`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`AYLA PHARMA LLC,
`Petitioner
`
`v .
`
`NOVARTIS AG,
`Patent Owner.
`
`U.S. Patent No. 9,533,053 to Gamache et al.
`Issue Date: January 3, 2017
`Title: High Concentration Olopatadine Ophthalmic Composition
`
`Inter Partes Review No.: IPR2020-00295
`
`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
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`
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`TABLE OF CONTENTS
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`Page
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`B.
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`C.
`
`I.
`
`II.
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`INSTITUTION SHOULD NOT BE DENIED BASED ON § 325(D) .......... 1
`A.
`Petitioner’s Asserted Grounds Were Not Considered During
`Prosecution (Becton Factors (a-d)) ..................................................... 1
`Additional Evidence and Facts Presented in the Petition
`Warrant Reconsideration (Becton Factor (f)) ..................................... 3
`The Examiner Erred in Its Evaluation of the Asserted Prior Art
`(Becton Factor (e)) ............................................................................. 4
`THE APPLE FACTORS DO NOT SUPPORT DENIAL OF
`INSTITUTION UNDER § 314(A) ............................................................... 6
`A.
`Apple Factors 1 & 2 ........................................................................... 7
`B.
`Apple Factor 3 .................................................................................... 7
`C.
`Apple Factors 4 & 5 ........................................................................... 9
`D.
`Apple Factor 6 .................................................................................. 11
`III. CONCLUSION ......................................................................................... 12
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`TABLE OF AUTHORITIES
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` Page(s)
`
`Cases
`Apotex v. UCB Biopharma,
`IPR2019-00400, Paper 17, 24 (July 15, 2019).............................................. 1, 12
`Apple Inc. v. Fintiv, Inc.
`IPR2020-00019 Paper 11 (PTAB March 20, 2020) .................................. passum
`Apple v. Omni Medsci,
`IPR2020-00029, Paper 7, 55 (April 22, 2020) .......................................... 5, 7, 11
`Artic Cat v. Polaris Indus.,
`IPR2017-00433, Paper 17, 19 (July 5, 2017) ................................................... 12
`Clim-A-Tech v. Ebert,
`IPR2017-01863, Paper 13, 18 ............................................................................ 2
`Ex parte Ditzik,
`2018-000087, 6 (PTAB Mar. 2, 2018) ............................................................. 10
`Ethicon v. Quigg,
`849 F.2d 1422 (Fed. Cir. 1988) .......................................................................... 6
`Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Paper 19 (PTAB Sept. 6, 2017) ........................................... 8, 9
`Hyperbranched Medical Tech. v. Confluent Surgical,
`IPR2018-01097, Paper 14, 24 (PTAB Nov. 14, 2018) ....................................... 1
`Lowe’s. v. Nichia,
`IPR2017-02011, Paper 13, 18 (Mar. 12, 2018) ................................................. 12
`Meitzner v. Mindick,
`549 F.2d 775 (CCPA 1977) ............................................................................. 11
`Mylan Pharmaceuticals Inc. v. Almirall, LLC.
`IPR2019-01095, Paper 12 (PTAB Nov. 27, 2019) ............................................. 9
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`Mylan Pharms. Inc. v. Merck Sharp & Dohme Corp.,
`IPR2020-00040, Paper 21 (PTAB May 12, 2020) ................................ 4, 8, 9, 11
`
`NHK Spring Co., Ltd. v. Intri-Plex Techs.
`Case IPR2018-00752, Paper 8 (Sept. 12, 2018) ................................................. 6
`Novartis AG v. Noven Pharm. Inc.,
`853 F.3d 1289 (Fed. Cir. 2017) .......................................................................... 6
`Petroleum Geo-Servs. v. W. Geco,
`IPR2014-01477, Paper 18, 32 (March 17, 2015) .............................................. 12
`Steadymed LTD. v. United Therapeutics Corp.,
`IPR 2016-00006 ................................................................................................. 9
`TRW Automotive v. Magna Elecs.,
`IPR2014-00261, Paper 19, 12 (June 26, 2014) ................................................... 1
`Valve Corp. v. Elec. Scripting Prods., Inc.,
`IPR2019-00064, Paper 10 (May 1, 2019) ........................................................... 8
`ZTE v. Bell Northern Research,
`IPR2019-01365, Paper 13 (PTAB Feb. 11, 2020) .............................................. 5
`
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`I.
