Trials@uspto.gov
`571-272-7822
`
` Paper 20
`
` Entered: October 31, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`CIPLA LTD.,
`Patent Owner.
`____________
`
`Case IPR2017-00807
`Patent 8,168,620 B2
`____________
`
`
`
`Before JAMES T. MOORE, ZHENYU YANG, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`SAWERT, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Denying Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`571-272-7822
`
` Paper 20
`
` Entered: October 31, 2017
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`ARGENTUM PHARMACEUTICALS LLC,
`Petitioner,
`
`v.
`
`CIPLA LTD.,
`Patent Owner.
`____________
`
`Case IPR2017-00807
`Patent 8,168,620 B2
`____________
`
`
`
`Before JAMES T. MOORE, ZHENYU YANG, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`SAWERT, Administrative Patent Judge.
`
`
`
`
`
`DECISION
`Denying Patent Owner’s Request for Rehearing
`37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`
`IPR2017-00807
`Patent 8,168,620 B2
`
`
`
`
`
`
`I.
`INTRODUCTION
`Argentum Pharmaceuticals LLC (“Petitioner”) filed a Petition for an
`inter partes review of claims 1, 4–6, 24–26, 29, and 42–44 of U.S. Patent
`No. 8,168,620 B2 (“the ’620 patent,” Ex. 1001). Paper 2 (“Pet.”). The
`Board instituted an inter partes review of claims 1, 4–6, 24–26, 29, and 42–
`44 on the ground of obviousness over Hettche,1 Phillipps,2 and Segal,3 and
`on the ground of obviousness over Hettche, Phillipps, Segal, and the Flonase
`Label.4 Paper 11 (“Instit. Dec.”), 27. The Board declined to institute an
`inter partes review of claims 1 and 25 on Petitioner’s proposed ground of
`anticipation by Segal. Id. at 14. Patent Owner now files a Request for
`Rehearing of both obviousness grounds. Paper 15 (“Rehearing Request” or
`“Reh’g Req.”). For the following reasons, we deny Patent Owner’s
`Rehearing Request.
`
`II. STANDARD OF REVIEW
`A party requesting rehearing bears the burden of showing that a
`decision should be modified. 37 C.F.R. § 42.71(d). The party must identify
`all matters the party believes the Board misapprehended or overlooked and
`the place where each matter was addressed previously in a motion, an
`opposition, or a reply. Id. When rehearing a decision on petition, we review
`
`
`1 Helmut Hettche, U.S. Patent No. 5,164,194 (Nov. 17, 1992)
`(“Hettche”). Ex. 1007.
`2 Gordon H. Phillipps, et al., U.S. Patent No. 4,335,121 (Jun. 15,
`1982) (“Phillipps”). Ex. 1009.
`3 Catherine A. Segal, Int’l Publication No. WO 98/48839 (Nov. 5,
`1998) (“Segal”). Ex. 1012.
`4 FLONASE® (fluticasone propionate) Nasal Spray, 50 mcg Product
`Information (Dec. 1998) (“Flonase Label”). Ex. 1010.
`2
`
`
`
`
`
`
`
`IPR2017-00807
`Patent 8,168,620 B2
`
`
`
`the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of
`discretion occurs when a “decision was based on an erroneous conclusion of
`law or clearly erroneous factual findings, or . . . a clear error of judgment.”
`PPG Indus. Inc. v. Celanese Polymer Specialties Co., 840 F.2d 1565, 1567
`(Fed. Cir. 1988) (citations omitted).
`III. DISCUSSION
`Patent Owner requests rehearing on the ground of obviousness over
`Hettche, Phillipps, and Segal, and on the ground of obviousness over
`Hettche, Phillipps, Segal, and the Flonase Label. Patent Owner contends
`that the Board’s Institution Decision “misapprehended or overlooked key
`evidence and arguments” Patent Owner presented in its Preliminary
`Response. Reh’g Req. 2.
`In the Institution Decision, the Board determined that “no claim term
`requires express interpretation for purposes of this Decision.” Instit. Dec. 7.
`In its Rehearing Request, Patent Owner argues that the Board
`“misapprehended or overlooked the importance of construing the terms
`‘nasal spray’ and ‘suitable for nasal administration’” found in all the
`challenged claims. Reh’g Req. 2. In particular, Patent Owner asserts that
`those terms mean “pharmaceutical formulations that are tolerable to patients,
`homogeneous, and can be suitably deposited onto the nasal mucosa.” Id.
