In Mexico, the parties to an infringement proceeding are the affected owner or owners of the patent as the plaintiff, and the alleged infringer as the defendant.

In the case of co-owners of patent rights, unless there is an agreement to the contrary duly recorded before the Mexican Institute of Industrial Property (hereinafter IMPI per its acronym in Spanish) they must act jointly. They may also appoint one of the owners as a common representative.

In terms of the Federal Law for the Protection of Industrial Property (hereinafter LFPPI per its abbreviation in Spanish), licensees, whether exclusive or non-exclusive, have the right to exercise the necessary actions in defence of the patent that is the subject of the licence, including the proceedings of infringement, unless otherwise expressly stated in the licence agreement. In the case of sublicensees, they can only take actions in defence of the patent if said right has been expressly agreed in the sublicence.

For licensees of a patent, whether exclusive or non-exclusive, to initiate an infringement proceeding, the licence must be duly registered before IMPI.

Recently, the IMPI and the Specialised Chamber on Intellectual Property Matters (SEPI per its acronym in Spanish) of the Federal Court of Administrative Justice (TFJA per its abbreviation in Spanish) have established that in order to have legal standing for filing the administrative declaration of invalidation of a patent, the plaintiff must demonstrate that the patent at hand causes real and direct damage (actual harm). For both authorities, it is not enough to be part of the life sciences and pharmaceutical market or industry for requesting the invalidation of a patent. However, this criterion has generated various litigations, promoted mainly by the generic pharmaceutical drugs industry. A decisive resolution from the Supreme Court of Justice of the nation is expected in the first half of 2024.

Concerning infringement requests in the field of life sciences and pharmaceuticals in Mexico, the defendants tend to mainly be the manufacturers and distributors of the pharmaceutical products in question.

Likewise, it is common for patent owners to take legal action against the regulatory authority, specifically against the Federal Commission for the Protection against Sanitary Risks (COFEPRIS per its acronym in Spanish), by requesting the invalidation of marketing authorisations, arguing a violation of the linkage system to the detriment of their patent rights.

It is important to clarify that infringement proceedings are commonly processed in the first instance before IMPI, which acts as a contentious authority and decides upon such proceedings.

The LFPPI allows the possibility to file for a preliminary injunction at the request of a party and without a prior hearing of the alleged infringer. Thus, requests for preliminary injunctions in Mexico will always be ex parte. IMPI is the authority which grants preliminary injunctions.

In order to decide whether to grant preliminary injunctions, the IMPI must consider the following.

• To analyse the appearance of good right (fumus boni iuris) principle (which means that the plaintiff has minimum legal basis for bringing a further legal action) and non-contravention of public order provisions.
• To consider that periculum in mora principle must be met (which means that the authority must assess if any delay in granting the preliminary injunction could harm the plaintiff’s rights.)
• To verify that the preliminary injunction does not affect the general interest.
• To consider the seriousness of the alleged infringement and the nature and scope of the requested preliminary injunction.

In the request for a preliminary injunction, the affected patent owner, in addition to providing proof of ownership of the right allegedly affected and a sufficient guarantee to respond for the damages that may be caused to the defendant because of the wrongful granting of the preliminary injunction, must also prove any of the following presumptions.

• The existence of a violation of their right.
• The imminent violation of their right.
• The possibility of suffering irreparable damage.
• A well-founded fear that evidence will be destroyed, hidden, lost, or altered.

As noted above, the main requirement to request a preliminary injunction is proof of ownership of a valid industrial property right that has been affected. A pending application or a translation does not provide the right to request preliminary injunctions.

A request for preliminary injunction can be filed immediately after the respective patent is granted. Regarding the “quia timet” relief, it is important to point out that this will be granted as long as it is demonstrated that the violation of the patent right is imminent, there is the possibility of suffering irreparable damage or there is a well-founded fear that evidence will be destroyed, hidden, lost or altered.

Some examples of acts that may constitute an imminent threat of infringement of pharmaceutical patents that give rise to quia timet relief are the following.

• The publication of studies or research results that suggest the unauthorised use of a patented formula or procedure.
• The issuance of import permits by the Regulatory Authority regarding substances or products covered by a patent.
• Advertisements or promotions of pharmaceutical products that indicate the use of a technology or formula protected by a patent without the consent of the owner.
• Conducting R&D activities that suspiciously imitate or replicate a patented formula or method, suggesting future infringement.

In patent litigation related to life sciences cases, there are no special considerations for granting preliminary injunctions; it is enough to prove ownership of the patent that is the basis of the action, as well as the demonstration of any of the requirements indicated above.

In Mexico, the alleged infringer is notified of the preliminary injunction through personal notification, which in principle must be carried out immediately, a situation subject to IMPI’s workload. Once the alleged infringer is notified of the preliminary injunction, they have ten business days to respond and submit the evidence which is considered relevant to either demonstrate the inadmissibility of the measures or disagree with the amount of the guarantee provided by the plaintiff. IMPI usually gives important relevance to the alleged infringer’s response to the preliminary injunction. Thus, the preliminary injunction may be modified or reversed, and the amount of the guarantee may be re-evaluated, based on what is proved and argued by the alleged infringer’s response.

Given the possibility that preliminary injunctions may be taken against them, pharmaceutical companies of generic drugs, biosimilar drugs and medical devices must be well prepared to demonstrate non-violation of patents (free-to-operate – FTO) and have documentation that serves to preliminarily reject the plaintiff’s claim. Likewise, they must know that they have the possibility of lifting the preliminary injunctions by granting a counter-guarantee, demonstrating that they have the appearance of good law, and demonstrating that the impact that they would suffer from the measures is more significant than what the applicant would suffer if the PIs were lifted.

