Trials@uspto.gov
`571-272-7822
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` Paper 21
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`
` Entered: May 24, 2017
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LUPIN LTD. AND LUPIN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`POZEN INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01774
`Patent 8,852,636 B2
`
`____________
`
`Before JACQUELINE WRIGHT BONILLA, Vice Chief Administrative
`Patent Judge, TONI R. SCHEINER, and LORA M. GREEN,
`Administrative Patent Judges.
`
`SCHEINER, Administrative Patent Judge.
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`571-272-7822
`
`
`
`
`
`
`
`
`
`
`
` Paper 21
`
`
` Entered: May 24, 2017
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`LUPIN LTD. AND LUPIN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`POZEN INC.,
`Patent Owner.
`____________
`
`Case IPR2015-01774
`Patent 8,852,636 B2
`
`____________
`
`Before JACQUELINE WRIGHT BONILLA, Vice Chief Administrative
`Patent Judge, TONI R. SCHEINER, and LORA M. GREEN,
`Administrative Patent Judges.
`
`SCHEINER, Administrative Patent Judge.
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
`
`
`
`IPR2015-01774
`Patent 8,852,636 B2
`
`
`I. INTRODUCTION
`In denying institution of an inter partes review in this case, we
`determined that Petitioner had not established a reasonable likelihood that it
`would prevail in showing the unpatentability of challenged claims 1–6 and
`13–15 of U.S. Patent 8,852,636 B2 (Ex. 1001, “the ’636 patent”) on any of
`the five grounds advanced in the Petition (Paper 4, “Pet.”). Paper 15
`(“Decision” or “Dec.”). Subsequently, Lupin Ltd. and Lupin
`Pharmaceuticals Inc. (collectively “Petitioner”) filed a Request for
`Rehearing (Paper 16, “Reh’g Req.” or “Request”) asking us to reconsider
`our Decision denying an inter partes review on two of the grounds advanced
`in the Petition: (1) whether claims 1–6 and 13–15 are unpatentable under
`35 U.S.C. § 103(a) over Chen1 and Gimet;2 and (2) whether claims 1–6 and
`13–15 are unpatentable under 35 U.S.C. § 103(a) over Gimet,
`Chandramouli,3 and Phillips.4
`We deny Petitioner’s Request for Rehearing for the reasons set forth
`below.
`
`
`1 U.S. Patent No. 6,544,556 B1, issued April 8, 2003 to Chen et al. (“Chen”)
`(Ex. 1004).
`2 U.S. Patent No. 5,698,225, issued December 16, 1997 to Gimet et al.
`(“Gimet”) (Ex. 1007).
`3 Jane C. Chandramouli & Keith G. Tolman, Prevention and Management of
`NSAID-Induced Gastropathy, 8 J. PHARM. CARE PAIN & SYMPTOM CONTROL
`27–40 (2000) (“Chandramouli”) (Ex. 1011).
`4 PCT Int’l Patent Appl. WO 00/26185, published May 11, 2000, by Phillips
`(“Phillips”) (Ex. 1012).
`
`2
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`IPR2015-01774
`Patent 8,852,636 B2
`
`
`II. STANDARD OF REVIEW
`When reconsidering a decision on institution, the Board reviews the
`
`decision for an abuse of discretion. See 37 C.F.R. § 42.71(c). An abuse of
`discretion occurs if a decision is based on an erroneous interpretation of law,
`if a factual is not supported by substantial evidence, or if the decision
`represents an unreasonable judgment in weighing relevant factors. See Star
`Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold
`P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203
`F.3d 1305, 1315–16 (Fed. Cir. 2000). “The burden of showing that a
`decision should be modified lies with the party challenging the decision.”
`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,768 (Aug. 14,
`2012). In its request for rehearing, the dissatisfied party must, in relevant
`part, “specifically identify all matters the party believes the Board
`misapprehended or overlooked, and the place where each matter was
`previously addressed in a motion, an opposition, or a reply.” 37 C.F.R.
`§ 42.71(d); Office Patent Trial Practice Guide, 77 Fed. Reg. at 48,768. We
`address Petitioner’s arguments with these principles in mind.
