Hall Of Fame

Firms To Watch: Life sciences

The life sciences and health practice at Santillana Hintze Abogados handles regulatory and compliance matters across the pharmaceuticals, food and beverages, and consumer and health care products (including medical devices) sectors, from manufacture, labelling and storage through to transportation, marketing and distribution; the team also undertakes counselling on patent and generic drugs, and permitting and licensing for product commercialization. Co-founding partner Gustavo Santillana -whose practice ranges from corporate matters to health law and regulation- is the key contact.

Life sciences in Mexico

Baker McKenzie Abogados, S.C.

Global firm Baker McKenzie Abogados, S.C. pulls no punches when it comes to its life sciences offering in Mexico, fielding a ‘well-developed practice' consisting of 14 partners (drawn from a diverse range of practice groups), plus a further four associates and two senior technical experts, thereby allowing the firm to put together teams with capability in the distinct segments of the sector. Practice head Christian Lopez-Silva is a recognised and dedicated specialist whose practice takes in  both advisory and regulatory healthcare and life sciences matters, associated IP and IT&C matters, life sciences transactions, medical devices, pharmaceuticals and biotech, product liability and recall, and public law and regulatory disputes. He is flanked - as necessary - by a further five key partners: foreign trade and customs specialist José Hoyos-Robles; head of the firm's technology, media and telecommunications (TMT) industry practice group in Mexico, privacy specialist Carlos Vela-Treviño; IP specialist Marina Hurtado-Cruz - who has particular expertise regarding health, advertising and consumer law and whose practice also takes in administrative litigation; Guadalajara-based Fernando Robles, also an IP specialist (particularly as regards litigation and enforcement), who in addition has a niche specialism as regards the beverage and alcoholic drinks sector; and Roberto Cardona, a tax specialist and head of the firm's public and administrative law practice in Mexico. At associate level, following the March 2022 departure of senior David Campos, the firm hired Carla Calderón -also as a senior- in November 2022; a dedicated specialist whose practice encompasses life sciences regulation, pharmaceutical law and biotechnology matters, she arrived at the firm after almost a decade as chief legal officer at government contractor EXIMCO, where she gained considerable experience in administrative law. The group's caseload indicates ongoing consolidation of the practice offering, particularly as regards regulatory litigation (notably, for a number of medical device companies), private health service matters (for regional private hospitals such as Puerta de Hierro and Christus Muggerza), digital health, public acquisitions and patent linkage (for clients such as Glaxo Smith Kline, Biogen and Procter & Gamble).

Practice head(s):

Christian Lopez-Silva


Key clients

Bristol Myers Squibb


Biomarin


Biogen


Chinoin


UKDIT


Beckton Dickinson


Alcon


Novo Nordisk


Nissan Foods


Takeda


Stryker


Boston Scientific Corporation


Bausch & Lomb


Medline Industries


Parexel


Glaxo Smith Kline


Procter & Gamble


Puerta de Hierro


Christus Muggerza


Sonrisas Mexicanas


Church of Jesus Christ of Latter-Day Saints


Work highlights


  • Assisted big pharma, orphan drug companies and local companies with their navigation of the new system of procurement of medicines implemented by UNOPS.
  • Assisted Beckton Dickinson in addressing multiple legal and commercial implications resulting from regulatory delays, leading to administrative litigation against the health regulator.
  • Represented Alcon in regulatory applications relating to COFEPRIS.

Galicia Abogados S.C.

