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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`MYLAN PHARMACEUTICALS INC.,
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`Petitioner,
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`V.
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`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
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`
`
`Case No. IPR2018-016751
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`Patent No. 8,603,044
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`MYLAN REPLY TO PATENT OWNER PRELIMINARY RESPONSE
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`1 Mylan filed essentially the same reply in IPR2018-01675, -01676, -01678
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`and -01680. Underlining indicates case-specific differences.
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`
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`
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`MYLAN PHARMACEUTICALS INC.,
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`Petitioner,
`
`V.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`Patent Owner.
`
`
`
`Case No. IPR2018-016751
`
`Patent No. 8,603,044
`
`MYLAN REPLY TO PATENT OWNER PRELIMINARY RESPONSE
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`1 Mylan filed essentially the same reply in IPR2018-01675, -01676, -01678
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`and -01680. Underlining indicates case-specific differences.
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`
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`The Board authorized this Reply (Paper 14), allowing Mylan to respond to
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`Sanofi’s argument in its Patent Owner Preliminary Response (“POPR”) that the
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`Board should exercise discretion under §314(a)2 and deny the Petition on the basis
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`of co-pending district court litigation. Sanofi’s arguments are legally and factually
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`incorrect, and improperly invite shenanigans.
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`1. Failure of proof
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`Sanofi asserts without evidence3 that Mylan’s district-court invalidity
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`contentions include the “exact same” grounds as the Petition, i.e., obviousness over
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`Burroughs. POPR, 7 (citing NHK Spring Co. v. Intri-Plex Techs., Inc., IPR2018-
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`00752, Paper 8, 19 (2018)); see also POPR, 11. Sanofi asserts Mylan’s contentions
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`state that “Burroughs, alone,” or in combination renders the challenged claims
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`obvious. POPR, 11 (guoting EX2009, 268-269; citing EX2008, 202; EX2010).
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`Actually, Mylan contended “Burroughs alone or in combination with” thirfl-three
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`additional references renders the claims obvious, with no accompanying argument.
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`EX2009 269; see also Intel Corp. v. Qualcomm, Inc., IPR2018-01152, Paper 9,
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`2 Sanofi also cites §324(a) (POPR, 4), which is inapplicable to IPRs.
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`3 New evidence with any sur-reply would be inappropriate. Sanofi had the
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`opportunity to support its arguments in its POPR, but chose not to do so.
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`
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`14-19 (2019) (noting differences between IPR and district court proceedings).
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`Similarly, Mylan’s amended invalidity contentions are a claim chart listing the
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`teachings of numerous references, with no additional argument (EX2010), while
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`Sanofi’s evidence of its allegedly detailed validity positions is merely an email
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`demonstrating service (EX2011).4 Thus, Sanofi’s evidence does not support its
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`allegation that Mylan’s invalidity contentions and IPR grounds are the same. The
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`Board should decline to exercise its discretion under §314(a) on this basis alone.
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`2. Multiple petitions
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`Sanofi’s focus on the number of petitions flled, rather than the number of
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`patents it asserted in district court, distorts the actual reason for the multiple filings.
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`POPR, 11 n.5, 18. The ten IPR petitions address five device patents that Sanofl
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`chose to assert against Mylan (in addition to two formulation patents). Mylan
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`simultaneously filed two petitions for the ’044 patent due to the word limits (37
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`4 Sanofi designated its contentions as confidential, leaving Sanofi in control of
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`whether the Board could see them or not. In any case, Mylan denies Sanofl’s
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`assertion that its validity contentions were sufficiently detailed to offer “two bites
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`at the apple.” POPR, 13.
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`
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`CFR §42.24ga)(1n, which the Office expressly allows. 77 Fed. Reg. 48612, 48635
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`(2012) (Response to comment 91); Intel, IPR2018-01152, Paper 9, 15- 16. Sanofi’s
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`suit created a time bar forcing Mylan to file petitions against all asserted patents
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`within 1 year or forgo its remedies under the AIA.5 35 U.S.C. 315(b); see also
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`Click-to-Call Tech., LP, v. Ingenio, Inc., 899 F.3d 1321 (2018). Paradoxically,
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`denying institution for timely filing multiple petitions within the AIA timeframe
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`would penalize Mylan for Sanofi’s litigation decision to assert multiple patents
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`against Mylan in district court.
