`
`———————
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`———————
`
`
`
`Regeneron Pharmaceuticals, Inc.,
`Petitioner,
`
`v.
`
`Novartis Pharma AG,
`Novartis Technology LLC,
`Novartis Pharmaceuticals Corporation,
`Patent Owner
`
`———————
`
`Case IPR2020-01317
`U.S. Patent No. 9,220,631
`———————
`PETITIONER’S REQUEST FOR REHEARING
`PURSUANT TO 37 C.F.R. § 42.71(d)
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED ................ 1
`I.
`LEGAL STANDARD ........................................................................... 3
`II.
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED .............. 3
`A.
`Reliance on Fintiv to Discretionarily Deny Institution
`Based on a Parallel ITC Investigation Frustrates
`Congressional Intent ................................................................... 4
`The Board’s Analysis of Certain Fintiv Factors Was
`Erroneous and Should Not Have Supported Denying
`Institution .................................................................................. 10
`1.
`Fintiv Factors 1, 2, 5, and 6 ............................................ 11
`2.
`Fintiv Factors 3 and 4 ..................................................... 14
`IV. CONCLUSION ................................................................................... 15
`
`B.
`
`
`
`
`
`
`i
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`I.
`
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed its inter partes review
`
`petition only 27 days after being accused of infringement of U.S. Patent No.
`
`9,220,631 (“the 631 patent”) in complaints filed in the International Trade
`
`Commission (ITC) and in district court by Patent Owner Novartis. By statute (28
`
`U.S.C. § 1659), the district court proceeding was stayed in favor of the ITC
`
`investigation. While the ITC investigation is moving forward, the ITC’s final
`
`determination on the validity of the 631 patent will have no preclusive effect and
`
`will not prevent Patent Owner from proceeding in district court.
`
`
`
`In its Patent Owner Preliminary Response (Paper 10), Novartis argued, inter
`
`alia, that the Board should exercise its discretion pursuant to 35 U.S.C. § 314(a)
`
`and deny institution of trial based on the pending ITC investigation. Novartis did
`
`not argue that institution should be denied based on the stayed district court case.
`
`Regeneron asked for and was granted permission to file a reply brief (Paper 13),
`
`and Novartis filed a sur-reply (Paper 14). As Regeneron explained, the facts here
`
`showed that Regeneron: (a) filed the instant petition before the ITC had even
`
`instituted an investigation based on Patent Owner’s complaint; (b) challenged
`
`every claim of the 631 patent; and (c) stipulated that it would not pursue any
`
`invalidity arguments in the ITC that would be the subject of an IPR trial. See Paper
`
`13 at 11-13. In short, these facts presented a clear case for instituting trial.
`
`
`
`
`1
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`
`
`Nonetheless, on January 15, 2021 the Board relied on Apple Inc. v. Fintiv,
`
`Inc., IPR2020-00019, Paper 11 (PTAB May 13, 2020) (“Fintiv”) and exercised its
`
`“discretion under 35 U.S.C. § 314(a) to deny institution” based solely on the
`
`pending ITC investigation. Paper 15 at 1. Regeneron now requests rehearing of the
`
`Board’s institution decision. The denial of institution here demonstrates that the
`
`Board has created a nearly per se rule that IPR trials are largely off-limits to ITC
`
`respondents. That outcome cannot be what Congress intended. It is an abuse of
`
`discretion for the Board to deny institution based on parallel proceedings before
`
`the ITC, which undisputedly cannot issue findings or render decisions on patent
`
`validity that have preclusive effect. The Board’s denial of institution in these
`
`circumstances is at odds with Congress’s intent that IPR proceedings “serve as a
`
`less-expensive alternative to courtroom litigation and provide additional access to
`
`the expertise of the Patent Office on questions of patentability.” See 157 Cong.
`
`Rec. S1352 (daily ed. Mar. 8, 2011) (statement of Sen. Udall).
`
`
`
`Regeneron will ask for Precedential Opinion Panel (“POP”) review of this
`
`request for rehearing, and requests that the POP hold that Fintiv should not be the
`
`basis for denying institution of IPRs when there is a parallel ITC investigation.1
`
`
`1
`Regeneron notes that this issue – reliance on the Fintiv factors as a basis to
`
`discretionarily deny IPRs based on a parallel ITC investigation – is also before the
`
`
`
`
`2
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`II. LEGAL STANDARD
`
`Pursuant to 37 C.F.R. § 42.71(d), a “party dissatisfied with a decision may
`
`file a single request for rehearing.” The request must “specifically identify all
`
`matters the party believes the Board misapprehended or overlooked….” Id.