Highlighted for its ‘very deep knowledge of current regulations, the sector and its risks‘, which thereby allows the eight-strong team to ‘provide practical solutions‘, the life sciences practice at Galicia Abogados S.C. is co-led by Bernardo Martínez Negrete and counsel Lisandro Herrera. The group acts for a deep roster of pharmaceutical and healthcare industry clients on matters ranging from logistics and compliance to licenses and dispute resolution. Moreover, as part of a full-service firm the practice has experience throughout the multiple segments that constitute the practice – from issues related to digital health, UNOPS and governmental procurement processes; health care mergers, acquisitions and joint ventures; the regulatory aspects of the release, sale, labelling, promotion, advertising and distribution of medicines, medical devices and human vaccines; along with the drafting and negotiation of agreements and regulatory data protection. Senior figure Martínez-Negrete has been involved in various innovative healthcare projects (not least his advice to Sanofi on the implementation of the first public-private partnership for the manufacturing and commercialisation of influenza vaccines in Mexico), and more recently on projects directly related to Covid-19 and, subsequently, post-pandemic developments; while fellow practice co-head Herrera spent over a decade in house at companies including Sanofi Aventis, Teva and the Asociación Mexicana de Industrias de Investigación Farmacéutica (AMIIF) before moving into private practice and becoming a recognised expert in health regulation, governmental procurement processes, pharmaceutical regulation, medical devices and compliance, among other matters. At associate level,  the experienced Luis Marin Tijerina and younger colleague Martha Contreras advise clients on regulatory matters concerning pharma products, innovative and generic drugs, high-tech equipment, biotechnology, food supplements and medical devices, as well as clinical studies, cosmetics and personal hygiene products, digital health, tobacco products, and toxic and controlled substances. Marin’s practice also takes in consumer protection matters, safety and product liability, and more generally all aspects of the consumer goods sector.

Practice head(s):

Bernardo Martínez-Negrete; Lisandro Herrera


Testimonials

Great availability (24/7) and the ability to work as a team. Extensive experience in life sciences, antitrust and amparo law.

Galicia is an excellent firm and its lawyers have robust experience and a very deep knowledge of current regulations, the sector and its risks. This allows them to provide practical solutions.

They issue trustworthy legal opinions that are really applicable to the company I represent.

Key clients

FUNSALUD


Work highlights


  • Advised independent civil association FUNSALUD on the design and drafting of the draft digital health bill that was submitted to the Federal Congress and is under discussion.

Hogan Lovells

Delivering ‘legal research that is usable from a business standpoint’, the small but experienced team at Hogan Lovells has impressive life sciences credentials and expertise in industries including pharma, health care, consumer goods, chemicals, and technology; and advises on matters including M&A transactions, the restructuring of business models and operations, labelling and advertising issues, the launch of new products, product liability and antitrust, as well as handling litigation. Recent matters include regulatory advice to ensure full compliance with labelling requirements (under the amendments to NOM-051) and sanitary control regulations for products, services and advertising; operational regulatory advice; administrative litigation to secure product marketing authorisations; and assisting clients with navigation through public procurement procedures, among others. The practice is led by Ernesto Algaba Reyes, a 20-year veteran in the sector who focuses primarily on health law and regulatory compliance matters for the pharmaceutical and medical devices industries. Specialist support is provided by counsel Cecilia Stahlhut Espinosa who also has over 10 years’ sector experience regarding regulatory drug matters, medical devices, biotechnology, product compliance and general health regulatory compliance, as well as a background in related international trade matters. On the contentious front, the pair can call on counsel for global regulation, Alan Ramirez, and senior associates Giovanni Sosa (corporate and finance) and Marino Castillo (litigation and arbitration), as necessary; while on intellectual property-related mattes, practice head Bernardo Herrerías is the key contact. Former specialist associate Héctor Mercado moved to Cuesta Campos y Asociados S.C. in June 2022. Since publication, Stahlhut has been raised to the partnership - effective as of January 2024.

Practice head(s):

Ernesto Algaba Reyes


Testimonials

The lawyers of the life sciences team are highly skilled in their field, but are also sensitive to the nature of our lines of business, which allows them to deliver legal research that is usable from a business standpoint.

Their best qualities are their concern for their clients, the search to ensure clarity in the information requested, and the importance they give to ensuring the protection of our company, as well as the ease of communicating with them.

Ability to identify aspects in the “blind spot” of the company. On more than one occasion they have alerted the company of real risks that we had not identified.

The depth of each review. The level of detail in their opinions and reviews is surprising, but never sacrificing response time.

In-depth knowledge of food regulation and as well as regulatory knowledge of other industries that helps to anticipate and better understand potential changes and future requirements in our industry.

