Cellectis S.A. v. Precision Biosciences Inc.
MEMORANDUM OPINION. Signed by Judge Sue L. Robinson on 8/6/2012. (nmfn)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
Civ. No. 11-173-SLR
Chad M. Shandler, Esquire of Richards, Layton & Finger LLP, Wilmington, Delaware,
Counsel for Plaintiff. Of Counsel: David L. Delucia, Esquire, Paul M. Richter, Jr.,
Esquire and Anne Elise Herold Li, Esquire of Kenyon & Kenyon LLP.
Richard L. Horwitz, Esquire and David E. Moore, Esquire of Potter Anderson & Corroon
LLP, Wilmington, Delaware. Counsel for Defendant. Of Counsel: David B. Bassett,
Esquire, Vinita Ferrera, Esquire and Allen C. Nunnally, Esquire of Wilmer Cutler
Pickering Hale and Dorr LLP.
Dated: August 6, 2012
Plaintiff Cellectis S.A. ("Cellectis") filed the present action against defendant
Precision Biosciences, Inc. ("Precision") on March 1, 2011, alleging infringement of
U.S. Patent No. 7,897,372 ("the '372 patent"), which is assigned to Cellectis. (D.I. 1)
The '372 patent, entitled "1-Crel Meganuclease Variants with Modified Specificity,
Method of Preparation and Uses Thereof," is directed to particular 1-Crel
meganucleases having mutations that permit binding and cleavage of DNA at specific
8) Currently before the court is Precision's motion to stay the present
litigation pending the completion of ex parte reexamination of the '372 patent. (D.I. 41)
Also before the court is Precision's motion for leave to amend its answer and
counterclaims to add allegations of inequitable conduct in the procurement of the '372
patent. (D. I. 113) For the reasons that follow, the court denies both motions.
A. Procedural Posture
The litigation history between Cellectis and Precision is extensive. In March of
2008, Cellectis sued Precision in the United States District Court for the Eastern District
of North Carolina for infringement of U.S. Patent Nos. 6,610,545 ("the '545 patent") and
7,309,605 ("the '605 patent"). See Cellectis S.A. v. Precision BioSciences, Inc., Civ.
No. 08-118 (E.D.N.C.) ("North Carolina/'). The '545 and '605 patents each issued from
an application first filed by lnstitut Pasteur in 1992, and relate to DNA encoding the
meganuclease 1-Scel. Subsequent to the initiation of suit, Precision requested, and was
granted, inter partes reexamination of the '545 and '605 patents. Precision filed a
motion to stay North Carolina I, which motion was granted in August 2010 at the close
of fact discovery. (D.I. 23 at 6) The United States Patent and Trademark Office ("PTO")
has since rejected the claims of the '545 and '605 patents, and the Board of Patent
Appeals and Interferences affirmed the rejection. 1
On March 1, 2011 at 5:59a.m., as soon as U.S. Patent No. 7,897,372 ("the '372
patent") issued and was publicly available from the PTO's website, Cellectis filed the
instant litigation against Precision for infringement of the '372 patent. 2 Later that same
day, Precision filed a declaratory judgment action on the '372 patent in North Carolina
(E.D.N.C. Civ. No. 11-91 ("North Carolina If')).
On March 22, 2011, Cellectis filed a motion to enjoin Precision from prosecuting
its declaratory judgment actions. (D. I. 7) 3 Thereafter, Precision answered the complaint
in this action and asserted affirmative defenses and counterclaims of non infringement
and invalidity of the '372 patent. (D.I. 10) On April 8, 2011, Precision filed a motion to
transfer the present action to the United States District Court for the Eastern District of
North Carolina. (D.I. 16)
On April 18, 2011, Cellectis amended its complaint in this action and added
1t is not clear whether Cellectis has appealed to the Federal Circuit. (E.D.N.C.
Civ. No. 08-119, D.l. 213)
Previously, on November 30, 2010, Cellectis filed an action for infringement of
U.S. Patent No. 7,842,489 ("the '489 patent") against Precision in this court. (Civ. No.
10-1033-SLR) On December 6, 2010, Precision filed a declaratory judgment action in
the Eastern District of North Carolina regarding the '489 patent. The parties have since
resolved both cases by stipulation filed on October 28, 2011. (Civ. No. 10-1033, D.l.