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`INSTITUTION SHOULD NOT BE DENIED BASED ON § 325(D)
`A.
`Petitioner’s Asserted Grounds Were Not Considered During
`Prosecution (Becton Factors (a-d))
`There is no dispute that the Examiner never put forth any prior art rejection
`
`during the prosecution of the ’053 patent, including the grounds advanced in the
`
`Petition and supporting declarations. The crux of Novartis’ argument under §
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`325(d) is: (1) the Examiner “considered” Argentum’s IPR petition to the ’154
`
`patent because it was disclosed in an IDS during prosecution of the ’053 patent,
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`and (2) the Examiner issued a Schneider-based rejection during the prosecution of
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`the related ’154 patent. POPR at 31. These arguments fail for several reasons.
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`First, Novartis presumes that its mere disclosure, in an IDS, of the Argentum
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`IPR petition and/or the other prior art references, meant that the Examiner
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`considered and relied on them. Presumptive awareness, however, is not enough for
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`a § 325(d) denial. TRW Automotive v. Magna Elecs., IPR2014-00261, Paper 19,
`
`12 (June 26, 2014). “The Board has consistently declined to exercise its discretion
`
`under § 325(d) based on the mere citation of references in an IDS that were not
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`applied by the Examiner.” Apotex v. UCB Biopharma, IPR2019-00400, Paper 17,
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`24 (July 15, 2019); Petition, 12 (citing cases). Where, as here, the prior art is
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`“simply being of record, but not applied in any rejection by the Examiner during
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`examination … provides little impetus for [the PTAB] to exercise [its] discretion to
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`deny institution under § 325(d).” Hyperbranched Medical Tech. v. Confluent
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`Surgical, IPR2018-01097, Paper 14, 24 (PTAB Nov. 14, 2018).1
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`Second, recognizing that the Examiner did not apply any prior art rejection,
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`Novartis relies on a Schneider-based rejection, made over two years prior, during
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`the prosecution of the ’154 patent. POPR, 36-38. However, Novartis does not cite
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`a single decision where the Board denied a petition under § 325(d), because one of
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`the prior art references was relied upon in a related application. Rather, under such
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`circumstances, the Board has refused to exercise discretion under § 325(d). See
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`Petition at 39 (citing cases).
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`Finally, Novartis concedes that Ground 3 in Ayla Pharma’s Petition is not in
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`Argentum’s IPR petition (POPR, 31-32). Consequently, the Examiner did not
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`consider the references, as combined in Ground 3, and as such, there is no overlap
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`in the arguments between Ground 3 and those presented during examination.
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`Similarly, the additional evidence and facts (identified below) were not before the
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`Examiner and do not overlap with those presented during examination. See infra
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`I.B. Novartis does not present any arguments or evidence to the contrary.
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`In sum, (i) none of the references were applied in any prior art rejection, and
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`(ii) there is no overlap between Ayla Pharma’s above-identified arguments and
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`1 Novartis’s reliance on Clim-A-Tech v. Ebert is misplaced. POPR, 40. Unlike
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`here, it involved a number of amendments submitted during prosecution that
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`presented arguments related to a prior art reference. IPR2017-01863, Paper 13, 18.
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`those presented during prosecution. Thus, Becton factors (a)-(e) favor institution.
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`B.
`
`Additional Evidence and Facts Presented in the Petition Warrant
`Reconsideration (Becton Factor (f))
`Given Novartis’ reliance on its IDS disclosure, the most noteworthy thing is
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`what its disclosure omits. This is best shown through a review of the timeline of
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`events that took place during the prosecution of the ’053 patent.
