`
`PGR2019-00001
`U.S. Patent 9,856,287
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`ADELLO BIOLOGICS, LLC, APOTEX INC. and APOTEX CORP.,
`Petitioners
`
`v.
`AMGEN INC. and AMGEN MANUFACTURING, LIMITED,
`Patent Owner1
`______________________
`Case PGR2019-00001
`Patent 9,856,287
`______________________
`
`
`
`
`PATENT OWNER’S OPPOSITION TO
`PETITIONERS’ MOTION TO SUSPEND THE RULES TO MAINTAIN
`FILING DATE WHILE AMENDING ORIGINAL OCTOBER 1, 2018
`MANDATORY NOTICES
`
`
`
`
`
`
`
`
`
`
`
`
`
` 1
`
` While Petitioners listed both Amgen Inc. and Amgen Manufacturing, Limited in
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`the caption as “Patent Owner,” Amgen Manufacturing, Limited is an exclusive li-
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`censee.
`
`
`
`
`
`Exhibit
`EX2001
`
`EX2002
`
`EX2003
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`EX2004
`
`EX2005
`
`EX2006
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`EX2007
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`EX2008
`EX2009
`
`EX2010
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`EX2011
`EX2012
`EX2013
`EX2014
`
`EX2015
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`PGR2019-00001
`U.S. Patent 9,856,287
`
`LIST OF EXHIBITS
`
`
`Description
`Amgen Inc. et al. v. Adello Biologics, LLC, Case No. 2:18-cv-
`03347 (D.N.J.), DE1 (Amgen’s Complaint)
`Amgen Inc. et al. v. Adello Biologics, LLC, Case No. 2:18-cv-
`03347 (D.N.J.), DE50 (Amgen’s Amended Complaint)
`Amgen Inc. et al. v. Adello Biologics, LLC, Case No. 2:18-cv-
`03347 (D.N.J.), DE54 (Defendant Adello Biologics, LLC’s An-
`swer, Defenses and Counterclaims to Plaintiffs’ First Amended
`Complaint)
`Amgen Inc. et al. v. Adello Biologics, LLC, Case No. 2:18-cv-
`03347 (D.N.J.), DE57 (Amneal Pharmaceuticals, Inc. Proof of Ser-
`vice)
`Amgen Inc. et al. v. Adello Biologics, LLC, Case No. 2:18-cv-
`03347 (D.N.J.), DE58 (Amneal Pharmaceuticals, LLC Proof of
`Service)
`Amgen Inc. et al. v. Adello Biologics, LLC, Case No. 2:18-cv-
`03347 (D.N.J.), DE59 (Miller Appearance for Amneal Pharmaceu-
`ticals, LLC and Amneal Pharmaceuticals, Inc.)
`Amgen Inc. et al. v. Adello Biologics, LLC, Case No. 2:18-cv-
`03347 (D.N.J.), DE60 (Gabay Appearance for Amneal Pharmaceu-
`ticals, LLC and Amneal Pharmaceuticals, Inc.)
`File History of U.S. Patent 9,856,287
`Luis Felipe Vallejo & Ursula Rinas, Optimized Procedure for
`Renaturation of Recombinant Human Bone Morphogenetic Pro-
`tein-2 at High Protein Concentration, Biotechnology and Bioengi-
`neering, Vol. 85 No. 6, 601-09 (March 2004)
`Amgen Inc. et al v. Apotex Inc. et al, Case No. 0:15-cv-61631 (S.D.