Docket item numbers will hereinafter reference the present suit, unless
otherwise specifically noted.
claims of unfair competition ("count II") and violations of the Lanham Act, 15 U.S.C. §
1125(a) ("count Ill"), each relating to allegedly false and misleading commercial
representations on Precision's website. (D.I. 22 at 1J1J15-19, 24-31) Precision filed a
Request for Ex Parte Reexamination of the '372 patent with the PTO on April 29, 2011.
(D.I. 42 at 6) Precision filed its answer to Cellectis's amended complaint on May 5,
2011, adding a third affirmative defense that Cellectis is barred from relief on counts II
and Ill of its amended complaint "in whole or in part by laches, estoppel and/or other
equitable doctrines." (D. I. 27 at 5) The court entered a scheduling order on May 17,
2011. (D.I. 33)
The PTO granted Precision's request for ex parte reexamination of the '372
patent on July 8, 2011 and, on August 8, 2011, Precision filed a motion to stay the
present suit pending the outcome of that proceeding. (D.I. 41; D.l. 42 at 1, 6)
On December 6, 2011, Cellectis filed a request for a certificate of correction for the '372
patent to change its claim of priority under 35 U.S.C. § 119 to a claim of priority under
35 U.S.C. § 120. (D.I. 113, ex. A at 1J31) The PTO issued the certificate on January
Discovery has since proceeded in the litigation. On March 28, 2012, Precision
moved for leave to amend its answer to add claims of inequitable conduct in the
procurement of the '372 patent. (D. I. 113) On May 3, 2012, upon consideration of all
of the relevant factors, the court found that Precision did not tip the scales in favor of
transferring the case to North Carolina, and denied Precision's motion to transfer. (D. I.
134; D.l. 135) The court also found that the instant suit (Civ. No. 11-173) was the firstfiled case vis a vis North Carolina II. Insofar as none of the exceptions to the first-filed
rule were applicable, the court granted Cellectis' motion to enjoin the North Carolina
B. The '372 Patent
The '372 patent, entitled "1-Crel Meganuclease Variants with Modified Specificity,
Method of Preparation and Uses Thereof," is directed to particular mutated 1-Crel
meganucleases that bind and cleave DNA at specific sites. The '372 patent issued from
U.S. Patent Application Serial No. 11/908,798 ("the '798 application"), the U.S. phase
application under 35 U.S.C. § 271 of PCT No. PCT/182006/001203, filed March 15,
2006 (hereinafter, the "Parent PCT"). The Parent PCT, in turn, claimed priority to two
foreign applications: (1) PCT/182005/000981 (March 15, 2005); and (2)
PCT/182005/003083 (September 19, 2005). The '372 patent names two inventors:
Philippe Duchateau ("Duchateau"); and Frederic Paques ("Paques").
C. Reexamination Status
The PTO mailed its initial Office Action rejecting all claims (1-54) of the '372
patent on January 18, 2012. Therein, the examiner rejected claims 1-10, 13-16, 19-28,
31-34, 37-46 and 49-52 as anticipated under 35 U.S.C. § 102(e) by another Cellectis
patent application, WO 2004/067736 by Arnauld et al. ("Arnauld"). (D. I. 70) Arnauld is
a PCT (international) application bearing a filing date of January 28, 2004; priority is
claimed to two United States publications published January 28, 2003 and August 1,
2003. 4 (0.1. 113, ex. 1) Arnauld lists several inventors: (1) Duchateau; (2) Paques; (3)
January 28, 2003 is more than a year before the earliest claimed priority date of
the '372 patent; Arnauld's publication date (August 12, 2004) is less than a year from
the filing date of the '798 application that issued as the '372 patent.
