Paper No. __
`Filed: April 1, 2016
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`________________
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`PAR PHARMACEUTICAL, INC., WOCKHARDT BIO AG, and
`AMNEAL PHARMACEUTICALS LLC,
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`Petitioners,
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`v.
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`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-005541
`Patent 7,688,730
`________________
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`
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`PATENT OWNER’S OPPOSITION TO PETITIONERS’
`MOTION PURSUANT TO 37 C.F.R. § 42.5(c)(3)
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`1 Case IPR2015-01818 has been joined with this proceeding.
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`Filed: April 1, 2016
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`
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`PAR PHARMACEUTICAL, INC., WOCKHARDT BIO AG, and
`AMNEAL PHARMACEUTICALS LLC,
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-005541
`Patent 7,688,730
`________________
`
`
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`PATENT OWNER’S OPPOSITION TO PETITIONERS’
`MOTION PURSUANT TO 37 C.F.R. § 42.5(c)(3)
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`
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`1 Case IPR2015-01818 has been joined with this proceeding.
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`Patent Owner Opposition to 37 C.F.R. § 42.5(c)(3) Motion IPR2015-00554
`Patent 7,668,730
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`Patent Owner (“Jazz”) submits this opposition to Petitioners’ motion to
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`excuse their late filing of objections under 37 C.F.R.§ 42.5(c)(3) (“Mtn.”).
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`I.
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`RESPONSE TO PETITIONERS’ “STATEMENT OF FACTS”
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`On May 19, 2015, 37 CFR § 42.64(b)(1) was amended “to require filing of
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`objections, which also requires service under 37 CFR 42.6(e)(2).” 80 Fed. Reg.
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`28563. Thus, for objections to be proper, they must be both filed and served. See
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`id. The amendment was published in the Federal Register. See id. On November
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`13, 2015, Petitioners served, but did not properly file, objections to evidence Jazz
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`submitted with its Response. See Ex. 1060 at 3. Jazz denies that Petitioners
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`“inadvertently” did not file their objections as they assert. See Mtn. 1. If they truly
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`did not know of the rule, their failure to comply with it could not be inadvertent.
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`Jazz also denies Petitioners’ assertion that because Jazz served supplemental
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`evidence, “Jazz had actual notice of Petitioners’ objections here.” See Mtn. 1.
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`Instead, by rule: “Once a trial has been instituted, any objection must be filed
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`within five days of service of evidence to which the objection is directed.” 37
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`C.F.R. § 42.64(b)(1) (emphasis added). Also, by rule: “The party relying on
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`evidence to which an objection is timely served may respond to the objection by
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`serving supplemental evidence within ten business days of service of the
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`objection.” 37 C.F.R. § 42.64(b)(2) (emphasis added). In other words, serving
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`certain supplemental evidence in response to “timely served” objections under
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`Patent Owner Opposition to 37 C.F.R. § 42.5(c)(3) Motion IPR2015-00554
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`Patent 7,688,730
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`§42.64(b)(2) is not a concession or acknowledgment of timely “filed” objections
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`under §42.64(b)(1). And in fact, Jazz expressly “reserve[d] the right to argue that
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`Petitioners have waived their objections.” Ex. 1059 at 1.
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`Four months later, Petitioners e-mailed Jazz, asking “whether Jazz will
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`object to Petitioners seeking leave to file these evidence objections before the
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`Board. . . .” Ex. 1060 at 5. Jazz denies that it refused Petitioners’ request “on the
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`sole grounds that the request was untimely,” as Petitioners assert. See Mtn. 2. Jazz
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`also raised, and continues to assert, issues of prejudice. See Ex. 1060 at 1-2.
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`II. ARGUMENT
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`Petitioners bear the burden of proving that they are entitled to relief. See 37
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`C.F.R. § 42.20 (c). The Board stated that “Petitioners’ motion [to excuse their late
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`objections] must make a showing of good cause to support their request and
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`explain why ‘consideration on the merits would be in the interests of justice.’”
