Firms To Watch: Life sciences

Campos Mello Advogados in cooperation with DLA Piper  offers a broad-based life sciences practice, advising pharmaceutical and medical devices companies and investment funds on cross-border portfolio acquisitions and restructurings; Bruna Rocha  leads the practice, which covers regulation and policy issues.
XVV Advogados is well versed in assisting organisations, companies and institutions in navigating regulatory issues in the life sciences sector, strengthened by the practitioners’ public law backgrounds; the team is jointly led by Beto Vasconcelos, Felipe de Paula and Ivo Corrêa.

Life sciences in Brazil

Kestener & Vieira Advogados

A pioneer in the life sciences sector in Brazil, Kestener & Vieira Advogados is distinguished by its longstanding expertise in the sector, and remains at the forefront of new and critical changes in the pharmaceuticals and healthcare sub-sectors. Proficient in complex litigation and dispute resolution, the team stands out for its capacity to represent clients before the Brazilian Health Surveillance Agency (ANVISA) and courts in high-level administrative and judicial litigation. The team advises on all aspects of the development, authorisation, manufacturing and licensing life cycle for health and food-related products, including product liability issues such as recalls. Pricing and reimbursement negotiations with the government also fall within the scope of the firm’s expertise, as do public tenders. Founding partner Beatriz Kestener  leads the team and is known for her ‘great depth’ and ‘quality’ advice, particularly in the healthcare industry. Highly recommend by clients is fellow founding partner Fabio Alonso Vieira , an expert in corporate transactions in the life sciences space. Flávio Spegiorin Ramos  can regularly be found advising companies in the pharmaceutical, food, agriculture, cosmetics, medical devices and technology sectors. Also of note within the team is Carolina Barbosa Cunha Costa .

Practice head(s):

Beatriz Kestener

Testimonials

‘The office is very specialized in life sciences and is a reference for the subjects of this theme, always being able to add to the discussions and help in thinking about solutions.’

‘Very experienced team with in-depth knowledge of the area. Deliveries with great depth and quality, I highlight the availability and commitment of Beatriz Kstener.’

‘The quality of work is very high. The cost-benefit ratio is the best on the market. The partners who advise the company are diligent, helpful, transparent and have a clear knowledge of the issues dealt with by the company. Fees are flexible and fair. They are the best on the market.’

‘The partners Beatriz Kestener, Flávio Vieira and Henderson Fürst are excellent, transparent, interested, they study the client’s subjects before, during and after, participate in the work with their associates and always propose innovative alternative solutions. Would recommend all partners to other companies.’

‘KGV Advogados, through its professionals, provides services related to life sciences efficiently, with impeccable technical capacity and within the established deadlines. The enhanced dedication of its professionals makes us feel as if we were exclusive, paying attention to the details of each demand, with a meticulous and updated approach in the areas in which our company has its activities.’

‘The professionals who stand out the most in the team and with whom I have the most contact are Beatriz Kestener, Fábio Vieira and Carolina Costa. Its qualities are high efficiency and assertiveness in its positions, ability to resolve our highly complex issues, availability in requests, especially those involving urgent actions and monitoring of actions to be taken, including monitoring deadlines.’

Key clients

Takeda Pharma

Baxter Hospitalar

Produtos Roche Químicos E Farmacêuticos

Divegen Gestão E Tratamento De Dados

Boehringer Ingelheim Do Brasil Química E Farmacêutica

BL Industria Ótica

BRF

Zodiac Produtos Farmacêuticos

Abbvie Farmacêutica

Halex Istar Industria Farmacêutica

Japan Tobacco International Brazil

Pinheiro Neto Advogados

The well-established life sciences practice at Pinheiro Neto Advogados assists and advises clients in the pharmaceutical, medical devices, food and food supplement, cosmetics, agribusiness and healthcare industries. At the forefront of this practice, the firm has recently assisted clients related to the National Immunisation programme for the Covid-19 pandemic in Brazil. Multidisciplinary in its offering, the team is also engaged in transactional work, covering acquisitions, distributor and licensing agreements, clinical trials, research and development, technology transfers, and more, drawing on the strength of the firm’s leading corporate and M&A practice. Angela Kung, a co-founder of the life sciences practice at the firm, maintains a focus on regulatory and transactional work that is complex in nature, covering all segments of the life sciences industry, including emerging technologies. At the non-partner level, senior associate Nicole Aun is also a key member of team, closely involved in technology transfer projects in the pharmaceuticals sub-sector within the context of public and private partnerships. Laura Oliveira Barboza is also of note; she focuses on IP and administrative issues. Since publication, Camila Martino Parise has been raised to the partnership – with effect from January 2023.

