Trials@uspto.gov
`571-272-7822
`
`Paper 11
`Entered February 14, 2019
`
`
`
`
`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 Owner.
`
`
`
`
`
`
`
`
`
`Case PGR2019-00001
`Patent No. 9,856,287 B2
`____________
`
`
`Before ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`J. JOHN LEE, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`ORDER
`
`PETITIONERS’ MOTION TO AMEND MANDATORY NOTICES
`and
`PATENT OWNER’S REQUEST FOR DISCOVERY
`
`35 U.S.C. § 322(a)(2) and 37 C.F.R. §§ 42.5, 42.8, 42.71
`
`
`571-272-7822
`
`Paper 11
`Entered February 14, 2019
`
`
`
`
`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 Owner.
`
`
`
`
`
`
`
`
`
`Case PGR2019-00001
`Patent No. 9,856,287 B2
`____________
`
`
`Before ZHENYU YANG, CHRISTOPHER G. PAULRAJ, and
`J. JOHN LEE, Administrative Patent Judges.
`
`YANG, Administrative Patent Judge.
`
`
`
`ORDER
`
`PETITIONERS’ MOTION TO AMEND MANDATORY NOTICES
`and
`PATENT OWNER’S REQUEST FOR DISCOVERY
`
`35 U.S.C. § 322(a)(2) and 37 C.F.R. §§ 42.5, 42.8, 42.71
`
`
`
`PGR2019-00001
`Patent No. 9,856,287 B2
`
`With our authorization, Adello Biologics, LLC, Apotex Inc., and
`Apotex Corp. (collectively “Petitioners”) filed a Motion to Amend
`Mandatory Notices. Paper 9 (“Mot.”). In the Motion, Petitioners seek to
`amend their mandatory notices to add Amneal Pharmaceuticals LLC
`(“Amneal LLC”) as a real party in interest (“RPI”) without altering the
`petition filing date. Id. at 1. Patent Owner opposes Petitioner’s request.
`Paper 19 (“Opp.”). Patent Owner also “requests authorization to move for
`discovery into the pertinent facts.” Id. at 7. After considering the parties’
`arguments and evidence, we grant Petitioners’ Motion and deny Patent
`Owner’s request.
`On October 1, 2018, Petitioners filed a Petition (Paper 3, “Pet.”),
`requesting a post-grant review (“PGR”) of claims 1–30 of U.S. Patent No.
`9,856,287 (“the ’287 patent”). In addition to Petitioners, the Petition also
`identified Amneal Pharmaceuticals, Inc. (“Amneal Inc.”), Apotex
`Pharmaceuticals Holdings Inc., Apotex Holdings, Inc., ApoPharma USA,
`Inc., and Intas Pharmaceuticals Limited as real parties in interest. Pet. 2.
`On January 2, 2019, Patent Owner contacted Petitioners’ counsel,
`stating that Amneal LLC also should have been named as an RPI. Ex. 2023.
`According to Petitioners, they “promptly investigated the issue, and agreed
`that Amneal LLC should have been listed as a[n] RPI.” Mot. 1. Petitioners
`assert that “there was no intentional concealment or bad faith” in the
`“inadvertent omission” of Amneal LLC as an RPI. Id. at 4.
`Noting that the RPI issue is not jurisdictional, Petitioners request that
`we exercise our discretion under 37 C.F.R. §§ 42.5(a), (b), and (c)(3) to
`allow them to amend the mandatory notices to add Amneal LLC as an RPI,
`while maintaining the current filing date. Id. at 1–6. According to
`
`
`
`2
`
`
`
`PGR2019-00001
`Patent No. 9,856,287 B2
`
`Petitioners, doing so would ensure the proper application of the statutory
`estoppel provisions, and would not prejudice Patent Owner. Id. at 3–6.
`Patent Owner responds that we should deny Petitioners’ Motion.
`Opp. 2. Patent Owner contends that 35 U.S.C. § 322(a)(2) requires
`Petitioners to identify all RPIs “when they file their petition.” Id. at 1.
`According to Patent Owner, Petitioners “were well aware of the central role
`played by the missing RPI” at the time the Petition was filed. Id. Patent
`Owner argues that the surrounding circumstances “raise[] serious questions”
`about Petitioners’ “gamesmanship or bad faith” in omitting Amneal LLC as
`an RPI. Id. at 5–6.
`We find Petitioner’s arguments more persuasive. Although we agree
`with Patent Owner that it is important for the petition to identify all RPIs, if
`a petition fails to do so, “the Director can, and does, allow the petitioner to
`add a real party in interest.” Wi-Fi One, LLC v. Broadcom Corp.,
`878 F.3d 1364, 1374 n.9 (Fed. Cir. 2018). Indeed, “the PTO has established
`procedures to rectify noncompliance” of § 322(a)(2). Id.1
`Patent Owner contends that because Petitioners did not identify all
`RPIs, they are “indisputably time-barred from bringing a PGR.”2 Opp. 1–2
`(citing 35 U.S.C. § 322(a)(2); 37 C.F.R. § 42.206(b)), 7. But neither the
`
`
`1 In Wi-Fi One, the Federal Circuit recognized that a mistake in identifying
`RPI is correctable in an inter partes review. We see no reason, nor have the
`parties identified a reason, why the same is not also true for a post-grant
`review.
`2 “A petition for a post-grant review may only be filed not later than the date
`that is 9 months after the date of the grant of the patent.” 35 U.S.C.
`§ 321(c). The ’287 patent issued on January 2, 2018 (Ex. 1001). Thus, a
`petition for a PGR of the ’287 patent must be filed no later than October 2,
`2018.
