Mexico: Pharmaceutical IP And Competition Law In Mexico: Overview

Last Updated: 21 August 2017
Article by Alejandro Luna and Armando Arenas

Co-authored by Karla Olvera

PATENTS

1. What are the legal conditions to obtain a patent and which legislation applies? Which products, substances and processes can be protected by patents and what types cannot be patent protected?

Conditions and legislation

Patent applications are regulated by the Industrial Property Law and its regulations. Patentable inventions must (Article 16, Industrial Property Law):

  • Be novel.
  • Result from an inventive step.
  • Be industrially applicable.

Scope of protection

Products and processes can be the subject of patent protection under the Industrial Property Law. The IMPI grants patents protecting compounds, formulations, uses and manufacturing processes for medicines.

Article 19 of the Industrial Property Law excludes medical procedures from being the subject matter of an invention. However, a patent can be obtained for a therapeutic method by drafting the claims in the Swiss-style format, that is, claiming the medical use of the compound for the treatment of a specified illness.

2. How is a patent obtained?

Application and guidance

Applications must be filed with IMPI. Details of government fees are available in Spanish only at the IMPI website (www.impi.gob.mx).

Process and timing

Generally, it takes from four to six years to obtain a patent in Mexico, depending on the field of technology.

A patent application includes a narrative statement that sets out:

  • A description of the invention that is sufficiently clear and complete to allow it to be fully understood, and to guide any person knowledgeable in the invention's field.
  • The best method known by the applicant of putting the invention into practice.
  • Drawings required for an understanding of the description, when necessary.
  • A claims chapter, which must be clear and concise, and must describe the invention's concept without overlapping with the description.

If the application is filed in English, a corresponding Spanish translation must be filed within two months from the filing date.

For applications under the Paris Convention for the Protection of Industrial Property 1883 (Paris Convention), a certified copy of the priority right document must be filed within three months from the filing date.

The IMPI conducts a formal examination of the documentation and can order clarifications or further details, or that an omission be remedied. An official communication is issued to request any outstanding documents, usually four to six months after filing. The IMPI grants the applicant a term of two months, and two additional months on payment of extra fees, to comply with these requirements. If the applicant fails to comply, the application is deemed abandoned.

After all the formal documents have been filed, an official communication is issued that notes the priority claimed, when applicable. An abstract of the application is published in the Official Gazette. This step normally occurs 18 months after filing of the priority claim, or if no priority is claimed, 18 months from the filing date.

Examination on the merits of the invention begins automatically after the corresponding fees are paid with filing of the application.

An official action is issued about three years after the filing date, either requesting amendments to the claims (for example, due to disapproval or clarification regarding novelty), or granting the protection sought and requesting payment of the final IMPI fees, together with payment of the first five annual fees.

IMPI has implemented Patent Prosecution Highway (PPH) pilot programmes to accept examinations by the United States Patent and Trademark Office (USPTO), the Japanese Patent Office (JPO), the Spanish Patent and Trade mark Office (SPTO), the Korean Intellectual Property Office (KIPO) and the State Intellectual Property Office of China (SIPO). These programmes are an attempt to accelerate pending applications.

3. How long does patent protection typically last? Can monopoly rights be extended by other means?

Duration and renewal

The term of a Mexican patent is 20 years from the filing date of the patent application in Mexico. For Patent Cooperation Treaty 1970 applications, the effective filing date is the date of filing of the international patent application.

Extending protection

There are no provisions for exclusivity term extensions or supplementary protection certificates in Mexican law.

In theory, the life term of a patent can be extended under certain international treaties (for example, the North America Free Trade Association (NAFTA)), where the health authority has delayed the process to obtain a marketing authorisation for a patented product. However, in practice no-one has yet attempted this. We would suggest that anyone seeking to extend the life term of a patent on these grounds would need to argue that the international law has supremacy over Mexico's domestic legislation. In relation to data package exclusivity, COFEPRIS has recently provided some recognition of data package exclusivity according to international treaties.

In addition, Mexico is participating in the Trans-Pacific Partnership (TPP) which has not yet entered into force in Mexico. The TPP contemplates patent term adjustments due to unreasonable delays in patent prosecution and unreasonable curtailment of patent protection due to the regulatory processes. Taking into consideration that the current law expressly limits the life term of a patent to 20 years as from the filing date, in this case Mexican IP law and the Health Law should be amended. There are transitional periods for some countries to be obligated to comply with the TPP. In the case of Mexico this is five years for any case of RDP and four and a half years for unreasonable curtailment of the life term of a patent due to regulatory delays.

