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Unlike in the EU, Canada does not have additional pharma patent protection to compensate for regulatory delays, but that looks set to change, as Shirley Liang, an IP lawyer in Canada, explains.
To ensure for the public the safety and efficacy of drugs, such products are subjected to a rigorous and generally lengthy regulatory approval process before marketing authorisation (MA) is available. Furthermore, the extensive testing, including pre-clinical and clinical studies required to support a MA application may take a number of years.
At the same time, the term of patent protection is calculated from the application filing date regardless of when MA is granted for the corresponding pharmaceutical product. Therefore, by the time such a product actually comes to market, a number of effective years of patent protection have been ‘lost’.
Recognising the need to counteract this unique gap in patent protection with respect to pharmaceutical products, in the early 1990s the EU introduced supplementary protection certificates (SPCs).
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Shirley Liang, SPCs, Comprehensive Economic and Trade Agreement, TPP, Trans-Pacific Partnership, Canadian Intellectual Property, patent, patent protection,