Monday, March 25, 2013

Sufficiency Assessed as of Publication Date

Novartis Pharmaceuticals Canada Inc v Teva Canada Ltd / zoledronate (NOC) 2013 FC 283 Hughes J
            ZOMETA ACLASTA / zoledronate / 1,338,895, 1,338,937

As discussed in my last post, Hughes J held that the ‘937 patent was not invalid for Sildenafil insufficiency because it claimed only a single compound. Recall from the prior post that the ‘937 patent had been placed in conflict with the ‘837 patent, and both had originally claimed a broad class of compounds. The claims of the ‘937 patent had been narrowed to zoledronate after filing, as a result of a settlement between the parties. Hughes J remarked that:

[178] The [‘937] patent was issued and granted with only two claims – both specific to zoledronate. For the same reasons as previously set out, I have distinguished this patent from that considered by the Supreme Court in Teva [Sildenafil] on the basis that the claims were specific to zoledronate, only. However, when the application was filed in Canada, the application contained claims to many compounds, including genus claims and claims to specific compounds; including, but not restricted to, zoledronate. If I were to consider sufficiency as of the date of filing the application, I would find that the application was no different than that considered by the Supreme Court in Teva, and thus was invalid for lack of sufficient disclosure.

(As discussed in my last post, I’m not entirely sure that the situation would have been the same because of possible differences in the number of compounds that had been tested, but Hughes J did not explore this point.)

Hughes J dealt with this problem by addressing the issue of the date for assessing sufficiency. He noted that “Canadian law has not been clear as to what is the date for considering sufficiency” [179], and while the SCC in Free World Trust 2000 SCC 66 [53-54], had held that the date of publication is the correct date for claim construction, it had left open the question of whether this is also the correct date for assessing sufficiency [182]. He reviewed the case law, including in particular Biogen v Medeva [1996] UKHL 18, in which Lord Hoffmann had held that the appropriate date was the date of the application (that is, the filing date, not the date of the priority application, and not the date of publication), largely on the ground that otherwise an application that was insufficient when filed might be sufficient when published as a result of intervening advances in the common general knowledge. As Hughes J put it, “An applicant should not be able to take advantage of intervening advances in the state of the art so as to render sufficient an insufficient application as filed” [185].

While Hughes J accepted that this “would make sense” [186], he held that the Sildenafil decision mandated a different result:

[187] The Teva decision has caused me to distinguish the '937 patent at issue here from that considered by the Supreme Court on the basis that in the '937 patent, the claims were limited to a single compound. Claims can be added, removed or amended at any time during the application process, whether one is dealing with the “old” or “new” Patent Act. Even after a patent has been issued and granted it may, within a limited period, be reissued with fewer or more or different claims; claims may be reduced by disclaimer and possibly even by dedication. The patentee is not seeking advantages because of advances in the scientific state of the art; but rather, is seeking to keep up with the state of the jurisprudence.

[188] I find that the most appropriate date for consideration of sufficiency of a Canadian patent is, as found by Buckley LJ in Standard Brands, as referred to by Lord Hoffman in Biogen, that of the date of publication. That is the date that the public is seized with the application. That is the date that the person applying for the patent has committed to claims for the invention in a manner available to the public. In the case of an “old” Act patent, this would be the day that the patent was issued and granted. In the case of a “new” Act patent, it would be the date of publication.

While Hughes J relied primarily on Sildenafil, this reasoning and conclusion strikes me as consistent with the holding in Free World Trust that the claims are construed as of the publication date. We can’t know whether the invention is properly disclosed until we know what it is. If “the invention” is the invention as claimed, we don't know what the invention is until the publication date. (And see 2007 FC 596 Hughes J. at [140-41], and 2009 FC 638, Kelen J at [108] to this general effect).

But what if “the invention” is not the invention as claimed? If the invention is the inventive concept which emerges from the disclosure, then it would be possible to decide whether the disclosure is sufficient even in the absence of any claims at all. One difficulty with this argument is that it is not consistent with Sildenafil, in which the SCC held that “the specification as a whole must be examined.” The whole specification includes the claims: “We must look to the whole of the disclosure and the claims to ascertain the nature of the invention” and “It is possible . . .for each claim in a patent to disclose a separate invention” [64]. This seems to be clear that the claims must be considered, as well as the disclosure. This strongly supports Hughes J’s conclusion.

So, while Hughes J’s reasoning in light of Sildenafil seems sound, having sufficiency assessed as of the publication date does leave the policy objection that an invention that is insufficient at the filing date may be sufficient at the publication date because of advances in the common general knowledge. Perhaps this is not a conclusive objection – after all, no one will be relying on the disclosure before publication – but it is certainly disquieting. I cannot think of any entirely satisfactory answer to this problem.

1 comment:

  1. The reasoning doesn't recognize that patents are amended after filing. A patentee is only required to have one claim on filing and no requirement exists in the rules or the act that the patentee keep that claim. The issue should be sufficiency of the patent as granted not the application as of a particular date.