`571-272-7822
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` Paper 16
`
`Entered: October 27, 2016
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`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`PAR PHARMACEUTICAL, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`Patent Owner.
`____________
`
`Case IPR2016-01059
`Patent 5,665,772
`____________
`
`BRECKENRIDGE PHARMACEUTICAL, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`Patent Owner.
`____________
`
`Cases IPR2016-01023, IPR2016-01103
`Patent 5,665,772
`____________
`
`
`
`____________
`
`ROXANE LABORATORIES, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS AG,
`Patent Owner.
`____________
`
`Case IPR2016-01102
`Patent 5,665,772
`____________
`
`
`
`
`
`
`
`
`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and
`ROBERT A. POLLOCK, Administrative Patent Judges.
`
`CRUMBLEY, Administrative Patent Judge.
`
`
`
`
`DECISION
`Granting, Granting-In-Part, and Denying Motions for Joinder
`35 U.S.C. § 315(c); 37 C.F.R. § 42.122(b)
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`INTRODUCTION
`
`I.
`On April 29, 2016, the Board instituted an inter partes review trial of
`claims 1–3 and 8–10 of U.S. Patent No. 5,665,772 (Ex. 1001,1 “the ’772
`patent”). Par Pharm. v. Novartis AG, Case IPR2016-00084 (“Par I”), Paper
`8. Trial in that matter is pending on the following grounds of
`unpatentability:
`1. Whether claims 1–3 and 10 are unpatentable under 35 U.S.C.
`§ 103(a) as having been obvious over Morris,2 Van Duyne,3
`Rossmann,4 Yalkowski,5 and Lemke;6 and
`
`2. Whether claims 8 and 9 are unpatentable under 35 U.S.C.
`§ 103(a) as having been obvious over Morris, Van Duyne,
`Rossmann, Yalkowski, Lemke, and Hughes.7
`
`
`1 Unless otherwise indicated, when essentially identical documents have
`been filed in each of the cases, for simplicity we will cite only to the docket
`of IPR2016-01023.
`2 Randall Ellis Morris, Rapamycins: Antifungal, Antitumor,
`Antiproliferative, and Immunosuppressive Macrolides, 6 TRANSPLANTATION
`REVIEWS 39–87 (1992) (Ex. 1005).
`3 Gregory D. Van Duyne et al., Atomic Structure of the Rapamycin Human
`Immunophilin FKBP-12 Complex, 113 J. AM. CHEM. SOC’Y 7433–35 (1991)
`(Ex. 1006).
`4 Michael G. Rossmann et al., Three-Dimensional Coordinates from
`Stereodiagrams of Molecular Structures, B36 ACTA CRYST. 819–23 (1980)
`(Ex. 1024).
`5 Samuel H. Yalkowsky, Estimation of Entropies of Fusion of Organic
`Compounds, 18 INDUS. ENG’G CHEM. FUNDAM. 108–11 (1979) (Ex. 1007).
`6 Thomas L. Lemke, Chapter 16: Predicting Water Solubility, REVIEW OF
`ORGANIC FUNCTIONAL GROUPS 113–21 (2d ed. 1988) (Ex. 1008).
`7 U.S. Patent 5,233,036 (Aug. 3, 1993) (Ex. 1009).
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`Four additional petitions have now been filed with the Board, each
`seeking joinder with Par I. We summarize these petitions below.
`In IPR2016-01059 (“Par II”), Par Pharmaceuticals, Inc. filed a
`Petition requesting inter partes review of claim 7 of the ’772 patent. Par II,
`Paper 1, “Par II Pet.” Concurrently with its Petition, Par filed a Motion for
`Joinder (Paper 3, “Par II Mot.”), seeking joinder with the Par I case. The
`owner of the ’772 patent, Novartis AG, filed an Opposition to the Motion for
`Joinder (Paper 11) and a Patent Owner Preliminary Response (Paper 16,
`“Prelim. Resp.”1).
