Shire Canada Inc v Apotex Inc2016 FC 382

When using expert witnesses in patent litigation, blinding them may be persuasive to a court, however the primary focus should be ensuring the substance and reasoning of their opinion is reliable.

In this case, the Federal Court (“FC”) concluded that Apotex Inc.’s (“Apotex”) allegations of non-infringement in respect of Shire Canada Inc.’s (“Shire”) Canadian Patent No. 2,348,090 (“the ‘090 Patent”) were justified and accordingly denied Shire’s requested prohibition order. [7]

Background: The ‘090 Patent

The ‘090 Patent, entitled “Oral Pulsed Dose Drug Delivery System,” describes a system for treating ADHD. [9] This system involves multiple pulsed doses of mixed amphetamine salts (“MAS”) being delivered by means of a single administration comprising a first, immediate pulse followed by a second, delayed pulse, which is intended to mimic the effect of taking two separate doses throughout the day. [14] Apotex’s product, in contrast, does not achieve extended-release characteristics by way of immediate and delayed release tablets, but rather uses an initial mechanism of diffusion of MAS followed later by a mechanism of diffusion and erosion once the tablets have reached the intestines. [24]

Shire filed an application under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”) for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex. [1] In response, Apotex alleged that (i) none of the claims in issue will be infringed by its product, (ii) in the event that the claims in issue are construed as Shire argues, they are invalid for overbreadth, ambiguity, insufficiency and lack of utility, and (iii) none of the claims in issue are relevant under the PM(NOC) Regulations because Shire’s product does not fall within the scope of said claims. [6]

Expert Blinding: Persuasive But Not Primary Interest

Apotex argued that its expert witnesses should be favoured over Shire’s because Apotex blinded its experts to certain facts and their legal position, whereas Shire did not. [42] The FC stated that while expert blinding may be persuasive, the primary interest is in the substance of the expert’s opinion and the reasoning that led to it. [45] Concern about whether an expert was blinded may arise in situations where the expert’s opinion seems tortured or less well-reasoned. [45] The FC also noted that blinding of witnesses is not a guarantee that expert evidence is reliable as it would be possible for a party to seek blind opinions from a number of experts and retain an outlier that provided the opinion that was sought after. [46]

Claims Construction and Infringement: Non-Infringement Allegations Justified

After completing a lengthy claims construction analysis on the essential elements of the claims at issue, the FC concluded that none of the ‘090 Patent’s claims were infringed by Apotex’s product. [181] As the FC concluded that Apotex’s non-infringement allegations were justified, it did not comment on the remaining allegations of invalidity and the claims not being relevant to the PM(NOC) Regulations. [182-183]

Commentary

The FC recently addressed the issue of expert blinding in two other cases, Bayer Inc v Apotex Inc, 2016 FC 1013 [Bayer] and Gilead Sciences, Inc v Canada (Health), 2016 FC 857 [Gilead], with similar conclusions that expert blinding is not determinative. In Bayer, the FC concluded that expert blinding may be persuasive and helpful in weighing the evidence where credibility concerns arise, but the principal concern remains the substance of the expert’s opinion and the reasoning that led to that opinion. In Gilead, the FC found that blinding of a witness is one of perhaps several factors that influences weight given, but it is not a matter that goes to admissibility. The FC further stated that blinding is a question of relevance, reliability and weight, and noted that the greater experience and knowledge of Gilead’s experts and two false statements made by Apotex’s witnesses were factors that affected weight given.