eligible for listing: there are strict subject matter and timing requirements. T e Food and Drug Regulations allow a generic competitor to facilitate and expedite the regulatory approval of a generic equivalent by relying on the established safety and effi cacy of the innovator’s marketed product, and bioequivalence testing, in an abbreviated new drug submission (ANDS). Where a patent is listed on the patent register at the date of an ANDS fi ling (or a submission for a subsequent entry biologic), the NOC Regulations are triggered. T e marketing approval—a NOC— of the generic product is then delayed until the expiry of all patents listed on the register, subject to the generic company serving the innovator with a qualifying allegation, such as non-infringement or invalidity, in respect of each listed patent. T e innovator has 45 days from the date of the service of the notice of allegation to commence a court proceeding in which it seeks an order prohibiting the grant of a NOC to the generic on the basis that none of the allegations is “justifi ed”. T e court proceeding is summary in nature and preliminary in eff ect. It is based on a written evidential record containing fact and expert affi davits and cross-examination transcripts. A judge decides the case based on the record and the counsels’ written and oral submissions.
During the proceedings, which may take up to 24 months, the generic’s NOC is precluded. If the innovator fails to establish that all of the generic’s allegations are not justifi ed, the court application is dismissed and section 8 liability is triggered. If the innovator prevails in the proceeding, the generic’s NOC is delayed until patent expiry. But that is subject to a reversal on appeal or to an earlier determination in a full-blown court action (which includes discovery and live testimony, and fi nally determines patent rights between the parties) that the patent is invalid or will not be infringed by the generic product. T is is an example of the ‘dual litigation’ inherent in the regulatory and legislative pharma framework existing in Canada. If the innovator does not challenge the notice of allegation by a summary court proceeding, there is no potential liability to it and the generic can enter the marketplace ‘at risk’ once its ANDS is approved. T e innovator can still sue for patent infringement in a court action, but as a preliminary injunction is typically not available to innovators in Canada, the generic will normally keep selling and ‘genericise’ almost the entire market by the time a decision aſt er a trial is available. While the issue remains to be determined where an innovator fails under the NOC Regulations but prevails (continued on page 29)
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