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.
Bibliographic sources
https://www.wipo.int/edocs/statistics-country-profile/es/mx.pdf
Luis Fernando Granados Castro
fgranados@uhthoff.com.mx