Following the signing of the Comprehensive Economic and Trade Agreement (CETA) with the European Union, the Government of Canada has amended Canada's pharmaceutical drug linkage regulations, the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations), which link the drug regulatory approval system to the patent system. The PMNOC Regulations are comparable to the Hatch-Waxman Act in the United States.
In Canada, to gain authorisation for a new innovative drug, an innovator submits to Health Canada a New Drug Submission (NDS) setting out data establishing the safety and efficacy of the drug. Upon regulatory approval by Health Canada, a Notice of Compliance (NOC) is issued authorising the drug for sale. Relevant patents pertaining to the innovative drug are eligible to be listed on a public Patent Register and are entitled to protection under the PMNOC Regulations.
A generic manufacturer that files an Abbreviated New Drug Submission ("ANDS") with Health Canada seeking approval of a generic version of an innovative drug must successfully address each relevant patent listed on the Patent Register before an NOC will be granted for the generic version. The generic manufacturer may, for example, serve a Notice of Allegation (NOA) alleging non-infringement and/or invalidity of listed patents, triggering proceedings under the PMNOC Regulations.
The amended PMNOC Regulations apply to all submissions for which an NOA is served on or after September 21 2017. At a high level, the previously existing summary proceedings have now been replaced by a full right of action, with accompanying procedural guarantees and discovery obligations, ending dual litigation. The amendments alter the regime that has governed pharmaceutical patent litigation in Canada for nearly 25 years.
The PMNOC Regulations previously provided a summary procedure in which allegations of patent infringement and invalidity could be decided. Parties, however, remained free to challenge or assert the same patent as between the same parties and for the same drug in a separate action under the Canadian Patent Act. Dual litigation was thus possible for the same patent and drug, leading to potentially inconsistent results. The summary proceedings, heard on a written record, have now been replaced with a full right of action involving up-front disclosure and discovery, and concluding in a trial.
Under the amended PMNOC Regulations, the only opportunity for an innovator to sue on patents addressed in an NOA is within 45 days of receipt of the NOA. No other action may be brought for infringement of any patent that is the subject of the NOA, unless the innovator did not have a reasonable basis for bringing the action at the time. There is also now the ability for an innovator to sue on patents beyond those listed on the Patent Register, on the basis of information received in the NOA.
Additional notable developments in the pharmaceutical patent-regulatory interface flowing from CETA include the introduction of Certificates of Supplementary Protection (CSPs), which have been implemented to compensate innovators for lost patent term due to regulatory delays.
Tamara O’Connell |
Smart & Biggar/ Fetherstonhaugh55 Metcalfe Street Suite 900PO Box 2999 Station DOttawa ON K1P 5Y6Tel: 613 232 2486Fax: 613 232 8440 ottawa@smart-biggar.cawww.smart-biggar.ca
