Wednesday, July 29, 2020

Minister Intends Narrow Interpretation of CSP Regulations

ViiV Healthcare ULC v Canada (Health) 2020 FC 756 Fuhrer J

2,606,282 / JULUCA / dolutegravir and rilpivirine

In this judicial review of the Minister of Health’s decision denying ViiV’s application for a Certificate of Supplementary Protection (CSP) in respect of its 282 patent, Fuhrer J, applying reasonableness review [9], found the Minister’s approach to the interpretation of the relevant statutory provisions to be unreasonable. Fuhrer J’s legal analysis was straightforward: s 3 of the CETA Implementation Act provides that the regulations implementing the CSP regime must be interpreted harmoniously with CETA itself, but the Minister failed to consider CETA at all, relying instead on the RIAS for the CSP Regs and associated the Guidance Document, neither of which are law. This is the second decision relating to the new CSP regime, following Glaxosmithkline 2020 FC 397, and it is the second decision in which the Federal Court has found the Minister to have adopted an unreasonable interpretation of the relevant provisions: see here. Moreover, in this case the Minister has clearly signaled that she intends to interpret the CSP Regulations as restrictively as possible. Unfortunately, in light of these decisions, we cannot say that she intends to interpret them as restrictively as reasonably possible; it appears rather that the Minister intends to interpret the provisions as restrictively as the courts will allow. The CSP forecast is calling for a steady rain of judicial review applications.

Friday, July 24, 2020

Routine Correction of Inventorship

Alfasigma SPA v Canada (Attorney General) 2020 FC 561 Grammond J


This was a routine correction of inventorship under s 52. One inventor has been named on the Italian priority application, but his name had inadvertently been left off the PCT application [3]. The application was supported by affidavits of all the other inventors [4]. No interesting issues were raised and the application for correction was granted [5].

Monday, July 20, 2020

Summary Trial Instead of Markman Hearing in the US

IPKat has a post today about order made by Judge Alsup canceling a Markman hearing and effectively ordering a summary trial instead. This may be of interest in light of recent emergence of summary trial / judgment decisions we have seen here.

Wednesday, July 15, 2020

The underlying facts were NOT in fact disclosed

Apotex Inc v Wellcome Foundation Ltd / AZT 2002 SCC 77, aff’g [2001] 1 FC 495 (FCA), var’g T-3197-90, 79 CPR (3d) 193 (FC) Wetston J


The law of utility has become much quieter since AstraZeneca 2017 SCC 36, so I’ve been spending some time reviewing the case law to see where we have ended up. One issue that remains contentious relates to the enhanced disclosure requirement that arises when utility is established on the basis of a sound prediction. In Wellcome / AZT 2002 SCC 77 at paragraph 70 the SCC remarked that:

Normally, it is sufficient if the specification provides a full, clear and exact description of the nature of the invention and the manner in which it can be practised. It is generally not necessary for an inventor to provide a theory of why the invention works. Practical readers merely want to know that it does work and how to work it. In this sort of case, however, the sound prediction is to some extent the quid pro quo the applicant offers in exchange for the patent monopoly.

This suggests that something other than the normal disclosure is required, though the SCC did not go on to explain what that might be. This passage has been interpreted as requiring a heightened disclosure requirement in the case of a sound prediction, such that the factual basis for the prediction must be disclosed, or at least referred to, in the patent itself: Raloxifene 2011 FCA 220 [46]-[47] aff’g 2010 FC 915 [116]-[17]. This enhanced disclosure requirement is substantively controversial: see Gauthier JA’s remarks in Clopidogrel 2013 FCA 186 [132] and Rennie J’s remarks in Nexium 2014 FC 638 [158-59]. Even parsing the SCC’s statement is not easy: see Rennie J’s careful discussion in Nexium [139-60] arguing that “this sort of case” refers to a new use, not sound prediction generally.

In this post, I am not going to tackle either the interpretation of paragraph 70 or the substantive merits of an enhanced disclosure requirement. Instead, I will focus on a purely factual point. The reason the SCC gave for not elaborating further is that the precise disclosure requirements “do not arise for decision in this case because both the underlying facts (the test data) and the line of reasoning (the chain terminator effect) were in fact disclosed, and disclosure in this respect did not become an issue between the parties” [70, my emphasis]. Similarly, the SCC said that “[t]he trial judge has found that the inventors possessed and disclosed in the patent both the factual data on which to base a prediction,” as well as the line of reasoning necessary to support a sound prediction [75, my emphasis]. In this post I will show that the SCC’s statement that the underlying facts supporting the sound prediction “were in fact disclosed,” is, in fact, false.

This is a purely factual point, involving a comparison between what was disclosed in the patent with the evidence that was found to support a sound prediction. The bulk of this post is devoted to supporting my claim that the factual basis was not disclosed by going through the decision and the patent in rather pedantic detail. It may seem at times that I am belabouring the obvious, but since I am arguing that the SCC made a factual error, I would like to be clear as to the basis for my assertion. I’ll finish by considering the doctrinal implications of this observation.

I should stress that I am not disagreeing with any of the key holdings in AZT. I am arguing that the SCC’s statement at [70] was based on a factually erroneous premise; but that statement was expressly obiter. Given that the remarks were obiter, it is understandable that the SCC was perhaps not as careful in dealing with the issue as it might have been. An obiter comment of this type is clearly not binding in any event: R v Henry 2005 SCC 76 [57]. My argument is that the underlying factual error is one more reason for not placing significant weight on this obiter comment in the future development of the law on this point.