Revised NOC Regulations to Come Into Force on September 21, 2017

The Government of Canada has announced that the amended NOC regulations will come into force on September 21, 2017. These amendments will implement sweeping changes to pharmaceutical patent litigation in Canada pursuant to obligations imposed under CETA. The changes will apply to proceedings commenced in respect of NOAs served on or after September 21, 2017.

The final text of the amended NOC Regulations does not differ from the initial draft published on July 15, 2017, as summarized by our previous blog here.

In the accompanying Regulatory Analysis Impact Statement, the Government explained why it decided against making any further changes in response to the following concerns raised during the public consultation period:

  1. No extension to 24-month bar on NOC issuance – The Government believes that the new procedural rules and the Court’s ongoing efforts to streamline matters will lead to the timely resolution of patent actions. In addition, since mootness is no longer an issue, the Government points out that if an NOC issues prior to a decision being rendered, the innovator can seek damages against a generic for any infringement.
  2. No consensual extension of the 24-month bar on NOC issuance – The Government believes that consensual extensions are unnecessary since mootness issues will not arise under the new regime. The Government also hopes that an inability to seek extension will incentivize the parties to prosecute matters more quickly.
  3. No section 8 liability if Order overturned on appeal – The Government makes clear that any trial Order that is set aside or vacated on appeal will be deemed to not exist as a matter of law. This means that an innovator who is fully successful on appeal will not attract section 8 liability.
  4. Language of section 8 to be kept broad – In response to concerns that section 8 results in overcompensation and undercompensation, the Government believes that the language of section 8 provides parties with broad flexibility to make submissions on remedies. The Government defers to the Federal Court’s expertise to craft appropriate remedies.

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litigation NOC Regulations patent patent litigation Patented Medicines (Notice of Compliance) Regulations pharmaceutical PM(NOC) Regulations

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