At a meeting held on Friday (10/10), members of the Administrative Council for Economic Defense (CADE) presented the Brazilian Intellectual Property...
OUR TEAM
Viviane Kunisawa, Dr. is a PARTNER at Danieal Law and Head of the Patent Litigation and Regulatory Law for Life Sciences & Agribusiness Groups. She has extensive experience in strategic litigation, consultancy, and advocacy initiatives, with more than two decades of experience in high-risk patent litigation, focusing on complex multijurisdictional disputes. She served as chief strategist and led the patent litigation team in several major disputes in Brazil. Having worked on cases related to patent infringement and invalidity, as well as unfair competition projects, she leverages her expertise in regulatory law to protect the clients' interests. Some of her representative cases have been in pharmaceuticals, agrochemicals, biotechnology, and engineering sectors, including telecommunications. She has vast experience with advocacy projects, from drafting bills and regulatory norms to preparing legal opinions and white papers. Viviane’s experience as an in-house counsel for a multinational company in the agribusiness sector allowed her to combine legal skills with business acumen. She obtained a Law Degree from UERJ and holds a Ph.D. in Law from the University of Munich (Ludwig-Maximilians-Universität), having conducted her doctoral research as a fellow at the Max Planck Institute for Innovation and Competition. She also served as a guest researcher at the Institute of Intellectual Property (Chizaiken) in Tokyo.
Practice Areas
Life Sciences;
Agribusiness.
Education
LL.M. in Intellectual Property Law – Munich Intellectual Property Law Center (MIPLC);
Law degree – UERJ.
Affiliations, Commissions and Collegiate
Member of the Intellectual Property Brazilian Association (ABPI);
Member of the MIPLC Alumni Network;
Member of the Brazilian Bar Association, registered in the State of Rio de Janeiro.
Languages
Articles
Decree No. 12.651/2025 regulates Law No. 14.874/2024 on research with human beings
On October 7, 2025, Decree No. 12.651/2025 was published, regulating provisions of Law No. 14.874/2024, also known as the "Brazilian Clinical Trials...
ANVISA Opens Public Consultation on the Regulation of Handmade Cosmetics and Hygiene Products
The Brazilian Health Regulatory Agency (Anvisa) has opened Public Consultation No. 1,353/2025 to discuss the regulation of handmade cosmetics,...
CADE Seminar Addresses the Landscape of Standard-Essential Patents in Brazil and Abroad
Last Thursday (September 25), CADE held the seminar Economy & Competition Defense: “International and National Overview of Standard-Essential...
MAPA issues Act No. 40/2025 on pesticide registration applications
On September 2, 2025, Act No. 40/2025 was published, establishing significant changes to the procedures for filing pesticide registration...
ANVISA sets new rules for the importation of liraglutide, semaglutide, and tirzepatide for compounding purposes
On August 25, 2025, the Official Gazette of the Federal Government published Order No. 97 issued by ANVISA’s Collegiate Board, establishing stricter...
Brazilian Antitrust Authority Publishes a Report on SEP
In the recent past, the Brazilian Antitrust Agency, the Administrative Council for Economic Defense (CADE), has been involved in a couple of...
ANVISA’s Resolution 894/2024 comes into force on August 28 and requires mandatory reporting of serious cosmetic adverse events
On August 28, 2025, ANVISA’s Collegiate Board Resolution – RDC 894/2024 will come into force, establishing Good Cosmetovigilance Practices...
New Environmental Licensing Guidelines – Presidential Vetoes and Government Proposals Aim to Ensure Legal Certainty and Streamline Strategic Projects
Written by: Viviane Kunisawa, Mariana Cuzziol and Estela Alves The Brazilian President has vetoed 63 provisions of Bill No. 2,159/2021, which...
Brazil Outlines 2025-2027 Intellectual Property Action Plan
The Interministerial Group on Intellectual Property (GIPI) has officially approved the Action Plan for the 2025-2027 period, which was published in...
