Tuesday, March 5, 2013

Claim in the Alternative

In Pfizer / pregabalin (NOC) 2013 FC 120 Hughes J held a claim to “a therapeutically effective amount of pregabalin or its racemate” to be invalid on the basis that the utility of the racemate was not established: see my post here. Anon commented on that post that “The patent didn't claim that the recemate ‘as well as’ pregabalin were effective, it claimed these in the alternative (see 27(5))!” On its face, s 27(5) certainly appears to be applicable:

For greater certainty, where a claim defines the subject-matter of an invention in the alternative, each alternative is a separate claim for the purposes of sections 2, 28.1 to 28.3 and 78.3.

The “for the purposes of" includes utility which is a requirement by virtue of s 2. Thus it seems like the claim should or, at least, could have been construed as effectively two separate claims, one to pregabalin and one to the racemate, and therefore only the claim to the racemate should have been invalid.

The difficulty is that in Abbott Labs v Apotex / clarithromycine (NOC) 2005 FC 1332, dealing with 2,261,732, Phelan J, concerned “that alternative claims can result in a vast number of claims and the general adverse consequences of overclaiming,” construed s 27(5) narrowly, and held that it “is principally an administrative provision for purposes of a patent application. Therefore, even if the claim [at issue] is in the alternative, if Apotex establishes that an alternative is not patentable, the whole claim fails – at least for purposes of an NOC.” Phelan J’s decision was affirmed 2007 FCA 153, but this point was not an issue on appeal. Snider J subsequently adopted this interpretation as well in Schering-Plough Canada v Pharmascience / desloratadine (NOC), 2009 FC 1128, where she stated “Section 27(5) does not save [the claim in question], if one of the alternatives in the claim is otherwise invalid for anticipation” [90].

To my mind, this interpretation is not persuasive. I find it hard to see what it means to say that s 27(5) is applicable for the purposes of a patent application. If all of the alternatives are valid, then it is irrelevant. On the other hand, if the Patent Office is of the view that any of the alternatives are invalid, it would not be proper to grant the application in that form. Even if s 27(5) applies, the Patent Office would have to object to one of the alternatives, if it is considered as a separate claim, and to the entire claim if it is not. It is difficult to see what is gained in a practical sense by considering alternatives to be separate for the purposes of an application. This is particularly so since the alternatives are only to be considered separate claims for the substantive purposes listed, and not for purposes that might be related solely to examination, such as fees. Nor am I persuaded by the point regarding overclaiming. There are substantive doctrines, such as overbreadth, aimed at exactly this problem. If the claim is not substantively objectionable as being overbroad, then it seems wrong to throw up technical hurdles.

Barrigar §27:2630 notes that the same patent was at issue in Abbott Laboratories v Ratiopharm / clarithromycine (NOC) 2005 FC 1095, where von Finckenstein J pointed that the claims at issue (1 and 15) were Markush claims, using classic “selected from the group consisting of” language, and consequently they should be held as claiming a single class, not millions of alternative compounds [27].

In GD Searle v Novopharm / celecoxib (NOC) 2007 FC 81 Hughes J considered Claim 8 of No. 2,177,576, which claimed use of a compound “selected from compounds according to any of Claims 1-7.” Hughes J held that s 27(5) did apply, so that Claim 8 was construed “to refer to claims 1 to 7 separately, thus can be construed to refer to claim 4 only” [32]. In her recent imatinib decision Snider J similarly interpreted Claim 46 of the patent at issue, which claimed a use of a compound "according to any one of claims 1 to 39" to treat tumours, where those claims included both genus claims and claims to individual compounds. Snider J construed that claim as encompassing alternatives, so that "Claim 29 together with Claim 46 means a claim to imatinib when used in the chemotherapy of tumours" [113]. Snider J made no mention of s 27(5), and indeed made no comment at all as to whether the entire claim should be invalid if one alternative is invalid. 

In celecoxib Hughes J distinguished Phelan J's clarithromycine decision by saying “In Abbott the claim stated, in effect, that all members of the group were useful whereas at least some were found on the evidence not to be” [31]. That is a very reasonable interpretation of the patent at issue, but it is von Finckenstein J’s interpretation, not that of Phelan J. Also, there is still Snider J's desloratadine decision to deal with, where the claim was to “tablet or capsule form” [89]. Might this also be construed as being to a class including tablet and capsules, rather than in the alternative?

The point made by Barrigar and Hughes J that the clarithromycine patent really claimed a single class as the invention, so that there were no alternatives, allows us to reconcile the clarithromycine decision with celecoxib and imatinib. This is not a formal distinction; there is a real difference between a Markush claim to a class, and a claim to alternatives, and the claims at issue in celecoxib and imatinib were clearly claims to alternatives. The objection to that interpretation is that it would require ignoring the express interpretation of s 27(5) stated by Phelan J in clarithromycine and Snider J in desloratadine. But I don’t see any other obvious way of reconciling Phelan J’s clarithromycine decision with Hughes J's celecoxib decision and Snider J’s imatinib decision.

Snider J's desloratadine decision can also be reconciled if we construe the claim
to “tablet or capsule form” as claiming a class. To my mind this isn't as clear a case. The "or" seems to signify alternatives, but it is difficult to be confident without a more thorough claim construction exercise. Snider J did not address this point because of her holding that s 27(5) did not apply. 

What about Hughes J’s pregabalin decision, which started off this discussion? The question of claims in the alternative was not expressly raised in that decision, and given Hughes J’s holding in celecoxib, I don’t think he implicitly adopted Phelan J’s reading of s 27(5). I can only speculate that the point was not argued – perhaps because of the clarithromycine precedent?

It is possible to reconcile all the cases on the basis that s 27(5) does apply post-grant, but a very narrow view is taken of what constitutes an "alternative," so the use of (dare I say) alternatives separated by "or" signifies as class, rather than true alternatives. But this is not at all a satisfactory reconciliation, as it ignores the express basis for the decisions in clarithromycine and desloratadine. The better view is that there is a conflict in the case law as to the correct interpretation of s 27(5). 

The bottom line is that there is a clear line of authority, expressed by Phelan J, to the effect that s 27(5) does not mean what it appears to say on its face. Accordingly, if a patentee really does mean to claim alternatives, rather than a class of compounds, this should be done by separate claims, rather than by alternatives within one claim; and that, unfortunately, is exactly the practice which s 27(5) was apparently intended to avoid.

1 comment:

  1. Masterful analysis as usual. With no pun intended, perhaps an alternative approach to an exhaustive multiplicity of claims may be workable. Perhaps it's time to start explicitly claiming alternatives using language such as "or, in the alternative,..."

    The case law leaves some residual uncertainty about even this language, but the statute does seem to offer fairly clear reassurance that alternatives should have a life of their own.