Filed on behalf of: Par Pharmaceutical, Inc.
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`Entered: November 10, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_______________________
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`PAR PHARMACEUTICAL, INC.
`Petitioner
`
`v.
`
`NOVARTIS AG
`Patent Owner
`_______________________
`
`
`
`Case IPR2016-01059
`U.S. Patent No. 5,665,772
`_______________________
`
`
`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and ROBERT A.
`POLLOCK, Administrative Patent Judges.
`
`
`
`PETITIONER’S REQUEST FOR REHEARING OF
`THE BOARD’S DECISION DENYING JOINDER
`
`
`
`
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`
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`Entered: November 10, 2016
`
`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
`U.S. Patent No. 5,665,772
`_______________________
`
`
`Before LORA M. GREEN, CHRISTOPHER L. CRUMBLEY, and ROBERT A.
`POLLOCK, Administrative Patent Judges.
`
`
`
`PETITIONER’S REQUEST FOR REHEARING OF
`THE BOARD’S DECISION DENYING JOINDER
`
`
`
`
`
`
`Case IPR2016-01059
`U.S. Patent No. 5,665,772
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`TABLE OF CONTENTS
`
`I.
`
`II.
`
`Legal Standard ................................................................................................. 3
`
`Argument ......................................................................................................... 3
`
`A.
`
`B.
`
`C.
`
`The Board improperly applied a new requirement that a joinder
`motion must explain why the first petition was lacking. ....................... 3
`
`The Board improperly applied a new requirement that the
`Board’s joinder decision must issue before the patent owner
`files its response in the first proceeding. ............................................... 8
`
`The Board erred in failing to take into account the public
`interest. ................................................................................................ 12
`
`III.
`
`Suggestion for Expanded Panel ..................................................................... 14
`
`IV. Conclusion ..................................................................................................... 15
`
`
`
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`i
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`U.S. Patent No. 5,665,772
`TABLE OF AUTHORITIES
`
`CASES
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`Page(s)
`
`Ariosa Diags. v. Isis Innovation,
`IPR2012-00022, Paper 104 (Oct. 31, 2013) ......................................................... 11
`
`Ariosa Diags. v. Isis Innovation,
`IPR2012-00022, Paper 72 (Sept. 17, 2013) ............................................................ 7
`
`Ariosa Diags. v. Isis Innovation,
`IPR2013-00250, Paper 24 (Sept. 3, 2013) ................................................... 5, 6, 13
`
`Ariosa Diags. v. Isis Innovation,
`IPR2013-00250, Paper 4 (Apr. 19, 2013) ........................................................ 6, 10
`
`Assoc. of Am. R.R. v. DOT,
`821 F.3d 19 (D.C. Cir. 2016) ................................................................................ 15
`
`Butamax Advanced Biofuels v. Gevo,
`IPR2014-00581, Paper 8 (Oct. 14, 2014) ............................................................... 7
`
`Conopco v. Procter & Gamble,
`IPR2014-00628, Paper 23 (Mar. 20, 2015) ............................................................. 7
`
`Consol. Bearings Co. v. United States,
`348 F.3d 997 (Fed. Cir. 2003) ................................................................................. 3
`
`Cuozzo Speed Techs. v. Lee,
`136 S. Ct. 2131 (2016) ................................................................................... 12, 15
`
`Enzymotec v. Neptune Techs. & Biores.,
`IPR2014-00556, Paper 19 (July 9, 2014) ...................................................... passim
`
`FCC v. Fox Television Stations,
`556 U.S. 502 (2009) ................................................................................................ 3
`
`In re Gartside,
`203 F.3d 1305 (Fed. Cir. 2000) ............................................................................... 3
`
`James V. Hurson Assocs. v. Glickman,
`229 F.3d 277 (D.C. Cir. 2000) .............................................................................. 13
`
`ii
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`U.S. Patent No. 5,665,772
`Linear Tech. v. In-Depth Test,
`IPR2015-01994, Paper 7 (Oct. 20, 2015) ............................................................... 9
`
`Mendoza v. MSPB,
`966 F.2d 650 (Fed. Cir. 1992) ............................................................................... 15
`
`Micro Motion v. Invensys Sys.,
`IPR2014-01409, Paper 14 (Feb. 18, 2015) ............................................................. 7
`
`Praxair Distrib. v. Mallinckrodt Hosp. Prods.,
