Patents and Trademarks
Need to know the legal situation for patents and trademarks in Mexican pharma? Then read on! Prepared in association with Olivares, a leading global law firm, this is an extract from The Pharma Legal Handbook: Mexico, available to purchase here for USD 99.
1. What are the basic requirements to obtain patent and trademark protection?
To obtain the protection of a trademark for a sign, it is required to file an application before the IMPI and to comply with the formalities established by the IP law.
While in the case of patents it also necessary to file an application before the IMPI and to comply with the formalities established by the IP law.
2. What agencies or bodies regulate patents and trademarks?
In Mexico patents and trademarks are regulated by the Mexican Intellectual Property Office (IMPI).
3. What products, substances, and processes can be protected by patents or trademarks and what types cannot be protected?
In accordance with the IP Law, all visible signs can be protected, provided that they are sufficiently distinctive and able to identify the products or services to which they apply or intended to apply with respect to those in the same class.
Audible, olfactory and taste perception cannot be protected in Mexico. This limitation of trademark protection to visible signs was justified in the past by the need of delimiting the granted right making clear the scope of protection to thirds.
According to IP Law, inventions that are new, involve inventive steps, and are capable of industrial application are patentable.
In Mexico, methods and process claims are considered patentable subject-matter as long they fulfill the patentability requirements, with exception of: i) essentially biological processes for obtaining, reproducing and propagating plants and animals; ii) methods for carrying out mental processes, playing games or doing business, and mathematical methods; iii) methods of presenting information; and iv) methods of surgical, therapeutic or diagnostic treatment applicable to the human body and to animals.
Regarding therapeutic treatment methods, please note that the patentability thereof can be dependent upon the formulation of the claims. IMPI, for example allows Swiss type claims (Use of Compound/Composition X for the manufacture of a medicament for treating Y), or as purpose-limited product claims (Compound/composition X for use in …). In this respect, please note that currently there is an absence of criteria and guidelines in IMPI about which medical use claims can be accepted, since some Examiners accept both purpose-limited product claims and Swiss type claims. Taking into consideration that IMPI usually follows EPO’s criteria and that it is easier to argue that purpose-limited product claims encompass products, preferably we recommend filing the purpose-limited product claim format. Please note that product claims are easily listed in the patent linkage gazette in order to prevent the violation of the patent through approvals before the regulatory agency.
According to the IP Law, computer programs are not considered as inventions. Software is protected under copyright laws. It is worth mentioning that they can be patentable as computer-implemented processes.
4. How can patents and trademarks be revoked?
I) Invalidity action
The grounds of invalidation established by the IP law are:
- The trademark is identical or confusingly similar to another one that has been used in Mexico or abroad prior to the date of filing of the application, and it is applied to the same or similar products or services, provided that the party who asserts the greater right for prior use proves the have used the trademark continuously in Mexico or abroad prior to the mentioned filing date or declared use, then the applicable statute of limitations is three years as of the date the Trademark Gazette that published the disputed registration was put into circulation;
- The registration was granted on the basis of false information mentions in the application. The applicable statute of limitations is five years as of the date the Trademark Gazette publishes the disputed registration.
- The existence of a senior registration for a trademark identical or similar to that covered by a junior registration, and the goods or services covered thereby are similar or identical in nature. The applicable statute of limitations is five years from the publication date of the Trademark Gazette detailing the disputed registration;
- Registration is obtained by the agent, representative, user or distributor without the authorization of the owner of the foreign trademark registration. No statute of limitations applies to this action; or
- A general cause of invalidity is available and it relies on the granting of registration against any provisions of the IP law or the law in force at the time registration was granted. This cause of cancellation has no statute of limitations.
II) Cancellation Actions
The IP law establishes that if a trademark is not used for three consecutive years on the products or services for which it was registered, the trademark registration will be subject to cancellation for lack of use, unless the holder or the user of a recorder-granted license has used it during the three consecutive years immediately prior to the filing date of the cancellation action for lack of use.
Furthermore, a cancellation action can be brought against a registration when the owner of it has provoked or tolerated a trademark has become a generic term.
The IP law establishes several grounds on which a patent can be invalidated:
- When the patent was granted in contravention of the provisions on requirements and conditions for the grant of patents.
