Canada 'out of step on (drug) data protection'

A recent ruling by the Canadian Federal Court against Bayer, shows thatCanada is out of step with data protection in Europe and the USA, according to intellectual property layer Patrick Kierans, writing in The Lawyers Weekly. He says that the Federal Court has interpreted the North American Free Trade Agreement in a manner inconsistent with the protection of the investment made by innovators in carrying out clinical trials on new drugs.

If the decision (which is being appealed) is correct, then he says that Canada may be in contravention of its obligations under NAFTA and the data protection provisions of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights

The decision in the case of Bayer Inc versus Ministry of Health, where the company took action against the Minister seeking an order prohibiting him from issuing a Notice of Compliance to a generic manufacturer filing an Abbreviated New Drug Submission within five years of the original approval of the Bayer drug in question, has denied pharmaceutical innovators protection in Canada for their investment in confidential clinical trial data, says Mr Kierans. That investment, he notes, is internationally recognized and protected by the NAFTA and WTO/TRIPS.