Finally, protective letters/orders are not considered in the Mexican legal system.

In Mexico, infringement and nullity proceedings are carried out independently but in parallel. Thus, in an infringement case, if the defendant counterclaims the invalidation of the patent, the processes are carried out separately. However, the final decision of both proceedings is given in a single resolution. In the case that the invalidation of the patent is declared, the infringement proceeding will be declared without merits, and only if the nullity of the patent is denied will the IMPI or the judge study the merits of the case regarding the infringement.

Mexico does not have an opposition proceeding as such. The LFPPI allows the submission of third-party observations within two months of publication of the patent application. However, once the patent has been granted, it is only through the filing of a nullity action by a third party with legal standing that it can be subsequently invalidated.

Regarding the deadlines to file an action, it is essential to consider the following time frames.

• Infringements – five years counted from the moment that the infringing conduct ceases. If the infringement continues over time, the action can be filed at any time.
• Nullities – there is no deadline. The action may be filed as long as the applicant has legal standing.

Notifications to the alleged infringer or the patentee in the case of nullities are delivered personally. There is no deadline in the Law for notifications to be made; however, if the domicile of the party to be notified is within Mexico City or the Metropolitan area, in practice, it is often carried out in an average of one month. If the domicile of the alleged infringer, or the patentee in the case of nullities, is in another state, the notification may take from two to six months.

In infringement and nullity proceedings, the average time to issue a resolution in the first instance is three years (before IMPI).

In the intermediate steps, before the resolution is issued, the deadlines are listed below.

• Once the defendant is served, they will have ten business days to respond in the case of infringement actions and one month in the case of nullity actions.
• Once the claim has been responded, the alleged infringer, or defendant in the nullity proceeding, will have three days to provide a statement regarding the response.
• The scheduling of evidence presentation will depend on the workload of IMPI, which may set dates ranging from two months to a year.
• Once the parties have submitted their evidence and rendered their expert opinions, IMPI sends the file to its Patent Division so that they can issue a technical opinion. There is no deadline for issuing the technical opinion, which takes one or two years due to IMPI’s workload in these matters.
• Once the technical opinion is issued, IMPI gives the parties ten days to submit their final arguments.
• Once the allegations have been submitted, IMPI has three months to issue a resolution. However, this deadline is generally not respected, with the issuance of the resolution being delayed for up to a year.

The main requirement for filing an infringement action is that the patent has been granted. In this sense, the earliest that an infringement action can be initiated is the day after the patent is granted.

Although an infringement action can only be filed once the patent has been granted, the patentee has the right to claim damages for infringing activities that occurred after the publication of the application.

In the case of process patents, it is possible to reverse the burden of proof as long as one of the following requirements is met.

• The product obtained by the patented process is new.
• There is a significant probability that the product was manufactured using the patented process, and the patentee has failed to establish the actual process used by the alleged infringer despite trying to do so.

In Mexico, there is no discovery procedure before initiating the infringement proceeding. However, once the proceeding has begun, IMPI may, at the plaintiff’s request, order the defendant, or any third party with relevant information, to submit documents, evidence or any information crucial to the case. This is done through a formal request and must be justified, clearly specifying the relevance of the information requested for the ongoing proceeding.

Furthermore, in urgent cases or where an infringement is presumed, IMPI has the power to issue inspection orders to verify the possible commission of acts that infringe the plaintiff’s patent rights. These inspections may include access to facilities, the review of documents, and the collection of samples or evidence that may later be used as a crucial foundation for an infringement resolution.

It is important to note that although IMPI may request this information, the requested party may oppose the delivery of specific documentation through the interposition of a means of defence, such as the Amparo trial, especially in the case of confidential or sensitive information, or if the information is considered directly self-incriminating.

Regarding materials obtained in other jurisdictions, these may be admitted as part of the evidence in the proceeding provided that they comply with the formal requirements stipulated by Mexican laws regarding the deadlines by which they must be offered, and in the case of public documents, that they are duly legalised or apostilled.

In Mexico, the affected owner has the right to request and obtain an inspection visit where the allegedly infringing merchandise can be provisionally seized. Inspection visits must be carried out by an official IMPI. During the visit, the official has the authority to collect samples, take photographs, and document any relevant evidence that supports the allegations of infringement.

It is crucial that the request for an inspection visit specifically details the location to be inspected and specific aspects of the infringement to be demonstrated. Additionally, the applicant must provide preliminary or prima facie evidence to substantiate the suspected infringement.

Materials obtained in other jurisdictions may be admitted as part of the evidence in the proceeding if they comply with the formal requirements stipulated by Mexican laws regarding the deadlines by which they must be offered and, in the case of public documents, that they are properly legalised or apostilled.

In Mexico, there is no declaratory relief as in other jurisdictions. However, as a result of infringement or patent invalidation proceedings pending counterclaim, IMPI may issue resolutions in which the non-infringement of a patent is determined or its invalidation is declared.

Thus, the issuance of these resolutions in Mexico is usually reactive and occurs in response to an infringement claim or a request for invalidation, and not as a proactive declaration by a court or the IMPI. This reflects a more limited approach to declaratory relief compared to other jurisdictions, where parties can actively seek these types of resolutions to clarify their legal position without being involved in infringement or nullity litigation.

In Mexico, there is no Doctrine of Equivalents. The scope of patents must be interpreted literally according to the explicit content of their claims. Apparently, there is only one isolated, non-binding court precedent regarding this type of claim interpretation.

In Mexico, there is no obligation as such to “clear the way”. It is recommended that pharmaceutical companies carry out an FTO before starting the development of a new product with the purpose of identifying possible patent obstacles that could prevent or restrict the launch of the product. A detailed FTO helps assess the risk of infringement of existing patents and provides crucial information for strategic decision making.

