Generics (UK) Ltd v H Lundbeck A/S Rev 1

A statutory presumption that a product was made by a patented process remains only a presumption and may be rebutted before trial by compelling evidence. For interlocutory amendments and service out of the jurisdiction, the court may assess whether the proposed claim has reasonable prospects of success. An overseas supplier is not a joint tortfeasor merely because it knowingly supplies goods to a customer intending to sell them in the United Kingdom. The supplier must be sufficiently involved in the infringement to make the infringing act its own. Supplying regulatory information which enables lawful sale does not, without more, make the supplier part of the customer’s commercial venture.

Lundbeck owned a patent covering escitalopram and a process for making citalopram. Generics brought proceedings seeking revocation. Lundbeck sought to amend its defence and add a counterclaim alleging infringement of the process claim, relying on the statutory presumption concerning a new product. It also sought to join an Indian supplier, X, as a joint tortfeasor and serve the claim out of the jurisdiction.

Mr Justice Pumfrey refused the process-infringement amendment and refused service out on X, while allowing an amendment concerning certain product claims: [2006] EWHC 804 (Ch). The Court of Appeal considered whether the proposed allegations had reasonable prospects of success.

1. Appeal dismissed. The reasonable-prospects-of-success test was common ground for both the proposed amendment and service out of the jurisdiction.
2. Section 100(1) of the Patents Act 1977 creates a presumption that a product made by another person was obtained by the patented process where the invention is a process for obtaining a new product. The presumption does not necessarily require a full trial before it can be rebutted. The court may assess at an interlocutory stage whether the evidence is sufficiently compelling.
3. The regulatory material and evidence that X followed the disclosed process provided compelling legal and commercial reasons for treating that process as genuine. The experimental evidence relied on by Lundbeck was indirect, weak and materially answered by contrary expert evidence. The presumption was completely displaced, so the process claim had no reasonable prospect of success.
4. On joint tortfeasorship, Sabaf v Meneghetti [2002] EWCA Civ 976 and [2003] RPC 264 stated the governing principle: a person must be so involved in the commission of the tort as to make the infringing act his own. Mere supply from outside the jurisdiction, even with knowledge of intended resale, is insufficient.
5. X’s direct provision of regulatory information enabled lawful sales but was not directed at the actual importation or sales. It did not make X part of Generics’ commercial venture, and there was no arguable case for service out. The Unilever case involved a materially closer corporate relationship and did not assist Lundbeck.
6. Lord Justices Neuberger and Chadwick agreed with Lord Justice Jacob. The order was: appeal dismissed.

• Court of Appeal (Civil Division): dismissed Lundbeck’s appeal and upheld the refusal to permit the process-claim amendment and to serve X out of the jurisdiction.
• Chancery Division, Patents Court: Mr Justice Pumfrey refused those parts of the proposed amendment and service application, while allowing an amendment concerning certain product claims: [2006] EWHC 804 (Ch).