The Court of Appeal sends s.8 case back to Trial Judge for redetermination
The Federal Court of Appeal (FCA) has granted Apotex' appeal and sent a case considering s. 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations) back to the Trial Judge for redetermination. The Trial decision can be found here and our summary of it can be found here.
The FCA considered the chronology of events and held that despite Apotex having been granted an NOC prior to the 1998 amendments to the Regulations, Merck's appeal of the prohibition proceeding was still pending before the Court. The FCA did not dismiss Merck's appeal until 1999. Thus, the 1998 Regulations and not the 1993 Regulations were applicable to Apotex' s. 8 claim. The FCA held that even though the issue of the NOC rendered the application moot, the Court nonetheless could have exercised its discretion to decided the question in dispute.
The FCA then considered whether Merck was liable to compensate under the 1998 version of s. 8(1). The FCA considered Merck's argument that Apotex was not entitled to compensation under s. 8 as it was infringing Merck's patent. Merck argued that it could not have been the legislator's intention to compensate an infringer for loss as a result of being prevented from starting to infringe sooner; using the principle of ex turpi causa. The FCA refused to limit the claim pursuant to s. 8(1) in the manner suggested by Merck. Instead, it held that s. 8(5) gives the Court a broad discretion to take into account all matters that it considers relevant to the assessment of the amount of compensation. The FCA held that s. 8(5) allows the factual situation in its entirety to be considered and that a Court is likely to find it easier to apply the ex turpi causa principle through the exercise of judicial discretion rather than through a definition of liability.
The FCA then returned the case to the Trial Judge to decide the case in accordance with the reasons given.
The Court of Appeal Upholds Findings of Infringement
The Federal Court of Appeal (FCA) dismissed the appeal of a judgment finding that Apotex and Apotex Fermentation had infringed Merck's patent for lovastatin. A copy of the Trial decision can be found here and our summary of it here.
The FCA held that the Trial Judge had written detailed and comprehensive reasons and that it was clear she had a firm grasp of the voluminous and complex evidence presented to her during the trial. Deference is owed to a Trial Judge for their findings of fact.
Thus, errors must be not only clear and obvious (palpable) but more importantly, overriding in order for an attack based on factual findings to succeed. This standard also applies to inferences drawn from the evidence.
The Court of Appeal was satisfied that the Trial Judge could reasonably infer from the totality of the evidence before her the findings that she made. Thus, the appeal was dismissed.
Other cases of Interest
Court Refused to Intervene re Interlocutory Decisions
The Federal Court of Appeal (FCA) held that there were no special circumstances to justify its intervention at this stage of the proceeding before the Copyright Board. Before the FCA were two applications for judicial review of interlocutory decisions of the Copyright Board with respect to a proposed tariff entitled "Educational Institutions Tariff (2011-2013)".
Decisions of the Commissioner of Patents
Patent Appeal Board has Jurisdiction to Consider New Defects Introduced by the Applicants Amendments made in Response to a Final Action
The application relates to a dual balloon catheter. The Applicant made amendments following a Final Action as to novelty. The amendments were supported by the application, but not previously found in any claim, and thus, required a new search. The application was referred to the Patent Appeal Board on the basis of obviousness, resulting from this new search. The Applicants argued that the Commissioner had no jurisdiction to identify any defects which may arise from the response to the Final Action. The Commissioner of Patents disagreed. Furthermore, the rejection as to obviousness was upheld and amendments were required based on certain dependant claims.
The Patent Appeal Board (PAB) held that this situation was distinguishable from previous jurisprudence as the issue of obviousness arose because of amendments made in response to a Final Action and not after a Commissioner's decision. The Patent Office has no control over the content of amendments submitted in response to a Final Action. Furthermore, the PAB held that it could not have been intended that claims be allowed without their patentability being considered, simply because they were presented to the patent office for the first time after a Final Action. In addition, the Applicant had an opportunity to respond to this issue prior to the hearing before the PAB.
The Applicant did not raise any substantive arguments regarding the obviousness rejection. The PAB considered obviousness in accordance with the Sanofi principles and rejected the claims.
Amendments Proposed after Application referred to Patent Appeal
Commissioner's Decision No. 1320
The application relates to a human cell line that is able to proliferate indefinitely. The Examiner considered some of the claim language ("descended from", "derived from" and "modified") to be either vague or too broad. The applicant proposed amendments after the case was referred to the Patent Appeal Board. The Examiner could not consider those amendments, but the Commissioner could. A hearing was scheduled, as the proposed amendments still used language to which the Examiner objected. However, the Applicant was also informed that further amendments would be considered, if it wished to decline the hearing and expedite allowance. Further amendments were proposed and those were accepted by the Commissioner of Patents.
Postage Payment Patent Application Rejected as Obvious and Ambiguous
The application relates to methods and systems for evidencing postage payment. The Commissioner of Patents upheld the rejection on the basis of obviousness. Nothing in the dependant claims was found to render the independent claims non-obvious. Furthermore, several of the claims were also rejected for ambiguity as the preamble of the independent claim referred to printing digital stamps yet no step that would result in stamps being printed was described. The application was considered without an oral hearing.
Other Industry News
The PMPRB has updated the Patentee's Guide to Reporting.
Health Canada has published a Post-Notice of Compliance (NOC) Changes: Level III form.
Health Canada has published a Factsheet on Drug Shortages.
Health Canada has published Guidance Documents on Fees for the Review of Medical Device Licence Applications and Medical Device Licence Renewal and Fees for the Right to Sell Licensed Medical Devices.
CIPO is conducting a consultation on Proposed Amendments to the Trade-marks Regulations.
CIPO has announced an update to the Maintenance Fees payment system.
CIPO has announced that it will be consulting on practice respecting inventive concept, statutory subject matter, diagnostic methods and medical uses. It has indicated that the 30-day consultation will begin the week of April 2 and that further information, including the consultation documents will be available at that time on CIPO's Consultations and Discussions website at that time.
The Competition Bureau is seeking comments on its revised draft Enforcement Guidelines on the Abuse of Dominance Provisions (Sections 78 and 79 of the Competition Act).
The Competition Bureau has published two draft Pre-Merger Notification Interpretation Guidelines for consultation: #12: Requirement to Submit a New Pre-Merger Notification and/or ARC Request Where a Proposed Transaction is Subsequently Amended and #14: Duplication Arising From Transactions Between Affiliates.About BLG
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