14 years after the publication of the reforms that establish the linkage system between the Mexican Intellectual Property Institute (IMPI) and the Federal Commission for the Prevention of Health Risks (COFEPRIS), there are still doubts in the application and operation of the system among health and intellectual property professionals.
The linkage system between IMPI and COFEPRIS aims to allow authorities to identify health registration applications that infringe granted patent rights in Mexico, this will lead to a sanitary registration denial, thus preventing the marketing of illegal products. Although the linkage system was created with a clear aim, the clarity deficiency of article 47 Bis of the Regulation of the Industrial Property Law (RLPI) drafting, as well as the limited scope of article 167-bis of the Regulation of Health Inputs (RIS) has caused doubts and lack of efficiency in the application of the linkage system for both patent holders and laboratories interested in generic products marketing.
Article 47 Bis of the RLPI establishes IMPI obligation to publish a list of allopathic medicines that have granted patent rights, excluding "patents that protect drug formulation or production processes." It is possible to make two different interpretations about the kind of patents that should be included in the list: i) patents related to allopathic medicines, except those related to production processes or formulation processes; or ii) patents related to allopathic medicines, except those related to production processes and new formulations.
In current practice, IMPI includes, by its own initiative and by the request of patent holders, those patents related to new active principles, enantiomers and polymorphs leaving out of the list those related to new uses, formulations and production processes. In the case of patents related to new uses and formulations, it is possible for the patent holder to request and obtain the patent inclussion in the list through a formal application to the IMPI based on the jurisprudence of the Supreme Court of the Nation No. 7 / 2010 issued on January 20, 2010, which establishes that patents that do not constitute drugs production or formulation processes and that in their pharmaceutical composition include an ingredient, substance or active principle, must be included in the publication. However, such resource could not be accepted by the IMPI, in which case it may be necessary to require the list inclussion at higher instances.
On the other hand, Article 167 bis of the RIS establishes the obligation of a sanitary registration applicant to include in the application documentation that proves he is the patent holder of the active substance or ingredient, or a copy of a patent license granted by the patent holder; otherwise and in accordance with the list of products established in article 47 bis of the RLPI, state that he complies with the applicable patent provisions regarding the active substance or ingredient. In the second case, COFEPRIS will request the cooperation of IMPI to determine if there is an infrigement of granted patent rights related to the substance or active ingredient. It is interesting to note that article 167 bis of the RIS seems to focus its wording on non-infringement of active principle patents, leaving out of its scope those patents that claim new formulations and uses. This, along with the incomplete coverage of the medicines list with granted patent protection (in light of local practice), would seem to favor a scenario where products that infringe granted patents of use or formulation obtain a sanitary authorization. According to IMPI examiners, when carrying out the review referred in Article 167 bis of the RIS, all patents granted are taken into account and not only those contained in the list published according to Article 47 Bis of the RLPI.
In Mexico there is no clear legislation regarding the linkage between IMPI and COFEPRIS; also, Mexico lacks a complete and public list that allows knowing all the patents related to a active principle. It is therefore necessary to have legislation that clarifies both the procedure for linkage between instances (IMPI-COFEPRIS) and the mechanisms for disclosure of all patents related to medicines, regardless of whether they are patents of active principle, use or formulation in order to guarantee the fulfillment of patent granted rights and facilitate to generic developers knowing if a medicine is currently protected by a patent.