4. How can a patent be revoked?

The validity of a patent can be challenged through a nullity action before the IMPI. A patent can be established as invalid by proving one of the following:

  • The patent covers subject matter that cannot be regarded as an invention, product or process.
  • The subject matter qualifies as an invention but the patent does not meet one or more of the patentability standards or conditions (novelty, inventive activity or step and industrial application).
  • The patent was granted in contravention of the law and does not comply with formal or technical legal provisions.
  • The patent was granted due to an error or serious oversight, or was granted to someone not entitled to obtain it.

In the first three situations the nullity action can be exercised at any time. In the fourth situation the nullity action must be exercised within five years from the date on which publication of the patent in the Official Gazette occurred or when registration becomes effective.

5. How is a patent infringed? How is a claim for patent infringement made and what remedies are available?

Conditions for infringement

The Industrial Property Law grants patentees the right to the exclusive exploitation of the patented invention and to exclude others from making, using, offering for sale or importing the covered invention. In a patent infringement action, the claimant must prove either of the following, without authorisation:

  • Production, offering to sell or importing of the patented invention. A manufacturer can infringe directly, while infringement by sellers requires prior notice of the infringement. If a claimant claims infringement of a patented process, the defendant must prove use of a process other than the patented process. There are no grounds in the Industrial Property Law to apply the contributory infringement doctrine.
  • Use of the patented invention. The Industrial Property Law only recognises literal infringement, and there is no doctrine of equivalence. The claimant must prove that the wording of the patent's claim or claims cover the alleged infringing product or process. The Industrial Property Law provides that the scope of the claims is determined by their wording, aided by the description and drawings.

The burden of proving authorised use is on the defendant. The doctrine of implied licence has not been tested before the Mexican courts.

Claim and remedies

Proving patent infringement in Mexico is difficult, since Mexico follows a strict civil law system which has formalistic rules for both evidence and proceedings. A patent infringement claim must be submitted to the IMPI. The claim is served on the alleged infringer, who then has ten working days to respond and, if applicable, bring a counterclaim. That response is then served on the claimant for the claimant to refute it. The evidence is then analysed and a decision is issued. That decision can be challenged before the federal courts. The IMPI is an administrative authority. There is no judge or jury participation in patent infringement actions.

The IMPI can take certain preliminary measures while investigating the infringement (Article 199 bis, Industrial Property Law). They include ordering:

  • The recall of infringing goods, or preventing their circulation.
  • Infringing articles to be withdrawn from circulation, including tools used in the manufacture, production or obtaining of infringing articles.
  • The alleged transgressor or third parties to suspend or cease all acts that violate the law.
  • Suspension of services or closure of an establishment, when other measures are insufficient to prevent or avoid a violation of rights protected by law.

Administrative infringements can incur penalties ranging from a fine up to 20,000 times the minimum wage (about US$76,190) to final closure of the establishment (Article 214, Industrial Property Law). Repeated infringement is also considered a criminal offence (Article 223, Industrial Property Law).

Once an infringement has been declared and cannot be appealed, the claimant can bring an additional civil action for damages and lost profit, accruing from the date on which the existence of the infringement can be proved (see Article 221 bis, Industrial Property Law). The civil courts impose a tariff scheme specifying the costs that can be claimed for reasonable attorneys' fees, regardless of whether this reflects the actual fees charged.

6. Are there non-patent barriers to competition to protect medicinal products?

Mexican domestic law is silent about data package exclusivity. However, on 19 June 2012 COFEPRIS published an internal decree on its website, providing some recognition of data package exclusivity according to international treaties. The primary features of the guidelines issued by COFEPRIS are that:

  • Information submitted in a process of regulatory approval is protected against unfair commercial use and disclosure.
  • Five years maximum protection. During this period of time, no one can use information provided by the innovator for the commercialisation of the drug.
  • COFEPRIS will grant approvals for generics once the five years of protection lapses, unless the generic drug proves safety and efficacy independently.

Conversely, there are some pending issues, such as that COFEPRIS has stated that the guidelines do not apply to biological products. The internal decree is also silent about the proceedings and measures to enforce and observe the right, which would provide certainty to all the involved parties. The main question and test will be the weight and strength of these guidelines as an internal decree against the lack of domestic statutory law recognising DPE.

The Trans-Pacific Partnership (TPP), which has not yet entered into force in Mexico states that protection would be at least three years for new formulations, new indications or new methods of administration, or at least five years for new chemicals. Parties may limit the period of protection for three and five years respectively. Currently, Mexico is granting "de facto" five years for chemicals. The TPP establishes at least eight years or five years plus for biologics. "Other" measures, recognising market circumstances, also contribute to effective market protection, to deliver a comparable outcome in the market.

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