Case 1:20-cv-01630-RGA-JLH Document 97 Filed 01/04/22 Page 1 of 12 PageID #: 1642
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`INC., AMARIN
`PHARMA,
`AMARIN
`IRELAND
`PHARMACEUTICALS
`LIMITED, MOCHIDA PHARMACEUTICAL
`CO., LTD.
`
`Plaintiffs;
`
`Civil Action No. 20-1630-RGA-JLH
`
`V.
`
`HIKMA PHARMACEUTICALS USA INC. ,
`HIKMA PHARMACEUTICALS PLC, AND
`HEALTH NET, LLC,
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`Defendants.
`
`MEMORANDUM OPINION
`
`Jeremy D . Anderson, FISH & RICHARDSON P.C., Wilmington, DE, Elizabeth M. Flanagan,
`Michael Kane (argued), Deanna J. Reichel, FISH & RICHARDSON P.C., Minneapolis, MN;
`Jonathan E. Singer, FISH & RICHARDSON P.C., San Diego, CA;
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`Attorneys for Plaintiffs.
`
`Dominick T. Gattuso, HEYMAN ENERIO GATTUSO & HIRZEL LLP, Wilmington, DE;
`Charles B. Klein (argued), Claire A. Fundakowski, WINSTON & STRAWN LLP, Washington,
`DC; Eimeric Reig-Plessis, WINSTON & STRAWN LLP, San Francisco, CA; Alison M. King,
`WINSTON & STRAWN LLP, Chicago, IL;
`
`Attorneys for Defendants Hikma Pharmaceuticals USA Inc. and Hikma Pharmaceuticals
`PLC.
`
`John C. Phillips, Jr. , David A. Bilson, PHILLIPS MCLAUGHLIN & HALL, P.A., Wilmington,
`DE; Don J. Mizerk (argued), HUSCH BLACKWELL LLP, Chicago, IL; Dustin L. Taylor,
`HUSCH BLACKWELL LLP, Denver, CO;
`
`Attorneys for Defendant Health Net.
`
`January 4, 2022
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`Case 1:20-cv-01630-RGA-JLH Document 97 Filed 01/04/22 Page 2 of 12 PageID #: 1643
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`'ltc:il;,~,
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`I referred this very interesting case to a magistrate judge. (D .I. 16). She wrote a Report
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`and Recommendation on three pending motions to dismiss. (D.1. 64). Defendants filed
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`objections (D.I. 70, 71), to which Plaintiffs responded (D.I. 77, 78). There is even an amicus
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`brief. (D.1. 75). I heard oral argument on October 14, 2021. For the following reasons, I will
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`ADOPT-IN-PART the Report and Recommendation. (D.1. 64). Hikma's motion to dismiss the
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`First Amended Complaint (D.I. 19) is GRANTED. Hikma' s motion to dismiss the original
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`complaint (D.I. 11) is DISMISSED AS MOOT. Health Net's motion to dismiss the First
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`Amended Complaint (D.1. 30) is DENIED.
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`I.
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`BACKGROUND
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`Plaintiffs sued Defendants for induced infringement of three patents that describe
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`methods of using icosapent ethyl for the reduction of cardiovascular risk. (D.I. 17). Plaintiffs
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`manufacture and sell VASCEPA, a branded version of icosapent ethyl. (Id. at ,r,r 1, 57-58).
`Defendant Hikma is a generic manufacturer of icosapent ethyl. (Id. at ,r 1). Defendant Health
`Net is an insurer that provides coverage for Vascepa and Hikma' s generic version. (Id. at ,r,r
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`139-40).
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`II.
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`LEGAL STANDARD
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`A motion to dismiss for failure to state a claim upon which relief may be granted is
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`considered a dispositive motion. D. Del. LR 72.l(a)(3). A magistrate judge's Report and
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`Recommendation regarding a case-dispositive motion is reviewed de nova. Fed. R. Civ. P.
