ZOMETA ACLASTA / zoledronate / 1,338,895
What is the relationship between sufficiency and utility? Recall that claim 14 of the ‘895 patent, which was to a broad class, was held to lack utility on the basis that the it was not possible to predict the potency of any individual compound without testing. Hughes J held the ‘895 patent to be insufficient for the following reason:
[177] For the same reasons as discussed with respect to utility, I find that the '895 patent,
claim 14, is insufficient, even at the date that the patent was issued and granted. No
further discussion is required in respect of that patent.
I have to admit this reasoning is not transparent to me. Hughes J made this statement at the very outset of his sufficiency analysis, so there is no context that might shed light on his reasoning. There was no suggestion in the discussion of utility (or anywhere in the decision) that the ‘895 patent did not adequately disclose how to make the compounds in question (“classic insufficiency”). I don't see an obvious link to Sildenafil insufficiency. Could this be a reflection of the US doctrine that an invention that lacks utility is necessarily insufficient, on the logic that “Obviously, if a claimed invention does not have utility, the specification cannot enable one to use it.” In re Brana, 51 F.3d 1560, 1565 (Fed. Cir. 1995)? But I had not understood that to be established in Canadian law; and in the UK it seems that this proposition has been rejected: see Tetra Molectric’s Application [1977] R.P.C. 290 (CA) at 297: “if much of Mr. Walton's argument on this branch of the case be right, every failure to achieve the promised result could, as my Lord pointed out during the argument, be attacked for insufficiency under section 14. For my part, I cannot think this is right."
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