Infringement of Use Claim by Manufacture

Eli Lilly Canada Inc v Apotex Inc 2019 FC 884 Tabib J
            2,226,784 / 2,371,684 / 2,379,948 / tadalafil

This procedural decision raises the question of whether a claim in the form of “a composition for use in the treatment of” a disorder can be infringed by manufacture of the composition intended for treatment of the disorder, even if the composition is not actually used. The broader question is the extent to which relatively subtle differences in claim structure can result in substantive differences in what constitutes infringement.

Lilly’s 784 patent has claims of the general form “a composition for the treatment of ED comprising tadalafil.” Lilly won in NOC proceedings against various generics based on its 784 patent, which were therefore prohibited from obtaining an NOC until its expiry. When the 784 patent did expire, several generics received their NOC and immediately launched. Lilly brought an action for infringement based on several patents, including the 784 patent, even though no product was sold until after the 784 patent expired.

In this motion Lilly sought leave to amend to add an allegation that the generics infringed by reason of the manufacture, import and stockpiling of tadalafil for the treatment of ED prior to the expiry of the 784 Patent [13]. The defendant generics opposed the amendment. None of them sold or could sell their product in Canada until the expiry of the ‘784 patent, so the question is whether manufacture and stockpiling could constitute infringement of a claim of this type. The generics argued in effect that because the 784 patent is a “use” patent, they could only infringe by inducement, and since direct infringement is an element of inducement, and there was no actual use, and therefore no direct infringement, prior to the expiry of the 784 patent and launch of the generic product, it followed that there could be no infringement by manufacture and stockpiling [18]. While the issue arose because of the particular facts, the question is of more general significance, because if Lilly is right, a claim to a composition for treatment of a disorder can be directly infringed by manufacture for that purpose, without the need to establish use.

Tabib J rejected the defendants’ argument. She noted the potential distinction between claims of the form “a composition for use in the treatment of” and those drafted as “use of a composition in the treatment of” [23]. The former claim is arguably a claim to the composition itself, which might therefore be infringed by manufacture and stockpiling. Without going through the cases reviewed by Tabib J, her conclusion that it is reasonably arguable that a claim to “a composition for use” is a composition claim [33], strikes me as clearly correct. With that said, there is merit to the basic argument made by the generics, that both types of claim are really directed to a second medical use. If the substance of the invention is the same, it would seem to be undesirable that idiosyncratic differences in claim structure could lead to substantive differences in outcome. But maybe the answer to that is that claim to “use of a composition in the treatment of” should also be infringed by manufacture for purpose of the claimed use.

In the end, Tabib J allowed the amendment by Lilly, subject to bifurcation to address scheduling issues.