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`3. Litigation timeline
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`Sanofi’s district-court timeline is speculative. Sanofi asserts that the litigation
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`“should” (POPR, 8) “likely” (id., 12) be finished before the final written decision
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`issues, since the parties requested a trial date in October 2019 and the 30-month
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`stay of regulatory approval of Mylan’s application expires March 18, 2020.
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`According to Sanofi, the final written decision “on the same prior art and
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`arguments would not issue until April 2020, six months after the likely date of the
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`District Court case trial.” Id., 12. Yet a Markman hearing is not scheduled to occur
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`5 Leahy-Smith America Invents Act Pub. L. No. 112-29, 125 Stat. 284 (2011).
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`
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`until March 21, 2019, and most deadlines are tied to the issuance of the Markman
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`order, making Sanofi’s predictions entirely speculative. Moreover, the Board has
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`already held unpatentable all claims of two more Sanofi patents asserted in the same
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`litigation. Sanofi has appealed those decisions to the Federal Circuit (IPR2017-01526,
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`Paper 94; IPR2017-01528, Paper 92) but does not discuss how that appeal may alter
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`the litigation timing. Sanofi’s assertion about the litigation timing is too selective and
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`speculative to support judgment on equitable grounds.
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`4-. Petition timing
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`Sanofi’s delay arguments are wrong, unsupported, and contrary to statute.
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`Sanofi alleges that Mylan waited until “the eve of the one year statutory bar” and
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`“intentionally staggered” its filings to gain an advantage. POPR, 1-2, 5-7, 15-16
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`(citing Gen. Plastic Indus. Co. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper
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`19, 16-17 (2017) (precedential) (“GP”)). Sanofi again offers no evidence for this
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`incorrect assertion. With one exception, Mylan filed its petitions on the same day—
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`not staggered—almost 2 months before the end of the 1-year grace period.6 Sanofi
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`6 The only petition filed close to the §315(b) date, IPR2019-00122, was submitted
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`to correct a filing error in the since-dismissed IPR2018-01677.
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`
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`also ignores the effect of unusual docketing delays ranging from 1 to 3 months.
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`EXIOXX. Indeed, it is Mylan that has been prejudiced by these delays since they
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`enable Sanofi to modify its responses serially according to What happens in the
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`earlier-docketed IPR proceedings.
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`Sanofi’s position is also contrary to the AIA framework. Although the Director
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`has discretion under §314(a), that discretion is not unfettered. SAS Institute, Inc., v.
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`Iancu, 138 S.Ct. 1348, 1356 (2018) (“SAS”). Congress addressed timing between
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`the IPR and co-pending district court litigation in §315(b) and made a considered
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`decision to give defendants a full year to file IPR petitions after service of a
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`complaint. Sanofi invites shenanigans by urging an expansive use of discretion to
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`countermand express congressional intent.
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`In Click-to-Call, the Federal Circuit explained that §315(b) is clear,
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`unambiguous and binding. Id. at 1332 (quoting Cuozzo Speed Tech., LLC v. Lee,
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`136 S.Ct. 2131, 2142 (2016)) SAS, 138 S.Ct. at 1355. The court held “315(b)’s
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`time bar concerns ‘real-world facts that limit the agency’s authority to act under
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`the IPR scheme,’ reflecting Congress’s ‘balancing [of] various public interests.
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`7”
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`Click-to-Call, 899 F.3d at 1331. The Federal Circuit also discussed §315(b)’s
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`legislative history to support its construction, noting “the section 315(b) deadline
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`afford defendants a reasonable opportunity to identijfv and understand the patent
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`
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`claims that are relevant to the litigation.” Id. 1332 (quoting 157 Cong. Rec. S5429
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`(daily ed. Sept. 8, 2011)). Judge Taranto concurred, noting “[l]egislative history
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`indications of congressional policy at most establish that §315(b) is generally
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`based on an assessment of the period suitable for a formally accused infringer...to
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`shape any IPR petition after formally receiving notice of a patentee’s charges of
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`infringement, with the patentee and district courts thereafter given repose against
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`IPR petitions filed by that accused infringer....” Id. at 1347. Thus, Congress already
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`balanced the competing interests, and §315(b) reflects the compromise Congress
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`struck for the timing of district-court and IPR proceedings. Congress makes policy,
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`SAS, 138 S.Ct. at 1358, and the Director must “follow its commands as written, not
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`supplant those commands with others [he] may prefer.” Click-to-Call, 899 F.3d
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`at 1332; SAS, 138 S. Ct. at 1355.
