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The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and the Mexican Institute of Industrial Property (IMPI) begin coordinated work process to strengthen the generic drug industry

Dec 01, 2020

On November 16th, the IMPI Media Release 015/2020 was published, through which the following relevant information is disclosed:

  • The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and the Mexican Institute of Industrial Property (IMPI) began a coordinated work process to strengthen the generic drug industry, by eliminating existing bureaucratic barriers and the generation of an adequate competitive environment.
  • The development of this industry represents an advance in terms of public health, since it allows more people to have access to timely medical treatments. In addition to this, a high potential industry is being promoted that generates jobs and economic spillover.
  • Additionally, it will promote competition in the generic market, which will translate into savings for Mexican households and for the federal treasury.
  • Linkage mechanism: Modifications have been made to both the technical cooperation request form made by Cofepris, and the response issued by IMPI. Thus, now there is a precise query and a specific response that allows the health authority to have specific elements for analysis, which gives greater clarity and legal certainty to the registration procedure of a generic drug in a transparent environment.
  • Bolar Clause: The Federal Law for the Protection of Industrial Property expressly materialized the possibility that those interested in producing generic drugs could carry out studies, research and tests before the expiration of a patent, in order to obtain the registration sanitary.
  • In this way, the well-known “Bolar Clause” is formalized and put into practice, through which facilities will be provided to the generic drug industry so that it is prepared in a timely manner and is able to enter the market after the expiration of the patent correspondent.

In terms of transparency and access to information on current patents, the IMPI makes three new online tools available to the public, which from today will be available on the Institute’s portal

  1. The list of patents that will expire in the next 10 years.
  2. Agile search engine for patents associated with allopathic drugs.
  3. IMPI’s responses to COFEPRIS on patents.

Read full article (Spanish)