A pioneer in the life sciences sector in Brazil, Kestener & Vieira Advogados remains at the forefront of the market, often advising on cutting-edge matters for a client base of leading pharmaceutical and healthcare companies. Of particular note is the firm’s experience in complex judicial and administrative litigation; a recent case in point was its successful defence of Baxter Hospitalar in a class action brought in the state of Pará, which alleged that the defendants would be manipulating the market by failing to supply drugs needed for dialysis procedures. Clients also regularly turn to the team for advice on regulatory matters, with recent advice covering genetically modified organisms (GMOs), soil and advertising regulations, among other areas. The department is also well versed in pricing and reimbursement matters. Founding partner Beatriz Kestener is a well-known specialist in the field of life sciences. She leads the team, which includes experienced senior associate Tatiana Gualberto Kascher. Since publication, Rubens Granja, Júlia de Castro Kesselring and Natássia Misae Ueno have left the firm - effective December 2021.
Life sciences in Brazil
Kestener & Vieira Advogados
‘Personalised service. The firm understands the company’s day-to-day life in order to deal with issues with a technical eye, in addition to a legal eye.’
‘Bia actively participates in our work meetings and Flávio, who acts as her right hand in our cases, conducts impeccable service.’
‘Expertise, high quality, creative, specialists.’
‘Beatriz Kestener and Tatiana Kascher are recommended.’
BL Industria Ótica
Boehringer Ingelheim Do Brasil Química E Farmacêutica
Produtos Roche Químicos e Farmacêuticos
Zodiac Produtos Farmacêuticos
- Represented Fleury in a writ of mandamus with preliminary injunction filed against the president of the Brazilian Health Surveillance Agency (Anvisa) to obtain a decision to allow the use of batches of tests for Covid-19 wrongly considered expired.
- Provided regulatory assistance to Hefesto Desenvolvimento e Criação de Tecnologia Médica on the execution of Project Breath4life, regarding the fast production of pulmonary ventilators through 3D printing technology within the context of the Covid-19 health emergency.
- Represented Baxter Hospitalar in a class action against two companies which claimed that the companies would be manipulating the market by failing to supply drugs needed for dialysis procedures.
Highlighted for its ‘in-depth technical knowledge‘ and the ‘availability of senior partners and associates‘, Pinheiro Neto Advogados maintains a busy life sciences department, which is equipped to advise clients across all relevant sub-sectors, from pharmaceuticals to cosmetics to medical devices. The department’s extensive regulatory expertise sees it providing advice on biodiversity, advanced therapy and sanitary protocols, and the team has also been particularly busy assisting clients on matters relating to Covid-19 and immunisation. The firm’s leading corporate and M&A practice, combined with its life sciences specialism, also makes it well placed to advise on corporate transactions in the sector. Angela Kung, a co-founder of the firm’s well-established life sciences practice, is highly regarded for her expertise in this field. Healthcare law specialist Théra van Swaay de Marchi and senior associate Nicole Aun, whose expertise spans compliance, regulation, data protection and IP, are also names to note. Associate Júlia de Castro Kesselring left in June 2021.
‘In-depth technical knowledge; availability of senior partners and associates; ability to understand the practical situation and search for effective and safe solutions in the implementation of the projects.’
‘Pinheiro Neto Law Firm is the biggest and renowned law firm in Brazil, formed by highly qualified professionals in the areas of expertise, especially in the Life Sciences area. Due to deep knowledge in the area, knowledge of legislation and regulatory and sanitary standards, it makes the firm one of the best for legal advice in Brazil. In addition to deep knowledge in the Life Sciences area, Pinheiro Neto Law Firm also demonstrates high qualification and remarkable knowledge in the area of bidding, which is essential for that area.’
‘Angela Kung and Nicole Recchi Aun are recommended.’
‘Carlos Lima; Angela Kung; Gerson Durant Gomes Filho; Alexandre Magri Trevini: these are distinguished professionals, because of the knowledge of the areas in which they work, specialisms in the themes and deep knowledge of the pharmaceutical sector, M&A and tenders. They are always willing to contribute with business strategies.’
