Merck Sharp & Dohme Ltd v Glaxosmithkline Biologicals SA

In patent case-management proceedings, the court may require a claimant to narrow the claims said to be independently valid before providing a product and process description, while allowing later amendment if the description changes the issues. Disclosure for a prior-use defence should ordinarily await its pleading and definition of the issues. A confidentiality regime need not require every solicitor, barrister or support worker to sign an individual undertaking where the firm assumes responsibility for compliance. Confidential information disclosed for patent proceedings may generally be used for the claim and counterclaim, including considering amendments to preserve validity, subject to the statutory limits on amendment and Civil Procedure Rules 1998 r 31.22.

This was a case-management hearing in patent proceedings brought by Merck Sharp & Dohme Ltd to clear the way for launch of a multivalent conjugated pneumococcal vaccine. Glaxosmithkline Biologicals SA brought an infringement counterclaim and identified claims said to be independently valid.

The court determined the timing of the product and process description, disclosure relating to a possible prior-use defence, and two disputes concerning the confidentiality regime. The central issues were whether GSK should narrow its independently valid claims before receiving the description, whether disclosure should be ordered before the prior-use defence was pleaded, who should provide confidentiality undertakings, and whether confidential information could be used in considering patent amendments.

1. Case-management directions. GSK was required to use its best endeavours to narrow the list of independently valid claims before the product and process description was served, with liberty to apply after service to alter or amend the list. The court also observed that inspection of the process, with measurements and samples where appropriate, might prove more efficient than an inadequate description.
2. Prior use. Standard disclosure was not ordered before the prior-use defence had been pleaded. The scope of disclosure should be determined after the defence and the issues had been clarified. MSD was nevertheless required to decide within 28 days whether it would plead the defence.
3. Confidentiality undertakings. Counsel, solicitors and support staff acting for GSK were not required to sign individual undertakings. The agreed regime required Powell Gilbert to take all reasonable steps to ensure compliance, and the firm’s responsibility was considered a satisfactory protection for the confidential information.
4. Use of disclosed information. Warner-Lambert v Glaxo and the other cited authorities informed the balance between protecting confidential information and enabling a defendant properly to defend the proceedings. Under Civil Procedure Rules 1998 r 31.22(1), “proceedings” included both claim and counterclaim. It was therefore procedurally permissible to use the product and process description when considering amendments directed to curing invalidity, provided the statutory limits on amendment were respected.
5. MSD’s proposed restriction on use of the information was rejected because it would impose a disproportionate and procedurally unworkable fetter on GSK’s conduct and representation of the combined infringement and validity proceedings.