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[COURT OF APPEAL] |
REGINA v. LICENSING AUTHORITY ESTABLISHED UNDER |
MEDICINES ACT 1968, Ex parte SMITH KLINE & FRENCH |
LABORATORIES LTD. (No. 2) |
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High Court - Procedure - Injunctive relief - Manufacturer's confidential research data supplied to licensing authority to obtain product licence - Licensing authority seeking to use research data when assessing other applications for product licences - Whether injunction available to prohibit use - Crown Proceedings Act 1947 (10, 11 & 12 Geo. 6, c. 44), ss. 21(2), 38(2)1 - Supreme Court Act (c. 54), s. 31(1)(2)2 |
Judicial Review - Crown - Interim injunctive relief - Drug manufacturer claiming confidential research data not useable without consent - Interlocutory injunction sought against statutory authority or minister pending determination of petition for leave to appeal - Whether jurisdiction to grant interlocutory injunction against officer of Crown - Whether stay of proceedings available - R.SC, Ord. 53, r. 3(10)(a)(b)3 |
A research-based pharmaceutical company, which had invented and been engaged in the development and manufacture of a drug which was used in the treatment of, in particular, gastric ulcers, had obtained the necessary product licences to market the drug from the licensing authority established under the Medicines Act 1968.4 For the purposes of those licence applications, the company supplied the licensing authority with a substantial quantity of information representing the results of its research programme carried out over a period of 12 years. It was not in dispute that such information was highly confidential and represented a valuable commercial asset to the company. A number of other pharmaceutical companies had applied to the licensing authority for the grant of product licences to market generic versions of the drug, and the licensing authority claimed that it was entitled to refer to the innovative company's confidential information to determine those applications. On the company's application for judicial review by way of, inter alia, a declaration, order of prohibition and injunction to prevent the licensing authority's proposed use of the confidential information, the judge granted the applicant a declaration that the licensing authority's proposed reference to the information without the applicant's consent was unlawful. The Court of Appeal allowed the licensing authority's appeal and refused the applicant leave to appeal to the House of Lords. |
On the applicant seeking an interim injunction restraining the licensing authority from using the applicant's confidential information without its consent pending the determination of the applicant's petition for leave to appeal to the House of Lords, and for a stay of proceedings: - |
Held, dismissing the application, (1) (per Woolf and Taylor L.JJ.) that the provisions of section 31 of the Supreme Court Act 1981 and the rules of court made pursuant to it altered and |
1 Crown Proceedings Act 1947, s. 21(2): see post, p. 384G-H. |
S. 38(2); see post, p. 385C-D. |
2 Supreme Court Act 1981, s. 31(1)(2): see post, p. 386B-D. |
3 R.SC, Ord. 53, r. 3(10)(a)(b): see post, pp. 385E-F, 386E-F. |
4 Medicines Act 1968, s. 6: "the authority responsible for the grant . . . of licences . . . shall be a body of Ministers consisting of all the Ministers specified in paragraphs (a) and (b) of section 1(1) . . . Any function conferred on the licensing authority by . . . this Act may be performed by any one of those Ministers acting alone . . ." |
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extended the scope of the High Court's jurisdiction to provide a remedy by way of the prerogative orders by enabling it, in the exercise of its discretion, to grant both declaratory and injunctive relief against officers of the Crown in an application for judicial review; that the prohibition on the grant of an injunction against the Crown and its officers in civil proceedings in section 21(2) of the Crown Proceedings Act 1947 was not applicable, by virtue of the exclusion of proceedings on the Crown side of the Queen's Bench Division in section 38(2); and that, therefore, the Act of 1947 did not apply to applications for declaratory or injunctive relief in judicial review proceedings (post, pp. 390E-F,391B-C, H, 392F-G, G-H, 395G-H). |
(2) That, where the circumstances were appropriate, the court had power to grant a stay in judicial review proceedings which was binding on the Crown and its officers within the terms of R.SC, Ord. 53, r. 3(10)(a); that "proceedings" in paragraph (a) had to be construed widely in the light of the availability of relief by way of judicial review; but (per Dillon L.J. that the applicant was essentially seeking an injunction that could not be granted and not merely a stay) that in any event the terms of the application for a stay were too severe in curtailing the licensing authority's exercise of its statutory functions, and that, therefore, the court would not exercise its discretion to grant a stay (post, pp. 388A-C, D-E, 389B-C, 393E-F,395C, D-E, E-F, G, 396E). |
(3) (Dillon L.J. dissenting) that the terms of R.SC, Ord. 53, r. 3(10)(b) did not operate so as to restrict the court's jurisdiction to grant interim relief in judicial review proceedings; that the final words of sub-paragraph (b) simply described the availability to the court of the interlocutory remedies in writ actions; and that, accordingly, although its jurisdiction might be sparingly exercised, the court did have power to grant interim injunctive relief against an officer of the Crown in judicial review proceedings although as a matter of discretion it would not grant the relief sought (post, pp. 392H - 393A, F-G, 395E-F, 396B-C, D, E). |
Reg. v. Secretary of State for the Home Department, Ex parte Herbage [1987] Q.B. 872 approved. |
Reg. v. Inland Revenue Commissioners, Ex parte Rossminster Ltd. [1980] A.C. 952, H.L.(E.) distinguished. |
Per Dillon L.J. The direct effect of sub-paragraph (b) of Ord. 53, r. 3(10) is to make the position in respect of interlocutory relief such as it would have been if an action had been brought against the Crown; if such an action had been brought, then the action would plainly be within the Act of 1947 and no interim injunction could have been obtained (post, p. 387D-E). |
The following cases are referred to in the judgments: |
Anisminic Ltd. v. Foreign Compensation Commission [1968] 2 Q.B. 862; [1967] 3 W.L.R. 382, [1967] 2 All E.R. 986, C.A. |
Gouriet v. Union of Post Office Workers [1978] A.C. 435; [1977] 3 W.L.R. 300; [1977] 3 All E.R. 70, H.L.(E.) |
International General Electric Company of New York Ltd. v. Commissioners of Customs and Excise [1962] Ch. 784; [1962] 3 W.L.R. 20; [1962] 2 All E.R. 398, C.A. |
