Pharmaceutical IP and competition law in Mexico: overview

by Alejandro Luna Fandiño, Armando Arenas and Karla Paulina Olvera Acevedo

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 (IP Law) and its regulations. Patentable inventions must (Article 16, IP 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 IP Law. The Mexican Patent and Trademark Office (Instituto Mexicano de la Propiedad Industrial) (IMPI) grants patents protecting compounds, formulations, uses and manufacturing processes for medicines.
Article 19 of the IP 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 provided some recognition of data package exclusivity according to international treaties.
In addition, the free trade agreement formerly known as the Trans-Pacific Partnership (TPP), which has been renamed the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP) and the United States–Mexico–Canada Agreement known as USMCA 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 provided these agreements are ratified by all their signatories.
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 IP 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 IP Law to apply the contributory infringement doctrine.
  • Use of the patented invention. The IP 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 IP 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, IP 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 USD76,190) to final closure of the establishment (Article 214, IP Law). Repeated infringement is also considered a criminal offence (Article 223, IP 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, IP 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.
The Mexican Supreme Court issued a decision at the end of 2017 relating to the interpretation of the 40% rule to claim damages. This rule is derived from the violation of exclusive rights protected under the Mexican IP Law (for patents, trade marks and designs) (copyrights are governed by a different set of laws and rules). In summary, the Supreme Court decided whether it was necessary to prove the “causal nexus” between the illicit act and the damage or harm to the claimant. This criterion is not mandatory, particularly for patent infringement cases, but the precedent is highly persuasive and lower courts would need to provide strong and lawful arguments if they opt to depart from this precedent.
More recently, a Circuit Court recently observed that industrial property owners can be awarded with actual damages plus 40% of infringing products sales as punitive damages. The Mexican IP Law, Article 221bis, provides that damages awarded to the claimant must be no less than 40% of the sales of the infringing product at the price of sale to consumers (the 40% rule).
Based on an analysis of punitive damages in the US legal system, the Circuit Court reasoned that the 40% rule seems to apply the principle of punitive damages in the Mexican legal framework. Therefore, the Circuit Court commented that judges can impose both:
  • Compensatory damages for loss suffered, provided that the requirements established by the Supreme Court are met.
  • The 40% rule as punitive damages.
At first sight, this may seem like a more favourable interpretation of the IP Law for claimants. Conversely, the text of the ruling is ambiguous, and the proposed interpretation of the Law may mean that the court has unlimited discretion to determine the amount of compensatory damages, further to imposing the 40% rule. According to the Mexican legal system, this Circuit Court precedent is not binding and, we therefore consider that the application of the rule of 40% continues.
Mexico’s Senate recently published in its Official Gazette a proposal to modify the IP Law among others, to empower IMPI to issue decisions including compensation for damages caused by the violation of IP rights. However, the proposal disregards the fact that, based on the Mexican Constitution, it could be questioned whether administrative authorities such as IMPI can determine awards or enforce damages, as IMPI is not a court of law. If the purpose of this proposal is to provide faculties to IMPI to award damages, other bodies of law should be modified and it still could be considered unconstitutional.
6. Are there non-patent barriers to competition to protect medicinal products?
Mexican domestic law is silent about data package exclusivity (DPE). Based on the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS) and the North America Free Trade Agreement (NAFTA), and other international treaties to which Mexico is a signatory, the authors’ firm has been making efforts to obtain recognition of data package exclusivity for products that deserve this protection, and has obtained court precedents recognising and ordering COFEPRIS to observe data package exclusivity.
On 19 June 2012, COFEPRIS published guidelines for observing and protect data package exclusivity in Mexico. According to the guidelines (and a minimum term set by NAFTA), a marketing authorisation holder has a five-year exclusive right, where his/her/its information cannot benefit or be used to support a third party application for registration of a generic drug.
These guidelines show that COFEPRIS is now willing to recognise and protect data package exclusivity, according to NAFTA and TRIPS, and provide a higher degree of confidence for innovators, for example, the exclusivity has been obtained for new small molecules. However, certain issues are not clear and require further clarification, for example:
  • Whether the guidelines apply to biological products.
  • Whether other key approvals, such as new formulations and indications, are protected.
  • The proceedings and measures to enforce and observe data package exclusivity rights, which are not covered in the guidelines.

