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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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`FRESENIUS KABI USA, LLC,
`Petitioner,
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`v.
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`NOVO NORDISK A/S,
`Patent Owner.
`______________
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`Case IPR2022-00657
`Patent 8,114,833
`______________
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`PATENT OWNER PRELIMINARY RESPONSE
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`IPR2022-00657
`Patent 8,114,833
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`TABLE OF CONTENTS
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`Page
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`I.
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`INTRODUCTION ........................................................................................... 1
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`II.
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`BACKGROUND ............................................................................................. 3
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`III. THE BOARD SHOULD DENY INSTITUTION OF PETITIONER’S
`IDENTICAL FOLLOW-ON PETITION ........................................................ 7
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`A.
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`B.
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`The Unified Patents decision demonstrates that discretionary
`denial is appropriate here ...................................................................... 9
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`The General Plastic and Valve Corp. factors support
`discretionary denial ............................................................................. 13
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`1.
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`2.
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`3.
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`4.
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`5.
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`Factor one: Petitioner challenges the same claims of
`the same patent based on the same art as its
`“competitors” Mylan and Pfizer did years ago .............. 13
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`Factor two: Petitioner knew or should have known of
`the prior art asserted in its Petition when the
`Mylan/Pfizer petition was filed in December 2019 ........ 17
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`Factor three: Petitioner had access to Patent Owner’s
`preliminary response, the Board’s institution decision,
`and many other relevant documents from the
`Mylan/Pfizer IPR before filing its petition ..................... 18
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`Factors four and five: Petitioner fails to explain when
`it first learned of the asserted art and the time lapse
`before filing its petition .................................................. 22
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`Factors six and seven: the Board’s finite resources and
`the requirement that it issue a decision within one year
`of institution support discretionary denial here .............. 26
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`IV. CONCLUSION .............................................................................................. 27
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`ii
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`CASES
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`IPR2022-00657
`Patent 8,114,833
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`TABLE OF AUTHORITIES
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`Page(s)
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`Apple Inc. v. GUI Global Prods. LTD., d/b/a Gwee,
`IPR2021-01289, Paper 11 (P.T.A.B. Feb. 4, 2022) ................................ 20, 23, 24
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`Choirock Contents Factory Co. v. Spin Master Ltd.,
`IPR2019-00900, Paper 17 (P.T.A.B. Sept. 26, 2019)....................... 20, 21, 22, 27
`
`Cuozzo Speed Techs., LLC v. Lee,
`579 U.S. 261 (2016) .............................................................................................. 7
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`Ericsson Inc. v. Uniloc 2017, LLC,
`IPR2019-01550, Paper 8 (P.T.A.B. Mar. 17, 2020) ........................................... 14
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`Facebook, Inc. v. Windy City Innovations, LLC,
`973 F.3d 1321 (Fed. Cir. 2020) .......................................................................... 21
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`General Plastic Industrial Co., Ltd. v. Canon Kabushiki Kaisha,
`IPR2016-01357, Paper 19 (P.T.A.B. Sept. 6, 2017)....................................passim
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`Google LLC v. Parus Holdings, Inc.,
`IPR2020-00846, Paper 9 (P.T.A.B. Oct. 21, 2020) ............................................ 25
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`Google LLC v. Realtime Adaptive Streaming LLC,
`IPR2019-01037, Paper 9 (P.T.A.B. Dec. 4, 2019) ....................................... 15, 25
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`Google LLC v. Uniloc 2017, LLC,
`IPR2019-01584, Paper 9 (P.T.A.B. Oct. 16, 2020) ............................................ 16
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`Harmonic Inc. v. Avid Tech, Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) ............................................................................ 7
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`Intel Corp. v. Inst. of Microelectronics, Chinese Acad. of Sci.,
`IPR2019-00834, Paper 11 (P.T.A.B. Oct. 4, 2019) ............................................ 27
