Generics (UK) Ltd & Ors v H Lundbeck A/S

The House of Lords dismissed the appellants' challenge to product claims for the (+) enantiomer of citalopram (escitalopram). The court held that a valid product claim to a single, novel chemical compound is not rendered insufficient merely because the only inventive step lay in a process for making that compound. Relevant provisions of the Patents Act 1977 considered include section 1 (novelty and inventive step), section 14(3) and 14(5)(c) (enabling disclosure and support), and section 72(1)(c) (revocation for insufficiency). The Court distinguished this case from Biogen and aligned its approach with established EPO jurisprudence on product claims and enantiomers.

The appellants (manufacturers of generic citalopram) sought revocation of Lundbeck's patent claiming the (+) enantiomer of citalopram and pharmaceutical compositions containing it. The High Court (Kitchin J) held the product claims to be insufficient because the inventive contribution was said to be limited to a particular method of preparation; the Court of Appeal reversed, upholding the product claims; the appeal to the House of Lords followed.

(i) Relief sought: revocation of the patent claims to the (+) enantiomer and related pharmaceutical compositions.

(ii) Issues framed:

• whether the product claims (claims 1 and 3) were invalid for insufficiency under section 72(1)(c) of the Patents Act 1977 because the specification disclosed only the inventive method of preparation and not other methods that later became available;
• relatedly, whether a product claim must be limited so that its scope corresponds to the patentee's technical contribution when that contribution resides only in a process.

(iii) Reasoning and conclusion: the House accepted that escitalopram was new and involved an inventive step (novelty and obviousness were not pursued on appeal). The Lords held that, for a single chemical compound, the technical contribution can be the product itself and that a patent validly claiming such a product need not be confined to the particular method by which the patentee first made it. The court distinguished Biogen as involving a different and more complex claim situation, and relied on the statutory framework (sections 1, 14 and 72 of the Patents Act 1977) and persuasive EPO decisions dealing with enantiomers and product claims. Consequently, the appeal was dismissed and the Court of Appeal's decision upholding the product claims was affirmed.

Appeal dismissed. The House held that a product claim to a single, novel chemical compound (the (+) enantiomer, escitalopram) was not invalid for insufficiency merely because the only inventive contribution lay in a particular method of producing it; the specification enabled the product and EPO jurisprudence supported allowing product claims for separable enantiomers. Biogen was distinguished as concerned with a different kind of claim.

High Court (Patents Court), Kitchin J: revocation of product claims for insufficiency ([2007] EWHC 1040 (Pat); reported [2007] RPC 32). Court of Appeal: appeal allowed, product claims upheld ([2008] EWCA Civ 311; [2008] RPC 19). House of Lords: appeal dismissed ([2009] UKHL 12).