Lilly & Company v Human Genome Sciences Inc

A holder of a basic patent may, in principle, apply for a supplementary protection certificate relying on a marketing authorisation granted to an unconnected third party. The statutory conditions in the SPC Regulation contain no additional connection requirement. The Patents Court has jurisdiction to grant declaratory relief concerning a potential SPC where there is a defined legal issue and a genuine commercial need for certainty. The court should nevertheless be cautious where the dispute requires factual findings ordinarily suitable for determination by the Comptroller. An immediate reference to the Court of Justice should generally await an established factual background, particularly where the proposed reference concerns the relationship between the patent holder and the marketing-authorisation holder.

Lilly sought declarations concerning any supplementary protection certificate which Human Genome Sciences might obtain in reliance on a marketing authorisation for Lilly’s antibody, potentially based on HGS’s patent. Lilly argued that an SPC could not be obtained using an authorisation granted to an unconnected third party and that the patent claims did not sufficiently specify the antibody.

Lilly applied for an immediate reference to the Court of Justice. HGS applied to strike out the claim as premature, hypothetical and inconsistent with the statutory procedure for SPC applications. The court considered the third-party SPC issue, the specification issue, jurisdiction to grant declaratory relief, and the timing of any reference.

1. Third-party SPC issue. The wording of Articles 3 and 6 of the Council Regulation No 469/2009 does not require the marketing authorisation to be held by the basic-patent holder or a connected person. The holder of a basic patent may rely on an authorisation granted to an entirely unconnected third party. Reading such a requirement into the Regulation would create uncertain and fact-sensitive criteria unsupported by its text or purpose.
2. The reasoning in Biogen Inc v SmithKline Biologicals SA supported that conclusion. The decision proceeded on the basis that divergent ownership of the patent and marketing authorisation was possible, and the Regulation was intended to confer supplementary protection on basic-patent holders without preferential treatment.
3. Specification issue. The guidance from the Court of Justice in Medeva and related decisions requires the relevant active ingredient to be specified in the wording of the patent claims, rather than merely falling within the claims on an infringement analysis. The precise application of that test to the antibody claim remained unclear. A reference would therefore be required if the issue had to be finally determined.
4. Declaratory jurisdiction. The court had jurisdiction to entertain Lilly’s claim. Declaratory relief is discretionary. Relevant considerations included justice to both parties, whether the declaration would serve a useful purpose, the clarity of the issue and the need for commercial certainty. The claim was not purely hypothetical because Lilly faced a real commercial uncertainty.
5. The action should not be struck out. It should, however, be stayed pending the Court of Appeal’s decision on the validity of the patent. An immediate reference was refused because the relevant facts, including the alleged relationship between the parties’ research and the technical specification of the antibody, had not been established. The reference application could be renewed after the factual position became clearer.

The judgment records earlier proceedings concerning the patent, including decisions of the Patents Court, the Court of Appeal and the Supreme Court. Those decisions formed part of the same litigation and were not decisions under appeal in this judgment.