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`Mylan Institutional LLC v. Novo Nordisk A/S,
`IPR2020-00324, Paper 2 (P.T.A.B. Dec. 19, 2019) ............................................. 4
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`iii
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`IPR2022-00657
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`TABLE OF AUTHORITIES
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`(continued)
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`Page(s)
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`Mylan Institutional LLC v. Novo Nordisk A/S,
`IPR2020-00324, Paper 67 (P.T.A.B. Apr. 16, 2021) ........................................... 5
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`Mylan Institutional LLC v. Novo Nordisk A/S,
`IPR2020-00324, Paper 80 (P.T.A.B. June 21, 2021) ........................................... 5
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`NetApp, Inc. v. Realtime Data LLC,
`IPR2017-01354, Paper 16 (P.T.A.B. Nov. 14, 2017) ............................. 16, 24, 27
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`Nichia Corp. v. Document Security Sys., Inc.,
`IPR2019-00398, Paper 10 (P.T.A.B. Apr. 15, 2019) ......................................... 18
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`Pfenex, Inc. v. GlaxoSmithKline Biologicals SA,
`IPR2019-01478, Paper 9 (P.T.A.B. Feb. 10, 2020) ...................................... 19, 20
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`Pfizer Inc. v. Novo Nordisk A/S,
`IPR2020-01252, Paper 2 (P.T.A.B. July 22, 2020) .............................................. 4
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`Pharmacosmos A/S v. Am. Regent, Inc.,
`IPR2019-01142, Paper 13 (P.T.A.B. Dec. 18, 2019) ......................................... 27
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`Samsung Elec. Co. v. Rembrandt Wireless Techs., LP,
`IPR2015-00114, Paper 14 (P.T.A.B. Jan. 28, 2015) ............................................ 8
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`Samsung Elecs. Am., Inc. v. Uniloc 2017 LLC,
`IPR2018-01756, Paper 7 (P.T.A.B. Mar. 26, 2019) ........................................... 13
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`Sandoz, Inc. v. Genentech, Inc.,
`IPR2017-02036, Paper 13 (P.T.A.B. Mar. 4, 2018) ........................................... 16
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`Shenzhen Silver Star Intelligent Tech. Co., Ltd., v. iRobot Corp.,
`IPR2018-00761, Paper 15 (P.T.A.B. Sept. 5, 2018)........................................... 24
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`Unified Patents Inc. v. Finjan, Inc.,
`IPR2019-01611, Paper 18 (P.T.A.B. Apr. 13, 2020) ..................................passim
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`Valve Corp. v. Elec. Scripting Prods. Inc.,
`IPR2019-00062, Paper 11 (P.T.A.B. Apr. 2, 2019) ....................................passim
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`iv
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`IPR2022-00657
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`TABLE OF AUTHORITIES
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`(continued)
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`Page(s)
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`STATUTES AND RULES
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`37 C.F.R. § 42.122(b) ................................................................................................ 4
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`35 U.S.C. § 314(a) ................................................................................................... 13
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`35 U.S.C. § 315(c) ................................................................................................... 21
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`OTHER AUTHORITIES
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`Patent Trial and Appeal Board Consolidated Trial Practice Guide
`(November 2019) ................................................................................................ 26
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`v
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`EXHIBIT
`2001
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`2002
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`2003
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`2004
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`2005
`2006
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`IPR2022-00657
`Patent 8,114,833
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`TABLE OF EXHIBITS
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`DESCRIPTION
`Declaration of Ryan P. Johnson in Support of Patent Owner’s
`Motion for Admission Pro Hac Vice of Ryan P. Johnson Under 37
`C.F.R. § 42.10(c)
`Declaration of Laura T. Moran in Support of Patent Owner’s Motion for
`Admission Pro Hac Vice of Laura T. Moran Under 37 C.F.R. § 42.10(c)
`March 13, 2012 Submission From Patent Owner to FDA Requesting
`Approved Drug Products with Therapeutic Equivalence Evaluations (the
`“Orange Book”) Listing of the ’833 patent
`Excerpt from the 2013 Annual Edition of the Approved Drug Products
`with Therapeutic Equivalence Evaluations (the “Orange Book”),
`Victoza® Listing
`European Patent 1,687,019 B1
`Fresenius Kabi Deutschland GmbH Notice of Opposition Against
`European Patent 1,687,019 B1
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`vi
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`IPR2022-00657
`Patent 8,114,833
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`Pursuant to 35 U.S.C. § 313, Patent Owner Novo Nordisk A/S (“Patent
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`Owner”), submits this Preliminary Response to Fresenius Kabi USA, LLC’s
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`(“Petitioner”) Petition for Inter Partes Review (the “Petition” or “Pet.”) of U.S.