`Fla.), DE250 (Day 4 Transcript of Bench Trial held on July 14,
`2016)
`Declaration of Saurabh Gupta
`Declaration of Catherine Nyarady
`Amneal Pharmaceuticals, Inc., Form S-1 (May 7, 2018)
`Amneal Pharmaceuticals LLC, M&A Call Transcript (October 17,
`2017)
`“Lenders’ Presentation” by Amneal Pharmaceuticals LLC and Im-
`pax Laboratories (March 7, 2018)
`
`
`
`
`
`Exhibit
`EX2016
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`EX2017
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`EX2018
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`EX2019
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`EX2020
`
`EX2021
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`EX2022
`EX2023
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`EX2024
`
`EX2025
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`
`
`PGR2019-00001
`U.S. Patent 9,856,287
`
`Description
`Amgen Inc. et al. v. Adello Biologics LLC, Case No. 2:18-cv-03347
`(D.N.J.), DE47 (October 1, 2018 letter to U.S. Magistrate Judge
`Mark Falk)
`Mylan Pharmaceuticals Inc. v. Yeda Research and Development
`Co. Ltd., IPR2015-00643, EX1076 (Stipulated Protective Order in
`In re Copaxone 40 mg Consolidated Cases, No. 1:14-cv-01171
`(GMS))
`Amgen Inc. et al. v. Adello Biologics, LLC, Case No. 2:18-cv-
`03347 (D.N.J.), DE70-1 (Brief in Support of Motion to Dismiss)
`Amgen Inc. v. Apotex Inc., Appeal No. 17-1010 (Fed. Cir.), DE 42-
`3 (Joint Appendix Volume III of III)
`Amgen Inc. et al v. Apotex Inc. et al, Case No. 0:15-cv-61631 (S.D.
`Fla.), DE247 (Day 1 Transcript of Bench Trial held on July 11,
`2016)
`Amgen Inc. et al v. Apotex Inc. et al, Case No. 0:15-cv-61631 (S.D.
`Fla.), DE245 (Partial Findings Regarding
`Apotex’s Assertion of Invalidity of the ’138 Patent)
`Impax Laboratories, Inc., Schedule 14A (Feb. 12, 2018)
`Emails between counsel for Petitioners and counsel for Patent
`Owners, dated January 2, January 8, January 10, and January 11,
`2019
`Email from counsel for Amgen to counsel for Petitioner Adello Bi-
`ologics, LLC, dated September 19, 2018, and attachments
`Email from counsel for Petitioners to the Board, dated January 15,
`2019
`
`
`
`
`
`
`
`
`ii
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`PGR2019-00001
`U.S. Patent 9,856,287
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`
`CASES
`Aerospace Comm’s Holdings Co. v. Armor All/Step Prods. Co.,
`IPR2016-00441, Pap.12 (June 28, 2016) .......................................................... 3, 6
`Amazon.com, Inc. v. Appistry, Inc.,
`IPR2015-00480, Pap.18 (July 13, 2015) .............................................................. 4
`Atlanta Gas Light Co. v. Bennett Regulator Guards, Inc.,
`IPR2013-00453, Pap.88 (Jan. 6, 2015) ................................................................. 7
`Cisco Sys., Inc. v. Hewlett-Packard Enter. Co.,
`IPR2017-01933, Pap.9 (Mar. 16, 2018) ............................................................... 5
`Dispersive Networks, Inc. v. Nicira, Inc.,
`PGR2018-00063, Pap.24 (Aug. 30, 2018) ............................................................ 7
`Elekta, Inc. v. Varian Medical Systems, Inc.,
`IPR2015-01401, Pap.19 (Dec. 31, 2015) .............................................................. 6
`Lumentum Holdings, Inc. v. Capella Photonics, Inc.,
`IPR2015-00739, Pap.38 (Mar. 4, 2016) ............................................................... 7
`Worlds Inc. v. Bungie, Inc.,
`903 F.3d 1237 (Fed. Cir. 2018) ............................................................................ 2
`Zoll Lifecor Corp. v. Philips Elecs. N. Am. Corp.,
`IPR2013-00606, Pap.13 (Mar. 20, 2014) ............................................................. 4
`
`
`STATUTES
`35 U.S.C. §321(c) ...................................................................................................... 7
`35 U.S.C §322(a)(2) ................................................................................................... 1
`
`
`
`iii
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`PGR2019-00001
`U.S. Patent 9,856,287
`
`
`OTHER AUTHORITIES
`37 C.F.R. §42.206(b) ............................................................................................. 1, 2
`37 C.F.R. §42.5(c)(3) ................................................................................................. 2
`
`
`iv
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`
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`The statute (§322(a)(2)) and rules (§42.206(b)) obligate petitioners to “iden-
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`PGR2019-00001
`U.S. Patent 9,856,287
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`
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`tif[y] all real parties in interest” when they file their petition—not just if and when
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`they are caught.2 Petitioners here were well aware of the central role played by the
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`missing RPI at the very time they were filing their Petition, and still refuse to pro-
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`vide the Board and Patent Owner with any explanation at all about the surrounding
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`circumstances (offering, instead, only counsel’s conclusory assertion that all is
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`well) despite being asked directly before and during the January 18 call. Thus,
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`while the Board may take petitioners at their word if no RPI issue is raised, and
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`may consider suspending the rules on a persuasive showing that the particular fac-
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`tual circumstances justify it, the Board here should follow its rules and deny Peti-
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`tioners’ unsupported request to keep its original filing date.3
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`A PGR petition “may be considered only if . . . the petition identifies all real
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`parties in interest.” §322(a)(2). “Where”—as Petitioners admit here (Mot.1;
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`EX2023; EX2012 ¶6)—“a party files an incomplete petition, no filing date will be
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` 2
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` All abbreviations are from Papers 8 and 9, all emphasis/annotations added, and
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`all statutory/regulatory citations to 35 U.S.C. or 37 C.F.R., unless otherwise stated.
