Feds make changes to drug patent legislation

The federal government has introduced changes to the regulations governing patented medicines that is says will strengthen the economy "by restoring certainty, predictability and balance to Canada's intellectual property framework for pharmaceuticals and biopharmaceuticals". Effective October 5/06, the changes to Health Canada regulations extend the period of market exclusivity for new and innovative drugs from five-to-eight years and an additional six months of market exclusivity for drugs that are the subject of pediatric clinical trials. The changes also affect Industry Canada regulations, restoring their "original policy intent" to allow lower-cost, generic versions of innovative drugs to enter the market "immediately following the expiry of relevant patents". Rx&D, the industry association representing Canada's patent-holding pharmaceutical firms, welcomed the changes but expressed concern that "incremental innovation will no longer be fully respected and recognized". The Canadian Generic Pharmaceutical Association (CGPA) countered that the changes will drive up the cost of prescription drugs by as much as $600 million over five years. The CGPA says the legislation limiting incremental changes to drug patents (evergreening) are long overdue and "merely codify a Supreme Court decision" that had already prohibited the practice....