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`As shown above, the applicant filed six IDSs. However, what is troubling is that
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`the Board’s intervening Argentum Institution Decision (dated 07/18/2016) was
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`never disclosed to the Examiner. EX1015. Novartis does not explain why it
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`failed to disclose this document in its subsequent sixth IDS (dated 10/14/2016), nor
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`is there any legitimate reason for withholding this document. Compare EX015, 1
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`to EX2001, 617-627. Clearly, the Argentum Institution Decision is material to the
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`patentability of the challenged claims of the ’053 patent, particularly in light of the
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`“undisputed similarity” to the claims of the ’154 patent. See POPR at 2.
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`Novartis cannot hide behind the veil of § 325(d) when it failed or
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`intentionally omitted to disclose the Board’s Argentum Institution Decision. By
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`doing so, it deprived the Examiner from gaining any meaningful insight from the
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`Board’s analysis of the prior art and its highly material teachings, as well as the
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`impact on the patentability of the challenged claims, which Novartis did not
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`challenge or dispute. In support of its Petition, Ayla Pharma submitted the
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`Argentum Institution Decision (EX1015) and presented prior art challenges
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`consistent with the Board’s construction and analysis. See, e.g., Petition, 6, 17, 42.
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`This additional evidence and fact, which was not before the Examiner, warrants
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`reconsideration of the prior art and/or arguments.
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`Moreover, in support of its Petition, Ayla Pharma submitted the expert
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`declarations of Dr. Laskar (EX1014) and Dr. S. Craig Dyar (EX1042)—none of
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`which was rebutted or challenged by Novartis. These expert declarations, as well
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`as the associated exhibits, provide volumes of additional evidence and facts that
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`was not before the Examiner—and Novartis does not contest otherwise. For
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`example, Dr. Laskar’s declaration, which Dr. Dyar adopts, explains, among other
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`things, the significance of the prior art disclosures and why it would be obvious to
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`a POSITA to combine the references. See, e.g., EX1014, 25-29 & 83-91. Thus,
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`this evidence further warrants reconsideration of the prior art and arguments. See
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`Mylan Pharms. Inc. v. Merck Sharp & Dohme Corp., IPR2020-00040, Paper 21 at
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`20 (PTAB May 12, 2020). As such, Becton factor (f) strongly favors institution.
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`C.
`
`The Examiner Erred in Its Evaluation of the Asserted Prior Art
`(Becton Factor (e))
`Novartis accuses Ayla Pharma of failing to “acknowledge the extent to
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`which the asserted art and arguments were evaluated during examination”. POPR
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`at 39. However, the record is silent since the Examiner did not make any specific
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`analysis of the prior art or issue any rejections based on the art during the
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`prosecution of the ’053 patent. In similar circumstances, the Board does not
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`require the petitioner to speculate from such a silent record. ZTE v. Bell Northern
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`Research, IPR2019-01365, Paper 13 at 8 (PTAB Feb. 11, 2020).
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`Regardless, the Examiner’s statement that the claims of the ’053 patent are
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`allowable (EX2001, 634) is simply incorrect, particularly in light of the
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`“undisputed similarity” with the claims of the ’154 patent. POPR, 2. Given the
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`Board’s sound conclusion and analysis on the significance of the prior art in the
`
`Argentum Institution Decision, “reasonable minds cannot disagree that the Office
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`erred in a manner material to patentability in its treatment of the art by failing to
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`reject the claims of the [’053 patent] over the references cited in Petitioner’s
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`challenges.” Apple v. Omni Medsci, IPR2020-00029, Paper 7, 55 (April 22, 2020).
`
`As detailed in the Argentum Institution Decision, the prior art reads directly
`
`on the undisputedly similar limitations of the related ’154 patent. Novartis does
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`not dispute that they also read on the challenged claims of the ’053 patent. Thus,
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`unlike Alarm.com v. Vivint, Inc., which Novartis relies on (POPR, 40), reasonable
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`minds cannot disagree that, here, the Examiner misapprehended or overlooked the
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`specific teachings of the relevant prior art and their impact on the patentability of
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`the challenged claims. As such, Becton factor (e) also favors institution.
