Friday, March 15, 2013

Sildenafil Doctrine Not About Data Disclosure

Apotex Inc. v. H. Lundbeck A/S / escitalopram 2013 FC 192 Harrington J
            CIPRALEX / escitalopram / 1,339,452

With the recent Sildenafil 2012 SCC 60 decision, we can expect to see Sildenafil-type insufficiency raised regularly, at least until the bounds of the doctrine are fleshed out. This is second case to deal with the doctrine, and it is consistent with Snider J’s imatinib 2013 FC 141 decision (blogged here) in holding that the Sildenafil doctrine is not about disclosure of data, it is about disclosure of the invention.

The issue in this case was that the specification stated that “results upon administration to human beings have been very gratifying.” This was not true, as the enantiomers had not been tested on humans until after filing [225]. Apotex argued that the patent should therefore be declared void on the basis of s 27(3), which is to say on the basis of the disclosure requirement as interpreted in Sildenafil.

Apotex had raised the same statement in the NOC proceedings, arguing both s 27(3) and s 53 (though of course not relying on Sildenafil). In that case, Harrington J had dealt with it on the basis of s 53, which states that a patent is void “if any material allegation in the petition of the applicant in respect of the patent is untrue.” (He noted in this case that in so doing he had conflated the two provisions.) He had held in the NOC preoceedings that read in context, the statement was not misleading, nor had anyone been misled: 2009 FC 146 [147].

In this case, the point was based on s 27(3), not s 53 [229]. Harrington J again rejected the argument, but on an entirely different basis, tailored to the different provision. He held that the Sildenafil doctrine simply did not apply. In Sildenafil, “the invention was the use of sildenafil for the treatment of ED,” and it was this that had to be disclosed [233, quoting SCC [72]], whereas “In this case, the invention, (+)-Citalopram and how to get there, was properly disclosed” [235]. This strikes me as a correct interpretation of Sildenafil. It is also consistent with Snider J’s imatinib 2013 FC 141 [375] decision, in which she held that failure to disclose test data cannot in itself result in a finding of insufficiency. In imatinib the issue was failure to disclose test data, and in this case it was disclosure of erroneous data, but in either case, the basic principle is that the Sildenafil doctrine is not about disclosure of data, it is about disclosure of the invention.

Finally, I note that Harrington J accepted the view that the SCC in Sildenafil had “declared the patent void, notwithstanding that the appeal was in a PM (NOC) application” [234]. As discussed here, my own view is that the SCC did not hold the patent void in rem.

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