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` Paper 33
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` Entered: November 21, 2016
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`Trials@uspto.gov
`571-272-7822
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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 IPR2015-01773
`Patent 8,858,996 B2
`
`
`
`Before TONI R. SCHEINER, LORA M. GREEN, and
`JACQUELINE WRIGHT BONILLA, Administrative Patent Judges.
`
`BONILLA, Administrative Patent Judge.
`
`
`DECISION
`Denying Petitioner’s Request for Rehearing
`37 C.F.R. § 42.71
`
`
`
`
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`IPR2015-01773
`Patent 8,858,996 B2
`
`I.
`
`INTRODUCTION
`In our Decision instituting an inter partes review in the current case,
`we determined that Petitioner had established a reasonable likelihood that it
`would prevail in showing the unpatentability of challenged claims 1 and 3–
`11, but not claims 2 and 12–19, of U.S. Patent No. 8,858,996 B2 (Ex. 1001,
`“the ’996 patent”). Paper 15 (“Decision” or “Dec.”). Thereafter, Lupin Ltd.
`and Lupin Pharmaceuticals, Inc. (“Petitioner”) filed a Request for Rehearing
`(Paper 17, “Reh’g Req.” or “Request”) in relation to our Decision denying
`an inter partes review of claims 2 and 12–19 of the ’996 patent.
`We deny Petitioner’s Request for Rehearing for the reasons set forth
`below.
`
`STANDARD OF REVIEW
`II.
`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 finding 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
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`IPR2015-01773
`Patent 8,858,996 B2
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`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
`The challenged claims are directed to tablet pharmaceutical
`compositions comprising two drugs, naproxen, a non-steroidal
`anti-inflammatory drug (NSAID), and esomeprazole, a proton pump inhibitor.
`In independent claim 1, “at least a portion of said esomeprazole is released
`regardless of the pH of the medium, and release of at least a portion of said
`naproxen is inhibited unless the pH of said medium is 3.5 or higher.” Ex.
`1001, 21:24–35 (emphasis added). In independent claim 12, a core layer
`comprising naproxen “has a coating that inhibits release of said naproxen
`from said core layer unless said dosage form is in a medium with a pH of 3.5
`or higher,” and a layer comprising esomeprazole that “has a non-enteric film
`coating that, upon ingestion by a patient, releases said esomeprazole into the
`stomach of said patient.” Id. at 22:17–26 (emphasis added).
`
`A. Claim Construction of “Inhibit”
`In our Decision, we construed the term “inhibit” to mean prevent
`(stop), hinder, or restrain. Dec. 7–8 (citing Paper 14 (“Prelim. Resp.”) 7–8
`(citing Ex. 2012, 6; Ex. 2013, 1)). More specifically, we considered the
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`IPR2015-01773
`Patent 8,858,996 B2
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`ordinary and customary meaning of the term in view of the specification and
`the claims themselves when we stated:
`For example, claim 1 of the ’996 patent recites that “release of at
`least a portion” of naproxen “is inhibited unless the pH” is 3.5
`or higher (emphasis added). Claim 12 recites a “coating that
`inhibits release of said naproxen from said core layer unless said
`dosage form is in a medium with a pH of 3.5 or higher”
`(emphasis added).
` Thus, “inhibit” refers to preventing,
`hindering, or restraining the release of naproxen “unless” the
`dosage form is exposed to a pH of 3.5 or higher. The use of
`“unless” in claim 1 and 12 and “at least a portion” in claim 1
`indicates that the terms “inhibited” and “inhibits” in the claims
`do not encompass a “slowing down” of a release when the pH is
`below 3.5 (which would make “at least a portion” superfluous in
`claim 1), but rather refers to no release of “at least a portion”
`(claim 1) or all (claim 12) of the drug “unless” the dosage form
`is in a medium with a pH of 3.5 or higher.
`Dec. 7–8. Thus, “inhibit” refers to preventing, hindering, or restraining the
`release of naproxen “unless” the dosage form is exposed to a pH of 3.5 or
`higher.
`In its Request for Rehearing, Petitioner contends that we erred in our
`construction of “inhibit.” According to Petitioner, the broadest ordinary and
`customary meaning of “inhibit” is “slow down,” as Petitioner argued in its
`Petition. Reh’g Req. 4–7 (citing Pet. 11). Petitioner states that the
`specification of the ’996 patent “teaches use of pH-sensitive enteric coatings
`to ‘inhibit’ release,” and “Patent Owner itself admits such coatings were
`known to permit release of up to 10% of a coated drug material under low
`pH conditions.” Id. at 5 (citing Prelim. Resp. 14). Referring to dictionary
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`definitions of record, Petitioner also argues that “inhibit” reasonably may be
`construed to mean “slow down,” and not necessarily stop the release of
`naproxen. Id. at 5–6 (citing Ex. 2012, 6; Ex. 2013, 1).
