Mexico is the leading country in exports of pharmaceutical products in Latin-American. The pharmaceutical sector in Mexico is considered one of the top ten industries interested in patent protection for its products, processes or uses. From the available current data of the IMPI and World Intellectual Property Organization (WIPO), the main technical field of filed patent applications in Mexico corresponds to pharma products and technologies, while about 93% of all filed patent applications are filed by foreign applicants and companies, normally having several sister parallel applications for an invention of interest.
When assessing the patentability of inventions, Mexican Examiners at the IMPI tend to be influenced by foreign results, mainly those issued by EPO and United States Patent and Trademark Office (USPTO), but is important to consider that the criteria of the IMPI is mostly in line with the European practice. Co-operation in terms of Patents between IMPI and EPO have been in constant development for some time now, generating advantages for applicants and owners.
In this sense, Europe is one of the most important markets in pharma and life science industries, and the EPO is currently a worldwide leading office regarding international co‑operation in the field of patents. In 2019, IMPI and EPO signed a Memorandum of Understanding (MoU) on Reinforced Partnership, further strengthening the longstanding co-operation between Europe and Mexico in the area of patents.
This strategic partnership was recently updated in September 2023, by means of a biennial work plan outlining future co-operation strategy to enhance accessibility of the global patent system and provide support to innovators in Europe and Mexico. Considering the affinity in common practices between IMPI and EPO, and from the point of view of the Mexican practice, the strategic cooperation directs the IMPI to enhance the efficiency, timeframe, and quality of its patent granting process mirroring criteria of EPO. IMPI examines EPO analysis and work products seeking for an effective re-use of efforts while providing EPO with patent data and continuous development from Latin America applicants. The biennial work plan also considers the possibility of facilitating technology transfer from Europe to Latin America by creating local hubs, and the opportunity to launch the process of assessing the feasibility of a validation system in Mexico, allowing users to obtain patents in Mexico directly by the patent granting procedure EPO.
At the time, and available since 2015, IMPI and EPO have an in-force agreement for use a positive examination result as a basis to accelerate the corresponding examination in Mexico via the Patent Prosecution Highway (PPH) Program IMPI-EPO.
In fact, PPH agreement between IMPI and EPO is one the most important available in Mexico, considering a wide number of possibilities for using a positive EPO result as a basis for accelerating examination. Is not a requirement for the Mexican applications to be directly derived from an EP priority, as in some other available agreements; a Mexican application could request accelerated examination if shares foreign priority with an EP application or if both applications are derived from a PCT application, with or without claimed priority. The same applies in case where the MX application corresponds to recognized priority of the EP application, either by Paris convention or PCT application. It is additionally relevant to note that a positive resolution in a Written Opinion of International Search Authority (WO/ISA), a Written Opinion of International Preliminary Examination Authority (WO/IPEA) or an International Preliminary Examination Report (IPER), indicating that at least one claim is patentable/allowable could be a base for requesting accelerated examination from the EPO resolution, as noted by the agreement, the ISA and the IPEA which produced the WO/ISA, WO/IPEA and the IPER must clearly be performed by the EPO, but, if a priority is claimed, the priority claim can refer to an application in any Office.
This provides applicants in Mexico a wide range of circumstances to use EPO work products and analysis to try to accelerate examination, which could result in a reduced timeframe for obtaining granting, in most cases with an additional considerable reduction of costs, mainly in prosecution. It is worth mentioning that Mexican Examiners will analyze any PPH request and will decide if the subject matter related to a positive result by the EPO complies with the MX practice and IMPI criteria. If at the consideration of the IMPI the claimed subject matter does not meet the patentability requirements, an accelerated official action will be issued informing the in-depth resolution and the technical reasoning for not obtaining allowance.
In the pharmaceutical area, we consider worth noting some important facts related to the local MX practice, for example the provisions of Article 49, fraction IV, of the Federal Law for Protection of Industrial Property (FLPIP), noting that, as in EP, methods of surgical or therapeutic treatment of the human or animal body and diagnostic methods applied to them are not patentable in line with the MX Law.
By practice, IMPI accepts medical use claims complying with the EPC-2000 and Swiss-style formats, however, recently it seems that the position of the IMPI is directed to only allow claims complying with Compound for use format. This is not an official change of practice, but objections to Swiss-style format have been slowly increasing for some time now. The position of the IMPI is to only accept second medical uses, always including in the medical-use-claim the specific disorder of diseases for which the invention is useful, reason by which first medical uses are normally not accepted. As long as the prior art does not teach the use of a Compound X for treating a specific disease or disorder, the subject matter in the claim would be patentable, even if Compound X itself is known in the art, as noted in Article 47, fraction VII, of the FLPIP.
Accordingly, positive results issued for parallel applications by the EPO could be considered as a very good base for defining the strategy to be followed in the parallel MX application in order to try to expedite prosecution.
The positive strategic partnership between both patent offices could only be a good sign for Mexican applicants aiming for better timeframes and quality of its patent granting process.
Luis Fernando Granados Castro