If the FTO reveals patents that could be an impediment to the development and launch of the product, companies have the option of initiating nullity actions against said patents. However, due to the recent criteria of IMPI and the courts of appeal, the possibility of initiating nullity actions based on the legal standing that arise from the intention to develop a pharmaceutical product that might infringe a patent, or simply being part of the pharmaceutical industry, is not considered sufficient; it is also necessary to demonstrate a direct and real harm caused by the patent in question.

These criteria greatly limit the ability of pharmaceutical companies to take concrete actions to clear the way for the development and launch of a generic drug (see 1.1 Claimants/Plaintiffs to an Action).

Other options may include modifying the product to avoid infringement or restricting its therapeutic indications (“carve out”), negotiating licences with patent owners, or even changing the product launch strategy. The decision of which path to pursue will depend on factors such as the strength of the patents in question, the cost and viability of alternatives, and the strategic importance of the product for the company.

In Mexico, it is common for the parties to submit expert evidence to support their actions and defences during infringement and invalidation proceedings related to pharmaceutical patents. This evidence usually takes the form of written reports known as expert opinions. These opinions are of crucial importance in the analysis of the merits of the matter since they provide essential guidance to IMPI expert officials when issuing their technical opinions, which form the basis of the final resolution of the case.

These opinions are formulated from questions that are given in writing to the expert by the proposing party. It is important to note that the counterparty has the opportunity to add questions to the initial questionnaire. This process ensures that the parties can contribute to the expert evaluation, thus allowing for a more complete and balanced exploration of the technical issues in dispute.

Although each party can submit its own expert opinion prepared by its own designated expert, these experts have the responsibility to maintain scientific objectivity by focusing on the relevant technical aspects. When the opinions of the parties’ experts are essentially contradictory, however, IMPI may appoint an independent third-party expert who will render his or her own impartial opinion.

The period for IMPI to designate the third-party expert in disagreement cannot exceed 15 business days, unless there are justifiable circumstances that prevent the timely designation of the expert.

In Mexico, there is no specific mechanism dedicated exclusively to the submission of experimental results as evidence in patent infringement or invalidation proceedings. However, it is common and feasible for parties to introduce these results as part of their documentary evidence. However, to guarantee their probative value, the said experimental results must be reinforced with other types of complementary evidence, such as expert evidence. This combination of experimental and expert evidence contributes significantly to the soundness and credibility of the arguments submitted to IMPI or a court.

In Mexico, it is not common for the plaintiff or the petitioner to disclose information about their product, its manufacturing process, or even commercial information. Although IMPI may request this information, the requested party may oppose its delivery through the interposition of a means of defence, such as the Amparo trial, especially if it contains confidential or sensitive information, or the information can be considered directly self-incriminating.

However, it is important to point out an exception in the case of process patents, especially when the burden of proof is shifted to the alleged infringer. In these cases, the alleged infringer can submit diagrams, logs, and other documents on a confidential basis, and can even offer an inspection visit to the production plant so that the inspector can verify the process used.

In the case of nullity actions through counterclaim, the evidence offered by the owner is generally necessary to defend the validity of the patent. The owner may need to provide evidence to demonstrate the validity of the patent, which may include, but is not limited to, technical data, evidence of novelty, and inventive step.

According to the LFPPI, an alleged infringer can argue different types of exceptions and defences. Among them are the following.

• Experimental use – the patent was used for the purposes of carrying out purely scientific or technical experiments, trials, or teaching activities in the private or academic sphere and for non-commercial purposes.
• “Bolar Exemption” – the patent was used with the sole objective of generating evidence, information or experimental production necessary to obtain a marketing authorisation (MA) for a medication.
• Exhaustion of the right – the use of the patented invention happened after it had been lawfully introduced into commerce in Mexico or abroad.
• Prior use – the person accused of infringing the patent was already independently using or manufacturing the invention in good faith before the patent application was filed.
• Nullity or invalidation – the patent that is the basis of the action is null (or invalid). In this case, the IMPI will refrain from issuing a resolution until the nullity proceeding of the patent that is the basis of the action is resolved.

In Mexico, the issuance of a final resolution in infringement proceedings can be suspended at the request of the defendant. This suspension is applicable in cases where the validity of the patent that is the basis of the infringement proceeding is being analysed in other proceedings initiated within Mexican territory, whether by the defendant him-/her-self or by a third party. It is important to highlight that proceedings carried out abroad do not have a direct or binding impact on the decisions of IMPI or the Mexican courts, but they can be guiding judgments. As such, infringement or nullity proceedings cannot be suspended in Mexico due to pending resolutions in foreign jurisdictions.

Regarding the requirements and considerations relevant to the granting of a stay, the defendant must file a formal request arguing the relevance and direct influence of the parallel Mexican proceeding on the determination of the validity or infringement of the patent in question. The decision to suspend the proceeding rests with IMPI or the judge responsible for resolving the merits of the issue raised.

In terms of process and time, the duration of the suspension generally aligns with the estimated time for the resolution of the linked parallel proceeding.

In Mexico, it is possible for the owner of a patent to amend his/her patent at any time, so long as the amendment’s objective is to correct an error that does not modify the scope of the invention, or only seeks to limit the scope of its claims. However, in terms of the LFPPI, any request to amend a patent will be rejected if there is a proceeding pending resolution regarding the validity of the patent. In other words, if litigation has been initiated questioning the validity of the patent, the owner will not be able to make any modification until said proceeding is resolved.

In Mexico, IMPI has traditionally been the authority in charge of resolving first-instance cases related to patent disputes, including pharmaceutical and life sciences cases. However, with the issuance of the new LFPPI in 2020, a significant change was introduced: now, ordinary judges in civil matters are also authorised to resolve patent infringement proceedings in the first instance, within a damage claim.