`In IPR2016-01023 (“Breckenridge I”), Breckenridge Pharmaceuticals,
`Inc. filed a Petition requesting inter partes review of claims 1–3 and 8–10 of
`the ’772 patent. Breckenridge I, Paper 4, “Breckenridge I Pet.”
`Concurrently with its Petition, Breckenridge filed a Motion for Joinder
`(Paper 5, “Breckenridge I Mot.”), seeking joinder with the Par I case.
`Novartis filed an Opposition to the Motion for Joinder (Paper 12) and a
`Patent Owner Preliminary Response (Paper 17).
`In IPR2016-01103 (“Breckenridge II”), Breckenridge filed a Petition
`requesting inter partes review of claim 7 of the ’772 patent. Breckenridge
`II, Paper 1, “Breckenridge II Pet.” Concurrently with its Petition,
`Breckenridge filed a Motion for Joinder (Paper 4, “Breckenridge II Mot.”),
`seeking joinder with the Par I case. Novartis filed an Opposition to the
`Motion for Joinder (Paper 10) and a Patent Owner Preliminary Response
`(Paper 15).
`
`
`1 Novartis filed identical Preliminary Responses in each of the four cases.
`We will cite to them generally as “Prelim. Resp.”
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`In IPR2016-01102 (“Roxane”), Roxane Laboratories, Inc. filed a
`Petition requesting inter partes review of claims 1–3 and 7–10 of the ’772
`patent. Roxane, Paper 2, “Roxane Pet.” Concurrently with its Petition,
`Roxane filed a Motion for Joinder (Paper 3, “Roxane Mot.”), seeking joinder
`with the Par I case. Novartis filed an Opposition to the Motion for Joinder
`(Paper 11) and a Patent Owner Preliminary Response (Paper 14).
`The grounds of unpatentability asserted, and the claims challenged, in
`all five proceedings may be summarized as follows:
`Ground of Unpatentability Challenged Claim(s) Case
`Morris, Van Duyne,
`1–3, 10
`Par I (instituted)
`Rossmann, Yalkowski, and
`Breckenridge I
`Lemke
`Roxane
`Morris, Van Duyne,
`Par I (instituted)
`Rossmann, Yalkowski,
`Breckenridge I
`Lemke, and Hughes
`Roxane
`Par II
`Breckenridge II
`Roxane
`
`8, 9
`
`7
`
`
`
`As a threshold matter, we determine that the Motions for Joinder were
`timely. Our Rules provide that a request for joinder must be filed “no later
`than one month after the institution date of any inter partes review for which
`joinder is requested.” 37 C.F.R. § 42.122(b). The Motions were filed on or
`before May 26, 2016, less than one month after the April 29, 2016 institution
`date of the Par I inter partes review, and are thus timely.
`For the reasons explained below, we grant the Breckenridge I Motion,
`grant-in-part the Roxane Motion, and deny the Par II and Breckenridge II
`Motions.
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`II. THE PETITIONS WARRANT INSTITUTION
`The controlling statute regarding joinder of inter partes reviews is
`35 U.S.C. § 315(c), which reads as follows:
`(c) JOINDER.--If the Director institutes an inter partes review,
`the Director, in his or her discretion, may join as a party to that
`inter partes review any person who properly files a petition under
`section 311 that the Director, after receiving a preliminary
`response under section 313 or the expiration of the time for filing
`such a response, determines warrants the institution of an inter
`partes review under section 314.
`The statute makes clear that joinder of a party to an instituted inter
`partes review is within the Board’s1 discretion. That discretion may only be
`exercised, however, if the party seeking joinder “files a petition . . . that the
`Director . . . determines warrants the institution of an inter partes review.”
`35 U.S.C. § 315(c). As a threshold issue, therefore, we must first determine
`whether the Par II, Breckenridge I, Breckenridge II, and Roxane Petitions
`warrant institution of an inter partes review.
