New Gazette Helps IP Users Obtain Health Registrations

As part of the linkage system to improve communication between the Mexican Institute of Industrial Property (IMPI) and the competent health authority, in this case the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS), IMPI launched on Feb. 19 the Industrial Property Gazette, in which it provides a list of susceptible in-force patents to be used in allopathic drugs, in accordance with Article 162 of the new Federal Law for Protection of Industrial Property (LFPPI). This article established that the institute must publish, at least biannually and in coordination with the competent health authority, a gazette that lists patents related to the susceptible inventions to be used in allopathic drugs.

Besides data related to the active ingredient, the information published in the gazette includes the patent number, patent expiry and a fundamental part of the patent life cycle. The annuity payment can be found since in accordance with Article 53 of LFPPI, and the expiry of a patent will be subjected to the corresponding fee of each annuity.

The gazette also serves as a tool that allows the applicants to obtain a health registration, to acknowledge when they can use the active ingredients listed there or to know when the patents could be possible for free use. This according to the notice issued by COPEFRIS on Aug. 27, 2020, wherein it is established that the applicant of a health registration may begin the activities necessary to obtain a health registration from the day following the granting of the innovative drug.

At the same time, the Gazette includes the in-force patents that do not comply with Article 162 of LFPPI, wherein IMPI deems the patents:

To be patents granted for susceptible inventions to be used in allopathic drugs, in the terms provided in Article 167 bis of the Health Input Regulation and,

Fail to protect drug formulation or production processes.

It must be mentioned that IMPI clarifies that this measure does not constitute a pronouncement about the expiry or enforceability of the patents against third parties, i.e., the holder of said patents has the possibility to assert its industrial property rights and ensure that no third party uses its granted rights without its consentment, even when not appearing on the list.

The gazette is divided in two sections:

First section: Patent applications related to inventions that are not susceptible to be used in allopathic drugs;

Second section: Patents related to patents that do not protect the appointed matter in the respective request.

In the first section, patents addressed for the use of active substances which include brolucizumab, linagliptin, combinations of active ingredients such as pertuzumab, trastuzumab, carboplatine and docetaxel.

in the second section, the patents having the category defined as method and pharmaceutical composition are listed. the active ingredients included in this list are, for example, oxycodone hydrochloride, etrolizumab and abatacept.

These gazettes are complemented with the digital tools launched by IMPI in November 2020, which are the “Patent Associated to Drugs Search Engine” and “COFEPRIS Patents Response.” These tools provide information such as a list of the patents near to expiry according to the search criteria and the information of the responses that IMPI has granted through its technical inquiry in matter of patents associated to drugs executed by COFEPRIS in response to a health sanitary application.

Each of these tools are free to access; hence, any applicant can consult them and establish the development strategies for their new products in terms of the plan for the health registration application with the certainty of not infringing industrial property rights, in addition to the possibility of going to market once the patent of the innovative product expires.

It is important to note the fact that a patent might not appear in the gazette, considering that for pharmaceutical patents there are different factors (active ingredient, use, pharmaceutical compositions, dosages) and therefore many of them are excluded from the gazette’s in-force susceptible patents to be use in allopathic drugs. These ones do not lose their rights; therefore, they must be considered during prior art review, even when they are not included in any gazette.