alternative-remedies
Viktor Gladkov / Shutterstock.com
20 June 2014AmericasJosé R. Trigueros

IP in Mexico: alternative remedies

The enforcement of intellectual property rights in the pharmaceutical and biopharmaceutical industries is one of the pillars supporting research in, and the development of, new life-saving and life-changing medicines. The time and money spent on R&D, and the overarching need to attract investors willing to risk funds in the sprawling biotech start-up industry, require strong IP protection and effective enforcement tools for the defence of new inventions.

In Mexico, IP firms have traditionally resorted to infringement actions as their only enforcement option, but it is worth noting that there are additional alternatives that may offer relief to companies affected by infringement. The development of such strategies requires more than an extensive and detailed knowledge of IP litigation—expertise in the pharmaceutical regulatory framework and in civil litigation are also required.

Mexico has been traditionally known as a country where enforcement and litigation, notwithstanding the issue or legal area, are extremely slow and cumbersome topics to deal with. However, improvements have been made during the last five to ten years and, while the legal system still has plenty of room to develop, some optimism is in the air.

Tackling infringement

While patent infringement actions are still the backbone of an IP enforcement strategy, patents are lagging behind the advances achieved in the biotech field. Biotechnology developments have provided us with structurally complex biological drugs that are physically different from traditional drugs, a situation that has huge legal implications and, to a degree, has led to uncertainty about the nature and scope of protection for new inventions.

Therefore, new legal strategies for the enforcement and protection of pharmaceutical drugs and medicines in Mexico should also explore and analyse the pharmaceutical regulatory framework, where complex regulations may offer new ways to obtain evidence of infringement, such as through the detailed manufacturing logs that innovator and generic companies are ordered to keep.

Furthermore, careful analysis of the ‘sanitary authorisations’ issued to generic companies may shed light on errors or illegalities in the process and can provide another avenue for putting pressure on infringers, as an innovator company can be in a position to file for the annulment of a generic company’s sanitary registrations.

As a result, an alleged infringer can come under fire from two different fronts: an infringement action strongly consolidated with regulatory elements to strengthen the case, or the annulment of the infringer’s sanitary registration which, if obtained, would deal a devastating blow to the infringer’s standing as information could be offered by the plaintiff to either of the authorities deciding each case.

Finally, the filing of preliminary measures in preparation for a damages suit before the federal civil courts, by means of which the alleged infringer would be required to submit financial records of the possibly illicit gains made by the sale of infringing goods, would show the infringer that the threat is real and present.

"a settlement with one infringer may cause other or would-be infringers to fall into line and establish contact to reach a similar settlement."

In the past, IP infringement cases almost never followed successful infringement actions with claims for damages before the federal civil courts. One of the many reasons was the time and money that would be involved in new litigation, with a high degree of uncertainty. However, civil litigation may now be finalised in two or three years, depending on the complexity of the matter, which would mean that the plaintiff would be able to recoup a portion of its damages while dealing another blow to the infringer.

A combined strategy may provide quick relief for innovator companies when dealing with infringement issues in Mexico. Swift action from three different fronts may put a strain too hard to bear on the infringer, forcing it to reach a settlement that would put a quick end to the matter.

Does it work?

LMT has implemented strategies such as the one described in the preceding paragraphs with varying levels of success.

Ideally, reaching a settlement and providing quick relief for the infringement is the best available outcome. Both parties avoid lengthy and costly litigation and a settlement with one infringer may cause other or would-be infringers to fall into line and establish contact to reach a similar settlement or to prevent additional infringements from other interested third parties.

However, the ideal outcome is not always obtained and both parties may have to prepare for a complex, costly and lengthy trial. Of course, the infringer would have to retain representation for IP litigation, regulatory litigation and possible civil litigation, a situation that would definitely strain the resources of medium to small generic companies that would face hefty legal fees as well as the preliminary measures that would be levied against them.

The scarcity of capable and experienced litigators in the regulatory area would also come into play, as well as the fact that coordinating a defensive strategy between three different counsels with often diverse opinions would present an additional issue to deal with.

A thoroughly prepared strategy may not always reach a positive outcome. However, it should be emphasised that a well-rounded legal strategy is more likely to produce results than a plain patent infringement suit. In the end, our clients have been quite pleased with the results and, after all is said and done, that is what matters.

José R. Trigueros is a partner at Leyva, Montenegro, Trigueros, Abogados SC. He can be contacted at: jtrigueros@lmt.mx