`IPR2016-00777, Paper 10 (Sept. 22, 2016) ............................................................ 6
`
`Ramaprakash v. FAA,
`346 F.3d 1121 (D.C. Cir. 2003) ....................................................................... 2, 15
`
`Samsung Elecs. v. Va. Innovation Scis.,
`IPR2014-00557, Paper 10 (June 13, 2014) .................................................. 5, 7, 13
`
`Samsung Elecs. v. Va. Innovation Scis.,
`IPR2014-00557, Paper 3 (Mar. 28, 2014) ........................................................ 5, 10
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`Target v. Destination Maternity,
`IPR2014-00508, Paper 18 (Sept. 25, 2014) .......................................................... 10
`
`Target v. Destination Maternity,
`IPR2014-00508, Paper 28 (Feb. 12, 2015) .................................................... 12, 13
`
`Target v. Destination Maternity,
`IPR2014-00508, Paper 3 (Mar. 14, 2014) ........................................................ 6, 10
`
`Target v. Destination Maternity,
`IPR2014-00508, Paper 31 (Feb. 12, 2015) ................................................ 8, 10, 11
`
`Zhongshan Broad Ocean Motor Co. v. Nidec Motor Corp.,
`IPR2014-01121, Paper 17 (Nov. 10, 2014) ............................................................ 4
`
`Zhongshan Broad Ocean Motor Co. v. Nidec Motor Corp.,
`IPR2014-01121, Paper 20 (Jan. 15, 2015) .............................................................. 4
`
`Zhongshan Broad Ocean Motor Co. v. Nidec Motor Corp.,
`IPR2015-00762, Paper 16 (Oct. 5, 2015) .................................................... 4, 8, 14
`
`iii
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`Zhongshan Broad Ocean Motor Co. v. Nidec Motor Corp.,
`IPR2015-00762, Paper 4 (Feb. 20, 2015) ............................................................... 4
`
`STATUTES
`
`35 U.S.C. § 316 .......................................................................................................... 9
`
`OTHER AUTHORITIES
`
`157 Cong. Rec. S1376 (Sen. Kyl) ....................................................................... 9, 12
`
`77 Fed. Reg. 48680 .................................................................................................... 9
`
`PTAB SOP 1 § III.C, D (Rev. 14, May 8, 2015) ..................................................... 14
`
`REGULATIONS
`
`37 C.F.R. § 42.100 ..................................................................................................... 9
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`37 C.F.R. § 42.122 ..................................................................................................... 9
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`37 C.F.R. §42.71 ........................................................................................................ 3
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`
`
`
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`iv
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`U.S. Patent No. 5,665,772
`Petitioner Par Pharmaceutical respectfully requests rehearing of the joinder
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`decision, Paper 19 (Oct. 27, 2016) (“Dec.”), and suggests an expanded panel.
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`The Board agreed that Par’s second petition (this proceeding, “Par II”)
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`established—based solely on the prior art and evidence filed in Par’s first
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`petition—that dependent claim 7 is likely obvious. The only difference between
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`claim 7 and claim 1 is that claim 7 recites a composition comprising a
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`therapeutically effective amount of the compound of claim 1 “and a
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`pharmaceutically acceptable carrier.” Par’s first petition (IPR2015-00084, “Par I”)
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`demonstrated that the compound of claim 1 and methods of claims 8 and 9 of
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`administering a therapeutically effective amount of the compound are likely
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`obvious. Merely including an acceptable carrier does not add patentable subject
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`matter. Despite finding that Par demonstrated that claim 7 is likely unpatentable,
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`the Board did not institute review. Instead, if Par prevails, the Board’s decision
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`would leave claim 7 as a barrier that would block the public from using an obvious
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`compound even for its obvious methods of use.
