Trials@uspto.gov
`571-272-7822
`
`
`Paper 107
`Entered: April 13, 2022
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`LABORATOIRE FRANCAIS DU FRANCTIONNEMENT ET DES
`BIOTECHNOLOGIES S.A.,
`Petitioner,
`v.
`NOVO NORDISK HEALTHCARE AG,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`IPR2017-00028
`Patent 9,102,762 B2
`
`Before ERICA A. FRANKLIN, SUSAN L. C. MITCHELL, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`MITCHELL, Administrative Patent Judge.
`
`
`ORDER
`Denying Petitioner’s Motion to Terminate, Dismiss, and Vacate
`37 C.F.R. §§ 42.71 and 42.72
`
`
`
`
`
`571-272-7822
`
`
`Paper 107
`Entered: April 13, 2022
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`LABORATOIRE FRANCAIS DU FRANCTIONNEMENT ET DES
`BIOTECHNOLOGIES S.A.,
`Petitioner,
`v.
`NOVO NORDISK HEALTHCARE AG,
`Patent Owner.
`
`
`
`
`
`
`
`
`
`IPR2017-00028
`Patent 9,102,762 B2
`
`Before ERICA A. FRANKLIN, SUSAN L. C. MITCHELL, and
`CHRISTOPHER G. PAULRAJ, Administrative Patent Judges.
`MITCHELL, Administrative Patent Judge.
`
`
`ORDER
`Denying Petitioner’s Motion to Terminate, Dismiss, and Vacate
`37 C.F.R. §§ 42.71 and 42.72
`
`
`
`
`
`
`IPR2017-00028
`Patent 9,102,762 B2
`
`
`Laboratoire Francais du Fractionnement et des Biotechnolgoies S.A.
`(“Petitioner”) moves to terminate and dismiss this inter partes review
`because a final written decision has not been entered as to all grounds in the
`Petition. Petitioner’s Motion to Terminate, Dismiss, and Vacate (Paper 98,
`“Mot.”) 1, 12. Petitioner also moves to vacate the Final Written Decision
`that we issued on April 5, 2018, which disposed of a subset of grounds in the
`Petition upon which an inter partes review was originally instituted, and all
`interlocutory decisions in this proceeding. Id. at 12. According to
`Petitioner, “any final determination issued now would be outside the
`Board’s statutory limits and in excess of its jurisdiction” and “the Board can
`no longer issue a final determination addressing all grounds raised in the
`petition as required by SAS.” Id. (citing Cuozzo Speed Techs. LLC v. Lee,
`136 S. Ct. 2131, 2140–42 (2016)).
`Novo Nordisk Healthcare AG (“Patent Owner”) responds that
`[Petitioner] LFB seeks to have its petition dismissed as if it
`never filed it in the first place and escape the effect of its loss
`on the originally instituted grounds, a clearly prejudicial result
`to Patent Owner Novo Nordisk. Setting aside the the equities
`of [Petitioner] LFB’s motion (which clearly favor Novo
`Nordisk), the motion has no basis in the law and should be
`denied in its entirety.
`Patent Owner’s Opposition to Petitioner LFB’s Motion to Terminate,
`Dismiss, and Vacate (Paper 100, “Opp.”) 1–2.
`
`As explained below, we have jurisdiction here and will proceed to a
`final written decision on the remaining grounds now before us.
`
`Background
`A review of the procedural posture of this proceeding provides
`context for determining the relative merits of the parties’ positions. On
`
`2
`
`
`
`IPR2017-00028
`Patent 9,102,762 B2
`
`April 11, 2017, we instituted an inter partes review for challenged claims of
`U.S. Patent No. 9,102,762 B2 (“the ’762 patent”), based upon only a subset
`of the grounds presented in the Petition. Paper 7, 5 (all grounds), 23
`(instituted grounds). The inter partes review did not include certain grounds
`based on Eibl ’023, 1 for which we determined Petitioner had not
`demonstrated a reasonable likelihood of prevailing. Id. at 20–22. We also
`determined that Petitioner had not demonstrated a reasonable likelihood of
`prevailing with respect to its anticipation challenge based on Tolo. 2 Id.
`at 18. A trial was conducted on the grounds on which we instituted trial.