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`Patent No. 8,114,833 (“the ’833 patent”).
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`I.
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`INTRODUCTION
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`Patent Owner respectfully requests that the Board exercise its discretion and
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`deny institution of inter partes review of the ’833 patent.
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`The Petition is essentially a word-for-word copy of two prior petitions that
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`similarly situated parties filed approximately two years ago. If Petitioner wanted to
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`make the same exact arguments as these similarly situated prior petitioners, which
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`Petitioner describes as its “competitors,” it could have and should have joined the
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`initial IPR. Indeed, the second of the two prior petitioners did just that. Instead,
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`Petitioner asks the Board (and Patent Owner) to re-do from the beginning an IPR
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`that was all but complete when it was terminated over a year ago; the only unmet
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`milestone was a final written decision. That is just the sort of inefficiency that
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`discretionary denial guards against.
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`The Petition is silent as to when Petitioner became aware of the asserted art
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`and why it waited over two years after the first petition to seek inter partes review.
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`But any suggestion that Petitioner first learned of the ’833 patent and the asserted art
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`only recently would be farfetched. The patent has been publicly listed in the FDA’s
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`“Orange Book” since 2012, putting generic drug companies like Petitioner on notice.
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`In 2018, Petitioner’s German affiliate opposed the grant of the patent’s European
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`counterpart based on the very same reference underlying all three grounds of the
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`Petition. And in 2020, the prior petitioners sought inter partes review based on the
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`same two references that Petitioner relies on. Petitioner’s silence on when it learned
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`of the asserted art and why it waited so long to file its Petition leaves the Board to
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`assume that Petitioner has been aware of those references since the first petition’s
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`filing two years ago at the very latest and has no justification for its delay. The
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`Board should not bear the brunt of Petitioner’s failure to join the prior IPR and its
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`long delay in filing this one. Nor should Patent Owner.
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`According to Petitioner, this IPR would be no burden at all—it has stuck so
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`close to the prior petitions that it would be an easy do-over. That theory belittles the
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`substantial work the Board (and patent owners) must do to adjudicate any IPR, no
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`matter how similar to prior proceedings. It is therefore no surprise that the Board
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`often exercises its discretion to deny institution of copycat petitions like Petitioner’s,
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`to avoid the improper burdens that follow-on IPRs place on the Board and repetitive
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`attacks place on patent owners.
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`A prior Board decision denying institution based on very similar facts, as well
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`as an analysis of the General Plastic/Valve Corp. factors—which Petitioner
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`improperly asks the Board to simply ignore—show that this is a clear case for
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`discretionary denial, as explained in detail below.
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`II. BACKGROUND
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`For nearly a decade, Patent Owner Novo Nordisk A/S’s ’833 patent has been
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`listed in the FDA publication, “Approved Drug Products with Therapeutic
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`Equivalence Evaluations” (the “Orange Book”) for multiple market-leading diabetes
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`and obesity therapies. EX2003 (March 13, 2012 submission from Patent Owner to
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`FDA requesting Orange Book listing of the ’833 patent); EX2004 (excerpt from the
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`2013 Annual Edition of the Orange Book showing listing of the ’833 patent). The
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`success of these therapies has attracted much interest from generic drug
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`manufacturers like Petitioner. By the time Petitioner filed its Petition, Patent Owner
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`had already sued several generic companies for infringing the ’833 patent, dating
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`back to March 2017.1
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`1 See Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc., Case No. 1:17-cv-00227
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`(D. Del); Novo Nordisk Inc. v. Mylan Institutional LLC, Case No. 19-cv-01551 (D.
