`
`.BEFORE THE PA TENT TRJAL AND APPEAL BOARD
`
`GLAXOSMITHKLINE CONSUMER HEAL TH CARE HOLDINGS (US) LLC,
`Petitioner,
`
`V.
`
`CIPLALTD,
`Patent Owner.
`
`Case IPR2020-003 71
`Patent No. 9,901,585
`
`PETITIONER'S NOTICE OF APPEAL
`
`-l
`
`-:-- ., ( "~~
`c-· .• )
`r·.-; - ~
`
`r,...:,
`,·:-:-,
`! ...... 1
`C::'.J
`~.:,
`(·-)
`__ _.
`
`(
`)
`i "1
`
`
`
`Case IPR2020-003 71
`Patent No. 9,901 ,585
`Pursuant to 37 C.F.R. §§ 90.2(a) and 90.3, and 35 U.S.C. §§ 141 and 142,
`
`and 28 U.S.C. § 1295(a)(4)(A), Petitioner GlaxoSmithKline Consumer Healthcare
`
`Holdings (US) LLC ("Petitioner") provides notice that it appeals to the United
`
`States Court of Appeals for the Federal Circuit from the Decision Denying
`
`Institution of Inter Partes Review in Case No. IPR2020-003 71 entered July 31 ,
`
`2020 (Paper 7), and from all underlying orders, decisions, rulings, and opinions.
`
`In accordance with 37 C.F.R. § 90.2(a)(3)(ii), the issues on appeal are
`
`anticipated to include, but are not limited to, whether the USPTO's discretionary
`
`denial of institution in IPR2020-003 71 was improper as based upon an improperly
`
`promulgated or inappropriately applied rule and whether the discretionary denial of
`
`institution in the underlying IPR should be vacated. See 35 U.S.C. § 316(a)(2), 5
`
`U.S.C. § 706(2)(D); 5 U.S.C. § 553; 5 U.S.C. § 706(2)(C).
`
`A copy of the decision being appealed is attached to this Notice.
`
`Pursuant to 35 U.S.C. § 142 and 37 C.F.R. § 90.2(a), this Notice is being
`
`filed with the Director of the United States Patent and Trademark Office, and a
`
`copy of this Notice is being concurrently filed with the Patent Trial and Appeal
`
`Board. In addition, a copy of this Notice and the required docketing fees are being
`
`filed with the Clerk's Office for the United States Court of Appeals for the Federal
`
`Circuit via CM/ECF.
`
`- 1 -
`
`
`
`Case IPR2020-003 71
`Patent No. 9,901 ,585
`
`Dated: October 1, 2020
`
`Respectfully submitted,
`
`By: / Charles E. Lipsey I
`Charles E. Lipsey, Lead Counsel
`Reg. No. 28,165
`
`- 2 -
`
`
`
`Case IPR2020-003 71
`Patent No. 9,901 ,585
`CERTIFICATE OF SERVICE AND FILING
`
`The undersigned certifies that on this 1st day of October 2020, in addition to
`
`being filed and served electronically through the Board's E2E system, a true and
`
`correct copy of the foregoing PETITIONER'S NOTICE OF APPEAL was filed
`
`and served on the Director of the United States Patent and Trademark Office via
`
`hand delivery at the following address:
`
`Director of the United States Patent and Trademark Office
`c/o Office of the General Counsel
`Madison Building East, Room 1 0B20
`600 Dulany Street
`Alexandria, VA 22314
`
`The undersigned also hereby certifies that on this 1st day of October 2020, a
`
`true and correct copy of the foregoing PETITIONER'S NOTICE OF APPEAL
`
`and the filing fee were filed with the Clerk's Office of the United States Court of
`
`Appeals for the Federal Circuit via CM/ECF.
