Teva UK Ltd v Janssen Pharmaceutica N.A.

At a case management stage, an issue is an “issue for disclosure” where its fair resolution may require reference to contemporaneous documents. The existence of such an issue does not justify wide or unfocused disclosure. A party seeking extended disclosure must identify document classes with sufficient specificity and demonstrate their potential relevance and materiality to the issues for trial.

Where the substantive issue can be determined principally from public regulatory documents and expert evidence, general disclosure of communications with a regulator is ordinarily inappropriate. A focused request for underlying data or studies may be dealt with separately where properly formulated. The appropriate order may be limited to Model B disclosure of key documents relied upon and documents necessary to understand the case to be met.

Teva brought a claim seeking a declaration that Janssen’s supplementary protection certificate for Xeplion was invalid under Articles 3(c) and 3(d) of the Supplementary Protection Certificate Regulation 2009. The principal substantive issue was whether the active ingredient of Xeplion was paliperidone or paliperidone palmitate.

At the first case management conference, the parties disputed whether that issue qualified as an issue for disclosure and whether Teva should obtain extended disclosure under Models C or D. Teva sought communications, submissions, studies and data provided to the European Medicines Agency. Janssen opposed the breadth of the request and offered limited disclosure of underlying data and study results.

1. The identified issue was an issue for disclosure. Whether paliperidone or paliperidone palmitate was the active ingredient of Xeplion was properly characterised as an issue for disclosure. The issue could fairly be resolved with some reference to contemporaneous documents, including the summary of product characteristics and the European Public Assessment Report.
2. Wide Model C or Model D disclosure was unjustified. The requested classes of communications and documents relating generally to the active ingredient were insufficiently focused. The court was not persuaded that Janssen’s own statements to the European Medicines Agency would materially assist determination of the issue, which would be decided essentially from public documents and expert evidence. Any known adverse document would remain disclosable as such.
3. The European Public Assessment Report was a public document that had to be interpreted according to its own terms. There was no sufficient reason to assume that material information supplied by the applicant was absent from, or unreflected in, the report.
4. A more focused request for specific documents, further information, a notice to admit or specific disclosure might become appropriate, but no such properly formulated request was before the court. Janssen’s offer to provide non-privileged underlying data and study results, subject to reasonable limitations, was more appropriate than the broad disclosure sought.
5. Order. Extended disclosure was ordered on Model B terms for both parties, limited to key documents relied upon in support of the pleaded cases and key documents necessary to enable each party to understand the case it had to meet. Teva was ordered to pay Janssen’s costs of attending and arguing the disclosure issue. The remaining costs were costs in the case.