Key clients

Laboratórios Pfizer

Merck Sharp & Dohme Farmacêutica

Bristol-Myers Squibb Farmacêutica

Apple

Amazon Servicos de Varejo do Brasil

Exact Sciences

Amryt Pharma

Galderma

BioCryst Pharmaceuticals

Work highlights

  • Advising Pfizer on the negotiations for the supply of Covid-19 vaccine to the Brazilian Ministry of Health.
  • Advising Merck Sharp & Doheme Farmaceutica on a collaboration agreement for Molnupiravir.
  • Advised Apple on legal matters related to life sciences in Brazil.

Fialdini Einsfeld Advogados

Fialdini Einsfeld Advogados‘ life sciences practice focuses on complex litigation matters, assisting and representing clients before the Drug Market Regulation Chamber (CMED) and ANVISA. Pedro Sergio Fialdini Filho and Alexandre Einsfeld co-lead the practice.

Practice head(s):

Pedro Sergio Fialdini Filho; Alexandre Einsfeld

Mattos Filho

Mattos Filho’s life sciences practice group is known for its ‘solid and reliable’ expertise. A leading full-service firm in Brazil, its life sciences offering benefits from cross-practice collaboration, providing clients with a strong combination of regulatory and transactional expertise with litigation experience. With a presence in New York and London, the firm has a strong international focus, which is beneficial for its client base of large multinational pharmaceutical and biotechnology companies, as well as medical devices companies, healthcare assistance providers, food and beverage companies, and investors. The team regularly advises on M&A transactions, agreement drafting and negotiations, clinical trials, public and private partnerships, and product development. Ana Cândida Sammarco is praised for her ability to ‘understand the urgency of commercial matters to the business and offer pragmatic solutions’. She chairs the life sciences and healthcare practice and is an expert in regulatory matters, particularly in structuring healthcare plan agreements, new technology implementation, and supply and distribution agreement negotiations and drafting. Following his arrival from SPLaw, Gustavo Swenson Caetano co-chairs the practice alongside Sammarco, representing domestic and international clients before a range of governmental agencies such as CMED, ANVISA and the Ministry of Health, and leverages his background in IP matters when advising clients.

Testimonials

‘Ana Candida Sammarco leads our team at the firm. She ensures all the team members have the appropriate skills for our work, bringing in extra people as needed. They truly work as a team and take time to co-ordinate with each other in our interests.’

‘Ana Candida Sammarco, Jose Daniel Gatti Vergna and Jessica Tolotti Canhisares are constantly on top of the open files and proactively chase up on replies. They understand the urgency of commercial mattters to the business and offer pragmatic solutions.’

‘Mattos Filho has a solid and reliable practice in the life sciences and healthcare industries.’

‘Ana Cândida Sammarco leads a great team at Matto Filho, with associates Renata Rothbarth, Giovanna Pasquini Malfatti, among others.’

‘It is a renowned firm and the team of lawyer Gustavo Swenson serves us very well, with expertise and agility.’

‘Gustavo Swenson is a very competent lawyer, with a broad legal view on the issues, and always available to assist in the demands of his specialty.’

Key clients

Fresenius-Kabi Brazil

Amgen

Laboratórios Pfizer

Sanofi Farmacêutica

Hypera Pharma

Roche

DASA Diagnósticos da América

Kintor

Aché

Establishment Labs

Grupo DPSP

DIMED Distribuidora de Medicamentos (PANVEL)

Moderna

RaiaDrogasil

Associação Educadora São Carlos (AESC) – Mãe de Deus Hospital

Work highlights

  • Advised Vaxxinity on all the regulatory aspects concerning the negotiation, structure and execution of two public partnerships with the Brazilian Ministry of Health.
  • Advising Fresenius and its Brazilian subsidiary on the negotiation of a productive development partnership, as well as the production, productive and technological qualification of two biosimilar drugs.
  • Advising Aché in an agreement to co-develop a therapy with the potential to treat general anxiety disorder (GAD) and post-traumatic stress disorder (PTSD) with MSRD.

