Monday, May 26, 2014

Emphasis on Good Faith in Teva / Sildenafil Duty to Disclose the Invention

Alcon Canada Inc v Cobalt Pharmaceuticals / moxifloxacin (NOC) 2014 FC 462 Phelan J
            moxifloxacin / 1,340,1142,342,2112,192,418 / VIGAMOX

Friday’s post discussed the promise issue raised by the 114 patent. This post addresses the Teva / Sildenafil 2012 SCC 60 duty to disclose the invention, which was also raised in the context of the 114 patent. In my article “The Duty to Disclose 'The Invention': The Wrong Tool for the Job,” (2013) 25 IPJ 269, I argued that the SCC’s analysis was problematic because it used an objective requirement to disclose the invention under s 27 in addressing what was really an issue of subjective good faith. Phelan J’s moxifloxacin (NOC) decision may indicate a trend of emphasizing the good faith aspect of Teva / Sildenafil.

Cobalt argued that “like the Sildenafil patent, the 114 Patent claims millions of compounds but obscures the identity of the compound that is the subject of this proceeding” [90]. Phelan J held that

[91] Sildenafil is distinguishable from the case at hand in several important respects. Firstly, in that case only sildenafil of the many claimed compounds had been shown to have the promised effect in the treatment of erectile dysfunction. In the case at hand, all of the Example compounds have the promised high antibacterial activity to some degree.

This is indeed an important distinction. As I argued in my “Wrong Tool for the Job” article, the Teva / Sildenafil doctrine will be most problematic when the patentee believes that its invention is a class of compounds with similar properties, so that it does not specifically identify any particular compound, but then it turns out that most of the compounds are not patentable. The patentee will have failed to disclose the true invention – the compound that was in fact patentable – even though it made a good faith disclosure of what it knew at the time. The real test of what Teva / Sildenafil means will come on those facts: if the duty is really to disclose the objective invention, the patent will be invalid, but if the duty is to make good faith disclosure, the patent will be valid. Because, in this case, all the key compounds were useful, this problem did not arise. The true invention really was the class of compounds. This means that moxifloxacin (NOC) does not address this problematic case, which has not yet arisen post-Sildenafil.

With that said, Phelan J strongly emphasized the good faith disclosure aspects of Teva / Sildenafil. After the statement quoted above, he immediately went on to say

More importantly, in Sildenafil there was evidence of bad faith; Pfizer was aware there was only one effective compound and hid it within a larger class in order to mislead” [91, my emphasis].

There are similar references to “improper purpose” [92], “intentionally. . . misleading” [97], “mislead[ing] the public” [98], “bad faith” [100]. In the absence of evidence the patentee withheld information in order to mislead, Phelan J held that the patent was not invalid for inadequate disclosure [98]. I’m not sure that we can really say that this emphasis on good faith disclosure is a trend in the application of Teva / Sildenafil, but it is at the very least consistent with the previous cases.

In my view the emphasis on good faith disclosure is the best interpretation of Teva / Sildenafil, because the alternative approach, which views it as imposing an objective duty to disclose the compound which ultimately turns out to be the true patentable invention, places an impossible burden on the patentee, and eviscerates s 58 of the Act. With that said, the emphasis on good faith disclosure has its own problems, namely that it is unclear how the Teva / Sildenafil duty of good faith disclosure interacts with the wilful misleading provision in s 53, which on its face addresses the same problem. It seems that Teva / Sildenafil has created a new freestanding duty, and it will take some time to ascertain its limits. But that is certainly no criticism of Phelan J’s decision, which takes one step along that path of discovery.

No comments:

Post a Comment