Trials@uspto.gov
`Tel: 571-272-7822
`
`Paper 14
`Entered: November 17, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`____________
`
`IPR2020-01317 (Patent 9,220,631 B2)
`IPR2020-01318 (Patent 9,220,631 B2)
`____________
`
`
`Before ERICA A. FRANKLIN, ROBERT L. KINDER, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`KINDER, Administrative Patent Judge.
`
`
`
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. §§ 42.5, 42.20
`
`
`Tel: 571-272-7822
`
`Paper 14
`Entered: November 17, 2020
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`REGENERON PHARMACEUTICALS, INC.,
`Petitioner,
`
`v.
`
`NOVARTIS PHARMA AG,
`NOVARTIS TECHNOLOGY LLC,
`NOVARTIS PHARMACEUTICALS CORPORATION,
`Patent Owner.
`____________
`
`IPR2020-01317 (Patent 9,220,631 B2)
`IPR2020-01318 (Patent 9,220,631 B2)
`____________
`
`
`Before ERICA A. FRANKLIN, ROBERT L. KINDER, and
`KRISTI L. R. SAWERT, Administrative Patent Judges.
`
`KINDER, Administrative Patent Judge.
`
`
`
`
`
`ORDER
`Conduct of the Proceeding
`37 C.F.R. §§ 42.5, 42.20
`
`
`
`IPR2020-01317 (Patent 9,220,631 B2)
`IPR2020-01318 (Patent 9,220,631 B2)
`
`
`INTRODUCTION
`
`
`
`On October 29, 2020, a conference call was held among counsel for
`
`the parties, including Anish Desai for Regeneron Pharmaceuticals, Inc.
`
`(“Petitioner”) and Elizabeth Holland for Novartis Pharma, AG, et al.
`
`(“Patent Owner”), and Judges Erica A. Franklin, Robert L. Kinder, and
`
`Kristi L. R. Sawert. A transcript of the call is entered as Exhibit 1065 in
`
`each proceeding.
`
`The purpose of the call was to discuss Petitioner’s request to file a
`
`reply to address Patent Owner’s arguments in the Preliminary Responses
`
`(a) that we should exercise our discretion under 35 U.S.C. § 314(a) to deny
`
`institution, and (b) that we should exercise our discretion under 35 U.S.C.
`
`§ 325(d) to deny institution. See Ex. 3001 (email requesting teleconference
`
`to discuss these issues).
`
`
`
`
`
`For the reasons that follow, Petitioner’s request is granted.
`
`DISCUSSION
`
`Patent Owner argues in its Preliminary Responses that we should
`
`exercise our discretion to deny institution under § 314(a), providing an
`
`analysis discussing the factors identified in Apple Inc. v. Fintiv, Inc.,
`
`IPR2020–00019, Paper 11 (Mar. 20, 2020) (designated precedential May 5,
`
`2020) (“Fintiv”). See IPR2020-01317, Paper 10, 5–14; IPR2020-01318,
`
`Paper 10, 4–13.1 Patent Owner also contends that we should exercise our
`
`discretion to deny institution under § 325(d). Id. at 15–17. Petitioner did
`
`not address either discretionary issue in its Petitions. Below, we first
`
`address the issues pertinent to § 314(a) and then § 325(d).
`
`
`1 Later citations are to IPR2020-01317 only; the briefing in each proceeding
`is similar in scope.
`
`2
`
`
`
`IPR2020-01317 (Patent 9,220,631 B2)
`IPR2020-01318 (Patent 9,220,631 B2)
`
`
`35 U.S.C. § 314(a)
`
`
`
`During the conference call, Petitioner asked for briefing to address
`
`Patent Owner’s Fintiv arguments. Petitioner argued that it did not include a
`
`detailed Fintiv analysis in the Petition because Petitioner “filed these IPRs
`
`five days before the ITC case was instituted,” and “if 314 precludes PTAB
`
`review, then the PTAB review is effectively foreclosed.” Ex. 1065, 7:1–10.
`
`
`
`Petitioner also believed it necessary to correct timing issues raised in
`
`the Preliminary Responses as to when the ITC proceeding will conclude. Id.
`
`at 8:12–25. Petitioner noted that, although “the ALJ initial determination” is
`
`set for July 29, 2021, “[t]he Commission’s decision is due November 29,
`
`2021,” with the “60-day precedential review period” set for January 29,
`
`2022. Id. at 8:22–9:13.