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`3 Amgen would not oppose filing of a Mandatory Notice that reflects all RPIs to-
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`gether with an adjustment of the filing date as required by §42.206(b).
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`
`
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`accorded…” §42.206(b); see Worlds Inc. v. Bungie, Inc., 903 F.3d 1237, 1240
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`PGR2019-00001
`U.S. Patent 9,856,287
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`(Fed. Cir. 2018) (importance of “[c]orrectly identifying all [RPIs]”). As with the
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`prior incorrect representation that all RPIs had been fully identified (Pap.3, 2), reli-
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`ance here on attorney representations is insufficient. See Worlds, 903 F.3d at
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`1242-43, 1245-46. To support their motion to suspend the rules under §42.5(b)
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`and (c)(3), Petitioners must establish that, on the facts of this situation, it would be
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`in the interests of justice to do so. See, e.g., §42.5(c)(3); Mot.5 (citing Dispersive
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`Networks, Inc. v. Nicira, Inc., PGR2018-00063, Pap.24, 2 (Aug. 30, 2018)). Be-
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`cause Petitioners (the movants) offered only legal conclusions from PGR coun-
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`sel—not facts—and nothing at all from their common litigation counsel, they have
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`not even tried to meet that burden, and their motion must be denied. See Mot. 4-6
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`(only “expressly represent[ing] that there was no intentional concealment or bad
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`faith”; labeling as “accidental” and “inadvertent”);4 Worlds, 903 F.3d at 1242-46.
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`Petitioners’ suggestion that Amgen “has not presented any evidence suggest-
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`ing . . . intentional action or bad faith” (Mot.5) misstates the burden (absent any
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` 4
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` Petitioners’ assertion “Petitioners promptly investigated the issue, and agreed that
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`Amneal LLC should have been listed” conspicuously begs the question: Why did
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`Petitioners not investigate before filing, and, if they did, how did this occur?
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`2
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`
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`supporting evidence from Petitioners, Amgen need not prove the contrary) and is
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`PGR2019-00001
`U.S. Patent 9,856,287
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`wrong: as detailed in the January 18 call and Preliminary Response (Pap.8), even
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`the limited facts available to Amgen confirm Petitioners were aware of Amneal
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`LLC’s central importance at the very time they prepared and filed their Petition and
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`actively represented that they had identified every RPI (Pap.3, 2). Contrast, e.g.,
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`Aerospace Comm’s Holdings Co. v. Armor All/Step Prods. Co., IPR2016-00441,
`
`Pap.12 (June 28, 2016) at 4-5 (cited at Mot.4) (unlike this case, owner there “pre-
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`sented no argument or evidence calling into question Petitioner’s express represen-
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`tation”). The missing RPI, Amneal LLC, is the entity actually responsible for sell-
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`ing, marketing and pricing the proposed biosimilar product accused of infringing
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`the patent challenged here—the product of its “research partner,” Petitioner
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`Adello. See EX2013, 97, 146; EX2003, ¶19; EX2014, 5; EX2015, 20; Pap.8, 9-12.