`Petitioner’s position regarding alternative “ordinary” meanings of the
`term “inhibit” rehashes an argument it raised in the Petition, which we
`squarely address in our Decision. Dec. 7–8 (discussing Pet. 11). Although
`we considered “ordinary” meanings of the term, we also took into account
`how the term “inhibit” was used in the claims themselves. Id. As stated in
`our Decision, the “use of ‘unless’ in claim 1 and 12 and ‘at least a portion’ in
`claim 1 indicates that the terms ‘inhibited’ and ‘inhibits’ in the claims do not
`encompass a ‘slowing down’ of a release when the pH is below 3.5 (which
`would make ‘at least a portion’ superfluous in claim 1).” Id. at 8. Thus, the
`terms indicate that “inhibited” and “inhibits” refer to no release of “at least a
`portion” (claim 1) or all (claim 12) of the drug “unless” the dosage form is in
`a medium with a pH of 3.5 or higher. Id. Petitioner does not persuade us
`that we erred in our claim construction of “inhibit.”
`
`B. Ground Based on WO ’185 (Ex. 1015)
`In our Decision, we did not institute an inter partes review of
`dependent claim 2, independent claim 12, or its dependent claims 13–19 of
`the ’996 patent. Dec. 39. Among other reasons, we were not persuaded that
`Petitioner had established a reasonable likelihood of prevailing on the
`ground that those claims would have been obvious over the ’225 patent
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`(Ex. 1013)1 in view of Chandramouli (Ex. 1009)2 and WO ’185 (Ex. 1015).3
`Dec. 32–38.
`In its Request for Rehearing discussing this ground (“Ground 4”),
`Petitioner points out that our Decision states that “Petitioner does not
`address the teaching on page 19 of WO ’185 regarding the impact of a
`bicarbonate salt on an enteric coating, a coating that the ’225 patent
`discloses as surrounding the NSAID, a coating that inhibits NSAID release
`until the pH is 3.5 or higher (i.e., in the lower G.I. tract), as recited in the
`challenge claims.” Reh’g Req. 8 (citing Dec. 36 (citing Ex. 1015, 19:16–23;
`Ex. 1013, Fig. 2, 6:24–44)). In its Request, Petitioner does not dispute that it
`failed to address the teaching on page 19 of WO ’185 in its Petition. Id. at
`8–10. Instead, Petitioner asserts we misread the relevant passage on page 19
`of WO ’185 in our Decision. Id. at 8–9; see also Dec. 33 (quoting page 19
`of WO ’185).
`Because Petitioner does not indicate in its Request where it raised an
`argument regarding the teachings on page 19 of WO ’185, Petitioner does
`not show adequately that our Decision should be modified based on such an
`
`
`1 U.S. Patent No. 5,698,225, issued Dec. 16, 1997, to Gimet et al. (“the ’225
`patent”) (Ex. 1013).
`2 Chandramouli et al., Prevention and management of NSAID-Induced
`Gastropathy, J. PHARM. PAIN AND SYMPTOM CONTROL, 8(4):27–40 (2000)
`(“Chandramouli”) (Ex. 1009).
`3 PCT Int’l Patent Appl. WO 00/26185, published May 11, 2000, by Phillips
`(“WO ’185”) (Ex. 1015).
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`argument now, or that we misapprehended or overlooked an argument by
`Petitioner in this regard. See 37 C.F.R. § 42.71(d).
`C. Ground Based on the ’556 Patent (Ex. 1007) and Reasonable
`Expectation of Success
`In our Decision, we were not persuaded that Petitioner had established
`a reasonable likelihood of prevailing on the ground that claims 1–19 of the
`’996 patent would have been obvious over the ’556 patent (Ex. 1007),4
`either alone or in view of Chandramouli (Ex. 1009) or the ’225 patent (Ex.
`1013). Dec. 16–29.
`In relation to this ground (“Ground 2”), Petitioner raises several
`arguments in its Request for Rehearing. Reh’g Req. 10–15. First, Petitioner
`asserts that we erred when we “improperly dismissed [Dr. Banakar’s
`Declaration] as a ‘conclusory statement.’” Id. at 10–11. As stated in our
`Decision, we determined that “conclusory statements by Petitioner and its
`declarant do not explain sufficiently, nor provide adequate support as to,
`why an ordinary artisan would have done the opposite of what the ’556
`patent taught to address the issue of PPI stability at lower pHs.” Dec. 21
`(citing Ex. 1007, 8:17–40, 12:4–32). We remain persuaded that neither the
`Petition nor Petitioner’s declarant adequately addresses this point.
`Petitioner’s arguments in its Request, which do not explain where the
`
`
`4 U.S. Patent No. 6,544,556, issued Apr. 8, 2003, to Chen et al. (“the ’556
`patent”) (Ex. 1007)
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`IPR2015-01773
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`Petition and Petitioner’s declarant address the ’556 patent, do not persuade
`us otherwise. Reh’g Req. 11–12.
