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:
- An applicant for an innovative drug must post a copy of the patent covering the active ingredient of the medicine to be approved with the Mexican Regulatory Agency (COFEPRIS) and prove that the applicant is the owner or licensee of said patent.
- COFEPRIS will integrate and publish a list of approved innovative products, citing only one patent per product covering the active ingredient and its expiration date.
- Only one patent can be listed per each innovative chemical synthesis drug.
- If the patent is granted after the authorization of the innovative drug, it should be included in the list issued by COFEPRIS no later than a term of one month after issuance of the patent.
- The generic applicant must include a statement under oath that the sanitary registration of a generic medicine does not infringe the active ingredient patent rights along with a corresponding analysis of why it does not infringe.
- The generic applicant can request that generic registration is granted immediately after the expiration of the active ingredient patent term related with the innovative drug.
- The information provided by the applicant for a generic marketing authorization to COFEPRIS should be sent to the Mexican Patent Office (IMPI) for an analysis limited to the active ingredient patent related to the product; IMPI should provide a response to COFEPRIS within a term of 10 working days. If IMPI does not respond within that time period, the generic application is assumed to have a green light to proceed, and COFEPRIS can authorize the generic product.
- Patents for biologics will not be considered.
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.