Law v. National Greyhound Racing Club Ltd. [1983] 1 W.L.R. 1302; [1983] 3 All E.R. 300, C.A. |
O'Reilly v. Mackman [1983] 2 A.C. 237; [1982] 3 W.L.R. 1096; [1982] 3 All E.R. 1124, H.L.(E.) |
Reg. v. Inland Revenue Commissioners, Ex parte Rossminster Ltd. [1980] A.C. 952; [1980] 2 W.L.R. 1; [1980] 1 All E.R. 80, H.L.(E.) |
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Reg. v. Licensing Authority Established under Medicines Act 1968, Ex parte Smith Kline & French Laboratories Ltd. [1988] 3 W.L.R. 896; [1989] 1 All E.R. 175, C.A. |
Reg. v. Secretary of State for the Home Department, Ex parte Herbage [1987] Q.B. 872; [1986] 3 W.L.R. 504; [1986] 3 All E.R. 209 |
Ridge v. Baldwin [1964] A.C. 40; [1963] 2 W.L.R. 935; [1963] 2 All E.R. 66, H.L.(E.) |
The following additional cases were cited in argument: |
Padfield v. Minister of Agriculture, Fisheries and Food [1968] A.C. 997; [1968] 2 W.L.R. 924; [1968] 1 All E.R. 694, H.L.(E.) |
Pearce v. Secretary of State for Defence [1988] A.C. 755; [1988] 2 W.L.R. 1027; [1988] 2 All E.R. 348, H.L.(E.) |
Smith Hogg & Co. Ltd. v. Black. Sea & Baltic General Insurance Co. Ltd. (1940) 162 L.T. 11, C.A. |
INTERLOCUTORY APPLICATION |
By an application dated 19 October 1987 the applicant, Smith Kline & French Laboratories Ltd., applied for judicial review of the policy and/or practice of the Licensing Authority Established under the Medicines Act 1968 with regard to the use by the licensing authority, in its assessment of applications by third parties for product licences in respect of generic versions of the pharmaceutical product, cimetidine, of confidential information supplied to it by the applicant as originator of that product in support of the applicant's own application for a product licence in respect of that product. The applicant had sought relief by way of, inter alia, (1) a declaration that the licensing authority might not have recourse to any of the applicant's previous product licence applications (i) to remedy any deficiency in a third party's application with regard to the results of physico-chemical, biological or microbiological tests, and/or (ii) in so far as a third party relied in support of its application on evidence relating to pharmacological and/or toxicological tests and/or clinical trials carried out with one of the applicant's products, to establish the essential similarity of the third party's product to the applicant's application or applications to make good such deficiency and/or to establish such essential similarity; (2) an order of prohibition restraining the licensing authority from granting product licences in the circumstances mentioned; and (3) an injunction to restrain the licensing authority from having recourse, without the express consent of the applicant, to any of the applicant's product licence applications for those purposes. On 21 December 1987 Henry J. allowed the application for judicial review and made an order granting the applicant a declaration on 23 February 1988. |
The licensing authority appealed against that decision, and on 29 June 1988 the Court of Appeal [1988] 3 W.L.R. 896 allowed the appeal, discharging Henry J.'s order and refusing the applicant leave to appeal to the House of Lords with liberty to apply. At the hearing of the appeal, the court had given leave to two companies, Generics (U.K.) Ltd. and Harris Pharmaceuticals Ltd., which had made applications for licences of right to market generic versions of cimetidine, to appear as interveners in support of the licensing authority. |
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Pursuant to the liberty to apply granted by the court by its order dated 6 July 1988, the applicant sought (a) an injunction restraining the licensing authority whether by itself, its officers, employees, agents or otherwise howsoever, when determining applications made by persons other than the applicant for product licences in respect of medicinal products containing cimetidine from making use of or having regard to, otherwise than with the consent of the applicant, any confidential information supplied to the licensing authority by the applicant in connection with applications by the applicant for product licences in respect of such products, pending the determination of the applicant's petition for leave to appeal to the House of Lords from the decision of the Court of Appeal given on 29 June 1988; (b) a stay of proceedings in relation to the determination by the licensing authority of such applications for product licences made by persons other than the applicant to the same effect as (a) above and for the same period. |
The facts are stated in the judgments. |
Sydney Kentridge QC and Derrick Turriff for the applicant. |
Andrew Collins QC and Helen Rogers for the licensing authority. |
Jonathan Sumption QC for Generics (U.K.) Ltd. |
Henry Carr for Harris Pharmaceuticals Ltd. |
DILLON L.J. The background to the applications with which we have been concerned yesterday and today is that the applicant, Smith Kline & French Laboratories Ltd., is a pharmaceutical company which manufactures various drugs, and one of its products is an extremely successful drug called cimetidine which it has marketed under the brand name Tagamet. It holds a patent in respect of cimetidine and it also holds necessary product licences under the Medicines Act 1968 without which it is not permissible to market a drug or pharmaceutical product in this country. |
To obtain those product licences the applicant has had to supply a lot of information about the drug to the licensing authority established under the Medicines Act 1968 which is the Minister of Health. It is not in doubt that the information so supplied goes far beyond anything disclosed in the patent specification and is confidential information which the applicant would not gladly see disclosed to any trade rivals. |
As a result of the provisions of the Patents Act 1977 the cimetidine patents are now marked "licences of right" and the two interveners in these proceedings, Generics (U.K.) Ltd. and Harris Pharmaceuticals Ltd. have obtained licences of right under the patent. However, they also need product licences in respect of their generic cimetidine or any formulations of it under the Medicines Act 1968 and for these they have applied. Apparently there are some eight other companies which have also applied for product licences and there may in the future be others. The licences of right only apply during the final four years of the twenty- year life of the patent under the Act of 1977. The product licences under the Medicines Act 1968 will continue to be required even after the patent has finally expired. |
In these circumstances the applicant applied for leave to move for judicial review and in its notice of application, form 86A, it set out as the judgment, order, decision or other proceeding in respect of which relief was sought: |
