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.
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.
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.
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.