The Pest Management Regulatory Agency’s generic registration proposal provides balance between the rights of chemical developers and the generic companies that follow them to market, says an organization that represents both groups.
“We do a lot of internal fighting before we come out with an external position and this proposal matched that pretty closely,” said Peter MacLeod, executive director of CropLife Canada.
He noted the PMRA proposal provides patent holders with the potential to extend the exclusivity period for their products through minor use applications for up to five years, which is two years longer than companies have in the United States.
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MacLeod said that was a necessary concession because otherwise there is little incentive for companies to invest in products for minor use crops like pulses, fruits and vegetables. The provision will mainly pertain to insecticides and fungicides, which are the types of products that tend to have minor use applications.
“It’s going to be very difficult for registrants in Canada to get additional exclusive use for herbicides,” said MacLeod.
In the second phase of product protection, Canadian registrants will have 12 years of compensable data protection compared to 15 years in the U.S.
During that phase, generic competition is allowed but only if the patent holder is adequately compensated for releasing the data required by the PMRA to have the generic recognized as a pesticide. Companies typically spend up to 10 years and $300 million bringing a product to market, a process that can involve up to 160 tests.
“That data has tremendous value,” said MacLeod.
PMRA has proposed a period of negotiation and arbitration before generics can be brought to market to settle the data compensation issue. In the U.S. the generics are allowed to hit the market as soon as an offer is tabled.
Critics say the PMRA proposal will lead to lengthy delays, meaning U.S. farmers will continue to have access to cheaper products long before their Canadian counterparts.
But MacLeod said that system is preferable to one in which the two parties could be tied up in costly legal battles.
“In our Canadian society we like to do things with negotiations and I’m sure that’s what the PMRA had in mind when they put this in their proposal.”
He noted that the agency has suggested a 90 day negotiation period followed by a 90 day arbitration period if required. If both were maxed out that would be 180 days, which MacLeod doesn’t consider a lengthy delay.
“That’s not even a growing season,” he said.
After the 12 years are up, generic companies will be able to come on the market quickly and cheaply without any data compensation fees.
MacLeod said when you add up the protection offered by the two systems, it is essentially the same.
“Canada has offered additional exclusive protection on the front end and the U.S. has a greater degree of protection on the back end,” he said.
The comment period on the proposed generic registration rules has closed. PMRA will make any changes it feels are necessary and is expected to implement the new policy in July.
