As the pandemic situation caused by the COVID-19 virus advances in the world, the search for a vaccine will be a primary activity in which pharmaceutical scientists and laboratories will focus their efforts. This priority objective will not only have humanitarian and material effects, but also legal situations that shall be analyzed, since that invention could obtain legal protection under the figure of a patent.
In Mexico, article 25 of the Industrial Property Law establishes that the exclusive right of exploitation of a patented invention confers on its owner or the person authorized by it: a) the prerogative to prevent other people from manufacturing, using, sell, offer for sale or import the patented product, without your consent, if the subject matter of the patent is a product, and b) the right to prevent other people from using that process and who use, sell, offer for sale or import the product obtained directly from that process, without your consent, if the subject matter of the patent is a process.
Nevertheless, the right to the exclusive use of a patent has an exception (article 77 of the Industrial Property Law) through the granting of public interest licenses, which will be granted for reasons of emergency or national security, including declared serious illnesses of priority attention according with the General Health Council.
The characteristics of this figure in Mexican legislation are as follows:
- Justification of the General Health Council regarding the emergency situation, including the reasons why not granting the concession of a public interest license prevents, hinders or makes more expensive for the population the production, provision or distribution of basic goods or medicines.
- Declaration (administrative office action) that will indicate the information of the patents which its exploitation is authorized.
- Publication of the Declaration issued by the Mexican Institute of Industrial Property in the Official Gazette of the Federation
- The granting of a public interest license will have the same validity as the emergency situation and may be declared by initiative of the General Health Council or at the written request of national institutions specialized in the disease.
- Once the Declaration has been published, the pharmaceutical companies may request the granting of a public interest license to the Mexican Institute of Industrial Property and it will grant it within a period not exceeding 90 days.
- The owner of the patent will be entitled to receive royalties, which will be established by the Mexican Institute of Industrial Property.
The closest precedent in Mexico regarding the public interest licenses had place in 2009 with the A-H1N1 influenza epidemic, however, at that time the authorities determined that the conditions described above were not being met.
Today, several countries have granted provisional authorizations for the use of Remdesivir retroviral, a drug protected by a patent in various parts of the world, as an alternative treatment to some patients infected with COVID-19. If its results are positive, an extensive demand very difficult to suppl. Under this situation, Mexico may apply the exception to the patent right by granting public interest licenses.
The authorities of the Health System, the Mexican Institute of Industrial Property and pharmaceutical companies should evaluate this possibility in the short term, considering that this can be an effective measure to fight this pandemic.
Juan Carlos Hernández
Mexico City, March 30th, 2020.