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 Reply to Patent Owner’s Preliminary Response
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`___________________
`
`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 Reply to Patent Owner’s Preliminary Response
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`B.
`
`C.
`
`I.
`II.
`
`TABLE OF CONTENTS
`INTRODUCTION ........................................................................................... 1
`INSTITUTION SHOULD NOT BE DENIED BASED ON §325(D) ............ 2
`A.
`Petitioner’s Asserted Grounds Are Not Cumulative of Art
`Considered during Prosecution (Becton Factors (a-d)). ........................ 3
`Petitioner Advances Arguments That Were Not Made during
`Prosecution (Becton Factor (d)). ........................................................... 6
`Petitioner Has Pointed out Sufficiently How the Examiner Erred
`in Its Evaluation of the Asserted Prior Art (Becton Factor (e)). ........... 7
`Additional Evidence and Facts Presented in the Petition Warrant
`Reconsideration of the Prior Art (Becton Factor (f)). ........................... 9
`THE GENERAL PLASTIC FACTORS DO NOT SUPPORT DENIAL
`OF INSTITUTION UNDER §314(A) ........................................................... 10
`IV. CONCLUSION .............................................................................................. 10
`
`D.
`
`III.
`
`i
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Actavis LLC v. Abraxis Bioscience, LLC,
`IPR2017-01103 Paper 7 (October 10, 2017) .................................................... 8, 9
`Becton, Dickinson and Company v. B. Braun Melsungen AG,
`IPR2017-01586, slip op. (PTAB Dec. 15, 2017).........................................passim
`General Plastic Industrial Co., Ltd. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Paper 19 (PTAB Sept. 6, 2017) ............................................... 10
`In re Peterson,
`315 F.3d 1325 (Fed. Cir. 2003) ............................................................................ 9
`Intel Corp. v. Godo Kaisha IP Bridge 1,
`IPR2018-00753, Paper No. 11 .............................................................................. 5
`Koios Pharms. LLC v. medac Gesellschaft für klinische
`Spezialpräparate mbH,
`IPR2016-01370, Paper 13 (PTAB Feb. 8, 2017) .................................................. 7
`Microsoft Corp. v. Saint Regis Mohawk Tribe,
`IPR2018-01594, Paper 21 (PTAB April. 12, 2019) ....................................... 1, 10
`Quanergy Systems, Inc. v. Velodyne Lidar, Inc.,
`IPR2018-00256, Paper 14 (PTAB May 25, 2018) ............................................... 7
`Samsung Elecs. Co. Ltd. v. Immersion Corp.,
`IPR2018-01499, Paper 11 (Mar. 6, 2019) ............................................................ 1
`Statutes
`35 U.S.C. § 314(a) ............................................................................................... 1, 10
`35 U.S.C. § 325(d) ............................................................................................passim
`
`ii
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`I.
`
`INTRODUCTION
`Apotex Inc.’s (“Apotex”) Petition demonstrated that inter partes review
`
`(“IPR”) should be instituted for all challenged claims of U.S. Patent No. 8,633,194
`
`(“the ’194 patent”). UCB Biopharma Sprl (“UCB” or “Patent Owner”) does not
`
`dispute any substantive argument advanced by Apotex. Instead, UCB limits its
`
`Preliminary Response (“POPR”) to unavailing §325(d) and §314(a) arguments.
`
`UCB’s implicit contention under 35 U.S.C. § 325(d) seems to be that if an
`
`Examiner applies a reference for a limitation during prosecution, then any other
`
`reference for that limitation would be per se cumulative. This interpretation of
`
`§325(d) is untenable, effectively insulating every patent from inter partes review.
`
`The PTAB expects some degree of similarity between an IPR Petition and the events
`
`that occurred during patent prosecution. Samsung Elecs. Co. Ltd. v. Immersion
`
`Corp., IPR2018-01499, Paper 11, at 13 (Mar. 6, 2019) (“[a]ny similarity of the art
`
`in this proceeding to art previously applied to [the claim] is due to the fact that any
`
`ground applied to [the claim] must address the subject matter of [that claim].”).
