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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`_______________________________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`_______________________________
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`ADELLO BIOLOGICS LLC, APOTEX INC. and APOTEX CORP.
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`Petitioners
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`v.
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`AMGEN INC. and AMGEN MANUFACTURING LIMITED
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`Patent Owners
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`____________________
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`PGR2019-00001
`Patent No. 9,856,287
`____________________
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`PETITIONERS’ MOTION TO AMEND MANDATORY NOTICES AND
`MAINTAIN THE CURRENT FILING DATE AND SCHEDULE
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`
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`Petitioners move to amend their mandatory notices to identify Amneal
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`Pharmaceuticals LLC (“Amneal LLC”) as a real party-in-interest (“RPI”) without
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`altering the October 1, 2018 petition filing date. On January 2, 2019, Patent Owner
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`contacted Petitioners’ counsel by email, noting that Amneal Pharmaceuticals, Inc.
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`(“Amneal Inc.”) was listed as a RPI and questioning whether Amneal LLC also
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`should have been named. Petitioners promptly investigated the issue, and agreed
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`that Amneal LLC should have been listed as a RPI. Petitioners informed Patent
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`Owner that they intended to approach the Board to seek permission to amend the
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`RPI listing. Ex. 2023, Ex. 2025. In a January 18, 2019 conference call, the Board
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`heard the parties’ positions and ordered this motion and a response.
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`I.
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`The Board Should Allow Petitioners to Amend the RPI Listing While
`Maintaining the Original Filing Date.
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`The Federal Circuit has noted that the real party-in-interest requirement of
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`35 U.S.C. § 312(a) is “correctable.” WiFi One v. Broadcom Corp., 878 F.3d
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`1364, 1374, n.9 (Fed. Cir. 2018). The Board has the authority to grant Petitioners
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`leave to file an amended mandatory notice and the discretion to maintain the
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`original filing date. Lumentum Holdings, Inc. v. Capella Photonics, Inc.,
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`IPR2015-00739, Paper 38; Elekta, Inc. v, Varian Med. Sys., Inc., IPR 2015-01404,
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`Paper 19. Indeed, the Board has exercised that authority and discretion on facts similar
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`to those presented here. Id.; see also Dispersive Networks Inc. v. Nicira. Inc. and
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`VMware, Inc., LLC, PGR2018-00063, Paper 24, at 2 (allowing petitioner to
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`1
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`
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`update its mandatory notice and amend its RPI disclosure to add wholly owned
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`subsidiary without changing the filing date).
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`A.
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`35 U.S.C. § 312(a) and 37 C.F.R. § 42 allow amendment of the RPI
`disclosure while maintaining Petitioner’s original filing date.
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`35 U.S.C. § 312(a) sets forth requirements that must be satisfied for the
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`Board to give consideration to a petition, including the identification of all real
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`parties in interest. §§ 312(a)(1), (2). In Lumentum—a precedential decision—the
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`Board addressed § 312(a) and allowed the petitioner to amend the real parties-in-
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`interest. Lumentum at 3-5. The Board found that while Ҥ 312(a) sets forth
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`requirements that must be satisfied for the Board to give consideration to a
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`petition, . . . a lapse in compliance with those requirements does not deprive the
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`Board of jurisdiction over the proceeding, or preclude the Board from permitting
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`such lapse to be rectified.” Id.
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`Lumentum relied heavily on Elekta, in which the Board “exercise[d] [its]
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`discretion to maintain the Petition’s original filing date despite Petitioner’s amended
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`RPI disclosure.” Elekta at 6. In so holding, the Board in Elekta, as in Lumentum,
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`made clear that § 312(a) is not jurisdictional. Id. at 6-7. See also Wi-Fi One, LLC v.
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`Broadcom Corp., 878 F.3d 1364, 1374 n.9 (Fed. Cir. 2018) (“[I]f a petition fails to
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`identify all real parties in interest under § 312(a)(2), the Director can, and does,
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`allow the petitioner to add a real party in interest” using “established [PTO]
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`procedures.”)