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`Ex. 1060 at 1. Petitioners fail to meet their burden on both points.
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`A.
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`Petitioners cannot show good cause
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`First, Petitioners admit that they failed to comply with §42.64(b)(1). Mtn. 2.
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`The only excuse Petitioners offer is that their attorneys were ignorant of the law—
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`i.e., the version of §42.64(b)(1) that requires filing objections. Id. at 2-3. But that
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`version of §42.64(b)(1) was enacted and published in the Federal Register on
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`May 19, 2015—six months before Petitioners failed to file the objections.
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`- 2 -
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`Patent Owner Opposition to 37 C.F.R. § 42.5(c)(3) Motion IPR2015-00554
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`Patent 7,688,730
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`Even if Petitioners’ counsel’s lack of knowledge of what was published in
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`the Federal Register was reasonable, it does not excuse Petitioners’ counsel’s
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`ignorance of the law. Indeed, the PTAB has refused to grant motions under
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`§42.5(c)(3) when the requirement missed was published in the Federal Register
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`and the movant “misunderstood the law.” Reflectix Inc. v. Promethean Insulation
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`Tech., IPR2015-00039, 2015 WL 1927414, at *7 (Apr. 24, 2015). That is the case
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`here, and the Board should similarly refuse Petitioners’ motion.2
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`Second, Petitioners argue that the Board “has allowed parties who timely
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`served their evidence objections under the prior rule to file them with a motion to
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`exclude after promulgation of the new rule.” Mtn. 3 (emphasis added). To be
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`clear, in the IPR cited, the rule changed after the party served its objections in
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`March 2015. TRW Auto v. Magna Elecs., IPR2014-01348, Paper 25 at 3 (Jan. 15,
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`2 Petitioners’ motion is ironic given their position that the references in this IPR
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`qualify as prior art because a POSA, interested in “drug distribution, safety and
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`abuse,” would “[n]aturally” look to the Federal Register. See Paper 46 at 8. Here,
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`not one of Petitioners’ counsel—registered patent attorneys who litigate IPRs—
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`was aware of the rule governing IPRs that was published in the Federal Register.
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`- 3 -
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`Patent Owner Opposition to 37 C.F.R. § 42.5(c)(3) Motion IPR2015-00554
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`Patent 7,688,730
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`2016). Here, the rule changed six months before Petitioners failed to comply.
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`Any implication by Petitioners that this case supports their position is misleading.
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`Third, Petitioners allege that “[g]ood cause exists to extend a deadline where
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`delay is due to an attorney error and the extension causes no prejudice.” Mtn. 3.
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`Again, the caselaw cited does not support Petitioners’ position. In Bronner, the
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`delay was only seventeen days, not four months, and was caused by a calendaring
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`error, not ignorance of the rule. Bronner v. Unum Life Ins., No. 03-5742, 2008 WL
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`4951031, at *1-2 (N.D. Cal. Nov. 18, 2008). Further, the opposing party “d[id] not
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`explain how they would suffer actual prejudice from an extension.” Id. at *2.3
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` But here, prejudice is irrelevant under the rule. Nintendo of Am. v. Motion
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`Games LLC, IPR2014-00164, Paper 51 at 26-27 (May 15, 2015) (finding untimely
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`objections waived and refusing to allow an exception based on argument of no
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`prejudice). Regardless, Jazz explained how it would be prejudiced. For example,
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`Petitioners seek to rely on their improper objections to exclude a third-party’s
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`deposition as hearsay. See Paper 54 at 8-9. While Jazz disagrees with Petitioners’
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`3 Lopez v. Burris Logistics has nearly the same facts. No. 31-1039, 2013 WL
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`5962100, at *2-3 (D. Conn. Nov. 6, 2013) (extending deadline where the three-day
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`delay was caused by a calendaring error and the other side admitted no prejudice).
