Wednesday, July 31, 2013

The Promise of the Patent Must Be Explicit

Sanofi-Aventis v Apotex Inc / clopidogrel 2013 FCA 186 Pelletier JA, concurred in by Noël, Gauthier JJA; separate concurring reasons by Gauthier JA, rev’g 2011 FC 1486 Boivin J
            1,336,777 – PLAVIX

In Canadian law, utility is measured by the promise of the patent:

Where the specification does not promise a specific result, no particular level of utility is required; a "mere scintilla" of utility will suffice. However, where the specification sets out an explicit "promise", utility will be measured against that promise. The question is whether the invention does what the patent promises it will do.
[47, original emphasis] quoting Olanzapine (No 1), 2010 FCA 197 [76]

This doctrine has resulted in a number of pharmaceutical patents being invalidated, and in my article “The False Doctrine of False Promise,” (2013) 29 CIPR 3 (draft version available here), I argued that the promise doctrine is both unsound in principle and contrary to the Canadian Patent Act. The FCA is evidently of the contrary opinion, as the Court expressly and emphatically reaffirmed that “The promise of the patent is the standard against which the utility of the invention described in the patent is measured,” [47]: and see [48], quoted above. The FCA also expressly affirmed what I have argued is the most objectionable aspect of the promise doctrine: “An inventor whose invention is described in a patent which would otherwise be valid can nonetheless promise more for his invention than required by the Act so as to render his patent invalid” [54].

However, the FCA did significantly modify the doctrine, by emphasizing that the promise must be explicit, and that not every patent necessarily contains a promise (my emphasis):

[49] If the inventor does not make an explicit promise of a specific result, the test for utility is a “mere scintilla” of utility. If, on the other hand, the inventor makes an explicit promise of a specific result, then utility will be assessed by reference to the terms of the explicit promise.

[50] When this Court said at paragraph 80 of Olanzapine, cited above, that the promise of the patent must be ascertained, it should not be taken to have assumed that every patent contains an explicit promise of a specific result since, subject to what is said below with respect to selection patents, there is no obligation on the part of the inventor to disclose the utility of his invention in the patent. In Olanzapine, the Court was simply indicating that the firs step in assessing utility was to determine the standard against which utility will be measured. This requires the Court to construe the patent to determine if a person skilled in the art would understand it to contain an explicit promise that the invention will achieve a specific result. If so, the inventor will be held to that promise. If there is no explicit promise of a specific result, then a mere scintilla of utility will do.

Moreover, on the facts, the FCA reversed Boivin J on the basis that “He erred in law in reading into the ‘777 patent a promise for use in humans on the basis of inferences, in the absence of language at least as clear and unambiguous as that used to establish the advantages of the selection over the compounds of the genus patent” [66]. The FCA held that the patent made no promise [71], and therefore the fact that the invention had sufficient utility to support a selection patent was enough.

While the FCA Clopidogrel decision is formally consistent with the prior case law, the decision departs from the current practice both in the Court’s insistence that the promise must be explicit for it to serve as the touchstone for utility, and in emphasizing that not every patent has such a promise. The focus in previous cases has been to determine what the promise of the patent was, and not whether the patent contains a promise at all. So, in Olanzapine (No 1) the FCA said “The promise of the patent must be ascertained, [80] and “the promise of the patent is to be ascertained at the outset of an analysis with respect to utility” [93]. Clopidogrel implies that this is no longer entirely accurate, as it must first be ascertained whether the patent has a promise at all. Because the of need to ascertain the promise, if the language of the specification was not express, it would be finely parsed to extract a promise. Clopidogrel holds that this fine parsing is also misguided.

If Clopidogrel represents the law going forward, we should expect to see utility measured by the promise less often, and consequently, fewer utility attacks will be successful. The crucial question will be how explicit a promise must be in order to establish the standard for utility. Given that the doctrine was specifically affirmed, and given that the specification never has a statement beginning “This patent promises...”, I expect that direct statements of use such as “The compounds of this invention . . . are useful in the treatment of high blood pressure [and are] useful in the treatment of cardiovascular disorders and particularly mammalian hypertension” will be treated as an explicit promise: see Sanofi v Apotex / Ramipril 2009 FC 676 [122]. But where exactly the line of “explicitness” will be drawn is difficult to predict for any given patent. As I noted in my False Promise article at 41, “The root of the difficulty is that, under the promise of the patent doctrine, the utility of the invention is defined in the disclosure. The traditional purpose of the disclosure is to describe how to make and use the invention.” This disconnect remains, even if the promise must be explicit.

I said “if Clopidogrel represents the law going forward,” because it is not clear whether the views of this panel represent the views of the Court as a whole, particularly in light of Pfizer v Apotex / latanoprost (NOC) 2011 FCA 236 in which Trudel JA (Sharlow, Stratas JJA concurring), very aggressively implied a promise which was certainly not explicit in the patent. Latanoprost and Clopidogrel simply cannot be reconciled, and Clopidogrel made no attempt to do so; the Latanoprost decision was never mentioned. The question is whether we have a split in the FCA – the two decisions did not share any judges – or whether Clopidogrel represents a new consensus. If the former, then the outcome of promise cases on appeal will depend on the particular panel of the FCA. I note that the two other FCA decisions since Latanoprost endorsed a modest interpretation of the patent: Anastrozole (NOC) 2012 FCA 109 Evans JA: Sharlow, Dawson JJA (blogged here) and Donepezil (NOC) 2012 FCA 103 Mainville JA: Sharlow, Gauthier JJA (blogged here), in which the FCA remarked that “the jurisprudence does not permit an unescorted and unchaperoned romp through the disclosure” [57]. This suggests that Clopidogrel represents the culmination of a trend, but I am hesitant to draw firm conclusions; with a such a small sample size, it may be that this is not a trend at all, but a reflection of the composition of the particular panels.

On the whole, the FCA Clopidogrel decision is a very welcome development which should restrain some of the worst excesses of the false promise doctrine. However, restraining those excesses is as far as the FCA was willing to go. This is the most extensive consideration of the promise of the patent doctrine that the FCA has undertaken. That the Court reaffirmed the doctrine at the same time that it significantly restricted it, means that there is no question but that the promise of the patent doctrine will remain part of Canadian law, at least until the SCC might choose to deal with it. That is unfortunate, as I remain of the view, expressed in my False Promise article, that the doctrine is unjustifiable in any version; but as the saying goes, half a loaf is better than none.

No comments:

Post a Comment