`
`The undersigned also hereby certifies that on this 1st day of October 2020, a
`
`true and correct copy of the foregoing PETITIONER'S NOTICE OF APPEAL
`was served electronically via email on counsel of record for the Patent Owner as
`
`follows:
`
`Brandon M. White
`Nathan K. Kelley
`Perkins Coie LLP
`700 13 th St., NW, Suite 600
`Washington, DC 2005
`
`
`
`Case IPR2020-003 71
`Patent No. 9,901,585
`
`White-ptab(q.)perkinscoie.com
`Kellev nathan-ptab(a)perkinscoic.com
`
`Emily J. Greb
`Perkins Coie LLP
`33 East Main Street, Suite 201
`Madison, WI 53 703
`Greb-ptab(a)perklnscole.corn
`
`dyrnista12~perkinscoie.corn
`
`I William Esper I
`William Esper
`Legal Assistant
`FINNEGAN, HENDERSON, FARABOW,
`GARRETT & DUNNER, LLP
`
`
`
`Trials@)uspto.gov
`571-272-7822
`
`Paper 7
`Date: July 31, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PA TENT TRIAL AND APPEAL BOARD
`
`GLAXOSMITHKLINE
`CONSUMER HEAL TH CARE HOLDINGS (US) LLC,
`Petitioner,
`
`V.
`
`CIPLALTD.,
`Patent Owner.
`
`IPR2020-003 71
`Patent 9,901,585 B2
`
`Before ZHENYU YANG, CHRISTOPHER M. KAISER, and
`MICHELLE N. ANKENBRAND, Administrative Patent Judges.
`ANKENBRAND, Administrative Patent Judge.
`
`DECISION
`Denying Institution of Inter Partes Review
`35 USC§ 325(d)
`
`
`
`IPR2020-003 71
`Patent 9,901,585 B2
`
`I.
`INTRODUCTION
`GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
`("Petitioner") requests an inter partes review of claims 1- 30 ofU.S. Patent
`Number 9,901,585 B2, ("the ' 585 patent," Ex. 1004). Paper 1 ("Pet.").
`Cipla Ltd. ("Patent Owner") filed a Preliminary Response. Paper 6
`("Prelim. Resp.").
`Based on the particular circumstances of this case, we exercise our
`discretion under 35 U.S.C. § 325(d) and do not institute an inter partes
`review of the challenged claims.
`
`II. BACKGROUND
`A. Related Matters
`The parties do not identify any related matters involving the '585
`patent. See Pet. 66; Paper 4, 1- 2. The parties identify the following
`concluded district court litigation involving U.S. Patent Number 8,168,620
`("the ' 620 patent"), which is related to the '585 patent: Meda
`Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc. , No. 1: l 5-cv-
`00785-LPS (D. Del.); Meda Pharmaceuticals Inc. v. Perrigo UK FINCO
`Ltd., No. l:16-cv-00794-LPS (D. Del.); Meda Pharmaceuticals, Inc. v.
`Apotex Inc., No. 1: 14-cv-01453-LPS (D. Del.). Pet. 66-67; Paper 4, 1.
`The parties also identify as related Argentum Pharmaceuticals LLC v.
`Cipla Ltd. , IPR2017-00807 (PTAB) ("the Argentum IPR") an instituted
`proceeding challenging the '620 patent that the Board terminated prior to
`issuing a final written decision. Pet. 67; Paper 4, 1.
`Patent Owner also identifies three petitions requesting an inter partes
`review that Petitioner filed challenging patents related to the ' 5 85 patent:
`IPR2020-00368, challenging U.S. Patent Number 8,163,723 ; IPR2020-
`
`2
`
`
`
`IPR2020-003 71
`Patent 9,901,585 B2
`
`00369, challenging the '620 patent; and IPR2020-00370, challenging U.S.
`Patent Number 9,259,428. Paper 4, 1-2.
`B. The '585 Patent
`The '585 patent, titled "Combination of Azelastine and Fluticasone
`for Nasal Administration," issued on February 27, 2018. Ex. 1004, codes
`(45), (54). The '585 patent relates to phannaceutical formulations
`comprising azelastine ( 4-[( 4-chlorophenyl)methyl]-2-(hexahydro-l-methyl-
`1H-azepin-4-yl)-1(2H)-phthalazinone) and a corticosteroid. Id. at 1:64- 66,
`2:15-22. The corticosteroid may include fluticasone. Id. at 2:46- 54.
`The Specification explains that it is known to use antihistamines, e.g.,
`azelastine hydrochloride, in nasal sprays to treat allergy-related conditions.
`Id. at 1 :44-49. The Specification further explains that it is also known to
`treat allergy-related conditions with a corticosteroid to suppress nasal
`inflammatory conditions. Id. at 1 :50-53 . The Specification states that "[i]t
`would be highly desirable, however, to provide a treatment that combines
`the effects of anti-histamine treatments and steroid treatments, in a
`pharmaceutically acceptable formulation, which is tolerated in situ, without
`significantly disrupting the potency of the constituent pharmaceuticals." Id.