`
`A. Claims 1–3 and 8–10
`The grounds of unpatentability asserted against claims 1–3 and 8–10
`in the Breckenridge I Petition and the Roxane Petition are not materially
`different from those instituted in Par I.2 Breckenridge I Mot. 5; Roxane
`
`
`1 By regulation, the Director’s discretion has been delegated to the Board.
`37 C.F.R. § 42.4(a).
`2 Novartis notes that in the Par I case, Morris is identified as pre-AIA
`§ 102(a) art, whereas Breckenridge and Roxane identify it as both § 102(a)
`and § 102(b) art. As such, Novartis argues, the grounds raised in the
`petitions are not “identical.” Prelim. Resp. 5. Though this may be the case,
`Novartis does not allege that Morris is not prior art to the ’772 patent, or that
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`Mot. 5. Roxane relies on the same expert witness, Dr. William L. Jorgensen,
`as Par does in Par I, and states that Roxane and Par have agreed to work
`together with respect to his testimony. Roxane Mot. 8. Although the
`Breckenridge I Petition relies instead on the testimony of Dr. Steven W.
`Baldwin, Breckenridge argues that “the conclusions and underlying
`reasoning of the experts are essentially identical. . . .” Breckenridge I Mot.
`6. Furthermore, Breckenridge offers that it will rely on the testimony of Dr.
`Jorgensen if Par permits it to do so. Id.1
`We previously determined, upon consideration of the Petition and
`Novartis’ Preliminary Response in Par I, that the record in that proceeding
`established a reasonable likelihood that Par would prevail with respect to
`claims 1–3 and 8–10. Par I, Paper 10, 17. The arguments and evidence in
`favor of institution of trial as to claims 1–3 and 8–10 similarly support
`institution in the present cases, and we incorporate our analysis from the
`Par I Decision on Institution herein. In the Breckenridge I and Roxane
`cases, however, the Preliminary Responses filed by Novartis raise arguments
`and declaration evidence2 not presented in Par I. We must, therefore,
`determine whether Novartis’ newly presented arguments and evidence alter
`our prior determination regarding reasonable likelihood of success.
`The Preliminary Response filed by Novartis in Breckenridge I and
`Roxane focuses on two prior art references relied upon in Petitioners’ lead
`
`
`its prior art status differs under § 102(a) and § 102(b).
`1 During a conference call with the Board, counsel for Par agreed that
`Breckenridge could rely on the testimony of Dr. Jorgensen. Ex. 1031, 36.
`2 Declaration of Alexander M. Klibanov. Ex. 2401.
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`compound analysis: Yalkowski and Lemke. At a high level, Petitioners rely
`on Yalkowski’s discussion of the entropy of fusion for drugs and molecules,
`and the effect of the addition of flexible side chains on solubility of
`compounds. Breckenridge I Pet. 34–35. Lemke is cited for its summary of
`the solubilizing potential of various functional groups. Id. at 35–36.
`Petitioners argue that both references would guide the person of ordinary
`skill in the art in selecting appropriate substituents for increasing solubility
`of rapamycin. Id. at 45–49.
`Novartis argues that a person of ordinary skill in the art would not
`have relied on Yalkowski because its disclosure focuses on ideal solubility,
`and there is no evidence a person of ordinary skill in the art would have
`considered ideal solubility relevant to the actual water solubility of
`rapamycin. Prelim. Resp. 8. Novartis’ expert witness, Dr. Klibanov,
`testifies that ideal solubility only applies when a solute and solvent have
`“nearly identical physiochemical properties”; water and rapamycin,
`however, have “polarities and hydrophobicities” which are “vastly
`dissimilar.” Ex. 2401 ¶¶ 17–21. Novartis contends that the testimony of
`Petitioners’ expert Dr. Jorgenson on this point—that Yalkowski is applicable
`to “all solvent systems”—is conclusory and should not be given weight.
`Prelim. Resp. 14.
