Friday, February 28, 2014

Promise of the Patent, Obviousness, and Overbreadth

Alcon Canada Inc v Cobalt Pharmaceuticals Co / olopatadine (NOC) 2014 FC 149 Gleason J
             2,447,924 / olopatadine / PATANOL

In Alcon v Cobalt / olopatadine (NOC), Gleason J held the 924 patent invalid for failure to satisfy the promised utility. It would be tempting to read this case as illustrating how the application of the promise doctrine has, or has not, changed since Plavix 2013 FCA 186 (blogged here). But I don’t really see this as a promise case at all. To my mind, on the facts as found by Gleason J, the claim is clearly invalid, and the more interesting question is on what ground it is invalid. I suggest that the better, or at least alternative, grounds for invalidity are that the claims at issue were obvious and overbroad.

The technical contribution underpinning the patent was the discovery that a common excipient, PVP, improves the physical stability of higher concentration olopatadine solutions [51]. On the facts, Gleason J found this insight not to be obvious [120]. As construed, the claims in issue, 2 and 7, were to olopatadine solution of a specified concentration, around the 0.2% found in PATANOL,

and PVP having an average molecular weight of 5000 [5K] to 1600K and in an amount sufficient to improve the physical stability of the solution” [47].

(The inventive concept also encompassed the fact that five other excipients, which were excluded from the claims, do not enhance stability, but this aspect of the patent was not ultimately significant to the finding of invalidity.)

The difficulty for Alcon is that while there was evidence 58K grade PVP would indeed stabilize 0.2% olopatadine solution [191], the evidence was not sufficient to either demonstrate or soundly predict that 1300K grade PVP would stabilize 0.2% olopatadine solution [197]. Consequently, Gleason J held that “the promise of utility” was not established across the entire range specified in Claim 2 [209].

The phrase “in an amount sufficient to improve the physical stability of the solution” did not help, because there was no evidence that any amount of PVP of that grade would improve physical stability. Claim 7 fell for essentially the same reason [215]. While Gleason J noted that the factual basis for a sound prediction had to be disclosed in the patent itself [125], this issue was not determinative, as there was no evidence extrinsic to the patent to show utility.

In some sense, the claimed invention had utility, in that the specified solution could be used to treat allergic and inflammatory eye reactions, even using 1300K PVP. So it seems natural to say that it lacks utility for the promised purpose, namely to stabilize the olopatadine solution. But Gleason J expressly held that the promise of the patent and its inventive concept are “one and the same” [60], [63]. Therefore we might equally say that the claimed invention lacks utility for the purpose of supporting the inventive step.

This is exactly the European position. This case is essentially the same as the famous decision of the EPO Appeal Board in T 0939/92 AgrEvo, which concerned a product claim for a class of chemical compounds useful as herbicides. While the patent sufficiently described how to make the claimed compounds, Board there was nothing inventive in doing so, and consequently, if there was any inventive step it must lie in the discovery that the compounds had herbicidal properties. Under the problem-and-solution approach to obviousness used by the EPO, the technical problem facing the inventor was to find new herbicidal compounds, and the question was whether it was obvious that the claimed compounds were the solution to this problem. But, the Board reasoned, the claimed compounds could only be an inventive solution to the problem if they were actually a solution to the problem: [2.6]. It is not obvious, in a literal sense, to say that a potion of cat hair and chocolate is a cure for cancer, but that claim is fanciful, rather than inventive, unless it is true (my example, not theirs). Consequently, the Board held that it had to be “credible” (“plausible” is now the usual term: see T 1329/04) that the compounds were herbicides, and moreover, this had to be true of “substantially all” the compounds falling within the claim [2.5.4, 2.6] Because this could not be established, the claims were held to be invalid as lacking the inventive step required by EPC Art 56.

The same line of reasoning is accepted in UK law, as was explained colorfully by Jacob LJ in Actavis v Novartis [2010] EWCA Civ 82, discussing the “5¼ inch plate paradox.”

[36] This runs like this. Suppose the patent claim is for a plate of diameter 5¼ inches. And suppose no-one can find a plate of that particular diameter in the prior art. Then (a) it is novel and (b) it is non-obvious for there is no particular reason to choose that diameter. The conclusion, that the plate is patentable, is so absurd that it cannot be so.

[37] What then is the answer to the paradox? It is this: the 5¼ inch limitation is purely arbitrary and non-technical. It solves no problem and advances the art not at all. It is not inventive. And although "inventive step" is defined as being one which is not obvious, one must always remember the purpose of that definition - to define what is inventive. That which is not inventive by any criteria is not made so by the definition. Trivial limitations, such as specifying the plate diameter, or painting a known machine blue for no technical reason are treated as obvious because they are not inventive.