Key clients

Mondelēz International


Work highlights


  • Advised Mondelēz International on the regulatory due diligence and negotiations with Grupo Bimbo for the $1.3bn purchase of Ricolino, the latter’s confectionery business.

OLIVARES

Long known as one of Mexico’s leading IP practices, Olivares has developed its lifescience practice over the course of some 20-odd years, marrying its know-how in IP matters (especially as regards patents) with genuine commercial-side strength. The result is a department with profound regulatory-side knowledge (particularly in relation to life science clients’ R&D projects and novel products), arguably unequalled experience of patent litigation, and full corporate-side capability - including the structuring, drafting, negotiation and closure of asset purchases; supply chain and distribution matters; and procurement and license agreements (as related to M&A). It also handles associated corporate structuring and restructuring, and foreign investment issues for both foreign and local companies, along with administrative compliance and issues such as the transferral of marketing authorisations and portfolio sales. Indeed, the firm has earned a reputation for its ability to influence the regulatory landscape, particularly as concerns pharmaceuticals, having established precedents in relation to the legal framework for health authorisations and approvals, regulatory data exclusivity, pharmaceutical patent term corrections, patent linkage and filing amicus briefs concerning biologic drug regulations. It also has deep experience regarding administrative compliance. The firm’s life sciences and pharmaceutical law industry group is co-led by Gustavo Alcocer, head of the firm’s M&A, corporate and commercial department (and a former Banamex assistant general counsel), who is responsible for the corporate, transactional and financing aspects of the practice; and Alejandro Luna F, who coordinates the firm’s litigation activity and whose practice takes in IP litigation, contentious regulatory matters and administrative litigation; with almost 20 years’ experience as a partner, he is also co-chair of the IBA’s life sciences committee. Fellow partner Armando Arenas heads up the medicines anti-piracy/counterfeiting practice, but also leads on civil litigation matters (where Luna is also active, along with Abraham Díaz, co-head of the firm’s privacy and IT industry groups). Biologist Rommy Morales -who was raised to the partnership in January 2023- handles much of the practice’s patent-related work and is a key support for both regulatory and litigious matters. The partners can also draw on a capable associate bench: dedicated seniors Ingrid Ortiz (whose practice is centred on life science regulatory matters), and Karla Olvera (who in turn focuses solely on life sciences litigation) each have over 12 years’ experience. Additional technical support comes from (non-lawyer) patents coordinator Mauricio Sámano (who also has over a decade at the firm); while younger associate, administrative litigator Eduardo Arana is also of note for his niche expertise in liability and damages claims in the life sciences sector.

Practice head(s):

Gustavo Alcocer; Alejandro Luna; Armando Arenas; Rommy Morales


Key clients

Roche


Biogen


GSK


Novartis


Lilly


Abbvie


Sanofi


Work highlights


  • Handled the recognition of regulatory data exclusivity for various clients (Novartis and Janssen inter alia) and products (new chemical entities, formulation and new uses).
  • Undertook patent linkage improvement for innovator pharmaceutical companies through litigation and policy before the Mexican authorities – notably on behalf of the Mexican Association of Pharmaceutical Research Industries (AMIIF).
  • Advising and representing Sanofi Janssen as regards patent-term compensation litigation.

