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`IPR2019-00971
`U.S. Patent 9,856,287
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`FRESENIUS KABI USA, LLC and
`FRESENIUS KABI SWISSSBIOSIM GMBH,
`Petitioners,
`
`v.
`AMGEN INC. and AMGEN MANUFACTURING, LIMITED,
`Patent Owners.
`______________________
`
`Case IPR2019-00971
`Patent 9,856,287
`______________________
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`PATENT OWNERS’ SUR-REPLY IN SUPPORT OF ITS
`PRELIMINARY RESPONSE1
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` 1
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` This paper was authorized by Order on August 8, 2019 (Pap. 10, 3). All emphasis
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`is added unless noted.
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`Proceeding With An IPR Is Improper When A PGR Has Been Instituted.
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`IPR2019-00971
`U.S. Patent 9,856,287
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`Petitioners’ Reply (Pap. 11) posits that, despite Congress’s obvious concern that
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`PGRs be filed and addressed first after a patent’s issuance, Congress somehow en-
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`acted a legislative regime—and the PTO adopted a rule—with a gap allowing an
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`IPR to proceed while a PGR petition is pending, so long as it was filed after the 9-
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`month statutory bar and before the Board issued its institution decision for the PGR
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`petition. Given the clear temporal division between PGR and IPR proceedings es-
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`tablished by Congress and reflected in the rules (compare §321(c), with §311(c), and
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`compare §42.202(a), with §42.102(a)), there is no reason to assume Congress or the
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`PTO intended IPRs to run concurrently with PGRs. A scheme where the IPR peti-
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`tion bar briefly terminates and then restarts due to an instituted PGR makes no sense,
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`and is not what the statute or rule provide.
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`Petitioners erroneously suggest Amgen misplaced its reliance on Intex Recre-
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`ation because the Board supposedly “did not rely on the PGR as a basis for finding
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`a previously timely petition untimely; it merely recognized that a new IPR could no
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`longer be filed because the PGR had been instituted.” Not so: in discussing the
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`“timing of this petition for inter partes review,” the Board denied institution for two
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`reasons—because “this” IPR (which was filed at the same time as the PGR) was
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`premature and because the PGR had since been instituted. Intex Recreation Corp.
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`v. Team Worldwide Corp., IPR2019-00245, Pap. 7, 10 (May 15, 2019) (citing both
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`IPR2019-00971
`U.S. Patent 9,856,287
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`§311(c)(1) and §311(c)(2)).
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`Petitioners also assert “courts have repeatedly rejected arguments that the
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`timeliness of a filing was altered by subsequent events,” but mistakenly rely on cases
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`where district court litigants faced the inequity of being forever barred from appeal
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`due to actions taken by another party or subsequent rule changes.2 First, there is no
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`question Petitioners here can seek an IPR after the end of the PGR proceedings.
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`Second, as in those cases, Petitioners do not suggest Amgen has taken any action to
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`render the Petition untimely or identify any subsequent rule change that, if applied,
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`would make it untimely. Third, the fact that the PGR petition at issue had been filed
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`and was being considered was public knowledge and specifically known by Petition-
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`ers, who, as detailed in Amgen’s POPR, copied significant portions of it. Pap. 8
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` 2
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` Antonious v. Spalding & Evenflo Cos., 10 Fed. Appx. 801, 802 (Fed. Cir. May 7,
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`2001) (nonprecedential) (withdrawing appeal does not render responsive appeal un-
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`timely); Nickel v. Bank of Am. Nat’l Tr. & Sav. Ass’n, 1997 WL 419113, *3 (9th Cir.
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`July 25, 1997) (unpublished) (timeliness of motion determined under rules in effect
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`at filing); Bailey v. Sharp, 782 F.2d 1366, 1368 (7th Cir. 1986) (same).
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`2
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`(POPR), 24. Accordingly, contrary to Petitioners’ assertion, there is no “retroactiv-
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`IPR2019-00971
`U.S. Patent 9,856,287
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`ity” concern here—Petitioners simply need to wait until the PGR is completed, as
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`contemplated by the statute and rule. Petitioners’ attempt to game the system and
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`file just days before the institution decision in the PGR was due should not be re-
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`warded.
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`Discretionary Denial Is Warranted Under §314. With respect to factor 1
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`of General Plastic and Valve Corp., Petitioners admit to coordination with PGR pe-
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`titioners, but assert this is “different” from a serial filing strategy. Pap. 11, 3. How-
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`ever, Valve Corp. makes clear that, “when different petitioners challenge the same
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`patent, we consider any relationship between those petitioners when weighing the
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`General Plastic factors.” Valve Corp. v. Elec. Scripting Prods., Inc., IPR2019-
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`00062, Pap. 11, 2, 9 (Apr. 2, 2019) (precedential). Petitioners’ assertions regarding
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`the timing for its filing are entirely generic, providing no articulation for their par-
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`ticular timing here, and are thus insufficient. Juniper Networks, Inc. v. Parity Net-
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`works, LLC, IPR2018-01642, Pap. 11, 10 (Apr. 10, 2019) (General Plastic factor 5
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`weighed against institution where petitioner offered merely “generic justification”
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`for delay).