Sylvain Arnould ("S. Arnould"); (4) Jean-Pierre Cabaniols; (5) Patrick Chames
("Chames"); (6) Andre Choulika; Jean-Charles Epinat ("J.C. Epinat"); (7) Emmanuel
LaCroix ("LaCroix"); (8) Christophe Perez-Michaut; (9) Julianne Smith; and (1 0) David
The examiner asserts that Arnould discloses SEQ ID 70 as claimed in
independent claim 1, as Arnauld's SEQ ID 5 (Fig. 2C) encodes the first 164 residues of
this sequence. (D.I. 116, ex. 9 at p.4) Further, the examiner has rejected the claims
under 35 U.S.C. § 103(a) as obvious on several grounds, as follows: (1) claims 1-4, 622, 24-40 and 42-53 are obvious in view of Arnould in view of an article in Nucleic Acids
Reserch by Epinat et al.; 5 and (2) claims 1-4, 6-22-24-40 and 42-54 are obvious in view
of an article by Chevalier et al. and other references. 6 (ld. at p.6-9)
In response to the PTO's first office action in the reexamination of the '372
patent, Cellectis has petitioned the PTO to change inventorship on the '372 patent by
adding S. Arnould, Chames, Epinat and LaCroix as inventors, thereby creating unity of
inventorship between the '372 patent and Arnould. (D.I. 140 at p.12) More specifically,
Cellectis has provided a declaration stating that the subject matter of Arnould cited by
the examiner originated from these six inventors. (!d. at p.13) Cellectis has also asked
the examiner to confirm that the '372 patent has the benefit of priority to
PCT/182005/000981 -the earlier of the two foreign applications to which the Parent
Epinat et al., 31 (11) Nucleic Acids Res. 2952-2962 (2003).
Chevalier et al., 329 J. Mol. Bioi. 253-69 (2003); Seligman, D. et al., Mutations
Altering the Cleavage Specificity of a Homing Endonuclease, 30(17) Nucleic Acids
Research 3870-79 (2002); Chevalier et al., Design, Activity and Structure of a Highly
Specific Artificial Endonuclease, 10 Molecular Cell 895-905 (2002). (D.I. 70 at p.3)
PCT claims priority with a priority date of March 15, 2005. (/d.)
D. Facts Relevant to Precision's Motion to Amend
Arnauld is not only the subject of the currently-pending reexamination of the '372
patent, but was at issue during prosecution of the '798 application leading to the '372
patent. Precision avers that on May 20, 2010, before the PTO had issued a decision on
the merits of the '798 application, Paques and prosecuting attorney Dr. Vincent Shier
("Shier") attended an in-person interview with the examiner. (D.I. 113, ex. A at 1f 21)
The record of the interview indicates that Arnauld was discussed, specifically, the
examiner sought an explanation of the differences between Arnauld and the '798
application. (/d.) Cellectis, through Shier, responded to this inquiry by preliminary
amendment (dated July 26, 2010), stating as follows:
[T]he claimed invention differs from [Arnauld] in that this reference at best
provides for a library of mutant meganucleases where residues 44, 68 and
70 are altered. However, in the present invention, it is required that the
monomer further comprises at least one additional mutation of an amino acid
residue directly contacting a DNA target at other positions (see claims 59 and
95) and further defines that the at least one additional mutation of an amino
acid sequence directly contacting a DNA target sequence is selected from
the group consisting of positions 26, 28, 30, 32, 33 and 38 (see claims 60
and 96). This concept and the variant meganucleases are not disclosed in
[Arnauld] and, as such, would not affect the patentability of the claimed
(/d. at 1f 22; D.l. 113, ex. 2 at 20-21)
Precision claims that these statements were known to be "unequivocally false" by
Shier and Paques when they were made, and cites the purportedly missing specific
disclosures within Arnauld. (D.I. 113, ex. A at 1f1f 23-24) For example, Arnauld
discloses an intermediate library: "Lib1 (residues 26, 28, 30, 33 and 38 mutated[)]." (/d.
at 1f 24) Precision avers that, "[b]ut for these false statements, the PTO would not have
granted the claims of the '372 patent because the disclosure of [Arnould] includes all
elements of [the] claims of the '372 patent or would, at a minimum, render those claims
obvious." (/d. at 1J 26)
With respect to intent to deceive, Precision states generally that "Dr. Shier and
Dr. Paques knew these statements were unequivocally false since they were
characterizing Cellectis and Dr. Paques' own work and patent application, and since Dr.