SPLaw

‘Highly specialised’, the life sciences offering at SPLaw is known for its strong expertise at the cutting edge of where science and law meet. A go-to option for many Brazilian and international companies in domestic and cross-border mandates involving commercial, regulatory and IP law, the team is regularly trusted by major pharmaceutical, food and technology clients. Praised for his ‘broad and deep knowledge of technology, intellectual property, and regulatory and administrative issues’, founding partner Benny Spiewak leads the practice. At the senior associate level, Daniela Jambor and Gabriela Ongari are both key individuals in the team, with Ongari developing a specialism in data privacy aspects in the life sciences sector. Pedro Carneiro is also of note, particularly for his expertise in matters involving environmental issues.

Practice head(s):

Benny Spiewak

Testimonials

‘SPLAW is a long-time partner, with the partner’s availability to meet the demands and needs.’

‘Benny Spiewak – competent professional with long experience in the industry and always available for clients.’

‘Benny Spiewak understands everything in the health regulatory area, he is an expert, he understands the law, regulation, ways, in addition to being very quick and accurate in his answers. There’s a lot of confidence. He’s an excellent lawyer.’

‘Highly specialised office focused on client needs. Direct involvement of the partners in the demands, with excellent openness for direct dialogue. Constant dedication to excellent deliveries.’

‘Benny Spiewak has broad and deep knowledge of technology, intellectual property, and regulatory/administrative issues.’

‘Pedro Carneiro has extensive and in-depth knowledge of environmental issues.’

‘Responsiveness, good collaboration on several levels, good value for money.’

‘The team displays agility in understanding client needs and seeking innovative solutions for complex demands. Good availability for direct client engagement.’

Key clients

Teva Pharmaceuticals

Novartis

Daiichi Sankyo

Astellas Pharma

Eisai

Dr. Reddy’s Pharma

UCB Pharmaceuticals

Organon

SONOVA Holding

Moksha 8

Oxitec

Regeneron

General Electric Healthcare

ABIMED

Moleculin Pharma

Nestlé Health Sciences

Aurinia Pharma

Provivi

Ingredion

Eurofarma

Fujifilm

CNOGA Medical

Work highlights

  • Assisting Teva with a number of matters, including the challenges brought by the decision of the Supreme Federal Court over Article 40 concerning the time for which a patent is considered valid.
  • Supporting Novartis in understanding and navigating federal and state pricing and reimbursement laws in the successful launch of its monoclonal antibody treatment Cosentyx in Brazil.
  • Advising Fujifilm on a complex negotiation with Fiocruz to clinically evaluate and trial a highly disruptive, non-invasive tuberculosis treatment device.

Demarest Advogados

Demarest Advogados‘ life sciences department balances a broad workload, regularly providing advice to clients in the biotech, medicine, healthcare, cosmetics, animal health, nutrition and e-cigarette industries. Claudio Mattos and Camila Biral both leverage strong biotech and pharmaceutical expertise, and are key contacts for some of the firm’s big-name clients. Ana Paula Pinheiro Schedel is a go-to lawyer in the team for commercial contracts, and Bruno Aurélio is known for his expertise and advice to companies in heavily regulated sectors, including pharmaceuticals, healthcare and tobacco. For IP-related life sciences matters, Rio de Janeiro-based partner Tatiana Campello is a name to note.

Practice head(s):

Ana Paula Schedel; Bruno Aurélio; Claudio Mattos; Camila Biral; Tatiana Campello

Testimonials

‘Lawyers are attentive, helpful, meet deadlines and are always willing to help.’

‘The service is of good quality.’