`
`Institution decisions are reviewed on rehearing “for an abuse of discretion.” 37
`
`C.F.R. § 42.71(c). “An abuse of discretion occurs when a ‘decision [i]s based on an
`
`erroneous conclusion of law or clearly erroneous factual findings, or … a clear
`
`error of judgment.’” Apple Inc. v. DSS Tech. Mgmt., Inc., IPR2015-00369, Paper
`
`14 at 3 (PTAB Aug. 12, 2015) (citation omitted).
`
`III. STATEMENT OF REASONS FOR RELIEF REQUESTED
`
`The Board denied institution, finding that based on its “holistic review of all
`
`the Fintiv factors, the weight of the evidence sufficiently tips the balance in favor
`
`of exercising our discretion to deny institution under § 314(a).” Paper 15 at 24.
`
`Regeneron recognizes that, because it is a precedential opinion, the Board is bound
`
`to follow and apply Fintiv when a question arises regarding the status of parallel
`
`litigation. Regeneron asserts, however, that application of the Fintiv factors when
`
`
`POP in Garmin Int’l, Inc. v. Koninklijke Philips N.V., IPR2020-00754. See
`
`November 19, 2020 POP request by petitioners.
`
`
`
`
`3
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`the parallel litigation is an ITC investigation amounts to a “clear error of
`
`judgment” justifying rehearing.2
`
`A. Reliance on Fintiv to Discretionarily Deny Institution Based on a
`Parallel ITC Investigation Frustrates Congressional Intent
`The ITC does not have the power to cancel patent claims and its
`
`
`
`determinations cannot finally resolve questions of patent validity. Accordingly,
`
`discretionarily denying IPR institution based on a parallel ITC investigation is
`
`contrary to clear Congressional intent. See Paper 13 at 9-10; 157 Cong. Rec. S1352
`
`(daily ed. Mar. 8, 2011) (statement of Sen. Udall) (“Inter partes … proceedings are
`
`intended to serve as a less-expensive alternative to courtroom litigation and
`
`provide additional access to the expertise of the Patent Office on questions of
`
`patentability.”);3 see also S. Rep. No. 110-259, at 20 (2008) (stating that the
`
`purpose of the IPR procedure is to provide “a quick, inexpensive, and reliable
`
`alternative to district court litigation to resolve questions of patent validity”).
`
`When, as here, the petitioner has promptly filed its petition after service of an ITC
`
`
`2
`Regeneron is not impugning the judgment of the specific Board members in
`
`this IPR, who are required to apply precedential Board decisions. That is why
`
`Regeneron requests POP review of this request: to reconsider the appropriateness
`
`of relying on Fintiv to deny IPR institution based on a parallel ITC litigation.
`
`3
`
`Emphasis added unless otherwise noted.
`
`
`
`
`4
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`complaint,4 relying on the Fintiv factors to deny institution turns Congressional
`
`intent on its head—Congress certainly never intended that an ITC investigation
`
`should be considered a viable substitute for the expertise of the Patent Office when
`
`the validity of a patent is at issue. See pp. 7-9 infra (explaining that the ITC defers
`
`to the expertise of the Patent Office on matters of patent validity).
`
`
`
`There is a multitude of evidence of Congress’s intent in this regard. Most
`
`importantly, Congress gave preclusive effect to a Board’s invalidity determination
`
`(subject to Federal Circuit review). 35 U.S.C. § 318(b) (“If the [Board] issues a
`
`final written decision … and the time for appeal has expired or any appeal has
`
`terminated, the Director shall issue and publish a certificate canceling any claim of
`
`the patent finally determined to be unpatentable….”). In striking contrast, a finding
`
`by the ITC regarding patent invalidity has no preclusive effect, even if the Federal
`
`Circuit affirms the ITC’s finding. See Hyosung TNC Inc. v. Int’l Trade Comm’n,
`
`926 F.3d 1353, 1358 (Fed. Cir. 2019); Fintiv at 8-9 (citing Texas Instruments v.
`
`Cypress Semiconductor Corp., 90 F.3d 1558 (Fed. Cir. 1996)); Paper 13 at 9-10.
`
`This is because the ITC’s “primary responsibility is to administer the trade laws,
`
`not the patent laws.” Tandon Corp. v. Intern. Trade Comm’n, 831 F.2d 1017, 1019
`
`(Fed. Cir. 1987). Indeed, the Federal Circuit has made it abundantly clear that
`
`
`4
`Regeneron filed its petitions prior to institution of the ITC investigation.
