IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX INC.
`Petitioner,
`v.
`UCB BIOPHARMA SPRL
`Patent Owner.
`U.S. Patent No. 8,633,194 to Fanara et al.
`Issue Date: January 21, 2014
`Title: Pharmaceutical Composition of Piperazine Derivatives
`Inter Partes Review No.: IPR2019-00400
`
`PETITIONER’S RESPONSE TO PATENT OWNER’S MOTION TO
`EXCLUDE EVIDENCE PURSUANT TO 37 C.F.R. § 42.64(c)
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`APOTEX INC.
`Petitioner,
`v.
`UCB BIOPHARMA SPRL
`Patent Owner.
`U.S. Patent No. 8,633,194 to Fanara et al.
`Issue Date: January 21, 2014
`Title: Pharmaceutical Composition of Piperazine Derivatives
`Inter Partes Review No.: IPR2019-00400
`
`PETITIONER’S RESPONSE TO PATENT OWNER’S MOTION TO
`EXCLUDE EVIDENCE PURSUANT TO 37 C.F.R. § 42.64(c)
`
`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`
`Page
`Introduction ...................................................................................................... 1
`a.
`Legal standards ...................................................................................... 3
`b.
`Rule 45.51(b)(1)(iii) Makes the Excerpts from the Niazi Series
`(EX1032-1037) an Intractable Part of this Proceeding ......................... 5
`The PTAB Should Find that UCB Cannot Object to
`EX1032-1037 ........................................................................................ 7
`Neither Rule 1002 or 1004 Warrants Exclusion ................................... 7
`The PTAB Should Deny UCB’s Unauthorized Motion to
`Compel ................................................................................................10
`The PTAB Should Not Take Judicial Notice of Certain Facts
`about Exhibits 1032-1037 and 1041 or Accept UCB’s “Offer of
`Proof” ..................................................................................................12
`CONCLUSION ..............................................................................................13
`
`c.
`
`d.
`e.
`
`f.
`
`i
`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Amneal Pharmaceuticals, LLC et al. v. Almirall, LLC,
`IPR2019-00207, Paper 39 (P.T.A.B. Dec. 31, 2019) ................................... 5, 7, 9
`Garmin Int’l, Inc. v. Cuozzo Speed Techs. LLC,
`IPR2012-00001, Paper 26 (June 11, 2013) ......................................................... 10
`Nicha Corp. v. Emcore Corp.,
`IPR2012-00005, Paper 19 (P.T.A.B. Mar. 26, 2013) ................................... 5, 7, 9
`Rules
`Fed. R. Evid. 1002 ................................................................................................. 5, 7
`Fed. R. Evid. 1004 ......................................................................................... 5, 7, 8, 9
`Regulations
`37 C.F.R. § 42.7(a) ................................................................................................... 10
`37 C.F.R. § 42.52 ..................................................................................................... 10
`37 C.F.R. § 42.62(a) ............................................................................................... 3, 4
`37 C.F.R. § 45.51(2) ................................................................................................ 12
`37 C.F.R. § 45.51(b)(1)(iii) ...............................................................................passim
`
`ii
`
`
`
`I.
`
`INTRODUCTION
`
`UCB is seeking to exclude damaging excerpts from the prior art book series
`
`of its own expert—Dr. Niazi. That cannot be understated, because UCB’s motion
`
`seeks no more than to allow UCB to ignore those impeaching excerpts while at the
`
`same time advancing the Niazi Declaration for the truth in support of its tenuous
`
`validity positions. This approach should not be condoned.
