Paper No. __
`Filed: June 30, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
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`COALITION FOR AFFORDABLE DRUGS VI LLC
`
`Petitioner,
`
`v.
`
`CELGENE CORPORATION
`
`Patent Owner
`
`________________
`
`Case IPR2015-01102
`Patent 6,315,720
`________________
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`PATENT OWNER OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE
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`Filed: June 30, 2016
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`
`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`COALITION FOR AFFORDABLE DRUGS VI LLC
`
`Petitioner,
`
`v.
`
`CELGENE CORPORATION
`
`Patent Owner
`
`________________
`
`Case IPR2015-01102
`Patent 6,315,720
`________________
`
`
`
`
`
`
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`
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`PATENT OWNER OPPOSITION TO
`PETITIONER’S MOTION TO EXCLUDE
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`Patent Owner Opposition to Motion to Exclude
`
`Case IPR2015-01102
`Patent 6,315,720
`
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`Patent Owner Celgene Corporation (“Celgene”) hereby opposes Petitioner
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`Coalition for Affordable Drugs VI LLC’s (“CFAD”) motion to exclude certain
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`testimony from its declarant, Dr. Jeffrey Fudin, and Celgene’s reliance on the same
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`in its Patent Owner Response. See Paper 63.
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`CFAD seeks to exclude highly relevant testimony in which Dr. Fudin
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`admitted that CFAD’s proposed person of ordinary skill in the art (“POSA”) would
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`not have been able to design or implement the claimed inventions. See id.
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`According to CFAD, the testimony that it seeks to exclude is irrelevant
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`because Celgene allegedly argues that the challenged patent “claims systems, when
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`in fact [it] only claims methods for delivering a drug to a patient.” Id. at 1.
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`CFAD’s motion relies on the false premise that Dr. Fudin was “confus[ed]”
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`regarding Celgene’s alleged “undefined reference to ‘systems’” during Dr. Fudin’s
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`deposition. Id. at 2. But as explained below, the full testimony that CFAD seeks
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`to exclude shows that there was no such confusion. Nor were the “system[s]”
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`discussed during Dr. Fudin’s deposition “undefined,” as CFAD alleges. Id.
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`Dr. Fudin understood the questions, and also understood what is claimed in the
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`challenged patent; he simply answered Celgene’s questions in a way that harms
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`CFAD’s case by demonstrating that CFAD’s proposed POSA is incorrect.
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`Indeed, Celgene started the line of questioning that CFAD seeks to exclude
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`by clearly defining what is claimed and what is meant by “system[s]” within the
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`- 1 -
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`
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`Patent Owner Opposition to Motion to Exclude
`
`Case IPR2015-01102
`Patent 6,315,720
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`testimony:
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`Q. But let me be clear. The claims of the patent are talking about
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`methods that involve distribution from start to finish, from the
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`manufacturer to the patient, right?
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`A. Yes.
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`Q. Okay. If we’re designing such a system for dangerous drugs and
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`the goal and the focus of the entire patent is on avoiding adverse
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`events associated with such dangerous drugs, right?
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`A. Right.
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`Q. If we’re looking at who the POSA is in that circumstance, I’m
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`trying to understand why you think in that circumstance all we need is
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`a pharmacy – a pharmacist?
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`A. Because the pharmacist doesn’t need to design those systems.
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`The pharmacist needs to know how to use those systems in real time.
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`And they use those systems.
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`*
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`*
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`*
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`Q. So your pharmacist POSA does not need to be able to design the
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`full system claimed in the ’501 patent?
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`A. They don’t need to know how to design it, no.
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`Q. And they don’t need to know how to design the full system
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`claimed in the ’720 patent?
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`A. No.
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`*
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`*
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`*
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`Q. And you had said your POSA did not need to be able to design the
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`claimed systems, right?
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`A. Yes.
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`- 2 -
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`Patent Owner Opposition to Motion to Exclude
`
`Case IPR2015-01102
`Patent 6,315,720
`
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`Ex. 2061 at 199:10-200:3, 201:1-10, 328:25-329:2 (emphasis added). Thus,
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`the use of “system[s]” clearly refers to the claimed methods because Celgene
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`referred to the claimed methods as “such a system.” Dr. Fudin was not
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`confused. At no point did he say or even indicate that he was unsure about
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`whether the “system[s]” being discussed were explicitly referring to the
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`claimed methods.
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`Instead, Dr. Fudin admitted that the claims of the patents-at-issue cover
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`certain systems for controlling distribution of dangerous drugs like thalidomide:
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`Q. You don’t have any reason to believe that the three systems we’re
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`talking about here – original S.T.E.P.S., S.T.E.P.S., Enhanced
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`S.T.E.P.S., and the Thalomid REMS – you don’t have any reason to
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`believe that the claims of the ’501 and ’720 patent do not cover those
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`three specific systems, right?
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`A. I believe they’re all covered.