Trade marks

7. What are the legal conditions to obtain a trade mark and which legislation applies? What cannot be registered as a trade mark and can a medicinal brand be registered as a trade mark?

Conditions and legislation

A trademark is any sign that is perceptible by the senses and capable of being represented in a way that allows to determine the clear and precise object of protection, which distinguishes products or services from others of the same species or class in the market (Article 88, IP Law).
Scope of protection
Brands for medicinal products can be registered as trade marks.
Trade marks in Mexico are regulated under the IP Law. Article 90 provides a long list of prohibitions against registration of certain signs as trade marks. In addition, Article 4 prohibits registration of marks whose content or form is contrary to public order, morals and decency, or that contravene any legal provision.
Sounds and smells can be protected as trade marks. Three-dimensional forms can be protected as trade marks, as they are visible signs, if they comply with the principle of distinctiveness.
On granting marketing authorisations, COFERPRIS must ensure that when the proposed trade mark of a drug is orthographic or phonetically similar to another previously approved, this must differ at least by three letters in each word (Article 23, RIS). Such provisions are known in Mexico as the three letters rule, and although it is established in a Regulation of the Health Law, it has the rationale of avoiding the granting of a marketing authorisation with a distinctive denomination (trade mark) similar to a distinctive denomination of a prior marketing authorisation, but taking into consideration the number of different letter of the denomination. This regulation only binds the health authorities in charge of processing a marketing authorisation application. It has not been applied by IMPI when studying conflicts of trade marks applied to pharmaceutical products, as IMPI sustains that the rule is not contemplated in the IP Law or its regulation, and that it limits the likelihood analysis to a number of letters of the conflicting trade marks.
International non-proprietary names (INNs) cannot be registered as trade marks. Article 225 of the General Health Law expressly forbids the use of pharmaceutical trade marks that clearly or even slightly resemble an INN.
8. How is a trade mark registered?

Application and guidance

Applications must be submitted to the IMPI (www.impi.gob.mx).