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`72(b)(3).
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`When reviewing a motion to dismiss pursuant to Federal Rule of Civil Procedure
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`12(b)(6), the Court must accept the complaint's factual allegations as true. See Bell At!. Corp. v.
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`Twombly, 550 U.S. 544, 555-56 (2007). Rule 8(a) requires "a short and plain statement of the
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`claim showing that the pleader is entitled to relief." Id. at 555 . The factual allegations do not
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`have to be detailed, but they must provide more than labels, conclusions, or a "formulaic
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`recitation" of the claim elements. Id. ("Factual allegations must be enough to raise a right to
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`relief above the speculative level .. . on the assumption that all the allegations in the complaint
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`are true (even if doubtful in fact). "). Moreover, there must be sufficient factual matter to state a
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`facially plausible claim to relief. Ashcroft v. Iqbal, 556 U.S . 662, 678 (2009). The facial
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`plausibility standard is satisfied when the complaint' s factual content "allows the court to draw
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`the reasonable inference that the defendant is liable for the misconduct alleged." Id. ("Where a
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`complaint pleads facts that are merely consistent with a defendant' s liability, it stops short of the
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`line between possibility and plausibility of entitlement to relief." (internal quotation marks
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`omitted)).
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`Section 271 (b) provides, "whoever actively induces infringement of a patent shall be
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`liable as an infringer." 35. U.S.C. 271(b). To state a claim for induced infringement, the
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`complaint must allege that there has been direct infringement, that the defendant knowingly
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`induced infringement, and that the defendant has the intent to encourage another' s infringement.
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`MEMC Elec. Materials, Inc. v. Mitsubishi Materials Silicon Corp., 420 F.3d 1369, 1378 (Fed.
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`Cir. 2005). A generic manufacturer can be liable for inducing infringement of a patented method
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`even when the generic has attempted to "carve out" the patented indications. GlaxoSmithKline
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`LLC v. Teva Pharmaceuticals USA, Inc., 7 F.4th 1320, 1338 (Fed. Cir. 2021) (per curiam).
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`III.
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`IDKMA'S MOTION TO DISMISS
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`A. BACKGROUND
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`Amarin sells V ascepa (icosapent ethyl) for the treatment of severe hypertriglyceridemia
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`(the "SH indication") and cardiovascular risk reduction (the "CV indication"). (D.I. 17 at ,r,r 1,
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`56). Only the CV indication is covered by Plaintiffs' patents. (See D.I. 22 at 1). Hikma
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`received FDA approval to sell a generic version for the SH indication under the "skinny label" or
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`"section viii carveout" regime. (D.I. 17 at ,r,r 11, 95, 108). This regime allows a generic to
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`sidestep the typical FDA requirement that a generic' s labeling is the same as the brand's
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`labeling. 21 U.S.C. §§ 355G)(2)(A)(viii). The generic does so by removing the portions of the
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`label associated with the patented use, resulting in a "skinny label." Plaintiffs allege that
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`Defendant Hikma's label is "not-skinny-enough" and that the label, along with Hikma's public
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`statements, induce infringement of Plaintiffs' patents for the CV indication. (D.I. 22 at 1).
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`B. DISCUSSION
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`1. The Federal Circuit's GSK Decision
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`Two days after the Report issued, the Court of Appeals issued the most recent
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`authoritative opinion concerning skinny labels, albeit after the case was fully litigated in the
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`district court. See GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. [hereinafter
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`"GSIC], 7 F.4th 1320 (Fed. Cir. 2021). The Federal Circuit affirmed a jury's findings that Teva's
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`"partial label" induced infringement of GSK's patent, notwithstanding Teva' s attempt to exclude
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`the patented use from its label under the skinny label regime. (Id. at 1338). Ultimately, the
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`Federal Circuit concluded, "Teva's partial label did not successfully carve out the patented use,
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`and thus, Teva was selling its generic with a label which infringed the method claim." Id.
