CANADIAN GENERICS MAKERS TARGET NEW EXCLUSIVITY REGULATIONS

Canada's leading generic drug manufacturers have condemned new proposals that would extend data exclusivity for pharmaceuticals to eight years. Modernising Canada's so-called NOC regulations could bring the country into line with data-protection laws in the US and the European Union (EU), but generics makers have threatened to relocate to "other jurisdictions" if the plans go ahead.

According to the generics industry, the new measures -- which would also add a further six months' exclusivity in light of new paediatric indications -- could extend Canadian protection beyond comparable terms in the US. A survey found that 19 generics launched since 2000 would have been kept off the market for longer under the plans, costing the national healthcare system a further CAD581mn (US$499mn).

At present, data exclusivity is just five years in Canada, with patents protected for 20 years upon approval. However, the new regulation could push the average period of market exclusivity in Canada from 13.8 years to 15.2 years -- or roughly four years longer than the US average.

Canadian officials deny this, noting that US legislation allows for five years of data exclusivity, with a further three allowed in the event of "improvements" following new clinical trials. Under the EU's so-called "8+2+1" legislation, protection can last as long as 11 years, although Europe has no equivalent of US-style automatic stays on generic production while courts consider alleged patent violations.

Meanwhile, Canadian government sources claim that the new rules would see data exclusivity and patent protection run concurrently in the majority of cases. However, this is unlikely to satisfy the country's vibrant generics industry, which believes that original manufacturers will continue to use "evergreening" practices to extend patent life. Generics trade groups are now lobbying to "freeze" the country's patent list at the time of each generic submission, and have demanded that the data exclusivity term be set at the NAFTA- and TRIPS-compliant threshold of five years.