`at 1:58- 63.
`According to the Specification, the applicants "found that, very
`surprisingly, azelastine . . . can advantageously be combined with a steroid
`. .. to provide a stable, very effective combination product." Id. at 1 :64-2:6.
`"The combination can provide, in a single administration or dosing
`regime[n], the antihistaminic properties of azelastine and the anti(cid:173)
`inflammatory (and/or other) properties of the steroid, without any significant
`interference between the two, or adverse reaction in situ." Id. at 2:7- 11.
`
`3
`
`
`
`IPR2020-003 71
`Patent 9,901,585 B2
`
`The Specification discloses that the formulation may be in the form of
`an aqueous solution nasal spray. Id. at 2:47- 54. The Specification explains
`that "[t]he formulations preferably contain a preservative and/or stabilizer."
`Id. at 2:60-61. Preferred preservatives include edetate disodium,
`benzalkonium chloride, and phenyl ethyl alcohol. Id. at 2:61- 3: 12. The
`formulations may include further auxiliary substances: specifically
`surfactants, e.g., polyethoxylated sorbitan fatty acid esters (polysorbate);
`isotonization agents, e.g., glycerine, glucose, and sodium chloride; and
`thickening agents, e.g., methyl cellulose, and carboxymethyl cellulose
`sodium. See id. at 3:36- 50, 3:51- 54, 3:66-4:14. The Specification explains
`that "[i]t is also possible to add to the formulations buffer substances .. . to
`adjust the formulations to a pH value of 3 to 7, preferably 4.5 to 6.5." Id. at
`4:23-28.
`
`C. Illustrative Claim
`Petitioner challenges claims 1- 30 of the '585 patent, of which claims
`1, 16, and 27 are independent. Pet. 1. Claim 1 of the '585 patent is
`illustrative of the claimed subject matter and recites:
`1. A nasal spray formulation, comprising:
`from 0.001 % (weight/weight) to 1 % {weight/weight) of
`azelastine hydrochloride;
`from 0.0357% (weight/weight) to 1.5% (weight/weight) of
`fluticasone propionate;
`one or more preservatives;
`one or more thickening agents;
`one or more surfactants; and
`one or more isotonization agents.
`Ex. 1004, 11 :62- 12:3.
`
`4
`
`
`
`IPR2020-00371
`Patent 9,901,585 B2
`
`D. The Asserted Grounds of Unpatentability
`Petitioner challenges the patentability of claims 1- 30 of the '585
`patent based on the following grounds:
`35 u.s.c. §1
`Claims Challenged
`References/Basis
`1-30
`103(a)
`PDR 1999,2 Segal3
`1- 30
`103(a)
`Cramer,4 PDR 1999
`Petitioner supports the Petition with the testimony of Maureen D.
`Donovan, Ph.D. (Ex. 1060) and Robert P. Schleimer, Ph.D. (Ex. 1064).
`III. ANALYSIS
`A. Discretionary Denial under 35 USC§ 325(d)
`Patent Owner argues that we should exercise our discretion to deny
`the Petition under 35 U.S.C. § 325(d) because Petitioner presents
`substantially the same prior art and arguments the Office previously
`considered during the prosecution of the '585 patent and the related '620
`patent, and fails to identify a material error in the Office's analysis. Prelim.
`Resp. 20-28.
`Section 325( d) provides that in determining whether to institute an
`inter partes review, "the Director may take into account whether, and reject
`the petition or request because, the same or substantially the same prior art
`or arguments previously were presented to the Office." We use a two-part
`
`1 Because the claims at issue have an effective filing date before March 16,
`2013, the effective date of the applicable provisions of the Leahy Smith
`America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) ("AIA"), we
`apply the pre-AIA version of 35 U.S.C. § 1 Q3 in this decision.
`2 Physicians' Desk Reference, Flonase (fluticasone propionate) entry 1112-
`1124 andAstelin (azelastine hydrochloride) entry 3191-3192 (53rd ed.
`1999) (Ex. 1010).
`3 WO 98/48839 Al, published Nov. 5, 1998 (Ex. 1012).
`4 EP O 780 127 Al, published June 25, 1997 (Ex. 1011).