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`Accordingly, Teva's label was "not a skinny label." Id. at 1328.
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`The Federal Circuit also found that two Teva press releases supported the jury's verdict.
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`Id. at 1335-37. The first press release advertised Teva' s drug as "indicated for treatment of heart
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`failure" and did "not parse between congestive heart failure [the patented indication] or post-MI
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`L VD [an unpatented indication]." Id. at 1336. The second press release stated that Teva
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`received approval to market "its Generic version of GlaxoSmithKline' s cardiovascular agent
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`Coreg." Id. Expert testimony established that the phrase "' cardiovascular agent' ' indicated to
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`doctors they could use Teva' s carvedilol ' for all indications,' including heart failure. " Id.
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`The Court held that GSK is a "narrow, case-specific review" and that it is still the law that
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`"generics could not be held liable for merely marketing and selling under a ' skinny' label
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`omitting all patented indications, or for merely noting (without mentioning any infringing uses)
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`that FDA had rated a product as therapeutically equivalent to a brand-name drug." Id. at 1326.
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`An "AB rating," as the complaint explains, "reflects a decision [by the FDA] that a generic drug
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`is therapeutically equivalent to a branded drug when the generic drug is used as labeled[.]" (D.I.
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`17 at, 98). As GSK's discussion of Teva' s press releases illustrates, where a generic label does
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`not effectively carve out a patented use, advertisement that the drug is " AB rated" can support a
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`finding of inducement. GSK, 7 F.4th at 1335.
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`2. Amarin's Complaint
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`Amarin' s complaint pleads several factual allegations in support of its claim that Hikma
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`induces infringement. These allegations fall into two categories: Hikma' s label and Hikma' s
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`public statements. The Magistrate Judge recommends I deny Hikma' s motion to dismiss because
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`"several ... portions of Hikma's label, taken together with Hikma's public statements, instruct
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`physicians to use Hikma's product in a way that infringes the asserted patents." (D.I. 64 at 12).
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`The bulk of the briefing and oral argument was directed to Hikma's label, and I will address
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`those arguments first.
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`As to the label, Hikma objects that Arnarin' s complaint fails to plead instruction as to at
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`least two claim limitations-the requirement that icosapent ethyl be administered to reduce CV
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`risk and the requirement to co-administer with a statin. (D.I. 71 at 7-8). Because I agree with
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`Hikma that there has been no instruction as to CV risk reduction, I will not address Hikma' s
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`argument regarding co-administration with a statin.
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`Arnarin contends that Hikma' s label teaches CV risk reduction for two reasons. First,
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`Hikma' s label contains a notice regarding side effects for patients with CV disease. (D.I. 78 at 5-
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`6). Second, Hikma's label does not "state that Hikma's ' generic version' of VASCEPA should
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`not be used for the CV Indication or that the effect of icosapent ethyl on cardiovascular mortality
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`and morbidity in patients with severe hypertriglyceridemia has not been determined" (the "CV
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`limitation"). (D.I. 17 at ,r,r 108, 121). Hikma responds that (1) the notice regarding side effects
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`is a warning and thus not an instruction to use icosapent ethyl to reduce cardiovascular risk, and
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`(2) the removal of the CV risk reduction limitation is mere silence and that Hikma has no duty to
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`discourage infringing use.
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`Regarding the warning as to side effects, I agree with Hikma. The label states,
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`"Icosapent ethyl may cause serious side effects, including: ... Heart rhythm problems which can
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`be serious and cause hospitalization have happened in people who take icosapent ethyl,
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`especially in people who have heart (cardiovascular) disease or diabetes with a risk factor for
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`heart (cardiovascular) disease[.]" (D.I. 17, Ex.Kat 12-13 of 15). This is hardly instruction or
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`encouragement. See, e.g., Otsuka Pharm. Co. v. Torrent Pharms. Ltd. , 99 F. Supp. 3d 461 , 490
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`(D.N.J. 2015) ("[A] warning is just that-a warning. It is not an instruction[.]").
