OTHER CASES OF INTEREST
Security for Costs Order Upheld
The Prothonotary ordered that security for costs be paid into Court. The Federal Court upheld that decision, with the Plaintiffs arguing they were impecunious. A copy of the Federal Court decision can be found here. A copy of our summary can be found here. The Plaintiffs appealed to the Federal Court of Appeal (FCA), arguing, inter alia, that the rule (s. 416(a)) providing that security for costs may be granted if the plaintiff is resident outside Canada is contrary to the North American Free Trade Agreement (NAFTA) and the Agreement on Trade-Related aspects of Intellectual Property Rights (TRIPS).
The FCA held that it is not clear that the treatment of United States nationals under the rule is different than treatment of Canadian nationals who are not "ordinarily resident" in Canada. However, the FCA held it was not necessary to resolve this issue, as following previous case-law, an international treaty cannot be used to override the clear words used in a statute by Parliament. The rule provides the discretion to award security for costs in certain situations and construing NAFTA and TRIPS to preempt this discretion would give these treaties an effect they cannot have.
The FCA also commented on the Appellant's conduct in the United States regarding sanctions that had been ordered; citing this as another reason the Prothonotary was correct in his original decision. Finally, the Court dealt with the Appellants arguments that they were impecunious. The FCA held that the factual findings were open to the Prothonotary based on the evidence, and that he had made no errors as to the standard of proof required. Thus, the FCA held that there was no error in the Motion Judge's refusal to intervene in the Prothonotary's decision.
PATENT APPEAL BOARD DECISIONS
Patent Application Allowed on the Basis of Sound Prediction, Rejection as to Overbreadth Overturned
The application relates to genetically engineered transgenic animal models. The application was rejected for overbreadth as the claims refer to mutants that were not specifically exemplified. The final action also raised the issue of utility. The Commissioner of Patents overturned the rejection and recommended that the claims be allowed.
Regarding overbreadth, the Patent Appeal Board (PAB) considered the references cited in the description and held that much was known about the subject matter of the invention. The Examiner argued that the claims defined genes by their desired result and thus encompassed mutations not taught by the applicant. However, the PAB held that the expressions in the claims qualify the phenotype of each transgene when expressed.
Furthermore, the PAB held that the claims, thus, did not define the desired result, but rather identified a combination of transgenes that worked synergistically to achieve a desirable result. Thus, the skilled person would appreciate that the desired phenotypic effect of each type of transgene could be achieved using mutants other than those specifically exemplified. Furthermore, the PAB held that the skilled person would require only routine skill to practice the invention in respect of embodiments that had not been exemplified.
Regarding sound prediction, the PAB discussed the factual basis for the prediction. It then held that one example shows the sound line of reasoning and that a skilled person would accept that extrapolating these results to wider classes would be logical and reasonable. The fact that other mutants than those exemplified were available, means that the inventors' predictions were not so broad as to be unreasonable. Furthermore, a sound prediction does not mean a certainty. Thus, the prediction was held to be sound over the entire scope of the claims.
OTHER INDUSTRY NEWS
The Supreme Court of Canada denied leave to appeal in Corlac Inc. et al. v. Weatherford Canada Ltd. et al. (F.C.)(34459). The decision of the Federal Court of Appeal can be found here, and BLG's summary of the decision here.
Health Canada published a Consultation Document – Draft Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD). Questions and comments should be submitted no later than April 30, 2012.
Health Canada announced the release of the Draft Canadian Module 1 Schema Version 2.1, which will replace the 2004 Canadian Document Type Definition (DTD) Version 1.0 once it is final. The consultation is open for comment until April 30, 2012.
Health Canada announced the release of Draft Guidance for Industry: Creation of Canadian Module 1 Backbone, which will replace the 2004 Guidance for Industry: Creation of the Canadian Module 1 eCTD Backbone File once it is final. The consultation is open for comment until April 30, 2012.
The Natural Health Products Directorate of Health Canada has published a new Electronic Product Licence Application form, a Compendial from generated monograph Electronic Product Licence Application form and a NHP Online eSubmission Builder – Software application.
As we mentioned last week, CIPO is consulting on practice respecting inventive concept, statutory subject matter, diagnostic methods and medical uses. The consultation documents are now posted here. The consultation period is April 2, 2012 to May 2, 2012.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.