The Court of Appeal heard four appeals together. The appeals were from judicial review proceedings of decisions of the Minister of Health that the generic manufacturers were not required to address certain patents under the NOC Regulations. The Court of Appeal upheld the decision that the Minister was not wrong to issue NOCs to the generic manufacturers without first requiring them to address these patents.
The Court of Appeal found that the analytical approach adopted by the Minister in making the decisions under the review was adequate in light of the factual circumstances of the cases. As described by the Trial Division, in cases where the ANDS was submitted before October 5, 2006, the Minister looks at the first date on which the generic purchased the comparator drug to determine the NOCs that had been issued at that time. All patents that are listed in respect of the relevant NOCs at that date must be addressed. As to patents issued after the date of first purchase, the Minister determines whether the generic has made use of the changes made to the comparator drug since the original date of purchase and if so, the generic has to address all of the patents added to the patent list. Otherwise, the new patents do not need to be addressed by a generic.
The full text of this decision can be found at: http://decisions.fca-caf.gc.ca/en/2007/2007fca276/2007fca276.html
The full text of the decision of the Trial Division can be found at: http://decisions.fct-cf.gc.ca/en/2007/2007fc300/2007fc300.html