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`Del.); Novo Nordisk Inc. v. Sandoz Inc., Case No. 1:20-cv-00747 (D. Del.); Novo
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`Nordisk Inc. v. Hikma Pharmaceuticals USA Inc., Case No. 1:21-cv-01783 (D. Del.);
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`Novo Nordisk Inc. v. Teva Pharmaceuticals, Inc., Case No. 1:21-cv-01782 (D. Del.).
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`3
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`One of those generic companies, Mylan Institutional LLC (“Mylan”), filed an
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`IPR challenging the ’833 patent over two-and-a-half years ago, on December 19,
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`2019. See Mylan Institutional LLC v. Novo Nordisk A/S, IPR2020-00324, Paper 2
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`(P.T.A.B. Dec. 19, 2019). After institution, Pfizer Inc. (“Pfizer”) filed an essentially
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`identical petition and requested joinder with the Mylan IPR, which the Board granted
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`on December 4, 2020. Pfizer Inc. v. Novo Nordisk A/S, IPR2020-01252, Paper 2
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`(P.T.A.B. July 22, 2020), Paper 7 at 5 (P.T.A.B. Dec. 4, 2020). Pfizer promptly
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`sought joinder within 30 days of institution2 despite never having been sued for
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`infringing the ’833 patent. Petitioner in this proceeding was in the same position as
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`Pfizer but never requested joinder.
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`Mylan and Pfizer challenged claims 1-31 of the ’833 patent based on three
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`Grounds: anticipation by “Flink” (Ground 1); obviousness over Flink (Ground 2);
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`and obviousness over Flink in view of “Betz” (Ground 3). Flink and Betz are PCT
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`publications that are publicly available and readily accessible. See EX1004 (Flink);
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`EX1005 (Betz). Because Mylan and Pfizer’s petitions are also public, their reliance
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`on Flink and Betz was known to anyone who considered their filings.
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`The parties to the Mylan/Pfizer IPR reached settlements after the oral hearing
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`but before the Board issued a Final Written Decision, leading to termination of the
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`2 See 37 C.F.R. § 42.122(b).
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`4
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`IPR. The Board terminated the IPR with respect to Mylan on April 16, 2021, and
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`with respect to Pfizer on June 21, 2021. See Mylan Institutional LLC v. Novo
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`Nordisk A/S, IPR2020-00324, Paper 67 (P.T.A.B. Apr. 16, 2021); Paper 80
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`(P.T.A.B. June 21, 2021). Given the advanced stage of the proceedings, the record
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`of the prior IPR is extensive and includes the petitions, Patent Owner’s preliminary
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`response, the Board’s institution decision, Patent Owner’s response, Mylan’s reply,
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`Patent Owner’s surreply, the transcript of the oral hearing, the parties’
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`demonstratives, and various motions and other documents.
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`The Petition in this proceeding is essentially a word-for-word copy of Mylan’s
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`and, by extension, Pfizer’s. Petitioner admits as much, asserting that it “made no
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`substantive changes to the invalidity arguments” presented previously. (Pet., 67.)
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`Petitioner even offers a redline comparing its Petition to Mylan’s, demonstrating that
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`they are substantively identical. Id. (citing EX1077).
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`Petitioner challenges the same claims of the ’833 patent as Mylan and Pfizer
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`based on the same Grounds as in Mylan and Pfizer’s petitions, relying on Flink and
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`Betz. The only sections of the instant Petition that differ from the Mylan and Pfizer
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`petitions are several short initial procedural sections—identifying counsel,
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`describing related matters, providing Mandatory Notices, etc.—and Petitioner’s
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`short argument on discretionary denial under the General Plastic and Fintiv cases.
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`5
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`(See Pet., 65-69.) Petitioner relies on the same declarant as Mylan and Pfizer, and
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`his declaration is essentially identical to those he submitted previously.
