In August of 2007, by way of a Practice Notice and with little or no consultation with the public or the intellectual property community, the Canadian Patent Office formally expressed its position that computer programs existing in a transitory state (i.e., signal claims) are forms of energy that do not contain matter and therefore do not constitute patentable subject matter under section 2 of the Patent Act. What little commentary there has been regarding this decision appears to have been focused on whether or not the Patent Office is correct in its assertion that signal claims
Health Canada recently released a draft guidance document, for public comment only, in respect of a proposed regulatory approval process for Subsequent Entry Biologics (SEBs).1 This guidance document is the first step in the development of a comprehensive regulatory system to address SEBs that will, in all likelihood, also include regulatory amendments.
Since its release, the guidance document has been the subject of considerable public commentary. Key elements are briefly described below:
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