- When the patent was granted in contravention of the provisions of the law in force at the time when granting. Actions based on this cause of invalidity cannot challenge the legal representation of the applicant when prosecuting and obtaining a patent.
- When the patent application was abandoned while being prosecuted.
- When the patent granted by error or serious oversight, or when it is granted to someone not entitled to obtain it.
Actions based on causes (1) and (2) may be filed at any time. Actions based under causes (3) and (4) may only be filed within a five years term from the date when the publication of the patent in IP Gazette becomes effective.
Patent invalidity decisions are relatively difficult to obtain. The plaintiff must prove that the invalidity cause occurred. These actions usually require conclusive evidence even though a technical report from the Patent Department may be rendered by request of the Contentious Department, both of IMPI.
5. Are foreign patents and trademarks recognized and under what circumstances?
When the registration of a trademark is applied for in Mexico within the periods specified in international treaties or, failing that, within six months of the filing of applications in other countries, the filing date in the country of first filing may be recognized as the priority date.
For the priority referred to be recognized, the following requirements shall be met:
- The priority must be claimed, and proof given of the country of origin and of the filing date of the application in that country, when applying for registration;
- The application filed in Mexico must not seek to cover products or services additional to those provided for in the application filed abroad, in which case priority will be recognized only for those specified in the application filed in the country of origin;
- The requirements specified in international treaties, the IP Law and the regulations thereunder must be met within three months of the filing of the application.
Additionally, if a trademark is identical or confusingly similar to another that has been used in the country or abroad prior to the filing date of the application in respect of the registered trademark and has been applied to the same or similar products or services, provided that the person who asserts the stronger right by virtue of prior use proves uninterrupted use of the mark in the country or abroad prior to the filing date or, where applicable, prior to the date of first declared use by the person who has registered it; it shall be invalid.
Where a patent is requested having been applied for abroad, the filing date in the country of first filing may be recognized as the priority date, provided that filing in Mexico occurs within the periods specified by international treaties or, otherwise, within 12 months after the application for a patent in the country of origin.
To give priority referred shall meet the following requirements:
- Upon application for the patent, priority shall be claimed and the country of origin and the date on which the application was filed in that country shall be specified;
- The application filed in Mexico shall not seek the grant of rights additional to those deriving from the application filed abroad. For rights additional to those arising from the application filed abroad as a whole, the priority shall be only partial and relative to this application.
- The requirements specified in international treaties, the IP Law and the regulations thereunder shall be complied with within 3 months after filing the application.
It is worth mentioning that parallel imports are not recognized by the IP Law in Mexico.
6. Are there any non-patent/trademark barriers to competition to protect medicines or devices?
Yes, in Mexico there is no a specific body of legislation for Data package exclusivity (DPE) but in 2012 COFEPRIS issued internal guidelines to provide 5 years of protection limited to new chemical entities. However, the reliability and legal value of these guidelines is still uncertain.
Based on the interpretation of international treaties along with the Mexican legislation specifically related to approval of new molecules (new chemical entities, formulations and new indications), along with the New Molecules Committee’s (NMC) regulation (assists COFEPRIS with the analysis of technical and scientific data in connection with clinical trials, approval of new molecules and biologics) regulatory data exclusivity for 5 years for new chemical entities, formulations and new indications has been obtained through litigation. Regarding biologics, legal precedents are still pending. It is worth mentioning that NAFTA mentions that the protection should be for at least 5 years. On the other hand, some countries grant a wider length in regulatory exclusivity for biologics such as the United States and Canada, among others.
7. Are there restrictions on the types of medicines or devices that can be granted patent and trademark protection?
No, there are no restrictions to any types of medicines or devices that can be granted patent and trademark protection.
8. Must a patent or trademark license agreement with a foreign licensor be approved or accepted by any government or regulatory body?
The only requirement established by the IP law is that for the license to have effects on third parties it has to be duly recorded before IMPI.
Likewise, according to the linkage regulation established in article 147 BIS of the Mexican Industrial Property Regulations and article 167 BIS of the Health Law Regulations, COFEPRIS is bound to observe the patents which are listed in the gazette listing those patents in force that cover allopathic medicines, according to the generic name of the active ingredient, prior to granting marketing authorizations to third parties different to the titleholder, and alternatively to present the corresponding license.