2,379,948 / tadalafil formulation / CIALIS, ADCIRCA
After the discussion of abuse of process issues in Friday’s post, this post turns to the substantive issues in this Tadalafil Formulation decision. Gleason J held that Apotex’ product did not infringe the 948 patent [72], which claims a particular formulation of tadalafil, and that the 948 patent was invalid for obviousness as being obvious to try [112], but that it was not invalid for lack of utility [145].
The holdings on infringement and obviousness turned entirely on the facts, and Gleason J came to the same conclusion as did de Montigny J in Mylan Tadalafil III 2015 FC 178 (blogged here), which she referenced. Two points of some interest are that Gleason J relied on comity in coming to the same conclusion as de Montigny J regarding the inventive concept [92]; and Gleason J took a very dim view Lilly’s expert Dr. Bodmeier for having changed his evidence to avoid a conclusion unfavourable to Lilly [56]-[57].
The discussion of utility was interesting in two respects. It started, as is now standard, by considering the promise of the patent. Lilly submitted that the promise of the patent was limited to rapid onset of pharmacological response [124], while Apotex argued for a broader promise, including advantages such as improved stability, among others. Gleason J ultimately held in favour of the more modest promise advanced by Lilly [137].
What is interesting is that Gleason J emphasized throughout that a patent need not have a promise. As Gleason J noted in her general statement of the law, it is established that in principle a patent need not have any promise at all ([117], [118], [120]), but it nonetheless remains the norm to assess utility against a promise which is more stringent than the scintilla that would otherwise be required to support a patent. Consequently, it is not surprising that Lilly chose to advance a modest promise rather than arguing that the patent contained no promise at all. Even so, in her analysis Gleason J suggested at several junctures that the patent might not contain any promises. She noted that while a promise must be explicit “the Patent nowhere makes an explicit promise of any sort” [133], and after reviewing the particular statements of advantage in the patent, she remarked that “There is little in these few statements to found a promise, but, despite this, it is common ground between the parties that this Patent does make a promise” [136]. Her holding that there was a modest promise was qualified by statements such as “To the extent there is any promise made in the 948 Patent” [136] and “to the extent the relevant claims in the Patent make a promise,” it is a modest one [137]. Given the current state of the law, it is no doubt tactically safer for a patentee to choose to argue for a modest promise rather than none at all, but it is apparent that in this case Gleason J would have been open to finding that the 948 patent did not make any promise.
The utility discussion also raised an important legal point on the requirement to disclose evidence of utility. It is now established in Canadian law that when utility is based on sound prediction, the factual basis for that prediction must be disclosed in the patent itself. (Though there has recently been some suggestion that this rule is limited to certain types of patents: see here and here.) In this case, no studies or tests at all were disclosed in the 948 patent, so Lilly did not appeal to sound prediction to establish utility, and appealed instead to demonstrated utility [123].
On the basis of Latanoprost 2011 FCA 236, [30], Pharmascience / NEXIUM 2014 FCA 133 [39], [40], and Sildenafil FCA 2010 FCA 242, Apotex argued that even evidence supporting demonstrated utility must be at least referred to in the disclosure [129], [140]. This interpretation of those cases had been accepted by Roy J in Gliclazide Dosage Form 2015 FC 108, which Apotex also relied on [140]. Gleason J dismissed this argument:
[141] With respect, I believe that Justice Roy’s determination on this point is erroneous
and ought not be followed as it takes the obiter statements in Sildenafil FCA and
Latanoprost out of context and does not address the many other cases where an opposite
conclusion was reached.
I entirely agree with this view of of Latanoprost 2011 FCA 236 and Pharmascience / NEXIUM 2014 FCA 133, as discussed in my post on Roy J’s decision. Indeed, the FCA remarks relied on by Roy J were so tangential to the issues in those cases that I didn’t even mention them in my posts on those cases (see here and here). I must say that I read the Sildenafil FCA decision as providing stronger support for a requirement to disclose evidence of demonstrated utility in the patent, but that decision was brief and not entirely clear, and only a single sentence from it was being relied on. Moreover, in my view Gleason J was entirely right to conclude from her review of the case law generally that “the weight of authority is to the effect that the evidence of demonstrated utility need not be referenced in the patent for the patentee to rely on it” [142].
Gleason J’s holding on this point was not obiter, as she went on to find the promised utility was demonstrated on the basis of evidence that was not disclosed or even referred to in the patent [143]-[144]. I hope that Gleason J’s holding will settle this point, at least at the FC level
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