Legal context

In an earlier article, the authors examined various strategies for prolonging the protection given to existing products and managing competition from generic manufacturers. Since the publication of that article, there have been two important legal developments which are summarized here.

Key points

The Court of Appeal in Generics v Lundbeck has ruled that the principle of Biogen insufficiency is not of general applicability, and that the disclosure of one method of making a novel and inventive product is sufficient. Accordingly, the claim to a single enantiomer per se of a...

Legal context

In an earlier article, the authors examined various strategies for prolonging the protection given to existing products and managing competition from generic manufacturers. Since the publication of that article, there have been two important legal developments which are summarized here.

Key points

The Court of Appeal in Generics v Lundbeck has ruled that the principle of Biogen insufficiency is not of general applicability, and that the disclosure of one method of making a novel and inventive product is sufficient. Accordingly, the claim to a single enantiomer per se of a known compound previously available as the racemate was valid. In Actavis v Merck, the Court of Appeal has also taken the opportunity to align English practice with that of the EPO in respect of patents claiming a second pharmaceutical use of a known compound in the so-called Swiss form. Such a claim does not lack novelty merely because the sole difference between it and the prior art is a new dosage regime for a known medical condition, nor is it automatically invalid as being in respect of a method of treatment.

Practical significance

(1) It is now clear that the general principle that a patentee who has a product claim granted gets more than he has invented: that product made by any method, and all uses of the product, including those he had not thought of, even in circumstances where the product in question was obviously desirable and beneficial. However, the usual requirement of inventive step may limit the application of Generics v Lundbeck in respect of most claims to single enantiomers of known compounds. (2) Although it is now possible to obtain a second medical use patent without having to resort to Swiss form claims, there are a number of pre-EPC2000 patents using the Swiss form, and Actavis v Merck will be welcomed for bringing clarity and consistency to this area of law.