Alejandro Luna Fandiño
View from the Top

The Right Intellectual Property Protection

Wed, 09/09/2015 - 15:21

Q: What is the importance of the Life Sciences Industry Group for Olivares & Cia and to what extent has demand for expert legal services in this arena been growing?

A: The group is comprised of experts in both technical and legal aspects of the health sector that truly understand our client’s legal and commercial needs. It was founded ten years ago and has expanded on a yearly basis due to the continuous regulatory changes in the health sector. Historically the law in Mexico relating to pharmaceutical products stated that international companies were required to have facilities or plants in Mexico if they wanted to obtain a marketing authorization to commercialize their products. This requirement has been abrogated, allowing medium and large foreign companies in different areas including pharmaceuticals to commercialize their products through distribution agreements and partnerships with existing companies in Mexico. Such significant changes to the law as well as ongoing complex requirements have required international companies establishing in Mexico to seek the help of specialized consultants to help them carry out operations in compliance with the regulatory framework.

Q: What is the role of Olivares in helping innovative pharmaceutical companies to protect intellectual property?

A: We have an entire strategy model for this specific matter. We first contribute to encourage a culture of patentability in Mexico by emphasizing the necessity to protect patents, especially since developers and inventors tend to consider the expenses in the IP protection as an expense to be cut from their established budgets. The Linkage Regulation is an effective instrument to ensure that intellectual property regarding pharmaceutical products is safeguarded. After the linkage regulation was enacted in 2002, the Mexican Institute of Intellectual Property (IMPI) and COFEPRIS refused to recognize the legislation, an issue that Olivares addressed by filing constitutional actions to include the use and formulation of patents, with a high success rate. One particular case even reached the Supreme Court before being resolved and this verdict significantly impacted the pharmaceutical industry. Failure to address this issue would have meant the Linkage Regulation would only be bound to compound patents, leaving behind innovative formulation and use patents.

Q: How strong is the current framework for the protection of intellectual property in this fast growing industry?

A: The current framework to protect innovation is in line with global patent standards. Naturally, we still have some areas of opportunities to improve upon. However, it is currently more important to prioritize enforcement of current legislation to resolve uncertainty about IMPI’s criteria and the timeframes needed to resolve litigation, especially for patents. In cases regarding patents and trademarks in Mexico, a company cannot claim damages until it receives the final decision over whether a patent or trademark infringement occurred. There are two main pitfalls regarding law enforcement. One is that a company cannot claim damages until the final declaration and therefore companies must exhaust all administrative proceedings before the final decision is made. The second is the fact that preliminary injunctions can be overruled by posting a counter argument.

Q: How did the Mexican healthcare sector benefit from the protection of clinical data concerning innovative molecules?

A: Our law firm was hired by AMIIF to represent them in the TPP negotiations. Regarding data exclusivity, 20 years after NAFTA, we still do not have a domestic law recognizing the exclusivity of medical data in Mexico. Even though Mexico is part of NAFTA and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which both enforce exclusivity of medical data, there is nothing in Mexican regulation recognizing that protection. Medical data differs completely from patent protection but the issues can coexist. COFEPRIS published this on its website, stating that it would protect new chemical entities against direct and indirect replication by unauthorized parties for a term of five years. However, the problem is not the timeframe, it is that these guidelines have no true legal value. This is why we based our legal strategy on convincing COFEPRIS to provide this protection through a court order, which would protect companies not only in terms of confidentiality but also with regards to indirect reliance, which occurs when COFEPRIS gives generic manufacturers the authorization to produce drugs without the necessary tests by stating their medications are the same as innovators. This type of protection is provided by both NAFTA and TRIPS.