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`The Board identified only two reasons for denying joinder: (1) its conclusion
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`that Par’s inadvertent omission of claim 7 is not a “sufficient justification for the
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`grant of joinder,” and (2) its statement that Par’s joinder would “unduly complicate
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`or delay” the Par I proceeding. Dec. 14-17.
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`In denying joinder, the Board abused its discretion for three independent
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`reasons. First, it impermissibly set forth a new rule that a petitioner must explain
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`why, other than an inadvertent mistake, the first petition omitted the art, evidence,
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`or argument for the issue to be joined. The Board did not recognize that it was
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`deviating from its past decisions that granted joinder without such an explanation
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`from the petitioner and it did not provide a good reason for its deviation.
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`Second, the Board abused its discretion when it found that the Par II petition
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`would cause undue delays and unduly complicate Par I. Again, it failed to provide
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`a reasoned explanation why it treated Par differently than it treated similarly
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`situated parties, which filed later than Par and introduced more complications.
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`Third, the Board abused its discretion because it did not take into account
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`the public interest in quickly, efficiently, and fully resolving the dispute between
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`the parties and ensuring the integrity of the patent system. The Board did not
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`explain why these public interest factors, which have been dispositive for similarly
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`situated petitioners, were not considered here.
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`In short, the Office’s promise to consider the particular facts of each case
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`has devolved into impermissible “ad hocery” because it is “impossible at this point
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`to tell whether the Board, in the next [joinder] case, will” require an explanation
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`for omitting material from the first proceeding, or not; will insist that the joinder
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`decision issue before the POR is filed, or not; or will assess the public interest, or
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`not. Ramaprakash v. FAA, 346 F.3d 1121, 1130 (D.C. Cir. 2003). And because of
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`2
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`U.S. Patent No. 5,665,772
`the conflicting decisions by different Board panels, Par suggests an expanded panel
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`for this rehearing request.
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`I.
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`Legal Standard
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`A party seeking rehearing must identify the matters that the Board
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`misapprehended or overlooked. 37 C.F.R. §42.71(d). The Board reviews its
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`decision for an abuse of discretion, 37 C.F.R. §42.71(c), which occurs when the
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`“decision represents an unreasonable judgment in weighing relevant factors” or the
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`“the agency offers insufficient reasons for treating similar situations differently.”
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`In re Gartside, 203 F.3d 1305, 1315-16 (Fed. Cir. 2000); Consol. Bearings Co. v.
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`United States, 348 F.3d 997 (Fed. Cir. 2003).
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`II. Argument
`A. The Board improperly applied a new requirement that a joinder
`motion must explain why the first petition was lacking.
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`The Board’s decision turned on Par’s failure to establish any reason except
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`inadvertence for failing to include claim 7. Reply 1 (Par “regrets its inadvertent
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`omission of claim 7”); Dec. 17 (inadvertent omission is not a “sufficient
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`justification for the grant of joinder”). But this is a new requirement, and the Board
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`did not provide a reasoned explanation or even “display awareness” that it was
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`deviating from its past decisions. FCC v. Fox Television Stations, 556 U.S. 502,
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`515 (2009). The Board cited joinder cases as providing “at least some justification
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`[other than an inadvertent mistake] for the delay in raising the grounds,” but those
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`cases did not. Dec. 16 (emphasis in original).
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`For example, the petitioner in Zhongshan admitted that it twice inadvertently
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`failed to include a translator’s affidavit of accuracy in the first proceeding.
