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Sufficiency II

Written by Tim Mount on 31 January 2010

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The Court of Appeal held that the Biogen insufficiency principle was not applicable in this case as the claims here were to a single product, said product not defined by a class of processes of manufacture.

The trial judge in Generics v H Lundbeck had extracted too broad a principle from Biogen, which dealt not with a simple product claim but with a product-by-process claim, in fact a claim to a wide class of such products.

(A product-by-process claim defines a product in terms of the method (manipulative steps) used to manufacture the same, the resulting product must still be novel and original. In the House of Lords in 2004 Lord Hoffman rejected the longstanding UK practice of granting product-by-process claims where the product is already known, as incompatible with European Patent Office practice.)

In Generics, sitting in the Court of Appeal, Lord Hoffman said that the trial judge (Kitchin J). was mistaken in equating the inventive concept of the Lundbeck patent (i.e. the process), with the technical contribution. What he should have found was that the novel and non-obvious enantiomer was itself the technical contribution.

Lord Neuberger found that:

the product claim in the present case is valid. I appreciate that this means that, by finding one method of making a product, a person can obtain a monopoly for that product. However, that applies to any product claim.


In summary : regarding insufficiency / non-enabling disclosure issues -

consider the clarity and completeness of the specification (under section 14(3) Patents Act 1977)

consider also the support given by the description for the claims (s.14(5)(c)).

if a product is novel and non-obvious, the product itself is the technical contribution to the art;

The appeal to the House of Lords (RIP) was unanimously dismissed.

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