Trials@uspto.gov
`Tel: 571-272-7822
`
`
`Paper 9
`Entered: March 1, 2019
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`____________
`
`Case IPR2019-00207
`Patent 9,517,219 B2
`____________
`
`
`
`Before SUSAN L. C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`ORDER
`Authorizing Reply to Preliminary Response to Petitioners
`and Sur-reply to Patent Owner
`37 C.F.R. § 42.108(c)
`
`
`
`
`
`
`Tel: 571-272-7822
`
`
`Paper 9
`Entered: March 1, 2019
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`AMNEAL PHARMACEUTICALS LLC and AMNEAL
`PHARMACEUTICALS OF NEW YORK, LLC
`Petitioners,
`
`v.
`
`ALMIRALL, LLC,
`Patent Owner.
`____________
`
`Case IPR2019-00207
`Patent 9,517,219 B2
`____________
`
`
`
`Before SUSAN L. C. MITCHELL, CHRISTOPHER G. PAULRAJ, and
`RYAN H. FLAX, Administrative Patent Judges.
`
`FLAX, Administrative Patent Judge.
`
`
`
`
`ORDER
`Authorizing Reply to Preliminary Response to Petitioners
`and Sur-reply to Patent Owner
`37 C.F.R. § 42.108(c)
`
`
`
`
`
`
`
`IPR2019-00207
`Patent US 9,517,219 B2
`
`
`
`A conference call was held on February 27, 2019, between counsels
`for Petitioners and Patent Owner in the above-captioned Inter Partes Review
`(IPR). The conference call was requested by Petitioners by email to the
`Board on February 25, 2019, to discuss Petitioners’ request to file a Reply
`responsive to Patent Owner’s Preliminary Response (Paper No. 8) as it
`relates to 35 U.S.C. § 314(a) and 35 U.S.C. § 325(d). Patent Owner opposed
`the conference call as unnecessary, but nonetheless participated.
`In the above-referenced email, and as reiterated by Petitioners during
`the conference call, Petitioners seek to respond to contentions in Patent
`Owner’s Preliminary Response concerning certain alleged admissions in the
`Petition that Petitioners’ duty of candor obligates Petitioners to correct.
`Further, Petitioners also contend in the email, and reiterated at the
`conference call, that the Petition did not (preemptively) address the
`contentions in the Preliminary Response relating to § 314(a) and § 325(d)
`because Petitioners could not reasonably have anticipated such contentions.
`Petitioners request the opportunity to submit a Reply to the Preliminary
`Response addressing these issues.
`Patent Owner opposes Petitioners’ request for such a Reply, at least in
`part, to prevent Petitioners’ supplementation of the Petition.
`“A petitioner may seek leave to file a reply to the preliminary
`response in accordance with [37 C.F.R.] §§ 42.23 and 42.24(c). Any such
`request must make a showing of good cause.” 37 C.F.R. § 42.108(c). A
`denial of institution in an IPR under § 314(a) and/or § 325(d), for which
`Patent Owner argued in the Preliminary Response, concludes the case,
`generally, on the basis of redundancy and unfairness. We have the
`
`2
`
`
`
`IPR2019-00207
`Patent US 9,517,219 B2
`
`
`discretion to deny institution under either statutory basis. For a discretionary
`denial under § 314(a), such redundancy can take the form of substantial
`similarities between the patents, prior art, and grounds for unpatentability
`asserted in a second-petitioned IPR and those asserted in a first-petitioned
`IPR, and the unfairness is based upon potential tactical advantages afforded
`a petitioner and burden on a patent owner and the Board. See General
`Plastics Industrial Co. v. Canon Kabushika Kaisha, Case IPR2016-01357,
`Paper No. 19, slip op. 9–10 (PTAB Sept. 6, 2017) (precedential) (identifying
`factors to be considered under § 314(a)). For a discretionary denial under
`§ 325(d), such redundancy and unfairness may result from an overlap
`between the prior art and grounds asserted in an IPR petition and the prior
`art and arguments previously considered by the Office. See Becton,
`Dickinson & Co. v. B. Braun Melsungen AG, Case IPR2017-01586, Paper
`No. 8, slip. op. 17–18 (PTAB Dec. 15, 2017) (informative) (identifying
`factors to be considered under § 325(d)).
`In the Petition, Petitioners devoted about a page and a half to their
`position that there is no basis to deny the Petition under § 314(a) or § 325(d).
`Petition (Paper No. 3), 63–64. Patent Owner, however, devoted the entirety
`of its Preliminary Response to argue that institution should be denied under
`§ 314(a) and § 325(d). See generally Paper No. 8. Petitioners contend that,
`based on the facts of this case, they could not have reasonably foreseen
`arguments from Patent Owner on § 314(a) and § 325(d) so as to have
`addressed them in the Petition, but having now considered Patent Owner’s
`arguments thereon, Petitioners dispute that the necessary similarities and
`overlaps (redundancies) exist here for § 314(a) and/or § 325(d) to apply in
`
`3
`
`
`
`IPR2019-00207
`Patent US 9,517,219 B2
`
`
`this case. If Petitioners indeed could not have reasonably foreseen Patent
`Owner’s allegations under § 314(a) and § 325(d) as presented in the
`Preliminary Response, Petitioners should have an opportunity to respond.
`We find no basis to conclude that Petitioners could have reasonably
`anticipated the specific arguments made by Patent Owner in the Preliminary
`Response. We, therefore, conclude that Petitioners contentions of surprise
`provide a sufficient showing of good cause for granting authorization to file
`a Reply in this case. During the conference call, Petitioners did not oppose a
`Sur-reply for Patent Owner in the event a Reply was authorized.
`Accordingly, it is:
`ORDERED that Petitioners are granted permission to file a Reply of
`no more than ten (10) pages, within five (5) business days after issuance of
`this Order, responsive to the allegations under 35 U.S.C. § 314(a) and
`35 U.S.C. § 325(d) as set forth in Patent Owner’s Preliminary Response.
`The Reply Brief may also address any necessary corrections regarding any
`alleged admissions by Petitioners alleged in the Preliminary Response.
`FURTHER ORDERED that following Petitioners’ filing of the
`aforementioned Reply, Patent Owner is granted permission to file a
`Sur-reply of no more than five (5) pages, within five (5) business days. The
`Sur-reply should address only issues addressed in the Reply.
`
`
`
`
`
`
`4
`
`
`
`IPR2019-00207
`Patent US 9,517,219 B2
`
`
`FOR PETITIONERS:
`
`Dennies Varughese
`Adam C. LaRock
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`dvarughe-PTAB@skgf.com
`alarock-PTAB@skgf.com
`PTAB@skgf.com.
`
`
`
`FOR PATENT OWNER:
`
`James Trainor
`FENWICK & WEST LLP
`jtrainor@fenwick.com
`
`5
`
`
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