`
`Dr. Niazi was very aware of the content in the Niazi Series before he
`
`submitted his Declaration in this proceeding. EX1043, 220:1-221:21, 266:19-21.1
`
`Moreover, there is no dispute that a POSA in this matter would have used the Niazi
`
`Series. EX1043, 262:16-19; 8:22-9:2. Dr. Niazi must have known (or should have
`
`known) that the information in the Niazi Series conflicted with the positions he
`
`was advancing in this proceeding. Whether deliberately, or through sheer
`
`negligence on the part of Dr. Niazi, the excerpts of the Niazi Series were withheld
`
`1 To eliminate any doubt as to Dr. Niazi’s exhaustive understanding of the contents
`
`of the Niazi Series, when Dr. Niazi provided his PTAB Declaration (October 14,
`
`2019), the 3rd Ed. of the Niazi Series was scheduled to come out a week after
`
`Dr. Niazi’s deposition in this proceeding. EX1040, EX1043, 180:4-6, 220:7-
`
`221:10; 242:21-243:11. To that end, Dr. Niazi had been laboriously editing the
`
`Niazi Series during “all” of 2019. EX1043, 220:17-221:7.
`
`1
`
`
`
`in violation of 37 C.F.R. § 45.51(b)(1)(iii) which then allowed UCB and Dr. Niazi
`
`to advance factually misleading or simply untrue opinions and statements to the
`
`PTAB in the Niazi Declaration. EX2034.
`
`For example, the Niazi Series contained no less than 33 prior art
`
`formulations having a 9:1 ratio of methylparaben to propylparaben. EX1031,
`
`EX1032-1037, EX1043, 171:16-172:14, 173:15-175:19. Yet, when opining that
`
`such a 9:1 ratio would not have been obvious, Dr. Niazi made no mention of his
`
`awareness of these 33 prior art 9:1 formulations. The Niazi Series also reported
`
`the prior art 9:1 ratio of methylparaben to propylparaben formulation of the
`
`cetirizine hydrochloride syrup. EX1031 (entry #4); EX1034, 99; EX1043, 185:9-
`
`25. Further, Dr. Niazi stated that he was unaware of any prior art examples where
`
`the combined amount of methyl and propyl paraben was less than 2 mg/mL; the
`
`Niazi Series exemplified no less than seven such prior art examples. EX2034,
`
`¶184; EX1031; EX1043, 215:24-217:3, 239:16-22. In addition to impeaching
`
`numerous other material propositions, the Niazi Series showed that Dr. Niazi
`
`ignored certain material facts about UCB’s commercial cetirizine hydrochloride
`
`formulation. EX1031, (entry #4); EX1034, 99; EX1043, 185:9-25, 264:22-25.
`
`Specifically, Dr. Niazi suspected that the Niazi Series’ 9:1 prior art cetirizine
`
`hydrochloride formulation was UCB’s cetirizine hydrochloride formulation, but
`
`refused to confirm such facts with UCB. EX1043, 181:7-9, 184:5-12. Apotex,
`
`2
`
`
`
`through its own diligence, located the Niazi Series (EX1032-1037), proceeded to
`
`cross-examine Dr. Niazi, and in the process impeached almost every material
`
`proposition Dr. Niazi tried to advance.
`
`Under Rule 45.51(b)(1)(iii), UCB and Dr. Niazi should have produced the
`
`excerpts from the Niazi Series (EX1032-1037) that UCB is now seeking to exclude
`
`at the time it “serve[d]” the Niazi Declaration; Rule 45.51(b)(1)(iii) made the
`
`excerpts from the Niazi Series (EX1032-1037) part of this proceeding from the
`
`minute UCB served the Niazi Declaration. Apotex’s use of EX1032-1037 during
`
`the deposition of Dr. Niazi is hardly improper.
`
`a. Legal standards
`UCB states “[t]he Federal Rules of Evidence govern the admissibility of
`
`evidence and expert testimony in an inter partes review. 37 C.F.R. § 42.62(a).”
`
`Paper 44 at 1. The text of Rule 42.62(a) states, “[e]xcept as otherwise provided
`
`in this subpart, the Federal Rules of Evidence shall apply to a proceeding.” The
`
`reference to “subpart” in 37 C.F.R. § 42.62(a) is a reference to the “Subpart A-
`
`Trial Practice and Procedure” of the Code of Federal Regulations on found the
`
`USPTO
`
`website
`
`https://www.uspto.gov/web/offices/pac/mpep/consolidated_rules.pdf
`
`(reproduced
`
`below) on page R-417:
`
`3
`
`
`
`What Rule 42.62(a) actually states is that the Federal Rules of Evidence
`
`govern “except” where another rule is provided under “37 C.F.R. Subpart A - Trial
`
`Practice and Procedure.” Rule 45.51(b)(1)(iii), which falls under “37 C.F.R.