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"The performance by the licensing authority, as defined in section 6 of the Medicines Act 1968, of its functions under that Act in relation to the grant of product licences for pharmaceutical products: in particular, the policy and/or practice of the licensing authority . . . with regard to the use by the licensing authority, in the assessment of applications by third parties for product licences in respect of generic versions of a pharmaceutical product, of confidential information supplied to it by the originator of the product in support of the originator's own application for a product licence in respect of that product." |
The relief sought was a declaration that the licensing authority might not lawfully grant product licences to a third party in respect of a cimetidine product where the third party's application, if read without recourse to one or more of the applicant's product licence applications - (i) is deficient with regard to the results of physico-chemical, biological or microbiological tests, and/or (ii), in so far as the third party relies on evidence relating to pharmacological and/or toxicological tests and/or clinical trials carried out with one of the applicant's products, fails to establish the essential similarity of its product to the applicant's product; unless the applicant expressly consents to the authority having recourse to the applicant's application or applications to make good such deficiency and/or to establish such essential similarity. |
The declaration was formulated alternatively and in support of it an order of prohibition restraining the licensing authority from granting product licences in the circumstances mentioned, or an injunction to restrain the licensing authority from having recourse without the express consent of the applicant to any of the applicant's product licence applications, was sought. |
Leave to apply for judicial review was granted and the initial position was covered, under an order of Schiemann J. of 30 October 1987, by certain assurances given by the licensing authority and a certain undertaking given by the applicant. The assurances were that the licensing authority, in effect, would not grant any licence without giving seven days notice in writing to the applicant and the company applying for the licence and would make no use of any data submitted to it by the applicant in connection with the applicant's application for any grant of cimetidine product licences without giving 14 days notice in writing to the applicant and the relevant company applying for a licence. |
The application for judicial review came for hearing before Henry J. and by an order of 23 February 1988 he acceded to that application and made an order declaring that in considering an application for a product licence in respect of a medicinal product containing cimetidine made pursuant to the abridged procedure provided for by article 4.8(a)(iii) of Council Directive (65/65/E.E.C.) as amended by Council Directive (87/21/E.E.C.) the licensing authority may not for the purpose of such application use refer to or have recourse to any confidential information supplied to it by the applicant in connection with any application by the applicant for a product licence in respect of such a product except with the express consent of the applicant. |
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On 29 June 1988, leave to the applicant to appeal to the House of Lords was refused. The court took the view that it was appropriate that their Lordships should decide if they wanted to entertain an appeal in this case. A petition for leave to appeal to the House of Lords has now been lodged by the applicant. The possible timetables, as I see them, raise three main alternatives. The first and shortest timetable is if leave to appeal is refused by their Lordships. The second alternative is that leave is granted and the appeal is either allowed or dismissed by their Lordships without reference to the European Court at Luxembourg. The third alternative, which would lead to the longest time-lag in the disposal of the proceedings, is that leave to appeal is granted and their Lordships' House then directs a reference to Luxembourg before deciding to allow or dismiss the appeal. This would be likely to take a very considerable time. |
When the judgments of the Court of Appeal were handed down on 29 June 1988, leading counsel for the applicant asked for interim protection against the use by the licensing authority of the applicant's confidential information pending disposal of the application for leave to appeal or possibly pending final disposal of the appeal if leave was granted. It was intimated to the court that questions of principle and jurisdiction would be raised, but the division of the court which had decided the appeal was committed in other matters and had no time to proceed to hear the application for interim relief that day. Consequently interim assurances were given by the licensing authority until the end of July 1988 while the parties sought to see if there was any solution acceptable to them all. The application was then renewed on 28 and 29 July, coming before this division of the court, it being still impossible for reasons of listing to re-assemble the court as originally constituted for the hearing of the appeal. |
What is now sought, as set out in the skeleton argument of leading counsel for the applicant, is (1) an injunction restraining the licensing authority whether by itself, its officers, employees, agents or otherwise howsoever, when determining applications, made by persons other than the applicant, for product licences in respect of medicinal products containing cimetidine from making use of or having regard to, otherwise than with the consent of the applicant, any confidential information supplied to the licensing authority by the applicant in connection with applications by the applicant for product licences in respect of such products, pending the determination of the applicant's petition for leave to appeal to the House of Lords from the decision of the Court of Appeal given on 29 June 1988 or further order; (2) a stay of proceedings in relation to the determination by the licensing authority of such applications for product licences made by persons other than the applicant to the same effect as (1) above and for the same period. |
Although relief is only sought pending the determination of the applicant's petition for leave to appeal to the House of Lords, it is necessary, I think, to bear in mind that any interim protection granted over that period may well, if leave to appeal is granted and if there is a |
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reference to the European Court in Luxembourg, have to last very much longer. |