Key clients

Janssen-Cilag

JT International Distribuidora de Cigarros

DaVita

BRF

Freshfields Bruckhaus Deringer

Universal Assistance

Vitta Tecnologia em Saúde

West Pharmaceutical Services Brazil

Gelita do Brasil

Minerva

Work highlights

  • Advising KWS Seeds on matters related to the import of seed varieties.
  • Advising JTI on product registration and registration renewal.
  • Advising Bayer on the legal aspects in connection with the execution of a toll manufacturing agreement.

Licks Attorneys

Licks Attorneys’ life sciences practice is notable for its team of in-house pharmacists, chemists and scientists, which bolster the technical expertise of the firm's offering. The team, led by Otto Licks, Liliane Roriz and Eduardo Hallak, is particularly strong in patent litigation, and often assists domestic and international clients looking to protect and grow their life sciences portfolios in Brazil. Technology transfers, regulatory issues, procurement and bidding processes are also in the purview of the department. The team also continues to grow in size and expertise, with several associates recently promoted to partner.

Practice head(s):

Otto Licks; Liliane Roriz; Eduardo Hallak

Key clients

Total Energies

Arkema

Pierre Fabre

Decathlon

Christian Louboutin

Silimed

TozziniFreire Advogados

Praised for its ‘excellent service’ and ability to offer clients ‘comprehensive advice covering all relevant legal areas and commercial aspects’, TozziniFreire Advogados’ life sciences offering is multidisciplinary in nature, with strong regulatory expertise. Recent highlights include advising on vaccine manufacture, ventilator regulation and medical device refurbishment during the Covid-19 pandemic. The ‘client focused’ Marco Aurélio Torronteguy heads up the practice and is a go-to partner in the firm for all manner of regulatory matters. Senior associate Victor Hugo Callejon Avallone is also of note within the team, particularly for advice on clinical trials, administrative proceedings and health-sector M&A. Pro bono work continues to be a standout area for the firm, particularly in providing legal assistance to NGOs and similar entities.

Practice head(s):

Marco Aurélio Torronteguy

Testimonials

‘What makes the firm unique is the highly qualified staff, the promptness in service, that the team adapts itself to the client’s needs, and the quality of the work. The combination of so many qualities in a team only makes the service and the result unique.’

‘Marco Aurelio Antas Torronteguy is professional and very qualified. He provides an excellent service. Fast, efficient, effective and very well qualified.’

‘Tozzini’s practice is unique because of its long-established reputation and presence in the industry. Any potential client should know that they will receive comprehensive advice covering all relevant legal areas and due to its experience even advice on certain commercial aspects and decisions.’

‘Tozzini’s Life Sciences team is in contact with major pharmaceutical companies and therefore exposed to all types of situations. This gives Tozzini’s team a difference over other firms.’

‘Marco Aurelio Antas Torronteguy has proved to be a very enthusiastic and client focused attorney. He is always a available to respond in time about any regulatory matter, with deep knowledge and detailed analysis of each arising issue. It is not common to see this kind of commitment and this certainly makes a difference.’

‘Professionalism, creativity, client knowledge.’

Key clients

Laboratórios Pfizer

Amyris

Danone Brasil

CSL Behring

Elizabeth Arden Cosméticos Do Brasil

Torrent Do Brasil

Kavo Do Brasil

Kilpatrick Townsend & Stockton

Arnold & Porter Kaye Scholer

Covington & Burling

Work highlights

  • Advising a producer of cannabis medical products on the public health regulatory assessment of its products, including the description of ANVISA’s regulations.
  • Supporting a multinational pharmaceutical client with legal, regulatory and compliance assistance regarding the regulation on drug marketing and controlled drugs.
  • Assisting a biopharmaceutical company, which manufactures plasma-derived and recombinant therapeutic products on several matters in Brazil.

Trench Rossi Watanabe

Full-service firm Trench Rossi Watanabe’s life sciences practice covers public and administrative law, intellectual property, corporate and regulatory law to offer clients in the pharmaceutical and medical devices industries multidisciplinary advice. Prominent international household names such as Pfizer and AstraZeneca trust the team, which is co-led by Henrique Frizzo in São Paulo and Marcela Trigo in Rio de Janeiro. Frizzo focuses on healthcare regulations and governmental entity agency relationships, and Trigo heads up the patent disputes and advisory practice, covering rights, licensing and exclusivity rights, and litigation.

