Product Specificity

September 15, 2015

FCA Rejects “Exact Matching” Requirement in PM(NOC) Regulations

Eli Lilly Canada Inc v Canada (Attorney General), 2015 FCA 166 - The FCA rejected the notion adopted by the Federal Court that a higher level of specificity is required to adhere to the Regulations than is required for an element to be claimed as a matter of claim construction, bringing the law in line with Industry Canada proposed amendments.
May 21, 2015

FCA Upholds Gilead Product Specificity Requirement

ViiV Healthcare ULC v Teva Canada Limited, 2015 FCA 93 - The FCA confirmed that paragraph 4(2)(a) of the Patented Medicines (Notice of Compliance Regulations) requires that a patent listed on the register requires an “exacting threshold of specificity” between what is claimed in the patent and what has been approved in the Notice of Compliance. However, proposed amendments to the PM(NOC) Regulations would reverse this holding.
May 20, 2015

PM(NOC) Amendments to Reverse Gilead and Viiv Decisions Regarding Product Specificity Requirement for Combination Drugs

The proposed amendments would dispose of the product specificity requirement that was interpreted by the Federal Court of Appeal in paragraphs 4(2)(a) and 4(2)(b) of the PM(NOC) Regulations.
February 25, 2015

Federal Court Upholds Gap between Claim Construction and PM(NOC) Product Specificity Requirement for Combination Drugs

Eli Lilly Canada v Canada (Attorney General), 2014 FC 152 - This decision clearly states that a higher level of specificity is required to adhere to the Regulations than is required for an element to be claimed as a matter of claim construction.
December 22, 2014

Industry Canada to Amend PM(NOC) Regulations Respecting Patents Listed for Combination Drugs

The proposed amendments are said to clarify the patent listing requirements as they relate to single medicinal ingredients found in combination drugs and confirm Health Canada’s established practices which, in light of recent Federal Court and Federal Court of Appeal decisions, may need to change.