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`Zhongshan Broad Ocean Motor Co. v. Nidec Motor Corp., IPR2014-01121, Paper
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`17 at 2, 3 (original exhibit and corrected exhibit) (Nov. 10, 2014) (“Zhongshan I”);
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`Paper 20 at 10 (Board recognizing that the mistake was inadvertent). Nonetheless,
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`the Board granted Zhongshan’s joinder petition to add the ground to the instituted
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`proceeding. Zhongshan Broad Ocean Motor Co. v. Nidec Motor Corp., IPR2015-
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`00762, Paper 16 (Oct. 5, 2015) (“Zhongshan II”). That the Board (or opposing
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`counsel) first noted the inadvertent error, rather than Zhongshan itself, does not
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`make the error any less inadvertent. And to be sure, Zhongshan did not provide any
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`other reason for its mistake. Instead, it argued that joinder is justified because it “is
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`Petitioner’s last opportunity to consider Hideji on its merits.” Zhongshan II, Paper
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`4 at 6. The same is true here, joinder is Par’s last chance for the Board to consider
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`claim 7 on its merits. Nonetheless, the Zhongshan Board, unlike the Board here,
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`granted institution without considering why Zhongshan’s mistake occurred because
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`the public interest would be better served by considering the Hideji grounds.
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`Zhongshan II, Paper 16 at 8.
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`The Samsung petitioner also failed to provide any justification for delaying
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`its challenge of claims 58 and 63 as obvious over the combination of Karaoguz,
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`4
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`Palin, and Seaman until its second petition. Samsung Elecs. v. Va. Innovation Scis.,
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`IPR2014-00557, Paper 3 at 2-5 (Mar. 28, 2014). Instead, it asserted that joinder is
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`justified because there was significant overlap in the prior art and claimed subject
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`matter. Id. The Board agreed, and without considering why Samsung omitted this
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`new ground from its first petition, granted joinder because “the minimal additional
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`amount of work required on the part of Patent Owner…is strongly outweighed by
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`the public interest in having consistency of outcome concerning similar sets of
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`claimed subject matter and prior art.” Samsung, Paper 10 at 18.
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`Likewise, the first petition in Enzymotec omitted a showing that the art
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`inherently taught dependent claims 2, 3, 25, and 26, but the Board did not require
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`any explanation for the omission. Instead, it granted joinder because the impact of
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`joining the four dependent claims would “be minimal from both a procedural and
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`substantive view point.” Enzymotec v. Neptune Techs. & Biores., IPR2014-00556,
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`Paper 19 at 6 (July 9, 2014). The second petitioner in Enzymotec was a different
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`party than the first, but the Board here made no such distinction, punishing
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`Roxane, Breckenridge and the general public for Par’s inadvertent error.
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`The Board also stated that Ariosa’s second petition was justified because
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`“new claims [were] asserted against petitioner’s newly-launched product.” Dec. 16
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`(citing Ariosa Diags. v. Isis Innovation, IPR2013-00250, Paper 24 (Sept. 3, 2013))
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`(“Ariosa II”). In addition to being incorrect on the facts (Ariosa merely stated that
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`Isis “may assert” the new claims), it ignores that Ariosa did not provide any
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`rationale for delaying submission of the new evidence and ground for instituted
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`claim 8. Ariosa II, Paper 4 at 3. And in granting joinder, the Ariosa Board did not
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`take into account why Ariosa’s first petition omitted the missing claims or the
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`missing evidence for claim 8. Instead, it stated: “The same patents and parties are
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`involved in both proceedings. There is an overlap in the cited prior art. There is no
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`discernible prejudice to either party. Petitioner has been diligent and timely in
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`filing the motion. And while some adjustments to the schedule have been
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`necessary, there is not undue delay.” Ariosa II, Paper 24 at 5; see also id. at 3
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`(stating the Board “will not rely on the DeVore Declaration [asserting that Ariosa
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`launched a new product] in deciding Ariosa’s Motion for Joinder”).