`With respect to Lemke, Novartis addresses Petitioners’ reliance on
`Table 16-1 of the reference, particularly the solubilizing potential of various
`functional groups. Id. at 17–20. Novartis focuses on the fact that
`everolimus differs from rapamycin by the addition of two methyl groups and
`an ether oxygen, but that Dr. Jorgensen testifies that from Lemke’s Table
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`16-1 a person of ordinary skill in the art would have reason to add “flexible
`side chains with solubilizing groups, e.g., alkyl chains with amino, hydroxyl,
`or carboxylate groups.” Id. at 19; Ex. 1003 ¶ 84 (emphasis added).
`As with several of the arguments raised in Novartis’ Preliminary
`Response in Par I, these arguments may have merit. At this time, however,
`we consider them to put facts into dispute that must be considered at the
`conclusion of trial, when viewed as part of the entirety of the record. With
`respect to Yalkowski, Dr. Klibanov’s testimony calls into question the
`applicability of the reference to the lead compound analysis. But we
`disagree with Novartis that there is no evidence in support of Petitioners’
`case: Dr. Jorgenson testifies that Yalkowski discusses “fundamental
`physical chemistry of the dissolution of solids applicable to all solvent
`systems,” and cites Bell1 as applying Yalkowski’s teachings to increase
`solubility of a molecule. Ex. 1003 ¶ 78. Although Novartis may dispute the
`applicability of these teachings, there is not a complete lack of evidence in
`Petitioners’ favor.
`Similarly, with Lemke, Novartis is correct that everolimus differs
`from rapamycin by two methyl groups and an ether group. But the
`modification being proposed by Petitioners is not the insertion of these
`groups behind the terminal hydroxyl group, but rather the substitution of two
`methyls and a hydroxyl at the pre-existing C40 hydroxyl group.
`Breckenridge I Pet. 15–16; Ex. 1003 ¶ 142 (“Chemical reactions of hydroxyl
`groups are among the most fundamental and elementary reactions taught in
`
`
`1 Thomas W. Bell, Construction of a Soluble Heptacyclic Terpyridine, 51 J.
`ORGANIC CHEMISTRY 764 (1986) (Ex. 1021).
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`beginning organic chemistry courses. As such, hydroxyl groups would have
`been, and still are, the first positions a person of ordinary skill in the art
`would modify on a lead compound . . .”). Dr. Jorgensen’s testimony that a
`person of ordinary skill in the art would focus on “alkyl chains with amino,
`hydroxyl, or carboxylate groups” (Ex. 1003 ¶ 84) is not, on its face, contrary
`to this modification.
`Taking into account the newly raised arguments in the Preliminary
`Response, we remain persuaded that the Breckenridge I and Roxane
`Petitions establish a reasonable likelihood that claims 1–3 and 8–10 are
`unpatentable. The Petitions, therefore, warrant institution.
`
`B. Claim 7
`Claim 7 depends from claim 1, and recites “[a] pharmaceutical
`composition comprising a therapeutically effective amount of a compound
`according to claim 1 and a pharmaceutically acceptable carrier therefor.”
`The Par II, Breckenridge II, and Roxane Petitions each contain similar
`challenges to claim 7. The Petitioners note that claims 8 and 9, on which
`trial has been instituted, recite methods of using the compounds of claim 1
`as immunosuppressants or to prevent allograft rejection. Par II Pet. 50.
`Petitioners argue that “[t]here is no patentable distinction between the use of
`the compound for therapeutic effect and its formulation as a pharmaceutical
`composition in an effective amount with a pharmaceutically acceptable
`carrier.” Id.
`Petitioners argue that the validity of pharmaceutical composition
`claims “rise or fall with the validity of” the underlying compound claim. Par
`II Pet. 2 (citing Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d
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`1293, 1303 (Fed. Cir. 2007)). We disagree that the Federal Circuit set any
`such per se rule. The cited portion of Aventis stands for the unremarkable
`proposition that when the added limitations of dependent claims “appear
`almost verbatim in virtually all the prior art patents,” the validity of those
`claims “rise or fall with the validity of” the independent claim. Aventis, 499
`F.3d at 1303.