The objection is taken by the licensing authority, supported by the two interveners, that there is no jurisdiction to grant any such relief against the licensing authority, it being a representative of the Crown. Alternatively it is said that in the circumstances and in the light of certain proposals put forward by the licensing authority, with the agreement of the interveners, as a matter of discretion it would not be right to grant any interim relief as sought. |
Any consideration of a question of jurisdiction in relation to relief against the Crown will necessarily start with reference to the Crown Proceedings Act 1947. Section 1 of that Act provided that where a person had a claim against the Crown, and, if the Act had not been passed, the claim might have been enforced, subject to the grant of His Majesty's fiat, by petition of right, or a proceeding provided by any statutory provision repealed by the Crown Proceedings Act 1947, then, the claim might, subject to the proceedings of the Act, be enforced as of right, and without the fiat by proceedings taken against the Crown. |
Section 2 provided that the Crown should be subject to liabilities in tort. Section 13 provided that subject to the provisions of the Act, all such civil proceedings by or against the Crown as were mentioned in Schedule 1 to the Act were abolished, and all civil proceedings by or against the Crown in the High Court should be instituted and proceeded with in accordance with rules of court and not otherwise. The civil proceedings mentioned in Schedule 1 were various proceedings by what are now, at any rate, regarded as very archaic procedures. |
Section 21 of the Crown Proceedings Act 1947 is concerned with the nature of relief. It provides: |
"(1) In any civil proceedings by or against the Crown the court shall, subject to the provisions of this Act, have power to make all such orders as it has power to make in proceedings between subjects, and otherwise to give such appropriate relief as the case may require; Provided that: - (a) where in any proceedings against the Crown any such relief is sought as might in proceedings between subjects be granted by way of injunction or specific performance, the court shall not grant an injunction or make an order for specific performance, but may in lieu thereof make an order declaratory of the rights of the parties; . . ." |
Paragraph (b) contains provisions as to orders against the Crown for the recovery of land or other property. |
"(2) The court shall not in any civil proceedings grant any injunction or make any order against an officer of the Crown if the effect of granting the injunction or making the order would be to give any relief against the Crown which could not have been obtained in proceedings against the Crown." |
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The Act of 1947 proceeds in section 22 to deal with stays of execution and provides that subject to the provisions of the Act, all enactments, rules of court and county court rules relating to appeals and stay of execution shall, with any necessary modifications, apply to civil proceedings by or against the Crown as they apply to proceedings between subjects. It is, however, common ground in the present case that the ordinary stay of execution under R.SC, Ord. 59, r. 13, which is the stay of execution with which section 22 is concerned, is not appropriate. |
It has been pointed out in the argument on the present application that under section 23(2) of the Crown Proceedings Act 1947 the term "civil proceedings against the Crown" is limited to certain particular types of proceeding under the former archaic procedure and to such other proceedings as any person is entitled to bring against the Crown by virtue of the Act of 1947. The definition section, that is section does not include "proceedings on the Crown side of the King's Bench Division." |
In 1947, when that Act was passed, the procedure by what is now called judicial review was, under the Administration of Justice (Miscellaneous Provisions) Act 1938, a procedure by way of application for an order of mandamus, prohibition or certiorari. No relief by way of injunction in any relevant sense or declaration was possible in such proceedings; a fortiori there was no question of an interlocutory injunction or declaration being granted. |
Rules made to give effect to the provisions of the Act of 1938 shortly after that Act was enacted include provisions corresponding to the present R.SC, Ord. 53, r. 3(10)(a) which provides: |
"Where leave to apply for judicial review is granted, then - (a) if the relief sought is an order of prohibition or certiorari and the court so directs, the grant shall operate as a stay of the proceedings to which the application relates until the determination of the application or until the court otherwise orders . . ." |
In 1977 the Rules of the Supreme Court were amended to introduce the present Order 53. The objectives as I see them were first to streamline the procedure, that is make various other forms of interim |
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relief available and to provide for discovery and the hearing of evidence, but also to bring the claims for declarations and injunctions within the scope of the procedure under the Order and within the range of relief obtainable on judicial review. It was obviously undesirable that the fairly summary procedure by way of judicial review should have still running in parallel with it the slower procedure by writ for a declaration. |
The statutory authority for judicial review is now section 31 of the Supreme Court Act 1981. That provides: |
"(1) An application to the High Court for one or more of the following forms of relief, namely - (a) an order of mandamus, prohibition or certiorari; (b) a declaration or injunction under subsection (2); or (c) an injunction under section 30 restraining a person not entitled to do so from acting in an office to which that section applies, shall be made in accordance with rules of court by a procedure to be known as an application for judicial review. (2) A declaration may be made or an injunction granted under this subsection in any case where an application for judicial review, seeking that relief, has been made and the High Court considers that, having regard to [certain matters, including all the circumstances of the case] it would be just and convenient for the declaration to be made or the injunction to be granted, as the case may be. (3) No application for judicial review shall be made unless the leave of the High Court has been obtained in accordance with rules of court . . ." |
R.S.C, Ord. 53 and its rules previously made now have effect by virtue of section 17(2)(b) of the Interpretation Act 1978 as if made under the rule-making power in the Supreme Court Act 1981. Ord. 53, r. 3, besides the provision that I have just read from paragraph (10)(a) of rule 3, provides by paragraph (10)(b): |