Given that this new provision is relatively recent, there is currently neither enough information nor are there enough precedents to identify significant differences in practice between the cases resolved by IMPI and those brought before ordinary judges. Therefore, it remains to be seen how this change in jurisdictions will affect the resolution of cases in pharmaceuticals and life sciences and in patent litigation in general.

In Mexico, the acts that enable the owner of a patent to file an infringement action in relation to pharmaceutical products, whether small molecules or biologics, include:

• importation of the patented product or the basic components necessary for its production;
• the offer for sale of the pharmaceutical product, both in the private market and in tender processes;
• the granting of a MA;
• storage and manufacture of a patented product;
• circulation or use of products that incorporate a patented invention without the consent of its owner or the respective licence;
• the use of patented processes without the consent of the patentee or the respective licence; and
• the offer for sale or putting products into circulation that are the result of the use of patented processes that were used without the consent of the patentee or whomever had a licence of exploitation.

It is important to highlight that the rights conferred by a pharmaceutical patent have no effect against those who use, manufacture, offer for sale, or import a product with a valid patent exclusively to generate tests, information, and experimental production necessary to obtain marketing authorisations of medicines for human health.

Regarding patents for a second medical use, there are no restrictions or special considerations related to them or to labelling in Mexico, as long as the latter mentions the patent-free therapeutic indication. However, it is important to note that these patents, in principle, cannot be linked to a MA procedure for generic or biosimilar medicines.

According to the LFPPI, an offer for sale generally refers to any commercial proposal that makes a product available and is addressed to third parties. In the case of patented pharmaceutical products, this includes the marketing or advertising of the product both in private sales channels and in public tenders. The offer for sale is considered an infringement if the product offered is protected by a valid patent and if it is done without the consent of the patentee.

In Mexico, parallel imports in general are allowed, including in the pharmaceutical sector, so long as the products have been placed on the market for the first time by the patentee or with his/her consent.

In Mexico, data exclusivity is lightly regulated, with the primary source being international treaties such as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the United States–Mexico–Canada Agreement (USMCA). For example, COFEPRIS has no pre-established procedural mechanism to request data protection recognition or to challenge the recognition granted, which means that in most cases, this protection is granted by court order.

As such, there is no special regulation for orphan or pediatric drugs. In terms of the aforementioned international treaties, in particular what is established in the USMCA, the Mexican state must grant protection to undisclosed tests or data for a period of five years, provided that such information is a condition for the granting of the respective MA, it refers to a new chemical entity that has not yet been previously approved, which involves considerable effort.

There is no clear regulation in Mexico, so there are no specific deadlines to request and obtain data protection recognition. As mentioned, to obtain protection of undisclosed data in Mexico, it is commonly necessary to initiate strategic litigation with the purpose of compelling the health authority to grant protection in compliance with the international treaties signed by Mexico. This type of litigation can take up to one and a half years.

Data exclusivity for variations in the formulation of the product or for new indications is mainly obtained through strategic litigation, which is not public and, therefore, not visible to third parties. Thus, it is complicated and uncommon for third parties to challenge said protection in a timely manner. In any case, the challenge to an official data exclusivity recognition would have to be done through a federal contentious trial before the TFJA, or if said protection was previously obtained via judicial mandate, it would have to be done through an Amparo trial as an extraordinary means of defence. In this scenario, the health authority becomes the defendant, and the owner of the test data protection becomes the interested third party.

The use, manufacture, offering for sale, and import of a patented invention will be permitted as long as said activities are carried out exclusively to generate tests, information, and experimental production necessary to obtain medicinal marketing authorisation.

It is important to mention that in terms of the new LFPPI, the “Bolar” clause is not temporally limited. So, the use of a patented pharmaceutical invention may be made at any time during the validity of the patent, as long as said use has the ultimate and exclusive purpose of generating evidence and information necessary to obtain a MA.

Although the Regulation of Health Supplies establishes a Bolar period of three years for generic medicines and eight years for biosimilar medicines, application of the LFPPI will begin to predominate in practice, not only because it is more recent and has a superior normative hierarchy, but in addition the Health Authority itself (COFEPRIS) has indicated through various statements that the three- and eight-year restrictions will no longer apply.

In Mexico there is no “Orange Book” per se through which the Health Authority publishes relevant information on the approved reference medicines, the status of the respective patents, or data exclusivity.

The closest equivalent to an “Orange Book” is a gazette of pharmaceutical patents that must be taken into account within the linkage process when requesting marketing authorisations for medicines. As established by the applicable regulations, this list should only include those patents with an active substance or ingredient. However, this list also includes composition and formulation patents by virtue of a binding precedent issued by the Supreme Court of Justice. Second use or process patents are not included in this list and are not, therefore, part of the linkage.

Despite the above, it is a regular practice of IMPI, when linking, to analyse all the pharmaceutical patents related to the medicine that is the subject of the application for MA, without limiting itself to those patents published in the aforementioned gazette. As a result, second medical uses patents are frequently cited as an impediment to the granting of MA. This practice leads applicants, whose marketing authorisations have been denied due to a patent which is not listed in the gazette, to initiate litigation in order to obtain the revocation of said decision and acquire the corresponding grant.

In Mexico, the Health Authority periodically publishes information on MA applications for medicines. These publications are made at approximately three-month intervals, providing transparency and public access to general information about the applications in process. In addition, the Health Authority annually publishes a list of granted marketing authorisations. This means that general information for both marketing authorisation applications and MAs already granted are available to the public, facilitating the monitoring and consultation of this information without need to establish special monitoring in the jurisdiction, or make requests for freedom of information.