`
`Unremarkably, similarity alone is not a basis to exercise §325(d) discretion. Id. at
`
`12-13. Then, UCB tries to invoke §314(a) when the corresponding District Court
`
`case is stayed. “[T]here are no inefficiencies associated with this proceeding because
`
`the parallel proceeding is stayed pending this proceeding.” Microsoft Corp. v. Saint
`
`Regis Mohawk Tribe, IPR2018-01594, Paper 21 at 11 (PTAB April. 12, 2019).
`
`1
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`II.
`
`INSTITUTION SHOULD NOT BE DENIED BASED ON §325(D)
`Petitioner put forth two grounds of unpatentability in its Petition:
`
`Ground
`
`References
`
`1
`
`2
`
`in view of
`
`WO ’094
`Handbook
`EP ’203 in view of US ’558
`and the Handbook
`
`the
`
`Basis
`
`§ 103
`
`§ 103
`
`Claims
`Challenged
`1–11
`
`1–11
`
`The Examiner never rejected any claim of the ’194 patent based on WO ’094,
`
`EP ’203, US ’558 and/or the Handbook. Nor did the Examiner even discuss WO
`
`’094, EP ’203, or US ’558 during prosecution. UCB does not dispute this. POPR
`
`at 9 (UCB admitting “Petitioner’s prior art references may not have expressly been
`
`the subject of an office action.”). Rather, Patent Owner alleges that WO ’094, the
`
`Handbook, and EP ’203 were fully considered by the Examiner by the mere act of
`
`citing them on an information disclosure statement (“IDS”). POPR at 2, 4-6, 9, 12,
`
`13, 25. Applicable PTAB guidance suggests otherwise.
`
`The PTAB has consistently declined exercising its discretion under §325(d)
`
`when all a Patent Owner can do is show a reference was disclosed on an IDS but not
`
`applied by the Examiner. Pet. at 65-66 (citing multiple PTAB cases). As explained
`
`in its Petition and herein, the asserted Grounds are not cumulative of the art
`
`considered during prosecution. Further, as discussed below, all of the Becton,
`
`Dickinson and Company v. B. Braun Melsungen AG factors weigh against the Board
`
`2
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`exercising its discretion under §325(d). IPR2017-01586, slip op. at 17–18 (PTAB
`
`Dec. 15, 2017) (Paper 8) (informative).
`
`A.
`
`Petitioner’s Asserted Grounds Are Not Cumulative of Art
`Considered during Prosecution (Becton Factors (a-d)).
`The thrust of UCB’s position is that the teachings of Petitioner’s asserted
`
`grounds are the same or substantially the same as the teachings of the art considered
`
`during prosecution. For example, Patent Owner alleges that WO ’094 and EP ’203,
`
`in combination with US ’558, provide the same teachings as Dietrich and
`
`DeLongueville (used by the Examiner to formulate the rejections). POPR at 10.
`
`UCB’s position is undercut by its concession that there are differences between the
`
`prior art the Examiner considered and Apotex’s Grounds. POPR at 11 (“although
`
`the specific prior art references may differ between the Examiner’s rejections and
`
`Petitioner’s Grounds”) (emphasis added).
`
`Dietrich and DeLongueville are materially different. EX2001, EX2002.
`
`Dietrich provides a variety of embodiments and a laundry list of possible active
`
`ingredients and excipients of which levocetirizine, methyl paraben, and propyl
`
`paraben are just a few of many possibilities. POPR at 10 (“Among the active
`
`ingredients listed in the abstract is levocetirizine. See id. at ¶ 62”). Paragraph 62 of
`
`Dietrich, which contains a list of numerous chemicals, is the only time levocetirizine
`
`is ever mentioned in the reference; Dietrich provides no examples of the specific
`
`combination of elements, much less amounts of each element, as recited by the
`
`3
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`claims of the ’194 patent. Patent Owner can hardly say otherwise since it leveled
`
`the same criticisms against Dietrich during prosecution of the ’194 patent:
`
`The composition of Dietrich is not limited to any particular
`active ingredient; in fact, Dietrich’s list of possible active
`ingredients spans page 2, paragraph [0013] – page 18,
`paragraph [0401] of
`the reference.
