Wednesday, June 25, 2014

The Inventive Concept of the Claim Cannot Always Be Found in the Claim

Allergan Inc v Cobalt Pharmaceuticals Company 2014 FC 566 O'Reilly J
Allergan Inc v Apotex Inc 2014 FC 567 O'Reilly J
            2,585,691 / bimatoprost / LUMIGAN RC / NOC

In these companion cases, O’Reilly J granted an order prohibiting the Minister from issuing an NOC to Cobalt and Apotex for generic versions of LUMIGAN RC. The decision turned on the facts, though there are a couple points of some legal interest. The reasoning is the same in both cases, and the reasons themselves are largely identical, with some variation to deal with differing evidence and arguments. For convenience, paragraph numbers will refer to the Cobalt decision.

LUMIGAN and the newer LUMIGAN RC are eye drops used in the treatment of glaucoma and ocular hypertension [1]. The active ingredient in both is bimatoprost, which was apparently encompassed as a compound by patent 2,144,967, which expired in 2013. LUMIGAN contained 0.03% bimatoprost and 50 ppm benzalkonium chloride (BAK) as a preservative. LUMIGAN caused some dose dependent side-effects such as eye irritation. Allergan developed LUMIGAN RC to provide a comparable reduction of intraocular pressure (IOP), but with fewer side effects [6]. LUMIGAN RC has only a third as much bimatoprost and more four times as much BAK as LUMIGAN. The claims at issue in the 691 patent claim a composition with that formulation, namely comprising 0.01% bimatoprost and 200 ppm BAK, and the use of that composition for treating glaucoma [8].

The 691 patent was attacked for obviousness, lack of utility and anticipation. This post deals with obviousness, and tomorrow’s will deal with utility. I will not deal with the anticipation argument, as I do not see it as raising any interesting point of law.

The legal point of interest here is that the patent need not have one interpretation for all purposes. More specifically, “Cobalt maintains that the patent should be given only one interpretation for all purposes – infringement, obviousness, and utility” [23]. O’Reilly J held that while “the interpretation of the patent should be as consistent as possible across the various issues in play, . . . that does not mean that construction of the claims necessarily determines the inventive concept for purposes of the obviousness analysis” [24], [25]. In my view, read in context, O’Reilly J is clearly right on this point. As he pointed out, “Where the patent relates to a bare chemical formula, the court must refer to the claim and the specification to determine what the claim’s inventive concept is, [25, citing Sanofi, 2008 SCC 61, [77]). He is not saying that the claim is to be construed differently when assessing obviousness as compared with anticipation, or infringement, or anything else. This point must also be distinguished from the debate as to whether it is the inventive concept of the claim or the inventive concept of the patent which is at issue. The claim is always construed the same way, and in my view, is it is the inventive concept of the claim which is properly at issue, but the inventive concept of the claim is not the same thing as the claim itself, and it cannot always be discerned from the claim, as the example of a claim to a compound per se illustrates. It is well-established that a new compound is not patentable if it has no known use, even if it is new and not “obvious” in the narrow sense that no one would have had any motivation to make it. Such an invention is arbitrary, not inventive, as was explained by Jacob LJ in Actavis v Novartis [2010] EWCA Civ 82, [36], [37] discussing the "5¼ inch plate paradox." See also this post discussing the issue at more length. This is an instance where the EPO problem-solution approach is helpful. The problem faced by the inventors was to develop a formulation that was effective but with fewer side effects than LUMIGAN. The question then is whether a formulation with reduced bimatoprost and increased BAK was an obvious solution to this problem. It is still the claimed invention, which is defined by the claim as properly construed, and which is the same for all purposes, which must not be an obvious solution to the problem at hand; but whether it is an obvious solution cannot be determined by looking solely to the claim itself.

On the facts, O’Reilly J held that the claimed invention was not obvious, essentially because substantially reducing the amount of the active ingredient would be expected to reduce efficacy, and increasing the amount of BAK would be expected to increase side-effects, because BAK has its own side-effects [32]. It was therefore surprising that this combination would have similar efficacy and reduced side effects. It appears that this is because that formulation has greater permeability across the eye cell layers, which would not have been obvious to a skilled person [27].

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