Innovators’ growing use of the Patent Register is highlighted in the annual statistical report on the Patented Medicines (Notice of Compliance) Regulations and Data Protection issued by the Therapeutic Products Directorate (TPD) on July 14, 2017. This report includes data up to the end of fiscal year (FY) 2016/2017, which ended March 31, 2017.
As we reported, significant changes are coming to the Regulations and Patent Act in connection with the Comprehensive Economic and Trade Agreement (CETA) with the European Union. As a result, FY 2016/2017 is likely to be the last complete period of data under the existing scheme.
Statistics on the Patent Register and Patented Medicines (Notice of Compliance) Regulations
The growing use of the Patent Register and historically low rates of patent list rejection are contrasted by shrinking numbers of generic submissions addressing patents or involved in prohibition applications in this year’s figures from the TPD.
- Patent lists. More patent lists were added to the Patent Register in FY 2016/2017 than in any of the previous four periods. A total of 769 patent lists were added, including 430 patents that were not previously listed. The total number of patent lists received was similar to the last fiscal year, while there were fewer rejections.
- Patent register. As of March 31, 2017, there were 1,070 patents listed against 1,451 drug identification numbers (DINs) representing 583 drugs. Forty-six per cent of the drugs had only one patent listed against them, while an additional 47% had two to four patents listed.
- Prohibition proceedings.
- Generic submissions addressing patents. FY 2016/2017 saw the lowest number of submissions containing Form V and notices of allegation (NOAs) of any of the last five periods. The 126 Form Vs and 105 NOAs received are similar in number to FY 2014/2015, but lower than FY 2015/2016, which saw 200 Form Vs and 176 NOAs.
- Applications. Thirty-two prohibition applications were commenced in FY 2016/2017, up from 18 in the previous period; 14 prohibition applications were pending as of March 31, 2017. Over the last several periods, prohibition applications have taken much of the available 24 months but none have exceeded this time since FY 2012/2013.
Data protection under section C.08.004.1 of the Food and Drug Regulations continued to provide a means of protecting market exclusivity for innovative drugs with a minimum of litigation in FY 2016/2017.
- Human drugs. In FY 2016/2017, 31 human drugs were added to the Register of Innovative Drugs, nine with paediatric extensions. This trend is driven by a shrinking number of innovative pharmaceuticals (17); new biologics (12) and radiopharmaceuticals (2) are the highest that they have been in the past five periods.
- Veterinary drugs. One innovative veterinary drug was added to the Register in FY 2016/2017.
- Disputes. There were no judicial review applications concerning data protection in FY 2016/2017.
Submissions on IP Hold
Submissions on intellectual property (IP) Hold are those for which an NOC would be issuable, but for the operation of either the Regulations (“Patent Hold”) or data protection. The TPD reports these figures in the aggregate; it does not indicate what proportion of IP Holds are due to patents vs. data protection.
- Submissions previously on IP Hold. In FY 2016/2017, 201 submissions received notices of compliance (NOCs) following expiry of IP Hold. This number has increased in each of the last three periods and is the highest since at least FY 2012/2013.
- Time on IP Hold. For the 201 submissions that received NOCs in FY 2016/2017, the average length of the IP Hold was 271 days. This number has decreased in each of the last three periods and is the lowest since at least FY 2012/2013.
- Submissions remaining on IP Hold. As of March 31, 2017, 14 submissions were on IP Hold. While lower than the peak reached at the end of FY 2015/2016, when 29 submissions were on IP Hold, more submissions were on hold at the end of FY 2016/2017 than in five of the last nine periods.
The Therapeutic Products Directorate Statistical Report 2016/2017 for the Patented Medicines (Notice of Compliance) Regulations and Data Protection can be found here.