`
`
`
`
`5
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`patent-related ITC findings “neither purport to be, nor can they be, regarded as
`
`binding interpretations of the U.S. patent laws in particular factual contexts.” Texas
`
`Instruments, 90 F.3d at 1568-1569.
`
`
`
`Congress thus intended that IPR proceedings serve to finally resolve issues
`
`of patent validity by statutorily mandating that (unlike the ITC) the Board’s
`
`invalidity decisions have preclusive effect. See Nichia Corp. v. Lighting Sci. Group
`
`Corp., IPR2019-01259, Paper 21 at 27-28 (PTAB Jan. 15, 2020) (“Nichia”)
`
`(instituting IPR and rejecting § 314(a) argument because, inter alia, “the ITC does
`
`not have the authority to invalidate a patent in a way that is applicable to other
`
`forums, and thus ITC decisions do not preempt issues addressed in an inter partes
`
`review proceeding”). This result benefits competition and serves one of Congress’s
`
`important purposes in enacting the America Invents Act. See H.R. Rep. 112-98, at
`
`69 (2011) (stating that IPRs “limit unnecessary and counterproductive litigation
`
`costs”); 157 Cong. Rec. S1326 (Mar. 7, 2011) (Sen. Sessions) (stating that a goal
`
`of the AIA was to weed out “invalid patents … before they disrupt an entire
`
`industry”); see also Thryv, Inc. v. Click-To-Call Techs., LP, 140 S. Ct. 1367, 1374
`
`(2020) (stating that a purpose of IPRs is to “weed out bad patent claims
`
`efficiently”); Pope Mfg. Co. v. Gormully, 144 U.S. 224, 234 (1892)
`
`(“[C]ompetition should not be repressed by worthless patents.”).
`
`
`
`
`6
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`
`
`Moreover, as further evidence of Congressional intent, Congress also
`
`explicitly provided for IPR proceedings to have estoppel effect in any pending or
`
`future litigations involving the patent, including in parallel ITC investigations. 35
`
`U.S.C. § 315(e)(2) (“[T]he petitioner may not assert either in a civil action … or in
`
`a proceeding before the International Trade Commission under Section 337 of
`
`the Tariff Act of 1930 that the claim is invalid on any ground that the petitioner
`
`raised or reasonably could have raised during that inter partes review.”). Notably,
`
`there are no analogous statutory provisions for any type of estoppel based on
`
`arguments made (or arguments that reasonably could have been made) before the
`
`ITC. This further confirms that, between the Board and the ITC, Congress’s clear
`
`preference was that the Board determine the issue of patent validity. It follows that
`
`Congress did not intend for the Board to defer such validity challenges to the ITC,
`
`an agency that has no role in the vetting and issuance of patents in the first instance
`
`and is primarily concerned with trade laws. Tandon, 831 F.2d at 1019.
`
`
`
`Consistent with this clear expression of Congressional intent, the ITC itself
`
`has recognized that the Board is the “lead agency in assessing the patentability, or
`
`validity, of proposed or issued claims.” Certain Unmanned Aerial Vehicles and
`
`Components Thereof, Inv. No. 337-TA-1133, Comm’n Op. at 37 (Sept. 8, 2020);
`
`see Paper 13 at 9-10. Similarly, other Board panels have routinely recognized that
`
`the ITC cannot usurp the role of the Board with respect to validity issues. Nichia,
`
`
`
`
`7
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`Paper 21 at 27 (stating that because the ITC “does not have the authority to
`
`invalidate a patent, … ITC decisions do not preempt issues addressed in an inter
`
`partes review proceeding”); 3Shape A/S v. Align Tech., Inc.,. IPR2020-00223,
`
`Paper 12 at 33-34 (PTAB May 26, 2020) (“3Shape”) (same); Intel Corp. v. Tela
`
`Innovations, Inc., IPR2019-01636, Paper 16 at (PTAB March 31, 2020) (“Intel”);5
`
`see also Paper 13 at 10-11.