`
`5
`
`
`
`IPR2020-003 71
`Patent 9,901,585 B2
`
`framework in determining whether to exercise discretion under§ 325(d),
`specifically:
`
`( 1) whether the same or substantially the same art previously
`was presented to the Office or whether the same or substantially
`the same arguments previously were presented to the Office;
`and (2) if either condition of the first part of the framework is
`satisfied, whether the petitioner has demonstrated that the
`Office erred in a manner material to the patentability of
`challenged claims.
`Advanced Bionics, LLC v. Med-El Elektromedizinische Gerdte GmbH,
`IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential). In
`applying the two-part framework, we consider several non-exclusive factors ,
`including: (a) the similarities and material differences between the asserted
`art and the prior art involved during examination; (b) the cumulative nature
`of the asserted art and the prior art evaluated during examination; ( c) the
`extent to which the asserted art was evaluated during examination, including
`whether the prior art was the basis for rejection; (d) the extent of the overlap
`between the arguments made during examination and the manner in which
`Petitioner relies on the prior art or Patent Owner distinguishes the prior art;
`( e) whether Petitioner has pointed out sufficiently how the Examiner erred in
`its evaluation of the asserted prior art; and (f) the extent to which additional
`evidence and facts presented in the Petition warrant reconsideration of the
`prior art or arguments. Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 at 17-18 (PTAB Dec. 15, 2017) (precedential as to
`§ III.C.5, first paragraph). If, after review of factors (a), (b), and (d), we
`determine that the same or substantially the same art or arguments
`previously were presented to the Office, then factors ( c ), ( e ), and ( f) relate to
`whether the petitioner demonstrates that the Office erred in a manner
`material to the patentability of the challenged claims. Advanced Bionics,
`
`6
`
`
`
`IPR2020-003 71
`Patent 9,901,585 B2
`
`Paper 6 at 10. "At bottom, this framework reflects a commitment to defer to
`previous Office evaluations of the evidence or record unless material error is
`shown." Id. at 9.
`For the reasons set forth below, under the facts and circumstances of
`this case, we exercise our discretion under § 325( d) to deny institution of a
`trial. Before turning to the two-part framework, we briefly discuss the
`asserted references and the relevant prosecution history of the '585 and '620
`patents.
`
`1. Asserted references
`Below, we provide a brief summary of the references that Petitioner
`asserts against the challenged claims of the '585 patent.
`a) PDR 1999 (Ex. 1010)
`Petitioner relies on PDR 1999 for its disclosure of nasal spray
`compositions containing either fluticasone propionate, marketed under the
`brand name Flonase, or azelastine hydrochloride, marketed under the brand
`name Astelin. See, e.g., Pet. 4-5. The flonase prescribing information
`describes the commercially available "FLONASE Nasal Spray 50 mcg [as]
`an aqueous suspension of micro fine fluticasone propionate for topical
`administration to the nasal mucosa by means of a metering, atomizing spray
`pump." Ex. 1010, 1122. The formulation contains 0.05% w/w fluticasone
`propionate. Id. The "FLONASE Nasal Spray also contains microcrystalline
`cellulose and carboxymethylcellulose sodium, dextrose, 0.02% w/w
`benzalkonium chloride, polysorbate 80, and 0.25% w/w phenylethyl alcohol,
`and has a pH between 5 and 7 ." Id.
`The Astelin prescribing information describes the commercially
`available "Astelin® (azelastine hydrochloride) Nasal Spray, 137 micrograms
`
`7
`
`
`
`IPR2020-003 71
`Patent 9,901,585 B2
`
`(mcg), [as] an antihistamine formulated as a metered Spray solution for
`intranasal administration." Ex. 1010, 3191. "Astelin® Nasal Spray contains
`0.1 % azelastine hydrochloride in an aqueous solution at pH 6.8 ± 0.3 . It als~
`contains benzalkonium chloride (125 mcg/mL), edetate disodium,
`hydroxypropyl methyl cellulose, citric acid, dibasic sodium phosphate,
`sodium chloride, and purified water." Id.
`
`b) Cramer (Ex. 1011)
`Cramer describes "novel nasal spray compositions comprising a safe
`and effective amount of a glucocorticosteroid and an antihistamine."