`This institution and trial on only a subset of the grounds set forth in the
`Petition was consistent with Board practice at the time. In our Final Written
`Decision, issued on April 5, 2018, we concluded that Petitioner had not
`shown by a preponderance of the evidence that claims 1–15 of the ’762
`patent were unpatentable under 35 U.S.C. § 103 on the grounds upon which
`we instituted the inter partes review. Paper 53, 41.
`After our Final Written Decision was entered, but during the time in
`which Petitioner could still file a Request for Rehearing, the United States
`Supreme Court issued its opinion in SAS Institute, Inc. v. Iancu requiring
`that all claims challenged in a petition must be included in any trial. See
`SAS Institute, Inc. v. Iancu, 138 S. Ct. 1348, 1354–60 (2018) (“SAS”)
`(holding that 35 U.S.C. § 318(a) requires a final written decision addressing
`all of the claims challenged in a petition). Shortly thereafter, the Office
`issued guidance stating that “[i]f the PTAB institutes a trial, the PTAB will
`
`
`1 Eibl, WO 2004/011023 A1; Feb. 5, 2004 (Ex. 1008, “Eibl ’023”); Ex. 1009
`(English Translation).
`2 Tolo et al., WO 99/64441; Dec. 16, 1999 (Ex. 1006, “Tolo”).
`
`3
`
`
`
`IPR2017-00028
`Patent 9,102,762 B2
`
`institute on all challenges raised in the petition.” Guidance on the Impact of
`SAS on AIA Trial Proceedings (April 26, 2018) (“Office Guidance”)
`(available at https://www.uspto.gov/patents-application-process/patent-trial-
`and-appeal-board/trials/guidance-impact-sas-aia-trial).
`At the request of Petitioner, we held a conference call with the parties
`and granted Petitioner a three-week extension and more pages for its
`Request for Rehearing “to address all issues, including matters discussed in
`the Final Written Decision, SAS, and the previously non-instituted grounds.”
`Paper 54, 4. In deciding the Request for Rehearing, we stated “we find no
`reason to modify our analysis or conclusions in the FWD with respect to the
`Tolo Grounds.” Paper 60, 8. However, in view of SAS and the Office
`Guidance, we also stated that “it is appropriate to grant rehearing to now
`institute on the previously non-institued grounds.” Id. at 9. Therefore, on
`August 7, 2018, we instituted a supplemental trial focusing on the Tolo
`anticipation ground and the Eibl ’023 grounds that we did not consider in
`our prior Final Written Decision. Id. at 11. The parties filed supplemental
`briefs, and we held a supplemental oral hearing addressing these grounds on
`February 6, 2019. See Paper 67 (Patent Owner’s Supplemental Rehearing
`Response); Paper 81 (Petitioner’s Supplemental Reply); Paper 101
`(Transcript for Supplemental Oral Hearing).
`
`Analysis
`Petitioner asserts that we have no jurisdiction to render a final written
`decision on the remaining grounds for which we instituted trial on August 7,
`2018 because 35 U.S.C. § 316(a)(11) requires that a final determination be
`entered in an inter partes review no later than one year after institution
`unless extended by not more than six months for good cause. Mot. 4–5;
`
`4
`
`
`
`IPR2017-00028
`Patent 9,102,762 B2
`
`see 35 U.S.C. § 316(a)(11) (requiring regulations setting forth the prescribed
`time limits for issuing a final written decision). Petitioner asserts that
`issuing a final written decision now would be ultra vires because “[t]he 12–
`18 month limit is not a mere legislative suggestion nor mere housekeeping;
`rather, exceeding the time limit contravenes the statute’s purpose and goal,
`and deprives the Board of the authority to further adjudicate the merits.” Id.
`at 4, 7. Petitioner concludes:
`In sum, the statutory scheme and legislative history
`establish that the Board was never intended to have unfettered
`ability to ignore the 12–18 month deadline and issue final
`determinations whenever it wants. The intertwined provisions
`regarding the deadline and the application of estoppel, as well
`as Congress’s clear desire to avoid the open-ended timelines of
`prior PTO proceedings and to stay parallel litigation,
`unambiguously show the deadline imposed by § 316(a)(11) is
`jurisdictional and bars post-deadline final determinations by the
`Board.
`The Board issued its rehearing decision on Aug. 7, 2018,
`granting in-part [Petitioner’s] request and instituting review on
`the previously non-instituted grounds. Paper 60, 9. This was
`an institution decision. Accordingly, pursuant to 35 U.S.C.