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`- 4 -
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`Patent Owner Opposition to 37 C.F.R. § 42.5(c)(3) Motion IPR2015-00554
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`Patent 7,688,730
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`argument as explained in its Opposition to the Motion to Exclude, Jazz reasonably
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`relied on Petitioners’ failure to comply with the rules and did not burden a third
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`party, this Board, and a district court by moving to subpoena the third party. Jazz
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`also made other decisions regarding its supplemental evidence and case strategy as
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`a result of Petitioners’ failure to comply with the rules. Thus, Petitioners’
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`statement that “the parties have a fully developed record surrounding the
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`admissibility of the evidence in question” (Mtn. 4), is false. Further, there are only
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`weeks left until the oral hearing and there is no time to cure the prejudice.
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`Petitioners have not established good cause to excuse their ignorance of the law.
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`B. Allowing Petitioners to circumvent the rules would not be in the
`interests of justice
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`Petitioners erroneously argue that allowing their late objections would be in
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`the interests of justice. First, Petitioners argue that “Jazz seeks to avoid resolution
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`of Petitioners’ Motion to Exclude on the merits.” Mtn. 5. Not so. Jazz simply
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`seeks to have the Board enforce its rules in situations such as this, where
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`Petitioners waited until the eve of the oral hearing to seek to change the record in
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`this proceeding. As explained above, there is no time left to cure the prejudice to
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`Jazz. Had Petitioners complied with §42.64(b)(1), this would not be an issue.
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`Second, Petitioners argue that allowing their late objections would be in the
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`interests of justice because “Jazz availed itself of the option to more fully develop
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`- 5 -
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`Patent Owner Opposition to 37 C.F.R. § 42.5(c)(3) Motion IPR2015-00554
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`Patent 7,688,730
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`the evidentiary record” by serving supplemental evidence. Mtn. 5. Not so. Jazz’s
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`supplemental evidence is not part of the evidentiary record and only becomes so if
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`Petitioners’ motion to exclude is proper. Without the motion to exclude, the
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`evidentiary record stands as it is today, without any supplemental evidence. Valeo
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`does not support Petitioners’ argument that Jazz’s service of supplemental
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`evidence somehow makes Petitioners’ objections proper. Mtn. 5. Instead, in
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`Valeo, the PTAB held that certain documents called supplemental evidence when
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`they were served were “not supplemental evidence” because the opposing party’s
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`“objections were not effective.” Valeo N. Am. v. Magna Elecs., IPR2014-01208,
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`Paper 49 at 12 (Dec. 21, 2015). Just as in Valeo, Jazz’s service of what it called
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`“supplemental evidence,” does not make Petitioners’ untimely objections proper.4
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`
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`4 Petitioners contend that Jazz should overlook their four month delay because
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`they have given Jazz a brief extension in the past. Plainly these are not the same.
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`Further, Petitioners are incorrect that, without the extension, two exhibits they seek
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`to exclude would not have been ready by the original due date of Jazz’s Response.
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`The Response was originally due October 30, 2015. Paper 36 at 1. Ex. 2054 was
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`ready on October 28 (Ex. 2054 at 1) and Ex. 2057, although not prepared until
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`after October 30, would have been ready earlier if the Response was not extended.
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`- 6 -
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`Patent Owner Opposition to 37 C.F.R. § 42.5(c)(3) Motion IPR2015-00554
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`Patent 7,688,730
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`Finally, although not required, Jazz put Petitioners on notice of their failure
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`to comply with §42.64(b)(1). Specifically, Jazz stated that it “reserve[d] the right
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`to argue that Petitioners have waived their objections.” Ex. 1059. Petitioners now
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`attempt to use this as evidence that “the Board should reject any argument that Jazz
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`may present . . . that any delay in bringing this Motion is Petitioners’ fault.” Mtn.