`Petitioners also cite Geneva Pharm., Inc. v. Glaxosmithkline PLC, 189
`F. Supp. 2d 377, 384–85 (E. D. Va. 2002), aff’d 349 F.3d 1373 (Fed. Cir.
`2003), for the proposition that a pharmaceutical composition claim is
`patentably indistinct from method claims of administering the compound.
`Par II Pet. 3. In Geneva, the court noted in the context of an obviousness-
`type double patenting case that a pharmaceutical composition claim was
`“strikingly similar” to a method of treatment claim, and therefore the
`composition claim was obvious over the method claim. Geneva, 189 F.
`Supp. 2d at 384. While such a comparison is appropriate in an obviousness-
`type double patenting case, the question before us is not whether claim 7
`distinguishes over claims 8 and 9, but rather whether claim 7 would have
`been obvious over the cited prior art.
`Portions of Petitioners’ arguments as to claim 7—in particular, the
`lead compound analysis that allegedly results in the formation of
`everolimus—are the same as that raised in Par I as to claim 1. We,
`therefore, need not repeat our analysis herein. Having obtained everolimus,
`Petitioners argue, a person of skill in the art would have relied Hughes’
`disclosure that C40-rapamycin derivatives may be used in therapeutically
`effective amounts in pharmaceutical compositions. Pet. 52. Petitioners also
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`cite the ’772 patent’s statement that the claimed compounds may be
`administered by any conventional route. Id.
`Novartis responds that Petitioners’ arguments regarding claim 7
`conflict with those raised regarding the other claims. Specifically, Novartis
`notes that as part of the lead compound analysis, Petitioners argue that a
`person of ordinary skill would have had reason to modify rapamycin due to
`its low solubility in water, which limited its ability to be used in
`pharmaceutical formulations. Prelim. Resp. 22–23. This, Novartis argues,
`contradicts other statements—made in the context of claim 7—that
`rapamycin was known to have been formulated into pharmaceutical
`compositions. Id. at 23–25. Other than this alleged conflict, Novartis does
`not directly address the disclosure of Hughes or the merits of Petitioners’
`argument.
`We do not share Novartis’ concern regarding Petitioners’ arguments.
`It is not inconsistent to state that rapamycin had been included in
`pharmaceutical formulations (Par II Pet. 28–29 (citing Ex. 1005, Table 4,
`49)) while at the same time arguing that such formulation was difficult
`because of rapamycin’s low solubility (Par II Pet. 20 (citing Ex. 1005, 46;
`Ex. 1003 ¶¶ 75–76)). Both facts can be simultaneously true; the fact that
`rapamycin was difficult to formulate into pharmaceutical compositions does
`not mean that such formulation was impossible. We do not take Petitioners’
`arguments to be in conflict in the manner Novartis suggests. Institution of
`trial as to claim 7 on the Par II, Breckenridge II, and Roxane Petitions is
`warranted.
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`III. DISCRETION TO GRANT JOINDER
`
`Having determined that the newly-filed Petitions warrant institution,
`we must determine whether to exercise our discretion to join Breckenridge
`and Roxane as parties to Par I with respect to claims 1–3 and 8–10. With
`respect to claim 7, we must determine whether to join the ground of
`unpatentability raised by Par, Breckenridge, and Roxane to Par I.1
`
`A. Claims 1–3 and 8–10
`Breckenridge and Roxane contend that joinder is appropriate because
`a consolidated inter partes review procedure would avoid inefficiency and
`prevent inconsistencies. Breckenridge I Mot. 8; Roxane Mot. 8. The
`Petitioners also raise the prospect of prejudice, arguing that the decision in
`Par I will likely impact the district court actions to which they are party.
`Breckenridge I Mot. 8; Roxane Mot. 9–10. To simplify briefing and
`discovery, and avoid impact on the schedule of Par I, the Petitioners propose
`that they will work together with Par to manage questioning at depositions,
`and will rely on the same expert. Breckenridge I Mot. 5–6; Roxane Mot. 7–
`8. Breckenridge and Roxane suggest that they each be permitted to file
`seven additional pages to accompany any further briefs submitted by Par.
