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MEXICO: LIFE-CYCLE INSIGHTS 

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IPD’s Mexican subscription offers transparency and improved

forecasting to this highly complex market, featuring:

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  • Easy-to-use Mexican brand, biosimilar, 

       and generic launch tracking schedules

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  • Mexican litigation tracking and

       in-the-courtroom coverage with

       real-time updates

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  • Personalized consults with local Mexican intellectual property analysts ​

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  • Weekly updates including trending Mexican drug topics, recent publications, and

       loss-of-exclusivity information
 

  • Comprehensive Mexican clinical development tracking in every major disease class
     

  • Complete drug information with locally reviewed Mexican indications

World Map Highlighting Mexican Litigation Coverage

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"Can you give us a brief overview on how Mexico is unique?

 

...First, it is very hard to find cases. Third parties have limited or practically no access to case files, and publicly available information about cases, most of the time, is too limited or moot. You need to monitor cases in courts, or you will miss vital information. Our staff spends many hours every week searching for new cases. Finding c ases and connecting a decision to a drug, patent, or regulatory exclusivity is very challenging.

 

Second, Freedom of Information requests are key for regulatory exclusivities, pending generic or biosimilar applications. Because COFEPRIS, Mexico's drug regulatory agency, publishes almost no updated information of these applications on its website, our staff files strategically prepared Freedom of Information requests in order to monitor these applications and exclusivities.


Third, Mexico has numerous courts at every level, only in Mexico City, there are 16 District Courts and 23 Circuit Courts that can handle cases related to patents and regulatory exclusivities. However, all patent infringement and invalidity cases are heard at IMPI, Mexico's patent office."

Our International Legal Analysts discuss the ins and outs of the Mexican patent and regulatory system, including:

  • Key Differences Between the Patent and Regulatory Systems in the United States and Mexico

  • Drug Approval and Patent Linkage Systems

  • Mexico Drug and Regulatory Agency (COFEPRIS) and Mexico Patent Office (IMPI)

    • Challenges and Procedures

      • Brand Companies and Generic Drug Application (GDA) Filers

      • Competitor Defense at IMPI

    • Appeals and Absence of Juries

    • Reliance on Expert Opinions and Internal Reviews

    • Preliminary Injunctions

    • Patent Term Adjustments (PTAs) and Impact on Generic Competition

      • United States, Mexico, and Canada Agreement (USMCA)

      • Regulatory Exclusivity

    • Limited Public Access to Litigation, PTAs, and Regulatory Exclusivities

  • Key Takeaways

Listen to our podcast to learn more about the Mexican patent and regulatory system

Mexico Play
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