Thursday, April 14, 2016

More Disagreement with Rennie J on Application of Enhanced Disclosure Requirement for Sound Prediction

Allergan Inc v Apotex Inc 2016 FC 344 Zinn J
            2,307,632 / gatifloxacin ophthalmic

Zinn J packed a number of legal issues into this short decision. As well as the issue of blinding the expert witness, discussed in yesterday’s post, his analysis of utility is also interesting.

First, like Barnes J in Lilly v Hospira 2016 FC 47 (blogged here), Zinn J disagreed with the view expressed by Rennie J in Apotex / esomeprazole 2014 FC 638 [141] that the requirement to disclose the factual basis and the line of reasoning for a sound prediction of utility is “limited to the context of ‘new use’ patents, assuming such a utility disclosure requirement exists at all” (see here). Zinn J’s reasoning echoed that of Barnes J:

[57] With the greatest of respect to the views of Justice Rennie, I am not prepared to depart from established jurisprudence directly on point from the higher courts by relying on obiter statements of a few judges in cases where the issue of utility was not fully and thoughtfully addressed. In my view, until the Federal Court of Appeal or the Supreme Court of Canada rules otherwise, Canadian jurisprudence is that, with the exception of matters of common general knowledge, the factual basis and the line of reasoning must be included in the patent.

Thus it is increasingly clear that Rennie J’s view will not carry the day at the FC level without further guidance from a higher court.*

Second, Zinn J applied the promise doctrine to hold that to hold that utility should be assessed against three promises set out in the disclosure, and not against the lower scintilla standard [48]. He rejected the argument that expressed advantages were merely goals, on the basis that the promised utility was “clearly and unequivocally described” in the patent [46]. This reaffirms that any positive statement of utility will normally be taken as a promise. Zinn J’s holding is not particularly remarkable taken in isolation, but taken cumulatively with other cases on the promise of the patent, it is now evident that the FCA’s Plavix 2013 FCA 186 decision, which seemed to signal a more restrained approach to applying the promise doctrine, has turned out to have had very little impact on the law.

On the facts of the case, Zinn J held that not all of the three promises of the ‘632 patent had been met. The ‘632 patent claimed a pharmaceutical composition of gatifloxacin and disodium edetate (EDTA). Only Claim 10, which claimed EDTA in an amount of 0.01 to 0.1 w/v%, was in issue. One of the three promises was that the addition of EDTA would prevent precipitation of gatifloxacin crystals [46]. Utility was not demonstrated, because limited testing had been done [50], and while Zinn J accepted that EDTA in the tested formulations disclosed in the patent – 0.05% and 0.1% w/v% – did in fact impact the precipitation of gatifloxacin, he found that there was no evidence that this would allow a prediction that the same result would be obtained with the lower levels of ETDA (down to 0.01%) specified in Claim 10 [60]. It’s not clear to me how to reconcile this finding with Zinn J’s finding in the context of obviousness that “a POSITA would have a fair and reasonable expectation that combining gatifloxacin with EDTA would produce an effective ophthalmic compound that would have the three advantages set out in the 632 Patent“ [39], given that the three advantages considered in the context of obviousness corresponded to the three promises of utility, including prevention of precipitation [27]. Perhaps it would have been obvious to a POSITA that levels of EDTA greater than 0.05% would have reduced precipitation, but it would not have been predictable that lower levels would have the same effect. 

*UPDATE:  I've just recalled that in Gilead v Idenix 2015 FC 1156 [380] Annis J agreed with Rennie J on this point. That means the cases are divided 2-2 at the FC level, so it is perhaps not so clear how this will play out in the Federal Court. In any event, the matter will have to be resolved by the FCA in due course.

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