Laboratórios Pierre Fabre do Brasil
Canopy Growth Corporation
Boston Scientific Corporation
Merck Sharp & Dohme
Bristol-Myers Squibb Farmacêutica
Amazon Serviços de Varejo do Brasil
Fialdini Einsfeld Advogados
A ‘renowned law firm in Brazil‘, Fialdini Einsfeld Advogados receives recognition for its ‘culture of customer focus and agility‘. Complex life sciences litigation is the firm’s forte, where the team has vast experience in the lower and superior courts and in administrative proceedings. The team has recently been sought after for assistance and representation in price regulation procedures before the Drug Market Regulation Chamber (CMED) as well as product registration processes before the Brazilian Health Surveillance Agency (Anvisa). The department is also engaged by clients in pre-litigation matters, including preventive consultancy regulatory issues. ‘Creative partners‘ Pedro Sergio Fialdini Filho and Alexandre Einsfeld are ‘dynamic and competent in what they do‘. Other individuals receiving praise include associates Thiago Adorno Albigiante and Amanda Crispim Sampaio. Joaquim Augusto Melo de Queiroz left the firm in July 2021.
Pedro Sergio Fialdini Filho; Alexandre Einsfeld
‘The service offered by the office is of the highest quality. The professionals are extremely trained and efficient, and the care of the office with legal disputes is unprecedented in the market. I strongly recommend Alexandre Einsfeld and Pedro Fialdini, founders of the firm.‘
‘It is an office with high knowledge in the pharmaceutical industry. Its strength is strategic litigation. Pedro Fialdini is always available and attentive to clients’ needs.’
‘Personalised, agile service with high technical rigor.’
‘The firm’s differential is its high expertise in the company’s operating market, and the possibilities for measures to be taken based on the different challenges that the pharmaceutical industry currently presents.’
‘A firm that always brings innovative solutions, outside the traditional solution. Pedro Fialdini and Alexandre Einsfeld are two creative partners, dynamic and competent in what they do.’
‘Very high technical quality, proximity to partners, culture of customer focus and agility, as well as flexibility for negotiating fees. I’d highlight Pedro Fialdino, Thiago Albigiante, and Alexandre Einsfeld.’
‘Fialdini Einsfeld Advogados is a renowned law firm in Brazil, formed by highly qualified professionals in the areas of expertise, especially in the area of Life Sciences. Due to the deep knowledge in this area, knowledge of the legislation and the outcome in the courts, it makes the firm one of the best legal boards in Brazil. Fialdini Einsfield also demonstrates high qualification and remarkable knowledge in the area of bidding, which is essential for that area.’
‘Dr. Pedro Filadini; Dr. Thiago Albigiante; Dra. Amanda Sampaio: distinguished professionals, because of the knowledge of the areas in which they work, specialisms in the themes and deep knowledge of the pharmaceutical sector.’
- Represented a client in a lawsuit aiming at the annulment of an administrative decision preventing the company from taking part in public tenders for one year.
- Advising Allergan on the voluntary recall of breast implants, including in litigation brought by customers across Brazil.
- Represented various pharmaceutical clients in a public civil action filed by the municipality of Londrina claiming that the companies would be intentionally refraining from taking part in public tenders for the purchase of different medications.
The dedicated life sciences and healthcare practice at Mattos Filho, Veiga Filho, Marrey Jr. e Quiroga Advogados strikes a 'perfect balance between full knowledge of the industry and client needs'. As part of one of Brazil's leading full-service firms, the life sciences group benefits from cooperation with the corporate and IP departments. The firm's presence in London and New York is another advantage for the practice, which has a strong international focus and large client base of multinationals. In addition to major pharma companies, the team has also recently been supporting clients in other sectors with complex life sciences regulatory matters in the context of the Covid-19 pandemic. Other recent work keeping the team busy includes advising on clinical research, digital health initiatives, sanitary and ethical regulations and litigation. Also of note is the firm's well-established pro bono programme; recently, the firm has provided pro bono legal advice to hospitals and a temporary hospital facility. Key practitioners Ana Cândida Sammarco and associate Renata Rothbarth are 'highly skilled in complex matters'. Maria Fernanda de Almeida Prado e Silva and associate Caroline Aguiar Malatesta are also noted. The department was further strengthened in September 2021 with the arrival of life sciences expert Gustavo Swenson.