`§ 316(a)(11) and 37 C.F.R. § 42.100(c), the Board had
`12 months (Aug. 7, 2019)—or 18 months with good cause (Feb.
`7, 2020)—to issue a final determination. We are now well past
`those deadlines, without a final resolution.
`Mot. 11–12.
`
`The Final Written Decision on the originally instituted challenges,
`Petitioner asserts, cannot be considered a final written decision because it
`“did not address all grounds raised by petitioner” as required by SAS. Id.
`at 12. Petitioner asserts that the issued Final Written Decision should be
`vacated and this proceeding terminated “since the Board can no longer issue
`
`5
`
`
`
`IPR2017-00028
`Patent 9,102,762 B2
`
`a final determination addressing all grounds raised in the petition as required
`by SAS.” Id. at 12.
`
`Patent Owner responds that Petitioner’s argument “relies on the
`flawed assumption that rehearings are subject to the same statutory deadlines
`of 35 U.S.C. § 316(a)(11) as typical proceedings. . . . In this proceeding, the
`Board satisfied [the one-year] requirement by issuing the April 2018 FWD
`before April 11, 2018 – the one-year deadline for a determination following
`institution.” Opp. 6–7.
`Patent Owner’s position that our Final Written Decision entered in
`April 2018 satisfied the one-year statutory deadline for this inter partes
`proceeding is correct. 3 Our decision on rehearing to address the previously
`non-instituted grounds in light of the intervening SAS decision did not
`trigger another one-year statutory deadline. We have consistently held that
`once a final written decision is entered within one year of institution (or up
`to an additional six months for good cause shown) the requirement of
`35 U.S.C. § 316(a)(11) has been met.
`For instance, in Shaw Industries Group, Inc., v. Automated Creel
`Systems, Inc., we decided whether a stay should remain in place on a case
`that was remanded from the United States Court of Appeals for the Federal
`
`
`3 Petitioner acknowledges that the Trial Practice Guide states that no
`statutory time limit exists for completion of a re-opened proceeding
`following remand. See Mot. 13–14 (citing Trial Practice Guide Update 47
`(July 2019); see also Patent Trial and Appeal Board Consolidated Trial
`Practice Guide 89 (Nov. 2019) (“Although no statutory time limit exists for
`completion of a re-opened proceeding following remand, the Board
`recognizes that delays caused by re-opening the record after remand may be
`inconsistent with the Board’s stated goal of issuing a remand decision within
`six months from the mandate.”).
`
`6
`
`
`
`IPR2017-00028
`Patent 9,102,762 B2
`
`Circuit (“Federal Circuit”) pending a determination on a Supreme Court
`certiorari petition. See Shaw, IPR2013-00584, Paper 60, 2 (PTAB Oct. 14,
`2016). In Shaw, we maintained the stay stating “[w]e have authority to do
`so under 37 C.F.R. § 42.5(a), and doing so will not violate the statutory
`period for inter partes reviews under 35 U.S.C. § 316(a)(11) because our
`Final Written Decision was issued within one year of institution.” Id. at 3
`(citing Microsoft Corp. v. Proxyconn, Inc., Case IPR2013-00109, Paper 20,
`6 (PTAB Dec. 9, 2015)).
`In Microsoft, the Board stated that the Federal Circuit had determined
`that the Board had erred in the construction of certain terms and remanded
`the case to the Board for proceedings consistent with its opinion. Id. at 2–3.
`On remand, the patent owner in that case asserted that “the Board is ‘without
`authority to take further action’ because the 18-month time period for the
`Board to make a final determination has expired.” Id. at 4–5 (citing 35
`U.S.C. § 316(a)(11); 37 C.F.R. § 42.100(c)). The Board rejected that
`argument, stating:
`[I]f the 18-month deadline were applicable, the Board’s Final
`Written Decision was entered within 18 months of the
`institution of trial, whether that date is measured from the
`institution of trial in IPR2012-00026 or the joined proceeding in
`IPR2013-00109. The Federal Circuit’s partial vacatur does not
`negate the Board’s prior compliance with the deadline. If it did,
`that would essentially foreclose any further proceedings
`consistent with the Federal Circuit’s mandate in this case.
`Id. at 6.