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`Sanofi further disregards Congress’s role by effectively seeking a sector-
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`specific nullification of §315(b) for ANDA suits. Adding §315(b)’s 1 year to the 18
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`month of an IPR equals 30 months, which approximates the 30-month stay in FDA
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`approval in ANDA cases. See, e.g., POPR, 8 n3 (citing 21 U.S.C. 355(c)(3)(C)).
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`Thus, Sanofi’s proposal would essentially prevent all ANDA defendants from using
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`the full grace period established by Congress. Moreover, Congress has considered but
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`not adopted legislation addressing perceived redundancy between IPRs and Hatch-
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`
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`Waxman district court litigation, e.g., HR. 7251 (introduced 11 Dec. 2018), further
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`highlighting that balancing AIA and district court proceedings is a policy decision for
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`Congress, not an appropriate exercise of the Director’s discretion. SAS, 138 S.Ct. at
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`1358.
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`Sanofi relies on NHK to propose a profound expansion of discretion under
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`§314(a) that is contrary to statute and Federal Circuit precedent. POPR, 2. NHK
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`notes an earlier Federal Circuit decision stating that “the PTO is permitted, but
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`never compelled, to institute an IPR proceeding.” NHK, 11 (quoting Harmonic Inc.
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`v. Avid Tech., Inc., 815 F.3d 1345, 1367 (Fed. Cir. 2016)). Harmonic, however,
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`issued before the Federal Circuit’s Click-to-Call decision, as well as before the
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`Supreme Court’s SAS decision, and made this statement to uphold a partial
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`institution. Harmonic, 815 F.3d at 1364. Id. Harmonic articulates an understanding
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`of §314(a) that is no longer good law since SAS. Moreover, Click-to-Call
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`specifically cautions against adding equitable or other non-textual restrictions to
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`§315(b) when instituting under §314(a). Click-to-Call, 899 F.3d at 1331. Thus,
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`regardless of the timing of co-pending proceedings, the Director may not alter the
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`statutory balance to attain a different policy goal.
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`5. Procedural shenanigans
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`Even if such policy preferences could override congressional intent—and they
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`cannot—Sanofl’s proposal would violate the Administrative Procedure Act
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`(“APA”), which requires actual notice. 35 U.S.C. 552(a)(1) (“[A] a person may not
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`in any manner be required to resort to, or be adversely affected by, a matter
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`required to be published in the Federal Register and not so published.”). The
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`August 2018 Update to the Office Trial Practice Guide (“Update”) states that the
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`considerations under §316(b) may apply in situations other than follow-on petitions,
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`such as “events in other proceedings related to the same patent
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`[such as] in district
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`courts.” Update, 10. The Update, however, does not elaborate on what those other
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`considerations may be, imposes no actual requirement, and does not account for
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`Click-to-Call. Moreover, the Federal Circuit has noted the Trial Practice Guide is only
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`a guide, and not binding. Applications in Internet Time, LLC, v. RPX Corp, 897 F.3d
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`1336, 1344 n.2 (Fed. Cir. 2018). NHK is also not binding and issued after Mylan filed
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`the instant petition. American Silicon Technologies v. United States, 261 F.3d 1371,
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`1381 (Fed. Cir. 2001). Mylan thus complied with all then-applicable statutes and
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`rules. Imposing additional post hoc requirements would violate process due under the
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`APA.
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`Sanofi’s own discussion of the Update demonstrates the lack of notice. Sanofi
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`justifies its position by arguing that, per the Update, the Director’s discretion under
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`§314(a) is “informed by” the requirement of §316(b) to consider, inter alia,
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`efficiency and timeliness. POPR, 9 (quoting Update, 9). Yet §316(b) is explicitly a
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`rulemaking authority. Sanofi’s invocation of rulemaking considerations to justify a
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`policy imposed outside of the rulemaking process is internally inconsistent. Imposing
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`additional requirements on petitioners by applying the rulemaking considerations of
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`§316(b) via §314(a) discretion would be an end run around notice-and-comment
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`rulemaking requirements. See 5 U.S.C. 552(a), 553; 35 U.S.C. 2(b)(2)(B); Aqua
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`Products, Inc. v. Matal, 872 F.3d 1290, 1318-20 (Fed. Cir. 2017); Supernus Pharm.,
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`Inc. v. Iancu, No. 2017-1357, slip. op. 17-18 (Fed. Cir. Jan. 23, 2019).
