Trials@uspto. gov
`571.272.7822
`
`Paper No.13
`Entered: December3, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS,INC.,
`Petitioner,
`
`V.
`
`BAYER INTELLECTUAL PROPERTY GMBH,
`Patent Owner.
`
`Case IPR2018-01143
`Patent 9,539,218 B2
`
`Before JACQUELINE WRIGHTBONILLA,Acting Deputy Chief
`Administrative Patent Judge, RAMA G. ELLURU and
`TINAE. HULSE,Administrative Patent Judges.
`
`HULSE,Administrative Patent Judge.
`
`DECISION
`DenyingInstitution ofInter Partes Review
`35 U.S.C. § 314(a)
`
`
`571.272.7822
`
`Paper No.13
`Entered: December3, 2018
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`MYLAN PHARMACEUTICALS,INC.,
`Petitioner,
`
`V.
`
`BAYER INTELLECTUAL PROPERTY GMBH,
`Patent Owner.
`
`Case IPR2018-01143
`Patent 9,539,218 B2
`
`Before JACQUELINE WRIGHTBONILLA,Acting Deputy Chief
`Administrative Patent Judge, RAMA G. ELLURU and
`TINAE. HULSE,Administrative Patent Judges.
`
`HULSE,Administrative Patent Judge.
`
`DECISION
`DenyingInstitution ofInter Partes Review
`35 U.S.C. § 314(a)
`
`
`
`IPR2018-01143
`Patent 9,539,218 B2
`
`I. INTRODUCTION
`
`Mylan Pharmaceuticals Inc. (“Petitioner”) filed a Petition requesting
`an interpartes review of claims 1-4 of U.S. Patent No. 9,539,218 B2
`
`(Ex. 1001, “the ’218 patent”). Paper 2 (“Pet.”). Bayer Intellectual Property
`GmbH(‘Patent Owner”)filed a Preliminary Responseto the Petition.
`Paper6 (“Prelim. Resp.”). With our authorization, Petitioner filed a Reply
`to the Preliminary Response(Paper8, “Reply’’), and Patent Ownerfiled a
`Surreply (Paper 10 (confidential version); Paper 11 (public version)
`
`(“Surreply’”)).
`Wehaveauthority under 35 U.S.C. § 314, which providesthat an
`interpartes review maynotbe instituted “unless. .
`. there is a reasonable
`likelihood that the petitioner would prevail with respectto at least 1 of the
`claims challengedin the petition.” 35 U.S.C. §314(a). Upon considering
`the arguments and evidence, we determinethatit is appropriate to exercise
`our discretion to deny institution under 35 U.S.C. §§ 314(a) and 325(d).
`Accordingly, we decline to institute an interpartes review ofthe challenged
`
`claims of the ’218 patent.
`
`A.
`Related Proceedings
`Patent Ownerhas asserted the ’218 patent against Petitioner in a
`pending lawsuit styled BayerIntellectualProperty GmbHv. Mylan
`Pharmaceuticals Inc.,No. 1:17-cv-00584-RGA(D. Del.). Pet. 14; Paper 5,
`
`2. Patent Owneridentifies nine other pending cases involving the 218
`patent in the U.S. District Court of Delaware, which, along with the above-
`referenced case, have been consolidated into the case Bayer Intellectual
`Property GmbH v. Taro Pharmaceutical Industries Ltd. , 1:17-cv-462-RGA
`(D. Del.). Paper 5, 2-3.
`
`
`
`IPR2018-01143
`Patent 9,539,218 B2
`
`B.
`
`The ’218 Patent
`
`The ’218 patent relates to a methodoftreating a thromboembolic
`disorder by administering a direct factor Xa inhibitor once daily.
`Ex. 1001, 1:4-7. Factor Xa plays a keyrole in the blood coagulation
`cascade. Id. at 1:25~26. A preferred embodimentofthe invention relates
`to 5-Chloro-N-({(5S)-2-0xo-3-[4-(3-oxo-4-morpholiny])pheny]]-1,3-
`oxazolidin-5-yl} methyl)-2-thiophenecarboxamide, whichis referredto as
`rivaroxabanbythe parties. Jd. at 3:18-21. Rivaroxabanis a low
`molecular weight, orally administrable direct inhibitor of factor Xa. Id. at
`
`3:21-22.