Shier himself prosecuted the United States counterpart to [Arnould] in which
prosecution he made diametrically opposite representations to the PTO." (ld. at 1J 23;
see also id. at 1J 28) Specifically, Precision alleges that, six months prior to the
preliminary amendment dated July 26, 2010, Shier and Paques told the PTO that
Arnould teaches methods of making 1-Crel variant meganucleases with substitutions at
positions 26, 28, 30, 33, 38, 44, 68 and 70. 7 (ld. at 1J 29)
As noted above, Cellectis sought and obtained the request for a certificate of
correction for the '372 patent to change its claim of priority under 35 U.S.C. § 119 to a
claim of priority under 35 U.S.C. § 120. Precision avers that "Cellectis and [Shier's]
action in seeking the certificate of correction further evidences their knowledge that the
[Arnould] reference discloses the claimed invention of the '372 patent claims and that
[Shier and Paques'] earlier representations to the PTO regarding the scope and content
of [Arnould] on behalf of Cellectis were false." (/d.)
The court does not have before it the December 14, 2009 amendment to the
United States counterpart to Arnould referenced by Precision.
A. Motion to Stay
Motions to stay invoke the broad discretionary powers of the court. Dentsply lnt'l,
Inc. v. Kerr Mfg. Co., 734 F.Supp. 656, 658 (D. Del. 1990) (citing Bechtel Corp. v.
Laborers' lnt'l Union, 544 F.2d 1207, 1215 (3d Cir. 1976)). Three general factors inform
the court in this regard:
(1) whether the granting of a stay would cause the non-moving party to suffer
undue prejudice from any delay or allow the moving party to gain a clear tactical
advantage over the non-moving party; (2) whether a stay will simplify the issues
for trial; and (3) whether discovery is complete and a trial date set.
Enhanced Security Research, LLC v. Cisco Sys., Inc., Civ. No. 09-571, 2010 WL
2573925, at *3 (D. Del. June 25, 2010) (citing St. Clair Intellectual Prop. Consultants v.
Sony Corp., Civ. No. 01-557, 2003 WL 25283239, at *1 (D. Del. Jan. 30, 2003)).
B. Motion to Amend
"[L]eave to amend 'shall be freely given when justice so requires." Foman v.
Davis, 371 U.S. 178, 182 (1962) (quoting Fed. R. Civ. P. 15(a)). The court may
exercise its discretion to deny leave to amend in situations in which the moving party
has delayed seeking leave and the delay "is undue, motivated by bad faith, or
prejudicial to the opposing party." Bjorgung v. Whitetail Resort, LP, 550 F.3d 263, 266
(3d Cir. 2008) (citation omitted). Put another way, where the non-moving party will not
suffer "substantial or undue prejudice," "denial [of leave to amend] must be based on
bad faith or dilatory motives, truly undue or unexplained delay, repeated failures to cure
the deficiency by amendments previously allowed, or futility of amendment." USX Corp.
v. Barnhart, 395 F.3d 161, 166 (3d Cir. 2004) (quoting Lorenz v. CSXCorp., 1 F.3d
1406, 1413-14 (3d Cir. 1993)). Delay is "undue" when an unwarranted burden is placed
on the court or when the requesting party has had previous opportunities to amend.
See Estate of Oliva ex ref. McHugh v. New Jersey, 604 F.3d 788, 803 (3d Cir. 201 0)
A. Precision's Motion to Stay
This court has previously articulated factors which bear upon whether "there is
'even a fair possibility' that the stay would work damage on another party" in weighing
the propriety of staying litigation in favor of inter partes reexamination proceedings.
See Belden Techs. Inc. v. Superior Essex Comm's LP, Civ. No. 08-63, 2010 WL
3522327 (Sept. 2, 201 0) (citing Dentsply lnt'l, 734 F.Supp. at 658 (internal citations
omitted)). In passing the America Invents Act, Congress has negated the need for the
court's balancing of such factors. The court is now mandated to stay litigation in favor
of inter partes reexamination "unless the court before which such litigation is pending
determines that a stay would not serve the interests of justice."8 35 U.S.C. § 318.
No comparable stay provision was included in the AlA with respect to ex parte
reexaminations, which are granted by the PTO if a "substantial new question of
patentability" is presented. That is, there is no indication inherent to the granting of an
ex parte reexamination that continued prosecution will likely result in the changing of
Congress mandated that the PTO may now only grant inter partes
reexamination/review proceedings after September 16, 2011 if it believes there is a
"reasonable likelihood that the petitioner would prevail with respect to at least 1 of the
claims challenged in the petition." Leahy-Smith America Invents Act, Pub. L. No.