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`In any event, Click-to-Call’s construction of §315(b) bars Sanofi’s argument.
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`Click-to-Call issued after the Update, and NHK does not address its impact; neither
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`can overrule it. Nor does Sanofi address Click-to-Call and its impact on the cited
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`portions of the Update. Sanofi would hold Mylan to non-binding authority, while
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`ignoring clearly binding authority—Click-to-Call. Mylan filed after Click-to-Call and
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`complied with §3 15 (b). Sanofi’s assertion that Mylan had notice is thus wrong.
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`Sanofi also argues that GP factors favor non-institution. POPR, 15 -18. GP
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`addresses follow-on petitions, and Sanofi cannot shoehom litigation into the GP
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`
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`factors. Wirtgen America, Inc. v. Caterpillar Paving Products Inc. , IPR2018-
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`01201, Paper 13, 11 (2019).
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`6. Workload and resource shenanigans
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`Sanofl asserts that allowing an AIA challenge based on the “same invalidity
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`grounds” as in district court is not a quick and efficient alternative to litigation, but a
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`waste of the Board’s and the parties’ resources. POPR, 2 (citing H.R. Rep. No. 112—
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`98, pt. 1, at 48 (2011); NHK, 19-20). Sanofl is factually wrong about the “same”
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`grounds, and Congress has already struck the balance it wanted. Substituting
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`workload and resources considerations on a case-by-case basis is contrary to clear
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`statutory text, inviting further shenanigans. SAS, 138 S.Ct. at 135 9; Cuozzo, 136
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`S.Ct. at 2141-42. As discussed above, both the Supreme Court and the Federal
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`Circuit have explained that discretion under §314(a) is not unfettered. SAS, 138 S.Ct.
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`at 1356; Click-to-Call, 899 F.3d at 1329. This is especially true for workload and
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`resources.
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`Sanofl’s broad view of §314(a) is also “at odds with one of the most basic
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`interpretive canons” because it renders superfluous other specific grants of authority
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`to limit IPR institutions based on workload and efficiency considerations. Carley v.
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`United States, 556 U.S. 303, 314 (2009). In the AIA, Congress authorized the
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`Director to limit the number of IPRs instituted during the first four years to prevent
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`10
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`
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`the Office from being “overwhelmed”. Pub. L. 112-29, sec. 6(c)(2)(B)) 125 Stat. 304
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`(201 1); 157 Cong. Rec. 81376-77 (Mar. 8, 201 1). Congress thus believed it needed
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`to give the Director separate, express authority to limit the institution of IPRs for
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`workload, and Congress set that authority to expire in 2016. If capping for workload
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`and resources were inherent in §314(a) discretion, Congress would not have needed to
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`grant such authority. Similarly, Sanofi’s broad reading of §314(a) discretion would
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`render authority to deny institution under §325 (d) superfluous.
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`The legislative history cited in GP confirms that §314(a) discretion does not
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`extend to ad hoc consideration of workload issues beyond the merits of the
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`petition. GP notes that the “legislative history reflects recognition of a desire for a
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`‘safety valve’ to alleviate backlog,” stating further that the “exercise of discretion
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`under 35 U.S.C. § 314(a) [is not limited] to only circumstances in which there is a
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`high volume of pending proceedings.” GP, 19 (citing 157 Cong. Rec. 81377 (Mar.
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`8, 2011)). The cited Congressional Record text, however, requires the Director to
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`address workload by notice-and-comment rulemaking. The cited text invokes
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`rulemaking authority under §316, explaining that “[i]t is expected that the Office
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`will include in the threshold regulations a safety valve that allows the Office to
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`decline to institute further proceedings” when overwhelmed. 157 Cong. Rec.
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`81377 (Mar. 8, 2011) (emphasis added); 35 U.S.C. 2(b)(2)(B).