Practice head(s):

Henrique Frizzo; Marcela Trigo

Testimonials

‘Professionalism, creativity, client knowledge.’

‘I recommend Henrique Frizzo.’

Key clients

Abbott

Merck Co.

Novo Nordisk

Biogen

Pfizer

Baxter Hospitalar

AstraZeneca

Takeda

Acorda

Biotronik

Invitae

GE Healthcare

Ortho Clinical Diagnostics

Alnylam

Amicus Therapeutics

Boehringer

Johnson & Johnson

Ferring

Novartis

Olympus

Procter & Gamble

Regeneron

Seqirus

Unilever

Varian Medical

Bio-Rad

Biolab

Allergan

Shire

Novozymes

Translate Bio

Otsuka Pharmaceutical

Taiho Pharmaceutical

Sinocelltech

Organon

Parexel

Shiseido

Work highlights

  • Assisting AstraZeneca UK with the technology transfer contract with Fiocruz and Bio-manguinhos regarding the local production of its Covid-19 vaccine developed with the University of Oxford.
  • Assisted Alnylam in the administrative procedure before CMED and its technical executive committee related to the pricing approval for the drug Onpattro to be commercialised in Brazil.
  • Assisting Pfizer, Novartis and Takeda in pre-litigation patent matters.

Felsberg Advogados

Felsberg Advogados‘ multidisciplinary life sciences department services domestic clients as well as international companies looking to enter the Brazilian market. Public bids, contracts, medicine production, distribution and administrative proceedings before ANS, ANVISA and the Ministry of Agriculture and Lifestock Supply (MAPA) are all regularly handled by the team. The team is led by life sciences expert Marianne Albers, who provides counselling to companies, particularly in the environmental, chemical and regulatory contexts. Also of note in the team is Diego Vieira, who specialises in developing strategies for brand and patent portfolios for pharmaceutical companies. Thais Fernandes is also recommended.

Practice head(s):

Marianne Albers

Testimonials

‘The service provided by Felsberg is of high value. They have the ability to understand the business needs and provide legal advice with a very pragmatic approach.’

‘I recommend Marianne Albers.’

Key clients

Sandoz do Brasil Indústria Farmacêutica

Exeltis

Essity

BSN Medical

Amil – UHG Brasil

Bioxxi Serviços de Esterilização

Merck Brasil

NeilMed

Daki

NotCo

Ypê – Química Amparo

Kasznar Leonardos Intellectual Property

Kasznar Leonardos Intellectual Property’s life sciences practice acts for pharmaceutical, food, agribusiness, cosmetics and medical devices companies. Aline Ferreira and Priscila Kashiwabara lead the practice. Anderson Ribeiro and associates Matheus Montecasciano and Lucas Calabria left the firm in February 2022.

Lefosse Advogados

Rubens Granja leads the recently established life sciences offering at Lefosse Advogados following his departure from Kestener & Vieira Advogados. Granja has over 15 years of experience in the field, with specific expertise in regulatory matters, public procurement, administrative and civil law related to the pharmaceutical, food, cosmetics and medical devices industries. Working alongside him are several associates, including Natássia Misae Ueno and Júlia de Castro Kesselring, both of whom are adept at advising on matters involving highly regulated sectors.

Practice head(s):

Rubens Granja

Key clients

Laboratórios Pfizer

AbbVie Farmacêutica

Allergan Produtos Farmacêuticos

Boehringer Ingelheim do Brasil Química e Farmacêutica

Baxter Hospitalar

Ultragenyx Pharmaceutical

Diagnósticos da América – DASA

UHG – UnitedHealth Group

Steris Solutions do Brasil Importação e Comercialização de Produtos da Saúde

Daus Indústria de Alimentos

Work highlights

  • Advised Abbvie Farmacêutica on strategies to participate in the bidding promoted by the Ministry of Health for the purchase of a drug to supply the public health system.
  • Assisted Ultragenyx Pharmaceutical client in the negotiation of an exclusive rare disease drug to supply the Health Secretary of Paraná.
  • Advised Diagnósticos da América on the acquisition of several local health groups.