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`In addition to the Mylan/Pfizer IPR and the U.S. district court litigations
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`mentioned above, several challengers have filed unsuccessful oppositions to the ’833
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`patent’s European counterpart in the European Patent Office. EX2005 (European
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`Patent 1,687,019 B1).3 This includes Petitioner’s German affiliate, which filed an
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`opposition nearly four years ago, in August 2018. EX2006 (Fresenius Kabi
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`Deutschland GmbH Notice of Opposition Against European Patent 1,687,019 B1).
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`Petitioner’s German affiliate relied on Flink as its primary reference, as Petitioner
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`does here. EX2006 at 2-5, 7 (relying on Flink, WO 03/002136 A2, referred to as
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`“D1,” for arguments regarding lack of novelty and lack of inventive step, where
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`Flink served as the closest prior art).
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`Petitioner does not explain when it first became aware of the art it relies on or
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`why it waited nearly four years from its German affiliate’s opposition, more than
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`two years after Mylan filed its petition, and nearly a year after the Mylan/Pfizer IPR
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`3 Like the ’833 patent, EX2005 claims priority to PCT/DK2004/00792. Compare
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`EX2005 at (86) with EX1001 at (63). Both patents claim GLP-1 formulations
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`containing propylene glycol. Compare EX2005 at [0007] with EX1001 at 22:49-
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`54.
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`6
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`was terminated to file its substantially identical Petition. Left unanswered is when
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`Petitioner became aware of the Mylan petition and the art cited therein, and why,
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`unlike Pfizer, it chose not to join the Mylan IPR.
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`III. THE BOARD SHOULD DENY INSTITUTION OF PETITIONER’S
`IDENTICAL FOLLOW-ON PETITION
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`Institution of inter partes review is discretionary: “the PTO is permitted, but
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`never compelled, to institute an IPR proceeding.” Harmonic Inc. v. Avid Tech, Inc.,
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`815 F.3d 1356, 1367 (Fed. Cir. 2016); see also Cuozzo Speed Techs., LLC v. Lee,
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`579 U.S. 261, 273 (2016) (“[T]he agency’s decision to deny a petition is a matter
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`committed to the Patent Office’s discretion.”). The Board often exercises its
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`discretion to deny institution of follow-on petitions, that is, petitions challenging the
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`same patent as a prior (or parallel) proceeding. See generally General Plastic
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`Industrial Co., Ltd. v. Canon Kabushiki Kaisha, IPR2016-01357, Paper 19 at 15-16
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`(P.T.A.B. Sept. 6, 2017) (establishing factors for evaluating discretionary denial of
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`follow-on IPRs). This includes follow-on petitions filed by a different party than the
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`initial petitioner, as is the case here. Valve Corp. v. Elec. Scripting Prods. Inc.,
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`IPR2019-00062, Paper 11 at 2 (P.T.A.B. Apr. 2, 2019). A non-exhaustive list of
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`seven factors, discussed infra, guides the analysis. Valve Corp. at 8-9; see also infra
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`Section III.B.
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`Discretionary denial of follow-on petitions serves several important goals. It
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`minimizes the burdens and inefficiencies imposed on the Board by multiple petitions
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`on the same patent. General Plastic at 21 (“[M]ultiple, staggered petition filings …
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`are an inefficient use of the inter partes review process and the Board’s resources.”).
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`It ensures that the Board’s resources are focused on original petitions offering new
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`grounds, rather than follow-on petitions rehashing the same or similar issues as prior
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`petitions. Id. at 10; see also Samsung Elec. Co. v. Rembrandt Wireless Techs., LP,
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`IPR2015-00114, Paper 14 at 6-7 (P.T.A.B. Jan. 28, 2015) (“Permitting second
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`chances in cases like this one ties up the Board’s limited resources; we must be
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`mindful not only of this proceeding, but of ‘every proceeding.’”). And it prevents
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`repeated attacks on patents, which can constitute an abuse of the review process and
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`prejudice patent owners. General Plastic at 17. Follow-on petitions can be
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`especially inefficient when filed considerably later than the original, as the passage
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`of time robs the Board of any potential benefits of concurrent consideration of
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`similar issues or efficiencies associated with parallel proceedings. See Valve Corp.
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`at 15.
