Patented Medicines (Notice of Compliance) Decisions

Standard of Review of Palpable and Overriding Error Not Applied in Appeal from Rule 51 Appeal
Bayer Inc v Pharmaceutical Partners of Canada Inc, 2016 FCA 13

This is an appeal from the Federal Court's (FC) decision (2015 FC 797), which upheld the Prothonotary's decision allowing the generic Respondent's motion to strike all portions of the underlying NOC application by Bayer in relation to its ‘424 Patent (our summary here, Prothonotary's decision here).

The FC engaged in a de novo review and concluded that the Prothonotary did not err in granting the motion because the application had no chance of succeeding at the hearing. Bayer conceded there was no evidence of direct infringement, but rather argued the generic's Product Monograph (PM) would induce infringement. As found by the Prothonotary, the generic's PM spoke for itself and does not direct nor does it instruct use of the generic's product with sodium chloride in concentrations that infringe the ‘424 Patent, and thus, cannot be seen as inducing infringement.

On appeal, the Federal Court of Appeal (FCA) held that the standard of review of palpable and overriding error (as set out by the Supreme Court in Housen v Nikolaisen) would have applied, but for the fact that this was an appeal from a Rule 51 appeal. Past cases involving Rule 51 appeals establish a standard of review of whether "the decision of the Federal Court was arrived at on a wrong basis or was plainly wrong". The FCA applied this standard, even though the standard may have outlived its usefulness. In any event, the FCA would have reached the same result if it had considered the appeal on the basis of the standard of review in Housen .

Ultimately, the FCA was not persuaded that the FC had grounds to interfere with the Prothonotary's decision, nor that the decision of the Federal Court was arrived at on a wrong basis or was plainly wrong. Thus, the appeal was dismissed.

Patent Decisions

Prothonotary's Refusal to Strike Allegations Seeking to Deny Plaintiff's Legal Remedy Was Not Vital to Final Issues
Alcon Canada Inc v Actavis Pharma Company, 2015 FC 1323

The Federal Court (FC) dismissed the Plaintiffs' appeal from the Prothonotary's Order dismissing Alcon's motion to strike certain paragraphs from the Statement of Defence and Counterclaim.

Alcon sought to have struck the paragraphs that concerned the alleged anti-competitive behaviour by Alcon. Before the FC, Actavis clarified that its assertion was not that Alcon should be denied its claim for damages simply by virtue of its conduct, rather the amount of Alcon's damages should be reduced, either partially or entirely, after accounting for the effect of its allegedly inequitable conduct. Based on this characterization, the FC determined that the questions raised in the motion before the Prothonotary were not vital to the final issues of the case, and as such, the Order would not be disturbed unless it was "clearly wrong, in the sense that the exercise of discretion by the Prothonotary was based upon a wrong principle or upon a misapprehension of the facts".

Based on previous statements of the Court of Appeal, Alcon claimed that in order for Actavis to avoid having its allegations of inequitable conduct struck, the allegations must cast a shadow either on Alcon's title in the patent at issue or on the question of whether infringement has occurred. However, the FC noted that the remedy Actavis seeks to deny Alcon was a legal remedy, and not an equitable remedy. Therefore, the test set out by Alcon was not applicable in this case, given that it concerned disentitlement to equitable relief.

The FC found that the Prothonotary had properly described the applicable law and the relevant facts. The FC held that it was not an error to conclude that, due to the uniqueness of the facts in this case, it was not plain and obvious that the inequitable conduct allegations were doomed to fail.

Other Industry News

Health Canada has published Notice of the Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document: S10: Photosafety Evaluation of Pharmaceuticals.

Health Canada has published Notice of the Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document S9: Non-clinical Evaluation for Anticancer Pharmaceuticals.

Health Canada has published Notice of the Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document S8: Immunotoxicity Studies For Human Pharmaceuticals.

Health Canada has published Notice of the Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document S6(R1): Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals.

Health Canada has published Notice of the Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use.

Authors

Chantal Saunders 
CSaunders@blg.com
613.369.4783

Beverley Moore 
BMoore@blg.com
613.369.4784

Adrian J. Howard 
AJHoward@blg.com
613.787.3557

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