R v Licensing Authority Established under Medicines Act 1968, ex parte Smith Kline & French Laboratories Ltd (No. 2)

JurisdictionEngland & Wales
JudgeLORD JUSTICE DILLON,LORD JUSTICE WOOLF,LORD JUSTICE TAYLOR
Judgment Date29 July 1988
Judgment citation (vLex)[1988] EWCA Civ J0729-15
CourtCourt of Appeal (Civil Division)
Date29 July 1988
Docket Number88/0702

[1988] EWCA Civ J0729-15

IN THE SUPREME COURT OF JUDICATURE

COURT OF APPEAL (CIVIL DIVISION)

ON APPEAL FROM THE HIGH COURT OF JUSTICE

QUEEN'S BENCH DIVISION

(LORD JUSTICES DILLON, BALCOMBE AND STAUGHTON)

Royal Courts of Justice

Before:

Lord Justice Dillon

Lord Justice Woolf

and

Lord Justice Taylor

88/0702

NO. CO/1676/87

The Queen
and
The Licensing Authority
Respondent (Respondent)
Ex Parte Smith Kline & French Laboratories Limited,
Petitioner (Applicant)
Generics (UK) Limited

and

Harris Pharmaceuticals Limited
Intervening

MR. S. KENTRIDGE Q.C., MR. D. TURRIFF, and MISS V. ROSE (instructed by Messrs. Simmons & Simmons, London EC2) appeared on behalf of the Applicant (Petitioner).

MR. A. COLLINS Q.C., and MISS H. ROBERS (instructed by the Treasury Solicitor, London SW1) appeared on behalf of the Respondent (Respondent).

MR. J. SUMPTION Q.C. (instructed by Messrs. S.J. Berwin & Co., London WC1) appeared on behalf of Generics (UK) Limited.

MR. H. CARR (instructed by Messrs. Roiter Zucker, London NW6) appeared on behalf of Harris Pharmaceuticals Limited.

1

( )

LORD JUSTICE DILLON
2

The background to the applications with which we have been concerned yesterday and today is that Smith Kline & French Laboratories Limited ("SKF") are a pharmaceutical company which manufacturers various drugs, and one of their products is an extremely successful drug called Cimetidine which they have marketed under the brand name Tagamet. They hold a patent in respect of Cimetidine and they also hold necessary product licences under the Medicines Act 1968 without which it is not permissible to market a drug or pharmaceutical product in this country.

3

To obtain those product licences SKF have to supply a lot of information about the drug to the Licensing Authority under the Medicines Act who 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 SKF would not gladly see disclosed to any trade rivals.

4

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 (UK) Limited and Harris Pharmaceuticals Limited, 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 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 1977 Act. The product licences under the Medicines Act will continue to be required even after the patent has finally expired.

5

In these circumstances SKF applied for leave to move for judicial review and in their notice of application, Form 86A, they set out as the Judgment, Order, Decision or Other Proceeding in respect of which relief was sought: "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."

6

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 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 said 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.

7

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.

8

Leave to apply for judicial review was granted and the initial position was covered, under an order of Mr. Justice Schiemann of 30th October 1987, by certain assurances given by the Licensing Authority and a certain undertaking given by SKF. The assurances were that the Licensing Authority, in effect, would not grant any licence without giving seven days notice in writing to SKF and the applicant for the licence and would make no use of any data submitted to it by SKF in connection with SKF's application for any grant of cimetidine product licences without giving 14 days notice in writing to SKF and the relevant applicant for a licence.

9

The application for judicial review came for hearing before Mr. Justice Henry and by an order of 23rd 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/EEC as amended 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 SKF in connection with any application by SKF for a product licence in respect of such a product except with the express consent of SKF.

10

The Licensing Authority appealed against that order and on 29th June 1988 a division of this court consisting of Lord Justice Staughton, Lord Justice Balcombe and myself allowed that appeal and discharged the order of Mr. Justice Henry. On that occasion the two generic companies whom I have mentioned, Generics (UK) Limited and Harris Pharmaceuticals Limited, were given leave to appear and be heard in support of the Licensing Authority as they had been allowed to be heard before Mr. Justice Henry.

11

On 29th June 1988, leave to SKF 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 SKF. 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 EEC 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.

12

When the judgments of the Court of Appeal were handed down on 29th June, leading counsel for SKF asked for interim protection against the use by the Licensing Authority of SKF's confidential information pending disposal of the application for leave to appeal or possibly pending final disposal of the appeal if leave was granted.

13

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, that is the present month, while the parties sought to see if there was any solution acceptable to them all.

14

The application was then renewed yesterday and today, coming before this division of the court, it being still impossible for reasons of listing to reassemble the court as originally constituted for the hearing of the appeal.

15

What is now sought, as set out in the skeleton argument of leading counsel for SKF, is as follows: (1) An injunction restraining the Licensing Authority whether by itself, its officers, employees, agents or otherwise howsoever, when determing applications, made by persons other than SKF, for product licences in respect of medicinal products containing cimetidine from making use of or having regard to, otherwise than with the consent of SKF, any confidential information supplied to the Licensing Authority by SKF in connection with applications by SKF for product licences in respect of such products, pending the determination of SKF'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.

16

(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 SKF to the same effect as (1) above and for the same period.

17

Although relief...

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