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

An ordinary product claim is sufficiently enabled where the specification, read with common general knowledge, enables the skilled person to make the claimed product. One disclosed method may suffice, even where the inventive step consisted of finding that method and the claim covers the product however made.

Obviousness is assessed in all the circumstances. Relevant matters include the motive to solve the problem, available avenues of research, the effort involved and the expectation of success. A short and simple experiment is not necessarily obvious to try; there must be a reason to undertake it, normally including some expectation of a useful result.

Lundbeck held a patent claiming the (+) enantiomer of citalopram, pharmaceutical compositions containing it, and a method for its preparation. Generic manufacturers sought revocation for lack of novelty, obviousness and insufficiency.

Kitchin J rejected the novelty and obviousness challenges and upheld the process claim. He nevertheless revoked the product and composition claims because the patent disclosed only particular ways of making a product claimed however made. Lundbeck appealed that revocation. The generic manufacturers cross-appealed on novelty and the alleged obviousness of the amino-diol route.

The central questions were whether the product claim included the enantiomer as an unresolved component of the known racemate, whether the preparation route was obvious to try, and whether an ordinary product claim had to enable every possible method of making the product.

1. Disposition. The court unanimously allowed Lundbeck’s appeal and dismissed the respondents’ cross-appeals. Claims 1 and 3 were restored, while the judge’s refusal to revoke claim 6 remained undisturbed.
2. Novelty. Lord Hoffmann held that claim 1, properly construed through the eyes of the skilled person, did not include the (+) enantiomer merely as an unresolved component of the previously disclosed racemate. The patent’s title and specification made clear that it concerned the enantiomer and its isolation. The claim therefore was not anticipated. Jacob LJ agreed that the degree of purity required for infringement was immaterial to the novelty issue.
3. Obviousness. The judge had correctly considered whether the amino-diol route was obvious to try. The inquiry depended on all relevant circumstances, including the available avenues of research and the expectation of success. His rejection of the evidence that the ring-closing reaction looked promising left his conclusion unassailable. Jacob LJ added that the shortness and simplicity of an experiment do not suffice: there must be a reason to carry it out, normally involving some expectation that it may produce a useful result.
4. Sufficiency of an ordinary product claim. Under section 72(1)(c) of the Patents Act 1977, the invention requiring enablement is the invention defined by the claim. For an ordinary product claim, performance means making or otherwise obtaining the product. The specification need disclose only one enabling method. Sufficiency does not vary according to whether the inventive step lay in identifying the product’s properties or discovering how to make it.
5. Scope of Biogen. Biogen concerned a product-by-process claim defining a class through a range of recombinant processes. Such a class must be enabled across its scope. That reasoning did not impose the same requirement on an ordinary claim to a specific product. Where the statutory requirements are satisfied, the technical contribution is the product, even if the only inventive step was the method by which it was first made.
6. Breadth of monopoly. Product claims may cover uninvented methods of manufacture and uses not contemplated by the patentee. That breadth does not create an additional sufficiency test. Parliament has permitted product claims, and considerations about whether the patentee receives more than was deserved cannot displace the statutory language.

1. Court of Appeal (Civil Division): In [2008] EWCA Civ 311, unanimously allowed Lundbeck’s appeal against revocation of claims 1 and 3 and dismissed the generic manufacturers’ cross-appeals.
2. High Court, Patents Court: Kitchin J rejected the novelty and obviousness challenges, revoked product claims 1 and 3 for insufficiency, and upheld process claim 6. No citation for that judgment is stated.