` Hundreds of
`compounds are listed. Levocetirizine is one of the active
`ingredients listed, but it is not included in any of the
` Preservatives are
`examples or otherwise singled out.
`discussed only at paragraph [0439].
`EX1025 at 6 (emphasis added).
`
`Turning to DeLongueville: DeLongueville also provides no specific
`
`examples of levocetirizine with methyl paraben and propyl paraben in a liquid
`
`formulation. Again, Patent Owner noted the same criticisms against DeLongueville
`
`to the Examiner during prosecution: “DeLonguevill does not specifically teach an
`
`embodiment comprising levoceritrizine and a mixture of methyl-and propylparaben
`
`nor the total amount of paraben or their ratios.” EX1026, Patent Owner’s Response
`
`to Office Action (4/24/09) at 5. DeLongueville teaches only “an individual optical
`
`isomer of cetirizine” or racemic cetirizine, without any preference for which optical
`
`isomer is preferred. EX2002 at Abstract.
`
`Apotex never employed the “laundry list” approach when advancing its
`
`obviousness arguments. WO ’094, relied on by Petitioner, specifically teaches an
`
`4
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`embodiment comprising the combination of levocetirizine with methyl paraben and
`
`propyl paraben in a liquid formulation. Pet. at 15; EX1007 at 4:33-35. EP ’203
`
`similarly teaches explicit examples of liquid compositions of cetirizine (which as a
`
`racemate necessarily includes levocetirizine) with methyl paraben and propyl
`
`paraben. See EX1004 at Example 5; Pet. at 16. US ’558 teaches the advantages of
`
`the specific levocetirizine isomer, which neither Dietrich nor DeLongueville discuss
`
`at all. Pet. at 55; EX1015, Abstract.
`
`Citing Intel Corp. v. Godo Kaisha IP Bridge 1, UCB explains one of the
`
`relevant inquiries under §325(d) is the degree to which the references before the
`
`Examiner were “structurally similar” to the references advanced in the Petition.
`
`POPR at 13; IPR2018-00753, Paper No. 11 at pp. 18-19. The focused nature of the
`
`teachings of WO ’094 and EP ’203 distinguish them from Dietrich and
`
`DeLongueville and makes them structurally dissimilar. Indeed, UCB’s POPR makes
`
`no attempt to level the same criticisms against WO ’094 and EP ’203 (nor can it)
`
`that it made against Dietrich and DeLongueville during prosecution. Therefore,
`
`Petitioner’s art is not cumulative of what was previously considered by the Office.
`
`Patent Owner also contends that WO ’094 and EP ’203, in combination with
`
`US ’558 and the Handbook, provides the same teachings as Dietrich and
`
`DeLongueville in combination with Doron, Gilliland 1, Gilliland 2, and Routledge.
`
`POPR at 10-11 (“the Examiner combined Dietrich and DeLongueville with [Doron,
`
`5
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`Gilliland 1, Gilliland 2, and Routledge] that purportedly taught (a) combining
`
`methyl- and propylparabens in specific ratios and (b) a motivation to reduce the
`
`amount of parabens”). The deficiencies of Dietrich and DeLongueville are discussed
`
`above. But importantly, UCB does not contend (nor can it) that these deficiencies
`
`were cured by secondary references Doron, Gilliland 1, Gilliland 2, and/or
`
`Routledge. As UCB concedes, these secondary references had very limited
`
`teachings focusing on “combining methyl- and propylparabens in specific ratios and
`
`(b) a motivation to reduce the amount of parabens” (POPR at 10). Therefore Becton
`
`factors (a-d) weigh against the PTAB exercising its discretion under §325(d).
`
`B.
`
`Petitioner Advances Arguments That Were Not Made during
`Prosecution (Becton Factor (d)).
`UCB also concedes that, in addition to the foregoing discussion of Becton
`
`Factor (d), the arguments that Apotex advanced were not made during prosecution.