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`And in Target, the petitioner did not explain why it omitted Asada, a
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`publicly available Japanese patent. To be sure, the petitioner complained that the
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`patent owner did not disclose Asada until after it filed its first petition. Target v.
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`Destination Maternity, IPR2014-00508, Paper 3 at 2 (Mar. 14, 2014). But that is
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`not an excuse for failing to conduct a “reasonably diligent search of the relevant
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`prior art” before filing the first petition, and the Target board did not say it was.
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`Praxair Distrib. v. Mallinckrodt Hosp. Prods., IPR2016-00777, Paper 10 at 11
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`(Sept. 22, 2016).
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`Even putting aside this panel’s misapprehension of the facts in some of the
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`6
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`U.S. Patent No. 5,665,772
`cited cases, the Board’s decision makes it impossible to determine beforehand
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`when joinder will be granted. The Board states that joinder was justified in
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`Samsung, Enzymotec, and Zhongshan because those petitioners responded to the
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`Board’s reasoning in the previous decision. Dec. 16. But the Board has consistently
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`disfavored such “second bites at the apple, which use [the Board’s] prior decision
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`as a roadmap to remedy [the] prior, deficient challenge.” Butamax Advanced
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`Biofuels v. Gevo, IPR2014-00581, Paper 8 at 12-13 (Oct. 14, 2014) (Crumbley,
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`joined by Elluru and Begley); Conopco v. Procter & Gamble, IPR2014-00628,
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`Paper 23 at 3-5 (Mar. 20, 2015) (cited by Board). Indeed, the Board analogizes Par
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`to the petitioner in Micro Motion v. Invensys Sys., IPR2014-01409, Paper 14 at 14
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`(Feb. 18, 2015), but in that case the Board denied because “[t]he proposed ground
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`directed to claim 43 is a second bite at the apple for Petitioner.”
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`But unlike those cases, Par did not take a second bite for claim 7: it did not
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`hold any art or evidence back and it did not gain a strategic advantage. And to be
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`sure, other factors here do not weigh more heavily against granting joinder. The
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`cases cited by the Board where joinder was granted injected more substantive
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`complications into the existing IPRs. Ariosa Diags. v. Isis Innovation, IPR2012-
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`00022, Paper 72 at 10 (Sept. 17, 2013) (four new grounds for five new dependent
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`claims and claim 8, one new prior-art reference in two new combinations, two new
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`declarations) (“Ariosa I”); Samsung, Paper 10 at 19 (newly proposed combination
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`7
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`U.S. Patent No. 5,665,772
`of three references adding two dependent claims to the instituted proceeding);
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`Target, Paper 31 (added a new reference to form a new combination and a
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`dependent claim to the proceeding). Even Enzymotec and Zhongshan, which, like
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`Par, added no or very little new evidence, complicated the instituted IPR.
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`Enzymotec, Paper 19 at 8 (adding four dependent claims to the existing proceeding,
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`including a complicated inherency argument); Zhongshan II, Paper 16 at 9 (adding
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`an entirely new ground for all challenged claims). These complications are not
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`present in Par II, which seeks to add a single dependent claim based on precisely
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`the same art and evidence of instituted Ground 2.
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`B.
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`The Board improperly applied a new requirement that the
`Board’s joinder decision must issue before the patent owner files
`its response in the first proceeding.
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`As demonstrated in the previous section, Par’s joinder motion would have
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`introduced minor substantive complications to the first proceeding relative to the
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`cases where joinder was granted. The Board abused its discretion because it failed
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`to consider the relatively minor substantive complications which would have
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`weighed in Par’s favor. It also erred because it penalized Par for scheduling
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`complications beyond Par’s control that were no greater than those presented in
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`cases where it granted joinder. As such, the Board erred for not providing a
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`reasoned explanation for treating Par differently than similarly situated petitioners.
