Life sciences in Brazil
Kestener, Granja & Vieira Advogados has a well-established life sciences practice and is a popular choice for both international law firms and major pharmaceutical companies. Its areas of expertise span clinical trials, product liability, public procurement, and marketing and licensing, among others. On the contentious side, the team is equipped to represent clients before health authorities and the Brazilian courts in administrative proceedings, judicial litigation and class actions. Founding partner Beatriz Kestener, who has focused on regulatory matters since 1996, leads the team, with key support from co-founding partner Rubens Granja. Tatiana Gualberto Kascher and Natássia Misae Ueno are active associates in the department.
Produtos Roche Químicos e Farmacêuticos
Takeda Farmacêutica Brasil
Sarepta Farmacêutica Brasil
AstraZeneca do Brasil
Kellogg Do Brasil
Bausch & Lomb Indústria Ótica
- Successfully represented Valeant in an administrative appeal against a decision rendered by ANVISA cancelling a critical product’s marketing authorisation.
- Assisted Pfizer in all steps of the administrative procedures carried out by the Ministry of Health for the acquisition of a vaccine.
- Working with the firm’s data protection team to assist AstraZeneca with the development and implementation of the company’s plan for compliance with the General Data Protection Act.
Having established a life sciences practice in 2005, Pinheiro Neto Advogados has successfully carved out a place among the top firms in the market. The team is led by the highly regarded Angela Fan Chi Kung and covers the gamut of transactional and regulatory matters involving human and animal health in Brazil, acting for clients across the pharma, biotech, food, medical devices and cosmetics industries. Théra van Swaay de Marchi is an expert in the healthcare space; senior associate Nicole Aun has expertise in transactional, regulatory, compliance, technology, IP and data protection issues relevant to life sciences-sector clients; and associate Júlia de Castro Kesselring specialises in life sciences regulation.
‘The Pinheiro Neto team has a deep and genuine understanding of the Brazilian laws governing medicinal products and medical devices. This is very important to clients.‘
‘Angela Fan Kung, who leads the team, is responsive and precise, providing practical and realistic advice.‘
Laboratórios Pierre Fabre
Merck Sharp & Dohme
Fialdini Einsfeld Advogados
In the life sciences space, well-renowned boutique firm Fialdini Einsfeld Advogados is particularly strong in complex litigation, and also provides regulatory advice to clients, with areas of expertise including clinical trials, termination of distribution contracts, patent infringement and price regulations. It has recently expanded its already impressive client base with several new multinational pharma clients. Pedro Sergio Fialdini Filho and Joaquim Augusto Melo de Queiroz are 'real references for the life science legal market', and 'excellent attorney' Alexandre Einsfeld is 'highly qualified to handle complex matters in litigation, regulatory affairs and intellectual property'. Associates Ivan Fernandes de Cunha and Thiago Albigiante are also noted.
‘The team works in a harmonious way, so that all the lawyers involved have an excellent technical level, know the cases deeply and are able to meet the client’s demands.‘
‘First and foremost the tailor-made solutions and the way they dedicate their efforts to the client. Unlike other firms with a huge client portfolio and a one size fits all solutions, Fialdini is really willing to partner with the client to build together the best legal solution.‘
‘The firm is extremely careful, especially in litigation, and incredibly attentive to client’s needs. They are always willing to go the extra mile to address the clients’ requests.‘
‘Alexandre Einsfeld, one of the founding partners of the firm, is an excellent attorney, and is highly qualified to handle complex matters in litigation, regulatory affairs and intellectual property in general, a set of skills which are rarely found in the same individual.‘
‘Pedro Fialdini and Joaquim Queiroz are real references for the life science legal market while being on top of all relevant matters. Both have always been very close to our needs as external counsel.‘
‘Trust, partnership, commitment and technical knowledge, with emphasis on lawyers Alexandre Einsfeld, Joaquim Queiroz, Ivan Cunha and Thiago Albigiante.‘
Medley Indústria Farmacêutica
AstraZeneca do Brasil
- Represents Sandoz in a lawsuit concerning the definition of the price of the biological medicine Zarzio.
- Represented Ourofino and other companies in a public consultation on new rules regarding maximum residue limits (MRL) for veterinary drugs.
- Provided support to a client regarding all regulatory aspects in the establishment of a new company and the marketing authorisation for a veterinary medicine based on cannabidiol.