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`Adello and other Amneal companies doing business with Amneal LLC share legal
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`and other services through AE Companies LLC (EX2022, 261), and Amneal LLC
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`and named RPI Amneal Pharmaceuticals, Inc. (“API”)—the holding company
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`combining Amneal LLC’s and Impax Laboratories, Inc.’s business (EX2013, 8-
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`9)—share the same address and representative on whom the infringement com-
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`plaint was served (EX2004-EX2007), and both appeared in that suit through the
`
`same counsel (who conspicuously makes no submission here). API is Amneal
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`LLC’s sole managing member and shares at least some (if not all) board members.
`
`3
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`
`
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`EX2013, 8-9, 16, 175-179. As Petitioners and their named RPIs were well aware
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`
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`PGR2019-00001
`U.S. Patent 9,856,287
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`when they omitted Amneal LLC from the Petition, they “have a very close parent
`
`and wholly-owned subsidiary relationship with aligned interests.” See, e.g., Zoll
`
`Lifecor Corp. v. Philips Elecs. N. Am. Corp., IPR2013-00606, Pap.13, 10 (Mar. 20,
`
`2014) (denying institution). And contrary to Petitioners’ suggestion (Mot.4),
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`merely naming a parent does not suffice. See Amazon.com, Inc. v. Appistry, Inc.,
`
`IPR2015-00480, Pap.18, 3-6 (July 13, 2015) (denying institution for failure to
`
`name corporate entities between named companies).
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`Moreover, Amneal LLC’s role and connections to the ’287, the accused bio-
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`similar product and infringement litigation leading to this PGR, and the other
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`named Petitioners and RPIs, was being actively discussed with named Petitioner
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`Adello precisely when this PGR Petition was being finalized. See Pap.8, 12-15;
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`Pet., 2; EX2001. Amgen amended its complaint to add Amneal LLC and API
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`(EX2002) after an extended meet-and-confer process in the weeks and days before
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`October 1—the same day that the Petition was filed (naming API but not Amneal
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`LLC as an RPI), and that the proposed amended complaint (naming both Amneal
`
`LLC and API as additional defendants) was sent to the District Court and Adello.
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`By then, Adello had already agreed not to oppose the amendment after receiving a
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`draft complaint 1½ weeks before Petitioners filed this Petition. See EX2016;
`
`EX2024; EX2012 ¶4. Amneal LLC’s role and significance were front-and-center
`
`4
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`
`
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`for Petitioners and their named RPIs in the period leading up to Petitioners’ Octo-
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`PGR2019-00001
`U.S. Patent 9,856,287
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`ber 1 filing.5 Indeed, the very officer signing Adello’s Power of Attorney here,
`
`Kenneth Cappel (see Pap.2, 3), was previously Vice President of Global Intellec-
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`tual Property for Amneal LLC. EX2017, 14; see also EX2022, 261.
`
`Notwithstanding this knowledge and these active discussions with Petitioner
`
`Adello before and including the day of filing, the Petitioners6 omitted Amneal LLC
`
`from their Petition, rendering it incomplete under §322(a)(2)7—and in a way that
`
`
`
` 5
`
` The significance of properly naming RPIs was also a matter of significant public
`
`discussion before October 1, including as a result of Worlds (September 7).
`
`6 As co-Petitioners, both Apotex and Adello bore the obligation to identify RPIs
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`(cf. Mot.7) and, with shared PGR counsel, were in every position to do so.
`
`7 Moreover, while the role of Amneal LLC continued to be actively litigated by Pe-
`
`titioner Adello and named RPI API, Petitioners said nothing about their omission
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`until Amgen confronted them. See, e.g., EX2023; EX2012 ¶¶3, 5-6; EX2018, 10,
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`20-21, 23; Pap.8, 14-15 n.5; Cisco Sys., Inc. v. Hewlett-Packard Enter. Co.,
`
`IPR2017-01933, Pap.9, 8-9, 13, 17 (Mar. 16, 2018) (denying institution, noting
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`“Petitioner’s failure to apprise the Board before or after the filing of the Petition”).
`
`5
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`
`
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`at minimum raises serious questions about Petitioners’ claim of mere “inad-
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`
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`PGR2019-00001
`U.S. Patent 9,856,287
`
`verten[ce],” rather than gamesmanship or bad faith (including reckless disregard of
`
`Petitioners’ obligations to investigate before making representations). Cf. Mot.5.