`
`3
`
`
`
`PGR2019-00001
`Patent No. 9,856,287 B2
`
`statute nor the rule governing RPI disclosures is designed to award a patent
`owner such a windfall. Instead, requiring a petition to identify all RPIs
`serves “to assist members of the Board in identifying potential conflicts, and
`to assure proper application of the statutory estoppel provisions.” Office
`Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,759 (Aug. 14, 2012).
`Here, Petitioners explain, and Patent Owner does not dispute, that
`Amneal LLC, the missing RPI, is a wholly owned subsidiary of Amneal Inc.
`Mot. 4. Because the Petition properly identified Amneal Inc. as an RPI, the
`Board was able to check for conflicts.
`Requiring a petition to identify all RPIs also protects a patent owner
`from “harassment via successive petitions by the same or related parties,”
`and prevents parties from having a “second bite at the apple.” Trial Practice
`Guide, 77 Fed. Reg. at 48,759. Allowing Petitioners to––before an
`institution decision is made––add Amneal LLC as an RPI serves exactly this
`“core function.”
`Patent Owner emphasizes that “Amneal LLC’s role and connections
`to the ’287 [patent], the accused biosimilar product and infringement
`litigation leading to this PGR, and the other named Petitioners and RPIs, was
`being actively discussed with named Petitioner Adello precisely when this
`PGR Petition was being finalized.” Opp. 4. Even so, we decline to infer, as
`Patent Owner would have us do, that the omission of Amneal LLC suggests
`“gamesmanship or bad faith.” See id. at 5–6.
`After all, by filing the Motion, Petitioners and their counsel certify
`“[a]ll statements made therein of [Petitioners’] own knowledge are true, all
`statements made therein on information and belief are believed to be true.”
`37 C.F.R. § 11.18(b)(1). Indeed, Petitioners affirm their understanding of
`
`4
`
`
`
`PGR2019-00001
`Patent No. 9,856,287 B2
`
`duty of candor and good faith to the Office during the course of a
`proceeding. Mot. 4 (citing 37 C.F.R. § 42.11(a)). And “[w]ith that
`understanding, Petitioner Adello expressly represents that there was no
`intentional concealment or bad faith in the accidental omission of Amneal
`LLC as a[n] RPI.” Id. at 4–5. Given the severe penalties imposed on one
`who knowingly and willfully falsifies or conceals a material fact (see
`37 C.F.R. § 11.18(b)(1)), we are satisfied with Adello’s express
`representation that it did not act in bad faith, or engage in gamesmanship.
`We observe that although counsel for Patent Owner in this proceeding
`overlap with those in the parallel infringement action in district court
`(compare Paper 5, with Ex. 2002, 37), Petitioners are represented by
`different counsel in the two venues (compare Paper 2, with Ex. 2018). We
`also note that on January 23, 2019, Petitioners voluntarily added Kashiv
`BioSciences, LLC as an RPI. Paper 7. To be sure, neither fact exonerates
`Petitioners from omitting Amneal LLC as an RPI in the Petition.
`Nonetheless, they suggest the omission may have been a human error, and
`Petitioners, instead of attempting to circumvent estoppel rules, are
`attempting to be diligent in updating the mandatory notices.
`In sum, Petitioners’ delay in identifying all RPIs does not result in any
`undue prejudice against Patent Owner. Allowing Petitioners to update the
`mandatory notices while maintaining the original filing date promotes the
`core functions of RPI disclosures and secures a “just, speedy, and
`inexpensive resolution” of this proceeding. See 37 C.F.R. § 42.1. Thus, we
`exercise our discretion under 37 C.F.R. § 42.5(b) to allow Petitioners to add
`Amneal LLC as an RPI while maintaining the original filing date.
`
`5
`
`
`
`PGR2019-00001
`Patent No. 9,856,287 B2
`
`In an email communication with the Board, and during the January 18
`conference, Patent Owner requested “leave to file a motion for discovery
`regarding Petitioners’ asserted position” that “the missing real party‐in‐
`interest was inadvertently omitted.” Ex. 2025. In its Opposition, Patent
`Owner states that “to the extent the Board determines further evidence is
`needed to deny this motion, Amgen again requests authorization to move for
`discovery into the pertinent facts.” Opp. 7. Given that Amneal LLC is now
`disclosed as an RPI and is subject to the relevant statutory restrictions, such
`discovery appears to have little, if any, substantive relevance, and Patent
`Owner does not provide a persuasive explanation to the contrary. Thus, we
`deny Patent Owner’s request for authorization.
`
`Accordingly, it is
`ORDERED that Petitioners’ Motion to Amend Mandatory Notices to
`add Amneal LLC as a real party in interest is granted;
`FURTHER ORDERED that the filing date of the Petition shall remain
`unchanged; and
`FURTHER ORDERED that Patent Owner’s request for authorization
`to file a motion for discovery of facts surrounding the omission of Amneal
`LLC as a real party in interest is denied.
`
`
`
`
`
`
`
`
`
`
`6
`
`
`
`PGR2019-00001
`Patent No. 9,856,287 B2
`
`PETITIONER:
`
`Teresa Rea
`trea@crowell.com
`
`Deborah Yellin
`dyellin@crowell.com
`
`Shannon Lentz
`slentz@crowell.com
`
`
`PATENT OWNER:
`
`J. Steven Baughman
`sbaughman@paulweiss.com
`GRP-AmgenPGR@paulweiss.com
`
`Megan Raymond
`mraymond@paulweiss.com
`
`Catherine Nyarady
`cnyarady@paulweiss.com
`
`Jenifer Wu
`jwu@paulweiss.com
`
`
`
`
`
`
`7
`
`
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