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`Here, Petitioner seeks to re-do the prior Mylan/Pfizer IPR. It challenges the
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`same claims, based on the same art, over two years later. Its Petition is almost word-
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`for-word identical to Mylan/Pfizer’s. And it offers no explanation for the timing of
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`its filing or its failure to join the earlier proceeding. A prior Board decision
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`addressing very similar facts, as well as an analysis of the General Plastic/Valve
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`Corp. factors, show that discretionary denial is warranted here.
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`8
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`A. The Unified Patents decision demonstrates that discretionary
`denial is appropriate here
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`The Board has previously declined to institute under circumstances very
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`similar to those here, i.e., when a new petitioner seeks to challenge the same claims
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`based on the same art as in a prior IPR. Unified Patents Inc. v. Finjan, Inc., IPR2019-
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`01611, Paper 18 (P.T.A.B. Apr. 13, 2020). In Unified Patents, a first petitioner
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`(“Blue Coat”) sought inter partes review, and a second petitioner (“FireEye”) sought
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`joinder. Id. at 7. The Board initially denied institution but, after rehearing, instituted
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`Blue Coat’s petition and joined FireEye.4 Id. at 7-8. However, Blue Coat and
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`FireEye eventually settled with the patent owner, leading the Board to terminate the
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`IPR before reaching a final written decision. Id. at 9.
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`About a year-and-a-half later, Unified Patents filed a new IPR against the
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`same patent. Id. at 1. Unified Patents challenged an almost identical set of claims,
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`based on the same prior art references as in the Blue Coat/FireEye IPR. Id. at 5, 7,
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`11-12. The Board declined to institute based on this prior history, reaching several
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`conclusions along the way that are directly relevant to this proceeding.
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`First, although Unified Patents itself had not previously challenged the patent,
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`the Board “agree[d] with Patent Owner that the similarity of the set of challenged
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`4 A third petitioner (“ESET”) later sought but was refused joinder. Unified Patents
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`at 8-9.
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`9
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`claims, which has been repeated over multiple petitions … weighs in favor of a
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`discretionary denial.” Id. at 11-12 (discussing General Plastic factor one). Here
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`too, Petitioner is new, but it challenges the same claims based on the same prior art
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`as Mylan and Pfizer did previously. Instituting a new IPR based on these old theories
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`would be wasteful and inefficient, making discretionary denial appropriate.
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`Second, the Board highlighted the “long elapse of time” between the prior
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`proceedings and Unified Patents’ petition (two years, like in this case), and the
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`“significant time” that had elapsed since Unified Patents “should have known” of
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`the asserted prior art, based on the prior proceedings. Id. at 18-19; see also id. at 13
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`(“[T]he proceedings of the Blue Coat and FireEye IPRs were public such that the art
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`relied on in the instant Petition could easily have been found through the exercise of
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`reasonable diligence.”). The Board emphasized that “[t]here is no question that
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`significant time has elapsed since the prior IPRs,” and per Valve Corp., “having
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`multiple petitions challenging the same patent, especially when not filed at or around
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`the same time as in this case, is inefficient and tends to waste resources.” Id. at 18-
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`19 (emphasis added in original). This long lapse of time between proceedings,
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`leading to a waste of Board and party resources, weighed strongly against institution.
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`Here, just as in Unified Patents, more than two years have passed since Mylan
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`filed its IPR in December 2019 (with Pfizer subsequently joining the proceeding).
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`As of that date, the art and arguments reiterated in the instant Petition were publicly
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`available for all to see (including Petitioner). This lengthy interval between the
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`advancement of essentially identical art and arguments weighs against institution.
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`As the patent owner put it in Unified Patents, “if Petitioner were truly interested in
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`filing a Petition asserting the grounds raised herein, it could have and should have
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`joined [the prior IPRs] while those cases were pending.” Id. at 17-18. For whatever
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`reason, Petitioner chose not to do so. Having made that choice, Petitioner should
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`not now put the Board and Patent Owner through the inefficient exercise of re-
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`hashing the same issues years later.
