Provisional Measures in Mexico: Protecting Patent Rights

Imposition of provisional measures

IMPI may order products to be withdrawn, prevent their circulation or suspend specified acts under Articles 344 and 345 of the LFPPI. Those provisions require consideration of the prima facie merits of the asserted right, public order and the general interest, as well as the seriousness of the infringement and the nature of the measure requested. The applicant must also provide the required security. LFPPI, Articles 344 and 345.

For a patent, the grant establishes the existence of the right, but the application must also provide evidence connecting the product or process at issue with the subject matter protected by the claims, since the dispute may turn precisely on whether the third party uses that invention. Not all the evidence that will be taken in the infringement proceedings is necessarily available when provisional measures are decided. The assessment of the prima facie merits therefore allows a provisional decision on the available evidence, without requiring prior resolution of the very question for which the main proceedings were brought.

The applicant's security addresses the risk that the measures may harm the party subject to them and later be found unwarranted. Providing it does not relieve the right holder of establishing the grounds for the requested measures. If offering a sum of money were sufficient, a third party's activity could be prevented without even showing a connection between that activity and the asserted right. That outcome does not follow from Article 345, and it helps explain why the counter-bond cannot have that automatic effect either.

What IMPI must assess before lifting provisional measures

Article 346 of the LFPPI does not make the lifting of measures conditional solely on providing a counter-bond. It also requires consideration of the prima facie merits, an assessment and balancing of whether the harm to the party subject to the measures would exceed the harm to the party that requested them, and verification that public order or the general interest would not be adversely affected. The party seeking to lift the measures must therefore provide evidence for that assessment, and IMPI must decide on the evidence supplied by both parties, as the provision itself states. LFPPI, Article 346.

The reference to both parties matters because the holder obtained the measures on the basis of a right and evidence that the authority considered sufficient to grant provisional protection. In deciding whether to lift them, IMPI must therefore address that evidence and the objections raised against the alleged infringer's submissions. The fact that the holder was heard when requesting the measures does not mean it has had an opportunity to defend itself against the reasons and evidence subsequently advanced to lift them, particularly if the new request introduces a different technical explanation or attributes characteristics to the product that had not previously been discussed.

The holder must have an opportunity to know and challenge the evidence submitted to obtain the lifting of the measures before a decision is made. The Collegiate Circuit Court recognized this in the review appeal discussed in the final section, ordering that the holder be given access to the opposing party's submissions and evidence, together with a reasonable period in which to respond.

The counter-bond and the balancing of harms

I consider it incorrect to conclude that the party subject to the measures would suffer greater harm solely because it has established prima facie merits in its favor. That conclusion cannot replace a comparison of the harm to each party. Article 346 requires both assessments, since the apparent merits do not, by themselves, show what harm maintaining the measures would cause or what harm lifting them would produce. Resolving the second requirement merely by invoking the first therefore dispenses with a balancing exercise that the statute requires.

The omission can be identified by examining whether the decision specifies the harm to the party that requested the measures and weighs it against the harm to the party seeking to lift them. If the decision merely states that the holder has a counter-bond available, while considering the alleged infringer's inability to market its product and the commitments it has been unable to fulfill, the harms have not been compared. On one side, the harm was examined; on the other, the possibility of recovering against the security was treated as sufficient. The counter-bond may be relevant to assessing compensation, but it does not establish that the holder's harm is smaller or that its amount can cover everything the holder has alleged.

The same insufficiency arises when the holder's security is considered inadequate to justify maintaining the measures, but the alleged infringer's counter-security is treated as sufficient to lift them. If a bonded sum were enough to neutralize any harm, the security initially provided would have to receive equivalent treatment under that reasoning. And if the harm to the party subject to the measures warrants examining more than the existence of a bond, the holder's harm requires the same assessment.

Patent exclusivity and the time elapsed during litigation

To argue that the holder's harm is economic and can therefore be compensated at the end of the proceedings overlooks the fact that a patent confers exclusivity for a limited term, during which its holder may prevent unauthorized exploitation by third parties. Harm to that right does not require the holder to stop manufacturing or selling its product. It may continue doing so while losing the exercise of exclusivity against someone using the invention without its consent, if infringement is established. The possibility of continuing to market the product therefore does not establish that lifting the measures has no consequences for the holder.

In a procurement process, for example, the allegedly infringing product may displace the holder's product during a period within the patent term, and the supply may already have been completed by the time litigation ends. Infringement and its connection with that displacement must be proved, since a patent does not make its holder the successful bidder in every procurement process. But if those elements are established, a later decision does not allow the holder to compete again for a completed supply contract or to exercise exclusivity during a period that has already elapsed. That is the harm left unanswered when the entire discussion is reduced to recovery against the counter-bond.

In writing about patent term adjustment, I discussed the distinction between the term recognized for a right and the period during which it can be exercised, although that issue concerns the authority's delay in granting it. When measures are lifted, the patent has already been granted, and the dispute concerns the protection it receives while infringement is determined. The security provided neither extends its term nor restores the days that have elapsed. I therefore consider that a conclusion that damages can be compensated requires examining what compensation can actually cover and what part of the harm would remain despite it. The proprietary nature of the right does not make everything that occurs during its term reversible.