`
`
`
`Respectfully, the Board’s decision in this IPR to deny institution because of
`
`the ongoing ITC investigation fails to adequately address the lack of preclusive
`
`effect the ITC’s validity findings will have with respect to the challenged Novartis
`
`631 patent. While the Board acknowledged Regeneron’s argument (Paper 15 at
`
`23), it declined to give it meaningful weight because “Fintiv states that ‘as a
`
`practical matter, it is difficult to maintain a district court proceeding on patent
`
`claims determined to be invalid at the ITC.’” Id. (quoting Fintiv at 9). Neither the
`
`present Board panel nor the Fintiv panel, however, provided any explanation for
`
`this view. To the contrary, as Regeneron explained, it is not uncommon for patent
`
`owners to press forward with district court cases even following ITC invalidity
`
`
`5
`The Board panels in Nichia, 3Shape, and Intel rejected the patent owners’
`
`arguments that the existence of a parallel ITC investigation warranted discretionary
`
`denials under § 314(a).
`
`
`
`
`8
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`rulings, and indeed Novartis has shown an intent to do so here by filing a district
`
`court proceeding that is stayed pending the ITC outcome. Paper 10-11.6
`
`
`
`The problem with the Board deferring the invalidity analysis to the ITC,
`
`whose invalidity findings have no preclusive effect, is vividly demonstrated by the
`
`proceedings before the district court in Hyosung TNS, Inc. v. Diebold Nixdorf. See
`
`Paper 13 at 11. There, the district court allowed a patent infringement case to
`
`proceed even after the ITC found the patent in suit invalid and the Federal Circuit
`
`affirmed the ITC’s invalidity ruling. The district court nonetheless denied a motion
`
`for invalidity based on the same arguments that were before the ITC and Federal
`
`Circuit and ordered the case to proceed, stating that: “there may be evidence not
`
`presented on the ITC record considered by the Federal Circuit that could merit a …
`
`different conclusion regarding … validity.” Case No. 3:16-CV-0364-N, 2019 WL
`
`6684138, at *1-2 (N.D. Tex. Dec. 5, 2019).
`
`
`
`The prejudicial, costly, and inefficient nature of this type of outcome is
`
`clear—even if the patent owner fails to sustain its patent at the ITC, it is entitled to
`
`a second bite of the apple in district court. Conversely, the accused infringer is
`
`
`6
`As noted, Patent Owner has asserted the 631 patent against Petitioner in a
`
`case pending in the Northern District of New York (“the NDNY Patent
`
`Litigation”). Paper 15 at 3.
`
`
`
`
`9
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`required to prove invalidity not just once in the ITC, but twice (in the ITC and in
`
`district court). As the Board noted, that is what Regeneron now faces, because
`
`Patent Owner here has confirmed that it plans to proceed in district court after the
`
`ITC investigation ends. See Paper 15 at 12 (“Patent Owner notes the NDNY Patent
`
`Litigation has been stayed, but will proceed after the ITC Investigation is
`
`complete.”). This type of costly serial litigation could not occur if the Board was
`
`the agency that found the patent invalid, and is precisely what Congress intended
`
`for the AIA to prevent. See pp. 4-8, supra.
`
`
`
`For these reasons, application of the Fintiv factors to discretionarily deny
`
`trials under § 314(a) based on parallel ITC proceedings is contrary to
`
`Congressional intent. Accordingly, the Fintiv factors should not be relied on to
`
`justify denying trial in favor of ITC litigation.
`
`B.
`
`The Board’s Analysis of Certain Fintiv Factors Was Erroneous
`and Should Not Have Supported Denying Institution
`At the threshold level, the problems with applying the Fintiv factors based
`
`
`
`on parallel ITC proceedings are explained above. The Board followed those factors
`
`in denying institution, which was clear error given the facts here.7
`
`
`7
`As explained in Section III.A, application of the Fintiv factors goes against
`
`Congressional intent when the parallel proceeding is at the ITC. For that reason
`
`alone, Regeneron’s request for rehearing should be granted. Additionally, the
`
`
`
`
`10
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`Fintiv Factors 1, 2, 5, and 6
`1.
`Congress did not intend the Board to defer to the ITC determinations of
`
`
`
`patent validity. The Board’s Fintiv analysis did not give sufficient weight to
`
`Congressional intent, and also did not meaningfully address the lack of preclusive
`
`effect of ITC invalidity holdings and the risk of further duplicative litigation in
`
`district court. Regeneron’s arguments on these points are set forth in Section III.A
`
`above. See also Paper 13 at 9-11, 14-15.
`
`
`
`In addition, in its analysis of factor 6, the Board pointed to the number of
`
`parallel actions – specifically, the ITC investigation and the two district court cases
`
`(the NDNY Patent Litigation and the Southern District of New York antitrust case
`
`(“SDNY Case”)) – as justification for exercising its discretion to deny institution.