`
`C.
`
`Illustrative Claim
`
`Petitioner challenges claims 1-4 of the ’218 patent, of which claim |
`is the only independent claim. Claim1is illustrative and is reproduced
`below:
`
`1. Amethod of treating a thromboembolic disorder
`comprising:
`
`administering a direct factor Xa inhibitor that is S-Chloro-N-
`({(5S)-2-0xo-3-[4-(3-oxo-4-morpholinyl)pheny]]-1,3-
`oxazolidin-5-yl} methy]l)-2-thiophenecarboxamide no
`more than oncedaily forat least five consecutive days in
`a rapid-releasetablet to a patient in need thereof, wherein
`the thromboembolic disorderis selected from the group
`consisting of pulmonary embolisms, deep vein
`thromboses, andstroke.
`
`Ex. 1001, 10:63-1 1:5.
`
`
`
`\
`
`IPR2018-01143
`Patent 9,539,218 B2
`
`D.
`
`The Asserted Grounds ofUnpatentability
`
`Petitioner challenges the patentability of claims 1-4 of the ’218 patent
`
`on the following grounds:
`
`References
`
`°610 Publication! and Kubitza Abstracts?
`
`°610 Publication, Kubitza Abstracts, and Forsman?
`
`Petitioner also relies on the Declarations of Leslie Z. Benet, Ph.D.
`
`(Ex. 1002) and Neil E. Doherty,IIT, M.D., FACC (Ex. 1003) to support its
`
`assertions.
`
`IL ANALYSIS
`
`A.
`
` PersonofOrdinary Skill in the Art
`
`Petitioner asserts that a person of ordinary skill in the art would have
`had an advanced degree in pharmacology, drug design and formulation,
`
`.
`
`| Straub et al., US 2003/0153610 Al, published Aug. 14, 2003 (“the ’610
`Publication,” Ex. 1005).
`* Kubitzaet al., Multiple Dose Escalation Study Investigating the
`Pharmacodynamics, Safety; andPharmacokinetics ofBAY59-7939 an Oral
`Direct FactorXa Inhibitor in Healthy Male Subjects, 102 BLoopD81 1a,
`Abstract # 3004 (Nov. 16, 2003) (“Kubitza # 3004”); Kubitzaet al., Single
`Dose Escalation Study Investigating the Pharmacodynamics, Safety, and
`Pharmacokinetics ofBAY59-7939 an Oral, Direct FactorXa Inhibitorin
`Healthy Male Subjects, 102 BLOOD 813a, Abstract # 3010 (Nov.16, 2003)
`(“Kubitza # 3010”); Harderet al., Effects ofBAY 59-7939, an Oral, Direct
`Factor Xa Inhibitor, on Thrombin Generation in Healthy Volunteers, 102
`BLOOD 81 1a, Abstract # 3003 (Nov. 16, 2003) (““Kubitza # 3003”). Kubitza
`# 3004, # 3010, and # 3003 are collectively referred to by Petitioneras the
`“Kubitza Abstracts.” Ex. 1006.
`3 Forsmanet al., WO 00/13671, published Mar. 16, 2000 (““Forsman,”
`Ex. 1007).
`
`
`
`IPR2018-01143
`Patent 9,539,218 B2
`
`medicinal chemistry,or a related field. Pet. 11-12. Petitioner also asserts
`that a person of ordinary skill in the art would have had some combination
`of skill and experience, including experience in pharmacology,
`pharmacokinetics, toxicology, and formulation, and an understandingofthe
`role of anticoagulants in treating thromboembolic disorders. Jd. at 11 (citing
`Ex. 1002 J§ 42-43; Ex. 1003 { 19). Patent Ownerdoesnot contest
`Petitioner’s assertionsin this regard. Prelim. Resp. 4.
`Onthis record, we adoptPetitioner’s definition of the level of
`ordinary skill in the art. Wealso note that the prior art itself demonstrates
`
`the level of skill in the art at the time of the invention. See Okajima v.
