Changes to the Patent Act, Patent Rules, Patented Medicines (Notice of Compliance) Regulations and the Trade-marks Act, and new Certificate of Supplemental Protection Regulations come into force on September 21, 2017 as part of Canada’s implementation of CETA. Today, Health Canada released guidance documents on applying for Certificates of Supplementary Protection and on Health Canada’s administration of the PM(NOC) Regulations.
Proposed amendments to overhaul the patent linkage regime and add certificates of supplementary protection were published today in the Canada Gazette, Part 1. Amendments to the Patented Medicines (Notice of Compliance) Regulations will replace the current summary procedures with full actions including rights of appeal. New Certificate of Supplementary Regulations are proposed to provide for up to two years of additional exclusivity based on the time to obtain a notice of compliance for a drug containing a new medicinal ingredient or combination of medicinal ingredients. A number of other proposed regulatory amendments relating to CETA were also published. There is a 15-day consultation period.
Two IP related amendments are included in the July 1st Canada Gazette:
- As noted last week, changes to the PM(NOC) Regulations relating to patent listing of combination products have been made and the Canada Gazette publication includes the amendment, regulatory impact analysis, and responses to submissions made during the consultation period.
- Also published are changes to Schedule 1 to the Patent Act to add three patented HIV/AIDS treatments pursuant to Canada’s Access to Medicines Regime.
Amendments to the PM(NOC) Regulations relating to the listing of patents against combination drugs have been made. The amending regulations, substantially in the form published in May, were registered last week and will be formally published on July 1st in the Canada Gazette.
Proposed amendments to the PM(NOC) Regulations have been published in the Canada Gazette Part I, relating to the listing of patents claiming single medicinal ingredients found in combination drugs. The government indicated its plans to make these amendments in the fall of 2014, following Court decisions in Gilead and Viiv.
Yesterday, the Supreme Court of Canada issued an oral judgment at the hearing of Sanofi’s appeal in the ramipril Section 8 proceeding, dismissing the appeal with costs.
India’s highest court has ruled that the beta crystalline form of Imatinib Mesylate (Gleevec/Glivec) is not inventive because of features found in the known alpha crystalline form. The judgment includes a discussion of changes to patent legislation, the Indian pharmaceutical industry and compliance with TRIPs.
The Therapeutic Products Directorate of Health Canada has published an updated screening criteria for processing ANDS and SANDS pre-market submissions to replace the Integrated Review Process along with an attestation checklist required for submissions made after February 1, 2013.
Eli Lilly has filed a “Notice of Intent” to challenge the ‘promise doctrine’ in Canadian patent law through NAFTA. The focus of the statement is on the law of the ‘promise’ of a patent in determining patent validity whether it complies with Canada’s obligations under TRIPs and NAFTA.