Mexico preparing IP protection law

Mexico’s Congress this week is voting an Industrial Innovation Protection Law, which includes a Bolar clause to allow the development of generic and biosimilar medicines before an originator’s patent expires. According to the current draft, generics and biosimilars would get 3-year and 8-year periods before patent expiry respectively.

The bill comes as part of the modernized version of the North American Free Trade Agreement (NAFTA), which is expected to come into effect on July 1. Although it was announced last year that the agreement would drop clinical data protection norms, it was later noted that it would still promote intellectual property (IP) protection, and that Mexico would implement an Industrial Innovation Protection Law to comply to these provisions.

However, the Mexican Association of Pharmaceutical Laboratories (AMELAF) warned that the current version of the law allows secondary patents, which can delay the entry of generics by extending IP protection periods.

Revised NAFTA has been named the Mexico-United States-Canada Agreement (T-MEC) in Mexico, United States-Mexico-Canada Agreement (USMCA) in the US, and Canada-United States-Mexico Agreement (CUSMA) in Canada.


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