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`Amarin also argues that Hikma "removed" 1 the CV limitation from its label, which would
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`be "understood in the field to teach that Hikma' s product has been proven to reduce CV risk and
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`to encourage its use for that purpose" because other drugs in the same class have not been shown
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`to reduce CV risk. (D.I. 78 at 4). This amounts to an "affirmative statement" that it can be used
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`for cardiovascular risk reduction, according to Plaintiffs. (D.I. 85 at 62:16-62:5).
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`The Federal Circuit has previously rejected the argument that generic labels must contain
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`a "clear statement" discouraging use of the patented indication. Takeda Pharms. U S.A., Inc. v.
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`W-Ward Pharm. Corp. , 785 F.3d 625, 632 n.4 (Fed. Cir. 2015). Plaintiffs must plead that
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`"Hikma took affirmative steps to induce, not affirmative steps to make sure others avoid
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`infringement." Id. Even if Plaintiffs are right that Hikma' s label' s silence regarding CV risk
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`reduction communicates to the public that icosapent ethyl can be used to reduce CV risk,
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`"merely describing an infringing mode is not the same as recommending, encouraging, or
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`promoting an infringing use." Id. at 631 ( cleaned up). I therefore find that the lack of a CV
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`limitation on Hikma' s label does not plausibly teach CV risk reduction.
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`Since I find that the label does not instruct CV risk reduction, the question is whether
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`Hikma' s public statements, including press releases and Hikma' s website, induce infringement.
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`(D.I. 17 at ,r 127). Hikma' s press releases state that its product is the "generic equivalent to
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`V ascepa®" and that "Vascepa is a prescription medicine that is indicated, in part, as an adjunct
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`to diet to reduce triglyceride levels in adult patients with severe (~500 mg/dL)
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`1 Hikma contests Plaintiffs' use of the word "removal," noting, "Amarin removed the limitation
`of use from Vascepa' s label before Hikma launched its product, and Hikma was required to use
`'the same [labeling] as the labeling approved for the listed drug."' (D .I. 71 at 7 n.2 ( citing 21
`U.S.C. § 355(j)(2)(A)(v))). The facts pled in the complaint state that the removal happened
`during the FDA approval process. (D.I. 17 at ,r 108). At any rate, it appears that there is no
`allegation that Hikma' s product was ever marketed with a label containing the CV limitation.
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`hypertriglyceridemia. According to IQVIA, US sales ofVascepa® were approximately $919
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`million in the 12 months ending February 2020." (Id. at ,r 112). The sales figures cited by
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`Hikma include Vascepa' s sales of the patented indication. The complaint further alleges that
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`Hikma' s website states that Hikma' s generic is "AB rated" in the "Therapeutic Category:
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`Hypertriglyceridemia." (Id. at ,r 125).
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`Hikma' s press releases might be relevant to intent but they do not support actual
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`inducement. Hikma' s advertising of icosapent ethy 1 as the "generic equivalent" of V ascepa does
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`not expose Hikma to liability. GSK, 7 F.4th at 1335 n.7. The citation ofVascepa' s sales figures
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`go to Hikma's intent to induce. Intent alone is not enough; Amarin must plead an inducing act.
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`Amarin also alleges that Hikma' s website induces infringement by advertising its
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`product in the therapeutic category "hypertriglyceridemia." The complaint pleads,
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`"hypertriglyceridemia .. . does not match and is broader than the Indications and Usage sections
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`of Hikma' s Label, which includes only Severe Hypertriglyceridemia Indication (i.e.,
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`triglycerides 2':500 mg/dL)." (D.I. 17 at ,r 126). Accepting the facts in the light most favorable to
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`Amarin, Amarin has pled that the category "hypertriglyceridemia" includes infringing uses. The
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`question is whether this is enough, without a label or other public statements instructing as to
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`infringing use, to induce infringement.
