Intellectual Property Weekly Abstracts Bulletin - Week Of July 18, 2011

Edited by Chantal Saunders and Beverley Moore

NOC Proceedings

Motion to Set Aside Prohibition Order because of Impeachment Action Dismissed
Pfizer Canada Inc. v. Canada (Health)
Drug: amlodipine besylate

In 2006, the Federal Court of Appeal allowed an appeal from a decision of the Federal Court and issued an Order of prohibition (prohibition Order) preventing the Minister of Health from issuing a Notice of Compliance until expiry of the patent. The decision of the Federal Court can be found here. ratiopharm brought this motion pursuant to Rule 399 of the Federal Courts Rules, to set aside the Order of the Court of Appeal.

The motion was brought under Rule 399(2)(a) and (b), arguing a matter that was discovered subsequent to the making of the prohibition Order and because the prohibition Order was obtained by fraud. The basis for the motion was the decision by the Federal Court, and affirmed by the Court of Appeal, wherein Pfizer's patent was found to be invalid in an impeachment action. ratiopharm highlighted in its motion materials that it will be entitled to seek compensation pursuant to Section 8 of the NOC Regulations if the prohibition Order is set aside.

The Court agreed with Pfizer that the appeal is moot with respect to a determination that a new matter has been discovered. However, the Court of Appeal agreed with ratiopharm that the motion is not moot with respect to the allegation of fraud. Specifically, the Court of Appeal noted that the principle of finality does not apply when the judgment is obtained by fraud.

The Court found that the subsequent finding of invalidity in the impeachment action is not a new matter and accordingly does not provide a basis upon which the prohibition Order should be set aside. With respect to the allegation that the prohibition Order was obtained on the basis of fraud, the Court noted that the fraud must be material and in order to be material, it must have been committed in the proceeding in which the prohibition Order sought be set aside was rendered. The Court held that no perjured evidence and no forged documents were filed in the NOC proceedings; nor was there anything that indicated an intention to mislead. Furthermore, the Court held that the NOC proceeding was not an adjudication of the validity of the patent, and merely gave effect to the presumption of the validity of the patent.

Thus, the Court dismissed the motion to set aside the prohibition Order, holding that there was nothing on the record that showed the prohibition Order to have been induced by or resulting from the misrepresentations later found in the impeachment proceedings to have been made to obtain the patent.

Actions

Appeal with Respect to Utility Dismissed
Eli Lilly and Company v. Teva Canada Limited
Drug: atomoxetine

This was an appeal by Lilly of a decision of the Federal Court finding Lilly's patent invalid for lack of utility. The Federal Court decision is found here and our summary is found here. The Court of Appeal dismissed Lilly's appeal.

Lilly raised three legal issues on appeal. The Court of Appeal found that the Judge did not err with respect to construing the promise of the patent, and did not require too high a standard of proof of utility. The Court of Appeal found that the patent specifically promised that atomoxetine is a clinically effective treatment of ADHD and therefore, the utility of the patent is determined by examining whether the drug will do what the patent promised it would do. The Court of Appeal found that the question is whether Lilly had sufficient evidence to establish that the drug would deliver on the promise of the patent and the Judge concluded that Teva had established that the answer to the question was no. The Court of Appeal found no reversible error in this determination.

With respect to sound prediction, the Court of Appeal found that, following a previous decision, the factual basis of the prediction must be disclosed in the patent. The Court of Appeal further found no error of principle in the Judge's exercise of discretion in respect of the award of costs.

Other Cases of Interest

Decision of PMPRB Declared Null
Sanofi Pasteur Limited v. Attorney General of Canada
Drug: QUADRACEL and PENTACEL

Sanofi brought a judicial review proceeding in respect of a decision by the Patented Medicine Prices Review Board (Board), and specifically with respect to the portion of the decision addressing the remedy. The main argument in the proceeding related to the offsetting of excess revenues in respect of section 83(2) of the Patent Act.

With respect to the standard of review, the Court found the appropriate standard to be one of reasonableness given that the question to be determined by the Court is one of fact or mixed fact and law. The Court stated that this same standard should apply to pure questions of law. The Court concluded that it was not able to determine if the decision of the Board was reasonable. The Court declared that the Order of the Board is null and void, and the payment made by Sanofi was to be returned promptly.

Leave Denied by Supreme Court of Canada with respect to Data Protection Legislation
Apotex Inc. v. Minister of Health et al.

The Supreme Court of Canada denied leave from a decision of the Federal Court of Appeal finding that the data protection provisions of the Food and Drugs Regulations are intra vires. Our summary of the Court of Appeal decision is found here.

Interlocutory Injunction in Passing-Off Action Denied
Target Brands, Inc. v. Fairweather Ltd.

Target commenced an action seeking damages and a permanent injunction from using the trade name TARGET or the bull's-eye mark. The Defendants counterclaimed against Target for infringement of its registered trade-mark TARGET APPAREL. The Plaintiffs brought this motion for an interlocutory injunction. The Court found that Target had met the low threshold for identifying a serious issue but had not proved on the balance of probabilities that it will incur irreparable harm. The Court also found that the balance of convenience favours the Defendants.

Expungement of Trade-mark Upheld
Spirits International B.V. v. BCF S.E.N.C.R.L.

The Federal Court upheld a decision by the Registrar of Trade-marks, expunging a trade-mark registration. The Registrar expunged the trade-mark on the basis that the evidence was insufficient to allow it to conclude that the sales of the wares in association with the trade-mark by a particular company would benefit the trade-mark owner. In particular, the Registrar found that the Applicant had failed to establish that it asserted control over the quality or character of the registered wares. The Federal Court upheld this decision.

Other Industry News

Health Canada's Scientific Advisory Committee on Metabolic and Endocrine Therapies published its Terms of Reference and Membership List and Biographies.

Health Canada's Scientific Advisory Committee on Bioequivalence Requirements for Gender-Specific Drug Products published its Terms of Reference and Membership List, as well as an Agenda and Record of Proceedings from its June 2, 2011 meeting.

CIPO has announced it is streamlining its Patent Prosecution Highway agreements.

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