Process and timing

An application for a new trade mark follows the following process:
  • A formal examination, which checks compliance with the formal legal requirements (for example, the official application form must be duly completed and the government fees paid).
  • A second examination of the inherent registrability of the mark (without evidence of use), that is, whether it complies with the legal conditions for registration.
On 1 June 2016, some articles of the IP Law were amended and new articles were introduced, pertaining to the implementation of a trade mark opposition proceedings in Mexico.
Under the new provisions, all new applications filed in Mexico must be published for opposition purposes within ten working days of the filing date to allow any third party claiming that a published application falls within the absolute or relative grounds of refusal as provided in Articles 4 and 90 of the IP Law to submit a brief of opposition, within one month of publication of the application. The term is not extendable. The brief must be accompanied by all documentation supporting the opposition.
Once the one-month term for opposition expires, IMPI must publish within ten working days of filing all oppositions filed. Owners of opposed applications will have one month to raise arguments against the alleged grounds of opposition.
The opposition will not suspend prosecution of the applications, as IMPI will continue to conduct its official examination of trade mark applications on both absolute and relative grounds in parallel to the opposition proceeding.
It will be optional for IMPI to consider the arguments submitted by the opponent in an opposition, as well as the defensive arguments raised by the applicant. Thus, if the application is refused, IMPI will serve the opponent with a writ informing of such refusal. In turn, if the application matures into registration, IMPI will serve the opponent with a writ informing of the granted registration.
Finally, despite the outcome of an opposition proceeding, the post-registration grounds for invalidation currently established by the IP Law will remain available.
If the trade mark registration for a word mark does not face any objection as to its inherent registrability, and there is no known similar or identical prior registered mark, completing registration can take three to four months. For a design trade mark, it can take at least six months because searches for prior registrations relating to designs are mostly conducted manually by the IMPI.
Further, on 18 May 2018, articles of the IP Law were amended and new provisions dealing with trade marks were introduced. The main highlights are as follows:
  • Trade mark protection for non-visible signs, such as smells and sounds, and certain animated marks such as holograms and for “trade-dress” in the broad sense will be provided for the first time in Mexico.
  • Acquired distinctiveness (secondary meaning) will be recognised as an exception to the absolute grounds for refusal.
  • Consent and coexistence agreements will be allowed to overcome senior rights, except when dealing with identical trade marks for identical goods or services.
  • Bad faith, in a broad sense, is incorporated as a ground for opposition, and as a ground for invalidation.
  • Protection for certification marks is recognised.
  • Class headings will no longer be possible. It will be necessary to be specific in products and services descriptions according to the WIPO Nice Classification.
  • Oppositions will become binding for the Trademark Office, which therefore will have to issue decisions duly grounded and justified based on the merits of each opposition filed.
  • To clear non-used marks from the Mexican Register, a use declaration under oath will be required, which must be filed within three months from the third anniversary of the date of grant of the trade mark registration. If no use is declared by this date, the registrations will automatically lapse.
  • It will no longer be possible to renew a trade mark registration in a certain class based on the use of the same registered trade mark in other class.
9. How long does trade mark protection typically last?
Trade mark registrations are valid for ten years from the filing date and can be renewed for any number of further ten-year periods.
Renewal of trade mark registration can be requested by the holder from six months before its renewal date. However, the IMPI will accept and process renewal petitions filed within a six-month grace period after the renewal date, on payment of an additional government fee.
10. How can a trade mark be revoked?
If a trade mark is not used for three consecutive years in relation to the goods or services for which it is registered or when the declaration of real and effective use is not made in terms of Article 128 of the IP Law, the registration is subject to cancellation for non-use unless either:
  • A duly licensed holder or user has used the mark for three consecutive years immediately before the filing date of the cancellation action.
  • There are legitimate reasons for the non-use that are beyond the control of the trade mark owner (for example, import restrictions or other government requirements).
(Articles 130 and 152(II), IP Law.)
  • Trade marks can also be cancelled if:
  • The registration was granted in breach of the law, although the invalidity action cannot be based on a challenge to the applicant’s legal representation. An action on these grounds can be made at any time.
  • The trade mark is identical or confusingly similar to another that has been continuously used in Mexico or abroad before the application for registration, and is applied to the same or similar products or services. An action on these grounds must be made within three years of the trade mark’s registration.
  • The registration was granted on the basis of false information in the application. An action on these grounds must be initiated within five years of the trade mark’s registration.
  • The registration was granted by mistake, inadvertently, or another trade mark is registered that is considered infringed because it is the same or confusingly similar and is applied to the same or similar products or services.
  • The agent, representative, user or distributor of the holder of a trade mark, or any other person who has had a relationship with the holder, directly or indirectly, of a foreign trade mark, requests and obtains the registration of this or another confusingly similar, in its name without the express consent of the holder of the foreign trade mark.
  • The registration was obtained in bad faith.
    (Article 151, IP Law.)
11. How is a trade mark infringed? How is a claim for trade mark infringement made and what remedies are available?

Conditions

For administrative infringements, the claimant must prove use of a confusingly similar/identical trade mark by a third party without authorisation, to distinguish identical or similar goods or services to those covered by the registration.
Criminal proceedings can be brought against counterfeit goods with a trade mark identical to the one held by the claimant (counterfeiting).
A claimant can also bring an action for unfair competition. In this case, the claimant must prove that use of the trade mark by the infringer makes some form of false representation, that tends to cause consumers to believe that the defendant’s goods or services come from the claimant.