`
`Paper 15 at 23 (“[I]nstituting review in this proceeding will do little to resolve the
`
`disputes between the parties and achieve efficient resolution. The outcome of the
`
`ITC Investigation will be known months before we could reach a final
`
`determination. Petitioner also chose to pursue complex antitrust claims that
`
`
`analysis in this Section III.B addresses certain findings that the Board made under
`
`the individual Fintiv factors. As there is significant overlap between the factors
`
`(see Paper 15 at 10-11, listing the factors), the analysis applies across multiple of
`
`the factors and Regeneron has grouped the factors together for this reason.
`
`
`
`
`11
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`implicate many of the same issues before us. Our final determination, however,
`
`would be only one small piece of that complex puzzle.”).
`
`
`
`This rationale does not withstand scrutiny in light of the facts. To the
`
`contrary, were the Board to institute IPR and find the challenged claims invalid,
`
`the Board’s holding (which would be subject to preclusive effect under 35 U.S.C. §
`
`318) would eliminate the NDNY Patent Litigation and end the ITC investigation.
`
`With respect to the NDNY Patent Litigation, Regeneron challenged in its petition
`
`every claim of the 631 patent (see Paper 15 at 2; Paper 13 at 13); accordingly, if
`
`those claims were found invalid by the Board (and subject to review by the Federal
`
`Circuit), Patent Owner would be foreclosed from asserting the 631 patent again.
`
`Nestlé USA, Inc. v. Stueben Foods, Inc., 884 F.3d 1350, 1351 (Fed. Cir. 2018)
`
`(“Collateral estoppel protects a party from having to litigate issues that have been
`
`fully and fairly tried in a previous action and adversely resolved against a party-
`
`opponent.”). With respect to the ITC investigation, a finding of invalidity by the
`
`Board would likewise have collateral estoppel effect, and, importantly, would be
`
`the basis for rescission of any adverse remedial orders the ITC may enter. See, e.g.,
`
`Unmanned Aerial Vehicles, Comm’n Op. at 35 (“The Commission may issue an
`
`exclusion order in a patent-based investigation only if it finds that the accused
`
`
`
`
`12
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`articles ‘infringe a valid and enforceable United States patent.”) (citing 19 U.S.C. §
`
`1337(a)(1)(B)(i), (d)(1)) (emphasis in original).8
`
`
`
`With respect to the SDNY Case, Regeneron filed that case seeking redress
`
`for antitrust violations by Novartis and a third party. The SDNY case raises, among
`
`other things, inequitable conduct as to the 631 patent and does not seek an
`
`adjudication on patent validity. Paper 15 at 4; Ex. 2057. Unenforceability and
`
`invalidity are separate legal defenses. Smith Int’l, Inc. v. Hughes Tool Co., 759
`
`F.2d 1572, 1578 (Fed. Cir. 1985). The SDNY court will not be tasked with
`
`determining whether the 631 patent is invalid for obviousness under 35 U.S.C. §
`
`103, as the Board would do here. Accordingly, there will not be risk of duplicative
`
`or inconsistent decisions between the Board and the Court in the SDNY Case.
`
`
`
`For these reasons, the Board’s concerns that its final decision would be
`
`“only one small piece” of the bigger dispute between the parties is unfounded. Just
`
`as Congress intended, the Board’s analysis would instead serve as a less-expensive
`
`alternative to courtroom litigation – the NDNY Patent Litigation and further
`
`
`8
`The ITC explained that rescinding or modifying its remedial orders based on
`
`Board invalidity rulings is consistent with its practice of doing so when a district
`
`court has found the patent in question invalid. Unmanned Aerial Vehicles, Comm’n
`
`Op. at 37, fn. 17.
`
`
`
`
`13
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`proceedings in the ITC investigation. See, e.g., Intel, Paper 16 at 23-24 (“[W]e do
`
`not find the ITC Proceeding weighs in favor of denying institution, because it will
`
`not resolve the unpatentability issues raised in this Petition or the issues in dispute
`
`between the parties in the NDCA.”); Renesas Elecs. Corp. v. Broadcom Corp.,
`
`IPR2019-01040, Paper 9 at 8 (PTAB Nov. 13, 2019) (noting that although the ITC
`
`proceeding may resolve the issues between the parties at the ITC, even if the ITC
`
`finds the asserted claims invalid, the patent owner may continue to assert the
`
`claims at issue in the district court once the ITC action concludes); Nichia, Paper
`
`21 at 27-28 (instituting IPR and rejecting § 314(a) argument, holding that the
`
`existence of pending district court actions supports institution “because other
`
`courts may still need to address patentability once stays are lifted…. [W]e decline
`
`to deny institution … because the ongoing district court proceedings, including
`
`those currently stayed, may benefit from our patentability determination and
`
`override any perceived judicial inefficiency.”).