The right to health as a ground for lifting provisional measures in pharmaceutical cases

Invoking the right to health to lift provisional measures sometimes rests on the proposition that preventing the marketing of the product at issue restricts access to medicines. That connection cannot be treated as established merely because the patent and the product belong to the pharmaceutical sector. Maintaining measures against a particular medicine does not necessarily prevent access to treatment. If a medicine is available through other channels, that fact must therefore be assessed against the alleged harm to health, taking into account whether it can be supplied in the quantities, presentations and conditions patients require.

The existence of another medicine does not, by itself, resolve a supply or affordability problem either, but it requires the problem attributed to the measures to be specified. If maintaining them is said to cause shortages, demand must be considered in relation to supply capacity. If they are said to cause a price increase, the basis for that consequence and its effect on access to treatment must be examined. Without such evidence, lifting the measures is credited with an assumed health benefit, against which the holder is required to tolerate conduct whose lawfulness remains disputed.

The State bears the primary obligation to guarantee access to health through its policies for the supply, procurement and distribution of medicines. I consider it incorrect to shift that burden to a patent holder by asserting that it must allow an allegedly infringing product to be marketed because it is a medicine. The right to health protection and the recognition of temporary exclusivity for inventions form part of the same constitutional order. Applying Article 4 therefore does not authorize disregarding the protection recognized in Article 28 without examining the circumstances that would justify restricting it. Mexican Constitution, Articles 4 and 28.

If the product's connection with health were sufficient on its own to lift the measures, that reasoning could be applied to any pharmaceutical patent, and its provisional protection would depend from the outset on a circumstance that will always be present. My objection concerns that consequence. Serious harm that a measure may cause patients must be assessed where there is evidence to support it, but it cannot be presumed as a general matter against holders of patents covering medicines.

Technical evidence as part of the strategy for obtaining provisional measures

As part of the strategy for obtaining provisional measures in patent cases, technical evidence is submitted to determine whether the product or process at issue uses the protected invention. The existence of the patent must be connected with the acts attributed to the alleged infringer. Product studies and specialist opinions help explain that connection by reference to the patent claims and what was actually analyzed. Their findings support the allegation of possible infringement on which provisional protection is sought.

The fact that this evidence is also relevant to deciding the main proceedings does not allow its entire assessment to be deferred until the final decision. The prima facie merits must be examined at the provisional stage to determine the basis for the alleged infringement. IMPI must explain what each item of evidence establishes and how it relates to the right for which protection is sought. That assessment has the provisional scope inherent in the measures. Requiring infringement to be definitively established before granting them would prevent protection of the right while the dispute is decided.

If the lifting of the measures is subsequently requested, that evidence must be assessed against the opposing party's arguments and evidence, taking into account what each establishes about the disputed technical question. Faced with differing conclusions, the authority must explain the support it finds in each item of evidence and why some allow it to reach greater certainty than others.

In a favorable ruling we obtained on review, the Collegiate Circuit Court required precisely that comprehensive assessment of the scientific evidence together with the parties' other evidence, even though infringement remained to be decided in the main proceedings. Its reasoning was that the decision on lifting the measures was already determining which party would receive provisional protection against harm to its rights. Submitting that technical evidence with the application therefore also allows the holder to require IMPI to address it when the lifting of the granted measures is sought.

The scope of the favorable ruling obtained on review

In the case discussed here, we obtained a judgment reversing the decision under review and granting amparo relief, under Mexico's constitutional protection procedure. Its direct effect was to set aside the administrative decision that had lifted the provisional measures. The court ordered that the holder be given access to the submissions and evidence filed in support of the request to lift the measures and a reasonable period in which to respond. But it also held that IMPI's reasoning was insufficient because it had assessed the alleged infringer's evidence without genuinely weighing it against that of the party that had obtained the measures.

The difference from cases in which relief centers on allowing a response and ordering consideration of the evidence submitted is that this judgment specified how the assessment had to be conducted. IMPI was required to examine all the parties' arguments and evidence against each other and identify which provided greater certainty for weighing, under the prima facie merits assessment, who might suffer greater harm if the measures were maintained or lifted. Under that mandate, receiving the holder's submissions and mentioning them in the new decision was not enough to comply with the court's order.

The ruling on scientific evidence forms part of that scope. The court considered it necessary to assess such evidence together with the other evidence, even though the provisional decision would not definitively determine infringement. This has consequences for the defense of a holder that has submitted technical studies, because it requires their content to be examined when deciding who will retain protection during the proceedings. The authority must conduct that analysis on the available evidence and within the assessment of probability appropriate to this stage, without deferring it merely because the same evidence is relevant to the merits.

Regarding the right to health, the court considered the products' connection with health insufficient to justify lifting the measures. It stated that other factors had to be examined, such as the absence from the market of another product with the same generic name or the existence of shortages. It mentioned these as examples of circumstances relevant to assessing public order and the general interest. In doing so, it required the decision to rest on concrete conditions, rather than a general reference to health.

The judgment left IMPI to assess the specific evidence and decide anew whether to lift the measures, in accordance with the requirements established by the court. The definitive determination of infringement remains for the main proceedings.

I consider this ruling significant because it allows the holder to require the new decision to address the evidentiary conflict that prompted the request for protection, as well as ensuring that the holder can participate before the measures are lifted. In issuing the new decision on lifting the measures, IMPI must show how it assessed the parties' submissions against each other, what weight it gave the scientific evidence and what evidence supported any harm to the general interest it invokes. Those matters fell within the terms of the amparo relief and allow compliance with the judgment to be reviewed.