The Fallout of AstraZeneca Canada Inc. v. Canada (Minister of Health) (1)
Last November, we reported on the Supreme Court of Canada’s decision in AstraZeneca Canada Inc. v. Canada (Minister of Health) ("AstraZeneca"). In AstraZeneca, the Supreme Court held that a generic drug manufacturer was not required to address a patent that had been listed on the patent register against a drug that had never been marketed in Canada.
Since the release of AstraZeneca, generics have lobbied the Minister of Health to apply AstraZeneca in a way that limits the number of patents they are required to address under the Patented Medicines (Notice of Compliance) Regulations ("NOC Regulations"). As a result, the Minister adopted a new "two step" analysis for determining whether patents validly listed on the patent register need to be addressed by generics.
First, the date on which the generic purchases the comparator drug is used to determine the Notices of Compliance ("NOCs") that have been issued in respect of that comparator drug. All patents added to the patent register in respect of submissions that have received a NOC as of the date that the generic purchased the comparator drug must be addressed by the generic under subsection 5(1) and 5(2) of the NOC Regulations.
The second step considers whether the generic has made use of changes introduced to a comparator drug during the time period between the purchase of the comparator drug and the issuance of the NOC to the generic.
As a result of the Minister’s new post-AstraZeneca "two step" approach, the Minister issued NOCs to at least two generics for two different drugs (ALTACE® and DDAVP®), despite the fact that patents were validly listed on the patent register and despite the existence of outstanding prohibition proceedings prohibiting the Minister from issuing NOCs to those generics. In one case, the innovator did not receive any prior notice of the issuance of a NOC for a generic version of its drug.
The Minister’s decisions were the subject of a number of Judicial Review applications which were all heard together and recently decided by Justice Hughes.
Justice Hughes upheld the Minister’s decision and found that it was entirely consistent with AstraZeneca. He would have departed from the Minister’s approach in two respects: First, the date upon which the generic filed its ANDS should be used as the relevant date as opposed to the date the generic purchased the comparator drug. This would mean a generic need not address any patents listed in respect of a NOC that issues subsequent to the filing of the ANDS with Health Canada. Second, the "changes" in the Minister’s second step should be limited only to changes made by the generic necessary for the purpose of demonstrating bioequivalence.
Notably, the decision is limited in the same way that AstraZeneca is limited – neither deal with the application of the new NOC Regulations which were brought into force on October 5, 2006. However, if affirmed on appeal, this decision will radically affect the number of patents that a generic must address to obtain a NOC and has implications for Regulatory Affairs (DIN notifications and the like), Marketing and Sales strategy (implementing product changes) and, obviously, for patent filing and prosecution.
If you have any questions regarding this decision and its potential implication to your patent portfolio and drug submissions, please contact Steven Mason at 416-601-7703.