30 November 2020
Definitely, the year 2020 has been a sui generis year, which has shaken and revolutionized too many aspects in all sectors at worldwide level, and its consequences will last for the following years.
Notwithstanding, one of the very positive changes in Mexico is that, after more than 25 years following the implementation and amendments of several international treaties that were released in the 90’s, last July 1, 2020, a new Federal Law for the Protection of the Intellectual Property (FLPIP) was enacted, and has come force in Mexico, on November 5, 2020.
This New Mexican Law aligns many international treaties that were recently executed such as the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTTP), and the United States-Mexico-Canada-Agreement 2020 (USMCA) who was recently signed by these countries.
Certainly, these are very good news, since as science and technology have always evolved in leaps and bounds in comparison with the reforms that are taking place on the legal framework, leaving out of context relevant aspects which have affected the daily life of pharmaceutical industry; the implementation of this new law will contribute on a significant way to the harmonization of patent standards.
Therefore, it’s been worth the wait.
The most relevant aspects to consider in the new law are the following:
Double Patenting. Although it has always been the practice of the IMPI to refuse two patents for the same invention, this prohibition is now made explicit, and will be the basis for many objections during the technical examination.
Divisional Applications. This issue is very relevant, since the scope of protection of the product to be marketed will depend on the design of the strategy for the presentation of the divisions. For this reason, relevant changes have been made in this area.
The new law establishes that a divisional application cannot consist of divisions of other divisional applications, unless the IMPI decides to proceed with the subsequent divisional, or in cases where the IMPI requests the subsequent divisional due to the lack of unity of the invention. Consequently, cascade applications will no longer be allowed unless such divisional are required by the MXPTO.
Divisional applications resulting from a requirement of the MXPTO must be filed together with the response to the office action objecting to the lack of unity of the invention.
Likewise, the FLPIP establishes that the invention pursued in the divisional application must be different from the one claimed in the parent application and in other divisional applications. The new Intellectual Property Law also includes restrictions on the subject matter that can be included as a result of the division of an application, since it establishes that when an application is divided, either voluntarily or due to a requirement of the MXPTO, the subject matter that is no longer claimed cannot be included again in the initial application or in the application that originated the division.
Supplementary certificates. Certainly one of the biggest changes in the Mexican patent system is the introduction of patent term adjustments via supplementary certificates, which compensate patent owners for unreasonable delays directly attributable to the patent office during prosecution. Under the new law, a certificate will be available for a patent for which prosecution time from filing to allowance lasted longer than 5 years. The adjustment will be calculated only on the basis of the delay due to the patent office’s actions/inactivity and will be equal to half the number of days corresponding to such delay up to a maximum of five years. It is important to take into account that this only applies to applications filed from November 5, 2020
Utility Models. Mexico is one of the few countries in the world that has this figure of protection. This extension of the term of protection for utility models has come in continuation to the extension of the term of protection for industrial designs from 15 years to 25 years, established in 2018.
Utility models pending and/or granted under the previous law may benefit from the extension of the term by paying the corresponding fees within the six months prior to the expiration of their normal 10-year term of protection.
Grace period. Another benefit of the new law is the inclusion of more situations to make use of the 12-month grace period for first-time disclosure. For example, it now includes disclosures that were inadvertently or mistakenly made even by a patent office or a third party who directly or indirectly obtained the exposed information from the inventor or his assignee.
Bolar exemption. The Bolar exception has always been a controversial concept throughout the world, as it refers to the authorization to a third party to exploit a current patent in order to obtain the necessary regulatory approvals for research and development purposes without infringing the patent in question. Such protection is only available when a patent is within eight years of its expiration for a biological product, or within three years for a small molecule.
In the Old Mexican Law, the Bolar exception was silent, however it was defined by the health authority COFEPRIS, good news knowing that FLPIP includes a great change since it incorporates a totally new Bolar exception directed to a third party to be able to use, produce, offer for sale and import a patented product, with the only purpose of “producing tests, information and experimental production necessary to obtain a sanitary registry of medicines for human health”.
However new FLPIP failed in the following:
By not specifying the period of time within the exemption shall be observed, therefore it is said, that the time period established by COFERPIS (Health Authority) for biologicals and new molecules will remain applicable. Therefore, third parties that seek to benefit from this new exception will have to ensure that the patent of interest has a supplementary certificate in order to calculate the real time and not to fall into an infringement.
Let’s see how COFEPRIS adjusts its sanitary regulations according to the changes in this FLPIP.
Post-Grant amendments. In Mexico, post-grant amendments have been allowed in Mexico only for correcting typographical and obvious errors and/or for limiting scope of protection of the claims.
The new FLPIP has included the possibility of submitting post-grant amendments, directed to incorporate dependent claims into a granted claim set of patents and also for utility models, notwithstanding, it should be taken into consideration that those dependent claims should not include matter that may goes beyond the granted scope of protection.
Finally, getting into the one of the most controversial aspects for pharmaceutical companies, is the Mexican Patent Linkage system, which will be explained on a more detailed manner as follows:
Mexico’s patent linkage system was enacted in 2003 with the purpose of coordinating and strengthening communication between the Federal Commission for Protection against Health Risks (COFEPRIS, the regulatory agency in Mexico, and the Mexican Institute of Industrial Property (IMPI), in order to prevent the granting of marketing authorizations for generic versions of pharmaceutical drugs which fall within the scope of drug patents.
Actually, this system issues on a biannually way a list of drug patents in force including active ingredients and composition patents, whereas patents covering uses still need to go under litigation for being listed therein. However, several aspects still need to be reviewed since the system it’s still too rigid and has generated controversial situations in the pharmaceutical market.
A relevant change of the new LFPIP is that linkage system has been elevated to the rank of Federal Legislation (Ministry of Health) which for sure will not contribute to the autonomy and independence required for a regulatory authority. Additionally, a conflict of interest could be foreseen since public bidding for medicines are controlled by this Ministry of Health, therefore could Cofepris act on a freely and independent way when an impartial but crucial decision has to be made?
Another significant aspect to consider with the new law, is that Mexico’s authorities are now obliged to notify patent holders providing them with a feasible opportunity to present facts and arguments regarding a third-party request for sanitary registration. This is a great opportunity for pharmaceutical companies for identifying and hampering potential generic competitors generating a very intense debate within the industry.
At the time of writing, IMPI has just launched and made available to the public two new online tools that facilitate access to patent information associated with current medicines. One of these is a promising patent searcher.
The implementation of a new law generates great expectations, commercial interests and political debates.
The LFPIP has granted a term of 120 business days after publication of the law (July 2020) for the issuance of the general guidelines by Cofepris and IMPI, for this reason, until December 2020 many interests are still on the table.
The implementation of a new law, especially after the lack of initiatives during such a long period, generates great expectations, commercial interests, political debates and, why not, uncertainty, but it places Mexico in a privileged position when a world leading company comes to select a country with infinite development possibilities as one of its star players.
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