Solórzano Linaldi

The ‘professional and efficientSolórzano Linaldi is the the key stand-alone boutique in this market segment and -according to clients- has ‘the specialised personnel necessary’ and the ‘ability to adapt both technologically and in terms of human resources to meet the needs of its customers’; it handles the full range of life science matters, particularly as regards health and pharmaceuticals, chemicals, medical devices, cannabis, food and beverages, technology, media and entertainment, telemedicine and e-commerce. The team is led by Guillermo Solórzano, whose life sciences practice combines health regulation, intellectual property, foreign trade, and transactional corporate law; with over 25 years’ experience, he has led on relevant cases of biotech drugs in the market; on the design and implementation of legal strategies to obtain the marketing authorisation of drugs, generic drugs, biotech drugs and biosimilar drugs; and also undertaken successful litigation cases against major pharmaceutical companies. Fellow name-partner Luis López Linaldi’s expertise is primarily in the areas of international dispute settlement, technical barriers to trade, foreign investment, trade in services, and sanitary and phytosanitary measures; he also has particular knowledge of the practicalities and regulatory norms associated with export/import procedures concerning the life sciences sector. Of late the practice has been particularly active with judicial and administrative appeals, the obtaining of licenses and marketing authorisations, and cross border issues – particularly relating to regulatory processes. The firm continues to attract new clients – such as pharma company Novagenic Mexico and e-commerce distributor Riogrande – and recent headline mandates include representing Asofarma against Novartis’ opposition to its application for a sanitary registration, and representing the same client in an administrative infringement proceeding initiated by Wyeth and Pfizer before the Mexican Institute of Industrial Property (IMPI) – the case that is currently before the Supreme Court of Justice of the Nation. The arrival of  counsel Jorge Ortega – a January-2023 hire with extensive experience in the public sector (notably in the Secretaría de Hacienda y Crédito Público, and in the Secretaría de Gobernación) – has notably strengthened the firm’s capabilities in relation to compliance and public procurement matters. At associate level, key support comes from senior Eréndira Frias, who has over 15 years’ experience and primarily advises national and multinational companies on pharmaceutical, sanitary and administrative litigation; fellow senior Christian Parra, principally an IP litigator; and associate Alan Osorio Aragón who advises on market analysis and health regulation and also coordinates the operation of the firm’s “intelligence unit” regarding regulatory norms, globally. The 10-strong legal team can also draw on the input of three chemical engineers. Since publication, the team has been further strengthened with the hire of Mariana Larrea Arias - formerly of Santamarina y Steta - as counsel (effective as of October 2023).

Practice head(s):

Guillermo Solórzano Leiro; Luis López Linaldi


Testimonials

Solorzano Linaldi has been the company’s legal office for almost eight years, during which time it has distinguished itself by adapting to the different and growing needs of the company, and modifying its approaches to the different legal situations that the company faces. From my perspective Solorazno Linaldi’s main strength is this ability to adapt both technologically and in terms of human resources to meet the needs of its customers.

I would highlight that they have dedicated personnel with experience in different areas – such as the generation and review of contracts; personnel specialised in intellectual property, the legal framework in the pharmaceutical industry, etc. They have the specialised personnel necessary to attend to our needs as clients.

The combination of the talents of Guillermo and Luis make it worth all the investment in the fees, they quickly adapted to the virtual environment and are always available with the IT tools to conduct remote meetings.

Key clients

Novagenic Mexico


Pharmascience Inc


Apotex México


Glenmark Pharmaceuticals


Sun Pharma de México


Investigación Farmacéutica (IFA Celtics)


Chemistry Linkage Unit of the School of Chemistry, UNAM


Beam Suntory


Genbio


Vert Pharma


Gelpharma


Laboratorios Corne


Laboratorios Agroinsumos


Asesores en Calidad para Laboratorios


Work highlights


  • Analysed the regulatory aspects of a project with the Coalition for Epidemic Preparedness Innovations (CEPI  – an international foundation focused on the World Health Organization’s blueprint priority), to provide lab services focused on epidemics, including COVID 19.
  • Advising Vert Pharma on the implementation of a project for the design and manufacture of products with cannabidiol (CBD), including compliance with the regulatory requirements applicable to Cannabis and CBD products, good manufacturing practices (GMPs) and the negotiation and drafting of supply and manufacturing agreements with Vert Pharma’s suppliers and clients.
  • Ongoing representation of teh Asociación Mexicana de Laboratorios Farmacéuticos (AMELAF) in a constitutional appeal (amparo) against a decree wherein the Mexican government implemented a fast-track procedure for foreign drugs to obtain marketing authorisations in an expeditious manner, thereby discriminating against drugs produced in Mexico.

Creel, García-Cuéllar, Aiza y Enríquez, S.C.

