Generic drug maker suit against federal government reaches trial stage

From the Canadian Press:
Federal regulations that bar Canada's generic drug makers from copying brand-name products for eight years after patents expire will come under the judicial microscope Tuesday as a two-year-old lawsuit reaches Federal Court.

The generic drug makers want the court to set aside rules that they argue cost consumers $115 million in extra drug costs every year.

The regulations, implemented in 2006 under the Food and Drugs Act, were designed to protect the extensive and expensive data that manufacturers need to seek approval for a drug. The data include the results of studies and clinical trials.

The rules prohibit Health Canada from licensing a generic version - generally cheaper than the brand-name equivalent - until after the eight-year period for those drugs where patent protections have lapsed. ...more