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`II.
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`THE APPLE FACTORS DO NOT SUPPORT DENIAL OF
`INSTITUTION UNDER § 314(A)
`Novartis cannot dispute some simple facts. There is no parallel district
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`court litigation involving Ayla and Novartis involving any patent. The ’053
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`patent was never involved in any litigation before any district court. To the extent
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`the district court even adjudicated the validity of the ’154 patent, it only considered
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`the validity of Claims 8–9 and 21–24 of the ’154 patent. EX1030, ¶ 8. Further,
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`Novartis does not dispute Ayla’s position that the claims of the ’053 patent are
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`broader than the claims of the ’154 patent (POPR at 52), this difference will make
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`any invalidity challenge against the ’053 patent easier than the ’154 patent. POPR
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`at 52.2 Given these facts, where the PTAB reaches a different conclusion as it
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`relates to the validity of the ’053 patent, there would be no conflict with the district
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`court’s decision on the ’154 patent. Novartis AG v. Noven Pharm. Inc., 853 F.3d
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`1289 (Fed. Cir. 2017); Ethicon v. Quigg, 849 F.2d 1422, 1428–29 (Fed. Cir. 1988).
`
`Novartis’s § 314(a) arguments primarily rely on precedential decisions
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`Apple Inc. v. Fintiv, Inc., and (to a lesser extent) NHK Spring Co., Ltd. v. Intri-Plex
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`Techs. For the reasons discussed below, all of the Apple factors weigh in favor of
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`institution and Novartis advances no other argument warranting a § 314(a) denial.
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`2 Ayla notes that the district court decision was not appealed to the Federal Circuit.
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`Thus, it is technically nonbinding on the PTAB as it relates to the ’053 patent.
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`Apple Factors 1 & 2
`A.
`Apple Factors 1 & 2 are premised on the existence of a concurrent district
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`court litigation addressing the same patent. Apple at 6-9. There is no litigation
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`between Ayla and Novartis involving the ’053 patent; the ’053 patent has never
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`been litigated before any district court. Any other litigation involving other drug
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`manufacturers involving the ’154 patent did not involve Ayla because Ayla was
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`not in existence then.3 POPR at 23. Thus, Apple factors 1 and 2 favor institution.
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`Apple Factor 3
`B.
`Apple factor 3 deals with any prior investment by the Court and the parties
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`“at the time of the institution”. Apple, 9. As explained in Apple, this factor looks
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`at the district courts and the parties’ efforts “related to the patent at issue in this
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`petition.” Id. at 9-10. Neither the Court, nor any party, has invested any resources
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`related to the ’053 patent, i.e., “the patent at issue in the petition.” To the extent
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`Novartis “expended substantial time and resources throughout the litigation
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`defending the validity of the ’154 patent” against other drug manufacturers, Ayla
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`“should not, however, be foreclosed from petitioning the Board to hear its
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`challenge based on choices of the other drug manufacturers.” Mylan, IPR2020-
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`3 Novartis also pretends that it does not know of Ayla’s intent. POPR at 23. Ayla
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`sought to license the patent rights for the U.S. and abroad in order to avoid
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`needless litigation expenses, but Novartis ignored Ayla’s repeated efforts.
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`00040 at 29. But more importantly, Novartis does not claim that it has expended
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`anything with respect to the ’053 patent, i.e., “the patent at issue in the petition”.
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`According to Novartis, Ayla “spent only minimal resources preparing its
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`petition, which is effectively a copy of Cipla’s” and Ayla’s expert (Dr. Dyar)
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`copied Cipla’s declaration.4 POPR at 44. This fact actually supports institution
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`and limits the import of § 314(a). Ayla is well aware that the PTAB has discussed
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`the unfairness of subjecting a Patent Owner to serial petitions because of the
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`potential for a second petitioner to modify and cure deficiencies in the previous
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`petition. Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha, IPR2016-01357,
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`Paper 19 at 11 (PTAB Sept. 6, 2017) (precedential).