The September-2022 hire of senior associate David Campos -formerly at Baker Mckenzie- marked a notable step in the consolidation of the practice group at Creel, García-Cuéllar, Aiza y Enríquez, S.C.; in addition to ten years private practice experience (and a six-month secondment as in house counsel at Sanofi Pasteur), Campos also has an LLM in Global Health law. He joins a team that is primarily focused on providing regulatory and transactional advice (in the pharma, healthcare, medical device, biotech, and food and beverage industries), on matters such as compliance with sanitary regulations, labelling requirements, and the obtaining of registrations and authorisations, as well as transactional advice and -increasingly- contentious matters. It is also active in relation to the chemical industry, notably as regards the manufacture, import and marketing of toxic and hazardous substances, pesticides, and plant nutrients; and has seen an uptick in specialised administrative litigation related to COFEPRIS’ procedures and verification visits. The practice is co-led by senior regulatory and insurance partner Leonel Pereznieto and counsel Guillermo Govela, a former adviser to the Federal Commissioner at COFEPRIS and legal coordinator at Mexico’s Ministry for Health. Additional associate support is provided by semi-senior Rebeca Díaz (who has a focus on food and non-alcoholic beverage regulation), and Andrés Urbano (whose practice is centred on tobacco and alcoholic beverage regulation); both of them are also key to the firm’s ability to handle the due diligence processes of M&A transactions with a health care/life sciences component. On the contentious front, the team can call on the capabilities of counsel and administrative litigation specialist Héctor Anaya. Recent matters have seen the team particularly active with regard to regulatory reviews, analysis and opinions, while on the healthcare side, it has been engaged in a number of transactions in the private health segment (involving hospitals and clinics), as well as M&A involving laboratories.

Practice head(s):

Leonel Pereznieto; Guillermo Govela


Testimonials

They have experience not only as lawyers, but have also been members of different government bodies which allows them to know the different approaches that consultations can take.

Experience, practicality, business orientation.

In the case of health law, partner Guillermo Govela has extensive experience in this legal field.

Guillermo Govela has experience in the area of health, he worked for many years in that sector within the Government, which means that he knows the issues in depth.

Key clients

Bristol Myers Squibb de México


Amgen México


Grupo Nacional Provincial


Colgate Palmolive


The Bazooka Companies


The Not Company


Axa Seguros


FEMSA Servicios


Inovio Pharmaceuticals


Monster Beverage Corporation


Work highlights


  • Advised Inovio Pharmaceuticals on the regulatory implications of modifying the original purpose of its Covid-19 vaccine (for which the team had obtained the necessary clinical trial authorisations before COFEPRIS back in 2021), to use as heterologous booster, including an analysis on the Mexican applicable rules and regulations for emergency use authorisation.
  • Advising AXA Seguros (Mexico) on the M&A and insurance regulatory aspects of its joint venture with Keralty (for the purpose of including healthcare services a part of the insurance offering for AXA’s clients), so as to ensure that the structure of the transaction is compliant from a life sciences regulatory perspective.
  • Legal and regulatory advice for Bristo Myers Squibb de México regarding the regulation of orphan drugs (and the process for their inclusion in the National Compendium of Health Supplies), so as to ascertain the pros and cons of maintaing the status of two of BMS’s products as orphan drugs or switching their regulatory classification to that of allopathic drugs; the advisory involved procedures before both COFEPRIS and the National Health Council (CSG).

Ibarra, del Paso y Gallego

The medium-sized firm Ibarra, del Paso y Gallego  has ‘has a specialisation in life sciences and it shows in the highly complex level of consulting they provide’, clients suggest, also noting that it ‘has grown considerably in this area in recent years’. The experienced, eight-strong team provides comprehensive legal advisory across the entire array of life science segments, from research and development, agricultural, pharmaceutical, industrial and biotechnology products, through to medical devices, cosmetics and personal care, chemicals, agrochemicals, animal health, tobacco, and food and beverages. Originally more focused on regulatory and sanitary consulting and litigation, the practice has since built-out its IP-side capabilities, giving it additional reach, and today the group handles transactional and regulatory legal advice, life sciences-focused due diligence support, accompaniment in the obtaining of healthcare, biotech and other authorisations; litigation and representation before the Ministry of Health, COFEPRIS and other relevant authorities; and also undertakes risk and contingency assessments in relation to tech transfers, licensing agreements, M&A, joint ventures and export/import matters.  ‘A lawyer who know abouts the life sciences’, name partner and practice co-head Adrian Del Paso has approaching two decades focused on environmental, pharmaceutical and health sector matters. He advises both regulated companies and not-for-profit organisations on the full range of regulatory and life science matters and is also an experienced administrative litigator. Fellow co-lead, Juan Manuel Alvarez Del Castillo, who is also head of the intellectual property practice, manages the IP aspects of life science mandates - particularly those related to the pharmaceutical, chemical, technological, and food and beverage industries. Senior associate Mauricio Sandoval is also a key participant as regards administrative litigation; however, the firm will miss the specialist customs and international trade knowledge of dedicated associate Ricardo Koller, who left the firm in late 2022.