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`I hold that it is not. This statement does not rise to the level of encouraging,
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`recommending, or promoting taking Hikma' s generic for the reduction of CV risk.
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`Two recent Federal Circuit cases are instructive on this point. The GSK majority found
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`that Teva's advertising of "its Generic version of GlaxoSmithK.line' s cardiovascular agent,"
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`when "cardiovascular agent" was a category that included both infringing and non-infringing
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`uses, supported a jury' s finding of inducement. 7 F.4th at 1336. The Court emphasized that:
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`Teva did not merely say its drug is a cardiovascular agent, leaving the world to wonder
`about its uses. It said its product is a generic equivalent of GSK' s cardiovascular agent
`Coreg®. It was reasonable for the jury to conclude, especially in light of the prior press
`release that expressly mentioned heart failure, that Teva was again encouraging the
`substitution of its product for all of Coreg's® cardiovascular indications, including as
`claimed in the '000 patent.
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`Id. at 1337. In contrast, the Federal Circuit has found that a label indicated for " [m]oderate to
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`severe chronic pain," which included both infringing and non-infringing uses, did "not
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`specifically encourage use" of the generic for the patented treatment. Grunenthal GMBH v.
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`Alkem Lab'ys Ltd. , 919 F.3d 1333, 1339 (Fed. Cir. 2019) ("[E]ven if severe chronic pain includes
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`polyneuropathic pain, it also includes mononeuropathic pain and nociceptive pain. Therefore, the
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`proposed ANDA labels do not specifically encourage use oftapentadol hydrochloride for
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`treatment of polyneuropathic pain.").
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`Here, Hikma stated that its product was "AB Rated'" in a category that includes both
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`patented and non-patented uses. The "AB rating" points to the label, as the GSK court explained:
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`We do not hold that an AB rating in a true section viii carve-out (one in which a label
`was produced that had no infringing indications) would be evidence of inducement. In
`this case, Teva' s representation of AB rating would point physicians to its partial label,
`which, for the reasons above, the jury was free to credit as evidence of induced
`infringement.
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`GSK, 7 F.4th at 1335 n.7. Unlike Teva' s press release in GSK, Hikma has not pointed to
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`Vascepa' s patented uses in describing itself as Vascepa' s generic equivalent. This case is more
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`like Grunenthal, where the broader category simply includes both infringing and non-infringing
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`uses, without "specifically encourage[ing]" the use of the generic for the non-infringing uses.
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`919 F.3d at 1339.
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`Since I find that Amarin' s complaint has failed to plead inducement based on Hikma' s
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`label or public statements, I will grant Hikma' s motion to dismiss.
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`IV. HEAL TH NET'S MOTION TO DISMISS
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`A. BACKGROUND
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`Defendant Health Net provides insurance coverage for Plaintiffs' branded Vascepa and
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`Defendant Hikma' s generic version. According to Plaintiffs, Health Net' s formulary placement
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`induces infringement of Plaintiffs' patents by encouraging the use of Hikma' s generic for the CV
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`indication. Health Net' s formulary lists Hikma' s generic in a lower tier than Amarin' s Vascepa,
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`resulting in lower copays when a patient opts for Hikma' s generic. (D.I. 17 at ,r 143). Since it is
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`common for pharmacies to automatically substitute an AB-rated generic such as Hikma' s for the
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`branded version, Plaintiffs allege that this formulary placement leads to substitution on "all
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`VESCEP A prescriptions, not just the prescriptions directed to the" SH indication. (Id. at ,r 151 ).