112-29, § 314(a), 125 Stat 284 (Sept. 16, 2011 ). A stay of litigation is practical given
the PTO's determination that the claims under reexamination will likely change.
While the court's framework articulated in Belden, supra, and its progeny remain
applicable in this context, the Federal Circuit's recent jurisprudence is also informative.
In In re Baxter International, Inc.,- F.3d -, 2012 WL 1758093 (Fed. Cir. May 17,
2012) (hereinafter, "Baxter'), litigation on the patent at issue (U.S. Patent No.
5,247,434, or "the '434 patent") had concluded in the United States District Court for the
Northern District of California with that court reversing the jury's verdict that the '434
patent claims were invalid. /d. at *2. Meanwhile, concurrent reexamination proceedings
concluded with the examiner's rejection of several claims of the '434 patent as obvious
in view of the prior art. /d. The Federal Circuit thereafter affirmed the district court's
grant of judgment as a matter of law, albeit for different reasons than those articulated
by the trial court. /d. The Board of Patent Appeals and Interferences ("BPAI'') was
directed to consider the Federal Circuit's decision, but subsequently affirmed the
examiner's rejections citing the "lower standard of proof and the broadest reasonable
interpretation standard of claim construction [that] apply at the PTO[.]" /d. at *3.
On appeal (now for the second time), the Federal Circuit affirmed the rejection of
the '434 patent claims by the BPAI on the basis that substantial evidence supported the
BPAI's findings regarding the disclosures of the prior art. /d. at *6. In so doing, the
Court emphasized that the PTO and district courts "take different approaches in
determining validity and on the same evidence could quite correctly come to different
conclusions," i.e., "the two proceedings necessarily applied different burdens of proof
and relied on different records." 9 /d. at *6-7. Judge Newman dissented, arguing that the
PTO has no authority to nullify a final judicial determination, i.e., to ignore "the law of the
case." /d. at *8-13.
Baxter demonstrates that, while unification of result between concurrent PTO and
judicial proceedings is desirable, 10 it is neither the standard nor a practical reality given
that the Federal Circuit may reach different and, in fact, inconsistent results in the
subsequent appeals. That Court has made clear that "elevat[ing] a decision by the PTO
over a decision by a federal district court" would be "erroneous," id. at *7; therefore,
the court need not defer to the PTO's expertise in evaluating the claims at issue.
The court has previously "observe[d] that the strategy of responding to litigation
by pursuing reexamination is simply another example of forum-shopping, perfectly
legitimate but, nonetheless, a way to postpone a patent holder's day in court." Cel/ectis
S.A. v. Precision Biosciences, Inc.,- F. Supp. 2d -, 2012 WL 1556489 at *7 (D. Del.
May 3, 2012). As detailed above, the litigation history demonstrates that the parties at
bar have each maneuvered for their preferred forums. While Precision filed its
reexamination request promptly, Cellectis initiated the present suit on the day of the
'372 patent's issuance. Cf. Belden, 2010 WL 3522327 at *2 ("A request for
The Federal Circuit noted that "the patent examiner relied on new prior art that
had not been raised in the prior district court proceeding. Why Fresenius did not
present that prior art before the district court we do not know." Baxter, 2012 WL
1758093 at *7.
"When a party who has lost in a court proceeding challenging a patent, from
which no additional appeal is possible, provokes a reexamination in the PTO, using the
same presentations and arguments, even with a more lenient standard of proof, the
PTO ideally should not arrive at a different conclusion." Baxter, 2012 WL 1758093 at
reexamination made well after the onset of litigation followed by a subsequent request
to stay may lead to an inference that the moving party is seeking an inappropriate
tactical advantage.") (emphasis added). Furthermore, discovery in this case is nearing
completion 11 and the concurrent reexamination is still in its infancy. 12 In sum, the court
declines to stay the instant case in its discretion in view of Baxter and in further view of
the Belden factors articulated herein.
B. Precision's Motion to Amend
Futility of amendment occurs when the complaint, as amended, does not state a
claim upon which relief can be granted. See In re Burlington Coat Factory Sec. Litig.,
114 F.3d 1410, 1434 (3d Cir. 1997). If the proposed amendment "is frivolous or
advances a claim or defense that is legally insufficient on its face, the court may deny
leave to amend." Harrison Beverage Co. v. Dribeck Importers, Inc., 133 F.R.D. 463,
468 (D.N.J. 1990).