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`Regarding the schedule, Congress directed the Office to “set[] a time period
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`for requesting joinder” to ensure joinder petitions do not unduly impact the first
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`case. 35 U.S.C. § 316(a)(12). The Office made clear to Congress “that it intends to
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`use this authority to encourage early requests for joinder and to discourage late
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`requests.” 157 Cong. Rec. S1376 (Sen. Kyl); 37 C.F.R. § 42.122(b); Final Rules,
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`77 Fed. Reg. 48680, 48707 (one-month time period set in response to a comment
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`seeking “clarification on the timing for requesting joinder”). Thus, in setting the
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`one-month period, the Office established the timing to ensure the just, speedy, and
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`inexpensive resolution of the proceedings. Enzymotec, Paper 19 at 4. Filing sooner,
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`before Par I was instituted, was not an option because an early request could be
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`denied. Linear Tech. v. In-Depth Test, IPR2015-01994, Paper 7 (Oct. 20, 2015).
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`Congress and the Office did not promulgate this one-month period with the
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`notion it would disqualify most petitioners based on circumstances beyond their
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`control. Rather, the Office told Congress that it “anticipates that joinder will be
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`allowed as of right.” 157 Cong. Rec. S1376 (Sen. Kyl). To address the inevitable
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`scheduling complications, Congress gave the Office the authority to extend the
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`first proceeding’s schedule in case of joinder which “allow[s] [it] to manage the
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`more complex [joinder] case[s].” 77 Fed. Reg. at 48707; 35 U.S.C. § 316(a)(11);
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`37 C.F.R. § 42.100(c). This panel recognized as much during a conference call,
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`stating that a scheduling issue will typically “resolve[] itself if we have a little
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`more time in the first case” and the due date for the final written decision “might
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`need to move a little bit.” June 1, 2016 Conf. Tr. 22, 33 (Ex. 1031) (J. Crumbley).
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`Here, Par’s joinder motion was not merely timely; it was exceptionally
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`prompt. Par filed 12 days before the one-month deadline—sooner than all of the
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`successful petitioners except Enzymotec. Ariosa II, Paper 4 at 2 (at deadline);
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`Zhongshan II , Paper 16 at 2 (at deadline); Target, Paper 3 at 3 (at deadline);
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`Samsung, Paper 3 at 2 (8 days before deadline); Enzymotec, Paper 19 at 2-3 (20
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`days before deadline). But even though a petitioner should not be penalized for
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`scheduling complications caused by delays “beyond Petitioner’s control” (Target,
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`Paper 31 at 4), the Board found that Par’s request caused undue scheduling
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`complications, and did not provide a reasoned explanation why these other more
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`complicated cases did not.
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`In Par’s case, the Board applied a new and unreasonable requirement that a
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`joinder decision must issue before the first proceeding’s POR and without
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`explanation. Dec. 17-18. Normally, a timely joinder motion results in a joined
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`proceeding starting roughly seven months after the first: one month for the
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`deadline and six months for the decision. For example, the IPRs in Target
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`proceeded normally: the initial joinder decision issued seven months after
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`institution of the first IPR, after the parties had completed all discovery, briefing,
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`and motion practice. Target, Paper 18 (denying joinder on Sept. 25, 2014, after the
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`parties filed their replies in support of their motions to exclude, Papers 66 and 69
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`10
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`in the first proceeding, IPR2013-00530). Nonetheless, because the “Petitioner did
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`timely file its Motion for Joinder,” the Board did not penalize Target for any
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`scheduling complications, including rehearing. Target, Paper 31 at 4; see also
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`Ariosa I, Paper 104 at 5 (excusing scheduling complications because Ariosa timely
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`requested joinder ).