`
`
`
`Petitioner contended that Patent Owner’s § 314 briefing largely relies
`
`upon a Board decision that recently issued in October 2020, whereas the
`
`Petitions were filed in July 2020. Id. at 7:15–25. More specifically,
`
`Petitioner noted that “Novartis hinged its argument to the Board’s decision
`
`in IPR2020-00772 involving FitBit,” yet, “that decision issued on October
`
`19, 2020,” so Petitioner “could not have addressed and distinguished that
`
`specific case” in its Petition. Id. at 7:15–25.
`
`
`
`Petitioner also argued that, even though the Fintiv decision was made
`
`precedential in May 2020, shortly before the Petition was filed in July, that
`
`does not mean “Regeneron should have predicted Novartis’s argument and
`
`addressed it in the petition.” Id. at 11:10–13. Petitioner noted that at least
`
`one other Board decision “rejected a § 314 argument based on an ITC case,
`
`noting that the ITC does not have authority to invalidate a patent,” and the
`
`ITC also has different evidentiary standards. Id. at 11:14–20.
`
`3
`
`
`
`IPR2020-01317 (Patent 9,220,631 B2)
`IPR2020-01318 (Patent 9,220,631 B2)
`
`
`
`Finally, Petitioner argued that requiring petitioners to address
`
`discretionary factors in a petition is “contrary to the statutory requirements”
`
`and nothing in the Board’s regulations or “Trial Practice Guide . . . make it a
`
`requirement for a petitioner to address 314 and 325 arguments in the
`
`petition.” Id. at 12:11–23.
`
`
`
`At the outset, even before highlighting Patent Owner’s opposition to
`
`additional briefing, we reject Petitioner’s attempt to excuse itself from
`
`addressing §§ 314(a) and 325(d) by contending that nothing in the statutes,
`
`the Board’s regulations, or the 2019 Consolidated Trial Practice Guide
`
`(“Practice Guide”) require petitioners to address §§ 314(a) and 325(d)
`
`discretionary factors in their petitions.
`
`
`
`Whether we, on behalf of the Director, institute review is
`
`discretionary. See Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2140
`
`(“[T]he agency’s decision to deny a petition is a matter committed to the
`
`Patent Office’s discretion.”); 37 C.F.R. § 42.4(a); see also Deeper, UAB v.
`
`Vexilar, Inc., Case IPR2018-01310 (PTAB Jan. 24, 2019) (Paper 7)
`
`(informative). Whether we allow a petitioner to file a reply brief to address
`
`issues raised in a patent owner preliminary response is predicated upon
`
`petitioner showing “good cause.” 37 C.F.R. § 42.108(c) (2019); see also
`
`Xactware Sols., Inc. v. Pictometry Int’l Corp., IPR2016-00593, Paper 11, 3
`
`(PTAB Jul. 1, 2016) (determining mere alleged misstatements in the
`
`preliminary response do not give rise to good cause). The Practice Guide
`
`explains that “the Board does not expect that such a reply will be granted in
`
`many cases due to the short time period the Board has to reach a decision on
`
`institution.” Practice Guide, 52. Good cause to file a reply brief may not
`
`exist for issues that were reasonably known and could have been addressed
`
`4
`
`
`
`IPR2020-01317 (Patent 9,220,631 B2)
`IPR2020-01318 (Patent 9,220,631 B2)
`
`in a petition, but were not. ARM, Ltd. v. Godo Kaisha IP Bridge 1,
`
`IPR2016-00825, Paper 11 (PTAB Sep. 29, 2016) (denying a petitioner’s
`
`request to file a reply, explaining that “Petitioner had notice and opportunity
`
`to raise this issue” as demonstrated by the fact that the petition “makes clear
`
`that Petitioner at least contemplated the possibility” that the patent owner
`
`would rely on foreign priority).
`
`
`
`Petitioners are expected to address all material issues relevant to
`
`institution of trial in their petitions, including discretionary factors that could
`
`be case dispositive. In determining whether or not to exercise our discretion
`
`to institute review, the Board considers “at a minimum whether or not a
`
`party has satisfied the relevant statutory institution standard.” Practice
`
`Guide, 55. The Practice Guide further elaborates, “[t]he Board will also take
`
`into account whether various considerations . . . warrant the exercise of the
`
`Director’s discretion to decline to institute review.” Id. (citing 35 U.S.C.