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`Petitioners cite Niantic, Inc. v. Blackbird Tech LLC, IPR2019-00489, Pap. 8,
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`9 (July 11, 2019), in arguing the Board should not exercise its discretion. But Niantic
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`concerned simultaneously filed petitions, id. 6, not follow-on petitions. And neither
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`3
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`the patent owner, petitioner, nor the Board there addressed the General Plastic fac-
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`IPR2019-00971
`U.S. Patent 9,856,287
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`tors, which that panel viewed (pre-Valve Corp.) as “generally geared” for follow-on
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`petitions. Niantic, IPR2019-00489, Pap. 8, 8. Rather, that patent owner merely ar-
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`gued the prospect of facing two petitions on the same claims would be overly bur-
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`densome, and the Board disagreed. Id. 7-9.
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`Petitioners’ also cite Moderna Therapeutics, Inc. v. Arbutus Biopharma
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`Corp., IPR2019-00554, Pap. 8, 9 (July 24, 2019), as rejecting an argument that a
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`previously filed petition on one patent warrants denial of a later-filed petition on a
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`related patent. But there, the Board rejected patent owner’s General Plastic argu-
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`ment because the IPR represented the “first challenge to the [] patent.” Id., 10. The
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`present IPR is not the first challenge to this patent. Further, Amgen relies on a pre-
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`viously-filed PGR petition on the same patent and has also cited a previously-filed
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`a petition on a similar patent further confirming that Petitioners here had previous
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`knowledge of the prior art (factor 2) and did not have a sufficient explanation for the
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`timing of their Petition (factor 5), factors which Petitioners still have not substan-
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`tively explained. See Pap. 8 (POPR), 23-31.
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`Congressional intent was clearly not to allow an IPR to proceed while a PGR
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`is pending, and Petitioners attempted to game the system here by filing their Petition
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`only days before the PGR institution decision would be known. These considera-
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`tions further support the Board denying institution.
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`4
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`Discretionary Denial Is Also Warranted Under §325(d). Petitioners belat-
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`IPR2019-00971
`U.S. Patent 9,856,287
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`edly identify a handful of supposed differences between the PGR art and arguments
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`and their own. But Petitioners ask the Board to ignore the striking similarities be-
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`tween the grounds presented in the PGR and the IPR, see POPR, Pap. 8, 10-23, ig-
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`noring that, after SAS, institution would require the Board to review all of the over-
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`lapping references and arguments. Neology, Inc. v. Star Sys. Int’l Ltd., IPR2019-
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`00367, Pap. 9, 12-13 (June 6, 2019) (denying institution under §325(d) where sub-
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`stantially the same art and arguments considered during prosecution).
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`Petitioners also assert institution of their IPR would allow the Board to ad-
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`dress the arguments regarding the ’287 in the context of “coordinated proceedings.”
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`But Petitioners provide no practical proposal for such coordination where their IPR
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`was filed almost six months after the PGR, PGR petitioners’ expert has been de-
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`posed, and Amgen’s PGR §42.220 Response was already filed.
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`Dated: September 5, 2019
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`Respectfully submitted by:
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`/Megan F. Raymond/
`J. Steven Baughman (Reg. No. 47,414)
`Paul, Weiss, Rifkind, Wharton & Garri-
`son LLP
`2001 K Street, NW
`Washington, DC 20006-1047
`P: 202-223-7340/F: 202-403-3740
`sbaughman@paulweiss.com
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`5
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`IPR2019-00971
`U.S. Patent 9,856,287
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`
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`Megan Raymond (Reg. No. 72,997)
`Paul, Weiss, Rifkind, Wharton & Garri-
`son LLP
`2001 K St. NW
`Washington, DC 20006
`Tel: (202) 223-7300
`Fax: (202) 403-3777
`mraymond@paulweiss.com
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`Attorneys For Patent Owners
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`6
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`IPR2019-00971
`U.S. Patent 9,856,287
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of PATENT OWNER’S SUR-
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`REPLY IN SUPPORT OF ITS PRELIMINARY RESPONSE has been served in
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`its entirety by causing the aforementioned document to be electronically mailed to
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`the following attorneys of record for the Petitioners listed below:
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`Petitioners’ Counsel of Record:
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`Huiya Wu (Reg. No. 44,411)
`Robert V. Cerwinski (to seek pro hac
`vice)
`Linnea Cipriano (Reg. No. 67,729)
`Goodwin Procter LLP
`620 Eighth Avenue
`New York, NY 10018
`hwu@goodwinlaw.com
`rcerwinski@goodwinlaw.com
`lcipriano@goodwinlaw.com
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`Dated: September 5, 2019
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`Respectfully Submitted,
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`/Sayem Osman/
`By:
`Sayem Osman
`
`7
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