`Ex. 1011, 2:5-6. Cramer teaches the "[g]lucocorticoid agents most useful to
`the present invention include those selected from the group consisting of
`beclomethasone, flunisolide, triamcinolone, fluticasone, mometasone,
`budesonide, pharmaceutically acceptable salts thereof." Id. at 3: 15- 18. The
`glucocorticoid concentration in the compositions may range "from about
`0.001 % to about 0.2%, more preferably from about 0.01 % to about 0.1 %."
`Id. at 3:19-20. Cramer teaches useful antihistamines "include cetirizine,
`loratadine, azelastine and the like ... at a concentration of from about 0.01 %
`to about 4.0%, more preferably from about 0 .01 % to about 1 %."· Id. at 3 ,24-
`30.
`
`Cramer teaches "[p ]referred nasal dosage forms are solutions,
`suspensions and gels, which normally contain sodium chloride in a major
`amount of water (preferably purified water) in addition to the antihistamine
`and glucocorticoid." Id. at 3:45-47. Cramer teaches the compositions may
`include "[m]inor amounts of other ingredients such as pH adjusters (e.g., an
`acid such as HCl), emulsifiers or dispersing agents, buffering agents,
`
`8
`
`
`
`IPR2020-003 71
`Patent 9,901,585 B2
`
`preservatives, wetting agents and jelling agents ( e.g., methylcellulose )." Id.
`at 3:47--49. "Most preferably, the nasal composition is isotonic." Id. 3:49.
`Cramer describes a specific example of a pharmaceutical composition
`as Example III, reproduced below.
`
`Component
`triamcinolone acetonide
`azelastine HCl
`
`polysorbate 80
`
`glycerin
`
`hydroxypropyl methyl
`cellulose
`
`sodium chloride
`ethylenediamine
`tetraacetic acid
`
`Wgt%
`
`0.050
`
`0.070
`
`0.050
`
`2.000
`
`1.000
`
`0.900
`
`0.050
`
`benzalkonium chloride
`distilled water
`
`0.020
`
`q.s. to vol.
`
`Id. at 6:26--42. Cramer teaches that the composition is used to provide relief
`from allergy symptoms and "substantially similar results are also obtained
`using, in whole or in part, equivalent amounts of other glucocorticoid agents
`such as fluhcasone, mometasone, budesonide, pharmaceutically acceptable
`salts thereof and mixtures thereof." Id. at 6:43-46.
`c) Segal (Ex. 1012)
`Segal describes "topically applicable nasal compositions comprising a
`therapeutically effective amount of a topical anti-inflammatory agent and a
`therapeutically effective amount of at least one agent suitable for topical
`
`9
`
`
`
`IPR2020-003 71
`Patent 9,901,585 B2
`
`nasal administration and selected from the group consisting of ... an
`antihistamine." Ex. 1012, 2:10- 15. Segal discloses that the topical anti(cid:173)
`inflammatory agent is a corticosteroid, e.g., fluticasone propionate. Id. at
`2:23- 26. Segal also discloses suitable antihistamines, including azelastine.
`Id. at 3: 19- 20. Segal teaches that "[ t ]he use of an additional therapeutic
`agent in combination with an anti-inflammatory agent provides additive and
`synergistic effects in the treatment of nasal and sinus conditions." Id. at 3 :9-
`12.
`
`Segal teaches "[t]he compositions of the present invention can be
`conveniently administered nasally to a human subject in dosage unit form to
`elicit the desired therapeutic effect of the anti-inflammatory agent and the
`additional therapeutic agents described above. The compositions may be
`administered in the form of a.nasal spray." Id. at 4:20-23. Segal describes
`"nasal sprays containing a water buffered aqueous solution as a carrier." Id.
`at 4:4- 7. "The compositions are preferably isotonic," e.g., sugars and
`sodium chloride, and may contain additional agents, including a humectant,
`e.g., glycerin, pharmaceutically acceptable preservatives, and pH adjusters.
`Id. at 4:5-14.
`
`2. Relevant prosecution history
`The '585 patent issued from Application No. 15/070,839, which
`claims priority through a series of parent applications to Application
`No. 10/518,016, filed as application No. PCT/OB03/02557 on June 13 ,
`2003 , now the '620 patent. Ex. 1004, at [21], [60]. We discuss the
`prosecution of both the '620 patent and the '585 patent below.