Environmental Licensing – Brazilian Chamber of Deputies Approves Legislative Proposal to Modernize National Regulation
Written by Mariana Cuzziol, Viviane Kunisawa and Estela Alves In the early hours of Thursday, July 17, 2025, Brazil’s Chamber of Deputies approved...
Bill No. 2,159/2021 and the Future of Environmental Licensing in Brazil: Challenges and Opportunities for Agribusiness
Introduction The debate surrounding Bill No. 2,159/2021, which establishes the new General Law on Environmental Licensing, represents one of the...
Law No. 15,154 establishes exemptions for artisanal products intended for personal hygiene
On July 1, 2025, Law No. 15,154 of June 30, 2025, was published in the Official Gazette of the Union (DOU). The law amends the Health Surveillance...
Brazilian Federal Court of Appeals confirms the right of the applicant to convert claims into Swiss-type format
The Court of Appeals for the Second Circuit (TRF-2), in Rio de Janeiro, has upheld a lower court ruling that invalidated the Brazilian Patent and...
MAPA Ordinance No. 807 of June 16, 2025, Establishes the Sustainable Projects Program under the ABC+ Plan
Written by: Viviane Kunisawa, Mariana Cuzziol and Estela Alves The Ordinance No. 807, dated June 16, 2025, issued by the Brazilian Ministry of...
Establishment of the Interministerial Working Group to regulate Articles 13 and 17 of the Nagoya Protocol
Written by: Viviane Kunisawa, Mariana Cuzziol and Estela Alves The Ordinance No. 1,392, dated May 22, 2025 establishing the Interministerial Working...
Publication of Decree No. 12,502 of June 11, 2025, which regulates Law No. 14,515 of December 29, 2022
On June 12, 2025, Decree No. 12,502 of June 11, 2025, was published in the Official Gazette (DOU), regulating Law No. 14,515 of December 29, 2022....
Ordinance No. 805 of the Ministry of Agriculture and Livestock (MAPA) Establishing the National Program for the Traceability of Pesticides and Related Products
On June 10, 2025, Ordinance No. 805, dated June 9, 2025, from the Ministry of Agriculture and Livestock (MAPA), was published in the Federal...
New Decree on Biodiversity: Implications for Agribusiness
Written by: Viviane Kunisawa, Mariana Cuzziol and Estela Alves On June 4, 2025, Decree No. 12,485/2025 was published in Brazil’s Federal Official...
Brazil’s Role in SEP Litigation Continues to Evolve
Brazil remains a key jurisdiction for Standard Essential Patent (SEP) disputes, standing out as the fifth-largest smartphone market in the world and...
New agreement at COP16 strengthens global biodiversity financing
Countries approve a financial mechanism to boost biodiversity conservation, opening new opportunities for sustainable investment and demanding...
ANVISA Establishes Optimized Procedure for Reviewing Food-Related Petitions
New Normative Instruction No. 344/25, published on February 21, reduces processing times and establishes more efficient criteria for evaluating...
Brazil Sets New Biodiversity Conservation Goals for 2030
Plan Aligns the Country with the Kunming-Montreal Global Framework and Reinforces International Commitments The National Biodiversity Commission...
ANVISA Moves Forward with Herbal Medicine Regulation Overhaul
Brazil’s National Health Surveillance Agency (ANVISA) is taking decisive steps to modernize the regulation of industrialized herbal medicines. In a...
AGU Defends Tax Benefits for Pesticides in STF Trial
The Office of the Attorney General (AGU) has expressed support for maintaining tax benefits granted to pesticides, arguing that such incentives play...
ANVISA seeks public input on a proposed resolution to enhance the monitoring of health risks and compliance in establishments manufacturing pharmaceutical supplies.
On December 23, 2024, the Brazilian Health Regulatory Agency (ANVISA) published Public Consultation No. 1.303, which aims to draw up a regulatory...
ANVISA Enhances Regulatory Confidence with Selection of Priority Foreign Authorities
ANVISA adopts regulatory reliance to streamline processes and bolster trust in health products approved by internationally recognized authorities....
