Thursday, August 1, 2013

The Promise of Selection Patents

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

The ‘777 patent at issue in Clopidogrel is a selection patent over Canadian patent 1,194,875. This decision illustrates how the promise of the patent doctrine has distorted the analysis of selection patents in Canadian law, but it also illustrates that ultimately nothing turns on this. This reinforces the view that it may be time to abandon the doctrine entirely.

In Clopidogrel the FCA re-affirmed the point made by the SCC in Sanofi 2008 SCC 61 [9] and subsequently by the FCA in Olanzapine (No 1) 2010 FCA 197 [33] that “a selection patent is like any other patent” [44], in that it must satisfy the requirements that the invention be new, useful and non-obvious. It is also clear that in order to be valid, a selection patent must possess some unexpected property as compared with the genus, be it the presence of an advantage or the avoidance of a disadvantage. The question then, is whether the unexpected property is required as a matter of utility, or as a matter of non-obviousness?

In UK law the requirement that a valid selection patent possess a special advantage has always been understood as flowing from the inventive step requirement: see eg Beecham v Bristol (HL) [1978] RPC 521 at 579. This remains true now that the doctrine of selection patents as such is no longer part of UK law: see Pharmacia Corp v Merck & Co Inc [2001] EWCA Civ 1610 [60]; Dr Reddy's Laboratories (UK) Ltd v Eli Lilly & Company Ltd [2009] EWCA Civ 1362 [50], [109]. The same is true in the EPO: see AgrEvo T 0939/92, Wyeth T133/01, discussed in Dr Reddy’s. The logic is that is that all of the members of the genus have the properties disclosed for the genus itself, so there is no inventive step in selecting a species from that genus that possesses those properties. Such a selection is “arbitrary”: Dr Reddy’s [52]. The invention lies in selecting a member of the class that has unexpected properties. Utility is never raised in UK and EPO selection patent cases. Presumably this is because, if the genus is useful, the species must necessarily be useful. This follows from the fact that in UK and EPO law, utility is objective; there is one standard that applies to any patent. If the standard has been met by the genus, then all species encompassed in that genus must also be useful.

In Canadian law, in contrast, the unexpected advantages are also, and primarily, treated as a matter of utility. In Olanzapine (No 1) the FCA stated that “[t]he notion of selection permeates the entire analysis in relation to each of the grounds of alleged invalidity” [32]. In discussing obviousness, the FCA noted that “In the context of a selection patent, the obviousness analysis considers the special properties of the compound, along with its alleged advantages, as described in the selection patent disclosure, for it is there that the inventiveness of the selection lies” [57]. This corresponds to the European analysis.

Under the heading “Utility” the FCA stated

[78] With respect to selection patents, the inventiveness lies in the making of the selected compound, coupled with its advantage or advantages, over the genus patent. The selection patent must do more, in the sense of providing an advantage or avoiding a disadvantage, than the genus patent. The advantage or the nature of the characteristic possessed by the selection must be stated in the specification in clear terms (Sanofi, para. 114). In other words, the selection patent must promise an advantage in the sense that, if the advantage is not promised, the patentee will not be able to rely on the advantage to support the patent's validity.

The first three sentences are all true as a matter of the obviousness requirement, in both Canadia and European law. The twist is that in Olanzapine (No 1) the FCA interpreted these requirements as also being relevant to the utility requirement. A statement of unexpected properties is required as a matter of non-obviousness, but because the utility requirement under the promise doctrine is subjective, depending on the particular patent, rather than objective, as in European law, that statement is understood as being also a promise as to those properties. This raises the same basic difficulty as the promise of the patent doctrine generally, though in an exaggerated form. The basic problem with the promise doctrine is that the utility required in a specific case may well be greater than that required to support a valid patent: Clopidogrel [54]. The problem is exaggerated with selection patents, because the selection must have advantages over the genus, and if the advantages are interpreted as the promised utility, this means that the utility required in a selection patent over a valid genus will necessarily be greater than that which is required to support a valid patent.

Thus the contrast between Canadian and European law with respect to selection patents is that in Europe, utility will never be in issue, because the requirement will necessarily be satisfied in a selection over a valid genus patent, but in Canada, the utility will always be in issue, because the utility required will in a selection over a valid genus will always be higher than that required by the Patent Act.

The notion that the unexpected property is related to utility is repeated in Clopidogrel: “The element of utility is usually satisfied by the presence of a special property of an unexpected character, consisting in the advantage secured or the disadvantage avoided by the selection and which is at the heart of the inventive steps (Plavix above at paragraphs 9-10). Were it not so, no selection would meet the statutory criteria for patentability.” As noted, this is not the European position. The utility requirement is satisfied by the utility found in all members of the genus, so that even an arbitrary selection will satisfy the utility requirement, though it will fail on obviousness. But this is an inconsequential objection so long as the required utility is found in the very same advantage that satisfies the obviousness requirement, as the FCA indicates here is “usually” the case. If that is so, then the selection will be valid on both grounds, or invalid on both grounds. The reasoning may be different from European law, but the result will be the same.

So, in dealing with the facts, the FCA adverted to Boivin J’s finding that clopidogrel has better properties than other compounds in the genus [51-52], and stated that but for the fact that the promise doctrine can elevate the utility requirement above that mandated by the Act [54], “the promise of the patent has been met” [53]. That is, in the absence of an explicit promise, the same advantages that support non-obviousness will support utility.

Turning to the promise, and the effect of the fact that this was a selection patent, the FCA noted that “In the [Trial] Judge’s words, ‘the ‘777 selection patent cannot promise less than the ‘875 genus patent’” [68]. That is, for Boivin J, the utility required of a selection patent is necessarily greater than that required of the genus.

The FCA stated that “This reasoning is problematic for at least two reasons. First and foremost, it is improper to construe a patent with an eye to its validity. . . . The Trial Judge erred when he read into the patent a promise of use in humans in order to validate the patent as a selection patent, then used this promise in order to invalidate it for lack of utility” [69]. While the FCA described this as the foremost objection, it is not in itself an error of consequence. Even if it was wrong for Boivin J to require a higher utility in order to validate the patent as a selection patent, if he did not do so, and a higher utility is required, then the patent will be invalid anyway. The second point made by the FCA was, in effect, that the advantages that support obviousness will also support utility [70]. This is not conclusive either, if the patent has promised more. So the crucial third factor is that “the Trial Judge erred in law in his construction of the promise of the patent” [71]. That is, because, on a proper construction, the patent did not promise an elevated utility, the utility necessary to support obviousness was sufficient to support utility.

In summary, in my view the Canadian law of selection patents is misguided in treating the required unexpected properties as being a matter of utility, rather than as being solely a matter of obviousness. However, this does not cause any problems so long as the promised utility is understood to consist in the same advantages that are necessary in any event to support non-obviousness. Under the restrictive approach to interpreting the promise adopted in Clopidogrel, it will “usually” be the case that both requirements will stand or fall together. But Clopidogrel did not reject the promise doctrine; on the contrary, it was reaffirmed. Consequently, when an explicit promise is found, a higher standard of utility will be required. But that is the case for any patent when an explicit promise is made. This implies that either way, the doctrine of selection patents plays no special role with respect to selection patents. This reinforces the point that, despite the statement in Olanzapine (No 1) that “[t]he notion of selection permeates the entire analysis in relation to each of the grounds of alleged invalidity” [32], the doctrine of selection patents could be eliminated entirely, even given that the false promise doctrine is entrenched. The doctrine of selection patents permeates the analysis, but not in any helpful way.

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