"Where leave to apply for judicial review is granted, then . . . (b) if any other relief is sought, the court may at any time grant in the proceedings such interim relief as could be granted in an action begun by writ." |
That seems to me to underline that what was being done was to blend together in the one procedure the old procedure for a prerogative order and the newly developing procedure of the action by writ for a declaration or injunction. |
"(1) that, although section 21(2) of the Crown Proceedings Act 1947 had been construed as prohibiting the grant of an injunction against an officer of the Crown in civil proceedings, the subsection was not applicable to proceedings on the Crown side of the Queen's Bench Division and did not affect the jurisdiction of the court to grant prerogative orders against officers of the Crown; that the provisions of section 31 of the Supreme Court Act 1981 and R.SC, Ord. 53, r. 3(10) gave the court power to grant injunctive and interim relief in proceedings for judicial review and, therefore, the court now had |
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jurisdiction to grant an interim injunction against an officer of the Crown on an application for judicial review." |
It has to be borne in mind that the Act of 1947 was an enabling Act enabling certain proceedings to be brought against the Crown in the ordinary way under the Rules of the Supreme Court and section 21, prohibiting the grant of an injunction against the Crown, was an exemption from that enabling provision. It is not the case that there was any prior right to injunctive relief against the Crown which was only cut down in a limited field by the Act of 1947. |
As to Ord. 53, r. 3(10)(b), Hodgson J.'s view which was expressed in the passage of his judgment from pp. 885G-886C was that that provision was a mere enabling power allowing the court to grant to an applicant for judicial review all the interlocutory remedies available in an action begun by writ. He rejected the argument to the contrary presented on behalf of the Crown that the injunction would not lie against a servant of the Crown in proceedings brought by writ and that accordingly it could not, on the wording of Ord. 53, r. 3(10)(b), be granted against the Crown in proceedings for judicial review. |
There is, therefore, in my judgment no doubt that interim injunctions cannot be granted against the Crown even in proceedings for judicial review. I turn, therefore, to consider the application for a stay of proceedings as put in the second part of the applicant's application, that is to say, a stay of the proceedings to which the application for judicial review under Ord. 53, r. 3(10)(a) relates. |
I do not doubt that section 31 of the Supreme Court Act 1981 and Order 53 bind the Crown in the sense that judicial review can be obtained against the Crown and a final declaration can be made against the Crown. Indeed, no procedural objection was raised to the declaration which Henry J. made on the view of the law which he took. I see no need to consider the granting of a final injunction against the Crown |
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rather than a declaration because I cannot see that that is ever likely in practice to be granted. |
I do not for my part see why paragraph (10)(a) of Ord. 53, r. 3 should not bind the Crown in an appropriate case. It goes back historically to the Rules made after the enactment of the Act of 1938 which was concerned only with the prerogative orders. I would myself construe the words "the proceedings" in paragraph (10)(a) widely as having effect in the light of the modern scope of judicial review. The paragraph has effect under the Act of 1981, as I have endeavoured to explain. I see no basis for construing it narrowly as suggested by Mr. Collins by reference to the antithesis in the phrase "proceedings or matter" in section 7(2) of the Administration of Justice (Miscellaneous Provisions) Act 1938. The Act of 1938 has been repealed by the Supreme Court Act 1981. |
However, in my judgment, what the applicant is seeking in the second limb of its application is essentially an injunction which cannot be granted and not a mere stay within paragraph (10)(a) of rule 3. The applicant does not seek to stop the licensing authority from proceeding with the examination of applications for product licences in respect of cimetidine, but it seeks to stop the licensing authority from doing certain things which in the view of this court in the judgments handed down at the end of June the licensing authority are entitled to do in the proper exercise of their statutory functions. It seems to me that that is really a matter of injunction rather than stay of proceedings. |
Apart from that, a stay of the applications by the licensing authority, however curtailed in its wording, is, in my judgment, far too drastic relief. What this application is about is, of course, competition in the market. The applicant is seeking, so far as it lawfully can, to keep generic companies out of the market in cimetidine, even though the monopoly protection accorded by its patent is now by the Patents Act 1977, which itself was enacted as a result of the Convention on the Grant of European Patents (1978) (Cmnd. 7090), subject to licences of right, and even if the patent finally expires. |
Against that background certain proposals were put forward by the Treasury Solicitor on behalf of the licensing authority in correspondence. What was suggested was that licences issued by the licensing authority should contain the following conditions to cover the situation which would arise should any appeal by the applicant be successful. The conditions are: |
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It is impossible to provide a completely satisfactory interim solution to the rival demands of the applicant and the generic companies pending the ultimate decision of the House of Lords at whichever stage that may be reached. Also, there is the difficulty that there are the other companies which I have mentioned which have applied for product licences from the licensing authority but which are not parties to these proceedings and would not have the protection of the cross-undertaking in damages which the applicant has offered both to the licensing authority and to the two interveners in these proceedings. |
Bearing all these factors in mind, I take the view that even if paragraph (2) of the relief sought by the licensing authority could be said to be within paragraph (10)(a) of Ord. 53, r. 3, or otherwise relief which the court had power to grant, it would not be appropriate as a matter of discretion to grant it. |
Accordingly, I would for my part reject this application by the applicant for interim relief. |