‘Their care for our interests is second to none: cost-effective, accurate legal advice as soon as we need it. They pay attention to the different needs of our in-house business clients and ensure the team is able to develop good working relationships with them.’
‘Ana Candida Sammarco, Caroline Aguiar Malatesta and Jose Daniel Gatti Vergna are our main team. Ana is our relationship partner and took time to understand our needs very quickly, she ensures we have appropriate expertise on hand as soon as we need it. Caroline both project manages the work across the team but also provides astute commercial legal advice.’
‘Since the beginning of our partnership, it was clear that the team was very capable of answering our demands quickly and with high standards. We have deeply learned from them and support was given beyond the direct requests that we provided. Renata Rothbarth and Ana Sammarco always contributed in answering our demands. Both are very competent and professional colleagues, highly skilled in complex matters relevant to our field.’
‘Extremely competent team with great knowledge of the pharmaceutical segment. Flawless work. Availability and flexibility of schedules and meeting deadlines.’
‘Having a solid life sciences practice is of the essence for assisting clients fully engaged in this industry, becoming a partner of their business by providing up-to-date legal and practical advice with an innovative approach for complex transactions and day-to-day work. Working with a full-service firm that actually has a solid life sciences practice is a gold.’
‘Perfect balance between full knowledge of the industry and client needs, expedites work and support, with an innovative approach.‘
Roche Diabetes Care
DASA Diagnósticos da América
- Assisted Fresenius-Kabi Biossimilar in the negotiation of a ten-year productive development partnership for transferring biosimilar technology to a Brazilian public laboratory and supplying products to the Brazilian Ministry of Health.
- Provided advice to Diagnósticos da América on the regulatory aspects of a public-private partnership with the Brazilian Ministry of Health to process up to three million PCR diagnostic tests during the Covid-19 pandemic.
- Advised Laboratórios Pfizer on the legal assessment of structures to negotiate innovative and risk-sharing agreements with the Brazilian Ministry of Health involving oncology therapies.
'Excellent professional' Benny Spiewak leads the practice at specialised life sciences firm SPLaw. The firm's already extensive client base of major pharmaceutical companies continues to grow; among its new clients are Daiichi Sankyo, Cellera Farma and the Dana-Farber Cancer Institute. In addition, the firm is also sought by companies in other industries for advice on health and life sciences matters. The firm is particularly strong in complex, non-contentious regulatory matters and has recently provided advice on a range of issues including marketing authorisation for new food and medicinal products, drug pricing, clinical trials and regulatory compliance programmes. Daniela Jambor and Gabriela Ongari are names to note at the senior associate level. Gustavo Swenson left the firm in September 2021.
‘I have had an excellent experience working with SPLAW in the last few years, especially in the areas of contract, civil and compliance, focused on the life sciences market. Their knowledge of our industry is a very important differential and brings a lot of quality and assertiveness to the work.’
‘We have a lot of contact with Benny Spiewak. He is an excellent professional, always available and with a high knowledge of the topics.’
‘Availability and agility in responses and good level professionals in the different areas of law.’
‘Benny Spiewak, Ana Paula Maia and Pedro de Franco Carneiro are recommended.’
Dr. Reddy´s Pharma
Dana Farber Cancer Institute
The UK Intellectual Property Office
- Advising ABIMED (Brazil’s main medical devices industry association) on crucial issues arising from Covid-19.
- Acting for Boehringer Ingelheim on all compliance and other legal matters regarding its Brazilian human health and animal health operations, including recently challenging a Covid-19 related ban on certain exports.
- Assisting Cellera Farma in regard to an extensive drug marketing and distribution deal with Johnson & Johnson’s Janssen division.
The life sciences department at Demarest Advogados is 'highly qualified, updated and always on hand, even in times of crisis'. It balances a broad practice in the life sciences field, with expertise covering medicine, biotechnology, healthcare, cosmetics, animal health, e-cigarettes and nutrition. Camila Biral is well versed in both contentious and non-contentious matters; Claudio Mattos and Marina Zago are other key practitioners in the team. The firm is also gaining recognition for its diversity and inclusion initiatives, with one client commenting that 'the office is very innovative and in terms of diversity leads several initiatives that inspire and serve as an example for everyone'.
