Tuesday, February 12, 2013

Dicta on Disclosure of Utility

Pfizer Canada Inc v Pharmascience Inc / pregabalin (NOC) 2013 FC 120 Hughes J
            2,255,652 – LYRICA

As noted in yesterday’s post, Hughes J’s pregabalin decision provides an extended, 33 page discussion of the law of sound prediction and, particularly, disclosure of utility. As discussed yesterday, the entire discussion is obiter dicta. This is significant, as some of Hughes J’s analysis appears to go beyond established law.

So, without citing authority, Hughes J says at [103] (and see similarly [159] first bullet):

The law is clear that where a new compound, such as a pharmaceutical, is the invention, the specification must state the utility of that compound so as to satisfy the definition of “invention” in section 2 of the Patent Act.

This is at odds with the statement by the SCC in Consolboard [1981] 1 SCR 504, 526 that the inventor is not obliged “in his disclosure or claims to describe in what respect the invention is new or in what way it is useful. He must say what it is he claims to have invented. He is not obliged to extol the effect or advantage of his discovery, if he describes his invention so as to produce it.” The Consolboard position that the inventor is not required to state the utility at all is problematic, and I have argued in my Factual Basis article 28 CIPR 39, section 5, that ultimately the better view is that the utility must be disclosed in the specification, if it would not otherwise be obvious to a person skilled in the art. That is the law according to the US Federal Circuit, the EPO, the PCT Reg 5.1(vi), and the EPC Rule 42(1)(f). That is also how the Canadian Patent Office understands the requirement to disclose utility: Re Immunex CD 1302, 89 CPR(4th) 34 at 74. Consolboard is also consistent with this position on its facts, as the utility was obvious without an explicit statement. (The invention was a type of wooden board, which was obviously useful for construction.) But in Canada, in light of Consolboard, it cannot yet be said that it is clear law that utility must be disclosed even when it would not be obvious; and to say utility of a new compound must be stated in the disclosure, even if it would be obvious in any event, is very difficult to reconcile with existing law. It may well be that as a practical matter, the utility of a new compound will rarely be obvious, so a statement of utility will normally be necessary, and perhaps this is what Hughes J had in mind.

Hughes J also states that it is “established” that “where utility of a pharmaceutical has been established before the application for a patent was filed in Canada, it was sufficient to reference a study in the patent description” [153] first bullet. Even more strongly, he states at [159], third bullet, that:

there is a requirement in the jurisprudence that that [sic] the specification disclose information from which the utility can be confirmed or be said to be soundly predicted.

That studies supporting demonstrated utility must be disclosed in the patent is a novel proposition which would be very controversial if accepted. The only authority cited by Hughes J is a remark from Pfizer / sildenafil [Viagra] 2010 FCA 242 (rev’d on other grounds 2012 SCC 60) that “[s]o long as the disclosure makes reference to a study demonstrating utility, there do not appear to be any other requirements to fulfill section 2" [90]. But that remark was itself obiter, as the main point of the discussion by the FCA was that the argument that the patentee “was required to include evidence of demonstrated utility in the patent disclosure is without merit. The requirements for demonstrated utility can be provided in evidence during invalidity proceedings as opposed to in the patent itself” [90]. This passage in this FCA decision is essentially an affirmation of the holding of Kelen J at first instance 2009 FC 638 [82] that:

The Court finds that there is no requirement in patent law that evidence of the demonstrated utility of the patent must be included in the patent. It is sufficient that the patent states that the invention has been demonstrated to be useful, as the '446 Patent does by making reference to the clinical testing of the compound (Study 350), and that the patent-holder is able to show evidence of demonstrated utility if the validity of the patent is challenged.

In this passage, the reference to the study in the patent was simply the way in which this particular patent has made the necessary statement that the invention is useful. (As noted above, even such a statement is probably not generally required, though it was certainly necessary on the facts as the patent at issue was a use patent.) Therefore, Kelen J’s statement does not support the conclusion drawn by Hughes J, and the FCA statement really goes no further. Thus, the case law cited by Hughes J simply does not support his assertion that “there is a requirement in the jurisprudence that that [sic] the specification disclose information from which the utility can be confirmed or be said to be soundly predicted” [159].

Finally, I note that Hughes J also remarks confusingly that in the Viagra decision the SCC “said that there was no heightened requirement for disclosure in cases where utility is based on sound prediction,” [154] though in the next paragraph, he quotes the SCC as saying the point “does not arise in this case and need not be addressed,” [155], and he then emphasizes that “the comments as to sound prediction are strictly obiter” [156].

It remains to be seen whether Hughes J will give effect to the controversial statements of law set out in this discussion when they arise on the facts in a case before him. For now, we may note that this statements are obiter, and are by no means uncontroversial.

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