`
`Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining thatspecific
`findings regarding ordinary skill level are not required “wherethe priorart
`itself reflects an appropriate level andaneedfor testimony is not shown”)
`(quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158,
`
`163 (Fed. Cir. 1985)).
`
`B.
`
`Claim Construction
`
`In an interpartes review petition filed before November13, 2018,the
`Board interprets claim termsin an unexpired patent accordingto the
`broadest reasonable constructionin light of the specification of the patent in
`
`which they appear. 37 C.F.R. § 100(b); Cuozzo Speed Techs., LLC v. Lee,
`136 S. Ct. 2131, 2142 (2016) (affirming applicability of broadest reasonable
`construction standardto interpartes revicw proceedings); 83 l'ed. Reg.
`51,340 (Oct. 11, 2018) (changing the standardfor interpreting claims in inter
`partes reviewstiled on or after November 13,2018). Underthat standard,
`and absent anyspecial definitions, we generally give claim termstheir
`ordinary and customary meaning, as would be understood by oneofordinary
`skill in the art at the time of the invention. See Jn re Translogic Tech., Inc.,
`
`4
`
`
`
`IPR2018-01143
`Patent 9,539,218 B2
`
`504 F.3d 1249, 1257 (Fed. Cir. 2007). Any special definitions for claim
`terms mustbe set forth with reasonable clarity, deliberateness, and precision.
`
`See In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
`
`Theparties contest the meaning of “rapid-release tablet,” which
`appears in claim 1 of the 218 patent. Petitioner asserts that the ordinary and
`customary meaningof “rapid-release tablet”is a “conventionaltablet[] that
`[has] not been formulated to release the active compoundin a modified
`manner, such as through delayed or extendedrelease.” Pet. 22 (citing Ex.
`1002 ff 46, 49; Ex. 1003 4] 28-30). Patent Ownerasserts that the term
`should be construed accordingto its express definition in the ’218
`specification: “a tablet which, according to the USPrelease method using
`apparatus 2 (paddle), has a Q value (30 minutes) of 75%.” Prelim. Resp. 5
`(citing Ex. 1001, 8:21-24). Patent Ownerfurther notes that the Board in a
`previous ex parte appeal decision (Ex. 1004, 116) andthe district court
`judge in the copending case (Ex. 2002,1) have both construedthe term
`according to Patent Owner’s proposed definition. Prelim. Resp. 6-9.
`Having considered the parties’ respective arguments and evidence, we
`determine Patent Owner’s proposedinterpretationis the broadest reasonable
`interpretation. We find—asthe prior panel at the Boardand the district
`courtjudge have found—thatthe ’218 patent specification expressly defines
`the term “rapid-releasetablet.” Specifically, the ’218 patent specification
`
`states:
`
`The term “oral dosage forms”is used in a general sense to
`reference pharmaceutical products administered orally. Oral
`dosage formsare recognized bythose skilled in the art to include
`such formsasliquid formulations, granules, gelcaps, hard gelatin
`capsules orsachetsfilled with granules, and tablets releasing the
`active compound rapidly or in a modified manner.
`
`
`
`IPR2018-01143
`Patent 9,539,218 B2
`
`Tablets are preferred, in particular tablets rapidly releasing
`the active compound. Jn the context of the present invention,
`rapid-release tablets are in particular those which, according to
`the USP release method using apparatus 2 (paddle), have a Q
`value (30 minute) of 75%.
`
`Ex. 1001, 8:12-24 (emphasis added). Thus, the specification sets forth with
`reasonableclarity and deliberateness the definition of “rapid-release tablets”
`as being “‘in particular those [tablets] which, according to the USPrelease
`methodusing apparatus 2 (paddle), have a Q value (30 minute) of 75%.” Id.
`
`at 8:22-24.
`
`Petitioner does not identify any evidence that persuadesus to deviate
`
`from the prior Boarddecision, thedistrict court’s decision, and, most
`importantly, the °218 patent specification. For example, as support,
`Petitioner quotes the following passage from the specification, arguing that
`
`the specification uses the term in its customary manner:
`Oral dosage forms are recognized by thoseskilled in theart to
`include .
`.
