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Sufficiency in the UK is clarified

Sufficiency in the UK is clarified


Generics (UK), Arrow Generics and Teva v H Lundbeck A/S


The House of Lords has reined in Biogen. In a unanimous decision, the House of Lords dismissed the appeal of Generics (UK), Arrow Generics and Teva against the Court of Appeal's decision upholding H Lundbeck A/S's (Lundbeck) patent for the anti-depressant escitalopram. Lundbeck hold a patent (EP 0347066) for the anti-depressant escitalopram. Escitalopram is the (+) enantiomer of a racemate citalopram, first sold by Lundbeck in the late 1980s and which is no longer protected by a patent itself. 

A racemate is an equal mixture of the (+) and (–) enantiomers of an optically active compound.  The separation of the enantiomers can be advantageous as they may differ in their biological activity.

Generics and others relied heavily on the Biogen v Medeva case and argued that the protection available under Lundbeck’s patent should be limited to the specifically disclosed method of preparing escitalopram, and should not extend to the product itself, i.e. the product regardless of how it was made. 

The House of Lords dismissed this argument, distinguishing from the facts of the Biogen case. In Biogen the patent did not contain a simple product claim but rather a complex product-by-process claim relating to a broad class of products where more than one method of preparation was necessary to enable the skilled person to make all of the products covered by the claim. 

In the Lundbeck case, the racemate citalopram was known.  Prior to Lundbeck’s invention, however, there was no way of separating the enantiomers.  In this instance, the single method of separation described could be applied across the entire scope of the claim, thereby fulfilling the requirement of sufficiency of disclosure. 

The decision is important as it confirms the extent to which the findings in Biogen v Medeva may be applied.  It clarifies the amount of support required for simple product claims in the UK: disclosing one way of making the product can be enough.