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`The scheduling impact here is far less than in Target (with or without
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`rehearings). Thus, when faced with the same minor scheduling impact as Par, the
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`Enzymotec Board took the approach proposed by Par but rejected here: it ordered a
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`15-page supplemental POR to address only the newly added claims 2, 3, 25, and
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`26, calling it a “minimal [complication] from both a procedural and substantive
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`view point.” Enzymotec, Paper 19 at 7. Likewise, the Zhongshan Board issued a
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`supplemental schedule to address the newly joined obviousness ground, which
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`would have been necessary even without rehearing. Zhongshan I, Papers 30, 70
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`(POR on May 8 and schedule), Zhongshan II, Paper 12 (first joinder decision on
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`July 20). The Board’s new rule would have resulted in denying all three of these
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`joinder requests. The Board, however, did not provide any reasoned explanation
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`for treating Par differently, why it departed from its past practice, or why it created
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`a perverse incentive for patent owners to avoid joinder by simply refusing to
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`cooperate on scheduling.
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`Instead, the Board stated that a supplemental POR, like that in Target,
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`Enzymotec, or Zhongshan, is not justified here “especially given the lack of a
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`sufficient justification why claim 7 was not challenged in Par I.” Dec. 18. But that
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`reasoning circles back to the first factor, and as already demonstrated in the
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`previous section, the Board did not demonstrate any awareness that those
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`successful petitioners also lacked a “sufficient justification” or explain why Par
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`should be treated differently.
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`C. The Board erred in failing to take into account the public interest.
`In passing the AIA, Congress sought to “improve patent quality and restore
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`confidence in the presumption of validity” by giving the Office the “significant
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`power to revisit and revise earlier patent grants” to “screen[] out bad patents while
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`bolstering valid ones.” Cuozzo Speed Techs. v. Lee, 136 S. Ct. 2131, 2139-40
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`(2016) (citations omitted). Accordingly, the Office told Congress that “joinder will
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`be allowed as of right,” but retained the discretion to deny joinder only as a “safety
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`valve…to avoid being overwhelmed” by “a deluge of joinder petitions in a
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`particular case.” 157 Cong. Rec. S1376 (Sen. Kyl); Enzymotec, Paper 19 at 6 n.1
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`(quoting Sen. Kyl); Target, Paper 28 at 10 (“liberal joinder of reviews, including
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`those having new arguments”).
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`Here, the Board correctly found that the art and evidence in Par I
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`demonstrates that claim 7 is likely unpatentable, but instead of joining it to the
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`proceeding, it denied institution, punishing Par, Roxane, Breckenridge, and the
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`U.S. Patent No. 5,665,772
`public as a whole for Par’s inadvertent omission. The Board abused its discretion
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`because it did not take into account the public interest, subverting Congress’s
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`liberal joinder provision designed to protect the public from bad patents and fully
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`resolve the parties’ dispute. James V. Hurson Assocs. v. Glickman, 229 F.3d 277,
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`284 (D.C. Cir. 2000) (abuse of discretion to fail to consider relevant factors). The
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`Board further abused its discretion because it treated Par differently than similarly
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`situated parties: it failed to explain why it considered the public interest in the
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`cases where it granted joinder, but did not in Par’s case, where it would have
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`weighed strongly in Par’s favor.
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`For example, the Samsung panel found that the burden of adding a new
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`prior-art combination and claims 58 and 63 to the proceeding was “strongly
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`outweighed by the public interest in having consistency of outcome concerning
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`similar sets of claimed subject matter and prior art.” Samsung, Paper 10 at 18.
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`Samsung had no excuse for omitting that combination; it was taking a second bite
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`at the apple. Likewise, the Target panel analyzed the reasons Congress enacted the
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`AIA, and concluded that not addressing the un-instituted claim would be contrary
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`to the purpose of ensuring a “just, speedy, and inexpensive resolution.” Target,
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`Paper 28 at 12-16 (also noting that an unpatentable independent claim would “cast
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`doubt on Patent Owner’s entitlement to dependent claims”); see also Ariosa II,
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`Paper 24 at 5 (granting joinder of additional claims and grounds “to secure the just,
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`Case IPR2016-01059
`U.S. Patent No. 5,665,772
`speedy, and inexpensive resolution” of the party’s dispute); Zhongshan II, Paper 16
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`at 8 (public interest better served by considering the merits of the new ground).