Only the generic name of the medicine, its pharmaceutical form, as well as the name of the applicant are disclosed in these public lists. If more details about the application or the medication are required, it is necessary to formally request access to this information; however, information such as the qualitative–quantitative formula, indications, etc, is usually confidential, thus denying its disclosure to third parties.

Finally, it is necessary to point out that in practice, there is no difference in the treatment of the linkage and the Bolar clause between generic and biosimilar medicines, even though the Regulation of Health Supplies expressly provides for the linkage of generics and omits biosimilars.

In Mexico, the reimbursement system does not exist as such. According to the Law on Acquisitions, Leasing and Services of the Public Sector, direct awards are made for patented medicines. This means that the patentee has greater freedom to set the price of his/her products, especially since the Co-ordinating Commission for the Negotiation of Medicines and Health Supplies Prices ceased operating in 2018. However, the price may be subject to a market analysis by the corresponding agency in the case of tenders.

On the other hand, the relevant list in Mexico is the National Compendium of Health Supplies, which is public and accessible through the General Health Council. The owner of the marketing authorisation of the reference product is not notified about an application for a generic or biosimilar medicine. Therefore, follow-up regarding the public lists mentioned or a request for Freedom of Information may be necessary to obtain this information.

Finally, it is important to stress that in Mexico the pricing and bidding processes for patented medicines, including those with second medical use patents, are generally not specific regarding the particular therapeutic indication, although there are some exceptions. Regarding the reimbursement system for medicines, it is necessary to insist that there is no system as such in Mexico; the public purchase of medicines is done through bidding or direct awards in the case of patented medicines to satisfy social needs.

There is no distinction between generic and biosimilar patents.

There is no distinction between generics and biosimilars.

There is no distinction between generics and biosimilars.

There is no distinction between generics and biosimilars.

There is no distinction between generics and biosimilars.

The LFPPI establishes that when there are unreasonable delays in the processing of a patent directly attributable to IMPI that result in more than five years between the filing date of the application in Mexico and the granting of the patent, a Complementary Term Certificate (CTC) may be granted to adjust its validity at the request of the interested party.

The main provisions to consider are as follows.

• The maximum validity that the CTC may have is five years.
• Once the applicant is informed of the admissibility of the patent grant (notice of allowance), he/she will have two months to submit the CTC application.
• The CTC request must demonstrate that the delays in granting the patent are unreasonable and directly attributable to IMPI.
• Along with the CTC application, proof of payment of the corresponding fee, which is set annually by IMPI, must be submitted. (In 2023, the rate was around USD1,600.)
• When deciding the admissibility of the CTC, IMPI must do the following:
1. Verify that the patent process exceeded five years; otherwise, the petition will be dismissed.
2. If the processing of the patent exceeded this period, it will determine the period of time that corresponds to the reasonable delays and subtract it from the processing period.
3. If the resulting period is less than five years, the Institute will reject the request.
4. If the resulting period is greater than five years, IMPI will determine the number of days that correspond to an unreasonable delay, which will result in a CTC for one in every two days of unreasonable delay.
• Once IMPI informs the applicant of the admissibility of the CTC, the applicant has a period of one month to submit proof of payment, which is set annually by IMPI. (In 2023, the rate was around USD177.)

It is important to keep in mind that CTCs are available for all types of patents. The LFPPI does not distinguish between different products under the same patent, or a product protected by multiple patents. If the previously mentioned requirements are met and the existence of unreasonable delays directly attributable to IMPI that resulted in a period of more than five years between the filing date in Mexico and the granting of the patent is demonstrated, this must be granted.

Regarding the applicant’s identity, the LFPPI specifies that the CTC can only be requested by the patentee.

No special provision is stipulated in the Mexican legal framework in regard to pediatric extensions. This does not mean there is no protection for pediatric medications; there is simply no patent extension mechanism specifically designated for them as in other jurisdictions.

In Mexico, undertakings as to damages are required from patentees in exchange for a preliminary injunction. The patentee must warrant any harm that may be caused to the person against whom the injunction is sought. The amount of the guarantee (usually a bond) is generally quantified by the patentee; however, IMPI may require an increased amount in the event that the elements provided by the applicant, those from the case file, and statements from the alleged infringer convince that the amount is unsatisfactory.

Regarding the duration of the preliminary injunctions, these will subsist for the entire time that the proceeding lasts so long as the guarantee remains in force. However, the defendant has the opportunity to either post a counter-guarantee to lift the preliminary injunction or to judicially challenge it.

Unfortunately, no one can benefit from an undertaking as to damages besides the alleged infringer in Mexico. The guarantee provided by the patentee only serves to compensate the defendant when appropriate.

For preliminary injunctions to be enforceable, the following are required.

• The issuance of a written decision by IMPI.
• Personal notification to the alleged infringer of this decision.
• The payment of a sufficient guarantee by the applicant of the measures to respond for damages that could be caused to the alleged infringer.

Preliminary injunctions are enforceable as from service upon the defendant. The LFPPI stipulates that the person against whom any of these measures has been ordered has a ten-day period to submit observations to IMPI regarding the measure or the amount of the provided guarantee. This implies that the notification must be carried out promptly to allow this right of response. The law does not detail the timelines for carrying out the notification. Despite this, under the supplementary norms regarding administrative procedures, it is required that the notification be clear, precise, and within a reasonable timeframe that allows the defendant to respond adequately.

The scope of the preliminary injunction can vary. It may include the withdrawal of products from the market, the suspension of services or commercial activities, among others, depending on the nature of the infringement, the plaintiff’s request and the measures effectively imposed. The deadlines for the execution of these measures may vary depending on the specific case and the complexity of the measures ordered.