Practice head(s):

Adrián del Paso; Juan Manuel Álvarez del Castillo


Testimonials

Ibarra del Paso is an office with great service and quality. Its team responds with great speed and quality.

Adrian del Paso is a great lawyer who understands his clients’ needs very well and seeks to offer creative and solid solutions. It is always a pleasure to work with Adrian.

The team is made up of competent and experienced people, it is a very specialised practice area and not many law firms in Mexico handle this issue. The members of the team are willing to get involved in meetings and negotiations in which the clients participate and this adds value to their service.

The partners are flexible lawyers, who are willing to put themselves in the client’s shoes and adapt to their needs. Adrian del Paso is a lawyer who know abouts the life sciences subject and, in addition, is studious and in-depth in his analysis, which gives legal certainty to clients.

It is a firm that has grown considerably in this area in recent years. It has a specialisation in life sciences and it shows in the highly complex level of consulting they provide us. The team is made up of very professional specialists who provide services very close to the clients.

Adrián del Paso is a lawyer who does not stay on the plane of what is requested, he always goes for more and likes to understand the needs of his clients. He provides us with unparalleled support, he is part of our extended team and his work has made a difference to the company’s legal strategies. His accompaniment has undoubtedly led us to make better decisions.

Arochi & Lindner, SC

With offices in Madrid and México City as well as established corporate, dispute resolution and regulatory practices, well-known IP firm Arochi & Lindner, SC is well placed to offer services in the life sciences sector. The practice offers comprehensive, interdisciplinary legal advice to a full spectrum of life-science clients (from pharma, biotech, medical devices and diagnostics through to health care, vaccines, food, agriculture and cosmetics) throughout the product life cycle, from trade mark and patent prosecution, through registrations, licensing and collaboration agreements, to labelling, advertising and marketing. The practice also handles IP litigation and matters before/with COFEPRIS; and has particular experience in government procurement litigation in cases of conflicting interest among participants. Name partner and practice head Heidi Lindner has over 35 years’ IP experience and is one of the market’s foremost patent litigators in relation to life-science matters related to the pharma, biotech and medical device segments. A counsel to the Mexican Association of Generic Drug Companies, Lindner’s practice also takes in licensing and advisory on life sciences regulatory matters. Key associate support comes from the experienced Celmira Sanchez, whose practice focuses primarily on health regulation; and the equally experienced Manuel Morante whose practice is centred on IP litigation (particularly strategic matters), patents and life sciences. On the administrative litigation front the team can call on the experience of Alberto Santos; and more broadly, the practice also draws on strong non-legal associate specialist support including chemists Francisco Alvarez, Marcos Juarez and Georgina Pimentela; and biological and pharmaceutical chemists Mauricio Caballero and Juan Luis Espinosa. Since research concluded, the team has been considerably strengthened with the hire of dedicated life sciences and compliance practitioner Julio Copo Terrés (who has ‘an integral vision of the sector’, according to peers), as of counsel – effective as of October 2023.

Practice head(s):

Heidi Lindner


Basham, Ringe y Correa, S.C.

