IPR2019-00400
`Patent 8,633,194
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`APOTEX INC.
`Petitioner,
`
`v.
`
`UCB BIOPHARMA SPRL,
`Patent Owner.
`______________
`
`Case IPR2019-00400
`Patent 8,633,194
`______________
`
`[CORRECTED] PATENT OWNER’S
`OBJECTIONS TO PETITIONER’S DEMONSTRATIVES
`
`
`Patent 8,633,194
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
`
`APOTEX INC.
`Petitioner,
`
`v.
`
`UCB BIOPHARMA SPRL,
`Patent Owner.
`______________
`
`Case IPR2019-00400
`Patent 8,633,194
`______________
`
`[CORRECTED] PATENT OWNER’S
`OBJECTIONS TO PETITIONER’S DEMONSTRATIVES
`
`
`
`
`
`IPR2019-00400
`Patent 8,633,194
`
`Pursuant to the Board’s March 11, 2020 Order (Paper No. 41), Patent Owner
`
`
`
`respectively submits notice of its objections to Petitioner’s Demonstratives:
`
`Slides 12, 13, 30, and 33: These slides reference Exhibits 1031-1037 which
`
`are subject to Patent Owner’s pending Motion to Exclude Evidence (Paper No. 44).
`
`Slide 19: The third and fourth callouts mischaracterize Dr. Niazi’s deposition
`
`testimony and Patent Owner’s Preliminary Response, respectively, as explained in
`
`Patent Owner’s Sur-Reply (Paper No. 38). Id. at 5.
`
`The third callout omits context from Patent Owner’s expert’s explanation that
`
`the term “necessary amount” refers to an amount to perform a particular function,
`
`not an absolute minimum. Id.
`
`The fourth callout mischaracterizes Patent Owner’s summation of Petitioner’s
`
`argument by implying that a Table heading is an admission by Patent Owner. Id.
`
`Slide 32: This slide seeks to improperly incorporate argument presented only
`
`in Petitioner’s expert declaration to imply that it was presented in the Petition.
`
`Slide 35: The first callout is incomplete and therefore mischaracterizes Patent
`
`Owner’s Complete Response as it omits the remainder of the footnote cited, which
`
`explains how Applicant did not concede to the Examiner’s view of synergism.
`
`The last callout is a mischaracterization of Patent Owner’s Preliminary
`
`Response. As explained in Patent Owner’s Sur-Reply, the callout is Patent Owner’s
`
`summation of the Examiner’s prosecution statements, and Petitioner portrays it as
`
`1
`
`
`
`
`
`
`
`an admission by Patent Owner. See id. at 18.
`
`IPR2019-00400
`Patent 8,633,194
`
`
`Patent Owner submits that it is not necessary to have a pre-hearing call or
`
`additional time at the hearing to address Patent Owner’s objections.
`
`
`Dated: April 17, 2020
`
`
`
`
`
`Respectfully submitted,
`
`FENWICK & WEST LLP
`/Robert E. Counihan/ (electronically signed)
`James S. Trainor, Reg. No. 52,297
`Lead Counsel
`
`Robert E. Counihan, Reg. No. 61,382
`Back-Up Counsel
`
`FENWICK & WEST LLP
`902 Broadway, Suite 14
`New York, NY 10010
`(212) 430-2600
`jtrainor@fenwick.com
`rcounihan@fenwick.com
`
`Erica R. Sutter, Reg. No. 77,450
`Back-Up Counsel
`
`FENWICK & WEST LLP
`801 California Street
`Mountain View, CA 94041
`(650) 988-8500
`esutter@fenwick.com
`
`Counsel for Patent Owner UCB Biopharma
`Sprl
`
`2
`
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`IPR2019-00400
`Patent 8,633,194
`
`
`Pursuant to 37 C.F.R. § 42.6(e), I hereby certify that on April 17, 2020, the
`
`foregoing document is being served by filing this document through the Patent Trial
`
`and Appeal Board End to End System, as well as by delivering a copy via electronic
`
`mail upon the following counsel of record for the Petitioner:
`
`
`
`
`
`
`
`
`
`jitty.malik@kattenlaw.com
`alissa.pacchioli@kattenlaw.com
`joe.janusz@kattenlaw.com
`lance.soderstrom@kattenlaw.com
`
`
`Date: April 17, 2020
`
`
`Respectfully submitted,
`
`/Robert E. Counihan/
`Robert E. Counihan
`Reg. No. 61,382
`Phone: (212) 430-2600
`
`
`
`
`
`
`
`9:1 Ratio is “Widely Used”
`
`Niazi Dec. (EX2034) ¶162
`
`EX1031, (entry #4); EX1034,99
`
`12
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`12
`
`
`
`9:1 Ratio is “Widely Used”
`
`Prior Art Niazi Series has a total of 33 other examples of 9:1 formulations in all dosage forms
`
`Niazi Series (EXS 1031-37)
`
`13
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`13
`
`
`
`Minimizing Parabens
`
`“All useful antimicrobial agents are toxic substances.” EX2020, 1870
`
`Dr. Laskar: The POSA would “use as little of a particular compound as
`possible to achieve the desired effect.” Laskar Dec. (EX1002) ¶102-103; EX2010,
`45:12-46:5, 143:5-22
`
`Dr. Niazi: “[A] POSA would not put anything which is more than necessary.” Dr. Niazi: “[A] POSA would not put anything which is more than necessary.”
`
`Niazi Dep. (EX1043) 74:22-23
`
`UCB: “A formulation scientist would know to minimize the number of
`parabens present in the formulation.” PORP, 16
`
`19
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`19
`
`
`
`No 9:1 Examples in the Niazi Series
`Contained 4mg/ml of methylparaben or 1 mg/ml propylparben
`
`EX1031; EX1043 (Niazi Dep) 218:9-18, 224:23-227:10
`
`30
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`30
`
`
`
`Reasonable Expectation of Success
`
`Laskar Dec. (EX1002) ¶94; Petition at 26
`
`32
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`32
`
`
`
`Reasonable Expectation of Success
`
`UCB Response (Paper 34) at 14
`
`Dr. Niazi cannot contend otherwise since the Niazi Series contains 33 the
`prior art formulations having a 9:1 ratio of methylparaben to
`propylparaben, with some having paraben amounts falling within the
`challenged claims.
`
`Apotex Reply (Paper 34) at 12; EX1031-37
`
`33
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`33
`
`
`
`The Combination of Methyl and Propyl Paraben
`is Synergistic
`
`UCB to the PTAB: “As the Board noted, during prosecution, the ’194
`Applicants did not challenge the Examiner’s reference to an alleged
`“antibacterial synergistic effect” of parabens in Doren (EX2003).”
`
`UCB Response (Paper 22) at fn. 4
`
`PTAB: UCB did not dispute the Examiner’s finding that the combination of
`methylparaben and propylparaben is synergistic.
`
`Institution Decision, n.11
`
`UCB to the PTAB: “[Gilliland II] too teaches that methylparaben and
`propylparaben have synergistic effects and provides data on their effect on e.
`coli.”
`
`UCB’s POPR, 11
`
`35
`
`DEMONSTRATIVE EXHIBIT – NOT EVIDENCE
`
`35
`
`
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