The Federal Court of Appeal of Canada (the Court) recently dismissed the appeal in Apotex Inc. v Shire LLC, 2021 FCA 52.  This was an appeal of a decision holding that the claims of Canadian Patent No. 2,527,646 (CA 646), directed to L-lysine-d-amphetamine (LDX), were valid.  In this decision, the Court outlined that a selection patent is subject to the same requirements and vulnerable to the same attacks as any other patent, and in particular, that the validity analysis does not change depending on whether the patent was classified as a selection patent.

Anticipation Analysis

The Court noted that if the performance of a published reference does not necessarily result in infringement of a claim, then the published reference does not disclose that claim. 

When applied to the facts at hand, even though some of the claims of CA 646 were directed to the bare chemical formula for LDX, the Court noted that LDX was not an example described in in the prior art; it was merely one of a large class of “advantageous” compounds. As such, there are numerous other ways to “perform” the prior art without necessarily infringing CA 646.  Therefore, the bare chemical formula claims were not anticipated.

Obviousness Analysis

The Court held that the inventive concept remains the end point for the obviousness inquiry, and that identification of an inventive concept is a separate exercise from claim construction.  On occasion, the inventive concept may be readily apparent. If not, one must first determine whether it can be identified from the claim construction exercise. Where that is not possible, one may have regard to the patent specification.

In this case, the Court noted that for the claims directed to bare chemical compounds, the essential element of each of these claims is simply the chemical formula itself which, standing alone, says nothing as to inventiveness. As such, it is necessary to turn to the specification.  The lower court committed no error in having regard to the properties and beneficial features of LDX in determining the inventive concept of the claims in issue.

Summary By: Vanessa Komarnicki


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