On July 1, the New Federal Industrial Property Law (LFPPI) was published in the official gazette and will come into force in November. The law introduces important changes, particularly, for the pharmaceutical industry. Among these are:
- a third party can use, manufacture, offer for sale or import a product with an effective patent, exclusively to generate evidence, information, and experimental production, necessary to obtain sanitary registrations of medicines for human health; and
- the possibility of obtaining a supplementary certificate, in the event of unreasonable delays in the process of obtaining a patent, directly attributable to the Mexican Industrial Property Institution about the application in Mexico and the patent grating.
Derived from the changes made to the law, it was also established that the Mexican Industrial Property Institute (IMPI) shall partake overall with the Ministry of Health, through the Federal Commission for the Protection Against Sanitary Risks (COFEPRIS), the establishment of the corresponding technical collaboration mechanisms, for the inventions in terms of allopathic medicines.
Currently, a collaboration mechanism that is in place is the linking system (linkage), which basically consists of a technical consultation from COFEPRIS to IMPI, with which a link is generated through coordinated rules between the regulatory agency in charge of granting sanitary registrations for medicines (COFEPRIS) and the Mexican Patent Office (IMPI). The goal is to avoid the granting of sanitary registrations that may fall within the scope of protection of granted patents to medicines, providing, therefore, certainty to both sanitary registrations applicants and medicine patent holders.
It should be mentioned that this is in addition to what article 167-bis of the regulation of health supplies (RIS) establishes, which requires the applicant of a sanitary registration of an allopathic medicine to attach the documentation that proves that he/she is the substance or active ingredient patent owner or that he/she has the corresponding license, both registered at the Mexican Industrial Property Institution or by means of a freely written state, under oath and based on the list of products established in article 47 bis of the Regulations of the Industrial Property Law that complies with the provisions applicable in the matter of patents regarding the substance or active ingredient object of the application.
As can be seen, there is a very important legal framework with the idea of providing legal certainty to both the patent holder and the investor in the development of a generic product.
However, in August, COFEPRIS published the “RULES FOR THE PRODUCTION OF GENERIC MEDICINES FOR THE BENFIT OF THE POPULATION,” wherein three main points are established, with the objective of eliminating criteria that according to its perspective limited the production and availability of generic medicines.
The three points are:
- Be able to start the registration procedures from the following day after innovative medicine is granted (delete Bolar clause).
- For the registration granting, second-use patents will not be allowed, referring to therapeutic indications.
- A blank official letter will be issued if it is an authorization for the registration application, which will be exchanged for the sanitary registration once the corresponding patent has expired.
These points contradict some points that had already been established within the legal framework, while on others it ignores rights granted by the state, which creates uncertainty for the patent holders and disinformation for those interested in submitting a sanitary registration of a generic product.
Hence the importance of the new guidelines that COFEPRIS and IMPI will implement regarding allopathic medicines, taking into account the new LFPPI, the free trade agreement, the general health law, and the regulation of health supplies; considering that all should be adjusted in such a way that they are addressed in the same sense of giving certainty to the holders of exclusive rights obtained through patents. Also, so that generic manufacturers have the industrial property information that provides security that will not infringe the rights of others, considering that according to our current law and the new industrial property law, particularly, the pharmaceutical industry has a wide variety of protection options for its products for the different types of patents that it can obtain (patent of composition, uses, polymorphs, etc.)
It is worth mentioning that only allopathic drugs are being considered. It is necessary to include medical devices within these guidelines. These devices also have exclusive rights and due to the national and global health situation, devices have been proliferating that are not being monitored as well as allopathic medicines.