`. tablets releasing the active compound rapidly or in a
`modified manner. Tablets are preferred, in particular tablets
`rapidly releasing the active compound.
`
`Pet. 22 (quoting Ex. 1001, 8:14-30). But, as Patent Ownernotes,
`Petitioner’s block quotation is misleading. Prelim. Resp. 10. As seen in a
`fuller reading of the relevant passage in the specification itself, Petitioner
`has omitted the paragraph breakafterthe first sentence. When viewedin
`context, we agree with Patent Ownerthatthe specification identifies “tablets
`releasing the active compoundrapidly or in a modified manner”as an
`example ofan “oral dosage form.” Ex. 1001, 8:12-19. After the paragraph
`break, however, the specification goes on to discuss tablets and specifically
`defines “rapid-release tablets”“[iJn the context of the present invention.”
`
`Id. at 8:21-22.
`
`
`
`IPR2018-01 143
`Patent 9,539,218 B2
`
`Weare not persuadedto construe the term otherwise based on
`
`Petitioner’s assertion that the term is not in quotation marksin the
`
`specification. See Reply 2. A lack ofquotation marksis not dispositive,
`
`especially given the definition is in the section ofthe specification where
`“the following terms and abbreviationsare defined.” See Ex. 1001, 7:22—24.
`Thus, weare persuadedthat the specification has provided a clear and
`express definition of the term that is narrower than that proposed by
`
`Petitioner.
`
`To further support its construction, Petitioner cites extrinsic evidence
`
`in the form of testimony from its declarants and definitions from various
`
`textbooks and other publications. Pet. 22-24. Weare not persuaded,as
`such extrinsic evidence cannot outweigh the clear definition of “rapid-
`
`release tablet’ expressly set forth by the patent specification. See Tempo
`Lighting, Inv. v. Tivoli, LLC, 742 F.3d 973, 977 (Fed. Cir. 2014) (finding
`that “extrinsic evidenceis not irrelevant, but hasrelatively little probative
`
`value in view of the prevailing intrinsic evidence”).
`Finally, Petitioner points to alleged concessions made by Patent
`Ownerto the EuropeanPatent Office in an Opposition proceeding (Pet. 25—
`26) and to the district court in the copendinglitigation (Reply 1-2).
`Petitioner argues that Patent Owneragreed in the European Opposition that a
`“rapid-release tablet” means “‘anytablet that is not a sustained- or retarded-
`release tablet.” Pet. 25-26. Likc the district court, we are persuadedthat
`
`Patent Owner’s alleged concession appears to have been a position taken to
`streamline the Europeanlitigation. See Prelim. Resp. 15; Ex. 1015, 28 (“To
`simplify matters for the present proceedings, we will adopt for the purpose
`of the present proceedings the understanding proposedby the majority of the
`
`
`
`IPR2018-01143
`Patent 9,539,218 B2
`
`opponents... .”); see also Ex. 2002,3 (district court’s Markman Order
`
`accepting Patent Owner’s explanation).
`Petitioner also argues that the definition in the specificationis unclear,
`
`as evidencedbythe fact that Patent Ownerasked the district court to further
`construe the construction of “rapid-release tablet.” Reply 1-2. Thedistrict
`
`court denied Patent Owner’s request, stating that Patent Owner’s request for
`
`further construction amountsto an issue of fact to be determinedattrial.
`
`Ex. 1069, 1. Becausethe issuesin the district court case that gave rise to
`
`Patent Owner’s requestare not at issue here, we are not persuadedthat
`
`Patent Owner’s requestfor further construction in that casejustifies adopting
`
`Petitioner’s construction here.
`
`Accordingly, on this record, we construe the term “rapid-release
`tablet” to mean “a tablet that, according to the USP release method using
`
`apparatus 2 (paddle), has a Q value (30 minute) of 75%.”
`
`Wedeterminethatit is unnecessary to construe any other term for
`
`purposesof this Decision. See Wellman, Inc. v. Eastman Chem.Co., 642
`F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed‘to
`299
`the extent necessary to resolve the controversy.””) (quoting Vivid Techs.,
`Inc. v. Am. Sci. & Eng’g, Inc.,200 F.3d795, 803 (Fed. Cir. 1999)).
