Disclosure - Teva UK Ltd v Janssen Pharmaceutica N.A

Author Basher Eyre Licence CC BY-SA 2.0 

 





Jane Lambert

Patents Court (Mr Justice Fancourt) Teva UK Ltd v Janssen Pharmaceutica N.A. [2020] EWHC 3157 (Pat) (16 Nov 2020)

This was an application by the claimant for extended disclosure of correspondence and other documents under the PD51U-Disclosure Pilot for the Business and Property Courts. An issue in an action for a declaration that a supplementary protection certificate ("SPC") is invalid and should be revoked is whether the active ingredient of the SPC has already been protected by an earlier certificate.  The claimant has alleged that correspondence between the European Medicines Agency ("EMA") and the defendant would assist the court to determine that issue.

Accordingly, the claimant applied for the following disclosure under Model C of the practice direction:

"1. Correspondence and/or communications between the European Medicines Agency, EMA, and Janssen-Cilag, or any Janssen group company or agent on behalf of Janssen-Cilag, relating to the active ingredient of the medicinal product, the subject of the marketing authorisation applications for Xeplion, the Xeplion MA applications.
2. Any written submissions, results of studies and/or data submitted to the EMA by Janssen-Cilag or any Janssen group company or agent on behalf of Janssen-Cilag, in relation to the active ingredient of the medicinal product, the subject of the Xeplion MA applications."

The claimant subsequently modified its request for disclosure on Model D.

Four days before the case management conference at which the claimant's application was due to be considered, the defendant's solicitors made the following offer to the claimant's:

"Our client would in principle be prepared to provide your client with copies of the evidence (i.e. the data and/or results of studies) submitted to the EMA by Janssen Cilag as part of the Xeplion MA Applications on the basis set out below.
Following the inter-solicitor conference call on 5 November 2020, the correspondence to date and the DRD, we do not understand your client to be suggesting that all data and/or results of studies submitted to the EMA might be relevant to your case. However, it remains unclear which data and/or results of studies your client does consider to be relevant to the Issue for Disclosure identified by your client. Absent any explanation of your client's case, this makes it impossible for our client to understand how to comply with your client's Extended Disclosure Requests under either Model C or D. In circumstances where the EPAR is a public document that your client has access to, we therefore invite your client in the first instance to identify which particular tests and/or studies referred to in the Xeplion EPAR it considers to be relevant to your client's Issue for Disclosure. Subject to the reasonableness and proportionality of your client's request, our client is in principle prepared to provide your client with copies of any non-privileged documents containing the data and/or results underlying those tests and/or studies (suitably redacted to remove obviously irrelevant but confidential material and disclosed under the terms of an agreed confidentiality club)."

The CMC was heard by Mr Justice Fancourt on 16 Nov 2020.

The claimant rejected that offer on the ground that it was wrong to offer only objective documents and not communications or correspondence in which the defendant may have expressed its own views or asserted opinions about the active ingredient. This was explained on the basis of possible overlap in material in correspondence or communications.  The learned judge considered that the defendant's offer was more appropriate than ordering otherwise unjustified Model D disclosure. In his view, the parties should co-operate to deal with any limited disclosure in that way.  He decided to make an order for extended disclosure, but only on the basis of Model B disclosure for both sides.  Such an order would require disclosure to the extent it is not already complied with in initial disclosure of the key documents relied upon in support of the pleaded cases and the key documents that are necessary to enable each side to understand the case that they have to meet.   He expected that already to have been done on initial disclosure but his order might catch a few documents on either side that should be disclosed.

Even though it had been unsuccessful, the judge refused to award the defendant the costs of the application. First, it was an application for general directions at the CMC, which was needed in any event, and which covered other matters that were not agreed at the time when the application was made. Secondly, it was only at a relatively late stage that the defendant offered what his lordship considered to be the appropriate relief.  On the other hand, the claimant could have avoided the costs of the hearing had it accepted the defendant's offer.  He ordered the claimant to pay the defendant's costs in attending and arguing the matter and the remaining costs to be costs in the case.

Anyone wishing to discuss this article or SPC generally may call me on 020 7404 5252 during office hours or send me a message through my contact form.

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