One month after being published and before the new Federal Law for the Protection of Industrial Property (new IP Law) enters into force; the Lower Chamber of Representative, recently published two proposals to reform the law and limit the scope of the patent linkage system, as follows:

  • Expressly ban the granting of use patents/claims.
  • The publication of the linkage gazette must be a list of patents for reference medicines provided by the Mexican regulatory agency (COFEPRIS).
  • The way of communication between COFEPRIS and the Patent Office (IMPI) will be through a gazette issued by COFEPRIS in which it will include an active ingredient patent for each reference medicine.
  • It expressly establishes that health authorizations should not be denied when there are formulation or use patents.

In general, the initiatives contradicts the provisions of Article 28 of the Constitution and various articles of the Industrial Property Law. Likewise, the initiative contradicts the patent system itself, as well as the USMCA which is already in force.

We consider that the proposal has low chances to be approved as presented, however, it could be considered the most recent and new pressure by those against the rule of law, as it has occurred the last 15 years through the various attempts to limit the patent linkage system, but now under the scenario of the expected regulations of the law due by-December of this year, approximately. The battle to have influence in the regulation of the law in connection to patent linkage, already started.

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