Life sciences in Brazil

Kestener, Granja & Vieira Advogados

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 GranjaTatiana Gualberto Kascher and Natássia Misae Ueno are active associates in the department.

Practice head(s):

Beatriz Kestener

Key clients

Laboratórios Pfizer

Produtos Roche Químicos e Farmacêuticos

Cardinal Health

BRF

Takeda Farmacêutica Brasil

Sarepta Farmacêutica Brasil

AbbVie Farmacêutica

AstraZeneca do Brasil

Kellogg Do Brasil

Bausch & Lomb Indústria Ótica

Work highlights

  • 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.

Pinheiro Neto Advogados

Having established a life sciences practice in 2005, Pinheiro Neto Advogados has successfully established at the sector's to table. 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.

Practice head(s):

Angela Fan Chi Kung

Testimonials

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.

Key clients

Amgen

J&J

Pfizer

Novartis

Laboratórios Pierre Fabre

Eisai

Boston Scientific

Merck Sharp & Dohme

Sandoz

Amazon

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.

Testimonials

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.

Key clients

Laboratórios Pfizer/Wyeth

Bayer

Medley Indústria Farmacêutica

AstraZeneca do Brasil

Chiesi Farmacêutica

Takeda

Sanofi

Zambon

Sandoz

Allergan

Astellas

Aspen Pharma

BioMarin Brasil

Work highlights

  • 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

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.

Practice head(s):

Otto Licks; Eduardo Hallak

Testimonials

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.

Key clients

Celgene

Gilead

Novartis

Sanofi

Astellas

Merck Sharp & Dohme Corp

Genentech

Biogen International

Syngenta

Corteva

FMC Corporation

Suzano

Becton Dickinson

B Braun Melsungen

Samsung Bioepis

Ariad Pharmaceuticals

Lundbeck

Pierre Fabre Médicament

Work highlights

  • 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.

Mattos Filho, Veiga Filho, Marrey Jr. e Quiroga Advogados

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'.

Testimonials

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.

Key clients

Novartis

Hypera

Oncoclínicas

Amgen

Babylon

Diagnósticos das Américas

Cristália

Roche Diabetes

Verdemed

Laboratórios Pfizer

Work highlights

  • 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.

SPLaw

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 partnerBenny 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.

Practice head(s):

Benny Spiewak; Gustavo Swenson

Testimonials

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.’

Key clients

Teva Pharmaceuticals

Boehringer Ingelheim

Corteva

Eisai

Intrexon

Chiesi Pharmaceuticals

PTC Pharma

Alnylam

Covis Pharma

UCB Pharmaceuticals

ABIMED

Work highlights

  • 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.

TozziniFreire Advogados

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.

Testimonials

TozziniFreire’s life science team gave us very good support.

‘Very experienced, solution-oriented, fast responses.’

Key clients

Torrent do Brasil

Campbells Soup

Laboratórios Pfizer

CSL Behring Comércio de Produtos Farmacêuticos

Eckert & Ziegler Brasil Comercial

Vertex Farmacêutica do Brasil

Merck

AstraZeneca do Brasil

Kavo do Brasil Indústria e Comércio

Work highlights

  • 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

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.

Practice head(s):

Claudio Mattos; Camila Biral

Key clients

DaVita

Japan Tobacco International (JTI)

Bayer

Greenwood

Laboratórios Pfizer

Johnson & Johnson do Brasil

Work highlights

  • 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.

Kasznar Leonardos Intellectual Property

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.

Testimonials

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.

Key clients

Amgen

Merck Sharp Dome

Fiocruz

Takeda (Shire)

Laboratorio Bergamo (Amgen Brasil)

Van Hessen

Ajinomoto

Josapar

Dupont/Danisco

Abbott

Work highlights

  • 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.

Machado Meyer Sendacz e Opice Advogados

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.

Key clients

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)

Novartis

Sanofi

Accenture

Invista

Work highlights

  • 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.