`
`C.
`
`Whether to Exercise Our Discretion Under
`35 U.S.C. $325(d)for Ground |
`Institution of interpartes review is discretionary. See Harmonic Inc.
`v. Avid Tech, Inc., 815 F.3d 1356, 1367 (Fed. Cir. 2016) (explaining “the
`
`PTO is permitted, but never compelled,to institute an IPR proceeding’).
`For instance, § 325(d)states “[i]n determining whetherto institute or order a
`proceeding underthis chapter. .
`. [t]he Director may take into account
`
`
`
`IPR2018-01143
`Patent 9,539,218 B2
`
`whether, andreject the petition or request because, the sameor substantially
`the sameprior art or arguments previously were presentedto the Office.”
`In evaluating whether the sameor substantially the samepriorart or
`arguments were previously presentedto the Office under § 325(d), the Board
`has considered a numberof non-exclusive factors, including, for example:
`
`(a) the similarities and material differences betweenthe asserted
`art and theprior art involved during examination;
`
`(b) the cumulative nature of the asserted art and the prior art
`evaluated during examination;
`
`(c) the extent to which theasserted art was evaluated during
`examination, including whetherthe prior art was the basis
`for rejection;
`
`(d) the extentof the overlap between the arguments made
`during examination and the mannerin which Petitioner
`relies on the prior art or Patent Ownerdistinguished the
`prior art;
`
`(e) whetherPetitioner has pointed out sufficiently how the
`Examinererred in its consideration of the asserted priorart;
`and
`
`(f) the extent to which additional evidence and facts presented
`in the Petition warrant reconsideration of the asserted prior
`art or arguments.
`
`Becton, Dickinson & Co. v. B. Braun Melsungen AG, Case IPR2017-01586,
`slip op. 17-18 (PTAB Dec. 15, 2017) (Paper8) (informative) (“the Becton
`Dickinson factors”).
`
`1.
`The Prior Board Decision
`During prosecution ofthe ’218 patent application, the examiner issued
`a final rejection of the pendingclaims as obvious overthe ’610 Publication,
`
`
`
`IPR2018-01 143
`Patent 9,539,218 B2
`
`“Kubitza 1,”4 and Kubitza # 3010 (referred to by the Board as “Kubitza 2”).
`
`Ex. 1004, 111. Onappeal, the Board foundthat the claimsdirected to a
`
`“rapid-release oral dosage form” were obviousoverthe cited art. Jd. at 113—
`
`16. Then-pending claim 5, however,recited a “rapid-release tablet,” which
`the Board interpreted according to the “express definition thereofprovided
`in the Specification.” Jd. at 116. The Board could not determine based on
`
`the evidence of record whetherthe disclosure of Kubitza # 3010 taught or
`
`suggested a “rapid-release tablet” according to that interpretation. Jd. at
`116-17. Thus, the Board reversedthe rejection of claim 5. Jd. at 117.
`
`After the appeal, the examiner entered an examiner’s amendmentthat
`amendedthe claimsto recite a “rapid-release tablet” instead ofa “‘rapid-
`release oral dosage form.” Ex. 1004, 53-54. The Examinerstatedin the
`Reasons for Allowancethat the cited prior art “does not teach, disclose nor
`
`render obviousthe instantly claimed method wherem a rapid-release tabletis
`
`utilized.” Jd. at 55.
`
`Application ofOur Discretion Under 35 U.S.C. § 325(d)
`2.
`Patent Ownerarguesthat we should exercise our discretion to deny
`
`institution under § 325(d) because substantially the sameprior art or
`
`arguments were previously presentedto the Office. Pet. 20-25.
`
`4 The Boardidentified “Kubitza 1” as Kubitzaet al., Oral, Direct FactorXa
`Inhibitor—In Healthy Male Subjects, 102 BLOOD 811a (Nov.16, 2003).