Claim and remedies

Administrative actions for trade mark infringement can be brought before the IMPI. IMPI can impose a fine and order an immediate halt to the infringing activities. A civil action to claim damages in a civil court is possible once an IMPI resolution declaring infringement is final and cannot be appealed.
A criminal action against counterfeiting can be brought by filing a complaint with the attorney general’s office. On receiving the complaint, the attorney general’s office will conduct an inquiry, to determine whether a crime has been committed. If so, the district attorney submits the matter to a federal district judge. Criminal penalties range from between two and ten years’ imprisonment, to about USD100,000 in fines. Imprisonment and fines can be imposed simultaneously.
12. Outline the regulatory powers and enforcement action against counterfeiting in the pharmaceutical sector.
COFEPRIS has statutory authority to:
  • Seize any drug held for sale that is adulterated, misbranded, mislabelled, and/or lapsed.
  • Inspect at reasonable times, subject to reasonable limits and in a reasonable manner any place where health products are manufactured, packed and/or held for marketing.
Right holders can enforce border measures and the remedies provided by the IP Law (see Question 11), if applicable.
Measures against counterfeit medicines in Mexico have been introduced, including customs protection. Customs and IMPI are analysing whether the customs database of registered trade marks could be extended to patents.
On 22 December 2018, amendments to the Customs Law came into force. The amendment to Article 15 will directly impact the protocol for counterfeit or infringing products at Mexican customs The amendment affects certain infringement actions available to right holders in the IP Law, including the right to request that border control seizes the products at Mexican customs checkpoints before being imported into Mexico.
The amendment to Article 15 states that a right holder that causes any product to be seized at Mexican customs for alleged infringement of intellectual property and for matters other than Customs Law infringements or foreign trade matters, will have to pay:
  • Storage fees.
  • Customs handling fees.
  • Any other service fee related to storage.
Before the amendment, the customs used to exempt the payment for storage and necessary handling, not only in criminal proceedings before the Attorney General’s Office, but also in infringement proceedings before the IMPI. This new amendment to the Customs Law means that these services will not be exempted, so that right holders who are implementing these actions will have to pay for the storage and handling of the seized products.
Mexico’s Senate recently published in its Official Gazette a proposal to modify the Mexican IP Law, among others, to empower IMPI to seize goods to be imported, exported or that are in transit, in accordance with the Customs Law.

IP and competition law issues

13. Briefly outline the competition law framework in your jurisdiction and how it impacts on the pharmaceutical sector. In particular, the competition authorities and their regulatory powers, key legislation, whether pharmaceutical investigations are common, key recent activity and case law.
The Antitrust Commission (Comisión Federal de Competencia Económica) (COFECE) (https://www.cofece.mx/) enforces the competition legal framework in Mexico. This regulatory authority is an administrative agency with technical and operational autonomy, not governed by but related to the Ministry of Economy. The primary legislation is the:
  • Economic Competition Federal Law (Ley Federal de Competencia Económica) (ECL).
  • LEC Regulations (Reglamento de la Ley Federal de Competencia Económica) (ECR).
  • Administrative Rules (Disposiciones administrativas de carácter general reglamentarias).
The COFECE has statutory authority to review practices by pharmaceutical companies. In 2010, the COFECE published the imposition of a fine on six pharmaceutical companies for anti-competitive practices in public tender proceedings by the Social Security Institute (Instituto Mexicano del Seguro Social) (IMSS). Currently, COFECE is conducting an investigation into alleged irregularities in the market for the production, distribution and marketing of medicines.
14. Briefly outline the competition issues that can arise on the licensing of technology and patents in a pharmaceutical context.

Patent licensing and anti-trust law

In theory, an action could be brought against activities falling outside the scope of a patent, such as:
  • Non-competition agreements for products that are not covered by the claims.
  • Product-tying within that scope.
  • Unfair competition activities, such as advertising that a product is better than an alternative for the sole reason of it having a patent.
Actions could also be brought before the COFECE for other forms of abuse of patent rights, such as clearly unfounded attempts to enforce a patent.