`During the prosecution of the '620 patent, the Examiner rejected the
`claims as anticipated by Cramer or as having been obvious over Cramer
`
`
`
`IPR2020-003 71
`Patent 9,901,585 B2
`
`combined with other references. See Ex. 2001, 497-512, 603- 622, 721-
`742.5 For example, the Examiner found that Cramer discloses a nasal spray
`composition containing azelastine and fluticasone in the claimed amounts,
`further including the claimed excipients. S~e, e.g. , id. at 606- 608 ( citing,
`inter alia, Cramer's Example III).
`In response, the applicant filed three declarations from inventor
`Ms. Geena Malhotra as evidence supporting unexpected stability of the
`claimed formulation and the inoperability of Cramer's Example III. See id.
`at 336- 339, 568- 570, 698- 700. After a non-final rejection of the claims as
`anticipated by Cramer, the applicant amended the claims and filed additional
`declarations from Mr. Nikhil Chopra, Joachim Maus, M.D., and Sujeet
`Rajan, M.D. See id. at 254-283, 328- 334, 358- 364, 458-462. The
`additional declarations supported the applicant's assertions of commercial
`success, unexpected results, and long-felt need, respectively. See id.
`Following the response, the Examiner allowed the claims. See id. at
`192-199. In the Reasons for Allowability, the Examiner discussed in detail
`the Chopra, Maus, and Rajan declarations supporting objective evidence of
`non-obviousness. See id. at 195- 198. The Examiner found "the Chopra
`Declaration supports that the product of the invention has been a commercial
`success for both the inventors and the copiers ... [ and] that the product of
`the invention has filled a long-felt, but unmet need for an improved
`treatment for allergic rhinitis." Id. at 196. The Examiner found Dr. Rajan's
`declaration "also supports that the invention fills a long unmet need." Id.
`And the Examiner found that "Dr. Maus concludes that the superior results
`obtained with the combination of nasal fluticasone propionate and azelastine
`
`5 We cite to the page numbers that Patent Owner added to Exhibit 2001.
`
`11
`
`
`
`IPR2020-003 71
`Patent 9,901,585 B2
`
`HCl would have been unexpected at the time of filing of the application. On
`the basis of this information and declaration, the examiner concurs in this
`conclusion." Id. at 197 (internal citation omitted). Accordingly, the
`Examiner concluded "the invention [ of the '620 patent] is unexpectedly and
`surprisingly unobvious over, different from, and superior to the prior art of
`record." Id. at 198.
`During the prosecution of the '585 patent, the Examiner rejected the
`claims as anticipated by Cramer, or as having been obvious over Cramer
`with additional optional references. Ex. 1008, 4-5. 6 In so doing, the
`Examiner incorporated by reference the Office's "explanation of disclosures
`of the prior art and rationales for combing the disclosures of [the]
`references" as set forth in the '620 patent's prosecution, among others. Id. at
`5. In other words, the Examiner relied on the Office's previous findings and
`conclusions regarding Cramer, including Cramer's disclosure of a nasal
`spray containing azelastine and fluticasone, as well as Cramer's Example III.
`See, e.g., Ex. 2001, 501-502.
`In a response filed August 1, 2017, the applicant argued that one of
`Dr. Malhotra's declarations submitted during the '620 patent's prosecution
`established that Cramer's Example III was inoperable. See id. at 20-23.
`The applicant further argued that the Chopra, Maus, and Rajan declarations
`submitted during the '620 patent's prosecution were evidence of secondary
`considerations that the claimed formulations were nonobvious. See id. at
`23-27. The applicant also submitted an Information Disclosure Statement
`
`6 We cite to the page numbers that Petitioner added to Exhibit 1008.
`
`12
`
`
`
`IPR2020-003 71
`Patent 9,901,585 B2
`
`("IDS") listing the Argentum IPR petition, which asserted Segal, Hettche, 7
`Phillipps, 8 and Flonase Label9 against challenged claims of the '620 patent,
`all of which the Examiner considered. Ex. 1008, 36- 37 ("The references
`provided in the Information Disclosure were evaluated for their disclosure in
`view of the claims of the instant application."); Ex. 3001, 2 (August 1, 2017,
`IDS, first entry, titled "Petition for Inter Partes Review on U.S. Patent No.
`8,168,620, No. IPR2017-00807 filed February 2, 2017, Argentum
`Pharmaceuticals LLC v. Cipla Ltd., 73 pages").