`
`Fintiv Factors 3 and 4
`2.
`The Board acknowledged that Regeneron stipulated (see Paper 13 at 12-13)
`
`
`
`not to pursue at the ITC the invalidity grounds identified in the Petition should the
`
`Board institute trial. The Board characterized the stipulation as a “narrow” one that
`
`“does not alleviate concerns of duplication given the Petitioner’s ability to rely on
`
`substantially the same prior art by slightly varying the combinations.” Paper 15 at
`
`
`
`
`14
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`20-21. The stipulation, however, ensures that the ITC and the Board will not make
`
`duplicative and potentially inconsistent findings regarding the grounds in the
`
`Petition. In particular, had the Board instituted trial, it would have been the sole
`
`agency to address the obviousness of the claims based on Sigg and Boulange,
`
`which is the only combination asserted in the Petition. See Pet. at 22-23 (asserting
`
`five grounds, all of which require the combination of Sigg and Boulange).
`
`
`
`Thus, the ITC would not consider “the same arguments” as the Board asserts
`
`(Paper 15 at 21) – the ITC would not consider the argument that the challenged
`
`claims were invalid based on Sigg and Boulange, and there would have been no
`
`risk of inconsistent positions between the ITC and the Board as to those arguments.
`
`
`
`Finally, the Board’s conclusion that the stipulation did not apply to the
`
`NDNY Patent Litigation and therefore “the same grounds before us could later be
`
`asserted by Petitioner” there is incorrect. Paper 15 at 22. Had the Board instituted
`
`trial, the estoppel provisions of 35 U.S.C. § 315(e)(2) would prevent Regeneron
`
`asserting in district court that the 631 patent claims are “invalid on any ground that
`
`the petitioner raised or reasonably could have raised” during the IPR.
`
`IV. CONCLUSION
`
`For the reasons expressed herein, Regeneron respectfully requests that the
`
`Board or POP consider this request for rehearing, reconsider its institution
`
`decision, and institute inter partes review.
`
`
`
`
`15
`
`
`
`
`
`Dated: February 12, 2021
`
`
`
`
`IPR2020-01317
`U.S. Patent No. 9,220,631
`
`Respectfully submitted,
`
`/Elizabeth S. Weiswasser/
`Elizabeth S. Weiswasser (Reg. No. 55,721)
`Anish R. Desai (Reg. No. 73,760)
`Natalie Kennedy (Reg. No. 68,511
`Andrew Gesior (Reg. No. 76,588)
`WEIL, GOTSHAL & MANGES LLP
`767 Fifth Avenue
`New York, NY 10153
`T: 212-310-8000
`F: 212-310-8007
`E: REGN.IPR.Service@weil.com
`
`Brian E. Ferguson (Reg. No. 36,801)
`Christopher Pepe (Reg. No. 73,851)
`WEIL, GOTSHAL & MANGES LLP
`2001 M Street NW, Suite 600
`Washington, DC 20036
`T: 202-682-7000
`F: 202-857-0940
`E: REGN.IPR.Service@weil.com
`
`
`
`
`
`16
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`The undersigned hereby certifies that on February 12, 2021, the foregoing
`
`PETITIONER’S REQUEST FOR REHEARING PURSUANT TO 37 C.F.R. §
`
`42.71(d) was served via electronic mail upon the following:
`
`Elizabeth J. Holland
`Linnea Cipriano
`GOODWIN PROCTER LLP
`The New York Times Building
`620 Eighth Avenue
`New York, NY 10018-1405
`eholland@goodwinlaw.com
`lcipriano@goodwinlaw.com
`
`William G. James
` GOODWIN PROCTER LLP
`1900 N Street, N.W.
`Washington, D.C. 20036
`wjames@goodwinlaw.com
`
`Joshua Weinger
`GOODWIN PROCTER LLP
`100 Northern Avenue
`Boston MA 02210-1980
`jweinger@goodwinlaw.com
`
`
`
`/Lauren McDuffie/
`Lauren McDuffie
`IP Paralegal
`Weil, Gotshal & Manges LLP
`2001 M Street NW, Suite 600
`Washington, D.C. 20036
`202-682-7000
`lauren.mcduffie@weil.com
`
`
`
`
`
`
`