Overview
Officials with Mexico’s patent office and its pharmaceutical regulator have signed a new agreement aimed at preemptively clarifying patent protections for drugs in hopes of speeding the review process.
Introduction
The Federal Commission for Protection Against Health Risks (COFEPRIS) announced the agreement on February, calling it a key step in improving transparency and coordination between the institutions and a move that would help drug and device makers as well as assure steadier supplies of generics in local markets.
Under Mexico’s current system, in place since 2003, pharmaceutical patents are not linked to specific products but to active ingredients. It can be difficult for companies to identify which patents may apply to a particular product under review, leading companies to contract law firms for extensive outside analyses that can drag out the approval process.
New Rule
The new rule was developed under a framework established by the United States-Mexico-Canada Agreement, a free-trade pact in force since 2020. It establishes more detailed reporting requirements from COFEPRIS and from Mexico’s patent and trademark office (IMPI) that may reduce the need for outside research and analysis.
For every product under review, COFEPRIS will provide the patent office with information on its pharmacology, therapeutic indications, and mode of use, and whether any party has contested its registration. IMPI will publish more detailed information on product IP and will supply COFEPRIS with extensive information on its IP protections for each product under review, including on related patents, patent holders and licensees, and the type or category of patent protection.
Conclusion
Attorneys with Basham, a Mexico-City law firm, lauded the agreement as representing progress in IP protection for the pharmaceutical industry, saying it will enhance legal certainty and reduce bureaucratic hurdles. Industry experts also note that the streamlined patent verification process may accelerate market entry for new treatments while maintaining safeguards for intellectual property rights.
While some challenges remain, such as ensuring comprehensive enforcement and seamless inter-agency cooperation, the agreement marks a significant step toward modernizing Mexico’s pharmaceutical patent landscape. By aligning its regulatory framework more closely with international standards, Mexico is positioning itself as a more attractive market for pharmaceutical innovation and investment.
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References
Learn more about Mexico Patent. For the link, click here
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Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
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