UNITED STATES PATENT AND TRADEMARK OFFICE
`______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
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`FRESENIUS KABI USA, LLC and FRESENIUS KABI SWISSBIOSIM GmbH
`Petitioners,
`v.
`AMGEN, INC. and AMGEN MANUFACTURING LIMITED
`Patent Owner
`______________
`
`Case IPR2019-00971
`Patent 9,856,287 B1
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`Title: REFOLDING PROTEINS USING A CHEMICALLY CONTROLLED
`REDOX STATE
`______________
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`PETITIONERS’ REPLY TO PATENT OWNER’S
`PRELIMINARY RESPONSE
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`______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________
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`FRESENIUS KABI USA, LLC and FRESENIUS KABI SWISSBIOSIM GmbH
`Petitioners,
`v.
`AMGEN, INC. and AMGEN MANUFACTURING LIMITED
`Patent Owner
`______________
`
`Case IPR2019-00971
`Patent 9,856,287 B1
`
`Title: REFOLDING PROTEINS USING A CHEMICALLY CONTROLLED
`REDOX STATE
`______________
`
`PETITIONERS’ REPLY TO PATENT OWNER’S
`PRELIMINARY RESPONSE
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`TABLE OF CONTENTS
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`Page
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`The Petition Is Timely .................................................................................... 1
`I.
`II. Discretionary Denial Is Unwarranted Under §§ 314(a) and 325(d) ............... 3
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`-i-
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`TABLE OF AUTHORITIES
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` Page(s)
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`Cases
`Antonious v. Spalding & Evenflo Cos., Inc.,
`10 F. App’x 801 (Fed. Cir. 2001) ......................................................................... 2
`Bailey v. Sharp,
`782 F.2d 1366 (7th Cir. 1986) .............................................................................. 2
`Hospira, Inc. v. Genentech, Inc.,
`IPR2017-00739, Paper 16 (July 27, 2017) ........................................................... 4
`Intex Recreation Corp. v. Team Worldwide Corp.,
`IPR2019-00245, Paper 7 (May 15, 2019) ......................................................... 1, 2
`King Pharm., Inc. v. Eon Labs, Inc.,
`616 F.3d 1267 (Fed. Cir. 2010) ............................................................................ 4
`Moderna Therapeutics, Inc. v. Arbutus Biopharma Corp.,
`IPR2019-00554, Paper 8 (July 24, 2019) ............................................................. 5
`Niantic, Inc. v. Blackbird Tech.,
`IPR2019-00489, Paper 8 (July 11, 2019) ............................................................. 5
`Nickel v. Bank of Am. Nat. Tr. & Sav. Ass’n,
`119 F.3d 6 (9th Cir. 1997) .................................................................................... 2
`Samsung Elec. Am., Inc. v. Uniloc Luxembourg S.A.,
`IPR2017-01801, Paper 8 (Feb. 6, 2018) ............................................................... 3
`Valve Corp. v. Elec. Scripting Prods. Inc.,
`IPR2019-00062, Paper 13 (April 2, 2019) ........................................................... 3
`Statutes
`35 U.S.C. § 311(c) ................................................................................................. 1, 2
`35 U.S.C. § 314(a) ................................................................................................. 1, 3
`35 U.S.C. § 325(d) ................................................................................................. 1, 4
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`ii
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`Other Authorities
`37 C.F.R. § 42.102(a) ................................................................................................. 1
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`iii
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`The Board’s institution of post-grant review on Adello’s petition (PGR2019-
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`000001) neither requires nor warrants denial of this Petition for inter partes review.
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`The Petition was timely filed, and the parallel proceedings do not raise the core
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`concerns supporting discretionary denial of institution under §§ 314(a) and 325(d).
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`I.
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`The Petition Is Timely
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`35 U.S.C. § 311(c) and 37 C.F.R. § 42.102(a) provide that a petition for IPR
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`may be filed after the later of “the date that is 9 months after the grant of the
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`patent” or “if a post-grant review is instituted …, the date of the termination of
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`such post-grant review.” The Petition was filed on April 14, 2019. There is no
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`dispute that on that day, no PGR had been instituted, so the PGR bar did not apply.
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`The Petition was thus timely because it was filed more than nine months after the
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`’287 patent issued on February 1, 2017, and no other time bar was applicable.
