
` If there are no questions from the
`Board, that's it for Patent Owner.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`Thank you very much, Ms. Schwarz.
` Mr. Cottler, you have five minutes.
` MR. COTTLER: Yes, thank you.
` I would point the Board to page 13
`of the petition which does lay out some
`other diagrams dissecting the various types
`of tumors and genuses and species that we
`have been talking about. And I believe
`Patent Owner says that Petitioner never
`argued that the examples disclosed in the
`specification of the priority application
`are not representative of the generic
`claims and the '131 patent. I believe
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 25 of 46
`
`
`
`Page 26
`
`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
`
` TELEPHONIC PROCEEDINGS
`pages 13 and 14 make that very argument.
` I think a moment ago Ms. Schwarz
`said a lot of things that are not in
`dispute. What was -- what types of tumors
`were understood to be genitourinary tumors
`to a person skilled in the art was not
`disputed. It would have included excretory
`tumors, such as the kidney and bladder.
` But in the specification of the
`priority application, the patentee did
`redefine what is understood -- they
`redefined what genitourinary means by
`separating out RCC from the scope of
`genitourinary cancers.
` In other words, genitourinary
`cancers doesn't include kidney tumors. And
`given the omission of kidney tumors from
`the list of genitourinary cancers a POSA
`would be to believe that the patentee
`wasn't looking to tell the world that it
`was trying to disclose the use of
`everolimus for inhibiting the growth of all
`excretory system tumors.
` Again, getting back to this issue
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 26 of 46
`
`
`
`Page 27
`
`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
`
` TELEPHONIC PROCEEDINGS
`about whether the examples disclosed in the
`specification are representative of the
`full scope of the challenged claims, I
`didn't hear Patent Owner make any argument
`as to why the tumors disclosed are in fact
`representative of the full scope of the
`challenged claim.
` Again, Patent Owner is arguing that
`these were complex times, in that bolsters
`that idea that the examples disclosed in
`the specification are not representative of
`the full scope of tumors that Patentee now
`attempts to claim.
` Unless the Board has any questions,
`I think that's it for me.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`Thank you, Mr. Cottler. I don't think we
`have any questions right now.
` We can move on to Patent Owner's
`time. Counsel, you have 15 minutes to
`present your case with respect to
`antedating Luan and the exclusion of
`Dr. Komanduri's declaration.
` Would you like to reserve time for
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 27 of 46
`
`
`
`Page 28
`
`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
`
` TELEPHONIC PROCEEDINGS
`rebuttal?
` MS. SCHWARZ: Yes, your Honor. I
`would like to reserve five minutes please.
` ADMINISTRATIVE PATENT JUDGE POLLOCK:
`You are on the clock for ten.
` MS. SCHWARZ: I will start with the
`issue of Petitioner's motion to exclude
`Dr. Komanduri's declaration.
` There are two main reasons to deny
`that motion: There is no dispute that
`Dr. Komanduri is an expert in the treatment
`of patients with lymphoproliferative
`disorders, including lymphomas or liquid
`tumors, which is the subject of Wasik,
`Exhibit 1002.
` The first reason to deny
`Petitioner's motion is that the Petitioner
`argues the Dr. Komanduri declaration is
`inadmissible because he lacks the several
`years of specialized expertise that a
`person of ordinary skill would have. But
`as a factual matter, the Petitioner's
`argument is contradicted by its own expert.
` Dr. Pantuck admitted at deposition,
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 28 of 46
`
`
`
`Page 29
`
`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
`
` TELEPHONIC PROCEEDINGS
`a person of ordinary skill would have some
`education, training and experience with
`liquid tumors. That is in Exhibit 2113 at
`Page 19, lines four to eleven.
` The Petitioner admits Dr. Komanduri
`had those qualifications. That is on Paper
`55 at pages two to three.
` Also at deposition, Dr. Pantuck
`admitted a person of ordinary skill could
`consult with someone having experience
`treating liquid tumors. That is in Exhibit
`2113 at Page 20, line 13 to 19.
` So there is no dispute that a person
`of ordinary skill here could consult with
`someone with Dr. Komanduri's expertise.
` For these reasons, Dr. Komanduri is
`qualified to offer expert testimony on the
`treatment of liquid tumors, which is the
`subject of the Wasik reference in grounds
`one, two and three.
` The second reason to deny
`Petitioner's motion is that even if
`Dr. Komanduri does not meet every aspect of
`the definition of person of ordinary skill,
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 29 of 46
`
`
`
`Page 30
`
`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
`
` TELEPHONIC PROCEEDINGS
`his declaration is helpful to understanding
`the Wasik reference and is therefore
`admissible.
` The Patent Owner has offered
`Dr. Komanduri's declaration on the subject
`of Wasik. There is no dispute that Wasik
`generally relates to lymphoproliferative
`disorders, including liquid tumors.
`Petitioner admits this in Paper 39 at page
`18.
` There is no dispute that
`Dr. Komanduri is an expert on that very
`subject. Because of his expertise of the
`very subject of Wasik, Dr. Komanduri's
`declaration will help the Board understand
`the reference and the Petitioner has never
`suggested otherwise. Instead, the
`Petitioner says that Dr. Komanduri's
`experience has to perfectly match its new
`and revised definition of a person of
`ordinary skill that was set forth in the
`reply.
` I just note that the Petitioner
`revised its definition in the reply fully
`
`TSG Reporting - Worldwide 877-702-9580
`
`NOVARTIS EXHIBIT 2115
`West-Ward v. Novartis, IPR 2017-01592
`Page 30 of 46
`
`
`
`Page 31
`
`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
`
` TELEPHONIC PROCEEDINGS
`in an attempt to exclude Dr. Komanduri.
`Even if the new, revised definition of
`person of ordinary skill were to apply, the
`Board's Revised Trial Practice Guide at
`Page 3, clearly states there is no
`requirement for a perfec
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
