Friday, May 1, 2020

A Two-Step Approach to Enablement?

Amgen Inc v Pfizer Canada ULC 2020 FC 522 Southcott J
            1,341,537 / filgrastim / NEUPOGEN / NIVESTYM

Wednesday’s post gave an overview of the facts and discussed the main substantive holding in this decision, namely that the invention was obvious. The decision also raised an important point regarding the proper approach to sufficiency, and more particularly enablement (how to practice the invention). I suggest the parties have gone astray, as a consequence of neglecting the FCA’s statements in Leo Pharma 2017 FCA 50 [58] and Bombardier v Arctic Cat 2018 FCA 172 [78] that the SCC decision in Teva 2012 SCC 60 did not change the law of enablement. Ultimately, the doctrinal point made no difference to the outcome, but it is worth discussing nonetheless, as it could cause serious difficulties in future cases.
In Teva 2012 SCC 60 (relating to VIAGRA), the patentee had tried to hide the fact that sildenafil was the particular compound that had been tested and found to be effective in treating ED. LeBel J for the Court stated that:

[80] As a matter of policy and sound statutory interpretation, patentees cannot be allowed to ‘game’ the system in this way. This, in my view, is the key issue in this appeal. It must be resolved against [the patentee].

Whatever one might think of the Court’s policy analysis, its statutory interpretation was the very opposite of “sound”; it would be more accurately described as a horrific train-wreck that particularly mangles s 58, which provides that claims stand or fall independently: see Siebrasse, The Duty to Disclose “The Invention”: The Wrong Tool for the Job, (2013) 25 IPJ 269. The Federal Courts have largely avoided getting tripped up by the SCC’s blithe disregard of doctrinal details and statutory text, and have instead (properly, in my view) understood Teva as representing a broad injunction against attempts to game the system, which was, after all, the “key issue” that was resolved against the patentee.

Unfortunately, Teva’s doctrinal misstep has reared its head in this case, in the context of the approach to sufficiency. The parties both accepted that

[454] In Novopharm SCC, [aka Teva] the Supreme Court set out a two-step analysis for determining whether a patent’s disclosure is sufficient. The first step is to define the nature of the invention in the patent (see Novopharm SCC at para 53). The entire patent must be considered in making this determination, not just a particular claim, as a patent is issued for one invention (see Novopharm SCC at paras 55-60). The second step is to determine whether the disclosure is sufficient to enable the skilled person to practice the invention, i.e. to produce the invention using only the instructions contained in the disclosure (see Novopharm SCC at paras 70-71). None of these principles are controversial between the parties.

The parties disputed whether both of these requirements were to be assessed as of the filing date, or whether the issue date is appropriate for the first step [455].

In my view, the issue of timing is a red herring. I suggest that the parties should not have accepted that these statements from Teva set out the proper approach, as it is wrong in principle and not required by law.

This two-step approach means that sufficiency is assessed in terms of the patent as a whole, and not on a claim-by-claim basis. That is contrary to the principle that claims stand and fall independently. Consider a hypothetical case in which the patent discloses a genus of compounds, as well as two specific especially preferred compounds A and B, all of which are novel, non-obvious, and soundly predicted to have the same utility. Suppose further that the patent provides perfectly clear directions as to how to make compound A, but it is established on the facts that the patent failed to disclose a key step in making compound B, so that it could not have been made without undue burden. (To avoid raising issues of “gaming the system,” we may assume that the failure to disclose how to make B was innocent in that the patentee used as specific brand of equipment that was crucial to success, but did not name the brand because it had not realized its importance: see eg by Badische Anilin (1898) 15 RPC 359 (CA).) The patent claims compounds A and B in separate claims. The sensible result is that the claim to A is valid, and the claim to B is invalid for lack of sufficiency. If the sufficiency requirement is applied to each claim independently, that result is straightforward. But if there is a prior step of determining the nature of “the invention,” a sensible result is out of reach. If the “invention” is compound A, does this mean that the claim to compound B is valid? If the “invention” is compound B, does this mean that the claim to compound A is invalid? If the “invention” is the genus, does this mean the claim to compound A is invalid, on the view that the claim to genus is invalid?

None of these options is a sensible result. Nor does the law force us into an absurdity. The FCA has pointed out in Leo Pharma 2017 FCA 50 [58] and again in Bombardier v Arctic Cat 2018 FCA 172 [78], that Teva did not change the law of enablement: see here. Gauthier JA made the point explicitly in Bombardier [78] (my emphasis):

Enablement (how to practice the invention) is a concept completely distinct from the disclosure of the invention itself, the latter of which was at issue in Pfizer [aka Teva].

The point at issue in the case at hand was enablement, ie that “the disclosure in the patent is not sufficient to practice this invention” [451]. Gauthier J’s holding in Bombardier therefore clearly applies: enablement is “completely distinct” from disclosure of the invention, and Teva should not have been relied on for this point.

This issue ultimately did not matter to the result. The sufficiency issue only arose if the claim was interpreted to require the claim protein to have to be pluripotent in the sense of stimulating growth in multiple cell lineages, [462]. Southcott J rejected this construction, and the sufficiency attack failed for that reason [463]. Nothing turned on the two-stag approach or the timing issue that the parties had disputed.

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