Health Canada has published an update to its guidance document on the application of the Patented Medicines (Notice of Compliance) Regulations.1 The revised guidance document now contains an exemption to the requirement to address listed patents for an innovative drug when a generic company files an administrative drug submission that cross-references a submission for another generic drug product that has been previously approved by Health Canada.
The final update is essentially the same as that proposed in August 2011.
Under section 5 of the Patented Medicine (Notice of Compliance) Regulations (Regulations), a manufacturer that files an abbreviated new drug submission (ANDS) with Health Canada seeking approval of a generic version of an innovative drug must serve a notice of allegation for each relevant patent listed by the innovator on the Health Canada Patent Register. If the generic manufacturer alleges invalidity or non-infringement in respect of any listed patent, the innovator may apply to the courts for an order prohibiting Health Canada from approving the ANDS on the grounds that it would result in the infringement of a valid patent.
The update to the guidance document excludes certain drug submissions from the scope of section 5 in the context of licensing arrangements. If a drug manufacturer licenses rights to an approved drug to another manufacturer, the licensee is required to file an administrative drug submission with Health Canada, cross-referencing the licensor’s drug submission, in order to seek approval to sell its identical version of the drug under a different name. In the past, Health Canada had required the licensee to address any applicable listed patents when its administrative drug submission is filed. Now, only the originating drug submission (i.e., the licensor’s drug submission) will trigger the application of section 5 of the Regulations. Further, the licensee will not be required to address any patents that were listed on the Patent Register after the filing of a licensor’s submission.
The update is effective as of April 16, 2012, meaning that a manufacturer that submitted an administrative drug submission under a licensing agreement before April 16, 2012 will still be required to address any patents listed on the Patent Register as of the submission filing date.