Certainly. Thank you for the question. There are others from the industry here, I think, who can also speak to direct experience of how those things operate in practice, those linkage regulations.
The existing notice of compliance regulations under the Food and Drugs Act allow for an originator pharmaceutical company to file what's called a notice of allegation, alleging that a generic manufacturer that is seeking marketing approval of its generic equivalent version of an originator drug will infringe its patent. The automatic effect of filing that notice of allegation is that an injunction is issued against the federal health minister preventing the health minister from giving marketing approval to that generic product for up to 24 months. So merely by filing an allegation, you can buy yourself up to two years of additional market monopoly as an originator manufacturer.
You may lose, at the end of the day, with your claim that your patent would be infringed, but of course during that time, you've made a significant amount of extra money, so there's obviously an incentive to game the system. That system is one that Canada and the U.S. have, but to the best of my knowledge, no other industrialized countries have. It's the system that the Supreme Court of Canada has described as draconian; that is the Supreme Court's word, not mine.
There's a good example of how we're basically making the health regulator, Health Canada, which is supposed to be looking at the quality, safety, and efficacy of medicines, into patent police. We're using one system to try to enforce claims of patent validity, which are sometimes in the end shown to be overbroad. There is an example of regulatory chill that already exists in our current legislation. It's the sort of thing that a number of other TPP countries would now have to introduce under the TPP, which is not particularly helpful. TPP would help to lock in that kind of mechanism.