Case: Angiotech Pharmaceuticals v Conor [2007] EWCA Civ 5 ; [2007] RPC 20
Outcome: cited
am aware of the observations made by the English Court of Appeal in relation to the High Court's judgment in Astra in Angiotech Pharmaceuticals v Conor [2007] EWCA Civ 5 ; [2007] RPC 20 at [39] [45] which were quoted by Kitchin J in Generics v Lundbeck at [73]. Those observations are of no relevance to my task. Astra also stands as authority for the following propositions: While the evidence that was before Kitchin J in Generics v Lundbeck was clearly different from that which was before me, I assume that the evidence of the course of experimentation that was followed at Lundbeck was similar. In any event, his Lordship's summary (at [154]) accords with my findings on the evidence in the present case: Assuming the skilled person decided to embark upon the task of trying to obtain the individual enantiomers there was no real dispute between the parties that he would initially choose to attempt to resolve the final molecules. Only if this failed might he then consider alternative methods such as using enantiomerically pure precursors. But here his anxiety would be that subsequent reaction steps might result in the production of an enantiomerically impure final product. As I shall explain, scientists at Lundbeck attempted to resolve citalopram by classical resolution techniques using diastereoisomers, by using new resolving agents, by attempting to resolve derivatives and by using techniques of asymmetric synthesis, all over the period 1980 to 1988. In addition, they attempted to resolve citalopram using analytical chiral HPLC from 1983 to 1987. None of these techniques were successful. The claimants accepted that citalopram is not easily resolved by making diastereoisomers. However, they submitted the skilled addressee would not regard failure in relation to this molecule as the end of road. I accept that this was so. But the work Lundbeck undertook illustrates that the road to which the claimants referred was long and uncertain. The Product Claims The word "routine" that has become a common feature in formulations of the obviousness test in Australia (see [180] above) is more comfortably applicable to discussions of methods than products. However, the "matter of routine" test can be applied to product claims. The question to be asked is whether it would have been a matter of routine for those skilled in the art to adopt the goal of obtaining the enantiomers of citalopram for use of one of them as a drug for the treatment of depression. In Astra , the High Court described (at [53]) the reformulation of the "Cripps question" by Graham J in Olin at 187-188. Their Honours stated that that approach should be accepted. Adapting that test to the circumstances of the present product claims, I would state the test as follows: Would the hypothetical addressee or team as at 14 June 1988, equipped with the Australian Citalopram Patent and possessed of the common general knowledge within the field at that time, adopt as a matter of routine the aim of obtaining the (+)-enantiomer of citalopram in the expectation that it might well produce a useful alternative to, or a better drug than, citalopram? While I think that the hypothetical addressee or team in 1988 would have recognised the possibility of an advantage in obtaining the enantiomers because of the possibility of the therapeutic benefits of the racemate being found to reside in one of them, I do not think that the goal of obtaining the enantiomers would have been adopted as a matter of routine, as is required for the Australian test of obviousness to be satisfied. The Joint Report Again, a convenient starting point is the Joint Report. Professors Banwell and Davies were asked: "What were the motivations (chemically and academically, but excluding regulatory) for obtaining the enantiomers of a known racemate?"