The LFPPI does not specify a fixed amount for the guarantee that an applicant must provide when seeking injunctive relief. Instead, the applicant initially sets the amount unilaterally, based on the specifics of the case and potential damages that the measure might inflict on the opposing party. However, if the elements presented by the applicant or those arising from the case file suggest that the guarantee is significantly insufficient, IMPI has the authority to order an increase in this amount.

Moreover, for a preliminary injunction to remain effective, the patentee is required to file a main action. The LFPPI mandates that if the applicant does not file the corresponding infringement action within 20 business days – counting from the day after the measure is executed – the applicant will be deemed liable for any damages incurred by the person against whom the measures were implemented.

In Mexico, preliminary injunction can be suspended (stayed) via an Amparo suit before the federal district courts. However, this suspension is subject to the following requirements.

• The applicant of the stay demonstrates that the preliminary injunction causes irreparable harm.
• The stay of the preliminary injunction does not contravene public order or social interest.
• The petitioner of the stay provides sufficient guarantee to respond for the damages that this measure may cause to the affected party.

The LFPPI also provides the possibility for the alleged infringer to obtain the lifting of preliminary injunctions so long as the following requirements are met.

• A counter-guarantee is offered to respond for the damages that could be caused to the patentee by lifting of the preliminary injunction. The “quantum” or amount of this counter-guarantee depends on several factors, such as the economic value of the dispute, the possible damage to the patentee, and other circumstances pertinent to the case. However, in practice, to obtain the lifting of the measure, the alleged infringer usually provides a counter-guarantee equal to the amount guaranteed by the petitioner of the measures and an additional 40%. This percentage originates from what was established in the now-repealed Industrial Property Law. Therefore, although the new LFPPI does not specify a particular “quantum” for the counter-guarantee, in practice, it continues to be used and is commonly accepted by the IMPI.

• The alleged infringer can demonstrate an appearance of good right (fumus boni iuris).
• The impact of the preliminary injunction is greater than what could have been caused to the person who requested it.
• The public order and general interest are not affected.

Final injunctions become enforceable at the moment they are served to the defendant. However, as mentioned in 5.1 Preliminary Injunctive Relief, the LFPPI does not explicitly detail the timelines for carrying out the notification. Despite this, following supplementary norms regarding administrative procedures, it is required that the notification be clear, precise, and within a reasonable timeframe that allows the defendant to respond adequately.

There is no specific procedure to enforce final injunctions as such. However, their execution must follow the guidelines set by the IMPI within the resolution. This may include actions such as the withdrawal of products from the market and suspension of services or commercial activities, among others, depending on the nature of the infringement and the final injunction issued.

Patentees are not required to pay any bond for the final injunction to be enforceable. It is executed and remains in force as long as the affected industrial property right is valid.

Finally, it is important to mention that it is possible to obtain a stay of a final injunction through ordinary means of defence, either through a review appeal or a contentious trial before the SEPI. For this stay to be granted, it is necessary to demonstrate a prima facie case and that the suspension does not affect the social interest and public order. Also, when the stay could cause economic harm to the patentee, a bond must be granted, the amount of which will be determined by the authority or court handling the case.

It is important to clarify that in Mexico, the concepts of damages and injunctive relief are different legal entities and have different purposes in the legal system. While damages refer to monetary compensation awarded to one party for loss or damage suffered due to the actions of another party, precautionary measures are court or authority orders that seek to prevent harm or ensure compliance with a future court decision.

One of the main arguments to limit the scope of preliminary injunctions, or even to deny them in the cases of life sciences and pharmaceutical patent litigation, is the impact on the public order and social interest. Although these are indeterminate legal concepts, it is up to the courts to determine on a case-by-case basis whether the preliminary injunction could affect the population or the public order.

Examples of the above are situations in which a preliminary injunction could result in a shortage of an essential medicine or the interruption of vital treatment for patients. In cases like these, IMPI or the jurisdictional authority may determine that the public interest and the protection of public health prevail over the rights of the patentee. This consideration is because access to essential medicines is a fundamental principle of the human right to health.

Likewise, the authority may consider the proportionality of the requested precautionary measure. This involves assessing whether the restriction imposed by the measure is reasonable and proportional in relation to the potential harm that patent infringement may cause to the patentee. In this context, it can be argued that less restrictive measures, such as the payment of financial compensation, may be sufficient to protect the interests of the patentee without negatively affecting the public welfare or the interests of the alleged infringer.

Methods for Calculating Damages

According to the LFPPI, several methods can be used to calculate damages in cases of infringement of industrial property rights. Below are the methods and how they are applied.

Value of infringed products or services:

• Calculation – it is calculated based on the market price or the suggested retail price of the infringed products or services.
• Application – this method is useful when there is a clear market for the product or service, and it is possible to determine a target market price.

Lost profits:

• Calculation – it is based on the profits that the patentee would have obtained if the infringement had not occurred.
• Application – this method is applicable when the patentee can clearly demonstrate lost profits due to infringement. A causal link can be demonstrated between the decrease in profits and the beginning of the infringing conduct.

Profits obtained by the infringer:

• Calculation – focuses on the profits that the infringer has obtained as a result of the infringement.
• Application – this approach is used when how much the infringer has earned through the infringement can be established.

Hypothetical licence price:

• Calculation – how much the infringer would have paid for a legitimate licence is estimated, considering the commercial value of the infringed right and the existing licence fees.
• Application – this method is useful in cases where there is no direct loss of sales or profits, but where a right that would normally be licensed has been infringed.

The patentee can freely choose the method that he/she considers most appropriate for calculating damages, depending on the circumstances of the case and the nature of the infringement.