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`2
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`
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`Additionally, “Section 42.106 does not foreclose the Board’s discretion to
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`maintain a petition’s original filing date when a party amends its RPI disclosures
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`because, under § 42.5(b), ‘[t]he Board may waive or suspend’ § 42.106’s filing
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`date provisions.” Elekta at 8; Dispersive Networks Inc. v. Nicira. Inc. and
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`VMware, Inc., LLC, PGR2018-00063, Paper 24, at 2. Indeed, in Elekta and
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`Dispersive Networks the Board maintained the petition’s original filing date and
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`allowed the petitioner to amend the mandatory notice and add RPIs based on
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`§ 42.5(b). Id. at 8-10; Id. at 3. See also 77 Fed. Reg. 48,612, 616 (§ 42.5(a) and
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`(b); Lumentum at 7 (§ 42.5(c)(3) “provid[es] the Board discretion to permit late-
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`filing of the updated mandatory notice.”). The board therefore has authority to
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`provide the relief sought here.
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`B. Allowing amendment to the RPI disclosures here is consistent
`with the core function of the RPI Requirement.
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`The Trial Practice Guide describes the core functions of the RPI requirement
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`as
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`
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`to assist members of the Board in identifying potential conflicts,
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`and
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`to assure proper application of
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`the statutory estoppel
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`provisions. The latter, in turn, seeks to protect patent owners from
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`harassment via successive petitions by the same or related parties, to
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`prevent parties from having a “second bite at the apple,” and to
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`protect the integrity of both the USPTO and Federal Courts by
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`assuring that all issues are promptly raised and vetted.
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`3
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`
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`Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,759 (Aug. 14, 2012).
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`Here, Petitioners’ delay in identifying Amneal LLC, a wholly-owned subsidiary of
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`Amneal Inc., as an RPI “has no negative impact on the ‘core functions’ of the RPI
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`requirement as outlined in Our Trial Practice Guide.” See Elekta at 9. (citing 37
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`C.F.R. § 42.1); Dispersive Networks Inc. v. Nicira. Inc. and VMware, Inc., LLC,
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`PGR2018-00063, Paper 24, at 3. First, Petitioners’ identification of the parent
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`company, Amneal Inc., as an RPI provided sufficient notice to the Board to enable
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`it to identify potential conflicts. Nor has the inadvertent omission of Amneal LLC
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`resulted in successive petitions by the same or related parties. Rather, allowing
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`Petitioners to update the notice now – before any institution decision is made – will
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`clarify that both Amneal Inc. and Amneal LLC will be bound by any estoppel
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`effect flowing from this proceeding.
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`1.
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`There is no evidence here of bad faith or intentional
`concealment by Petitioner.
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`Petitioners understand that parties and individuals involved in proceedings
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`before the Office have a “duty of candor and good faith.” 37. C.F.R. §42.11(a);
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`Aerospace Commc’ns v. The Armor All Products Co., IPR2016-00441, 442, Paper
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`12 at 4. With that understanding, Petitioner Adello expressly represents that there
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`was no intentional concealment or bad faith in its accidental omission of Amneal
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`4
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`
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`LLC as a RPI.1 While Adello was aware of the existence of Amneal LLC at the
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`time of the filing, its failure to list Amneal LLC as an RPI was entirely inadvertent.
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`Nor can Patent Owner present any arguments to the contrary. Patent Owner has
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`not presented any evidence suggesting that there was intentional action or bad faith
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`on the part of Petitioner Adello in failing to name Adello LLC as an RPI. Absent
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`any evidence of bad faith,, the Board can “take petitioner at its word” and weigh
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`any comments presented by Patent Owner against Petitioner Adello’s express
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`representation. See id. 12 at 4.
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`Dispersive Networks Inc. v. Nicira. Inc. and VMware, Inc., LLC is
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`instructive in these circumstances. There, the PTAB, after citing Elekta and
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`Lumentum for its authority to allow a petitioner to amend its RPI disclosures
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`without changing the filing date, found that permitting the [PGR] petitioner to
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`add a party to its RPI disclosures was “in the interest of justice”. PGR2018-
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`00063, Paper 24, at 2. The PTAB noted that there was “no indication of
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`intentional concealment or any other bad faith in Petitioners delay in identifying
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`Dispersive Technologies, Inc. as an additional RPI” and that “[t]here is also no
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`indication of material benefit to Dispersive Networks, Inc. as a result of the
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`1 There is no allegation that co-petitioner Apotex was aware of or should
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`have been aware of Amneal LLC.