`(citing Paper 7, Preliminary Response (“Prelim. Resp.”), 9). Patent Owner
`alleges that, had the Board construed “nasal spray” and “suitable for nasal
`administration,” then the Board would have denied the obviousness grounds
`because “none of the combinations of cited art teach a person of ordinary
`skill in the art how to make the claimed fixed-dose combination ‘nasal
`
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`
`3
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`IPR2017-00807
`Patent 8,168,620 B2
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`spray’ or formulation ‘suitable for nasal administration’ with a reasonable
`expectation of success.” Id. at 2–3 (citing Prelim. Resp. 9).
`We are not persuaded that the Board abused its discretion by declining
`to expressly interpret “nasal spray” and “suitable for nasal administration” in
`the Institution Decision. As the Board explained in the Institution Decision,
`Petitioner showed sufficiently for the purpose of institution that the prior art
`teaches pharmaceutical compositions in the form of nasal sprays. Instit.
`Dec. 14. Specifically, the Board found that the prior-art references explicitly
`teach nasal sprays that are administered nasally. See id. (citing Ex. 1007
`(Hettche), 1:28–30, 2:12–17, 41–43), 15 (citing Ex. 1009 (Phillips), 32:57–
`60, 33:12–14). Patent Owner does not allege its proposed construction of
`“nasal spray” and “suitable for nasal administration” is different from the
`plain and ordinary meaning of those terms to an ordinarily skilled artisan.
`Id. at 4–6; see also Prelim. Resp. 9–11. As a consequence, we are not
`persuaded that the Board overlooked or misapprehended this matter or that
`the Board would have declined institution on the obviousness grounds had it
`explicitly adopted Patent Owner’s proposed interpretation.
`Patent Owner also argues that the Board’s findings about the prior art
`are insufficient because the prior-art reference Cramer5 (and by extension,
`Segal) “does not teach a [person of ordinary skill in the art] how to make a
`‘nasal spray’ that is ‘suitable for nasal administration.’” Reh’g Req. 7–8
`(citing Prelim. Resp. 12–16, 40, 41–42). We understand Patent Owner’s
`contentions about known formulation difficulties and the “unacceptably high
`
`
`5 Ronald Dean Cramer, European Patent (EP) Application No.
`0,780,127 A1 (published June 25, 1997) (“Cramer”). Ex. 1011.
`4
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`IPR2017-00807
`Patent 8,168,620 B2
`
`
`
`osmolality, poor spray quality, and unacceptable settling and caking”
`resulting from the attempted formulation of Cramer’s Example III. Id. at 8–
`10; see also Prelim. Resp. 25. The Board, however, addressed those issues
`in the Institution Decision and determined that “Patent Owner’s arguments
`and expert testimony highlight disputed issues of fact about whether the
`skilled artisan would have been motivated to combine the teachings of
`Hettche, Phillipps, and Segal to arrive at the claimed subject matter, and
`would have had a reasonable expectation of success.” Instit. Dec. at 20
`(citing Ex. 1002, 268–87; Ex. 2007 ¶¶ 40–47; Ex. 2111, 1; Ex. 2044, 1–2).
`The Board concluded that those “issues are best resolved following trial with
`the benefit of a full record.” Id. We are still of that view. Accordingly, we
`are not persuaded that the Board misapprehended or overlooked the issue of
`reasonable expectation of success.
`IV. ORDER
`
`Accordingly, it is
`ORDERED that Patent Owner’s Rehearing Request is denied.
`
`
`
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`5
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`IPR2017-00807
`Patent 8,168,620 B2
`
`
`FOR PETITIONER:
`Michael R. Houston
`Joseph P. Meara
`James P. McParland
`FOLEY & LARDNER LLP
`mhouston@foley.com
`jmeara-pgp@foley.com
`jmcparland@foley.com
`
`Tyler C. Liu
`ARGENTUM PHARMACEUTICALS LLC
`tliu@agpharm.com
`
`
`FOR PATENT OWNER:
`
`Dennies Varughese
`Deborah A. Sterling
`Adam C. LaRock
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`dvarughe-PTAB@skgf.com
`dsterlin-PTAB@skgf.com
`alarock-PTAB@skgf.com
`
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`6
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