Generics (UK) Limited and others (Appellants) v H Lundbeck A/S (Respondents)

A patent claim to a single chemical product is sufficiently disclosed where the specification enables a skilled person to make that product across the full extent of the claim. The patentee need not disclose every possible method of making it.

Where the product is new and non-obvious, its technical contribution may be the product itself, even though the inventive step lay in discovering the only then-known method of manufacture. The claim may therefore cover later methods which owe nothing to the disclosed process. The broader insufficiency reasoning applicable to claims encompassing multiple products, embodiments or processes does not govern a simple claim to one chemical compound.

Lundbeck obtained a patent for escitalopram, the isolated (+)-enantiomer of the antidepressant citalopram, a pharmaceutical composition containing it, and the process by which it had been isolated. The appellants, which wished to market generic products, sought revocation.

Kitchin J rejected challenges based on novelty and obviousness but held the product claims invalid for insufficiency: [2007] EWHC 1040 (Pat), [2007] RPC 32. The Court of Appeal reversed that conclusion and upheld the claims: [2008] EWCA Civ 311, [2008] RPC 19.

The sole issue before the House was whether a claim to one new and non-obvious chemical product was insufficient because the patent disclosed only one inventive method of making it, while later methods could owe nothing to that teaching.

1. Appeal dismissed unanimously. Lord Phillips recorded that every member of the Appellate Committee reached the same conclusion for the same reasons. Lord Walker, Lord Mance and Lord Neuberger delivered the principal reasoning.

2. Per Lord Neuberger, Lord Walker and Lord Mance, a specification satisfies sections 14(3), 14(5)(c) and 72(1)(c) of the Patents Act 1977 when it enables the skilled person to make the claimed single product across the full extent of the claim. Sufficiency does not require disclosure of every possible method by which that one product may be made. The patent disclosed an enabling method of producing escitalopram and therefore met that requirement.

3. For a simple claim to a single new and non-obvious chemical compound, the technical contribution may be the product itself. This remains so where the inventive step consisted of finding the first method of producing a known desideratum. The resulting product claim may cover later and superior manufacturing methods which owe nothing to the disclosed process. The statutory distinction between product and process inventions, including that reflected in section 60, supported this conclusion.

4. The House explained Biogen Inc v Medeva plc [1997] RPC 1. That decision did not establish a general rule restricting every product claim to the process or inventive step disclosed. Its claim identified a product partly by how it was made and partly by what it did, and embraced numerous methods or embodiments beyond the patent's teaching. Its insufficiency reasoning did not control a claim to one enabled chemical compound.

5. The conclusion accorded with the established jurisprudence of the European Patent Office. The monopoly must correspond to the technical contribution, but that principle prevents claims from extending to products, embodiments or methods which the skilled person cannot perform. It does not require every way of making an enabled single product to be disclosed.

6. Lord Scott additionally concluded, on an issue no longer pursued, that an enantiomer not previously made available in separated form was new for sections 1(1)(a) and 2 of the Patents Act 1977. That reasoning was not necessary to the disposition.

1. House of Lords: The appeal was dismissed unanimously. The Court of Appeal's decision upholding the product claims was affirmed: [2009] UKHL 12.
2. Court of Appeal: The court upheld the findings on novelty and obviousness but reversed the finding of insufficiency, holding the claims valid: [2008] EWCA Civ 311, [2008] RPC 19.
3. High Court: Kitchin J rejected the novelty and obviousness attacks but held the claims to escitalopram and its pharmaceutical composition invalid for insufficiency: [2007] EWHC 1040 (Pat), [2007] RPC 32.