`Following the Response, the Examiner allowed the claims. Id. at 36-
`42. The Examiner addressed the Argentum IPR petition, explaining"[ w ]ith
`regard to obviousness, all the references cited by the Argentum Petition are
`of record and have been previously evaluated, or disclose information
`redundant to information of record." Id. at 3 7. The Examiner further stated:
`With regard to the Declaration by Maus, the Argentum Petition
`asserts that the relevant comparator for the inventive formulation
`is concurrent use of fluticasone propionate nasal spray and
`azelastine nasal spray. The assertion is not persuasive because
`at the time of the invention, the field as a whole was divided as
`
`7 US 5,164,194, issued Nov. 17, 1992 (Ex. 1013). Hettche teaches a
`"medicament for nasal use ... which contains as [an] active ingredient
`azelastine or a physiologically acceptable salt." Id. at Abstract.
`8 US 4,335,121, issued June 15, 1982 (Ex. 1009). Phillipps discloses topical
`nasal sprays comprising fluticasone propionate formulated with one or more
`pharmaceutical carriers or excipients. Id. at 32:46-50, 32:57-60, 36:7-10.
`9 FLONASE® (fluticasone propionate) Nasal Spray, 50 mcg Product
`Information (Dec. 1998) (Ex. 1010). The Flonase Label discloses an aqueous
`suspension of micro fine fluticasone propionate that also contains
`microcrystalline cellulose and carboxymethylcellulose sodium, dextrose,
`0.02% w/w benzalkonium chloride, polysorbate 80, and 0.25% w/w
`phenylethyl alcohol. Id. at 1122.
`
`13
`
`
`
`IPR2020-00371
`Patent 9,901,585 B2
`
`to whether oral or nasal administration of antihistamine was
`better.
`Id. at 37. The Examiner considered arguments against the Chopra
`Declaration, finding that "[t]he Argentum Petition also argues that evidence
`of commercial success requires evidence of relative product pricing and
`marketing. Careful analysis of the Chopra data refutes the argument." Id. at
`38.
`
`In the Reasons for Allowance, the Examiner found that the Chopra
`Declaration supported commercial success, the Chopra and Rajan
`Declarations supported the invention filling a long-felt need, and the Maus
`Declaration supported superior unexpected results. See id. at 39-42 (making
`similar findings regarding the applicant's objective evidence to those the
`Examiner made during the '620 patent's prosecution). Accordingly, the
`Examiner found that the claims that issued as the '5 85 patent "are narrower
`than the independent claims allowed as US Patent No. 8168620" and that
`"the invention is unexpectedly and surprisingly unobvious over, different
`from, and superior to the prior art of record." Id. at 42.
`3. Whether the same or substantially the same prior art or
`arguments previously were presented to the Office
`We first consider whether Petitioner asserts the same or substantially
`the same prior art or arguments that previously were presented to the Office.
`Advanced Bionics, Paper 6 at 8. We conclude that Petitioner asserts not only
`substantially the same prior art, but also substantially the same arguments
`that previously were presented to the Office. 10 Petitioner asserts Cramer,
`
`10 Under Advanced Bionics, either the same or substantially the same prior
`art previously must have been presented to the Office or the same or
`substantially the same arguments previously must have been presented to the
`
`14
`
`
`
`IPR2020-003 71
`Patent 9,901,585 B2
`
`Segal, and PDR 1999 against the challenged claims of the '585 patent.
`Petitioner admits that the Examiner cited Cramer during prosecution of the
`'585 patent. Pet. 68. Indeed, as set forth above, the Examiner rejected all
`pending claims "as anticipated by, or in the alternative[,] ... as obvious over
`the disclosure of Cramer, optionally further in view of [ additional
`references]." Ex. 1008, 4-5. Thus, Cramer previously was presented to the
`Office.
`Further, as explained above, the Examiner rejected the claims after
`finding that Cramer teaches nasal spray compositions comprising azelastine
`and fluticasone in the recited amounts and suggests pharmaceutically
`acceptable salt forms, including hydrochloride and propionate. See, e.g.,
`Ex. 2001, 606-608. The Examiner also found that Cramer's composition
`may contain certain excipients, such as those recited in the claims. Id. at
`606-607 (citing, inter alia, Cramer's Example III). Petitioner relies on the
`same teachings. For example, Petitioner asserts that Cramer discloses nasal
`spray formulations comprising fluticasone and azelastine or
`pharmaceutically acceptable salt forms of each. Pet. 31. Petitioner also
`asserts that Cramer's formulations may contain other ingredients, i.e.,
`excipients, such as emulsifiers, pH adjusters, buffering agents, preservatives,
`wetting agents, and jelling agents. Id. And, like the Examiner, Petitioner
`points to Cramer's Example III. Id. at 31-32. Thus, Petitioner makes the
`same arguments the Office previously considered regarding Cramer.
