Generic drug makers want court to quash new brand-name protection rules

The organization that speaks for the manufacturers of originating prescription drugs in Canada said the European Union protects brand names for 10 years.

"We believe that eight years data protection, as adopted in the regulations, is a tool for our research-based pharmaceutical community in its efforts to attract international R&D investments and jobs here at home," said Jacques Lefebvre, spokesman for Canada's Research-Based Pharmaceutical Companies.

In Ottawa, Health Canada spokesman Alastair Sinclair said the court filing was still being assessed.

The regulations, under the Food and Drugs Act, are designed to protect the extensive and expensive data a manufacturer needs to amass in seeking approval for a drug, including the results of studies and clinical trials related to its development.

They are separate and distinct from patent protections, which prevent generic companies from copying a brand-name drug for 20 years. But patent protections are not infallible; they eventually expire and can also be challenged in court, Keon said.

Health Canada said the regulations could affect up to one-quarter of brand-name products with expired, invalid or no patents.

Initially, brand-name drugs were given five years of data protection in 1995 as part of the North American Free Trade Agreement.

However, under changes made Oct. 18, the time frame was extended to eight years - 81/2 years for pediatric drugs - from the moment Health Canada approves a drug.

The federal government said the changes were designed to clarify the rules and cut litigation costs.

Generics are typically half the cost or less than the original and estimates are that about 44 per cent of prescriptions in Canada are filled with generic equivalents to brand-name drugs, the association said.

In its application for a judicial review of the new rules, the association argues that the timing of a generic product going to market has a key impact on drug costs across the country.

"The ability of generic manufacturers to get marketing approval for generic drugs plays a fundamental role in controlling drug expenditures in Canada," the court document states.

"Three years (of extra protection), on a number of products, can be very, very expensive," said Keon.

"If we're not on the market, the only alternative (consumers) have if they're given that prescription is to buy that more expensive brand-name product."

Ontario Health Minister George Smitherman said he'll be watching the case closely, given that the province spends about $3.5 billion a year on prescription drugs.

"Generic product is one of those strategies we deploy most proactively to try and help address our costs," Smitherman said.

"If there are delays in bringing generic product to market, then that has considerable impact for public health-care systems and for private insurance programs."

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