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`B. DISCUSSION
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`The Report recommends I deny Health Net' s motion to dismiss because there are factual
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`questions regarding whether Health Net has taken an affirmative act to induce infringement and
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`whether Health Net's actions actually cause others to infringe. (D.I. 64 at 17). Health Net
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`objects, "Plaintiffs fail to allege facts (not conclusions or speculation) supporting a plausible
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`conclusion that Health Net was aware of the asserted patents, and once aware, took affirmative
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`steps with the specific intent to induce another ' s infringement of those patents-rather than
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`merely acting despite knowledge that others may infringe." (D.I. 70 at 2). I disagree.
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`I find that the complaint pleads enough facts to plausibly allege knowledge of the
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`asserted patents. Amarin sent a pre-suit letter to its point of contact for Health Net. (D.1. 17 at ,r
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`87). It is true that the pre-suit letter did not specify the patent numbers. However, the letter
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`states that Amarin has patent exclusivity for the CV indication, and the complaint elsewhere
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`pleads that the patents associated with the CV indication are readily available through a resource
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`well-known in the industry, the FDA's Orange Book. (Id at ,r,r 84, 88). Thus, I agree with the
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`Magistrate Judge that these facts, taken together in the light most favorable to the Plaintiffs,
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`make it plausible that Health Net had specific knowledge of the patents at issue.
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`Read in the light most favorable to Amarin, the complaint also plausibly alleges
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`affirmative acts taken with a specific intent to induce another's infringement. Formulary
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`selection and the prior authorization process, as pled, could be affirmative acts under the law of
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`induced infringement. Health Net argues that the selection of its formulary is automatic, based
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`on Plaintiffs own pricing as compared to the generic. (D.I. 85 at 75:5-12 (noting that "this is
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`done by a computer program")). This may be true, but it is not a shield. Health Net added
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`generic icosapent ethyl capsules to its formularies . (D.I. 17 at ,r,r 140-143). It is immaterial
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`whether the placement was done by a human or a computer.
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`Amarin also plausibly pleads specific intent to induce. At the very least, Health Net' s
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`prior authorization form supports an inference of specific intent because it lists the patented
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`indication on the generic icosapent ethyl capsules form. (D.I. 17 at ,r 159). Health Net' s
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`placement of generic icosapent ethyl on a preferred tier encourages the substitution of the generic
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`for the branded drug, including for the patented indication. (Id at ,r,r 145, 151). Together, this is
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`enough to plead specific intent to induce.
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`In its objections, Health Net argues that the "preferred" language in its formularies cannot
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`be an active step because they are required by state law to disclose which drugs are "preferred."
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`(Id at 5). This may be true, but it is not the language of the formulary that is at issue; it is the
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`incentives the formulary puts in place. (See id at ,r,r 145, 151).
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`Health Net stresses that they are just a payer, not the physician writing the prescription
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`nor the pharmacist making the substitution. (D.I. 70 at 9). As the Report points out, "It may ...
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`tum out that, despite knowledge of infringement by its beneficiaries and their providers, Health
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`Net' s actions in selecting its formulary and adopting its prior authorization procedure . . . do not,
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`in fact, influence the decisions of beneficiaries, pharmacists, and medical providers to use,
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`dispense, and prescribe Hik:rna' s generic product in an infringing way[.]" (D.I. 64 at 17; see
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`Warner-Lambert Co. v. Apotex Corp. , 316 F.3d 1348, 1364 (Fed. Cir. 2003) ("[I]f a physician,
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`without inducement by Apotex, prescribes a use of gabapentin in an infringing manner, Apotex's
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`knowledge is legally irrelevant. In the absence of any evidence that Apotex has or will promote
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`or encourage doctors to infringe the neurodegenerative method patent, there has been raised no
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`genuine issue of material fact. ")). These are factual questions that cannot be resolved on a
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`motion to dismiss.
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`Ultimately, I agree with the Magistrate Judge that Plaintiffs have pled enough to proceed
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`with their case against Health Net.
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`V.
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`CONCLUSION
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`An appropriate order will follow.
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`Page 12 of 12
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