After four years of negotiations, Canada and the European Union today signed a significant trade deal which includes elements directed towards intellectual property protection for life sciences patentees. While no text has yet been finalized, the two elements of particular interest for the life sciences industry are reported to include:
- addressing inequity under the Patented Medicines (Notice of Compliance) Regulations, under which patentees whose patents are challenged by generic companies do not have an equal right of appeal in litigation; and
- allowing a period of patent term restoration, up to two years, for patents whose duration has been eroded by time spent in regulatory review thereby resulting in a diminished patent term.
While the elements of the agreement have been announced, the agreement must undergo the approval processes required by the EU and its 28 Member States, as well as Canada’s provinces and territories.
Links to Press Releases Issued:
By Rx&D, the Trade Association for Innovative Pharmaceutical Manufacturers