`
`§§ 314(a), 324(a)) (emphasis added). These “various considerations”
`
`include discretionary factors related to §§ 314(a) and 325(d). Ultimately, as
`
`with many arguments, a petitioner may decide whether to address
`
`discretionary factors in a petition. However, when it would have been
`
`reasonably foreseeable that such factors may be at issue, choosing not to
`
`address those factors in a petition does not later entitle a petitioner to further
`
`briefing. Indeed, that choice may result in the petition being denied based
`
`upon our consideration of the discretionary factors without input from the
`
`petitioner.
`
`
`
`Accordingly, a good cause showing for requesting a reply brief to
`
`address §§ 314(a) and 325(d) discretionary factors is required. To show
`
`good cause, the moving party must explain why patent owner’s discretionary
`
`5
`
`
`
`IPR2020-01317 (Patent 9,220,631 B2)
`IPR2020-01318 (Patent 9,220,631 B2)
`
`arguments were not reasonably foreseeable, and thus not addressed in the
`
`petition in the first instance.
`
`
`
`We are cognizant of both the space limitations in petitions as well as
`
`the difficulty in foreseeing every patent owner argument related to
`
`discretionary factors. Yet, a reply brief to a patent owner preliminary
`
`response is not intended as a mechanism to allow additional briefing pages
`
`in every proceeding that may involve discretionary issues. The discretionary
`
`factors related to § 314(a), including the Board’s Fintiv decision, are
`
`expected to be addressed in some manner in the petition when it is
`
`reasonably foreseeable that patent owner may raise these issues.
`
`
`
`In these proceedings, Patent Owner opposes the request to allow a
`
`reply brief to the preliminary response in each proceeding. See Ex. 3001.
`
`Patent Owner contends that, as of May 2020 when Fintiv was made
`
`precedential, Petitioner should have known about the Fintiv precedential
`
`decision and addressed it in each July Petition. Ex. 1065, 17:10–18:17.
`
`Patent Owner also contends that, at the time Petitioner filed these Petitions,
`
`“there was not really any doubt at that point in time that [the ITC
`
`proceeding] was going to be instituted.” Id. at 18:18–23. Patent Owner
`
`believes that Petitioner’s failure to address § 314 in the Petitions was a
`
`strategic move designed to increase word count. Id. at 19:8–20:20.
`
`
`
`Based on the record before us, we find that good cause exists for us to
`
`authorize a reply to the Preliminary Response to address § 314(a)
`
`discretionary factors. In particular, Patent Owner relies extensively in its
`
`Preliminary Responses on a Board decision entered just a week before the
`
`Preliminary Responses were filed. See Prelim. Resp. 6–7 (citing Fitbit, Inc.
`
`v. Koninklijke Philips N.V., IPR2020-00772, Paper 14 at 13 (PTAB Oct. 19,
`
`6
`
`
`
`IPR2020-01317 (Patent 9,220,631 B2)
`IPR2020-01318 (Patent 9,220,631 B2)
`
`2020)). The Preliminary Responses cite the Fitbit decision at least five
`
`times (see id. at 6, 7, 9, 14, 15), and relies on that decision for the
`
`proposition that the Board may exercise its discretion to deny institution
`
`where “an ITC decision would pre-date a final written decision and . . . ‘the
`
`overlap of issues and parties presents a risk of inconsistent rulings between
`
`the Commission and the Board and the duplication of some efforts in
`
`addressing Petitioner’s patentability positions,’” id. at 15 (quoting Fitbit,
`
`Paper 14 at 23). Petitioner could not have reasonably foreseen Patent
`
`Owner’s extensive reliance on a decision involving a co-pending ITC
`
`investigation (Fitbit) that issued in October 2020, after the Petitions were
`
`filed in July.
`
`
`
`Additionally, Patent Owner filed its ITC Complaint (Inv. No. 337-TA-
`
`1207) on June 19, 2020, and the ITC voted to institute an investigation on
`
`July 21, 2020. The Petitions in these proceedings were filed on July 16,
`
`2020. See Paper 3. Petitioner’s decision to file these Petitions five days
`
`before the ITC investigation was instituted presents at least a plausible basis
`
`for Petitioner’s failure to address Fintiv in the Petitions.
`
`
`
`Combined, these reasons establish good cause sufficient to justify a
`
`reply to Patent Owner’s Preliminary Response in each proceeding to address
`
`§ 314 factors, including the Fintiv and Fitbit decisions.
