Hospira UK Ltd v Genentech, Inc

Under CPR 31.22, documents referred to in a public trial ordinarily enter the public domain, but the court may preserve confidentiality where cogent, specific reasons outweigh the requirements of open justice.

The burden lies on the party seeking continuing confidentiality. The court should assess the document’s role in the trial, its relevance to public scrutiny, the risk of commercial or third-party harm, and any chilling effect on proper disclosure. General assertions of confidentiality are insufficient. In patent cases, the same principles apply, with particular regard to the public importance of patent litigation and the need for full disclosure.

Genentech applied under CPR 31.22 for continuing confidentiality over six documents disclosed in patent proceedings against Hospira. The documents had been subject to a temporary confidentiality order during the trial.

The application concerned clinical-trial protocols, extracts from a biologics licence application, correspondence with the FDA, and dosage-regimen analyses. The court had to decide whether the documents, or particular pages, should remain confidential after having been read or referred to at a public trial, while also considering their potential use in related European Patent Office proceedings.

1. Applicable principles. The court applied the principles stated by the Court of Appeal in Lilly Icos v Pfizer (No 2) [2002] EWCA Civ 2. Very good reasons are required to depart from the normal rule of publicity. The applicant bears the burden of giving cogent and specific reasons for continued confidentiality.
2. The court must consider the document’s role in the trial and its importance to public scrutiny. It must also consider commercial prejudice, the potential chilling effect on disclosure, and the public importance of patent litigation. Assertions that material is confidential, or that publication may assist competitors, require specific evidential support.
3. The approach in Dendron GmbH v The Regents of the University of California [2004] EWHC 589 concerned permission to use disclosed documents for a collateral purpose. It was therefore not directly applicable to an application for permanent confidentiality after trial, although its reasoning might bear on the proposed use of the documents in European Patent Office proceedings.
4. A full clinical-trial protocol was properly kept confidential because it was a detailed blueprint, and the public could understand the trial from the relevant expert evidence. Similarly, most of the clinical and pharmacokinetic material in Exhibits RHE-6 and RHE-7 remained confidential. Page 14 of those exhibits had to be made public because its figure was important to understanding submissions about the quality of the fit between predicted and measured data.
5. Genentech failed to establish specific or convincing harm in relation to RHE-10, pages 1–9, and RHE-4 and RHE-5. Those materials were relevant to understanding the trial and the EPO plausibility issue, and the claims to confidentiality were refused.
6. Genentech’s application was granted for RCFL-8, RHE-10 pages 10–54, and the remaining parts of RHE-6 and RHE-7, subject to page 14 being public. It was refused for RHE-10 pages 1–9 and RHE-4 and RHE-5.