Licks Attorneys has a 'well-established patent practice' in life sciences and is also well versed in a range of regulatory matters affecting pharma, agrochemical and medical devices companies. The sizeable team was further expanded with the 2019-hire of Viviane Kunisawa, who - in addition to having broad knowledge of IP, unfair competition and regulatory law - stands out for her specialism in the biotech sector and arrived from an in-house position at Syngenta. The firm also stands out for having dedicated Asian and French desks; the former is led by Roberto Carapeto in the Tokyo office and the latter by Karlo Tinoco in São Paulo. Eduardo Hallak is another key contact in São Paulo, while founding partner Otto Licks is a name to note in the Rio de Janeiro office.
‘Strong team that is very well organised with a well established patent practice working on health regulation procedures.‘
‘We work with Mr. Karlo Tinoco who is a very knowledgeable attorney, enthusiastic and very reliable.‘
Merck Sharp & Dohme Corp
B Braun Melsungen
Pierre Fabre Médicament
- Represented Sanofi in several measures before the Federal Prosecutor Office and Federal Courts regarding the illegal direct purchase between the Ministry of Health and a company called Global of a drug commercialised by Sanofi called Aldurazyme.
- Assisting Novartis with the development of strategies for the product fingolimod (the active ingredient in MS-drug Gilenya) before the Ministry of Health, and securing an annual contract with the Federal Government.
- Assisted Gilead in a new bid procedure established by the Ministry of Health to procure drugs for the treatment of hepatitis C.
The 'outstanding team' at Mattos Filho, Veiga Filho, Marrey Jr. e Quiroga Advogados acts for leading life sciences and healthcare companies, covering all sub-sectors, from medical devices to food to digital health. Thanks to the firm's full-service offering, the department also benefits from the input of specialists in M&A, litigation and insurance. Corporate and M&A specialist Maria Fernanda de Almeida Prado e Silva assists life sciences and healthcare companies in corporate transactions, while Ana Cândida Sammarco focuses her practice in public law, administrative, corporate and regulatory matters. Senior associate Renata Rothbarth 'demonstrates unique knowledge of the life sciences and healthcare markets'.
‘They have excellent lawyers – partners and associates. Expertise in the life science area.‘
‘Ana Candida Sammarco – expertise in the life science matters. Fully available whenever requested.‘
‘Outstanding team is able to assist in a full array of regulatory matters pertaining to the sector, especially on regulations issued by ANVISA and health professional councils. Possesses extensive experience in structuring sophisticated transactions involving life sciences’ products, as well as complex agreements such as tech transfer, clinical studies and research and development.‘
‘The team anticipates new regulatory frameworks or relevant modifications and is able to think on efficient approaches together with in-house areas.‘
‘Renata Rothbarth demonstrates unique knowledge of the life sciences and healthcare markets, being a very active associate that already holds a reputation and high level of specialisation and experience in her field. She has a brilliant ability to synthesize complex matters into clear agreements and shows passion about challenging projects. Renata is very supportive, hardworking and has a systematic mindset.‘
Diagnósticos das Américas
- Advised Pfizer on clinical research matters and the divestiture of its antacid product (Magnésia Bisurada) to Aspen Pharmaceuticals.
- Provided legal advice to Canadian company Verdemed on the regulation of cannabis-based products and drugs
- Assisted Retrophin with the review of protocols, contracts and statements relating to the execution of a phase III trial vis-à-vis current Brazilian regulation.
Specialised life sciences firm SPLaw advises clients on strategies, licensing and development deals, IP matters, regulation and healthcare compliance, and is also equipped to handle complex litigation. Its already sizeable client base has recently expanded further as the firm continues to attract significant new clients in the pharma and medical technology sectors. Other significant recent developments include the promotion of 'super smart' lawyer Gustavo Swenson to partner and the hire of several new associates during 2019. 'Amazing partner' Benny Spiewak is 'able to give straight answers'. Also of note is senior partner Pedro Carneiro, who heads the firm's food, environmental and ingredients practice.
‘SPLaw is specialised in the pharma sector and this specific knowledge of the team is a big advantage whenever it comes to discussing contracts, compliance or civil matters.’
‘Benny Spiewak is an amazing partner and his knowledge of the market and trending topics and the position on certain matters really assisted us on how to operate and how to decide on some problems. He is very attentive, always available, able to give straight answers and assist us on all matter, hand on deck and all. Benny is our specialist for compliance matters.‘
‘We also work a lot with Gustavo Caetano on contract and civil issues, super smart, with straight answers and good deliverables, also specialised in our market.’