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`The Unified Patents Board was particularly critical of Unified Patents’ failure
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`to explain when it became aware of the art it relied on and why it waited so long to
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`file its petition. Unified Patents claimed it “was diligent,” and that it learned of the
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`art it relied on “upon reviewing [the challenged patent],” without specifying when
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`that occurred or elaborating on its alleged diligence. Id. at 12, 17. The Board was
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`not persuaded, finding that “the limited nature of [Unified Patents’] representations
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`… limit[ed the Board’s] ability to determine when it affirmatively knew of the prior
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`art asserted in its petition, against the backdrop of the lengthy and complex history
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`of [prior] proceedings.” Id. at 12. The Board further faulted Unified Patents for
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`“never clearly stat[ing] when it learned of the prior art it relies on” and “provid[ing
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`an] inadequate explanation for such a long elapse of time” between its petition and
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`the prior IPRs. Id. at 17, 19. All of which is equally relevant here, if not more so.
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`11
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`IPR2022-00657
`Patent 8,114,833
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`In fact, Petitioner provides even less detail on these points than in Unified Patents.
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`The Petition is silent as to when Petitioner became aware of the cited art, why it
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`waited to file when it did, and why it did not seek to join the prior proceeding.
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`Petitioner’s failure to address these issues strongly supports discretionary denial.
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`Petitioner suggests that its word-for-word copying of the prior petitions
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`absolves it of its delay and eliminates any hypothetical burden imposed on the Board
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`or prejudice to Patent Owner. (Pet., 67.) The Unified Patents Board rejected similar
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`arguments. Unified Patents at 19 (“Notwithstanding Petitioner’s assertions, we do
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`not perceive the similarity of challenges among the different proceedings as a factor
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`that mitigates the impact of a long elapse of time.”); see also infra at Section III.B.3
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`(further explaining why Petitioner’s copying of Mylan and Pfizer’s petition does not
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`support institution). The Board should reject them here as well.
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`In sum, Unified Patents is factually similar to this case and demonstrates that
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`discretionary denial is appropriate here. Petitioner seeks IPR based on the same art
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`and arguments advanced by two prior petitioners that settled with Patent Owner,
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`leading to termination of the prior IPR about a year ago. This mirrors the facts of
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`Unified Patents. Significant time has passed since the Mylan/Pfizer proceeding, yet
`
`Petitioner offers no explanation of when it learned of the relevant art and why it
`
`waited so long to seek review. The same was true in Unified Patents, where
`
`12
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`IPR2022-00657
`Patent 8,114,833
`
`petitioner’s failure to volunteer these details strongly supported discretionary denial.
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`As in that case, the Board should exercise its discretion to deny institution.
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`B.
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`The General Plastic and Valve Corp. factors support discretionary
`denial
`
`The Board considers seven “non-exhaustive” factors in deciding whether to
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`deny institution of follow-on petitions. General Plastic at 16; Valve Corp. at 8-9.
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`All seven factors support discretionary denial here.
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`1.
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`Factor one: Petitioner challenges the same claims of the same
`patent based on the same art as its “competitors” Mylan and
`Pfizer did years ago
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`There is no question that Petitioner is challenging “the same claims of the
`
`same patent” challenged in the Mylan/Pfizer IPR, as the Grounds asserted in the
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`Petition are nearly word-for-word identical to those in the prior proceeding. The
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`perfect match between the claims challenged and the art and arguments asserted here
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`and in the prior IPR supports discretionary denial. Samsung Elecs. Am., Inc. v.
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`Uniloc 2017 LLC, IPR2018-01756, Paper 7 at 11 (P.T.A.B. Mar. 26, 2019) (“[W]e
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`exercise our discretion to deny review under 35 U.S.C. § 314(a) because the same
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`or substantially the same prior art or arguments were previously presented to the
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`Board” by unrelated parties).
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`Petitioner is not the “same petitioner” as Mylan or Pfizer, but it is well-
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`established that discretionary denial is not limited to serial petitioners. Valve Corp.