`Here, we issued a Final Written Decision on April 5, 2018, which was
`within the one-year statutory period disposing of all issues presented during
`the trial. See Paper 54. At that point in time, no issue remained requiring
`resolution by the Board. As in Shaw and Microsoft, the deadline for
`
`7
`
`
`
`IPR2017-00028
`Patent 9,102,762 B2
`
`rendering a final written decision had been met. The supplemental
`institution of the remaining grounds from the Petition in our rehearing
`decision in view of SAS and the Office Guidance was not subject to any
`statutory deadline. 4 Therefore, we determine that we have the authority at
`this point to issue a supplemental decision on the remaining Tolo
`anticipation ground and the Eibl ’023 grounds.
`Petitioner also asserts that even if we have jurisdiction to render a
`decision on the remaining grounds, we “should terminate and dismiss this
`IPR and vacate the April 2018 non-final decision and both institution
`decisions,” because the Board has not provided a speedy resolution, which
`violates due process, is an abuse of discretion, is inconsistent with Office
`policy, and prejudices Petitioner. Mot. 12–15.
`Patent Owner responds that Petitioner’s
`claims of prejudice and injustice ring hollow as it waited nearly
`one year to raise this jurisdictional issue for the first time in its
`correspondence to the Board requesting the August, 5, 2020
`telephonic hearing. [Petitioner’s] own actions suggest it did not
`think a one-year deadline applied in August 2019 or it would
`have raised the argument then.
`Opp. 10–11 (citation omitted). Patent Owner also asserts that Petitioner’s
`arguments are premised on the flawed assumption that a statutory deadline
`exists for rendering a decision on the remaining grounds, and Petitioner is
`not prejudiced as it “requested and received two complete trials on all
`
`
`4 Patent Owner also points out that Petitioner’s actions with respect to its
`appeal to the Federal Circuit of the Final Written Decision appears
`inconsistent with the view that a one-year statutory deadline applied to
`resolution of the Tolo anticipation ground and the Eibl ’023 grounds. See
`Opp. 3–5 (discussing Petitioner’s request for a stay of the rehearing pending
`its appeal to the Federal Circuit of the Final Written Decision). We agree.
`
`8
`
`
`
`IPR2017-00028
`Patent 9,102,762 B2
`
`petitioned claims and grounds.” See id. at 11. Patent Owner asserts,
`however, that it would be prejudiced if this inter partes review were
`terminated and the April 2018 Final Written Decision vacated. Id. at 12.
`Patent Owner states: “All the time and resources [Patent Owner] has spent
`defending its intellectual property against these [Petitioner]-initiated
`proceedings would be for naught and [Petitioner] would likely challenge its
`’762 patent again.” Id.
`We do not agree with Petitioner that this case should be terminated
`and all of our decisions vacated. As we have stated, after our Final Written
`Decision was entered in April 2018, the statutory deadline was met. No
`such deadline attaches to the second decision that we will issue on the
`remaining grounds on which we instituted trial in light of SAS and Office
`guidance. We agree with Patent Owner that it would face significant
`prejudice if we were now to undo the previous work performed during this
`inter partes review by vacating previous orders and decisions that have
`resolved disputes between the parties concerning the patentability of the
`challenged claims. Having considered and decided this matter, we will
`proceed to a final determination on the merits for the remaining challenges
`in this inter partes review.
`Accordingly, it is hereby:
`ORDERED that Petitioner’s Motion to Terminate, Dismiss, and
`Vacate is denied; and
`FURTHER ORDERED that we will proceed to a determination on the
`merits for the Tolo anticipation ground and the Eibl ’023 grounds.
`
`
`
`9
`
`
`
`IPR2017-00028
`Patent 9,102,762 B2
`
`FOR PETITIONER:
`
`Michael R. Houston
`Jason N. Mock
`Jayita Guhaniyogi
`FOLEY & LARDNER LLP
`mhouston@foley.com
`jmock@foley.com
`jguhaniyogi@foley.com
`
`FOR PATENT OWNER:
`
`Jeffrey J. Oelke
`Ryan P. Johnson
`Laura T. Moran
`Catherine H. McCord
`FENWICK & WEST LLP
`joelke@fenwick.com
`ryan.johnson@fenwick.com
`laura.moran@fenwick.com
`cmccord@fenwick.com
`
`
`10
`
`
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