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`11
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`
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`The Director has only addressed workload and resources by rule in setting
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`petitioner fees, which must account for “the aggregate costs of the review.” 35
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`U.S.C. 311(a). No one contends that Mylan has failed to pay the fees for this
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`petition. Thus, even if Office did not have sufficient resources, the Director must
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`address that issue through rules, not on an ad hoc basis. Additionally, the Board is
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`at a high-point in staffing, while appeal and trial dockets are falling. See, e. g.,
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`Appeal and Interference Statistics, Patent Trial and Appeal Board, 2018, 3;
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`Organizational Structure and Administration of the Patent Trial and Appeal Board,
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`1. Sanofi provides no credible basis for using workload or resources to contravene
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`clear statutory requirements.
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`Sanofi proposes to repurpose §314(a) in a way that unfairly targets ANDA
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`defendants while violating the AIA, the APA, and Federal Circuit precedent. For the
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`reasons set forth above, the Board should not exercise discretion under §314(a) to
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`deny the petition. Mylan respectfully requests institution of inter partes review.
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`Date: 30 January 2019
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`/ Richard Torczon/
`Richard Torczon, Lead Counsel
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`Reg. No. 34,448
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`12
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`
`
`UPDATED EXHIBIT LIST
`
`
`Exhibit No.
`
`Description
`
`1001
`
`US. Patent 8,679,069, Pen-Type Injector (issued Mar. 25, 2014)
`
`1002
`
`US. Patent 8,603,044, Pen-Type Injector (issued Dec. 10, 2013)
`
`1003
`
`US. Patent 8,992,486, Pen-Type Injector (issued Mar. 31, 2015)
`
`
`
`1004
`
`US. Patent 9,526,844, Pen-Type Injector (issued Dec. 27, 2016)
`
`1005
`
`US. Patent 9,604,008, Drive Mechanisms Suitablefor Use in Drug
`Delivery Devices (issued Mar. 28, 2017)
`
`1006
`
`File History for US. Patent 8,679,069
`
`
`
`
`
`1007
`
`File History for US. Patent 8,603,044
`
`1008
`
`File History for US. Patent 8,992,486
`
`1009
`
`File History for US. Patent 9,526,844
`
`1010
`
`File History for US. Patent. 9,604,008
`
`Expert Declaration of Karl Leinsing MSME, PE in Support of
`
`1011
`
`Petition for Inter Partes Review of US. Patent Nos. 8,679,069;
`
`8,603,044; 8,992,486; 9,526,844 and 9,604,008
`
`13
`
`
`
`
`
`Exhibit No.
`
`Description
`
`1012
`
`Curriculum Vitae of Karl Leinsing MSME,PE
`
`1013
`
`1014
`
`U.S. Patent 6,221,046 - A. Burroughs et al., “Recyclable Medication
`Dispensing Device” (issued Apr. 24, 2001)
`
`U.S. Patent 6,235,004 — S. Steenfeldt—Jensen & S. Hansen, “Injection
`
`Syringe” (issued May 22, 2001)
`
`
`1015
`
`U.S. Patent Application US 2002/0053 578 A1 — C.S. Muller, “Injection
`
`Device” (pub’d May 2, 2002)
`
`1016
`
`U.S. Patent 6,932,794 B2 — L. Giambattista & A. Bendek,
`“Medication Delivery Pen” (issued Aug. 23, 2005)
`
`1017
`
`U.S. Patent 6,582,404 B1 — P.C. Klitgaard et al., “Dose Setting
`Limiter” (issued June 24, 2003)
`
`
`1018
`
`File History for U.S. Patent 6,582,404
`
`
`
`Plaintiffs’ Preliminary Claim Constructions and Preliminary
`
`1019
`
`Identification of Supporting Intrinsic and Extrinsic Evidence,
`
`Sanofi-Aventis U.S. LLC v. Mylan GmbH, N0. 2:17-cv-09105
`
`(D.N.J.) (filed Sep. 5 2018)
`
`1020
`
`U.S. Patent 4,865,591 — B. Sams, “Measured Dose Dispensing
`
`Device” (issued Sep. 12, 1989)
`
`1021
`
`U.S. Patent 6,248,095 B1 — L. Giambattista et al., “Low-cost
`Medication Delivery Pen” (issued June 19, 2001)
`
`14
`
`
`
`
`
`Exhibit No.