`
`Office to reach the second part of the framework, i.e., a showing of error
`material to patentability. Advanced Bionics, Paper 6 at 8. Here, however,
`both conditions of the first part of the framework are satisfied. Thus, we
`discuss both.
`
`15
`
`
`
`IPR2020-003 71
`Patent 9,901,585 B2
`
`Although Petitioner does not address whether Segal and PDR 1999
`were presented to the Office during the '585 patent's prosecution, we find
`that Segal previously was presented to the Office and that PDR 1999 is
`cumulative of references the Examiner considered during prosecution.
`Starting with Segal, the applicant listed it on an IDS that the Examiner
`considered. Ex. 2001, 786; see Advanced Bionics, Paper 6 at 7- 8
`( explaining that previously presented art includes "art made of record by the
`Examiner, and art provided to the Office by an applicant, such as on an
`Information Disclosure Statement (IDS), in the prosecution history of the
`challenged patent"). Segal also was asserted against the '620 patent claims
`in the Argentum IPR petition that the Examiner reviewed and discussed
`during the '585 patent's prosecution. See Ex. 1008, 36- 39 (Notice of
`Allowability discussing in detail the Argentum IPR petition); Ex. 3001 , 2
`(listing the Argentum IPR petition). And Petitioner admits that the Petition
`contains "siinilar arguments" to those in the Argentum IPR. Pet. 68.
`Accordingly, Segal previously was presented to the Office and Petitioner
`makes the same arguments the Office previously considered regarding
`Segal.
`Turning next to PDR 1999, we acknowledge that it was not before the
`Examiner during prosecution, but we agree with Patent Owner that the
`teachings in PDR 1999 do not differ "in any material way from the art and
`arguments already considered and overcome during prosecution." Prelim.
`Resp. 24. In other words, the disclosures in PDR 1999 are substantively the
`same as the disclosures in other references the Examiner considered and
`evaluated during prosecution, including the references asserted in the
`Argentum IPR. See Ex. 1008, 37 ("[A]ll the references cited by the
`
`16
`
`
`
`IPR2020-003 71
`Patent 9,901,585 B2
`
`Argentum Petition are of record and have been previously evaluated, or
`disclose information redundant to information of record."). Petitioner
`concedes as much, stating that "the Argentum IPR was instituted based on
`the cited prior art and similar arguments." Pet. 68. Further, as explained
`above, PDR 1999 discloses monotherapy nasal spray formulations
`comprising either azelastine hydrochloride or fluticasone propionate and
`Petitioner relies on PDR 1999 for those teachings, as well as for disclosing
`certain excipients the challenged claims require. See, e.g., Pet. 4-5; see also
`Ex. 1010, 1122 (PDR 1999 entry for Flonase, fluticasone propionate nasal
`spray), 3191 (PDR 1999 entry for Astelin, azelastine hydrochloride nasal
`spray). The Argentum IPR asserted similar references with essentially the
`same teachings, including Hettche, which discloses a nasal medicine that
`contains azelastine or a physiologically acceptable salt of azelastine, and
`Phillipps and Flonase Label, which each disclose nasal spray formulations
`comprising fluticasone propionate and other pharmaceutical carriers or
`excipients. See Argentum IPR, Paper 11 at 14- 22; Ex. 1013, Abstract;
`Ex. 1009, 32:46-50, 32:57-60, 36:7- 10; Ex. 1010, 1. Thus, PDR 1999 is
`cumulative of the art the Examiner considered during prosecution and
`Petitioner makes the same arguments that the Office previously considered
`when evaluating the '585 patent claims.
`Given the foregoing, we determine that the Petition presents not only
`substantially the same prior art, but also the same arguments that were
`previously presented to the Office during prosecution of the ' 585 patent.
`4. Error material to patentability
`Because we find that the "same or substantially the same prior art or
`arguments previously were presented to the Office," we tum to whether
`
`17
`
`
`
`IP