Onyvax Llimited V. Endpoint Research (uk) Limited
| Jurisdiction | Scotland |
| Judge | Lord Emslie |
| Neutral Citation | [2007] CSOH 211 |
| Court | Court of Session |
| Published date | 28 December 2007 |
| Year | 2007 |
| Date | 28 December 2007 |
| Docket Number | A613/07 |
| OUTER HOUSE, COURT OF SESSION [2007] CSOH 211 | |
| A613/07 | OPINION OF LORD EMSLIE in the cause ONYVAX LIMITED Pursuers; against ENDPOINT RESEARCH (UK) LIMITED Defenders: ________________ |
Pursuers: Sandison; Brodies LLP
Defenders: Hayhow; Thorntons Law LLP
28 December 2007
[1] In this motion for an interim order under section 47(2) of the Court of Session Act 1988, the pursuers seek delivery of a Trial Master File ("TMF") which is said to contain composite details of certain clinical trial work undertaken by the defenders on their behalf in connection with the development of a new cancer vaccine. The TMF is apparently the last outstanding document to be handed over by the defenders following the recent termination of their engagement and the transfer of all ongoing trial work to others. Having originally contemplated an amicable handover of this document, the defenders now decline to co-operate, and instead assert a common law lien on account of the pursuers' non-payment of work invoices to the tune of just over £147,000. On the basis of an arbitration clause in the parties' contract (the Master Service Agreement, or "MSA"), the defenders also maintain that this court has no jurisdiction to entertain the present application. The pursuers' position, on the other hand, is that the defenders have impliedly abandoned their right to arbitrate by raising a Sheriff Court action for payment of the outstanding invoices. More importantly, they point out that any arbitration would be subject to the UNCITRAL model law in terms of section 66 of the Law Reform (Miscellaneous Provisions) (Scotland) Act 1990, which preserves the jurisdiction of the court relative to interim orders unless and until the same matter is determined by the arbiter.
[2] The parties are in agreement that the proper approach to an application for an interim order under section 47(2) is that affirmed by an Extra Division in Scottish Power Generation Ltd v British Energy Generation (UK) Ltd 2002 S.C. 517. Paragraph [26] of the opinion of the court is in the following terms:
"From these authorities we derive the following principles which are relevant to a case of the present kind. First, the Lord Ordinary has to identify the issues in the action, including the legal basis of the claims with which he is dealing. Secondly, he has to consider whether the party seeking the order has demonstrated a prima facie case that an obligation exists, and that there is a continuing or threatened breach of that obligation which the order will address. Thirdly, he has to avoid significantly innovating on the parties' contractual rights and obligations. Fourthly, he has to consider whether the balance of convenience is such as to justify the making of the interim order, bearing in mind the nature and degree of the harm likely to be suffered on either side by the grant or refusal of the interim order, and the relative strength of the cases put forward by each party."
The parties are, however, in dispute as to whether these requirements for an interim order have been made out in the present case.
[3] Before me the pursuers' claim was pointedly not founded on any express handover obligation in the MSA, since the defenders might then admittedly withhold performance of such obligation while their invoices remained unpaid. On the contrary, the pursuers relied on their undisputed right of ownership of the TMF, and on the concomitant right to recover its possession from the defenders on demand. According to counsel this was a sufficient prima facie case for the purposes of section 47(2), especially when coupled with the invalidity of the alleged lien on which the defenders principally sought to found. In particular, it was said, no valid lien could be asserted here because that would be inconsistent with the express terms of the parties' agreement and of certain documents incorporated therein. Moreover, since lien was an equitable remedy, the court could not sanction it where the equities were in the pursuers' favour.
[4] On similar grounds, the balance of convenience strongly favoured the pursuers. The TMF contained essential details, unavailable to the pursuers, of the precise performance of the trials relative to individual patients in many countries across the world. The pursuers admittedly knew how these trials should, by design, have been carried out, but in the absence of actual data regarding dosages, dates and the like they could not be sure that all necessary information would be available to deal safely and effectively with any "adverse event" which might arise. This posed a serious potential risk to patients where neither the pursuers nor the new trial operator would be able to assess any link to prior trial activity, or indeed to determine the appropriate remedial treatment to be adopted. The new trial operator had to date proceeded on certain assumptions, but this state of affairs was highly unsatisfactory and represented a breach of the principles enshrined in the Declaration of Helsinki (1964) and other documents incorporated into the MSA, whereby patient safety was a paramount consideration. As stated in paragraph A5 of the Declaration, "... considerations related to the well-being of the human subject should take precedence over the interests of science and society". As a result of the defenders' failure to deliver the TMF, the pursuers were also placed in continuing breach of their obligation to keep and maintain a TMF under Regulation 31A(1) and (2) of the Clinical Trials Regulations 2004.
[5] In these circumstances, the defenders' withholding of the TMF for purely commercial reasons was irresponsible and immoral as well as unlawful, and an interim order for delivery was thus amply justified. Although the defenders clearly regarded the contents of the TMF as sufficiently valuable to warrant retention, they were unable or unwilling to identify the nature of that value. This seriously undermined their claim to have disclosed all relevant patient information to the pursuers already, and tended to support the pursuers' position on the balance of convenience. The defenders' private commercial interests could not be allowed to override the health and safety of patients, especially where an interim order for delivery would in no way innovate on the parties' contractual rights and obligations. Paragraphs 8.1 and 12.3 of the MSA were in the following terms:
"8.1 All Intellectual Property and work product generated in any form or media in the course of the performance of the Services by Endpoint ... is the sole and exclusive property of Onyvax and shall be remitted by Endpoint to Onyvax no later than the termination date of this Agreement.
12.3 Upon request of Onyvax and/or at the end of the work covered by this Agreement, Endpoint will promptly return all documents and information made available to Endpoint and created by Endpoint during the course of the work covered by this Agreement."
Nor could it be said that an interim order at this stage would be inappropriate as exhausting the pursuers' claims in this action. On the contrary, an interim order...
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