`
`Subpart A - Trial Practice and Procedure”, states:
`
`Unless previously served, a party must serve relevant
`information that is inconsistent with a position advanced
`by the party during the proceeding concurrent with the
`filing of the documents or things that contains the
`inconsistency. . . . This requirement extends to inventors,
`corporate officers, and persons
`involved
`in
`the
`preparation or filing of the documents or things.
`
`4
`
`
`
`The PTAB has repeatedly explained that provisions of Rule 45.51(b)(1)(iii)
`
`are self-executing and do not require assistance from the PTAB. Nicha Corp. v.
`
`Emcore Corp., IPR2012-00005, Paper 19 at 2 (P.T.A.B. Mar. 26, 2013) (“37
`
`C.F.R. § 41.51(b)(1)(iii). . . . places the burden upon Nichia to come forward and
`
`serve
`
`information
`
`inconsistent with
`
`a position
`
`advanced.”); Amneal
`
`Pharmaceuticals, LLC et al. v. Almirall, LLC, IPR2019-00207, Paper 39 at 2
`
`(P.T.A.B. Dec. 31, 2019) (“By rule. . . if not previously served, evidence relevant
`
`to information inconsistent with a position advanced by the producing party during
`
`the proceeding”). The rule and applicable guidance are clear— “persons involved
`
`in the preparation . . . of the documents” (i.e., Dr. Niazi) must “serve”
`
`information that is relevant and inconsistent with a position that person advanced
`
`in any “document”.
`
`b. Rule 45.51(b)(1)(iii) Makes the Excerpts from the Niazi Series
`(EX1032-1037) an Intractable Part of this Proceeding
`Whether UCB chooses to analyze the issue under FRE Rule 1002 or
`
`Rule 1004 (Paper 44 at 2-3), UCB ignores the fact that in this context, the
`
`provisions of Rule 45.51(b)(1)(iii) supersede FRE Rule 1002 and/or Rule 1004.
`
`Rule 45.51(b)(1)(iii) only requires service (from UCB) of information that “is
`
`inconsistent with a position advanced by the party during the proceeding.” Had
`
`Dr. Niazi and UCB abided by the mandate of Rule 45.51(b)(1)(iii), they would
`
`5
`
`
`
`have served the excerpts labeled as EX1032-1037 when they “serve[d]” the Niazi
`
`Declaration. Put another way, the only information that falls within the purview of
`
`Rule 45.51(b)(1)(iii) is the subset of information that is inconsistent and
`
`contradictory to Dr. Niazi’s Declaration, i.e., EX1032-1037.
`
`Therefore, the excerpts of the Niazi Series labelled as EX1032-1037 should
`
`have become part of this proceeding the minute UCB served the Niazi Declaration
`
`on October 15, 2019—and UCB should have “serve[d]” them on Apotex, not the
`
`other way around. There is no Rule UCB can cite that supplants Rule
`
`45.51(b)(1)(iii). Because of the violation of Rule 45.51(b)(1)(iii), Apotex had to
`
`put EX1032-1037 into the record, but under Rule 45.51(b)(1)(iii) the excerpts
`
`represented as EX1032-1037 are the correct portions of the Niazi Series.2
`
`2 Even under the direction of UCB’s counsel, Dr. Niazi could not dispute that the
`
`formulations provided in Vols. 3 and 5 of the Niazi Series were relevant to the
`
`challenged claims. EX1043, 256:17-25, 257:16-258:15, 264:22-25. Furthermore,
`
`Dr. Niazi was aware of the content of the Niazi Series. EX1043, 220:1-221:21,
`
`266:19-21. There is little doubt that the contents of the Niazi Series call into
`
`question the veracity of Dr. Niazi and the Niazi Declaration. Supra. Apotex’s
`
`Reply Complete Response (Paper 34) repeatedly highlighted these very issues, and
`
`Patent Owner’s Sur-Reply to Petitioner’s Response (Paper 38) had no real
`
`6
`
`
`
`c. The PTAB Should Find that UCB Cannot Object to EX1032-1037
`Had UCB and Dr. Niazi been following Rule 45.51(b)(1)(iii), UCB would
`
`have produced as exhibits the excepts of the Niazi Series labelled as EX1032-1037.