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`Ex. 2061 at 73:1-8. Dr. Fudin unequivocally understood what is claimed.1
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`Instead of acknowledging Dr. Fudin’s understanding, CFAD seeks to
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`conflate the fact that he did not know why he was being asked if CFAD’s proposed
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`1 Notably, Dr. Fudin alleges that his expertise is in distribution systems, further
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`emphasizing that methods and systems for restricting distribution of dangerous
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`pharmaceuticals are interchangeable in this case. See Ex. 1027 ¶13.
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`- 3 -
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`
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`Patent Owner Opposition to Motion to Exclude
`
`Case IPR2015-01102
`Patent 6,315,720
`
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`POSA could design the claimed inventions (see Paper 63 at 2 (citing Ex. 2061 at
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`200:4-17)) with his understanding of what the claimed “system” was. But as
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`evidenced from the testimony, Dr. Fudin clearly understood what was claimed and
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`what he was being asked regarding the claims, and whether his proposed POSA
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`could have designed what is claimed. CFAD’s motion should be denied. See
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`Ariosa Diagnostics v. Isis Innovation Ltd., IPR2012-00022, 2014 WL 4381564, at
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`*33-34 (Sept. 2, 2014) (denying motion to exclude declarant testimony that was
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`premised on alleged witness confusion).
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`Indeed, if anything, the fact that Dr. Fudin did not understand why he was
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`being asked certain questions merely highlights his unfamiliarity with how to
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`define a POSA. Indeed, Dr. Fudin testified that he arrived at his definition of a
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`POSA by “Googl[ing] it,” or going “back to a previous deposition and look[ing] at
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`what [he] put down as a POSA.” See Ex. 2061 at 161:17-163:12.
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`Here, Dr. Fudin repeatedly admitted that CFAD’s proposed POSA would
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`not have been capable of designing or implementing the claimed inventions. See
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`id. at 193:12-194:10, 201:1-10, 246:17-247:2, 328:19-329:9. Instead, as CFAD
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`admits, at most, Dr. Fudin testified that CFAD’s proposed POSA allegedly
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`“‘could’ design successful methods for risk management in delivering medication
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`by drawing upon the support of a ‘multi-disciplinary team.’” See Paper 63 at 2-3.
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`- 4 -
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`Patent Owner Opposition to Motion to Exclude
`
`Case IPR2015-01102
`Patent 6,315,720
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`Of course, this has nothing to do with his proposed POSA or the specific claims at
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`issue here.
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`Federal Circuit law requires that the POSA be able to develop the claimed
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`invention. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1257 (Fed. Cir.
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`2007). Whether CFAD’s proposed POSA could design an unspecified “risk
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`management program that was successful” is irrelevant to whether the POSA could
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`design the inventions at issue here. In contrast, the testimony that CFAD seeks to
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`exclude is directly relevant to whether CFAD’s proposed POSA would have been
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`able to develop the claimed inventions and, thus, directly relevant to who is the
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`correct POSA. CFAD’s motion should be denied.
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`- 5 -
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`Patent Owner Opposition to Motion to Exclude
`
`Case IPR2015-01102
`Patent 6,315,720
`
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`Date: June 30, 2016
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` Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` Andrew S. Chalson (pro hac vice)
` Eric C. Stops (Reg. No. 51,163)
` Frank C. Calvosa (Reg. No. 69,064)
` QUINN EMANUEL URQUHART &
` SULLIVAN, LLP
` 51 Madison Avenue, 22nd Floor
` New York, NY 10010
` Tel: (212) 849-7000
` Fax: (212) 849-7100
` nickcerrito@quinnemanuel.com
` ericstops@quinnemanuel.com
` andrewchalson@quinnemanuel.com
` frankcalvosa@quinnemanuel.com
`
`Anthony M. Insogna (Reg. No. 35,203)
`J. Patrick Elsevier (Reg. No. 44,668)
`JONES DAY
`12265 El Camino Real
`Suite 200
`San Diego, CA 92130
`Tel: (858) 314-1200
`Fax: (858) 314-1150
`aminsogna@jonesday.com
`jpelsevier@jonesday.com
`
`Gasper J. LaRosa
`JONES DAY
`222 E 41st Street
`New York, NY 10017
`Tel: (212) 326-3939
`Fax: (212) 755-7306
`gjlarosa@jonesday.com
`
`Attorneys for Celgene Corporation
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`- 6 -
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`COALITION FOR AFFORDABLE DRUGS VI LLC
`
`Petitioner,
`
`v.
`
`CELGENE CORPORATION
`
`Patent Owner
`
`________________
`
`Case IPR2015-01102
`Patent 6,315,720
`________________
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`CERTIFICATE OF SERVICE
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that PATENT
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`OWNER OPPOSITION TO MOTION TO EXCLUDE was served on June 30,
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`2016 by filing this document through the Patent Review Processing System, as
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`well as e-mailing a copy to sabdullah@skiermontderby.com,
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`sspires@skiermontderby.com, pkota@skiermontderby.com, and
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` Respectfully submitted,
`
`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` QUINN EMANUEL URQUHART &
` SULLIVAN, LLP
` 51 Madison Avenue, 22nd Floor
` New York, NY 10010
` General Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`
`Lead Counsel for
`Celgene Corporation
`
`
`
`pskiermont@skiermontderby.com.
`
`
`Date: June 30, 2016
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