`Breckenridge I Mot. 5–6; Roxane Mot. 7.
`
`
`1 Because we decide not to exercise our discretion as to claim 7, we need not
`address whether 35 U.S.C. § 315(c) permits a petitioner, otherwise barred
`under 35 U.S.C. § 315(b), to add a ground of unpatentability to a pending
`inter partes review trial through joinder. See generally Target Corp. v.
`Destination Maternity Corp., Case IPR2014-00508 (PTAB Feb. 12, 2015)
`(Paper 28).
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`Novartis argues that we should exercise our discretion to deny
`Breckenridge’s and Roxane’s Motions, but then states that it will not oppose
`joinder if the Board orders Breckenridge and Roxane:
`(i) to rely solely on the petition and evidence filed by Par in [Par
`I];
`(ii) to share with Par the pages currently allotted to Par in [Par I]
`for any written work product; and
`(iii) to share with Par the time currently allotted to Par in [Par I]
`for the cross and redirect examination of any witness.
`Breckenridge I, Paper 12, 8.1
`
`During a conference call with the Board, counsel for Par confirmed
`that Par does not oppose the Motions for Joinder. Ex. 1031, 36.
`Upon review, the Motions for Joinder demonstrate that joinder of
`Breckenridge and Roxane as parties to Par I is appropriate, and will lead to
`the more efficient resolution of the proceedings. With respect to claims 1–3
`and 8–10, the Breckenridge I Petition and Roxane Petition do not assert any
`new ground of unpatentability that is not already being considered in Par I,
`rely on the same arguments and evidence, and do not require any
`modification to the existing schedule. We, therefore, determine that joinder
`will not unduly complicate or delay the proceedings, and exercise our
`discretion to join Breckenridge and Roxane as parties to the Par I inter
`partes review.
`With respect to Novartis’ proposed requirements that the Petitioners
`act in concert, we consider them appropriate and in keeping with procedures
`
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`1 Novartis proposes similar requirements in the Opposition to Roxane’s
`Motion, with slight alterations due to the presence of a challenge to claim 7.
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`followed by the Board in other cases of joinder where the joining parties
`filed identical Petitions with identical evidence. We do not consider it
`necessary at this time to permit Breckenridge and Roxane additional briefing
`beyond that already permitted Par. The Petitioners should work together to
`present consolidated briefing in Par I, with Par as the lead Petitioner. If
`some disagreement arises which prevents a unified position, the Petitioners
`may request a conference call with the Board.
`
`B. Claim 7
`The Petitioners generally repeat the same justifications for joinder of
`the ground challenging claim 7. Par II Mot. 9–12. Par makes the additional
`argument that because “there are no substantive differences between the
`instituted claims and claim 7,” the validity of the claims “rise or fall”
`together and joinder would promote efficiency. Id. at 1–2, 7–9.
`Breckenridge requests joinder “[t]o the extent the Motion for Joinder filed
`on behalf of Par [in Par II] is granted.” Breckenridge II Mot. 1. Because of
`this, and because of the similarities in the arguments made in the Motions,
`we consider all three together.
`Though we recognize the arguments in favor of joining the claim 7
`ground to the pending inter partes review, two factors weigh strongly
`against such joinder. The first is that no explanation has been given for why
`claim 7—the validity of which, according to the Petitioners, is so closely
`related to claims 1, 8, and 9—was not raised in the Par I Petition. During a
`conference call with the Board, Par’s counsel was directly asked this
`question, and could only respond that it was an “inadvertent omission.”
`Ex. 1031, 19. Novartis contends that Par has been on notice of Novartis’
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`assertion of claim 7 since at least February 19, 2015, well before the filing of
`the Par I Petition.
