Shire Canada Inc v Apotex Inc, 2016 FC 382
Drug: amphetamine mixed salts XR
Apotex sent a NOA to Shire alleging its patent was invalid and will not be infringed by Apotex. The issues were narrowed for the hearing, where issues of non-infringement, overbreadth, ambiguity, insufficiency and lack of utility were argued, as well as an argument that the claims were not relevant under the PM(NOC) Regulations because Shire's product does not fall within the scope of the claims.
Following a lengthy discussion on claim construction the Court found that Apotex will not infringe the patent and did not address the remaining allegations. The patent was described as claiming an extended-release by a combination of coated (delayed release) and uncoated (immediate release) tablets. In contrast, Apotex's product was described as achieving its extended-release characteristics first by a mechanism of diffusion (while in the stomach) and later by a mechanism of diffusion and erosion (once the tablets have entered the intestines).
In its discussion regarding non-essential elements, the Court held that the SCC in Free World Trust likely did not intend for a patentee to establish that a claim element is not essential by succeeding on just one part of the Improver test. The Court held that the SCC likely intended that, in order for a patentee to establish that a claim element is non-essential, it must show both (1) that on a purposive construction of the words of the claim it was clearly not intended to be essential, and (2) that at the date of publication of the patent, the skilled addressees would have appreciated that a particular element could be substituted without affecting the working of the invention.
It can be noted that Apotex advocated that their witnesses should be preferred because they were blinded to the NOA and never told Apotex's legal position. Apotex argued that since claim construction should precede analysis of issues like patent infringement and validity, exposing experts to information about the allegedly infringing product or the relevant prior art could improperly taint their analysis on claim construction. Shire argued blinding of experts is not a requirement and there is no principle of law whereby testimony of blinded experts must be favoured. The Court found that blinding has not been raised to the level of a legal principle, and is merely persuasive. If the opinion is well-reasoned, there may be no reason for the Court to be concerned if the witness was blinded to certain facts, but a concern may arise where the expert's opinion seems tortured or less well-reasoned.
The Court further noted that blinding is no guarantee that the expert evidence is reliable. It would not be difficult to seek opinions from a number of experts, keeping them all blind to unnecessary information, then selecting the one expert who provides the opinion that the party sought.