That subsection states that the Commissioner of Patents “shall...authorize the person to make, construct and use a patented invention solely for the purposes directly related to the manufacture of the pharmaceutical product named in the application”.
So it ties the authorization to a specific product named in the application. It also ties it to a particular country that would be listed in schedules 2 to 4 of the Patent Act—to the original three country lists also named in the application.
So there are two critical parts of subsection 21.04(1): that the product has to named in the application and that the country has to be named in the application. The authorization is tied to those two elements.
Clause 4 of Bill C-393 would significantly alter this authorization by the Commissioner of Patents. It would allow the Commissioner of Patents to authorize any person to manufacture more than one pharmaceutical product under the Patent Act and sell it for export to more than one country. It would also eliminate the requirements that the product be named in the application and that the country be named in the application. Again, it unties the process. It adopts what was referred to previously in this committee as a one licence solution.