`
`III. ANALYSIS
`
`A. Claims 1–6 and 13–15—Asserted Obviousness over
`Chen (Ex. 1004) and Gimet (Ex. 1007)
`
`In relation to this ground, Petitioner asserts that we erred when we
`
`“dismiss[ed] Dr. Banakar’s testimony as a ‘conclusory statement.’” Reh’g
`Req. 5. This is in reference to our statement in the Decision that
`3
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`IPR2015-01774
`Patent 8,852,636 B2
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`“conclusory statements by Petitioner and Dr. Banakar do not explain
`sufficiently, nor provide adequate support as to why one of ordinary skill in
`the art would have done the opposite of what Chen teaches in order to
`address the issue of PPI stability at lower pHs.” Dec. 16 (citing Ex. 1004,
`8:17–40, 12:4–32). We remain persuaded, however, that neither the Petition
`nor Petitioner’s Declarant adequately addresses that point, that is, why the
`ordinary artisan would have done the opposite of what Chen teaches in order
`to address the issue of PPI stability at lower a pH. Petitioner’s arguments in
`its Request, which do not explain where the Petitioner and Petitioner’s
`Declarant address Chen, do not persuade us otherwise. Reh’g Req. 5–7.
`
`In addition, Petitioner argues that we misunderstood the teachings of
`the Pilbrant5 reference. Reh’g Req. 7. Petitioner asserts that our “analysis is
`contrary to the educational background and experience of a POSA for the
`[’636] patent” because “it dismissed Pilbrant based on a single phrase in the
`publication” (id.), and “overlooked all data disclosed in the publication” (id.
`at 8). However, we considered Pilbrant in its entirety in reaching our
`Decision. See Dec. 16–18, 21, 24 (citing Ex. 1008, 113–114, 116–117). We
`are not persuaded that we erred in denying an inter partes review of
`challenged claims in view of arguments by Petitioner we have considered
`already. Id. (discussing Pet. 15, 18).
`
`
`5 Å. Pilbrant & C. Cederberg, Development of an Oral Formulation of
`Omeprazole, 20 SCAND. J. GASTROENTEROL. 113–120 (1985) (“Pilbrant”)
`(Ex. 1008).
`
`4
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`IPR2015-01774
`Patent 8,852,636 B2
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`B. Claims 1–6 and 13–15—Asserted Obviousness over
`Gimet, Chandramouli, and Phillips
`In relation to this ground, Petitioner asserts that “the Board read
`[Phillips] to teach [that] ‘a sodium bicarbonate solution is capable of
`dissolving an enteric coating,” but “[t]his reliance is clear error because the
`cited statement of [Phillips] has no bearing on the obvious analysis.” Reh’g
`Req. 11. Petitioner argues that “[t]he cited passage in [Phillips] reads: ‘The
`coated omeprazole particles are mixed with a sodium bicarbonate (NaHCO3)
`solution which dissolves the enteric coating . . .’” but “the disclosure
`provides no suggestion that a solid salt form will impact the enteric coating.”
`Id. at 11–13 (citing Ex. 1012, 19:19–23).
`Because Petitioner does not indicate in its Request where it raised an
`argument regarding the teachings on page 19 of Phillips, Petitioner does not
`show adequately that our Decision should be modified based on such an
`argument now, or that we misapprehended or overlooked an argument by
`Petitioner in this regard. See 37 C.F.R. § 42.71(d).
`
`IV. CONCLUSION
`We have considered Petitioner’s Request for Rehearing, but are not
`persuaded that we abused our discretion in denying an inter partes review
`claims 1–6 and 13–15.
`
`5
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`IPR2015-01774
`Patent 8,852,636 B2
`
`
`V. ORDER
`
`Accordingly, it is
`ORDERED that Petitioner’s Request for Rehearing of the Decision
`denying an inter partes review of claims 1–6 and 13–15 of U.S. Patent
`8,852,636 B2 is denied.
`
`
`
`
`6
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`
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`IPR2015-01774
`Patent 8,852,636 B2
`
`For PETITIONER:
`Sailesh Patel
`John Hsu
`SCHIFF HARDIN LLP
`spatel@schiffhardin.com
`jhsu@schiffhardin.com
`
`For PATENT OWNER:
`Ricardo Rodriguez
`Thomas Blinka
`COOLEY LLP
`zIPR2015-01774@cooley.com
`zIPR2015-01774@cooley.com
`
`Dennis Bennett
`Lauren Stevens
`GLOBAL PATENT GROUP, LLC
`dennisbennett@globalpatentgroup.com
`lstevens@globalpatentgroup.com
`
`Stephen M. Hash
`Margaret J. Sampson
`Jeffrey S. Gritton
`VINSON & ELKINS LLP
`shash@velaw.com
`msampson@velaw.com
`jgritton@velaw.com
`
`Matthew Phillips
`Kevin Laurence
`RENAISSANCE IP LAW GROUP LLP
`matthew.phillips@renaissanceiplaw.com
`kevin.laurence@renaissanceiplaw.com
`7
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