Ottawa proposing changes to pharma patent legislation

The federal government has proposed changes to regulations for the pharmaceutical regulatory environment and has launched a 75-day consultation period. The proposed changes are designed to address key concerns of both the so-called innovative and generic drug manufacturing industries. But they don’t appear to satisfy either group nor reduce the level of animosity between them.

The first proposal would restore the original intent to the Patented Medicines Notice of Compliance Regulations (PMNOC) and stop the practice of so-called evergreening — making small changes to drug formulations or delivery mechanisms to extend the period of exclusivity. The original intent of PMNOC when it was introduced in 1993 was to allow firms to recoup the costs of R&D.

The second proposed change extends the period of data protection for trade secrets submitted to regulatory authorities by firms seeking approvals for new active substances. The extension would bring Canada in line with competing jurisdictions.

Canada’s Research-Based Pharmaceutical Companies (Rx&D) had little to say about the proposed changes except that it would be “reviewing the full impact of the amendments”, adding that evergreening only occurs in “exceptional circumstances”.

The Canadian Generic Pharmaceutical Association (CGPA) welcomed the government’s proposal for PMNOC stating that it was “pleased that the federal government has finally recognized that brand companies are abusing Canada’s drug patent laws”. CGPA added that the changes do not remove the incentive for brand companies to initiate litigation against generic firms. The changes provide for a 24-month ban on a generic drug from entering the market if a patent holding firm disagrees that a generic firm’s product should be allowed market entry.

CGPA opposes the extension of data protection, saying it puts its member firms at a disadvantage compared to their US counterparts. Data protection was introduced in 1995, bringing Canada into compliance with World Trade Organization agreements on intellectual property rights and the North American Free Trade Agreement.

All parties have until February 25, 2005 to submit their comments.

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