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`Against this plain application of text to facts, Amgen asserts that the
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`subsequent institution of Adello’s PGR has rendered the Petition untimely. In
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`support, Amgen relies on the Board’s denial of institution in Intex Recreation
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`Corp., v. Team Worldwide Corp., IPR2019-00245, Paper 7 (May 15, 2019). But
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`Intex’s petition was untimely when filed “because it was filed less than nine
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`months from the issue date” of the challenged patent. Id. at 10. Although the
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`Board noted that an IPR “may not be filed until … [the pending PGR] is
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`completed,” the Board did not rely on the PGR as a basis for finding a previously
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`1
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`timely petition untimely; it merely recognized that a new IPR could no longer be
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`filed because the PGR had since been instituted. Id.
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`Had Congress intended to bar filing of IPRs before institution of a related
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`PGR, it would have replaced the word “instituted” in § 311(c)(2) with the word
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`“filed.” Neither Amgen nor Petitioners have identified a single decision construing
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`the words “is instituted” to operate retroactively. To the contrary, courts have
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`repeatedly rejected arguments that the timeliness of a filing was altered by
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`subsequent events. See Antonious v. Spalding & Evenflo Cos., Inc., 10 F. App’x
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`801, 802–03 (Fed. Cir. 2001) (“Spalding cannot, ex post facto, make [other
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`appellant’s] appeal untimely by withdrawing its appeal.”); Nickel v. Bank of Am.
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`Nat. Tr. & Sav. Ass’n, No. 96-16497, 1997 WL 419113, at *3 (9th Cir. 1997)
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`(rejecting the “novel proposition” that the court “should review the timeliness
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`ruling as of the time of this appeal, rather than considering whether the motion was
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`timely when it was filed”); Bailey v. Sharp, 782 F.2d 1366, 1368 (7th Cir. 1986)
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`(“It would be unfortunate if parties were never sure which court had jurisdiction
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`because of the possibility that the time schedules would be changed at a later
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`date…. [T]he timeliness of a motion must be determined by the timetables in effect
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`when the motion was filed”). Such retroactivity—and resulting uncertainty—
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`would be particularly prejudicial in the IPR context for Petitioners and future
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`challengers in light of the substantial upfront investment required for preparation
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`2
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`of each petition and the competing statutory deadlines on AIA petitions. For these
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`reasons, the Board should reject Amgen’s contention that the Petition is untimely.
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`II. Discretionary Denial Is Unwarranted Under §§ 314(a) and 325(d)
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`“The discretion to deny petitions is for the panel to wield under certain
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`conditions, but not in every situation where a Patent Owner complains of repeated
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`challenges against its patents.” Samsung Elec. Am., Inc. v. Uniloc Luxembourg
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`S.A., IPR2017-01801, Paper 8 at 26 (Feb. 6, 2018). Here, denial of institution is
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`not warranted under § 314(a) because the Petition was not submitted as part of
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`either a jointly orchestrated series of filings or a unilateral attempt to use Adello’s
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`proceedings as a roadmap. C.f. Valve Corp. v. Elec. Scripting Prods. Inc.,
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`IPR2019-00062, Paper 13 at 9-13 (April 2, 2019) (Precedential). This is
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`Petitioners’ first petition against any claim of the ’287 patent or any related
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`patents, and the Petition was drafted and filed independently of Adello. The
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`parties were not joint defendants in related litigation, nor were they otherwise
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`affiliated. While Petitioners’ counsel attended PO’s deposition of Adello’s expert,
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`such coordination efforts in ongoing proceedings are not akin to a serial filing
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`strategy because they promote rather than obstruct the fair and efficient use of the
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`Board’s and the parties’ resources. To this end, Petitioners and Adello are willing
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`to coordinate this IPR with the instituted PGR, including by expediting Petitioners’
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`briefing and discovery, to facilitate joint consideration by the Board.
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`3
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`Moreover, the lapse in time between the Petition and Adello’s petition does
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`not show lack of diligence or deliberate delay. Petitioners were not engaged in
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`litigation over the ’287 patent and had no reason to assess invalidity positions any
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`earlier. While Petitioners could have waited for the outcome of Adello’s PGR,
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`they elected to file their Petition without the benefit of any decision from the
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`Board, so they could be heard in a timely manner.