`
`In Cipla’s ’053 Petition, Novartis never filed a POPR and the parties settled
`
`before the Board provided its Institution Decision. Valve Corp. v. Elec. Scripting
`
`Prods., Inc., IPR2019-00064, Paper 10 (May 1, 2019) (precedential) (Valve factor
`
`3). In an effort to eliminate any argument from Novartis that Ayla had materially
`
`changed Cipla’s ’053 Petition to Novartis’s detriment, Ayla effectively copied
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`Cipla’s ’053 Petition and the accompany declaration. POPR 44-45. By this action,
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`Novartis found itself in the exact spot it found itself in in Cipla’s ’053 IPR neither
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`suffering any prejudice nor receiving any advantage. Ayla, for its part, would be
`
`insulated from the Gen. Plastic/Valve § 314(a) challenge and that seems to be the
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`4Ayla notes that Cipla was not a party to the district court action. EX1030.
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`case since Novartis wisely chose not the raise such an argument. Indeed, Ayla’s
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`actions mimic those seen where a joinder petitioner files a so-called “me too”
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`petition thereby eliminating § 314(a) concerns. Mylan Pharmaceuticals Inc. v.
`
`Almirall, LLC. IPR2019-01095, Paper 12 (PTAB Nov. 27, 2019).
`
`Put simply, it is Ayla’s choice to use the PTAB route as opposed to the
`
`district court route. General Plastic at 16-17 (“an objective of the AIA . . . is to
`
`provide an effective and efficient alternative to district court litigation”). Ayla
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`“cannot be faulted for wanting to chart its own course in defense of its interests by
`
`petitioning for review of the []patent in a faster forum with a different evidentiary
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`burden.” Mylan, IPR2020-00040 at 30.
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`Apple Factors 4 & 5
`C.
`Patent Owner’s position seems to be that, since the two sets of claims at
`
`issue in the two forums are not patentability distinct, the district court’s decision on
`
`the validity of certain claims of the ’154 patent effectively insulates the ’053 patent
`
`from a validity challenge. In a somewhat analogous situation (although some
`
`differences do exist), the PTAB has refused to transpose a validity judgment from
`
`one patent to a related patent because the claims of the two patents are not
`
`“patentability distinct”. Steadymed LTD. v. United Therapeutics Corp., IPR 2016-
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`00006, Paper 84 at 2 (PTAB Apr. 6, 2017).
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`Even though Novartis denies it is doing so, Novartis is trying to invoke the
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`specter of issue preclusion/collateral estoppel using the district court’s (not even
`
`the Federal Circuit’s) validity determination for a handful of claims of the ’154
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`patent to all claims of the non-asserted ’053 patent against other pharmaceutical
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`defendants. POPR, 56.5 Ex parte Ditzik, 2018-000087, 6 (PTAB Mar. 2, 2018)
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`(informative) (laying out the relevant factors of issue preclusion). As but one
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`example, even if it were proper to use a validity determination for certain claims of
`
`the ’154 patent in a matter involving parties other than Petitioner and apply it to all
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`claims of the ’053 patent, Novartis has not explained how “seeking to prove
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`invalidity [that] failed to meet the higher standard of proof in district court, [says
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`anything] about whether the same evidence could meet a lower standard in the
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`PTO.” Ditzik at 9; Mylan, IPR2020-00040 at fn. 19 (explaining different burdens
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`between the two forums).
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`Moreover, Novartis’ reliance on the district court’s factual findings is
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`unavailing because it fails to recognize that, to the extent such findings conflicts
`
`with the Board’s Argentum Institution Decision, the weight of such evidence is
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`best resolved after institution and not at the institution stage, especially where Ayla
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`provided unrebutted expert testimony while Novartis does not even address the
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`merits of Ayla’s petition as it relates to the ’053 patent, choosing instead to focus
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`its attention on the ’154 patent. Regardless, in its Petition and accompanying
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`5 Issue preclusion requires the parties to be the same.
