Insuring IP Through Trade TreatiesWed, 06/26/2019 - 13:32
Q: How did Olivares enter the life sciences field and in what areas does it operate specifically?
A: Olivares was one of the first law firms in Mexico to have a team fully focused on the life-sciences sector. This department grew thanks to our experience in IP litigation, especially in the enforcement of pharmaceutical patents. Furthermore, there was a need to explore venues other than traditional IP proceedings to address actions such as removing infringing and substandard products from the market. This required expertise in the legal framework of pharmaceutical approvals. We are pioneers in several topics, such as patent term corrections of linked patents, invalid actions against marketing approvals that violate the Health Law and regulations, and regulatory or data package exclusivity.
Q: How can the industry protect itself against COFEPRIS’ delays in approvals?
A: For many years, delays were not a matter of concern in Mexico and we expect that during the current administration they will also not be an issue. However, there are some legal grounds and actions we can use to encourage authorities to comply with the terms provided in the law, international standards and treaties. There are international treaties, such as the USMCA, CPTPP and the Free Trade Agreement between Mexico and the European Union, which establish compensation mechanisms for unreasonable delays in regulatory approvals. Regardless of any current or future policy, Mexico has a strong legal framework for investment, innovation and production. International treaties will lead to changes in local law that will make Mexico even more attractive for innovative companies.
Q: What are the pharmaceutical industry’s main challenges regarding the regulatory and IP legal framework?
A: Based on the recent international treaties, there are many commitments made by the Mexican government to improve IP rights, for example the package of pharmaceutical patents. The most significant areas are patentable subject matter, regulatory protection, patent linkage and the compensation of patent terms.
The main challenge will now be to implement those commitments in the domestic laws. NAFTA included the obligation to recognize data package exclusivity for over 25 years. However, there were no local laws or regulations in Mexico put in place to recognize and enforce these rights. Therefore, innovators were bound to file legal actions to obtain the recognition of data package exclusivity of innovative products. The implementation of the new IP rights would benefit all stakeholders in the pharmaceutical industry.
The IP law must be amended to create a venue of civil remedies for the violation of patents and trademarks, instead of having to wait for a final decision of infringement proceedings. There are suggestions to provide jurisdiction to the Mexican Patent and Trademark Office (IMPI) so that they can award damages. This will not work because as an administrative agency, IMPI’s authority will be questioned when awarding damages. Instead, jurisdiction should be provided to the Mexican Civil Courts, both federal or local, to analyze the violation of IP rights and award damages.
Q: How will the proposed modification to the Mexican Health Law to reduce the scope of the linkage system for pharmaceutical patents affect the pharmaceutical sector?
A: This proposal aims to limit a patent to its active pharmaceutical ingredient (API) and is a significant step backward in IP protection. Moreover, it is anti-constitutional and breaches international agreements, especially CPTPP. Regulations cannot be limited to one patent per product as the proposal suggests. The patent linkage system has proven to act as a deterrent to potential patent infractions. It is not a barrier to generics. Mexican negotiators fought for the patent linkage system during the negotiation of CPTPP and USMCA, and this recent reform proposal aims to erase all these efforts.Improvements in the patent linkage system could include assigning rights and obligations to interested parties, which are the patent owners and generics manufacturers.