Friday, March 11, 2011

The Vanishing Distinction between Sound Prediction and Demonstrated Utility

GlaxoSmithKline Inc. v. Pharmascience Inc. / rosiglitazone (NOC) 2011 FC 239, Hughes J

The distinction between demonstrated utility and utility based on sound prediction is important, because in the latter case, but not the former, the data supporting utility must be disclosed in the patent itself. I suggested in an earlier post that the distinction is beginning to collapse, as the threshold for what must be disclosed is lowered: in Pfizer / sildenafil (NOC) 2010 FCA 242 the Court of Appeal indicated that it is enough to advert to the data, rather than specifically desribing it. In GlaxoSmithKline / rosiglitazone (NOC) we see the distinction collapsing along a different dimension, as Hughes J held that showing that rosiglitazone was of “potential use” in the treatment of hypoglycaemia was sufficient to establish demonstrated utility [95], [98], [117]. But how different is demonstrating “potential use” from demonstrating a “sound prediction” of use? If we take seriously the distinction between these concepts, then it follows that an inventor who establishes a sound prediction of potential use has therefore satisfied the utility requirement. This seems unreasonable.

As noted, the practical significance of the distinction is whether the data supporting utility must be disclosed in the patent itself. In GlaxoSmithKline / rosiglitazone (NOC), data supporting the utility for rosiglitazone was not disclosed in the patent, so it would have been invalid had utility been based on sound prediction. It is difficult to avoid the conclusion that Hughes J held that “potential use” amounted to demonstrated utility in order to avoid having to hold the patent invalid on this basis. Such contortions do the law no service. In my earlier post I argued that there is no basis in the Act or in policy for drawing this distinction. We now see that it is collapsing on two doctrinal fronts. The key problem is that view that the data supporting utility must be disclosed in the patent itself. It is time to simply recognize that this doctrine, though recent, is wrong. It must be explicitly rejected before the technical distinctions it has engendered become further entrenched in the law.

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