Proactive Pharma Patent Enforcement On Canadian Drug Combos

Canada is taking steps to improve drug patent owners' ability to enforce their patents.

Proactive Patent Enforcement - the NOC Regulations

The Canadian Patented Medicine (Notice of Compliance) Regulations ("NOC Regulations") allow a patent owner to apply to Federal Court to keep a generic company's potentially infringing medicine off the market before the generic company receives Health Canada approval to sell its medicine. Health Canada is the Canadian counterpart to the US FDA. The Health Canada approval for a brand name company or generic company to sell a medicine is called an NOC. Prior to the NOC Regulations, the patent owner often had to chase the generic company after the medicine was already on the market. Since interlocutory injunctions are difficult to obtain and it takes a long time to bring a patent infringement case through to trial, there are significant benefits to a patent owner in keeping a generic company from entering the market.