`
`POPR at 21 (“Finally, Petitioner repeatedly references a theory of ‘overlapping
`
`ranges.’ See, e.g., Pet. at 36, 37, 42, 49, 56, 57, 61, 62. While it may initially appear
`
`as though Petitioner’s theory did not arise during prosecution, a closer look proves
`
`that it bears no material difference with the Examiner’s rejection that the claims
`
`would be obvious as a result of ‘routine optimization.’”) (emphasis added). An
`
`argument was either objectively raised during prosecution or it was not. Based on
`
`the POPR, this argument was not raised. UCB’s musings as to the Examiner’s
`
`thought processes have no place in this proceeding.
`
`6
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`Further, WO ’094 and EP ’203 were cited by Petitioner for the proposition
`
`that there was no teaching in the art of an existing problem with bacteria in known
`
`solutions of levocetirizine. Pet. at 32, 52. None of the art cited by the Examiner
`
`during prosecution was cited for this proposition, and the Examiner failed to make
`
`this argument during examination. Again, this is a new argument, and UCB’s POPR
`
`does not contend otherwise. Petitioner’s argument is, therefore, different from any
`
`made by the Examiner’s rejections during prosecution.
`
`C.
`
`Petitioner Has Pointed out Sufficiently How the Examiner Erred in
`Its Evaluation of the Asserted Prior Art (Becton Factor (e)).
`Focusing on the declaration of Mr. Fanara submitted during prosecution and
`
`the alleged unexpected results of levocetirizine’s antimicrobial properties, UCB
`
`explains that “[t]his factor may weigh most heavily against institution of all”. POPR
`
`at 22. As explained in Apotex’s Petition, the PTAB routinely defers detailed
`
`consideration of any objective indicia—which includes any alleged unexpected
`
`results—until after institution once the record has been fully developed. Petition at
`
`63; Koios Pharms. LLC v. medac Gesellschaft für klinische Spezialpräparate mbH,
`
`IPR2016-01370, Paper 13 at 35 (PTAB Feb. 8, 2017); Quanergy Systems, Inc. v.
`
`Velodyne Lidar, Inc., IPR2018-00256, Paper 14 at 11 (PTAB May 25, 2018).
`
`Significantly, the fact that Patent Owner has to adhere so tightly to its alleged
`
`unexpected results declaration submitted during prosecution completely undercuts
`
`its §325(d) argument. As the PTAB has explained in the context of §325(d), relying
`
`7
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`on uncontested testimonial evidence from prosecution will not defeat an inter partes
`
`review for the purposes of institution. Actavis LLC v. Abraxis Bioscience, LLC,
`
`IPR2017-01103 Paper 7 at 8 (October 10, 2017) (“Also, the Examiner relied upon
`
`testimonial evidence that was not subject to cross-examination in determining
`
`patentability of the claims that are contested in this proceeding.”). Therefore, Becton
`
`factor (e)—which UCB avers “that weigh[s] most heavily against institution of
`
`all”—actually counsels against the PTAB exercising its §325(d) discretion. Id. In
`
`any event, Apotex dedicated considerable space in its Petition rebutting the alleged
`
`unexpected results (Pet. at 1, 30-32, 52), including pointing to the teachings of the
`
`prior art, applicable law, and the Declaration of Dr. Laskar. Pet. at 30-32; Laskar
`
`Dec. (EX1002 ¶106, ¶148).
`
`Further,
`
`the Examiner erred
`
`in evaluating
`
`these alleged secondary
`
`considerations because Patent Owner had not demonstrated that the purported
`
`unexpected results occur over the entire claimed range. Mr. Fanara provided a
`
`Declaration along with Exhibits C and D to support the alleged unexpected results.
`
`(EX1027). Mr. Fanara described Exhibit C as “results of testing of antimicrobial
`
`efficacy on several batches of oral drop solution having 5 mg/ml of levocetirizine.”
`
`(Id. at 2). Exhibit C states that the testing was done with Xyzal® 5 mg/ml oral drops.
`
`(Id. at 20). Exhibit D teaches that the active ingredient of Xyzal® 5mg/ml oral drops
`
`is levocetirizine dihydrochloride. (Id. at 27). Examples 1-5 and 7 of the ’194 patent
`
`8
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`specification also use the hydrochloride salt of certirizine and/or levocetirizine.