WOOLF L.J. Although this is only an application pending an appeal or possible appeal to the House of Lords, it raises a point of considerable importance as to the powers and the jurisdiction of the court to grant an interim injunction or stay against the Crown. |
"That there can be no mandamus to the sovereign there can be no doubt, both because there would be an incongruity in the Queen commanding herself to do an act, and also because the disobedience to a writ of mandamus is to be enforced by attachment." |
However, the precise ambit of the principle to which Lord Denman C.J. referred has never been clearly defined. In De Smith's Judicial Review of Administrative Action, 4th ed. (1980), p. 445, in dealing with injunctions and the Crown it is stated: |
"Before the Crown Proceedings Act 1947 an injunction would lie against an officer of the Crown if he committed a civil wrong in his personal capacity; it would never lie against the Crown; but whether it would lie against a government department, or against an officer of the Crown for a wrongful act done in his official capacity, was uncertain." |
The editors then go on to consider the position in greater detail, and in the notes draw attention to the fact that conflicting views are taken by distinguished academic writers as to the extent of the principle. |
The situation on applications for judicial review has been altered by the passing of the Supreme Court Act 1981. It is to be noted that while |
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that Act was a consolidating Act, it was also an amending Act. In so far as judicial review is concerned, to an extent, the Act of 1981 codified the provisions which had existed and had been in force (although subsequently amended) since 1977, which are contained in R.SC, Ord. 53. Order 53 had transformed the position with regard to the obtaining of public law remedies. |
The extent to which Order 53 altered the jurisdiction of the courts was in doubt until the Supreme Court Act 1981 was enacted. Indeed it may be fortunate that prior to that Act coming into force the vires of certain of its provisions was never fully considered by the courts. That question now becomes academic in consequence of the Act of 1981. Pursuant to section 17(2)(b) of the Interpretation Act 1978, Order 53 in its present form has to be treated as though it had been brought into existence under the Act of 1981. |
Turning to consider the provisions of the Act of 1981, it is important to note that there is a distinction between the way that the Act deals with the power of the courts to grant relief by way of injunction or by way of declaration from that which exists in relation to damages. Here, section 31(2) and section 31(4) are important. Section 31(2) provides: |
"A declaration may be made or an injunction granted under this subsection in any case where an application for judicial review, seeking that relief, has been made and the High Court considers that, having regard to - (a) the nature of the matters in respect of which relief may be granted by orders of mandamus, prohibition or certiorari; (b) the nature of the persons and bodies against whom relief may be granted by such orders; and (c) all the circumstances of the case, it would be just and convenient for the declaration to be made or the injunction to be granted, as the case may be." |
The effect of section 31(2), read literally, is that the court has a discretion to grant a declaration or grant an injunction at least in that class of cases where it was the practice previously to grant an order of mandamus, prohibition or certorari, subject to the qualification that application is against the type of body or persons in relation to whom those orders normally would be available. This is a different basis of jurisdiction from that which previously existed. |
Turning to section 31(4), that provides: |
"On an application for judicial review the High Court may award damages to the applicant if - (a) he has joined with his application a claim for damages arising from any matter to which the application relates; and (b) the court is satisfied that, if the claim had been made in an action begun by the applicant at the time of making his application, he would have been awarded damages." |
The position with regard to a claim for damages, therefore, is quite distinct from that in relation to a claim for a declaration or injunction because in respect of a claim for damages it has to be a situation where if the claim had been included in an action damages would be awarded. The key to the distinction between subsection (2) and subsection (4) of section 31 is that subsection (2) has the innovative effect of making a declaration or injunction for the first time a public law remedy in addition to being a private law remedy which could be used to obtain relief on the same basis against private bodies and public bodies, which |
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was the position prior to the coming into force of the new procedure of judicial review. |
However, in the case of damages the situation is otherwise. Damages could previously only be obtained in private law proceedings against a public body if private law, common law or statutory rights were breached and now the same restrictions apply in judicial review, that is public law proceedings, where damages are claimed. |
In my view, looking at the language of section 31 of the Act of 1981 alone, it is quite clear that the court's jurisdiction was being extended in relation to declarations and injunctions, but the court's jurisdiction was not being extended in relation to damages, and in relation to damages all that has happened is that there is a procedural change, whereas in relation to declarations and injunctions not only has there been a procedural change there has also been a jurisdictional change. |
That that is the position with regard to a declaration or injunction is in my view made abundantly clear when one considers the entitlement to a declaration rather than an injunction that existed prior to the changes to which I have referred. In order to obtain a declaration in private law proceedings, it was and still is necessary to establish that you have some private interest which was threatened with infringement or had clearly been infringed. You either had to show that you had a private right or that you had some other interest which had resulted in or could result in your suffering damage. |
Nowadays on an application for judicial review declarations are regularly being granted in circumstances where a declaration could not prior to the change in the law be obtained. There is no need for an applicant to concern himself with the question whether he could bring himself within the private law limits to which I have been referring. One of the most beneficial effects of the changes which have occurred as a result of the new remedy of judicial review is the growth in the circumstances where it is not only possible for the courts to intervene but appropriate for the courts to intervene in consequence of their power to grant declaratory relief. |