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`5
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`
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`delay, or negative effect on Patent Owner’s ability to challenge the Petition”.
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`Id. at 2-3. On the other hand, the Board found that the potential prejudice to
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`petitioner who would be outside the 9 month period for filing a PGR if a new
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`filing date was accorded would be “drastic”. Id. at 3.
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`2.
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`Permitting Petitioners to amend the mandatory notices and
`maintaining the current filing date will not prejudice Patent
`Owner.
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`Granting the relief Petitioners seek will not prejudice Patent Owner or
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`materially benefit Petitioners. On the contrary, adding Amneal LLC as a RPI will
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`fairly ensure that Amneal LLC is also subject to estoppel. This is not a case of an
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`unknown party from whom Patent Owner was deprived of needed discovery.
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`Patent Owner was aware of Amneal LLC prior to the filing of this PGR, and has
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`requested and received discovery about Amneal LLC in the co-pending litigation .
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`See, e.g. POPR at 13; Ex. 2024 (Amgen’s September 19, 2018 email regarding a
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`proposed amended complaint identifying Amneal LLC and Amneal Inc.)2
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`2 Nor is this the case of a time-barred party who would have triggered
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`estoppel if identified in the original petition. If the Board declines Petitioners’
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`request to amend, this PGR could be refiled as an IPR, in which case the time bar
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`of § 315 does not attach here until March 12, 2019. Refiling as an IPR would have
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`benefits and detriments to both Petitioners and Patent Owner. For example, an IPR
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`(Continued...)
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`6
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`3.
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`Denying Petitioners’ motion will prejudice Petitioners.
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`Denying Petitioner’s Motion will result in Petitioners’ corrected Petition
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`receiving a new filing date that would fall outside the nine-month time bar for
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`filing a PGR under 35 U.S.C. § 321(c). Depriving Petitioners of their chance to
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`pursue a PGR is a “drastic result” that does not balance the interests of justice.
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`Dispersive Networks Inc at 3. This is especially true with respect to Petitioner
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`Apotex who should not be precluded from making its PGR filing based on the
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`inadvertent mistake of its co-Petitioner.
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`II. CONCLUSION
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`For the foregoing reasons, Petitioners respectfully requests that the Board
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`authorize them to submit an amended mandatory notice identifying Amneal LLC
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`as a real party-in-interest, without altering the filing date.
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`
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`Date: January 28, 2019
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`Respectfully submitted,
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`/Teresa Stanek Rea/
`Teresa Stanek Rea (Reg. No. 30,427)
`CROWELL & MORING LLP
`Intellectual Property Group
`1001 Pennsylvania Ave, NW
`Washington, DC 20004-2595
`
`
`________________________
`is limited to prior art attacks, while the scope of a PGR is broader. 35 U.S.C.
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`§§311(b) and 321(b). But the threshold standard of review for a PGR is more
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`stringent than that of an IPR. 35 U.S.C. §§314(b) and 324(b).
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`7
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`CERTIFICATE OF SERVICE
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`The undersigned certifies that on the date indicated below a copy of the
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`foregoing PETITIONERS’ MOTION TO AMEND MANDATORY NOTICES
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`AND MAINTAIN THE CURRENT FILING DATE AND SCHEDULE
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`was served electronically by filing this document through the PTAB E2E System,
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`as well as by e-mailing copies to the following counsel of record for Patent Owner:
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`J. Steven Baughman
`sbaughman@paulweiss.com
`GRP-AmgenPGR@paulweiss.com
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`Megan Raymond
`mraymond@paulweiss.com
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`Catherine Nyarady
`cnyarady@paulweiss.com
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`Jennifer Wu
`jwu@paulweiss.com
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`Date: January 28, 2019
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`Respectfully submitted,
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`/Deborah Yellin/
`Deborah Yellin
`Reg. No. 45,904
`CROWELL & MORING LLP
`Intellectual Property Group
`1001 Pennsylvania Ave, NW
`Washington, DC 20004-2595
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`8
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`
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