`
`(EX1001). Mr. Fanara specifically points to Tables 5 and 6 of Example 2 of the
`
`’194 patent to support his allegation of unexpected results. (EX1027 at 2). Example
`
`2 utilizes levocetirizine dihydrochloride as the active ingredient. (EX1001 at Table
`
`4). When considering the various limitations of the challenged claims, there is no
`
`evidence the limited data provided in the declaration demonstrates alleged
`
`unexpected results across the entire claimed range. In re Peterson, 315 F.3d 1325,
`
`1331 (Fed. Cir. 2003) (holding that evidence of unexpected results must be
`
`commensurate in scope with the claims to which it pertains).
`
`D.
`
`Additional Evidence and Facts Presented in the Petition Warrant
`Reconsideration of the Prior Art (Becton Factor (f)).
`In support of its Petition, Apotex submitted a fulsome declaration by its
`
`expert, Dr. Paul Laskar. In response, UCB did not: (1) provide any rebuttal expert
`
`testimony to Dr. Laskar; (2) suggest that Dr. Laskar made any errors in his
`
`declaration; (3) challenge the expert qualifications of Dr. Laskar; or (4) even
`
`challenge Dr. Laskar’s definition of the proposed person of ordinary skill (POPR at
`
`2, fn. 1.). None of this is surprising, as UCB does not challenge the merits of the
`
`petition. UCB POPR does not allege that the evidence provided by Dr. Laskar is
`
`duplicative of evidence previously presented to the Examiner during prosecution.
`
`Actavis LLC, IPR2017-01103 Paper 7 at 8 (“Petitioner relies on a declaration from
`
`Dr. Berkland, which Patent Owner does not allege are duplicative of evidence
`
`9
`
`
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`previously presented to the Office.”) (emphasis added). Dr. Laskar’s declaration and
`
`associated exhibits provide volumes of additional evidence that was not before the
`
`Examiner—and UCB does not contest otherwise. Therefore, Becton Factor (f)
`
`weights against the PTAB exercising its §325(d) discretion.
`
`III. THE GENERAL PLASTIC FACTORS DO NOT SUPPORT DENIAL OF
`INSTITUTION UNDER §314(A)
`General Plastic Industrial Co., Ltd. v. Canon Kabushiki Kaisha, cited by
`
`Patent Owner, addresses serial petition situations. IPR2016-01357, Paper 19 (PTAB
`
`Sept. 6, 2017) (“Multiple, staggered petitions challenging the same patent and same
`
`claims raise the potential for abuse.”). The instant petition is not a follow-on
`
`petition. This is the first and only petition filed by Apotex, and the only IPR Petition
`
`ever filed against the ’194 patent. Since the ’194 petition was filed, the District
`
`Court has stayed the litigation pending this IPR. “[T]here are no inefficiencies
`
`associated with this proceeding because the parallel proceeding is stayed pending
`
`this proceeding.” Microsoft Corp., IPR2018-01594, Paper 21 at 11. Presumably for
`
`this reason, this Panel seemed disinterested in UCB’s §314(a) arguments. Order,
`
`Paper 12 at 2 (“Although Petitioner is welcome to apportion its argument as it sees
`
`fit, the Panel is particularly interested in its argument with respect to § 325(d).”).
`
`IV. CONCLUSION
`Petitioner respectfully requests that the Board institute the Petition.
`
`10
`
`
`
`Date: May 8, 2019
`
`Petitioner’s Reply to Patent Owner’s Preliminary Response
`
`RESPECTFULLY SUBMITTED,
`Katten Muchin Rosenman LLP
`/ Jitendra Malik /
`Jitendra Malik (Reg. No. 55823)
`
`Lead Counsel for Petitioner
`Apotex, Inc.
`
`11
`
`
`
`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 May 8, 2019, a complete copy of the foregoing Petitioner’s Reply
`
`to Patent Owner’s Preliminary Response, and all supporting exhibits were served via
`
`email to the Patent Owner’s counsel at:
`
`jtrainor@fenwick.com
`rcounihan@fenwick.com
`esutter@fenwick.com
`UCBXyzal@fenwick.com
`
`Respectfully submitted,
`Katten Muchin Rosenman LLP
`By: /Jitendra Malik/
`
`
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