So it is quite clear that in Europe, the 924 patent would have been found invalid for lack of inventive step (at least on the facts as found by Gleason J). But Gleason J held that the claimed invention was not obvious; she held that the inventive concept was that “PVP at sufficient concentrations improves the physical stability of higher concentration (0.2% to 0.6%) olopatadine solutions” [82], and that this concept was not obvious. The difference is that, implicitly at least, Gleason J did not require the claimed invention to be inventive across the full breadth of the claim. The inventive concept which she identified is that of the patent as a whole, not the inventive concept of the particular claims in issue. The inventive concept of Claim 2 in particular must be that PVP in the range of 5K to 1600K stabilizes olopatadine solutions. Suppose the claim in issue had been to 1300K PVP specifically. The European analysis would say that there is nothing inventive to a claim to 1300K PVP solution, because it does not in fact stabilize olopatadine solution. It is merely an “arbitrary” selection: T 0939/92 2.5.3. Consequently, a claim to the range including 1300K PVP is invalid on the principle that the claim must be valid across its breadth. It is clear in Canadian law that it is the inventive concept “of the claim in question,” which is at issue: Sanofi 2008 SCC 61, [67(2)], so the same analysis would imply that Claim 2 was invalid for obviousness in Canadian law as well.

The problem may also be characterized as one of overbreadth. While one way in which a claim may be overbroad is if the claim omits essential elements of the invention, the general principle is simply that “the monopoly claimed must not go beyond the consideration” Mullard Radio (1936) 53 RPC 323, 348 (HL). Straightforwardly, in this case a claim to 1300K PVP olopatadine solutions goes beyond the consideration, which is the discovery that 58K PVP olopatadine solutions has improved physical stability over what was previously known.

Gleason J did hold that the claim was overbroad, but she held that “overbreadth is simply another way of articulating the utility argument.” I am inclined to think that it is the other way around; the recent Canadian focus on utility, and the promise of the patent in particular, has led the parties and the courts characterize everything as an aspect of the promise doctrine. In the classic promise cases, the invention as claimed had sufficient utility to support a patent, and was otherwise valid, but some statement in the disclosure promised even greater utility, and that promise of greater utility was not met. In this case, the problem lies in the claim itself, which is where Gleason J found the promise at issue [55]. The real problem here is not that the specification promised more than the invention as claimed delivered; it is that the invention claimed more than the specification disclosed.

In UK law, the same problem might also be addressed as a matter of insufficiency, as discussed in Regeneron [2013] EWCA Civ 93 [100-01]:

It must therefore be possible to make a reasonable prediction the invention will work with substantially everything falling within the scope of the claim or, put another way, the assertion that the invention will work across the scope of the claim must be plausible or credible. . . .

On the other hand, if it is not possible to make such a prediction or if it is shown the prediction is wrong and the invention does not work with substantially all the products or methods falling within the scope of the claim then the scope of the monopoly will exceed the technical contribution the patentee has made to the art and the claim will be insufficient. It may also be invalid for obviousness, there being no invention in simply providing a class of products or methods which have no technically useful properties or purpose.

In context, the reference to insufficiency meant so-called “Biogen insufficiency.” I am not particularly a fan of Biogen insufficiency (and note that the EWCA says that the basis for invalidity may be either Biogen insufficiency or obviousness), as it is really another way of framing the overbreadth objection. Under the UK Patents Act 1949 the statutory basis for the overbreadth objection was the requirement in s 32(1)(i) that the be “fairly based” on the disclosure. The fair basis provision of the UK Act had been repealed by the time Biogen was decided, and As the High Court of Australia perceptively noted in Lockwood (No 1) [2004] HCA 58 [67], the House of Lords' reasoning in Biogen boils down “to the following Voltairean aphorism: ‘Since the fair basis doctrine no longer exists, it is necessary to invent it.’”

My inclination is to think that the obviousness and overbreadth approaches are most appropriate; the invention as claimed was not inventive, but arbitrary, and consequently the claim went beyond the consideration. For reasons just given, I do not see it as truly a promise case (whether or not the promise doctrine is sound), nor as a case of insufficiency, at least in the classical sense. But my point here is not to resolve this interesting conceptual debate, but simply to point out that while the promise doctrine is undoubtedly very powerful, not every defect in a patent is necessarily attributable to a false promise.

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