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`Because Petitioners have come forward with no evidence concerning the actual cir-
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`cumstances, and have refused any explanation beyond conclusory labels (Mot.5-6
`
`(“inadvertent,” “accidental”)), they cannot meet their §42.5 burden.
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`Petitioners’ arguments (Mot.3-4) about the function of §322(a)(2) and
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`§42.206(b) ignore that Amgen is not appropriately “protect[ed] from harassment” if
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`Petitioners can shift to Amgen the obligation to investigate and police Petitioners’
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`RPI violations. Indeed, even if Amneal LLC is added Petitioners offer no evidence
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`(or even assertions) that all RPIs would then be identified—and they make no
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`mention of investigating related entities like AE Companies LLC (see EX2022,
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`261; Pap.8), or others unknown to Amgen who might petition in the future. This
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`unquestionably prejudices Amgen, as does requiring Amgen to devote resources
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`(and Preliminary Response space) to addressing this issue. Cf. Mot.6. Nor do Pe-
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`titioners address the prejudice to post-AIA trials as a whole, and to all patent own-
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`ers, of requiring RPIs to be identified only when a petitioner is caught failing to do
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`so. See Petitioners’ cited decisions in Elekta, Inc. v. Varian Medical Systems, Inc.,
`
`IPR2015-01401, Pap.19 (Dec. 31, 2015) (Judge Boucher, dissenting), and Aero-
`
`space, IPR2016-00441, Pap.12, 9-10 (“we are cognizant” of concerns in Elekta
`
`6
`
`
`
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`dissent).8 And Petitioners’ arguments about being “time-barred” and prejudiced by
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`
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`PGR2019-00001
`U.S. Patent 9,856,287
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`their own actions are contradictory: Petitioners are indisputably time-barred from
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`bringing a PGR (see §321(c)) but argue they can bring an IPR instead. Mot.6.
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`Finally, to the extent the Board determines further evidence is needed to
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`deny this motion, Amgen again requests authorization to move for discovery into
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`the pertinent facts, which are uniquely in Petitioners’ possession, and reserves the
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`right to pursue this issue further. See, e.g., Atlanta Gas Light Co. v. Bennett Regu-
`
`lator Guards, Inc., IPR2013-00453, Pap.88 (Jan. 6, 2015) (vacating institution de-
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`cision and terminating review based on evidence showing failure to name RPIs).
`
`
`Respectfully submitted by:
`
`/J. Steven Baughman/
`J. Steven Baughman (Reg. No. 47,414)
`Lead Counsel For Patent Owners
`
`
`
`
`
`Dated: February 4, 2019
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` 8
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` As indicated on January 18: (1) unlike in Elekta, Amgen does not challenge “ju-
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`risdiction[]” (cf. Mot.2); and (2) Petitioners’ Lumentum case is inapposite because
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`the issue here is not “a lapse in compliance” (cf. Mot.2)—Petitioners never com-
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`plied (Lumentum Holdings, Inc. v. Capella Photonics, Inc., IPR2015-00739,
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`Pap.38, 6 (Mar. 4, 2016); see also Dispersive, PGR2018-00063, Pap.24, 1-2 (peti-
`
`tioner relying on “changed circumstances”)).
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`7
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`PGR2019-00001
`U.S. Patent 9,856,287
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of PATENT OWNER’S OP-
`
`POSITION TO PETITIONERS’ MOTION TO SUSPEND THE RULES TO
`
`MAINTAIN FILING DATE WHILE AMENDING ORIGINAL OCTOBER 1,
`
`2018 MANDATORY NOTICES has been served in its entirety by causing the
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`aforementioned document to be electronically mailed to the following attorneys of
`
`record for the Petitioner listed below:
`
`Petitioner’s Counsel of Record:
`
`Teresa Stanek Rea (Reg. No. 30,427)
`Deborah H. Yellin (Reg. No. 45,904)
`Shannon Lentz (Reg. No. 65,382)
`CROWELL & MORING LLP
`Intellectual Property Group
`1001 Pennsylvania Avenue, N.W.
`Washington, DC 20004-2595
`TRea@Crowell.com
`DYellin@Crowell.com
`SLentz@Crowell.com
`
`
`Dated: February 4, 2019
`
`
`
`
`
`
`Respectfully Submitted,
`
`/Sayem Osman/
`By:
`Sayem Osman
`
`
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