Sandoz Ltd v Bristol-Meyers Squibb Holdings Ireland Unlimited Company & Ors

At a case management conference in patent proceedings, the court may limit the number of claims which a patentee may assert as independently valid where it has sufficient information and understanding of the issues to do so confidently.

The appropriate limit is fact-sensitive. The court should consider the number and apparent overlap of the claims, the extent to which they represent distinct inventions, the pleaded validity and infringement cases, and the stage reached in the proceedings. The order should remain flexible where later evidence may justify a different number.

The court case-managed two related revocation actions brought by Sandoz and Teva concerning five formulation patents for apixaban. The actions were to be heard together.

At the first case management conference, the court determined the trial date and an application by Teva to limit the number of claims which the patentees could identify as independently valid. Teva sought a limit of six claims, while the patentees offered fifteen. The central issues were the appropriate trial listing and whether, in the circumstances, a restriction on independently valid claims should be imposed.

1. Trial date. The court rejected the February 2022 date because it was uncomfortably close to the trial of the related compound patent action. Given that Teva’s formulation action had commenced in February 2021, it was appropriate to list the trial from 26 April 2022 so that the commercial uncertainty could be cleared away as quickly as reasonably possible.
2. Power to limit claims. In some patent actions the court will not have sufficient information or understanding of the issues at the CMC to impose a limit on independently valid claims. In others, it will be able to develop a sufficient understanding to do so.
3. Application of the discretion. The five patents contained 59 claims, but the claims appeared to represent combinations of eight formulation features and were likely to involve considerable overlap. It was therefore extremely unlikely that they represented 15 separate inventions. The court considered it appropriate to restrict the patentees to no more than ten independently valid claims.
4. The patentees were required to identify those claims within 28 days after service of both PPDs. The court expected the number to reduce further before trial. All parties had liberty to apply if the evidence justified a greater or lesser number.