Bruno Aurélio; Claudio Mattos; Camila Biral; Tatiana Campello
‘Our company is attended by an extremely responsive, attentive and agile team. The professionals are always up-to-date, with an integrated and strategic view.’
‘The team led by partner Camila Biral is highly qualified, up to date and always ready, even in times of crisis when we need immediate responses. The level of work received is always excellent.’
‘The lawyers are deeply prepared, and know both the business and the understanding of the judiciary, pointing out risks and helping the company to make appropriate decisions at the right time.’
‘Luiz Fernando Santana: very prepared and competent. Maria Helena Bragaglia: super competent and prepared. Camila Biral: deeply knows the topics she takes care of and is super competent. Mauricio Levy: knows deeply the themes he handles, and is always available.’
JT International Distribuidora de Cigarros
Drogaria São Paulo
- Assisting Bayer with regulatory aspects for the commercialisation of a chemical product used to control vectors that cause tropical diseases (ie Dengue).
- Assisting Blok Bioscience with the import into Brazil of Covid-19 tests, including on complex regulatory matters.
- Assisted Sinovac in the protection of the vaccine trade mark CORONAVAC in Brazil and Chile.
'Proactive in bringing solutions', Kasznar Leonardos Intellectual Property acts for a client base of pharmaceutical, food, cosmetics, agribusiness and medical devices companies, and has notable experience in representing clients in proceedings before the Ministry of Health and Anvisa. Although the firm is well known for its IP expertise, it has also developed an impressive regulatory life sciences practice; the firm has demonstrated its investment in this area through the promotion of two dedicated life sciences practitioners – Priscila Kashiwabara and Aline Ferreira – in recent years. The highly regarded Anderson Ribeiro is another key practitioner in this field; associates Matheus Montecasciano and Lucas Calabria also attract praise.
Anderson Ribeiro; Aline Ferreira; Priscila Kashiwabara
‘What differentiates this firm is the vast knowledge of the pharmaceutical industry, not only in the procedural/litigation/administrative scope, but effectively in the functioning of the companies, the types of activities and interaction with the stakeholders etc., as if they worked at the company. This makes all the difference for both advisory and litigation services. In addition, they are very attentive and give feedback; they are proactive in bringing solutions.’
‘Anderson Ribeiro and Matheus Dias Montecasciano: They make us feel safe in the strategy and conduct of the processes. They are recognised within the scope of the pharmaceutical industry, providing services to other large multinational farms.’
‘It is originally an intellectual property agency that has evolved into an office to offer more services to its clients, including in the area of life sciences, in which, today, it seems to me to have one of the lawyers who best knows the market and is more technically skilled.’
‘Partner Anderson Ribeiro is the best active life sciences lawyer in Brazil. His lawyers Matheus Montecassino and Lucas Calabria are extremely competent.’
‘The firm has extensive knowledge and experience in health regulatory law, a subject that is little explored in Brazil.’
‘Anderson Ribeiro and Matheus Montecasciano are recommended.’
Young Living Essential Oils
- Acted for Stichting Sannamad in a leading case against Anvisa concerning the patentability of cannabis-based products.
- Advised an international client on the feasibility analysis of product authorisation under the regime of cannabis-based products in Brazil.
- Acted for Laboratório Químico Farmacêutico Bergamo in a case against a company which was offering and selling its medicine in public procurements in several states without price approval from the Chamber of Drug Market Regulation (CMED).
Licks Attorneys 'combines technical and legal knowledge, with professionals from interdisciplinary backgrounds'. Led by experienced partners Otto Licks and Eduardo Hallak, the team benefits from the input of its in-house chemists, pharmacists, scientists and patent specialists. The department has also seen recent growth, with the promotion of several associates – including Juliana Neves, Ricardo Campello and Roberto Rodrigues – to the partnership. Its client base has also expanded, with new clients including CropLife Brasil and Silimed. The firm excels in patent litigation, and is also well versed in technology transfers, procurement, bidding processes and regulatory matters. Biotechnology and crop protection specialist Viviane Kunisawa also receives praise.