The practice at Basham, Ringe y Correa, S.C. draws on the firm’s full service capabilities to field a team that is at its strongest regarding the IP-side of the life sciences practice, particularly as regards patent-related matters, on behalf of a client list with a strong big pharma component. It also acts for a range of firms in the alimentary and tobacco sectors on regulatory matters and has niche engagement with medical software developers (currently an unregulated area in México). The practice is perhaps best known for its success in arguing for the extension of the length of patent terms due to time-losses as a result of patent office delays in the granting of patent protection, a case with particular relevance in the life sciences segment. It has also been active in relation to medical technology and devices, orphan drug designations and in the alcoholic beverages sector, recently. The practice group is co-led by Adolfo Athié, who focuses on intellectual property consulting and administrative litigation (and is also involved in IT and privacy and data protection matters); and Claudio Ulloa is principally active on patent related matters. On the corporate side, Juan Carlos Serra and Jesus Colunga provide transactional experience and the group can also call on the firm’s solid standing in international trade matters where necessary. A former Secretaria de Estudio y Cuenta at the Supreme Court, Diana Rangel arrived as a counsel at the firm in January 2023 and should add further to the team’s administrative litigation capabilities. However, key associate Carolina Nogal is currently undertaking her LLM.

Practice head(s):

Adolfo Athié; Claudio Ulloa


Key clients

Bayer


Alexion Pharmaceuticals


Grupo Jumex


Work highlights


  • Assisted Jumex with advice on the status of diverse Mexican official Standards related to alcoholic beverages.
  • Prepared a legal opinion regarding Orphan Drug Designations (“ODD”) related to an of assignment of rights, and covering regulatory and contractual topics on behalf of Alexion.
  • Successfully obtained a patent extension on behalf of Bayer in the Supreme Court by evidencing unreasonable delay on behalf of the Patent Office.

CMS Woodhouse Lorente Ludlow

CMS Woodhouse Lorente Ludlow fields a small, four-strong practice in Mexico City but significantly the team sits as part of the international firm’s global life science practice which boasts more than 300 dedicated lawyers. The local practice group primarily handles work from the domestic and international pharma sector, along with clients across the medical devices, food and drink, and chemicals’ sectors, including administrative procedures, regulator-mandated audits, and market approval/launch matters. Practice head Mauricio Gómez Guerrero is a former chief of staff to the Federal Commissioner at COFEPRIS – the federal regulatory entity responsible for protection against health and sanitary risks; his practice focuses on life sciences regulatory matters, along with regulatory enforcement administrative procedures, issues concerning controlled substances, and government affairs strategy. Key support is provided by administrative (and constitutional) litigator, senior associate Manuel Ferrara Ibarra, who works across both the energy and life science sectors; he has particular expertise in both defence strategies before federal and local administrative procedures, and undertaking challenges related to regulatory, administrative and fiscal matters.

Practice head(s):

Mauricio Gómez Guerrero


Testimonials

High knowledge of the subject, specifically in terms of the regulatory issues for the health segment; they stand out for their immediate attention and availability.

Mauricio Gomez Guerrero, partner of the life sciences and healthcare practice, has extensive experience in regulatory health issues, complemented by his experience at COFEPRIS. Immediate and concrete attention.

Key clients

Boehringer Ingelheim


Essity Higiene y Salud México


Celanese Operations Mexico


Rubbermaid Commercial


Novag Infancia


Bioresearch de Mexico


Offenbach Mexicana


GT Technologies


Farmacéuticos Altamirano de Mexico


Randall Laboratories


Work highlights


  • Successfully advised Boehringer Ingelheim on a project and in negotiations with the authorities to evolve a rare disease drug with special authorisation.
  • Representing a client before the Federal Court to file an administrative claim against COFEPRIS.

Gonzalez Calvillo

The team at Gonzalez Calvillo has solid experience across both the advisory (licensing, compliance etc.) and the contentious aspects of the life science and healthcare sectors. The practice regularly handles matters concerning the import, marketing, distribution, storage, advertising, and sale of products such as drugs, medical devices, food supplements, food and beverages, spirits, and tobacco products. It is co-led by counsels Enrique Muñoz Guízar, who advises companies on identifying and obtaining the permits, licenses, authorisations, and concessions that they may require for their activities and operations; and administrative litigator Carlos Fernando Castilla, who works across the environmental, regulatory and life sciences segments, and has experience designing complex defence strategies. Key associate support is provided by senior Georgina Zavala who also has an administrative law background and works across environmental, agrarian and social impact; and life science, health care and sanitary regulation matters, including consumer protection and labelling.