`Ex. 1004, 110. The cited page 811a of BLoopD, however, does not include an
`abstract withthattitle. See Ex. 1006, 81la. Nevertheless, Petitioner appears
`to equate Kubitza 1 with Kubitza # 3004. See Reply 3-4 (citing the Board’s
`prior decision andreferring to “Kubitza abstracts # 3004 and # 3010 and the
`’610 publication”). Regardless,the relied-upon portions of Kubitza 1 appear
`to be substantially similar to the disclosures in Kubitza # 3004. Compare
`Ex. 1004, 112 (FF8 and FF9) with Ex. 1006, 81la. We, therefore, consider
`Kubitza 1 to be substantially similar to Kubitza# 3004.
`
`10
`
`
`
`IPR2018-01143
`Patent 9,539,218 B2
`
`Specifically, Patent Owner argues that Ground | is premised on the
`argumentsthat (1) the Board incorrectly construed the term “rapid-release
`tablet’’; (2) the Board should adopt a different construction here; and (3)the
`
`claims are obviousin view ofthat different construction. Jd. at21. Because
`
`there is no reason to construe the term differently now, Patent Owner asserts
`
`weshould exercise our discretion under § 325(d) becausethe substantive
`
`obviousnesspositions ofGround | were already considered andrejected by
`the Office during prosecution of the patent. Jd. at 20.
`
`Petitioner asserts that the Petition includes new evidence not
`
`presented during prosecution or before the Board in the ex parte appeal.
`Pet. 15-18 (citing new testimony and supporting reference evidence), But
`the new evidence regarding Ground1 relates to evidence in support of
`Petitioner’s proposed constructionofthe term “rapid-release tablet,” which,
`as explained above, we do notfind persuasive. See id. at 15—17; see also
`supra. Inresponse to Patent Owner’s § 325(d) argument for Ground1,
`Petitioner simply argues that Patent Owner’s argumentis unavailing because
`the Board should adoptits construction. Reply 3.
`Having considered the parties’ respective arguments and evidence, we
`are persuadedthat exercising our discretion under § 325(d) is appropriate for
`Ground 1. Becton Dickinson factors (a)(d)relate to whether and to what
`
`extent the prior art asserted in the Petition was considered and relied upon by
`the examiner during prosecution. Here, substantially the same priorart that
`Petitioner asserts in Ground 1 wasextensively considered by the examiner
`
`and the Board. Thatis, the examiner and the Board considered whetherthe
`claims were obviousover the ’610 Publication, Kubitza # 3004-(i.e., Kubitza |
`1), and Kubitza # 3010 (i.e., Kubitza 2). The Petition also relies on Kubitza
`#3003. See, e.g., Pet.34, 44. But Petitioner does not assert—nor do we
`
`11
`
`
`
`IPR2018-01143
`Patent 9,539,218 B2
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`ascertain—thatthe relied-upon portions of Kubitza # 3003 cure the
`
`deficiencies of the ’610 publication, Kubitza # 3004, or Kubitza # 3010.
`See, e.g, Pet. 34, 44-45 (discussing Ex. 3003); Reply (no citation to Ex.
`
`3003). Thus, these factors weigh heavily in favor of exercising our
`
`discretion to deny institution.
`Becton Dickinson factors(e) and (f) look to the Petition and whether
`
`Petitioner has madea casefor reconsidering the asserted prior art. Wefind
`
`that Petitioner has not. As noted above, weare not persuadedthatthe prior
`Board panel(orthedistrict court) erred in construing the term “rapid-release
`tablet” accordingto the express definition in the specification. Thus,
`Petitioner’s arguments regarding claim constructiondo not point out
`sufficiently how the Board and the examinererredin its consideration of the
`cited prior art. Nor has Petitioneridentified any additional facts and
`evidence unrelated to claim construction that justify reconsidering the prior
`
`art or argumentsset forth in Ground 1.
`Accordingly, underthe facts and circumstancesofthis case, we find
`that substantially the sameprior art and arguments were previously
`presentedto the Office. We, therefore, determinethat exercising our
`discretion under § 325(d) to deny institution is appropriate for Ground1.
`
`D.
