Thursday, September 8, 2022

Date for Assessing Sufficiency Redux

Pharmascience Inc v Bristol-Myers Squibb Canada Co 2022 FCA 142 Locke JA: de Montigny, Monaghan JJA affg 2021 FC 1 Zinn J FC Selection

2,461,202 / 2,791,171 / apixaban / ELIQUIS

In Teva / sildenafil 2010 FCA 242 [79] and Idenix v Gilead 2017 FCA 161 [46], the FCA held that the correct date for assessing sufficiency is the filing date, not the date of issue. In my post “What Is the Date for Assessing Sufficiency?” I indicated that Locke JA in Pharmascience v Bristol-Myers Squibb 2022 FCA 142 may have reopened the question, with a decision that might be taken to suggest that the date of issue was appropriate. Steve Hundal, has a recent blog post arguing that on the contrary, Locke JA was simply saying that it is the specification as issued that is relevant in assessing sufficiency, without disturbing the prior FCA holding that sufficiency is assessed in light of the common general knowledge as of the filing date. This is in the same way that novelty is assessed as of the claim date, but on the basis of the claims as issued. On reflection, I’m sure that is indeed the best way to read Locke JA’s decision.

In my defence, I will say that Locke JA indicated that the question was “the date for determining sufficiency” [26] “the relevant date for determining patent sufficiency” [28], and he spent several paragraphs discussing Zoledronate 2013 FC 283 [179]–[188] which clearly concerned the date for assessing sufficiency. (He also adverted to Merck v Apotex 59 CPR(3d) 133 (FCTD) [115]–[120], which also, on it’s facce, concerns the date for assessing sufficiency, though both the argument and the analysis in Merck v Apotex were a bit peculiar.)

But Mr Hundal is right to point out that there are other passages that indicate that Locke JA’s was simply saying that sufficiency is assessed in light of the specification as issued, not at some earlier date: see [32], [33]; and [31], which draws the parallel with assessing claims as issued for novelty and obviousness as of the claim date, and for utility as of the filing date. Further, I now see that the distinction between the date for assessing sufficiency, and the document to be assessed—the specification as filed or at some later date—is made very clearly by Zinn J at first instance: see eg [FC 37], [FC 43]. And this way of reading Locke JA’s decision has the great virtue that it is entirely consistent with the holding in Teva / sildenafil or Idenix v Gilead that sufficiency is assessed as of the filing date; it also explains why Locke JA did not mention those cases.

So, I think we can consider it still settled that the filing date is the correct date for assessing sufficiency, though it is the specification as issued that must be sufficient, not the specification as it was at some earlier date.

Now, there is still a problem. Some of Locke JA’s remarks could be taken to suggest that amendments to the specification might make a specification sufficient even thought it was insufficient as filed: eg “subsection 27(6) and section 38.2 of the Patent Act, while limiting the matter that can be added to a patent application by way of amendment, do permit amendments, and without restriction as to whether such amendments might buttress the sufficiency of the specification” [36, my emphasis]; and “it would effectively read out subsection 27(6), which contemplates amendments to bring the application into compliance with the sufficiency requirements” [33]. This raises some difficulties. In Idenix, the specification at filing did not enable a skilled person to synthesize the claimed compound, and indeed, the applicant did not know how to do so. The information on how to make the compound was subsequently made public, prior to issuance. It would be problematic if the applicant could have incorporated that into the specification, thereby rendering it sufficient: as Lord Hoffmann noted in Biogen v Medeva [1996] UKHL 18 [81],“[i]t would be illogical if a patent which ought to have been rejected [on examination by the Patent Office] is rendered immune from revocation [by the court] by advances in the art between the date of application and the publication of the specification.”

I think the answer to the problem is that, as Mr Hundal notes, “[t]here is the practical question of whether the specification as issued can differ appreciably from the specification as filed, given that section 38.2 of the Patent Act does not allow amendments that cannot be reasonably inferred from the specification and drawings contained in the application on its filing date.” Locke JA is right to say that s 27(6) and s 38.2 contemplate amendments to the specification, and they do not expressly exclude amendments which buttress sufficiency. But the “reasonably be inferred” standard from the 38.2 is restrictive, and probably does, as a practical matter, exclude amendments that would cure an insufficient specification. And while Locke JA noted that 27(6) “contemplates amendments to bring the application into compliance with the sufficiency requirements” [33], any such amendments are still subject to s 38.2.

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