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`at 9 (explaining that “application of the General Plastic factors is not limited solely
`
`13
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`IPR2022-00657
`Patent 8,114,833
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`to instances when multiple petitions are filed by the same petitioner.”) (emphasis
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`added). On the contrary, the Board has explained that “any relationship between …
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`petitioners” may be relevant under this factor and support discretionary denial. Id.
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`at 2 (emphasis added). Indeed, the Board has found that copying a prior petition can
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`create a relationship between petitioners that favors discretionary denial. Ericsson
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`Inc. v. Uniloc 2017, LLC, IPR2019-01550, Paper 8 at 11-12 (P.T.A.B. Mar. 17,
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`2020) (“We agree that, absent this petition, no such relationship … existed. We
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`determine, however, that Petitioner implicitly created such a relationship …. The
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`instant Petitioner’s decision to use the prior petitions as a roadmap for its own
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`petition ties the interests of all of the petitioners together.”). Here, Petitioner has
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`copied the substance, evidence, and even exact wording of Mylan’s and Pfizer’s
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`petitions, thus creating a relationship between the parties.
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`Moreover, Petitioner is another generic drug company that presumably seeks
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`to sell a copy of one of the drugs covered by the ’833 patent and therefore wants to
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`clear the patent from its path—just like prior petitioners Mylan and Pfizer, which are
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`Petitioner’s “competitors,” as Petitioner itself notes. (See Pet., 65 (“[T]he previous
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`petitioners are Fresenius’s competitors.”).) Petitioner’s posture is strikingly similar
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`to Pfizer’s, in that it has challenged the ’833 patent in an IPR prior to being sued for
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`infringement. Petitioner’s essentially identical commercial and legal posture and
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`motivations as the prior petitioners, coupled with its word-for-word copying of their
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`14
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`IPR2022-00657
`Patent 8,114,833
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`petitions, is relationship enough for this factor to favor discretionary denial or, at an
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`absolute minimum, come out neutral. See Unified Patents at 11-12 (finding factor
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`one neutral even where petitioner had no relationship with prior petitioners but
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`challenged the same claims based on the same prior art).
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`Petitioner cites Google LLC v. Realtime Adaptive Streaming LLC for the
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`proposition that factor one “weighs strongly against” discretionary denial here. But
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`that case is inapposite. First, the Board in Google suggested that the art and
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`arguments in the prior proceeding were different from those in the later-filed
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`petition. See id. at 19-20 (explaining that the prior IPR concerned “whether [the
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`earlier petitioner] provided a sufficient motivation to combine the two particular
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`references at issue in that proceeding,” while “the arguments [in the instant IPR] are
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`based primarily on anticipation,” making motivation to combine irrelevant). Here,
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`unlike Google, the challenged claims, asserted art, and all the arguments are identical
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`across the two proceedings. Moreover, the Board explained in Google that “Patent
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`Owner does not argue, nor do we find, any relationship between” the instant and
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`prior petitioners. IPR2019-01037, Paper 9 at 19 (P.T.A.B. Dec. 4, 2019). The
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`opposite is true here, as explained above.
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`Petitioner also contends that, because it allegedly has no relationship with the
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`prior petitioners, the Board need not even consider the other six factors. (Pet., 65-
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`66.) Petitioner is wrong. The Board has clearly explained that “consideration of the
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`15
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`IPR2022-00657
`Patent 8,114,833
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`second through the seventh [General Plastic] factors does not require a showing of
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`a specific relationship between the petitioners.” Google LLC v. Uniloc 2017, LLC,
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`IPR2019-01584, Paper 9 at 5 (P.T.A.B. Oct. 16, 2020) (emphasis added). And the
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`Board has expressly rejected the contention that factor one may be “dispositive of
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`the General Plastic analysis,” instructing instead that “each of the seven non-
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`exclusive General Plastic factors is to be considered and weighed according [to] the
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`facts of the particular case.” See NetApp, Inc. v. Realtime Data LLC, IPR2017-
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`01354, Paper 16 at 10-11 (P.T.A.B. Nov. 14, 2017). Numerous other decisions
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`confirm that the correct approach is to address all seven factors. See, e.g., Unified
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`Patents at 11-20 (considering all seven factors and denying institution despite
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