`Petitioners cite various cases in which the Board granted joinder of
`later-raised grounds of unpatentability. Par II Pet. 7–8, 11–12. In those
`cases, however, the petitioner provided at least some justification for the
`delay in raising the grounds. See Ariosa Diagnostics, Inc. v. Isis Innovation
`Ltd., Case IPR2013-00250 (PTAB Sept. 3, 2013) (Paper 24) (new claims
`asserted against petitioner’s newly-launched product); Samsung Elecs. Co. v.
`Va. Innovation Scis., Inc., Case IPR2014-00557 (PTAB June 13, 2014)
`(Paper 10) (Board partially denied first petition, second petition responded to
`Board’s reasoning); Enzymotec Ltd. v. Neptune Techs. & Bioresources, Inc.,
`Case IPR2014-00556 (PTAB July 9, 2014) (Paper 19) (same); Zhongshan
`Broad Ocean Motor Co. v. Nidec Motor Corp., Case IPR2015-00762 (PTAB
`Oct. 5, 2015) (Paper 16) (denial of first petition on procedural deficiency
`addressed by second petition); Target, Case IPR2014-00508 (PTAB Feb. 12,
`2015) (Paper 28) (new art asserted in co-pending district court action).
`In contrast, the case at hand is analogous to other cases in which the
`Board has declined to exercise its discretion to join. As we stated in Micro
`Motion, Inc. v. Invensys Sys., Inc.:
`We exercise our discretion and deny joinder of this proceeding. .
`. . In [the first petition], Petitioner neglected to include an
`analysis of claim 43 and offers now the analysis it could have
`offered then. . . . This is not a case where circumstances have
`changed that would make joinder an equitable remedy for
`Petitioner.
`Case IPR2014-01409 (PTAB Feb. 18, 2015) (Paper 14), 14.
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`There is merit in encouraging a petitioner to raise in its first petition
`all grounds and claims that reasonably could be raised, to avoid serial attacks
`against a patent and reduce the burden on patent owners of defending
`multiple proceedings. Cf. Conopco, Inc. v. The Procter & Gamble Co., Case
`IPR2014-00628 (PTAB Mar. 20, 2015), 3 (“a grant of review, under the
`particular circumstances presented here, would incentivize petitioners to
`hold back prior art for successive attacks, should a first petition be denied”).
`Granting joinder of petitions raising additional grounds, without sufficient
`justification from Petitioner regarding the reasons why the claims were not
`previously raised, would give petitioners incentive to raise fewer than all
`claims in a first petition. This concern is especially heightened after the
`expiration of the one-year 35 U.S.C. § 315(b) period, where but for joinder,
`the petition would be barred. Taking these considerations into account, we
`do not consider “inadvertent omission” of a ground of unpatentability to be
`sufficient justification for the grant of joinder.
`Second, we consider the effect joinder would have on the already-
`instituted trial. Though the statute provides that the one-year deadline for
`rendering a final written decision may be adjusted in the case of joinder (35
`U.S.C. § 316(a)(11)), we are hesitant to do so in cases where joinder will
`unduly complicate the existing proceeding, or “cause lengthy delays in an
`ongoing review.” Sony Corp. v. Network-1 Security Solutions, Inc., Case
`IPR2013-00386 (PTAB July 29, 2013) (Paper 16), 8.
`In Par I, Novartis filed its Patent Owner’s Response on September 16,
`2016, a date already extended by agreement of the parties from that set in the
`Board’s Scheduling Order. The parties are, therefore, over a month into
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`IPR2016-01023, IPR2016-01059, IPR2016-01102, IPR2016-01103
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`Par’s discovery period, and the Petitioner’s Reply is due December 5, 2016.
`The Patent Owner Response in Par I does not address claim 7, for obvious
`reasons. If we were to join grounds challenging claim 7 to Par I, we would
`either have to maintain two different schedules for two different sets of
`claims, or stay the proceedings as to claims 1–3 and 8–10 for several months
`until Novartis takes discovery on claim 7 and files a Response as to that
`ground. Although introducing such complications may be justified in some
`cases, it is not here, especially given the lack of a sufficient justification why
`claim 7 was not challenged in Par I.
