Guidance document : Patented Medicines (Notice of Compliance) Regulations. : H13-9/11-2018E-PDF

"The early working exception of subsection 55.2(1) of the Patent Act allows a subsequent manufacturer to use a patented invention for the purpose of seeking regulatory approval of that product. The provision, therefore, provides an exception from infringement. The Patented Medicines (Notice of Compliance) Regulations (PM(NOC) Regulations) provide the balance, through a patent enforcement mechanism, to ensure that the early working exception is not abused by linking the regulatory approval of a generic drug to the patent status of the innovative product. This guidance document provides information regarding the administration of the PM(NOC) Regulations by the Office of Patented Medicines and Liaison (OPML) within the Office of Submissions and Intellectual Property (OSIP), Therapeutic Products Directorate (TPD), Health Canada. It is applicable to drugs that receive a notice of compliance (NOC), including pharmaceutical, biological, radiopharmaceutical and veterinary drugs"--Introd., p. 7.

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