Wednesday Law Report: Grant of interim relief in public law case

7 October 1998 Regina v Ministry of Agriculture Fisheries and Food, ex parte Monsanto plc Queen's Bench Divisional Court (Lord Justice Rose and Mr Justice Bell) 31 July 1998

GUIDANCE WAS given by the Divisional Court on the principles to be applied on an application for interim relief in a public law case.

The court refused an application for interim relief by Monsanto plc against Clayton Plant Protection Ltd, pending a decision of the European Court of Justice as to the correct interpretation of Article 4(1)(b) of Council Directive 91/414 (EC).

Monsanto had developed and marketed Roundup, currently the world's best- selling herbicide, since its approval. The patent had run out in 1991 and protection for Monsanto's data had expired in 1996. The data had then become available for use by other generic manufacturers seeking "me too" approval for glyphosphate-based herbicides.

In 1997 Monsanto was granted leave to move for judicial review of the manner in which the Ministry of Agriculture Fisheries and Food ("MAFF") granted "me too" approvals pursuant to Part III of the Food and Environment Protection Act 1985 and the Control of Pesticides Regulations 1986, and also of the grant of a "me too" approval to I Pi Ci.

It was Monsanto's case that MAFF, in granting "me too" approvals in reliance on old data, were in breach of Article 4(1)(b) of Council Directive 91/414 (EC) by failing to require data "in the light of current scientific and technical knowledge". I Pi Ci gave an undertaking not to market pursuant to their approval, the proceedings were stayed, and questions as to the correct interpretation of Article 4(1)(b) were referred to the European Court of Justice, which was unlikely to give its decision before the year 2000.

Monsanto was subsequently granted leave to move for judicial review challenging the grant of a "me too" approval to Clayton in respect of its product Rhizeup. It was common ground that those proceedings should also be stayed pending the decision of the European Court, and the question arose whether Monsanto should be granted interim relief in the form of a stay of the operation of the approval of Rhizeup. Clayton had proffered ceiling undertakings limiting the sales of Rhizeup.

Gerald Barling QC, Sarah Lee and Mark Hoskins (S.J. Berwin) for Monsanto; Peter Mantle (Legal Department, Ministry of Ariculture, Fisheries and Food) for MAFF; Martin Howe QC and Lindsay Lane (Addleshaw, Booth & Co, Manchester) for Clayton as intervenor.

Lord Justice Rose said that it was common ground that in deciding whether to grant the relief sought, the court must have regard to the principles enunciated by Lord Diplock in American Cyanamid v Ethicon Ltd [1975] AC 396.

Although those principles were to be applied in the present case, that had to be done in the context of the public law questions to which the judicial review proceedings had given rise.

There was plainly an issue to be tried in the present case, but Monsanto had no sustainable claim for relief based on the inadequacy of damages, whereas it was doubtful that damages would provide an adequate remedy for Clayton.

With regard to the balance of convenience, where an order for interim relief would have the effect of restricting free competition, there was a strong presumption against the making of such an order; there was no suggested hazard to health or to the environment, which was an important objective of the Directive, from the use of Rhizeup; applications for "me too" approval should not be discouraged by the prospect that the costs thereof might be irrecoverable for a period of years if a competitor obtained interim relief, particularly when its patent and data protection had expired; it was in the public interest that the decision of a public body should be respected until set aside; and the purpose of the licensing provisions was to serve the public interest, not to protect private commercial interests, which were catered for by patent and data protection.

Kate O'Hanlon,

Barrister