The agreement signed on February 19, 2025, between the Federal Commission for Protection against Health Risks (COFEPRIS) and the Mexican Patent and Trademarks Office (IMPI) is, finally, an important step in formalizing technical cooperation that seeks to streamline the process of marketing authorization for pharmaceutical products, while ensuring that patents for inventions related to pharmaceutical products are respected. It also seeks to ensure that generic and biocomparable medicines, essential for access to health, are accessible to Mexican consumers.

However, this update also faces several challenges for the industry, which go beyond technical implementation and coordination among the authorities involved.

Objectives: transparency and protection of Intellectual Property

The agreement formally establishes the consolidation of a biannual list of patents in force related to allopathic and biotechnological drugs that includes data such as the generic name of the drug, chemical name, patent, term, holder, registered licenses, if any, and category of protection, among others. This list will be published by IMPI and will allow COFEPRIS to quickly identify whether an application for marketing authorization for a pharmaceutical product could infringe patent rights.

In this way, the process of evaluating and approving applications for marketing authorization  would theoretically be expedited, which would facilitate access to new treatments.

In addition, the agreement represents the regulatory trend adopted by Mexico in relation to the provisions of the United States-Mexico-Canada Treaty (T-MEC), which establishes the mechanisms for patent notification and protects the rights of patent holders against the commercialization of drugs that could be covered by patents.

Challenges for the pharmaceutical industry

Although this agreement has many advantages, it also presents several challenges that the pharmaceutical industry operating in Mexico must face:

1- Complexity in patent management or monitoring. The process of verifying the validity and enforceability of pharmaceutical patents can be complex and demand a high level of technical expertise. Pharmaceutical companies, especially small and medium-sized ones, may face difficulties in keeping up to date with patent listing updates and managing their marketing authorization applications efficiently. The obligation to thoroughly review published information may require the hiring of intellectual property and regulatory services experts.

2- Access to medicines and the price of generics. One of the key objectives of this agreement is to facilitate consumer access to cheaper generic products. However, public health policies face a real challenge in balancing intellectual property rights and innovation on the one hand, and access to affordable medications on the other.

3- Patent assessment and dispute. Although the agreement provides for a more efficient patent identification system, companies could face disputes over whether or not a drug infringes a patent. Lack of clear information or ambiguous interpretation of technical requirements can lead to disputes that delay the approval of new pharmaceutical products or incur additional litigation costs.

Despite the aforementioned challenges, this agreement also puts Mexico in a more competitive position in the global health market, thanks to the transparency and efficiency in the process of applications for marketing authorization for pharmaceutical products and patent surveillance, which represents opportunities for the pharmaceutical industry with operations in the country.

In this sense, the technical collaboration agreement signed between COFEPRIS and IMPI represents an important step forward in the formalization of the regulation of the Mexican pharmaceutical sector, with key implications for the protection of intellectual property and access to medicines. While it presents certain operational challenges for the industry in terms of patent monitoring, it also offers important opportunities to strengthen transparency in regulatory processes and an approach to compliance with Mexico’s international obligations.