Mexico’s Senate recently published in its Official Gazette a new proposal relating to the IP and Health law reform package that would include the following changes:
- “Patent exceptions”:
- The proposal would incorporate the Bolar clause provided in the Health Law Regulations into the IP law. As a result, a patent right would not take effect against a third party that manufactures or uses a patented product or process to conduct studies, testing and pilot production required to apply for a marketing authorization of a generic drug, when carried out within three years prior to the patent expiration date, or eight years in the case of a biocomparable product.
This Roche-Bolar clause is already established in the Health Law Regulations. Yet the proposal does not solve the confusions derived from the interpretation of this exception. Thus if the proposed patent exemptions remain unclear, it will increase uncertainty among patent owners and third parties, resulting in higher risks for violation of patent rights and unfair sanctions.
- The right conferred by a patent would not take effect against a third party that imports a pharmaceutical product that addresses a public health problem in case of an emergency or that threatens national security declared by the General Health Council (GHC), in accordance with Article 31 of the TRIPS Agreement.
This is already established in the law and international treaties.
- The proposal would modify Article 15 of the General Health Law, which sets the parameters of the Constitution of the GHC. The GHC would be conformed by the Health Secretary and 15 members, including the presidents of the National Medicine Academy; Mexican Surgery Academy; Directives of the Federal Commission for the Protection against Sanitary Risks; the Mexican Patent and Trademark Office (IMPI); the Mexican Healthcare System of Social Security (IMSS); and Social Security for State Workers (ISSSTE). These official positions will be appointed and revoked by the President.
We consider that IMPI and COFEPRIS should not be part of the GHC as their participation should be limited to technical assistance. The interest of health and economics are already issues represented by the corresponding Ministries of Health and Economy.
- IMPI periodically will publish a Public Domain Gazette of those patent applications and registrations of utility models and industrial designs that have not matured into granted patents or registrations.
IMPI will publish a list of patented inventions that can be used in allopathic medicines for production within 3 to 8 years prior to the patent expiration date. This list would not include formulation patents.
The wording in part 2 above is perplexing, as it suggests the list would include both applications that do not yet constitute IP rights and granted patents and registrations. It is safe to assume that this proposal was drafted in a rush, as it lacks any well-grounded legal or health policy strategy. The proposal has several wording errors that may lead to confusion, as well as a number of typos.