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`Here, the Board’s decision has already cast doubt on claim 7, finding that
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`institution on claim 7 “is warranted” based on the art and evidence in the Par I
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`petition. Finding the other challenged claims unpatentable will merely further
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`confirm that claim 7 should never have issued. But the public will be prevented
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`from using the using the claimed composition composed of an obvious compound
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`in the obvious methods recited in claims 8 and 9.
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`III. Suggestion for Expanded Panel
`Given the conflicting decisions by different Board panels, Par respectfully
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`suggests an expanded panel and asks this panel to relay the request to the Chief
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`Judge in writing. PTAB SOP 1 § III.C, D (Rev. 14, May 8, 2015). Reasons for
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`expanding a panel include issues of exceptional importance and the need to
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`maintain uniformity of the Board’s decisions. Id. §§ III.A.1, III.A.2.
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`As explained in the above sections, the Board’s joinder decision conflicts
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`with settled administrative law. Given a set of facts, it is impossible to determine
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`whether the Board will grant joinder, what factors the Board will apply, or even
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`whether a given fact weighs in favor or against joinder. Such “ad hocery” is
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`arbitrary, capricious, and an abuse of discretion, and “may be properly reviewable
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`in the context of § 319 and under the Administrative Procedure Act.”
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`U.S. Patent No. 5,665,772
`Ramaprakash, 346 F.3d at 1130; Cuozzo, 136 S. Ct. at 2142. This uncertainty
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`undermines the “one theme above all others [that] has dominated the Supreme
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`Court’s interpretation of the Due Process Clause: fairness.” Assoc. of Am. R.R. v.
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`DOT, 821 F.3d 19, 27 (D.C. Cir. 2016). “The doors of [a] tribunal are open to all
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`claimants but only on the same terms. This is the essence of due process and equal
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`treatment under the law.” Mendoza v. MSPB, 966 F.2d 650, 653 (Fed. Cir. 1992).
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`Further, the result of the Board’s decision—finding claim 7 likely
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`unpatentable but refusing to institute—is not merely an abstract public-interest
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`concern. It will impact patients needing life-saving drugs. Novartis asserts that the
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`claims cover formulations with over $2.6 billion in sales in the United States. POR
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`66. Yet the Board’s joinder decision would intentionally leave formulation claim 7
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`intact, forcing the public to purchase needed medicine from Novartis at a high
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`price even if the compound itself and methods of administering it are unpatentable.
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`That is not what Congress intended and may well attract public scrutiny.
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`IV. Conclusion
`For the above reasons, Petitioner respectfully requests a rehearing and
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`reversal of the joinder decision and further suggests an expanded panel.
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`Dated: November 10, 2016
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`Respectfully submitted,
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`By: /Daniel G. Brown/
`Daniel G. Brown (Reg. No. 54,005)
`Counsel for Petitioner
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`Case IPR2016-01059
`U.S. Patent No. 5,665,772
`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), I certify that on this 10th day of November,
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`2016, a true and correct copy of the foregoing PETITIONER’S REQUEST FOR
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`REHEARING OF THE BOARD’S DECISION DENYING JOINDER was
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`served by electronic mail on Patent Owner’s lead and backup counsel at the
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`following email address:
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`Nicholas N. Kallas (Reg. No. 31,530)
`Raymond R. Mandra (Reg. No. 34,382)
`Fitzpatrick, Cella, Harper & Scinto
`1290 Avenue of the Americas
`New York, NY 10104-3800
`ZortressAfinitorIPR@fchs.com
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`By: /Daniel G. Brown/
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`Daniel G. Brown (Reg. No. 54,005)
`Latham & Watkins LLP
`885 Third Avenue
`New York, NY 10022-4834
`212-906-1200; 212-751-4864 (Fax)
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`Counsel for Petitioner
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