`
`Nichia Corp., IPR2012-00005 at 2 (“37 C.F.R. § 41.51(b)(1)(iii). . . . places the
`
`burden upon Nichia to come forward and serve information inconsistent with a
`
`position advanced.”); Amneal Pharmaceuticals, IPR2019-00207 at 2. UCB could
`
`hardly object to its own exhibits. Given the impeaching subject matter, Apotex
`
`certainly would not have objected to UCB’s exhibits (i.e., what are now labelled as
`
`EX1032-1037). Therefore, the PTAB should find that UCB cannot object to
`
`EX1032-1037 because ordinarily those would have been UCB exhibits.
`
`d. Neither Rule 1002 or 1004 Warrants Exclusion
`Putting aside the fact that UCB’s Motion ignores the mandates of Rule
`
`45.51(b)(1)(iii) that required UCB to produce what are now labelled as EX1032-
`
`1037, neither Rule 1002 or 1004 warrant exclusion. With respect to Rule 1002,
`
`UCB points to no place in the record where such an objection was timely made.
`
`Paper 44 at 2. In any event, EX1032-1037 and EX1041 are photocopies of
`
`response. Because the information contained in the excerpts of the Niazi Series is
`
`inconsistent with Dr. Niazi’s Declaration, under Rule 45.51(b)(1)(iii) those
`
`excerpts should have been “serve[d]” on October 14, 2019 and are necessarily part
`
`of this proceeding.
`
`7
`
`
`
`excerpts from the original Niazi Series. They were put in front of Dr. Niazi—the
`
`sole author of the Niazi Series EX2034, ¶9, EX1043, 171:16-175:19. Dr. Niazi
`
`(i.e., the author) did not question their accuracy or dispute that the photocopies
`
`were true and original copies. Id.
`
`Regarding Rule 1004, and as an initial matter, Apotex disagrees that any
`
`objection was made timely. The excerpts from Niazi Series were introduced at
`
`page 170:16 of Dr. Niazi’s Deposition transcript (EX1043), and Apotex examined
`
`him on those excerpts for the remainder of the deposition. For its alleged
`
`objections, UCB points to the following pages: “172:7-12, 243:19-244:12.” Paper
`
`44 at 2. The complete text of the objection on page 172:7-12 is reproduced below:
`
`Just before you continue, we reserve the right to object to
`these, and this chart that you had, and I’m sorry, you kind
`of flew through those and I lost track of which one was
`the chart. Hearsay.
`
`There is no objection based on FRE 1004. After having cross examined
`
`Dr. Niazi for 70 pages, UCB then made an incomplete objection on pages 243:19-
`
`244:12. That is not a timely objection. Apotex made that very point on the record.
`
`EX1043 at 244:4-18. For that matter, the fact that UCB had to make an untimely
`
`objection 70 pages after the excerpts from the Niazi Series were first introduced,
`
`indicates the original objection on page 172:7-12 was insufficient.
`
`8
`
`
`
`Again, putting aside Rule 45.51(b)(1)(iii) which mandates introduction of
`
`inconsistent portions of the excerpts of Niazi Series by UCB (Nichia Corp.,
`
`IPR2012-00005; Amneal Pharmaceuticals, IPR2019-00207 at 2), the purpose of
`
`Rule 1004 is to put evidence into proper context. The purpose of Rule 1004 is not
`
`to fill up the record with extraneous information in an attempt to obscure the issues
`
`to be adjudicated. Dr. Niazi testified that since he had a Word™ copy of the Niazi
`
`Series, he searched for relevant formulations before submitting his Declaration
`
`explaining that his search was “[a] very simple exercise.” EX1043, 220:1-221:21;
`
`id. at 221:18-22 (“Q. Did it occur to you to do that on your 2000 formulations, just
`
`simply search for it? A. I did.”). Furthermore, Dr. Niazi maintained that he had not
`
`forgotten about the contents of the Niazi Series when providing his Declaration
`
`and that he had “no memory lapse”. EX1043, 266:19-267:5. To the extent Dr.
