The objection was that there were substantial doubts about the products efficacy for the designated purpose in the absence of either experimental data, or a coherent theory which could explain such an effect what the Board called a plausible technical concept. The Board of Appeal upheld the patent because it disagreed on point. It thought that there was a coherent theory. This was because it was common general knowledge in the art that the inhibition of certain kinases associated with chronic myelogenous leukaemia was an effective way to treat that condition. Dasatinib had significant functional and chemical affinities with another kinase inhibitor known to be effective. This was more than a mere assertion of efficacy. The patent disclosed a coherent theory to support it in the light of common general knowledge. All of these judgments deal with highly fact-specific issues arising from objections or potential objections on the ground of insufficiency. When reading them, it is important not to miss the wood for the trees. The fundamental principle which they illustrate is that
the patentee cannot claim a monopoly of a new use for an existing compound unless he not only makes but discloses a contribution to the art. None of them casts doubt on the proposition that the disclosure in the patent must demonstrate in the light of the common general knowledge at the priority date that the claimed therapeutic effect is plausible. On the contrary, they affirm it: see The Court of Appeals statement of the effect of the plausibility test has already been quoted (para 20 above). They considered that the threshold was not only low, but that the test could be satisfied by a prediction ... based on the slimmest of evidence or one based on material which was manifestly incomplete. Consistently with that approach, they considered (paras 40, 130) that the Boards observations in SALK laid down no general principle. I respectfully disagree. The principle is that the specification must disclose some reason for supposing that the
implied assertion of efficacy in the claim is true. Plausibility is not a distinct condition of validity with a life of its own, but a standard against which that must be demonstrated. Its adoption is a mitigation of the principle in favour of patentability. It reflects the practical difficulty of demonstrating therapeutic efficacy to any higher standard at the stage when the patent application must in practice be made. The test is relatively undemanding.
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