Compulsory licensing

After three years starting from the date of grant of the patent or four years from the filing date, whichever is later, any person can request from the IMPI the grant of a compulsory licence when the patent has not been used, except if there are justified reasons for the non-use (Article 70, IP Law).
A compulsory licence will not be granted when the patent holder or a licensee has been importing the patented product or the product obtained by the patented process (Article 70, IP Law). Further, the working of a patent by a licensee will be deemed to be worked by its holder, provided that the licence has been recorded with the IMPI (Article 69, IP Law).
A party applying for a compulsory licence must have the technical and economical capacity to efficiently work the patented invention (Article 71, IP Law).
Before the grant of the first compulsory licence, the IMPI will provide the patentee with the opportunity to begin working the patent, within one year from the date of personal notification given to him (Article 72, IP Law).
Following a hearing with the parties, the IMPI will decide on the grant of a compulsory licence. If the IMPI decides to grant it, it will set out its duration, conditions, field of application and amount of royalties to be paid to the patent holder. The royalties are established by the IMPI after a hearing with the parties and they should be fair and reasonable.
The authors’ are not aware of any compulsory licences being granted in recent years.
15. Are there competition issues associated with the generic entry of pharmaceuticals in your jurisdiction?
The IP Law grants patent holders capacity to oppose exploitation of patented goods, such as importation (see Question 5). The linkage regulation prevents violation of patents by preventing approval of marketing authorisations for patented products.
The linkage system contain a Bolar-type exemption. This allows generic companies to apply for marketing authorisations and use patented materials to meet the regulatory requirements, three years before the expiry of a patent covering chemicals and eight years before for biologics.
Problems arise because the law and regulation of import permits for raw materials is silent about IP related controls and does not provide a reference to the Linkage Gazette. Basically, there are no guidelines or standards to bind COFEPRIS to review and take into consideration the amount of raw materials (active pharmaceutical ingredients) (APIs) that are authorised to be imported. The main concern is that recently, there have been an increasing number of permits to import patented compounds in bulk, that clearly exceed the justified amounts for clinical trials or experimental use.
As a result, patent holders have had to attempt different strategies to attack these violations of their IP rights, including patent infringement actions, where co-ordination between the patent and customs offices is not always ideal, and challenges against import permits issued by COFEPRIS. Measures by the authorities would be welcome to prevent the entry of infringing pharmaceutical substances into Mexico. Examples are:
  • COFEPRIS using and observing the patent Linkage Gazette for the approval or rejection of import permits.
  • COFEPRIS establishing the amount of APIs sufficient to comply with regulatory tests for marketing authorisation for follow-on products, denying imports of non-adequate amounts.
  • COFEPRIS requiring importers to declare the destination of the imported products.
  • IMPI clearly establishing through case law the differences between the sole experimental use and the Roche-Bolar exception.
  • IMPI being careful when, on a case by case basis, it reviews what is an adequate amount to be imported for tests regarding a generic marketing authorisation application. In certain cases, a small amount of an API can represent the manufacturing of thousands of infringing products, which may end up in the grey and black market.
  • Customs to take advantage of the information in the patent Linkage Gazette, to detect and stop eventual substances entering Mexico in violation of valid patents.
16. Have abuse of dominance issues arisen in the pharmaceutical sector in your jurisdiction?
The COFECE published in 2010 the imposition of a fine on six pharmaceutical companies for anti-competitive practices in public tender proceedings by IMSS. This case is final (see Question 13). Currently, COFECE is conducting an investigation on alleged irregularities in the market for the production, distribution and marketing of medicines.
17. Have parallel imports of pharmaceuticals raised IP and competition law issues in your jurisdiction?
Although the Intellectual Property Law does not specifically address patents in this context, it is likely that the principle of exhaustion of rights also applies to them. The Mexican government has entered into two main treaties on the subject of international trade and intellectual property rights: the North American Free Trade Agreement (NAFTA) and the Trade Related Aspects of Intellectual Property Rights (TRIPS).
TRIPS allows countries to engage in parallel importation by adopting international doctrines of patent exhaustion, that is, once products are placed on the international market, patent holders’ exclusive rights are exhausted.
NAFTA expressly provides for the protection of IP rights as long as such protection does not constitute a bar on the free circulation of goods and services. Similarly, Article 1 of TRIPS can be interpreted as providing for a balanced system of rights between traders and IP owners.
18. Does a patent or trade mark licence and payment of royalties under it to a foreign licensor have to be approved or accepted by a government or regulatory body? How is such a licence made enforceable?
There is no requirement for a patent or trade mark licence and payment of royalties under it to a foreign licensor to be approved by a government or regulatory body.
Recording a patent or a trade mark licence is not mandatory and the agreement is enforceable between the parties regardless of whether or not it is recorded. However, to be effective against any third party, and to ensure the title holder has the use of the trade mark or patent, the licence must be recorded with IMPI (IP Law).
For information on pharmaceutical pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability, see Medicinal product regulation and product liability in Mexico: overview.

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