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`For similar reasons, denial of institution is not warranted under § 325(d)
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`because Petitioners’ interest in a fair opportunity to be heard is not outweighed by
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`the additional “resources of the Office” required for institution or by PO’s interest
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`in “quiet title” over its patent. C.f. Hospira, Inc. v. Genentech, Inc., IPR2017-
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`00739, Paper 16 at 18 (July 27, 2017) (informative). Petitioners seek to present at
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`least the following arguments not presented by Adello: (1) obviousness in view of
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`Schafer and Gilbert which illustrate the basic derivation of the allegedly novel
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`thiol-pair ratio (“TPR”) and buffer strength (“TPBS”) equations from general
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`redox chemistry principles (Pet. 55, 59-60, 62; Ex. 1002 ¶¶ 71, 207-215); (2)
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`anticipation by Ruddon (Pet. 38-46); (3) calculations of the TPR and TPBS of
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`refold solutions in Vallejo based on actual concentrations of GSH and GSSG (Pet.
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`27-30; Ex. 1002 ¶¶ 125-129); (4) anticipation of the “is calculated” limitation in
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`dependent claims 8, 9, 14-15, 23-25, and 30 under the “new and unobvious
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`functional relationship” standard articulated in King Pharm., Inc. v. Eon Labs, Inc.,
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`4
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`616 F.3d 1267, 1278-79 (Fed. Cir. 2010) (Pet. 34).
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`Institution of IPR allows the Board to address these arguments in the context
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`of coordinated proceedings. Moreover, because the Board’s jurisdiction to address
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`the merits of Adello’s prior art challenges is contingent on the AIA status of the
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`’287 patent (an issue Amgen continues to contest), institution of parallel IPR and
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`PGR proceedings would allow the Board to avoid wasting the resources expended
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`in considering the teachings of the Vallejo and Ruddon references should the
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`Board ultimately conclude that the ’287 patent is not subject to PGR review.
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`Furthermore, unlike arguments considered and rejected during prosecution
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`or terminated proceedings, Amgen has no expectation of “repose” with respect to
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`art and arguments pending in Adello’s PGR.1 The Board has rejected the
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`contention that “defending two concurrent challenges is so unfair, abusive, or
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`unduly burdensome for Patent Owner that discretionary denial is warranted.”
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`Niantic, Inc. v. Blackbird Tech. LLC, IPR2019-00489, Paper 8 at 9 (July 11, 2019).
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`For these reasons, and those presented in the Petition, institution should be granted.
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`1 The Board also recently rejected the argument, advanced by Amgen, that a
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`Petition against one patent (i.e. the ’138 patent) warrants denying IPR institution
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`on a related patent. Moderna Therapeutics, Inc. v. Arbutus Biopharma Corp.,
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`IPR2019-00554, Paper 8 at 9 (July 24, 2019).
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`5
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`Dated: August 22, 2019 Respectfully submitted,
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`/Huiya Wu/
`Huiya Wu (Reg. No. 44,411)
`Goodwin Procter LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018
`Tel: 212-813-8800
`Fax: 212-355-3333
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`Counsel for Petitioners Fresenius Kabi USA,
`LLC and Fresenius Kabi SwissBioSIM
`GmBH
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`6
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that, on August 22, 2019, a copy of the
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`foregoing Petitioner’s Reply to Patent Owner’s Preliminary Response was served
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`on the counsel of record for the Patent Owner by filing the same through the PTAB
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`E2E System as well as delivering a copy via electronic mail to the following
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`addresses:
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`Lead Counsel
`J. Steven Baughman (Reg. No. 47,414)
`PAUL, WEISS, RIFKIND, WHARTON & GARRISON LLP
`2001 K St. NW
`Washington, DC 20006
`Tel: (202) 223-7300
`Fax: (202) 403-3740
`sbaughman@paulweiss.com
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`Backup Counsel
`Megan Raymond (Reg. No. 72,997)
`PAUL, WEISS, RIFKIND, WHARTON & GARRISON LLP
`2001 K St. NW
`Washington, DC 20006
`Tel: (202) 223-7300
`Fax: (202) 403-3777
`mraymond@paulweiss.com
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`Catherine Nyarady (Reg. No. 42,042)
`Paul, Weiss, Rifkind, Wharton & Garrison LLP
`1285 Avenue of the Americas
`New York, NY 11019
`Tel: 212-373-3532
`Fax: 212-492-0532
`cnyarady@paulweiss.com
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`7
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`Dated: August 22, 2019
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`/s/ Huiya Wu
` Huiya Wu
` Registration No. 44411
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`8
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