To prove inequitable conduct, Precision must demonstrate that reexamination
counsel had the specific intent to mislead the PTO; intent cannot be solely inferred from
materiality. See Therasense, 2011 WL 2028255 at *1 0. "[T]o meet the clear and
convincing evidence standard, the specific intent to deceive must be the single most
The fact discovery deadline is August 31, 2012; expert discovery closes
October 31, 2012; and dispositive motions are due a week thereafter on November 7,
2012. (D. I. 142) The court is cognizant of the fact that Precision filed the motion at bar
in August 2011; as the court takes up the motion, discovery nears a close. See gen.
Belden, 2010 WL 3522327 at *2 (granting a request for stay later in the litigation is
prejudicial to defendant given their investment in the case).
See Belden, 2010 WL 3522327 at *3 ("[O]nly those reexamination proceedings
that have been substantially completed will weigh in favor of a stay.").
reasonable inference able to be drawn from the evidence." /d. (quotation omitted).
As explained above, the alleged inequitable conduct in this case is Shier and
Paques' alleged mischaracterization of Arnauld by Shier and Paques. (D.I. 113, ex. A
at 1J22) It is not the case that Precision alleges that Cellectis committed inequitable
conduct by, for example, intentionally withholding material prior art from the PTO. The
prior art allegedly mischaracterized -Arnauld -was a focus of the prosecution. The
examiner specifically sought the inventors' comments on the reference.
Precision does not offer evidence of deceptive intent separate and apart from
materiality, that is, Precision emphasizes that intent should be inferred from the
inconsistency between Shier and Paques' statements to the PTO during different
prosecutions and the fact that a certificate of correction was filed. (D. I. 136 at 3-5 ("Dr.
Shier and Dr. Paques must therefore have intentionally chosen to offer a different and
inaccurate description of [Arnound] in order to secure allowance of the '372 patent's
claims"); D.l. 113, ex. A at 1J1J23, 28, 31) The court cannot rely solely on a finding of
materiality to infer intent; both are separate requirements. See Cancer Research Tech.
Ltd. v. Barr Labs., Inc., 625 F.3d 724, 733 (Fed. Cir. 2010). That is, the court "must find
some other evidence that indicates that the applicant appreciated the information's
materiality." /d. (citation omitted) (holding that common authorship to a study containing
contradictory data did not establish that the data was withheld with an intent to deceive).
The court appreciates Precision's position that Shier and Paques expressly
contradicted the teachings of Arnauld. Precision does not cite authority demonstrating
that this fact may substitute for independent evidence of intent to deceive, however,
where the prior art at issue was a focus of the examination. Here, both examiners were
free to credit or discount Shier and Paques' characterizations of Arnauld in view of their
own readings. See gen. MPEP § 716.01 (c) ("The arguments of counsel cannot take the
place of evidence in the record."); Akzo N.C. v. U.S. Intern. Trade Com'n, 808 F.2d
1471, 1482 (Fed. Cir. 1986) (finding no inequitable conduct and stating that the
"examiner was free to reach his own conclusion" as to validity in view of the prior art
before him, notwithstanding counsel's arguments distinguishing that prior art).
Moreover, even assuming that Shier and Paques completely reversed their
interpretation of Arnauld prior to filing the July 26, 2010 preliminary amendment,
cannot drop the "atomic bomb" by mere conjecture that the prosecution
attorney's zealous arguments were inequitable conduct. Attorneys
prosecuting a patent should be able to correct mistakes, change their
opinion, or adjust their argument to convince the examiner without risking
invalidation of the patent by a later finding of inequitable conduct. As
devastating as inequitable conduct can be, pleading the charge should
Human Genome Sciences, Inc. v. Genentech, Inc., Civ. No. 11-6519, 2011 WL
7461786, *6-7 (C. D. Cal. Dec. 9, 2011) (citing Therasense, 649 F.3d at 1290). The
PTO's granting of a certificate of correction to Cellectis on its priority claim is not
evidence of deceptive intent and, absent more, Precision's proposed inequitable
conduct claim is deficient. Precision's motion to amend is denied on the basis of futility.
For the foregoing reasons, Precision's motions to stay and to amend its answer
and counterclaims are denied. An appropriate order shall issue.
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