- Acts as key regulatory counsel to the producer and owner of the genetically engineered (GE) male Ae. aegypti mosquitoes of the line OX513A.
- Acts as the key firm in charge of the institutional representation and legal counselling of ABIMED, the leading medical devices trade association in Latin America.
- Advised the UK Intellectual Property Office on standard agreements and a decision-making guide to assist Brazilian universities and companies participate in collaborative life science-focused research projects.
Leading multinational companies turn to TozziniFreire Advogados' life sciences and healthcare team for support and advice on complex issues, including licensing, drug pricing, clinical research regulations, patient data privacy issues and the regulatory aspects of M&A, among other areas. Elysangela de Oliveira Rabelo Maurer is a key name in the life sciences and healthcare space, where she has extensive expertise in non-contentious (including transactional) matters; she leads the team, which also includes experienced partner Marco Aurélio Torronteguy.
‘TozziniFreire’s life science team gave us very good support.‘
‘Very experienced, solution-oriented, fast responses.’
Torrent do Brasil
CSL Behring Comércio de Produtos Farmacêuticos
Eckert & Ziegler Brasil Comercial
Vertex Farmacêutica do Brasil
AstraZeneca do Brasil
Kavo do Brasil Indústria e Comércio
- Assisting Merck with regulatory and contractual matters for the implementation of the post-closing obligations related to P&G’s acquisition of Merck’s consumer health business.
Demarest Advogados counts leading pharma, consumer goods, biotech and healthcare companies among its clients. Taking a multi-disciplinary approach, the team covers a broad spectrum of contentious and non-contentious matters concerning licensing, marketing authorisation, commercialisation and product liability, among other areas. Biotech specialist Claudio Mattos and dispute resolution expert Camila Biral Vieira da Cunha Martins are names to note in São Paulo; IP and innovation head Tatiana Campello and transactional partner Guilherme Vieira da Silva are key contacts in Rio de Janeiro.
Japan Tobacco International (JTI)
Johnson & Johnson do Brasil
- Advised DaVita Healthcare Brazil on regulatory requirements to carry out dialysis services in Brazil.
- Assisting Bayer with the regulatory aspects of the commercialisation of a chemical product used to control vectors that cause tropical diseases.
Combining IP and regulatory strengths, Kasznar Leonardos Intellectual Property's life sciences group is regularly sought by pharma, food, animal health and cosmetics companies for advice and representation. The team is particularly strong in contentious matters and is well equipped to represent clients before ANVISA, the Ministry of Health, the Ministry of Agriculture and other bodies. The promotion of Priscila Kashiwabara to partner in 2019 was followed by the promotion of new partner Aline Ferreira in 2020; Ferreira's current areas of focus include access to genetic resources, GMOs and plant varieties. Anderson Ribeiro and João Luis Vianna are leading practitioners in the team.
‘Kasznar Leonardos is a great partner for American companies doing business in Brazil. This market is highly regulated and Kasznar Leonardos’ lawyers are very knowledgeable on all the local requirements and are also able to translate in a way that is easy for us to understand. They go the extra mile and are proactive to support our needs in Brazil.‘
‘Anderson Ribeiro and Matheus Dias Montecasciano are recommended.‘
Merck Sharp Dome
Laboratorio Bergamo (Amgen Brasil)
- Represented Tate & Lyle in a proceeding seeking the approval of a novel ingredient.
- Represented Solabia Biotecnológica in an administrative appeal following a precautionary measure applied by Anvisa to suspend the business activities of one of the company’s manufacturing plants.
The multi-disciplinary team at Machado Meyer Sendacz e Opice Advogados draws on the firm's traditional strengths in M&A and litigation to assist investors and life sciences companies with a range of matters, including regulation, M&A, dispute resolution, labour law, tax, licensing and technology transfers. Ana Karina Esteves de Souza and Laura Garcia de Freitas Souza are names to note.
LVMH Parfums Et Cosmetiques do Brasil
United Health Group
Kinea Private Equity Investimentos
EQT Fund Management
Freshfields Bruckhaus Deringer
CMPC and CMPC Melhoramentos (Softys Brasil)
- Advised LVMH Parfums Et Cosmetiques do Brasil in an administrative proceeding before ANVISA concerning the alleged non-payment of the “Sanitary Surveillance Inspection Fee”.
- Provided an analysis for EQT Fund Management of the legal and regulatory framework involving reproductive genetic diagnosis services in Brazil.