`
`35 U.S.C. § 325(d)
`
`
`
`We also determine that Petitioner has shown sufficient good cause to
`
`address § 325(d) discretionary factors in a reply brief. In its Petitions,
`
`Petitioner discusses the prosecution history of the challenged patent, the
`
`basis for several rejections, and also why it believes the reasons for
`
`allowance are contradicted by the prior art presented. See Pet. 2, 3 (“The
`
`7
`
`
`
`IPR2020-01317 (Patent 9,220,631 B2)
`IPR2020-01318 (Patent 9,220,631 B2)
`
`Examiner therefore did not have key prior art (e.g., Sigg and Boulange)
`
`demonstrating the obviousness of the claims of the ’631 Patent during
`
`prosecution.”), 20, 21 (“These reasons for allowance are plainly contradicted
`
`by the prior art presented in this Petition that was not before the
`
`Examiner.”). Thus, Petitioner addressed, at least to some degree, § 325(d)
`
`discretionary factors in its Petitions.
`
`
`
`Patent Owner appears to premise its § 325(d) position on the basis that
`
`arguments and art raised in the Petitions are not identical to, but instead
`
`“substantially the same as what was addressed during prosecution.” Prelim.
`
`Resp. 15–17. Patent Owner also presents specific arguments about the
`
`prosecution history, including discussing the Examiner’s awareness of
`
`certain features in the art. See id. at 22–25. The nature of these arguments
`
`are such that we agree with Petitioner that they would have been difficult to
`
`predict. Ex. 1065, 13:20–15:2. Under the circumstances of this case, we
`
`agree with Petitioner that it could not have reasonably predicted and
`
`addressed all of Patent Owner’s § 325(d) arguments initially in its Petitions.
`
`Accordingly, in these proceedings, Petitioner has established good cause to
`
`file a reply brief to address the specific § 325(d) arguments and evidence
`
`presented by Patent Owner.
`
`Summary
`
`
`
`We also find that further briefing would be helpful to us in deciding
`
`whether to exercise our discretion under §§ 314(a), 325(d). Thus, we
`
`authorize Petitioner to file a reply to Patent Owner’s Preliminary Response
`
`regarding the issue of discretionary denial under § 314(a) and § 325(d). We
`
`also authorize Patent Owner to file a sur-reply to address the arguments
`
`8
`
`
`
`IPR2020-01317 (Patent 9,220,631 B2)
`IPR2020-01318 (Patent 9,220,631 B2)
`
`regarding §§ 314(a), 325(d) in Petitioner’s reply. Both filings are limited to
`
`fifteen (15) pages.
`
`In view of the foregoing, is, therefore,
`
`ORDER
`
`ORDERED that Petitioner’s request for authorization to file a reply to
`
`
`
`
`
`address the question of discretionary denial of institution under 35 U.S.C.
`
`§§ 314(a), 325(d) in each proceeding is granted;
`
`
`
`FURTHER ORDERED that Petitioner’s reply in each proceeding
`
`shall be filed no later than November 25, 2020, is limited to fifteen (15)
`
`pages in length, and shall address only the issue of discretionary denial of
`
`institution under 35 U.S.C. §§ 314(a), 325(d); and
`
`
`
`FURTHER ORDERED that Patent Owner is authorized to file a sur-
`
`reply in each proceeding, which shall be filed no later than December 11,
`
`2020, is limited to fifteen (15) pages in length, and shall address only
`
`Petitioner’s arguments in the reply regarding discretionary denial of
`
`institution under 35 U.S.C. §§ 314(a), 325(d).
`
`
`
`
`
`
`
`9
`
`
`
`IPR2020-01317 (Patent 9,220,631 B2)
`IPR2020-01318 (Patent 9,220,631 B2)
`
`
`PETITIONER:
`
`Elizabeth Weiswasser
`Brian Ferguson
`Anish Desai
`Christopher Pepe
`WEIL GOTSHAL & MANGES, LLP
`Elizabeth.weiswasser@weil.com
`Anish.desai@weil.com
`Brian.ferguson@gweil.com
`Christopher.pepe@weil.com
`
`
`PATENT OWNER:
`
`Elizabeth J. Holland
`William G. James
`Linnea Cipriano
`Joshua Weinger
`GOODWIN PROCTER LLP
`EHolland@goodwinlaw.com
`WJames@goodwinlaw.com
`LCipriano@goodwinlaw.com
`JWeinger@goodwinlaw.com
`
`10
`
`
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