Practice head(s):

Enrique Muñoz Guizar; Carlos Castilla


Testimonials

The technical qualities of this team make it our reference firm in device regulatory issues.

Enrique Muñoz Guizar and Georgina Zavala González have outstanding technical knowledge in device regulatory law.

Key clients

Windmill


Amazon Lab


Eucalyptus Medical


Genomma Lab


Givaudan


Google


Hazel Technologies


Jafra Cosmetics


Kabisa Energy Drink


Kelly Deli


Little Caesar’s


M3 Resources


Mezcal Cinco 70


Mezcal El Silencio


Nutrición Ela


Pharmeta


Philip Morris International


TransEasy Medical Tech


Work highlights


  • Advised Windmill on determining the applicable regulations that air conditioners must comply with to be commercialised in Mexico, so as to expand the company’s business in the country.
  • Advised Kelly Deli on the launch of promotions and sweepstakes in Mexico.
  • Advised TransEasy Medical Tech on the preparation of a legal opinion explaining the regulatory framework on health matters in Mexico.

Sánchez Devanny

A recognised market presence, Sánchez Devanny routinely assists clients in the pharma, chemical, cosmetics, tobacco, and food and beverage industries on a range of life science matters including regulatory, compliance, approvals, marketing, labelling and litigation. The practice is co-directed by José Alberto Campos-Vargas, who handles regulatory matters, international trade and administrative litigation; and Juan Luis Serrano, who has experience in government procurement and crossover IP matters. In addition, the pair can call on the expertise of senior associate Maria Luisa Mendoza López who handles international trade and has a particular focus on the import and export requirements for regulated products which correspond to the life sciences industry. Recent mandates range from winning patent extensions and contentious labelling matters in the pharma sector, to import regulatory matters for with regard to chemicals and dietary supplement ingredients, and post-transacional regulatory advice.

Practice head(s):

José Alberto Campos-Vargas; Juan Luis Serrano


Testimonials

The team led by Juan Luis Serrano is always available and up-to-date on any new developments that arise in the industry, whether regulatory or IP.

The experience and capacity for analysis to find innovative solutions.

It is a highly capable team with sufficient experience to provide the necessary advice on regulatory matters for the pharmaceutical industry.

Juan Luis Serrano is always attentive to new possibilities and challenges and clearly recommends the steps to follow. I’d highlight his capacity for synthesis and explanation of issues to those who are not legal scholars, where he offers complex actions that are beneficial for companies in a clear manner.

Key clients

FEMSA-KOF


Schwan Stabilo


Procter & Gamble


L’Oreal


AstraZeneca


British American Tobacco


Teva


Grupo Embotellador Pepsico


Slimfast


Merck


Work highlights


  • Ongoing advisory to P&G on several regulatory scenarios related to the acquisition of Merck’s consumer health division, including available pathways before the authority.
  • Advised a company on the importation requirements for diverse products used in the manufacturing of dietary supplements and the applicable non-tariff restrictions and requirements
  • Represented a major pharmaceutical company in litigation to obtain term extensions for two patents concerning compounds used for medical treatments, successfully securing first stage District Court decisions ordering the Mexican Patent office to extend both patents.

Santamarina y Steta

The departure of specialist associate Mariana Larrea in September 2022 was an undoubted loss for the life sciences group at Santamarina y Steta; nevertheless, practice head Alejandro Luna has undoubted life science and consumer protection expertise (particularly in relation to manufacturing, pharmaceuticals, medical devices and the food and retail industries), as part of a broader practice that also takes in foreign trade and customs, anti-corruption and immigration law. Indeed, his foreign trade experience has proven invaluable in relation to import and supply chain strategies, product import/export strategies and customs consultations. A member of the Asociación Mexicana de Derecho y Regulación Sanitaria (AMDERSA), Luna also advises on the life science aspects of M&A transactions, with peers considering him 'a relevant player' for advisory matters in the sector.

Work highlights