`
`Niazi wanted to provide anything relevant from the Niazi Series, he clearly had the
`
`opportunity and could have done so. He chose not to—presumably because there
`
`was nothing else relevant to provide from the Niazi Series.
`
`Likewise, UCB’s Motion does not indicate any particular relevance to any
`
`other portion of the Niazi Series. EX1051, 21:17-20 (PTAB “So you don't think
`
`you need to submit anything else to make the record clear for us as to the scope of
`
`this six-volume set?” UCB: “That's right.”).
`
`9
`
`
`
`e. The PTAB Should Deny UCB’s Unauthorized Motion to Compel
`UCB seeks to compel Apotex to produce Volumes 1-6 of the first edition of
`
`the Niazi Series. Paper 44 at 3. At the outset, Apotex notes that it is highly
`
`improper to put an unauthorized Motion to Compel within a Motion to Exclude,
`
`and the PTAB should ignore it. Rule 42.7(a) (“The Board may expunge any paper
`
`directed to a proceeding or filed while an application or patent is under the
`
`jurisdiction of the Board that is not authorized under this part.”); EX1051, 12:22-
`
`13 (UCB: “[Rule] 42.7 which allows the Board to manage its own record and
`
`expunge inappropriate papers”). The PTAB has rules to compel discovery and
`
`UCB should have complied with those rules should it had believed a motion to
`
`compel was proper. See, e.g., Rule 42.52; Garmin Int’l, Inc. v. Cuozzo Speed
`
`Techs. LLC, Case IPR2012-00001, Paper 26 (June 11, 2013) (precedential).
`
`UCB’s Motion to Compel in its Motion to Exclude represents yet another violation
`
`of the Rules.
`
`In any event, Apotex does not have, and never has had, a complete copy of
`
`the first edition of the Niazi Series. There is only one person that has ever had a
`
`complete copy of the first edition of the Niazi Series—Dr. Niazi, UCB’s expert.
`
`As the PTAB can understand, at one point the (prior art) first edition of the Niazi
`
`Series was readily available at various libraries. Today, given the age of the first
`
`edition, there are fewer copies available. Copies of the non-prior art second
`
`10
`
`
`
`edition, however, are readily available. Apotex located the relevant entries from
`
`the second edition of the Niazi Series. Upon locating the first edition at a non-
`
`local university library, Apotex requested a photocopy of only the table of contents
`
`of the first edition and compared the content of the first edition and second edition
`
`of the Niazi Series.
`
`In some cases, this was a very simple exercise. For example, as Dr. Niazi
`
`stated:
`
`In my opinion, if a POSA had been directed to the oral
`syrup levocetirizine formulation of WO ’094, they
`would
`first
`look
`to other
`liquid pharmaceutical
`formulations involving levocetirizine or, like compounds,
`such as its racemate, cetirizine, to see what amounts and
`ratios of preservatives others had used.
`
`EX2034, ¶ 162 (emphasis added). Taking no more than a few minutes, Apotex
`
`merely looked up the entry for cetirizine in the Table of Contents of the second
`
`edition of the Niazi Series. EX1041 at p.033 (TOC entry for cetirizine
`
`hydrochloride syrup in second edition of the Niazi Series). The corresponding
`
`page number (page 210) in the volume series reveals that the cetirizine
`
`hydrochloride syrup had a 9:1 ratio with 0.9 mg/ml methylparaben to 0.1 mg/ml
`
`propylparaben. EX1041 at p.014. Then, it became nothing more than an exercise
`
`of confirming that cetirizine hydrochloride syrup existed in the first edition by
`
`11
`
`
`
`looking at the first edition’s Table of Contents and then requesting those specific
`
`pages. For expense reasons, Apotex then only requested the relevant pages of the
`
`first edition from the non-local university library.3 This is how EX1032-1037 were
`
`located and assembled.