The test that exists in seeing whether or not an application is appropriate to be before the court is one which is decided by looking first of all at the nature of the body who is the subject matter of the application, secondly, the nature of the function that body performs, and, thirdly, the interest of the applicant. With regard to the last matter a generous view is now appropriately being taken by the courts having regard to the safeguards which exist in relation to an application for judicial review which do not exist in the case of private law proceedings. |
Against that background to the statutory provisions I ask myself whether or not there is a power to grant an injunction against the Crown, and subject to what I have to say hereafter I conclude that there clearly is such a power under the new procedure. It is not challenged that there is the power to grant a declaration against the Crown. The same statutory provisions which create the power to grant a declaration apply equally to an injunction, and I cannot see how, on the language of |
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the Act of 1981, it is possible to draw any distinction between a declaration or an injunction. |
This is not, in my view, an astonishing result because an order of mandamus was always available, although it was used with great circumspection, against public bodies, including officers or ministers of the Crown, subject to the qualification that they must not be acting as the alter ego of the Sovereign or indeed be said to be acting in such circumstances where to grant relief would offend the statement which I cited earlier by Lord Denman C.J. so that the courts would be giving relief against the Sovereign. |
However, that statement of Lawton L.J. has to be read in the context of that case. What the court was there considering was whether or not judicial review was the appropriate procedure in relation to domestic tribunals, and, of course, with regard to that situation it can be fairly said, as Lawton L.J. did, that there had been a change of procedure but not a change of jurisdiction. If one looks at the other judgments in that case, they do not repeat the same approach indicated by Lawton L.J. and I do not regard that case as being any authority inconsistent with the approach that I have indicated. |
So far as any other statutory provision which impinges upon this approach is concerned, one immediately, of course, considers the Crown Proceedings Act 1947, the terms of which have been referred to by Dillon L.J. So far as section 21 of that Act is concerned, which was relied on by Mr. Collins with his characteristic force and clarity, I have no difficulty in coming to the conclusion that that Act cannot alter the view that I have formed as to the application of section 31 of the Supreme Court Act 1981. |
The Crown Proceedings Act 1947 was not dealing with injunctions on application for judicial review because, of course, you could not get injunctions on the Crown side in 1947. It was as a result of the change in procedure that they became available for the first time on the Crown side, and in my view it is quite clear that although the proviso to section 21(1) refers to "any proceedings against the Crown," that proviso has to be read subject to the opening words of section 21(1), and I am wholly in agreement with Dillon L.J. in rejecting Mr. Collins' argument in this regard. In so far as it had been necessary, I would have referred to sections 23, 38(2) and section 40(5) in support of that conclusion. |
It seems, therefore, clear to me that injunctive relief is available against the Crown on an application for judicial review. The next question, therefore, which is important to be answered here is whether interim relief is available against the Crown in the form of an injunction. It is here that I have the misfortune to differ from the view expressed by Dillon L.J. |
I start off by saying that if you are entitled to have a final injunction against the Crown in proceedings for judicial review, it is difficult to see what good reason there should be for not having interim relief in the |
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form of an injunction against the Crown. I then remind myself that in what is sometimes called "statutory certiorari" - and here I refer to the many different Acts which provide for statutory appeals to the High Court against orders by ministers - there is a power to grant interim relief, at least in the form of a stay. |
Taking one example, in section 245(4) of the Town and Country Planning Act 1971 it is provided that the court may by interim order suspend the operation of the order of the minister which is subject to challenge. If this formula has been statutorily recognised time after time going back for many years, long before the change in judicial review, one asks oneself, "If the minister can be subject to an order in that situation, why should he not, in appropriate circumstances on an application for judicial review, be subject to the same type of order?" Of course, one would always bear in mind that it is a power which the court would not exercise other than when it was warranted by the circumstances. |
However, it is difficult to envisage that you can have an interim declaration, although it is right to point out that in other jurisdictions, and I have particularly in mind the jurisdiction in Israel which is based upon our own system, I understand that they now do grant interim declarations, but certainly the problems with regard to interim declarations do not apply to interim injunctions. |
Furthermore, subject to the arguments advanced by Mr. Collins, if the court has power to grant a stay on an application for judicial review that is, in effect, identical to an injunction, and one asks oneself, "If it was intended that there should be, as against the Crown, a power to grant a stay by way of interim relief why should it not also be available in relation to injunctions?" |
The difficulty arises, however, because of the wording of Ord. 53, r. 3(10)(b). So far as Ord. 53, r. 3(10)(a) is concerned, Dillon L.J. has indicated why he rejects Mr. Collins' arguments that there should be no power to grant a stay against the Crown, and I respectfully adopt that reasoning. In so far as sub-paragraph (b) is concerned, the wording is capable of more than one interpretation. |
