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April 22, 2019
Mexico’s Senate recently published in its official Gazette a proposal to modify the Mexican Health Law to reduce the scope of the linkage system with respect to certain pharmaceutical patents.
In summary, the proposal includes the following changes to the linkage system:
Generally, the Health Law proposal contradicts what is established in Article 28 of the Constitution and other articles of the Industrial Property Law, which recognize exclusive rights for all inventions, without creating exceptions for certain categories.
The proposal also disregards the jurisprudence of the Mexican Supreme Court, which, after many years of discrimination against formulation patents, ruled that formulation patents should be part of the patent linkage system. For more information on this decision, please see our newsletter of July, 2011, available here.
The legislative proposal also contradicts definitions provided by the Health Law itself and contradicts international treaties, such as the text of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership, which establishes a linkage system contemplating protection of patents for approved pharmaceutical products. It also would violate the U.S.-Mexico-Canada Agreement (USMCA), which calls for a linkage system without discrimination, including for patents covering pharmaceutical products.
OLIVARES will closely follow these developments and oppose the bill as presented, as it appears to be unconstitutional. We will stay apprised of any modifications to the proposal or suggestions that can be submitted during the legislative approval process.
This newsletter is intended only as a general discussion of the addressed issues and should not be regarded as legal advice.
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