Canadian Patent No. 2,098,738 is set to expire on November 25, 2012. This patent is likely unique in the history of Canadian patented medicines in that its expiry is not being hailed as a benefit to the Canadian public by providing for the entry of lower priced generic. Rather, the expiry of this particular patent is being met with grave concern. The reason is Canadian Patent No. 2,098,738 has prevented low cost generic OxyContin from flooding the Canadian market.
There have been numerous articles written by the mainstream press detailing the concerns (links to several are provided below).
OxyContin is a time-release formulation of the highly addictive and powerful pain killer, oxycodone that was voluntary taken off the market in Canada by Purdue Pharma Canada in view of drug abuse concerns. In the Canadian market, OxyContin was replaced by OxyNeo a formulation designed to be more difficult to abuse and misuse by those addicted to the drug. OxyNeo is itself a patented medicine.
Although the expiry of the OxyContin patent is being met with concern, OxyContin’s replacement by OxyNeo has not been without controversy. In particular, critics of OxyNeo have alleged that Purdue Pharma Canada’s move to replace OxyContin with OxyNeo has more to do with the loss of exclusivity in the market that will occur once the ‘738 patent expires and generics enter the market then it does with drug abuse concerns (see link below).
It will be interesting to see if market approval is given to generic OxyContin. Regardless of whether market approval is given to the generics, one can be certain that not everyone will be happy with the decision Health Canada makes.
http://www.cbc.ca/news/health/story/2012/11/07/pol-oxycontin-oxyneo-generics.html
http://www.ctvnews.ca/health/generic-oxycontin-would-be-tragedy-ont-health-minister-says-1.1036120
http://www.thestar.com/news/canada/article/1165664--critics-allege-oxyneo-was-introduced-in-canada-because-of-impending-patent-expiry
By Claire Palmer