Special Situations for Calculating Damages

Regarding the influence of pricing transfer, this may be relevant in situations where transactions between related entities (such as companies in the same group) could affect the calculation of lost profits or realised profits. In such cases, whether pricing transfer has influenced profits or losses must be evaluated.

If the patentee does not have a competing product on the market, the assessment of damages may be more complex. In these cases, the approach may lean toward calculating lost profits based on market projections, or using the hypothetical licence price method, since there are no comparable direct sales.

In Mexico there are no specific guidelines for the quantification of damages in the pharmaceutical, biopharmaceutical, or medical device industries. Therefore, the quantification of compensation for patent infringement is based on the general principles of damages, following the guidelines and methods above.

In this regard, there are no special compensations in this type of industry; Mexican legislation does not expressly contemplate the figure of punitive damages or special compensation such as triple damages for intentional infringement. Compensations are based on the reimbursement of the actual damage suffered.

Period for Calculating Damages

Damages begin to accumulate or be quantified from the moment the violation occurs. However, they are not enforceable until the resolution imposing compensation is final. Regarding the payment of interest, Mexican law generally allows the imposition of interest on amounts owed as part of compensation for damages from the time it becomes payable. The calculation and interest rate depend on what is established in the corresponding court ruling and on the legally applicable rates in Mexico.

Procedural Moment for Calculating Damages

Damages can be considered in two contexts:

• In an administrative proceeding at IMPI, which begins after an infringement proceeding and once the technical resolution is enforceable.
• Directly before the ordinary civil courts as part of the technical trial on patent infringement, without the need for a prior administrative declaration of infringement. In this case, within the same resolution the infringement will be declared and the admissibility of compensation for damages will be decided.

Deadline for Payment of Compensation for Damages

The specific time for payment of damages is not detailed in the LFPPI or in the applicable procedural laws. It is only specified that after both parties have been heard, the judge will grant a reasonable period for the defendant to comply with the payment of the respective compensation. In practice, this period does not usually exceed ten business days.

Compensation to the Alleged Infringer for Wrongful Injunction

If it is proven that the violation alleged by the patentee does not exist, the alleged infringer will have the right to claim compensation for the damages suffered as a result of the measures granted. Unlike compensation, if the infringement is proven, in this case, there are no indicators of legitimate value or pre-established methods to quantify the amount of compensation, making it necessary for the defendant not only to prove that he/she suffered an economic damage, but also to demonstrate the clear causal link between the economic damage and the preliminary injunction that was incorrectly granted.

Finally, it is important to note that in Mexico, a third party that is not directly involved in the infringement litigation cannot claim compensation for damages.

When the infringement request and claim for damages is collectively filed before IMPI, legal costs, including IMPI’s fees, are not recoverable. However, when the infringement action or claim for damages is filed before a civil court, legal costs are recoverable.

In Mexico, the conduct of the plaintiff is not relevant when quantifying legal costs or damages.

Trade mark litigation in the pharmaceutical and life sciences sector is common in Mexico. Among pharmaceutical companies, there is usually conflict between the trade marks used by competitors, or the determinations made by IMPI, in relation to the refusal to grant trade mark registrations.

The primary sources of law regarding trade marks within the pharmaceutical and life sciences sectors are the LFPPI and the Regulations for the Industrial Property Law, which establishes the general framework applicable to trade marks, the General Health Law, the Regulation of Health Supplies, and the Official Mexican Standard NOM-072-SSA1-2012, which establish the specific restrictions trade marks are subject to in pharmaceutical matters.

We can name the following special considerations that apply to trade mark matters within the pharmaceutical sector in Mexico.

• The distinctive name cannot clearly or obscurely include the composition of the medication or its therapeutic action.
• The distinctive name cannot include words or phrases that may deceive or mislead the public.
• The distinctive name for generic and biosimilar medicines is optional.
• When a MA is revoked, no one can use the same distinctive name again, not even the same owner.
• If the distinctive name is made up of two or more words, these must appear on the same line or in a row, with the same font size and in a contrasting colour with respect to the background.

In Mexico, copyright litigation in the pharmaceutical and life sciences sectors is not very common; there are no special provisions in copyright law that are specifically applicable to this sector. Consequently, disputes related to copyright tend to be less frequent compared to patents or trade marks.

Copyright issues in the pharmaceutical and life sciences sector in Mexico usually relate to general copyright provisions, for example:

• product labels and packaging – there may be copyright issues related to the design, text, and images used on product labels and packaging;
• instructions for use – manuals and instructions for pharmaceutical products and medical devices often contain proprietary information, copying of which can lead to disputes;
• marketing materials – copyright disputes may arise from the unauthorised use of copyrighted materials in advertising and promotional content;
• research and development materials – although the information generated in the R&D process is usually protected by the figure of data protection, as trade secrets, the documents and materials created during said process could also be protected by copyrights, which could lead to litigation if used or copied without authorisation; and
• software and digital tools – many modern pharmaceutical tools involve software, which can be a source of copyright issues.

The relevant sources of law in this context are the Federal Copyright Law and the LFPPI and its respective Regulations. These provisions establish general rules for the protection of copyright and intellectual property, respectively, without particular distinction for the pharmaceutical and life sciences sectors.

In Mexico, litigation regarding trade secrets is not very common in the life sciences and pharmaceutical sectors; however, these litigations exist and constitute an important tool to combat and prevent unfair and dishonest conduct that compromises the secrecy of said information.

Among the common problems that can arise within the pharmaceutical and life sciences sector are the following.

• Misappropriation of confidential information – the obtention and use of confidential information without consent by employees or competitors can occur, for example, when a company hires former employees of one of its competing companies.
• Collaboration and partnership disputes – disagreements may arise over the use and ownership of trade secrets in joint ventures or collaborations.
• Data theft and cybersecurity breaches – unauthorised access to digital databases containing relevant commercial or industrial information can lead to trade secret disputes.