Otto Licks; Eduardo Hallak
‘Alexandre Dalmasso – professional of extreme competence and experience in compliance, with a strategic vision that combines technical and business vision. Eduardo Hallak – professional with extensive experience in civil litigation, bringing a broad and strategic vision for each topic.’
‘The life sciences team is profoundly aware of the problems facing the industry.’
‘Viviane Kunisawa and Eduardo Hallak are recommended.’
Merck Sharp & Dohme Corp
Pierre Fabre Group
- Assists the Brazilian branch of the CropLife association in several projects related to regulatory matters and IP that are relevant to its members (ie companies in the seeds, biologics and agrochemical fields).
- Successfully represented Gilead in two invalidity lawsuits filed against a sofosbuvir-related patent.
- Defending Genentech in an invalidation lawsuit against its patent PI9809387-8.
With 'excellent technical and pragmatic expertise', the life sciences group at TozziniFreire Advogados combines its experience in regulatory and transactional matters to advise on a broad range of issues. Among the areas covered are clinical research, regulation, drug pricing, data privacy, export and import issues and life sciences compliance. In addition, the team is equipped to represent clients in administrative and judicial proceedings. The firm is renowned for its innovation and diversity initiatives, and also stands out for its active pro bono practice. In a recent highlight, the firm dedicated 160 pro bono hours to the IDDD (Institute for the Defense of the Right to Defense) in a public civil action concerning health and sanitation matters in São Paulo's prisons. In a major development, former practice head Elysangela de Oliveira Rabelo Maurer left the firm in June 2021. However, Marco Aurélio Torronteguy remains a key contact; he is 'highly technical, engaged, committed to solutions and attentive'. Senior associate Victor Hugo Callejon Avallone is another active member of the team.
‘Excellent technical and pragmatic expertise.’
‘Marco Aurelio is a spectacular professional: highly technical, engaged, committed to solutions and attentive.’
CSL Behring Limited
AstraZeneca do Brasil
Torrent do Brasil
KaVo do Brasil Indústria e Comércio
Elizabeth Arden Cosméticos do Brasil
- Advising a company responsible for cosmetics brands on regulatory and environmental matters regarding the potential new structure for the company’s business in Brazil.
- Assisting KaVo in regulatory matters connected to the restructuring of the company in Brazil due to the factory closure.
- Advised a medical devices company on health regulatory matters involving medical devices and equipment in Brazil.
Trench Rossi Watanabe
Full-service firm Trench Rossi Watanabe combines its expertise in public and administrative, IP, corporate and regulatory law to assist household name pharmaceutical and medical devices clients on complex regulatory matters. The team is regularly sought for advice on product licensing, manufacturing and distribution. Its recent advice to AstraZeneca, on the regulatory model for the registration of its Covid-19 vaccine before Anvisa and the contracting model for its commercialisation in Brazil, was a major highlight. The firm adopts a number of corporate social responsibility programmes and initiatives, and has recently provided pro bono assistance to several health charities. Henrique Frizzo is noted for his 'in-depth understanding of regulatory and compliance issues, especially in the pharmaceutical area'. IP, IT and life sciences specialist Marcela Trigo co-leads the department.
Marcela Trigo; Henrique Frizzo
‘The law firm Trench Rossi Watanabe is a renowned law firm in Brazil, formed by highly qualified professionals in the areas of expertise, especially in the Life Sciences area, litigation and disputes. Due to the deep knowledge in this area, knowledge of the legislation and the outcome in the courts, it makes the firm one of the best legal boards in Brazil. In addition to deep knowledge in the Life Sciences area, Trench Rossi Watanabe also demonstrates high qualification and remarkable knowledge in the area of bidding, which is essential for that area.’
‘They have distinguished professionals, this because of the knowledge of the areas in which they work, specialisms in the themes and deep knowledge of the pharmaceutical sector, adaptability and convergence to the business. In addition, they are professionals with easy access and always willing to contribute with business strategies.’
‘Henrique Frizzo: very well oriented in business, in-depth understanding of regulatory and compliance issues, especially in the pharmaceutical area.’