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`6. Petitioners’ reasoning is that Jazz should have provided more detail on why
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`Petitioners waived their objections. Id. This is astonishing. It is not Jazz’s job to
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`advise Petitioners’ counsel on how to properly represent their clients.
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`Here, each of Petitioners’ counsel attested to this Board after the rule
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`change—in July 2015, before they failed to comply with §42.64(b)(1), and in
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`January 2016, after they failed to comply with §42.64(b)(1)—that they had “read
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`and intend[ed] to comply with . . . the Board’s Rules . . . as set forth in Part 42 of
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`the CFR.” Paper 43 at 2-3; IPR2015-00545, Paper 20 at 1. Jazz had no reason to
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`believe that Petitioners’ counsel were misrepresenting facts to the Board. Yet there
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`was not word one on Petitioners’ failure to comply with §42.64(b)(1) until March
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`15, 2016. Ex. 1060 at 5. Thus, any argument that the delay in bringing this motion
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`stems from any source other than Petitioners is disingenuous at best.
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`III. CONCLUSION
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`For the foregoing reasons, the Board should deny Petitioners’ motion under
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`37 C.F.R. § 42.5(c)(3), and expunge Petitioners’ Motion to Exclude (Paper 54).
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`Patent Owner Opposition to 37 C.F.R. § 42.5(c)(3) Motion IPR2015-00554
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`Patent 7,688,730
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`Date: April 1, 2016
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`Respectfully submitted,
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`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` Eric C. Stops (Reg. No. 51,163)
` Evangeline Shih (Reg. No. 50,170)
` Frank C. Calvosa (Reg. No. 69,064)
`QUINN EMANUEL URQUHART &
`SULLIVAN, LLP
`51 Madison Avenue, 22nd Floor
`New York, NY 10010
`General Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`ericstops@quinnmemanuel.com
`evangelineshih@quinnemanuel.com
`frankcalvosa@quinnemanuel.com
`
`John V. Biernacki
`Reg. No. 40,511
`JONES DAY
`North Point
`901 Lakeside Avenue
`Cleveland, Ohio 44114
`General Tel: (216) 586-3939
`Direct Tel: (216) 586-7747
`Fax: (216) 579-0212
`jvbiernacki@jonesday.com
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`Attorneys for Jazz Pharmaceuticals, Inc.
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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
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`PAR PHARMACEUTICAL, INC., WOCKHARDT BIO AG, and
`AMNEAL PHARMACEUTICALS LLC,
`
`Petitioners,
`
`v.
`
`JAZZ PHARMACEUTICALS, INC.
`
`Patent Owner
`
`________________
`
`Case IPR2015-005545
`Patent 7,688,730
`________________
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`CERTIFICATE OF SERVICE
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`5 Case IPR2015-01818 has been joined with this proceeding.
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`CERTIFICATE OF SERVICE
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`Pursuant to 37 C.F.R. § 42.6(e), the undersigned hereby certifies that
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`PATENT OWNER’S OPPOSITION TO PETITIONERS’ MOTION
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`PURSUANT TO 37 C.F.R. § 42.5(c)(3) was served on April 1, 2016 by filing this
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`document through the Patent Review Processing System, as well as e-mailing a
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`copy to bradford.frese@arentfox.com, richard.berman@arentfox.com,
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`janine.carlan@arentfox.com, and PCGallagher@duanemorris.com.
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`Date: April 1, 2016
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` Respectfully submitted,
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`By: /F. Dominic Cerrito (Reg. No. 38,100)/
` F. Dominic Cerrito (Reg. No. 38,100)
` QUINN EMANUEL URQUHART &
` SULLIVAN, LLP
` 51 Madison Avenue, 22nd Floor
` New York, NY 10010
` General Tel: (212) 849-7000
`Fax: (212) 849-7100
`nickcerrito@quinnemanuel.com
`
`Lead Counsel for
`Jazz Pharmaceuticals, Inc.
`
`
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`- 2 -
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