`
`Description
`
`US. Patent 6,921,995 B1 — A.A. Bendek et al., “Medication
`
`Delivery Pen Having An Improved Clutch Assembly” (issued
`
`July 13, 1999)
`
`US. Patent 5,226,895 — D.C. Harris, “Multiple Dose Injection Pen”
`
`(issued July 13, 1993)
`
`US. Patent 5,851,079 — R.L. Horstman et al., “Simplified
`
`Unidirectional Twist-Up Dispensing Device With Incremental
`
`Dosing” (issued Dec. 22, 1998)
`
`Application as filed: US. Patent App. 14/946,203 — R.F. Veasey,
`
`“Relating to a Pen-Type Injector” (filed Nov. 19, 2015)
`
`GB 03 04822.0 — “Improvements in and relating to a pen-type
`
`injector” (filed Mar. 3, 2003) (‘844 Priority Doc.)
`
`W0 99/3 8554 — S.Steenfeldt-Jensen & S.Hansen, “An Injection
`
`Syringe” (pub’d Aug. 5, 1999) (Steenfeldt-Jensen PCT)
`
`Mylan GmbH and Biocon’s Preliminary Claim Constructions and
`
`Supporting Evidence Pursuant to L. Pat. R. 4.2, Sanofi-Aventis
`
`US, LLC v. Mylan N. V., CA. No. 17-cv-09105 (filed Sep. 5,
`
`
`
`2018)
`
`Memorandum Opinion, Sanofi-Aventis US. LLC v. Merck Sharp &
`
`Dohme Corp, No. 16-cv-812 (filed Jan. 12, 2018)
`
`Memorandum Opinion, Sanofi -Aventis US. LLC v. Eli Lilly and
`
`Co., No. 14-cv-113 (filed Jan. 20, 2015)
`
`15
`
`
`
`
`
`Exhibit No.
`
`Description
`
`N. Sclater & N.P. Chironis, Mechanisms & Mechanical Devices
`
`1031
`
`Sourcebook 191-95, “Twenty Screw Devices” (3d ed., July 2,
`
`2001)
`
`EP 0 608 343 B1 — L. Petersen & N.-A. Hansen, “Large Dose Pen”
`
`(pub’d Oct. 18, 1991)
`
`1033
`
`A.G. Erdman &G.N. Sandor, “ Mechanical Advantage”, §3.7 in
`1 Mechanism Design: Analysis and Synthesis (1984)
`
`WO 01/83008 — S. Hansen & T.D. Miller., “An Injection Device, A
`
`1 034
`
`Preassembled Dose Setting And Injection Mechanism For An
`
`Injection Device, And A Method OfAssembling An Injection
`
`Device” (pub’d Nov. 8, 2001)
`
`K.J. Lipska et al., Association ofInitiation ofBasal Insulin Analogs
`
`vs Neutral Protamine Hagedorn Insulin With Hypoglycemia-
`
`1035
`
`Related Emergency Department Visits or Hospital Admissions
`
`and With Glycemic Control in Patients With Type 2 Diabetes,
`
`
`
`320 J. Am. Med. Ass’n 53-62 (2018)
`
`103 6
`
`Transcript, Conference Call (January 15, 2019)
`
`1037
`
`Redlined Petition Page 25
`
`1038
`
`Graph showing PTAB Days to Docketing for Review Proceedings
`Filed between 2016-2018
`
`16
`
`
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`CERTIFICATE OF SERVICE
`
`I certify that this Reply with Updated Exhibit List and EX1038 was served
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`on 30 January 2019, on the Patent Owner at the email correspondence address of
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`the Patent Owner as follows:
`
`Elizabeth Stotland Weiswasser
`
`elizabeth.weiswasser@weil.com
`
`Anish R. Desai
`
`anish.desai@weil.com
`
`Kathryn M. Kantha
`
`kat
`
`n.kantha weil.com
`
`William S. Ansley
`
`sutton.ansley@weil.com
`
`Matthew D. Sieger
`
`matthew.sieger@weil.com
`
`WEIL, GOTSHAL & MANGES LLP Sanof1.IPR.Service@weil.com
`
`Date: 30 January 2019
`
`Respectfully submitted,
`
`/ Richard Torczon/
`Richard Torczon, Lead Counsel
`
`Reg. No. 34,448
`
`17
`
`
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