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`declaration, Ayla addressed the district court’s decision, including devoting
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`considerable space explaining that even though Yanni taught suspensions (as
`
`opposed to solutions) that this fact should not preclude a finding the claims would
`
`have been obvious. Petition, 25-28 & 62-63; POPR, 50. Ayla recognized that the
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`district court had focused on this issue in connection with the ’154 patent which
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`was one of the reasons Ayla provided a detailed treatment in its Petition. In this
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`way, the evidence and arguments provided by Ayla are very different than
`
`anything that was presented before the district court. To the extent Novartis’
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`counsel disagrees, Ayla notes that Novartis did not provide an expert declaration
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`refuting Ayla’s expert. Meitzner v. Mindick, 549 F.2d 775, 782 (CCPA 1977)
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`(“[a]rgument of counsel cannot take the place of evidence lacking in the record”).
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`Finally, to the extent Novartis relies on NHK, E-One I and E-One II (POPR
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`at 54-55), in every case the same patent and parties were before the PTAB and the
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`district court concurrently. Apple, n. 26 (citing Nalox-1 distinguishing NHK)
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`because Petitioner was not a party to the parallel district court litigation). Also, the
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`FWD in those cases was expected well after trial. Mylan, IPR2020-00040
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`(describing this fact as “one of the pivotal considerations in NHK”). None of those
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`facts exist here. Thus, factors 4 and 5 favor institution.
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`D.
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`Apple Factor 6
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`Here, with an unopposed expert, Ayla’s arguments are “particularly strong
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`on the preliminary record.” Fintiv, 14, 15 n.29; Apotex, IPR2019-00400 at 18-19
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`(noting the absence of countervailing expert testimony). Further, the goal of the
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`AIA favors institution because Novartis’ position—once a patent is unsuccessfully
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`challenged before the district court, all other related patents are effectively
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`insulated from an IPR—would promote gamesmanship and encourage keeping
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`patent families open to strategically issue related patents when disputes arise.
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`Novartis cites no authority for this position, relying instead on authority where the
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`same patent, same parties were before the PTAB at the same time.
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`Finally, as to any alleged secondary considerations from the District Court
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`litigation relating to the ’153 patent, which Novartis relies on (POPR, 56-60), it is
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`premature to address at this stage. Lowe’s. v. Nichia, IPR2017-02011, Paper 13,
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`18 (Mar. 12, 2018). The evidence of secondary considerations, as it relates to the
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`’053 patent, has not been fully developed in this record, including with the support
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`of competent expert testimony. Under analogous cases, the PTAB has refused to
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`give much weight to the alleged secondary considerations. Artic Cat v. Polaris
`
`Indus., IPR2017-00433, Paper 17, 19 (July 5, 2017); Petroleum Geo-Servs. v. W.
`
`Geco, IPR2014-01477, Paper 18, 32 (March 17, 2015). Factor 6 favors institution.
`
`III. CONCLUSION
`Ayla Pharma respectfully requests that the Board institute the Petition.
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`Date: June 8, 2020
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`Respectfully submitted,
`
`KATTEN MUCHIN ROSENMAN LLP
`
`By: /s/ Jitendra Malik
`Jitendra Malik, Ph.D.
`Reg. No. 55,823
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`CERTIFICATION OF SERVICE
`Pursuant to 37 C.F.R. §§ 42.6(e), 42.8(b)(4), and 42.105, the undersigned
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`certifies that on June 8, 2020, a complete copy of the foregoing Petitioner’s Reply
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`to Patent Owner’s Preliminary Response were served via email on the Patent
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`Owner counsel as per below:
`
`atrask@wc.com
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`scott.chapple@novartis.com
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`peter.waibel@novartis.com
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`Respectfully submitted,
`
`KATTEN MUCHIN ROSENMAN LLP
`
`By: /s/ Jitendra Malik
`Jitendra Malik, Ph.D.
`Reg. No. 55,823
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