On July 14, 2017, Health Canada released the Therapeutic Products Directorate Statistical Report 2016/2017 for the Patented Medicines (Notice of Compliance) Regulations and Data Protection. The report compares annual statistics on Health Canada’s administration of the PMNOC Regulations and Data Protection Regulations. Annual statistics are compiled for the federal government’s fiscal year, which runs from April 1 to March 31.
With significant changes to Canada’s patented medicines regime on the horizon (see our previously reported articles on these changes Curtain lifted on proposed amended PM(NOC) Regulations and Certificates of supplementary protection: Canada's new sui generis patent term restoration regime), the Report highlights an increase in the use of the patented medicines regime by innovator companies, and, at the same time, a decrease in the number of generic submissions challenging the patents listed on the Patent Register and medicines subject to data protection.
Key trends from this year’s report:
Increasing number of patents added to the Register
Under the PMNOC regime, patent lists are submitted in relation to drug submissions (NDS and SNDS). The Therapeutic Products Directorate (TPD) has seen an almost doubling of the number of patent lists added to the Register over the past five years. Not all patent lists are new patents added to the Register, as some relate to supplemental submissions, which may include patents already on the Register. However, the 2016/2017 fiscal year saw an increase to 430 newly listed patents over the previous four year average of 185.
Decreasing percentage of patent lists rejected for inclusion on the Register
Coupled with the increasing number of patent lists being submitted and added to the Register, the Report shows a decreasing percentage of patent lists being rejected by Health Canada. Indeed, while the number of patent lists submitted for inclusion on the Register has steadily increased over the past five years, the total number of rejections in the 2016/2017 fiscal year (74 out of 835 patent lists) was the lowest over the same time period.
Decreasing challenges by generics to patents listed on the Register
Interestingly, while the number of patents and patent lists being added to the Register is increasing, the number of generic challenges (Notices of Allegation, “NOA”) received by Health Canada in relation to generic drug submissions (ANDS) has decreased. Similarly, the number of prohibition applications commenced by innovators, and the number of prohibition applications commenced as a percentage of the number of NOAs sent by generics both show a downward trend.
Faster resolution of prohibition applications
The average resolution time for a prohibition application shows a decrease over the past five years. Because the time it takes for the resolution of a prohibition application is counted for the fiscal year in which it is started, the data of the two most recent years is not as meaningful. Nonetheless, the Report shows a decrease indicating that almost all prohibition applications are resolved well within the 24-month statutory stay period, where generics are kept on Intellectual Property Hold (IP Hold).
Steady rise of data protection for biologics
The most interesting trend under the data protection regime, is the steady rise of new biologic drugs which are subject to data protection. While the total number of new drugs added to the Register of Innovative Drugs (and thus subject to data protection) has been relatively stable over the past five years, the portion of biologics has increased.
Less time on IP Hold
Largely due to the faster resolution of Prohibition Applications, the amount of time generic drugs are kept on IP Hold shows a downward trend. IP Hold is the period during which a NOC is not issued for a generic drug submission because of the operation of the PMNOC Regulations or the Data Protection Regulations.
It is impossible to predict exactly how the pending changes to the PMNOC Regulations will impact these trends. Indeed, new trends may emerge as the new Regulations are put into practice. In any event, as the current trends demonstrate and the proposed changes to the Regulations contemplate, both innovator and generic companies should be ready for faster paced resolution of intellectual property disputes in relation to patented medicines in Canada.