combination drugs

August 2, 2016

FC Denies Data Protection for Ester of a Previously Approved Medicinal Ingredient

2015 FC 959 - The Health Minister denied data protection for Cysview after finding it was not an “innovative drug”, and the FC indicated the scope of “innovative drug” does not extend to combinations of the enumerated variations of previously approved medicinal ingredients in the Regulations (salt, ester, enantiomer, solvate or polymorph).
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.