Shire Pharmaceutical Contracts Ltd & Anor v Mount Sinai School of Medicine of New York University

Samples relating to experiments deployed in patent proceedings may be ordered where their production is proportionate and enables the opposing party to understand and investigate the case advanced against it. Court-ordered production of samples attracts the implied obligation restricting collateral use, even where the Civil Procedure Rules do not expressly address the use of test results. The restriction may be lifted in special circumstances where doing so would not cause injustice. Parallel proceedings before the European Patent Office, the non-confidential nature of the material, and the fact that the experiments were deployed there as well as in the United Kingdom may together justify lifting the obligation. Whether the European Patent Office admits or uses the material remains entirely a matter for that tribunal.

The claim concerns a European patent for a method of producing secreted alpha-galactosidase-A, used in treating Fabry disease. Shire challenged the patent’s validity, including by alleging that the inevitable result of carrying out earlier experimental work anticipated a claim. Mount Sinai alleged infringement and sought production of a sample generated during Shire’s experiments, which had also been deployed in opposition proceedings before the European Patent Office.

The application concerned whether the sample should be produced and, if so, whether the implied obligation against collateral use applied and should be lifted to permit use of testing results in the European Patent Office proceedings.

1. Production of samples. The samples were not privileged. Although possible degradation and the timing of proposed repeat experiments were relevant case-management considerations, they did not justify withholding production. The samples related directly to a notice of experiments and would enable Mount Sinai to understand and respond to the experiments deployed against it. Production was therefore ordered as a proportionate step in the proceedings (paras [14]-[23]).
2. Implied collateral-use obligation. The court held that the general obligation arising in relation to disclosure or discovery applied to samples produced under the order, even though the Civil Procedure Rules, as written, did not expressly provide for restrictions on collateral use of test results. The court relied on the reasoning in Dendron GmbH v The Regents of the University of California and applied the principle identified in Alterskye v Scott. The material could not be used outside the proceedings without an order of the court or unless read or referred to in open court (paras [24]-[29]).
3. Lifting the obligation. The applicable principle, drawn from Smithkline Beecham plc v Generics (UK) Ltd, was that the court should not release or modify the implied undertaking except in special circumstances and where release or modification would not cause injustice. The general principle of co-operation between national courts stated in Human Genome Sciences v Eli Lilly was not relied upon because it was not germane to the issue (paras [30]-[32]).
4. Application of the exception. Special circumstances existed. The experiments and retained sample had been deployed in the European Patent Office, the forthcoming European Patent Office hearing preceded the United Kingdom trial, and the material was not confidential. Fairness therefore required the collateral-use obligation to be lifted so that Mount Sinai could use testing results in the European Patent Office. The European Patent Office retained complete control over whether to admit the material. The decision was distinguished from Tassilo Bonzel & Schneider (Europe) AG v Intervention Limited and A Or, which concerned confidential disclosure documents and different policy considerations (paras [33]-[40]).
5. The sample was to be provided by 12 December 2011. Costs were reserved. Permission to appeal was refused.