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Inside Internal Controls

News and discussion on implementing risk management

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pharmaceutical industry

The Quebec Court of Appeal renders a landmark decision regarding prescription drug manufacturers’ duty to warn

In a judgment rendered on May 8, 2019, the Quebec Court of Appeal[1] upheld a Superior Court decision[2] dismissing a class action in which the plaintiffs alleged that a manufacturer failed to provide sufficient information as to the risks of a prescription drug. This was the first time that the Court of Appeal considered the merits of a class action regarding a drug manufacturer’s duty to warn.

 

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Benefits of industry group intervention in the Federal Court of Canada

The Federal Court is tasked with hearing a wide variety of judicial review applications that can have a substantial impact on Canadian industry and technology sectors.

 

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Federal Court releases new guidelines for actions under the amended PMNOC Regulations

On September 21, 2017, the Federal Court released the Guidelines for Actions under the Amended PMNOC Regulations (the “Guidelines”) to coincide with the coming-into-force of the amended PMNOC Regulations (“PMNOC Regulations”).

 

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Significant changes to the Canadian patent system

Changes are coming swiftly, as the federal government moves to implement the Comprehensive Economic and Trade Agreement just days after it was signed by Prime Minister Trudeau in Brussels at the end of October 2016. These changes will significantly impact biologic/pharma patents in two major ways.

 

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