Draft Guidance Document: Patented Medicines (Notice of Compliance) Regulations

On January 23, 2007, the Minister of Health published a Draft Guidance Document (Guidance Document) on the Patented Medicines (Notice of Compliance) Regulations. When finalized, it will provide assistance to industry and health care professionals on how to comply with governing statutes and regulations, but will not have the force of law. The contents were developed in order to clarify the amendments to the Patented Medicine (Notice of Compliance) Regulations published in the Canada Gazette II on October 18, 2006. As is stated in the Guidance Document, the pharmaceutical patent policy objective is to "balance the effective patent enforcement over new and innovative drugs with the timely entry of their lower priced generic competitors" and to "provide the balance through a patent enforcement mechanism to ensure that the early working exception is not abused and that copy-cat drugs are not sold before the relevant patent expiry". Section 3 gives some guidance on the responsibilities of first and second persons and of the Office of Patented Medicine Liaison regarding patent eligibility and listing of patents on the Patent Register, the filing of Form Vs and Notices of Allegation. Section 4 provides a framework for on-going maintenance of the Patent Register, through which complaints about patents improperly listed on the Register may be processed. The Guidance Document is not intended to apply to patents listed on the Patent Register before June 17, 2006, but to all second person generic submissions, including those filed prior to the coming into force of the amendments on October 5, 2006. Comments on the Guidance Document are to be provided to the Office of Patented Medicines and Liaison by March 27, 2007. For the full text of the Draft Guidance Document, see: http://tinyurl.com/2u8mqg Summary by: Heather Watts