In the rapidly evolving life sciences sector, whether you are a startup or a multinational company, you need a trusted legal partner to deliver practical, cost-effective legal advice and to support you at every stage.

At Arochi & Lindner, we offer comprehensive and interdisciplinary legal advice to the full spectrum of customers in the field of life sciences including pharmaceuticals, biotechnology, medical devices, diagnostics, health care, vaccines, food, agriculture and cosmetics. Our practice covers each stage of the product life-cycle management, including trademarks and patents prosecution, sanitary registrations, license and collaboration agreements, labeling, advertising and marketing, IP litigation, as well as government relations.

Our attorneys have the ability to understand the unique and complex technology of our clients’ work because we have significant scientific industry experience in key industry areas. Thanks to our ability to blend both technical and legal insight on the most complex life sciences innovation, we can help you navigate the turbulent waters associated with the development and commercialization of innovative medical products and services.

Regulatory legal services

We counsel MA application submissions; compliance and enforcement with COFEPRIS; sales, marketing and advertising, and promotion of COFEPRIS-approved products; product testing and clinical trials; and parliamentary and regulatory activities and their impact on products and operations.

Intellectual property legal services

We provide technical/legal analysis such as State of the Art documentation and design around, Freedom to Operate, Patentability, Monitoring & Watch Service and Technology Maps & Patent Metrics delivering expert analysis that supports thorough counseling, portfolio management, transactions, licensing, enforcement and dispute resolution of inventions. We also assist clients in local and global patent prosecution subject to international treaties.

Litigation services

We have significant experience representing life science companies in litigation proceedings. Whenever IP and regulatory interests are threatened, we represent our clients in all litigation proceedings to help ensure optimal market presence. We also represent our clients in litigations presenting patent validity challenges, MA authorizations, and denials.

Government procurement counseling services

We can counsel on all administrative proceedings and agreements related to government procurement of pharmaceutical products, biotechnological products and medical devices. We have wide experience in government procurement litigation in cases of conflicting interests among participants.

Legal issues regarding Life Sciences have flourished in Mexico for the past 15 years. The main reason behind this development is the overall increase in longevity, leading to an aging population and generating an increase in chronic diseases and a need for more new pharmaceutical products in the market.

The legal regime for authorizing the marketing of pharmaceutical products (drugs, medical devices, etc.) is complex due to the extreme caution that needs to be taken in order to guarantee the safety, efficacy and quality of the pharmaceutical products. Clinical trials have to be conducted in order to achieve such high security standards.

Alongside marketing authorization proceedings, the requirement to have a pharmaceutical product or process patent to file for intellectual property protection must also be taken into account. If the marketing approval is for a generic drug, a proper search and study has to be conducted in order to establish that there is no patent infringement (freedom to operate documents).

Thus, in Mexico protection for innovative drugs is obtained by filing for patents and clinical data protection. Such legal procedures must be balanced in order to avoid any unlawful barrier of entry for a generic drug into the market and to curtail access to cheaper drugs.

After marketing authorization has been granted, pharmacovigilance is on-hand in order to avoid any reactions that might affect the health of the patients.

Litigation can ensue when a patent is infringed or when a marketing authorization is unlawfully granted. When litigation is based on a patent, the first instance is decided by the Mexican Institute of Industrial Property (IMPI) and the appellations are ruled by the Federal Courts. When the claim for litigation is grounded in marketing authorization, the first instance is decided by the Federal Court for Fiscal and Administrative Justice.

Life Science practice in Mexico is based on the General Health Law and on a vast array of health regulations and general standards, which seek to regulate all aspects of healthcare and the control of health products and services.

Regarding pharmaceutical products, any drug sold or used in Mexico must be approved by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). The mission of COFEPRIS is to to protect the population against sanitary risks, through sanitary regulation, control and promotion. It is worth mentioning that the sanitary registration process is “linked” to the patent system. The general idea is that COFEPRIS will not authorize the marketing approval of a drug that infringes a patent. The proceedings for a marketing approval are lengthy and costly. For this reason, a thorough review of the applications, documents and trial results that are submitted to COFEPRIS in order to obtain such approval is recommended. COFEPRIS is also in charge of the pharmacovigilance in place to prepare for any adverse reaction to a pharmaceutical product. Life science litigation is increasing due to the linkage system and clinical data protection.