`For these reasons, we decline to exercise our discretion to join the
`grounds of unpatentability challenging claim 7 to the Par I proceeding.
`IV. DENIAL OF INSTITUTION
`
`Petitioners acknowledge that the Par II, Breckenridge I and II, and
`Roxane Petitions were each filed outside the one-year time period set forth
`in 35 U.S.C. § 315(b). Ex. 1031, 18–19. The one-year bar does not apply,
`however, to a request for joinder under 35 U.S.C. § 315(c). Because we
`deny joinder as to the Par II Petition, the Breckenridge II Petition, and the
`Roxane Petition as to claim 7, those grounds are barred and we deny
`institution of trial on the grounds of unpatentability raised as to claim 7. We
`grant joinder as to the Breckenridge I Petition and the Roxane Petition as to
`claims 1–3 and 8–10, and therefore join Breckenridge and Roxane as parties
`to the Par I proceeding.
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`V. ORDER
`
`Accordingly, it is:
`ORDERED that Par’s Motion for Joinder (IPR2016-01059, Paper 3)
`is denied;
`FURTHER ORDERED that trial is not instituted as to the ground of
`unpatentability set forth in Par’s Petition (IPR2016-01059, Paper 1);
`FURTHER ORDERED that Breckenridge’s Motion for Joinder
`(IPR2016-01103, Paper 4) is denied;
`FURTHER ORDERED that trial is not instituted as to the ground of
`unpatentability set forth in Breckenridge’s Petition (IPR2016-01103,
`Paper 1);
`FURTHER ORDERED that Roxane’s Motion for Joinder (IPR2016-
`01102, Paper 3) is granted-in-part and denied-in-part;
`FURTHER ORDERED that trial is not instituted as to the ground of
`unpatentability challenging claim 7, as set forth in Roxane’s Petition
`(IPR2016-01102, Paper 2);
`FURTHER ORDERED that Breckenridge’s Motion for Joinder
`(IPR2016-01023, Paper 5) is granted;
`FURTHER ORDERED that Breckenridge and Roxane are joined as
`Petitioners to IPR2016-00084;
`FURTHER ORDERED that the grounds on which IPR2016-00084
`was instituted are unchanged;
`FURTHER ORDERED that, within one week of this Decision, any
`party may request a conference call with the Board to discuss changes to the
`Scheduling Order; in the absence of such changes, the Scheduling Order in
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`IPR2016-01023, IPR2016-01059, IPR2016-01102, IPR2016-01103
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`place for IPR2016-00084, as modified by the parties’ stipulation, shall
`continue to govern the joined proceeding;
`FURTHER ORDERED that, throughout IPR2016-00084, any paper,
`except for a motion that does not involve the other party, shall be filed by
`Par as a single, consolidated filing on behalf of Par, Breckenridge, and
`Roxane, pursuant to the page limits set forth in 37 C.F.R. § 42.24, and Par
`will identify each such filing as a consolidated filing;
`FURTHER ORDERED that except as otherwise agreed by the
`Petitioners, counsel for Par will conduct cross-examination and other
`discovery on behalf of Par, Breckenridge, and Roxane, and that Novartis is
`not required to provide separate discovery responses or additional deposition
`time as a result of the joinder;
`FURTHER ORDERED that Par, Breckenridge, and Roxane
`collectively will designate attorneys to present at the oral hearing (if
`requested) as a consolidated presentation;
`FURTHER ORDERED that IPR2016-01023 and IPR2016-01102 are
`terminated under 37 C.F.R. § 42.72, and all further filings these proceeding
`are to be made in IPR2016-00084;
`FURTHER ORDERED that a copy of this Decision will be entered
`into the record of IPR2016-00084; and
`FURTHER ORDERED that the case caption in IPR2016-00084 shall
`be changed to reflect the joinder, in accordance with the attached example.
`
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`IPR2016-01023, IPR2016-01059, IPR2016-01102, IP