It, therefore, seems to me that this is a case where there is jurisdiction to grant both a stay and interim relief in the form of an injunction. I would emphasise here that Mr. Collins submitted that there was no jurisdiction even to grant a stay and so far as that is concerned it has been the practice - so far as my knowledge goes - for stays to be regularly granted by High Court judges and by the Court of Appeal against the Crown, and although there may never have been an opportunity for the Crown properly to contest the matter before now it seems to me that this is a most important and appropriate jurisdiction. |
Indeed, two members of the Court of Appeal two days ago granted a stay pending the consideration of an application for leave to apply for judicial review and the facts of this case are worth recording in the course of considering this matter very briefly because they reflect the importance of the jurisdiction. |
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In that case there was a Tamil about to be removed from this country at 1 p.m. on the day the matter came before the court. It came before the court at 12.30 p.m. The court was told that the Home Office had been asked to hold their hand pending an application for judicial review. Bearing in mind the circumstances, not unnaturally, the Home Office were not prepared to hold their hand. When the matter came before the court, it was not able to deal with it within the time available before 1 p.m., so it granted a short stay to enable it to deal with it. Of course, there is a long tradition, which I hope will be maintained, of the Crown respecting the courts and avoiding the necessity for stays being granted by indicating that without any order of the court they will await the outcome. |
However, there are situations where it is important for the Crown to know what the attitude is of the court, otherwise they are left in a situation where they hold their hand quite needlessly. It is the experience of those who are engaged in the immigration field that would-be immigrants into this country were languishing in custodial establishments merely because they were making applications for judicial review which were doomed to failure and once the Crown was told that an application was intended to be made the Crown felt it had to hold its hand. |
If, on the other hand, the matter can be brought to the court and the court can in the appropriate cases grant stays, that would avoid that sort of problem. Of course, where there is good reason for the Crown not holding its hand and where the Crown is not content to leave it to the applicant to pursue any remedies, then the court has to consider any arguments advanced by the Crown for saying that interim relief should not be granted. |
However, I draw comfort from the fact that the case was being considered prior to the passing of the Supreme Court Act 1981. At that stage, of course, the argument that there was a new power to grant interim relief by way of injunction in public law proceedings against the Crown depended on a new rule of the Supreme Court alone. In my view their Lordships would not have made the same comments now having regard to the passing of the Supreme Court Act 1981. In particular Lord Scarman who dealt with the issue most fully would not, for reasons I have indicated, have said Ord. 53, r. 3 has not altered the substantive law if that rule had already been given the statutory backing of the Supreme Court Act 1981. |
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When one contemplates the problems involved in granting the sort of interim relief which the applicant seeks, I have come to the conclusion that as a matter of discretion this court should refuse that relief. Dillon L.J. has drawn attention to the fact that a stay would not be an appropriate machinery for bringing about that which the applicant seeks because it does not wish to stop the licensing authority considering an application, but only the manner in which the application is considered. |
It is also to be noted that although two interveners are before the court, there are apparently eight other applications pending. There are problems so far as they are concerned of achieving a satisfactory result by consent and speaking for myself, having paid attention to the offers which have been made on behalf of the licensing authority to the applicant in the correspondence to which Dillon L.J. has referred, the conclusion which I have come to as a matter of discretion is that this is not a case where interim relief should be granted. |
However, Mr. Collins relies upon the Crown Proceedings Act 1947, section 21(1)(a) of which, he says, excludes the grant of injunctions |
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against officers of the Crown. He argues that a stay, particularly in the circumstances of this case, is tantamount to an injunction and the court has no power to grant it. This is a startling proposition for reasons which Woolf L.J. has already developed. The court has, in fact, granted stays in many judicial review cases where justice seemed to require it, especially, as in the example given by Woolf L.J., in immigration cases. |
Mr. Collins grasps that nettle and says that such stays have been ultra vires. The fallacy in his argument, in my view, is that section 21 of the Act of 1947 is concerned with civil proceedings which by the definition contained in section 38(2) of the Act excludes proceedings on the Crown's side of the Queen's Bench Division. Accordingly, the Crown Proceedings Act 1947 does not apply to judicial review. |
As to Ord. 53, r. 3(10)(b), I agree with Woolf L.J. that there is power to grant an interim injunction against officers of the Crown. The contrary argument is that the final words of the sub-rule should be construed as requiring the court to ask whether against the particular respondent an interim injunction could be granted in an action commenced by writ. Since such a remedy could not be granted in such an action against officers of the Crown by reason of section 21 of the Crown Proceedings Act 1947, it cannot be granted under Ord. 53, r. 3(10)(b) in judicial review proceedings. |
I prefer the construction which appealed to Hodgson J. and to Woolf L.J. that those final words of the sub-paragraph are merely descriptive of the types of relief which have now been made available to the court upon judicial review. That construction is fortified by contrasting the wording of the sub-paragraph with the wording of section 31(4)(b) of the Supreme Court Act 1981 to which Woolf L.J. has referred. |
Accordingly, I consider that this court has power to grant either a stay under sub-paragraph (10)(a) or an interim injunction under sub-paragraph (10)(b). However, for the reasons given by Dillon and Woolf L.JJ. I do not think it appropriate here, as a matter of discretion, to grant either. |
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Solicitors: Simmons & Simmons; Treasury Solicitor; S. J. Berwin & Co.; Roiter Zucker. |
[Reported by ROBERT RAJARATNAM, ESQ., Barrister-at-Law] |