The relevant sources of law in this context are the LFPPI and the Regulation of Health Supplies.

Contesting Preliminary Injunctions

In Mexico, the only way to challenge and seek suspension of a preliminary injunction is via an Amparo suit before the federal courts. The period to file it is 15 business days from the notification to the defendant.

Once the indirect Amparo lawsuit is admitted, the date for holding the hearing is approximately one month later. In the judgment, the federal district judge will consider the arguments presented by the parties, as well as the records in the original file and previous procedural actions, evaluating whether the granting of the preliminary injunction was correct. Therefore, it is feasible to conclude that the matter is considered de novo.

A special consideration to bear in mind when challenging the granting of preliminary injunction is that for the appeal to be admissible, the appellant must demonstrate that such injunction irreparably violates one of their constitutional rights. Otherwise, the appeal may be dismissed or terminated without further consideration.

Challenge of the Resolutions Handed Down at the First Instance

Procedures at IMPI

Once the first instance resolution is notified to the parties, they have the following options:

• File review appeal before the Hierarchical Superior of the official who signed the resolution. This must be done within a timeframe of 15 business days. There is no specific legal deadline for resolving the review appeal, but in recent years, IMPI has taken an average of one and a half years. It is important to note that this resolution can be challenged through a contentious trial, where the appellant will have the possibility of directly challenging the validity of the original contested resolution, posting new arguments to those originally raised in his/her review appeal.

• Directly file a contentious administrative trial before the SEPI within a period of 30 days. For the resolution of the contentious trial, there is no specific legal deadline. However, in practice, each trial can take about a year. In both cases, both IMPI and SEPI are limited to examining the arguments of the parties, only analysing errors of appreciation and procedural flaws that occurred during the administrative procedure. It can be concluded that in these appeals, the matters are not studied de novo.

Proceedings before ordinary courts

When the proceedings for damages and the infringement action are brought together before an ordinary federal court, the period to file an appeal against the resolution of the first instance is eight business days. Once the appeal is admitted, the sentence is usually handed down on average in six months.

It is important to note that, similar to the review appeal and the contentious trial, the appeal before the ordinary courts only examines errors of appreciation and procedural flaws that occurred during the administrative procedure. It can be concluded that in these appeals, the matters are not re-examined from scratch (de novo).

Lifting of Preliminary Injunctions

In Mexico, when a preliminary injunction is revoked by a court decision, it is automatically lifted. This means that it is not necessary to carry out an additional procedure for the injunction to cease to have effect. However, if the measure involves the securing of product, the corresponding authority must physically go to the facilities of the alleged infringer to remove the seals or security strips. This procedure requires direct action by the authority.

If the patent underlying the action is declared invalid, it is necessary to submit a specific request for the preliminary injunctions to be lifted. The measure is not considered lifted until said request is resolved favourably. Similar to the case of product securing, it may take up to 29 days between the filing of the request to lift the measure and the issuance of the respective official writ by the authority.

Appeals against decisions made by IMPI can be addressed in two ways.

• They can be reviewed by IMPI itself, where the appeal is considered by a higher-ranking official than the one who issued the initial decision.
• Otherwise, they can be reviewed in a contentious trial filed before the SEPI (Specialised Court in Intellectual Property Matters).

It is important to note that the appeal resolution issued by IMPI can be challenged through a contentious trial, where the appellant will have the possibility of directly challenging the validity of the original contested resolution, posting new arguments to those initially raised in his/her review appeal.

An important matter to consider, applicable to all types of litigation and not only those involving life sciences or pharmaceutical patents, is that the ruling handed down in the contentious administrative trial by the SEPI can be challenged through an Amparo trial, wherein the matter will not be analysed de novo; instead, only the illegalities or flaws that may have occurred within the administrative contentious trial will be examined. This is considered a third and final instance.

The appeals filed against the resolutions issued by the ordinary courts in matters of compensation for violation of industrial property rights are heard by other ordinary courts that are not specialised in intellectual property matters.

Beyond the mechanisms previously discussed, no additional specific procedural rules or guidance provisions need to be considered for IP claims.

In Mexico, outside of IMPI and the ordinary courts, there is no other forum where litigation and actions regarding patents or life sciences can be heard. Even border measures applied by the Mexican Customs Authorities are ordered by IMPI at the request for preliminary injunctions, under the conditions and terms described (see 5.1 Preliminary Injunctive Relief).

Despite the introduction of conciliation in Mexico’s new LFPPI in 2020, it is important to note that this mechanism is limited explicitly to infringement actions.

Despite the inclusion of conciliation in the LFPPI, ADR in life sciences matters, such as arbitration and mediation, are still not widely adopted or explored by the parties in Mexico. This may be due to the familiarity and preference for traditional litigation processes and the specificity of the scope of settlement under the LFPPI.

Nevertheless, it is common for parties to reach settlements during litigation. These settlements enable quicker and more cost-effective resolution of disputes, granting the parties greater control over outcomes and often helping to preserve commercial or collaborative relationships.

In Mexico, there is no specific regulation that applies exclusively to agreements or arrangements in the pharmaceutical or biopharmaceutical sector in terms of antitrust considerations. However, the general provisions of the Mexican antitrust law would apply to these agreements. This encompasses the monitoring and assessment of any settlement or arrangement to ascertain that it neither hampers competition and free market dynamics, nor contributes to the formation of illegal monopolies or oligopolies. While there has not been notable targeted scrutiny on pharma/biopharma settlements in this jurisdiction, these agreements are subject to the general framework and principles of antitrust law enforcement.