`Second, Petitioner argues that we misunderstood the teachings of the
`Pilbrant reference (Ex. 1010). Reh’g Req. 12–13. Petitioner asserts that our
`“analysis is contrary to the educational background and experience of a
`POSA for the ’996 patent” because “it dismissed Pilbrant based on a single
`phrase in the publication” and “overlooked all data disclosed” in the
`reference. Id. We considered Pilbrant in its entirety in our Decision,
`however. See Dec. 23–25 (citing Ex. 1010, 113, 114, 116–117). We are not
`persuaded that we misapprehended or overlooked evidence or arguments
`before us. We are not persuaded that we erred in denying an inter partes
`review of certain claims in view of arguments by Petitioner we have
`considered already. Id. (discussing Pet. 21–24).
`Third, Petitioner contends that we “overlooked two common features
`known by a POSA” that would have led to a reasonable expectation of
`success, i.e., (1) “the self-propagating effect for PPIs, whereby
`bioavailability increases over time until reaching steady-state because less
`PPI degrades as pH increases,” and (2) “that any degradation of the PPI
`could have been overcome by raising the initial dose of the PPI.” Reh’g
`Req. 13–14 (citing Pet. 22–23). We did not overlook those assertions by
`Petitioner, but rather did not find them persuasive in view of teachings in the
`’556 patent (Ex. 1007) and Pilbrant (Ex. 1010), i.e., Petitioner’s own
`evidence. Dec. 17–18, 23–25 (discussing teachings regarding the
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`IPR2015-01773
`Patent 8,858,996 B2
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`degradation of PPIs and the need for protection from acidic gastric juice,
`e.g., through enteric coating).
`Fourth, Petitioner contends that we “incorrectly found Petitioner ‘does
`not rely on teachings in the ’556 patent itself’.” Reh’g Req. 14–15 (quoting
`Dec. 20) (citing Pet. 18). We disagree with Petitioner’s assessment of our
`finding in this regard. In our Decision, we addressed the specific portions of
`the ’556 patent cited by Petitioner. See Dec. 20 (citing Pet. 18 and
`discussing Petitioner’s citations to the ’556 patent). We stated that
`“Petitioner does not rely on teachings in the ’556 patent itself as disclosing
`or suggesting the limitations in challenged claims 1 and 12 regarding the
`release of esomeprazole (PPI) and naproxen (NSAID) based on pH.” Dec
`20; see also id. at n.8. (providing more detail regarding Petitioner’s analysis
`and claim charts). As we also explained in our Decision, “[i]nstead, the
`Petition cites to Dr. Banakar’s testimony in support of its contention that an
`ordinary artisan would have done the opposite of what the ’556 patent itself
`teaches.” Id. at 21. We are not persuaded that we overlooked or
`misapprehended arguments made by Petitioner in its Petition, or that our
`factual findings are not supported by the evidence before us.
`
`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 of
`claims 2 and 12–19 of the ’996 patent.
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`IPR2015-01773
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`V. ORDER
`
`It is
`
`ORDERED that Petitioner’s Request for Rehearing of the Decision
`denying an inter partes review of claims 2 and 12–19 of U.S. Patent No.
`8,858,996 B2 is denied.
`
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`IPR2015-01773
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`
`For PETITIONER:
`Sailesh Patel
`John Hsu
`SCHIFF HARDIN LLP
`spatel@schiffhardin.com
`jhsu@schiffhardin.com
`
`For PATENT OWNER:
`James B. Monroe
`Danielle C. Pfifferling
`FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER, LLP
`james.monroe@finnegan.com
`danielle.pfifferling@finnegan.com
`
`Ricardo Rodriguez
`Thomas Blinka
`COOLEY LLP
`rr@cooley.com
`tblinka@cooley.com
`zIPR2015-01773@cooley.com
`
`Lauren Stevens
`HORIZON PHARMA USA, INC.
`lstevens@horizonpharma.com
`
`
`Dennis Bennett
`GLOBAL PATENT GROUP, LLC
`dennisbennett@globalpatentgroup.com
`
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`IPR2015-01773
`Patent 8,858,996 B2
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`
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`Stephen M. Hash, Ph.D.
`Margaret J. Sampson, Ph.D.
`Jeffrey S. Gritton
`BAKER BOTTS LLP
`stephen.hash@bakerbotts.com
`margaret.sampson@bakerbotts.com
`jeff.gritton@bakerbotts.com
`
`
`Matthew Phillips
`Kevin Laurence
`RENAISSANCE IP LAW GROUP LLP
`matthew.phillips@renaissanceiplaw.com
`kevin.laurence@renaissanceiplaw.com
`
`
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