Machado Meyer Sendacz e Opice Advogados

The life sciences department at Machado Meyer Sendacz e Opice Advogados takes a multidisciplinary approach to advise and support its clients in the pharmaceutical and cosmetics industries, and also excels in advising companies in the tobacco, cannabis, and food and beverage sectors. Clients trust the firm to assist in navigating the Brazilian regulatory framework in the aforementioned sectors, as well as technology transfer agreements, clinical trials and research. The team is co-led by regulated market specialists Laura Garcia De Freitas Souza and Ana Karina Esteves de Souza. Gláucia Mara Coelho is also of note in the team, particularly in relation to regulatory agency disputes and strategic claims in the healthcare and pharmaceutical industries.

Practice head(s):

Ana Karina Esteves de Souza; Laura Garcia de Freitas Souza

Key clients

Química Amparo

Herbert Smith Freehills

Grupo Big

McKinsey

Norton Rose Fulbright

Química Amparo

Work highlights

  • Representing Química Amparo in an administrative proceeding before ANVISA arising from an infraction notice.
  • Assisting Herbert Smith Freehills in advising an international client in relation to the use of messages on cigarette packages.
  • Assisting an international tobacco company in providing legal and regulatory advice regarding the possibility of using, in Brazil, additives in the fermentation process of tobacco leaves.

Souto Correa Advogados

Souto Correa Advogados  invested heavily in its life sciences offering, bringing in several individuals and successfully establishing a new practice group. Following his move from Kasznar Leonardos Intellectual Property , Anderson Ribeiro  spearheads the team, bringing with him a large client portfolio. In addition, Matheus Montecasciano  , Leticia Pimental  , Isabella Fidell  and Lucas Calabria  have also joined. The team’s expertise covers pharmaceutical, food, cosmetics, medical devices and agribusiness-sector multinational and Brazilian companies investing in and expanding their operations in Brazil. Paulo Rosito , who was previously in-house counsel at US-based company Alexion Pharmaceuticals, also recently joined the firm.

Practice head(s):

Anderson Ribeiro

Testimonials

‘They have a lot of knowledge in material law and understanding of the sector, as well as being aware of new technologies and the challenges brought by them, in order to propose solutions that adhere to our reality.’

‘One of the main differentials of this technical team is its robust experience in dealing with health surveillance issues, especially ANVISA.’

‘The Life Sciences team in general is a qualified and very helpful team. More specifically in relation to Anderson Ribeiro and Matheus Montecasciano, they demonstrate solid technical knowledge and openness to discuss alternatives/legal approaches that are more appropriate to meet the client’s needs.’

‘Anderson Ribeiro has vast knowledge in the area, but, beyond knowledge, the team is able to focus on the company’s business in order to make them viable in light of regulatory standards.’

‘Anderson Ribeiro’s team, especially Matheus Montecasciano, advises my company quickly, efficiently and with a focus on making business viable.’

‘They understand the complexities that American companies have when expanding operations in Brazil.’

Key clients

BioMarin Pharmaceutical

Instituto Butantan

Henry Schein Brazil Dental

Young Living Essential Oils

Neo Vida Comércio e Importação De Produtos Naturais (PURAVIDA)

IFF

DuPont/Danisco

Chiesi Farmacêutica

Alexion

Teva

Tate & Lyle

Laboratório Catarinense

Merck

Work highlights

  • Advising a rare diseases company on a cooperation agreement with the Ministry of Health to conduct a real-world evidence study.
  • Advising an ice cream industry ingredient supplier regarding a product recall before ANVISA.
  • Representing a number of rare diseases companies in administrative challenges regarding public procurement disputes.

Zeigler Advogados

The life sciences practice at Zeigler Advogados serves pharmaceutical companies in the biosciences industry, and food and beverage companies looking to navigate the regulatory landscape in Brazil. Recent instructions include advising on matters related to the transition to a post-pandemic situation. The practice is co-led by Silvia Zeigler and Gerardo Figueredo. Ziegler’s practice spans regulatory, consumer, IP, tax and food law; Figueiredo also maintains a broad practice, as well as dealing with civil and administrative litigation and compliance.

Practice head(s):

Silvia Zeigler; Gerardo Figueiredo

Key clients

BRF

MSD

Danone

Allergan

Carrefour

Viatris