Twelve countries, including Canada, have agreed to the Trans-Pacific Partnership. No text has been released yet but reports are that protection of biologics was one of the final sticking points. The government has posted a high level summary on the IP issues in the agreement.
The TPP is generally a comprehensive trade agreement involving Canada, Australia, Brunei, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, US and Vietnam. Some of the contentious areas for Canada include diary, auto parts, investor-state dispute resolution.
The government’s summary on intellectual property (link) touches on copyright, enforcement, trademarks, industrial designs and patents and suggests that in most areas, Canada’s system already meets the requirements or the requirements are similar to those of CETA. For example, for pharmaceuticals, the summary states:
- Reflects Canada’s existing regimes, systems and laws on:
- Patent linkage;
- Protection for clinical trial data; and
- Early working exceptions.
- In line with outcomes secured in the Canada-EU Comprehensive Trade and Economic Agreement (CETA), Canada has retained the scope to meet its TPP obligations for patent term restoration for regulatory approval delays with a sui generis system. The TPP provision will have the necessary flexibility to allow Canada to retain its export exception and two year cap on additional protection.
- The TPP includes a strong regulatory review exception, reflecting Canada’s existing regime with respect to the availability of an early working exception. This will help ensure that generic drugs can continue to be introduced as soon as is practicable after the expiry of a patent across the region, as is the case now.
- As with other areas in the TPP, Parties have retained the flexibility to determine the best means of implementing the patent linkage obligations within their domestic regimes. Canada’s existing linkage regime is TPP compliant.
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