Abbott Laboratories Ltd v Medinol Ltd

Specific disclosure may be ordered where documents have a sufficiently arguable relevance to a live factual issue. Relevance may arise because the documents themselves may assist the court or because they may enable a further experiment or computational model capable of assisting the court. The court should assess proportionality by considering the importance of the proceedings, the existence and accessibility of the documents, the burden of disclosure, and the realistic prospect that the material can be used in time for trial. It is unnecessary for the applicant to establish that the documents will conclusively determine the issue.

Abbott sought revocation of three patents concerning stents, together with declarations of non-infringement. Medinol applied for specific disclosure of finite element models, modelling inputs and underlying data relating to Abbott stents. The material was sought to assist determination of whether loops in the stents widened longitudinally upon expansion while bent.

Abbott contended that the material was unnecessary, irrelevant and disproportionate because the disclosed analysis lacked a comparator and because existing photographs and expert evidence addressed the issue. The application concerned whether the requested documents were sufficiently relevant and proportionate to justify specific disclosure.

1. Application granted. Abbott was ordered to disclose the finite element models, modelling inputs and underlying data sought.
2. The existing product description, experiments and expert evidence did not conclusively determine the factual issue. A live issue remained as to what happened to the loops in situ, and specific disclosure was not precluded merely because Abbott had served a product description in lieu of standard disclosure.
3. The documents were sufficiently relevant. The data might itself permit measurements of loop width which could be compared with existing measurements. Even if the data lacked a comparator between an unexpanded bent stent and an expanded bent stent, disclosure of the model and data could enable Medinol to undertake further computational modelling capable of assisting the court.
4. Consafe Engineering (UK) Ltd v Emtunga UK Ltd [1989] RPC 154 was treated as recognising that such further modelling could amount to a further experiment. The court proceeded on the basis that this possibility was relevant to the disclosure application.
5. The disclosure was proportionate. The proceedings were a substantial patent action; the documents existed, had been created otherwise than for litigation, could be disclosed quickly and without significant burden, and further modelling might be completed before the existing trial window. The court left for later determination any question concerning permission for further experiments, additional evidence, or the consequences for the trial date.

Not stated in the judgment.