`
`Whether to Exercise Our Discretion Under
`35 U.S.C. §314(a)for Ground 2
`Patent Ownerasserts that we should also exercise our discretion under
`
`§ 325(d) for Ground 2. Prelim. Resp. 21-25. Ground 2, however,differs
`from Ground 1 because Petitioner asserts that even under the express
`definition of “rapid-releasetablet,” the claims are obvious. Pet. 46. To that
`end,Petitioner additionally relies on Forsman, which wasnotbefore the
`
`12
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`IPR2018-01143
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`Office during prosecution and whichallegedly teachesthe specific
`requirementsfor a “rapid-release tablet.” Pet. 17-18.
`Patent Ownernotes, however, that Forsmanis at issue in the
`
`copendingdistrict court case. Surreply 3. Moreover,Petitionerrelies on the
`samedeclarants (Drs. Benet and Doherty), and the samepriorart references
`(the 610 publication, the Kubitza Abstracts, and the Forsmanreferences)
`thatit relies on in the Petition. Jd. at 4. The district court also has construed
`
`“rapid-release tablet” as we have here, according to the expressdefinition set
`forth in the specification. Ex. 2002, 1. Finally, Patent Ownerindicatesthat
`
`the district court hassettrial for April 1, 2019. Surreply 4.
`
`It is well established that we have discretion regarding whether to
`
`institute trial under § 314(a). See 35 U.S.C. § 314(a) (authorizing institution
`of an interpartes review underparticular circumstances, but not requiring
`institution under any circumstances); see also Cuozzo Speed Techs., LLC v.
`
`Lee, 136 S. Ct. 2131, 2140 (2016) (citing § 314(a) and stating the PTO’s
`“decision to denyapetition is a matter committed to the Patent Office’s
`discretion”). As such, even assumingthereis a reasonablelikelihood that
`Petitioner would prevail with respectto at least one challenged claim (which
`wedo not assess here), we havediscretion on whetherto institute trial based
`
`on the facts and circumstances of each case.
`
`Having considered the parties’ respective arguments, we determine
`that exercising our discretion to notinstitute trial is appropriate here. Given
`the advancedstage ofthe copendingdistrict court case and the extensive
`overlap of the asserted prior art, expert testimony, and claim construction,
`wefind it would be an inefficient use of Board resources to proceed with
`
`this interpartes review in parallel with the district court case. See NHK
`Spring Co. v. Intri-Plex Techs., Inc., Case IPR2018-00752,slip op. at 19-20
`
`13
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`(PTAB Sept. 12, 2018) (Paper8) (finding the advancedstate of a copending
`district court proceeding addressing the samepriorart to be an additional
`factor weighing in favor of denying the petition under § 314(a)). That
`inefficiency is amplified where the district court trial is set to occur on April
`1, 2019, which is more than eight months before our Final Written Decision
`
`would be due in December2019, if we wereto institute trial.
`
`Thus, wefindthat instituting an interpartes review ofthe ’218 patent
`
`under these facts and circumstances would be contrary to the overall goal of
`
`the AIA to “makethe patent system moreefficient by the use of post-grant
`
`review procedures.” General Plastic Industrial Co., Ltd. v. Canon
`Kabushiki Kaisha, Case IPR2016-01357, slip op. at 16-17 (PTAB Sept.6,
`2017) (Paper 19) (precedential as to § II.B.4.i). Accordingly, we determine
`that exercising our discretion to denyinstitution under § 314(a) is
`
`appropriate as to Ground2.
`
`IH. CONCLUSION
`
`For the foregoing reasons, we exercise our discretion under 35 U.S.C.
`§§ 314(a) and 325(d) and decline to institute an interpartes review ofthe
`
`challenged claims ofthe ’218 patent.
`
`IV. ORDER
`
`In consideration of the foregoing, it is hereby:
`ORDEREDthatthe Petition is denied asto all challenged claims of
`
`the ’218 patent and notrial is instituted.
`
`14
`
`
`
`IPR2018-01143
`Patent 9,539,218 B2
`
`PETITIONER:
`
`Steven Parmelee
`Michael Rosato
`Jad Mills
`Wilson Sonsini Goodrich & Rosati
`sparmelee@wsegr.com
`
`mrosato@wsegr.com
`jmills@wsegr.com
`
`PATENT OWNER:
`
`Dov Grossman
`Ben Picozzi
`Williams & Connolly LLP
`dgrossman@wc.com
`bpicozzi@wc.com
`
`15
`
`
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