`
`f. The PTAB Should Not Take Judicial Notice of Certain Facts
`about Exhibits 1032-1037 and 1041 or Accept UCB’s “Offer of
`Proof”
`To the extent evidence exists in the record about the first edition of the Niazi
`
`Series, UCB should use that evidence and Apotex will respond. Paper 44 at 4.
`
`Putting aside the fact that Dr. Niazi testified that he had searched for relevant
`
`information from the Niazi Series and maintained that he had not forgotten about
`
`the contents of the Niazi Series when providing his Declaration (EX1043, 220:1-
`
`221:21, 266:19-267:5), if UCB felt the record needed additional facts about the
`
`Niazi Series, it should have requested assistance from the PTAB. Indeed, the
`
`Rules allow for such a request. Rule 45.51(2) (“Additional Discovery”).
`
`However, UCB chose not to even try to raise the matter with PTAB at any time
`
`since December 6th 2019 4 choosing instead to file an unauthorized Motion to
`
`3 Apotex does not have to bear the cost of photocopying the entire first edition
`
`when UCB and Dr. Niazi have easy access to it.
`
`4 This is the date Dr. Niazi was first deposed and when Exhibits 1032-1037 were
`
`first introduced by Apotex.
`
`12
`
`
`
`Compel in its Motion to Exclude. EX1051, 21:17-20 (PTAB “So you don't think
`
`you need to submit anything else to make the record clear for us as to the scope of
`
`this six-volume set?” UCB: “That's right.”).
`
`For the first edition, UCB wants the PTAB to take judicial notice that there
`
`are six editions. UCB should focus its attention about what is in the record. See,
`
`e.g., EX2034, ¶9; EX1051, 20:13-15 (PTAB: “And how would we take judicial
`
`notice of something that we really have not seen or heard about until today?”).
`
`UCB also wants the PTAB to note that the first edition of the Niazi Series has
`
`approximately 2000 entries. Paper 44 at 4. Dr. Niazi offered some testimony
`
`about the number of formulations in his own book series. See, e.g., EX1043,
`
`220:1-221:21. To the extent UCB offers what is in the record, it may do so, and
`
`Apotex will respond accordingly. Regarding Patent Owner’s request to take
`
`judicial notice of certain facts directed to the (non-prior art) second edition of the
`
`Niazi Series, it is not clear by UCB’s Motion if all of these facts are in the record.
`
`Apotex has the same response to Patent Owner’s “Offer of Proof” regarding the
`
`first and second editions of the Niazi Series. Paper 44 at 6.
`
`II.
`
`CONCLUSION
`
`For the foregoing reasons, the Board should deny the relief sought in
`
`UCB’s Motion to Exclude.
`
`13
`
`
`
`Date: April 7, 2020
`
`RESPECTFULLY SUBMITTED,
`Katten Muchin Rosenman LLP
`/s/ Jitendra Malik
`Jitendra Malik (Reg. No. 55,823)
`
`Lead Counsel for Petitioner
`Apotex, Inc.
`
`14
`
`
`
`CERTIFICATION OF SERVICE ON PATENT OWNER
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4), and 42.105, the undersigned
`
`certifies that on April 7th, 2020, a complete copy of the foregoing Paper was served
`
`via email to the Patent Owner by serving the correspondence address of record for
`
`the ’194 patent:
`
`James S. Trainor, Jr.
`Robert E. Counihan
`FENWICK & WEST LLP
`1211 Avenue of the Americas, 32nd Floor
`New York, NY 10036
`
`Erica R. Sutter
`FENWICK & WEST LLP
`801 California Street
`Mountain View, CA 94041
`
`Respectfully submitted,
`Katten Muchin Rosenman LLP
`By: /Jitendra Malik/
`
`15
`
`
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