‘Technical knowledge; availability and ability to understand practical situations and propose appropriate solutions; speed and efficiency of responses.‘
‘Phenomenal pragmatic expertise in the field of activity.’
‘It is an office with a solid reputation and with good lawyers in the areas where I consult them.’
Ortho clinical diagnostics
Johnson & Johnson
Procter & Gamble
- Assisted AstraZeneca with the commercialisation of the Covid-19 vaccine developed by the University of Oxford to Fioccruz and Bio-manguinhos (government-owned laboratories, under a mandate from the Ministry of Health).
- Advised Biogen on the review of its patient support programme (PSP) and on the implementation of its new diagnostic programme.
- Assisted Seqirus with the submission of the Flucelvax® vaccine application.
The multi-disciplinary life sciences team at Felsberg Advogados acts for healthcare and pharmaceutical companies, and is also a popular choice for clients in the food and beverage sector. Among its areas of expertise are the Brazilian regulatory framework, sanctioning proceedings before Anvisa and other health agencies, product registration and advertising, and life sciences compliance and corporate ethics. Life sciences, public law and regulatory specialist Marianne Albers is 'an outstanding adviser, with a very strong knowledge of the pharmaceutical industry'. IP expert Diego Vieira is another key contact.
‘The advice received from Felsberg Advogados has always been very pragmatic, business oriented and of high quality. In general terms, I would recommend Felsberg for, while keeping a high quality of legal advice, having a pragmatic approach focused on problem solving.’
‘Marianne Albers is an outstanding adviser, with a very strong knowledge of the pharmaceutical industry.’
‘Agility in the answers and knowledge of the client.’
‘The office has an excellent back office team that performs many bureaucratic activities in a short time. Lawyers can dedicate themselves to specific topics and clients.‘
‘Claudia Maniaci and Lucas von Wieser Ruggeri are recommended.’
Exeltis Laboratórios do Brasil
Ypê – Química Amparo
Hospital das Clínicas da Universidade de São Paulo (HCFMUSP)
- Acts as legal counsel for Exeltis in Brazil in a broad range of regulatory and contractual matters.
- Advised Monster Energy on regulatory matters connected to its launch of new drinks, classified by Anvisa as liquid dietary supplements.
- Advising Chilean-based start-up NotCo, which produces plant-based foods, on its establishment, growth and sale of products in Brazil.
Machado Meyer Sendacz e Opice Advogados fields a multi-disciplinary group of lawyers to assist life sciences companies on regulation, litigation and corporate and commercial transactions. In other work, the team has also been providing advice to clients on the development of cannabis and tobacco products. Regulatory and administrative law experts Ana Karina Esteves de Souza and Laura Garcia de Freitas Souza jointly lead the team, which includes dispute resolution, consumer law and product liability specialist Gláucia Coelho.
Ana Karina Esteves de Souza; Laura Garcia de Freitas Souza
LVMH Parfums Et Cosmetiques do Brasil
Koch Companies Public Sector
EQT Fund Management
- Provided legal advice to Aditum Services on Anvisa’s regulatory requirements in relation to the production of food supplements.
- Advised Chiesi Farmacêutica on the due diligence of certain assets owned by Boehringer Ingelheim.
- Acted as legal adviser to Alliance One, drafting a memorandum in respect of the legal framework applicable to the industrial cannabis sector in Brazil.
Leading pharmaceutical companies turn to the life sciences team at Zeigler Advogados for advice on clinical research, consumer protection, R&D and commercial agreements. Recently, the team has been kept particularly busy advising on matters related to Covid-19 vaccines and research. Silvia Zeigler‘s expertise spans regulatory, commercial, IP and food law; she co-heads the department with Gerardo Figueiredo Junior, who balances an equally broad practice, covering economic, administrative, regulatory and food law.
Silvia Zeigler; Gerardo Figueiredo Junior
‘Personalised service, expertise and knowledge of different subjects.’
‘Silvia Zeigler is a partner of the clients, understands the problems and seeks to propose the best solutions, with in-depth knowledge of the subject, using experience and expertise. They are always on hand for a conversation.’