President Lula Signs Law 15.070/2024: Regulatory Framework for Bioinputs Boosts Sustaintabilty and Innovation in Brazilian Agriculture
New legislation regulates the bioinput chain, promotes sustainability and encourages innovation in Brazilian agribusiness. In an initiative...
Brazilian IP Association Sets 2025 Goals for Essential Patents and FRAND Licenses.
On December 12, the Study Committee on Essential Patents and FRAND Licenses of the Brazilian IP Association held its last meeting of the year. On...
Seminar “The Importance of the Judiciary´s role in the SEP system”
On 13 September, the School of the Judiciary of the State of Rio de Janeiro and the Brazilian IP Association held a seminar entitled The Importance...
Senate Approves Regulatory Framework for Bioinputs in Brazil: A Milestone for Agricultural Sustainability
The Bioinputs Bill moves to presidential sanction, promising to transform agricultural practices in the country. Last Tuesday, the Federal...
STJ Sets Deadline for Regulation of Medicinal Cannabis Cultivation and Importation in Brazil
Unanimous decision grants six months for ANVISA to establish rules, highlighting benefits for patients and domestic industries. The Brazilian...
ANVISA Innovates with Artificial Intelligence in Medication Analysis
In a pivotal step toward modernizing its medication evaluation processes, Brazil’s National Health Surveillance Agency (ANVISA) has implemented an...
ANVISA Establishes Technical Chamber for Clinical Research on Medicines and Medical Devices (Catepec)
ANVISA (the Brazilian Health Regulatory Agency) has announced a significant initiative for the healthcare sector: the creation of the Technical...
New MAPA Ordinance for Technical Products and Pesticides
On June 27, 2024, the Ministry of Agriculture and Livestock (MAPA) published Ordinance No. 1,136, dated June 25, 2024, which establishes guidelines...
ANVISA Updates Food Expiry Guide with International References
The National Health Surveillance Agency (ANVISA) published the second version of the guide for determining the expiry dates of food products sold in...
Brazil Establishes National Policy for the Conservation and Sustainable Use of Genetic Resources
New measure aims to preserve and sustainably use genetic resources, promoting food security and innovation Decree No. 12,097, dated July 3, 2024,...
National Bioeconomy Strategy: A Pathway to Brazil’s Sustainable Future
In celebration of World Environment Day, on June 6, 2024, the Federal Government issued Decree No. 12,044/2024, which establishes the National...
Regulation of Biosimilars by ANVISA
Recently, the Brazilian Health Regulatory Agency (ANVISA) took a significant step by approving RDC No. 875 on May 28, 2024. This new regulation...
The Biotechnology Revolution: The Impact of the New WIPO Treaty on Genetic Resources
“The new WIPO Treaty on Patents, Genetic Resources, and Traditional Knowledge has the potential to transform global biotechnology, promoting a...
The Biotechnology Revolution with the New WIPO Treaty
The new WIPO treaty requires the disclosure of origins in patents and promotes the sharing of benefits related to the use of genetic resources and...
Brazil’s ANVISA Approves New Regulation for Biosimilar Drug Registration Simplifying the Development Process for Biosimilars
On May 27, ANVISA (Brazilian Health Regulatory Agency) approved a new regulation for the registration of biosimilar drugs, aiming to simplify and...
ANVISA maintains ban on electronic smoking devices in Brazil.
On April 19, ANVISA upheld the ban on electronic smoking devices (ESDs). ESDs involve different equipment and technologies, mostly consisting of a...
MAPA Introduces Alternative to Sanctions for Agricultural Establishments
On April 15, the Ministry of Agriculture, Livestock and Food Supply (MAPA), through its Secretary for Agricultural Defense, published Ordinance...
What’s Next After Brazil’s Enactment of the Nagoya Protocol
“Promulgation was the final step that was missing for [the Nagoya Protocol’s] formal incorporation into the national legal system. However, there...
ANVISA establishes optimized procedure applications for registration of medical devices
On April 8th, the Brazilian health regulatory agency ANVISA published a Normative Instruction (290/2024), establishing the optimized procedure on...
ANVISA approves the use of analyses from equivalent regulatory foreign authorities (EFRA)
On March 19th, during a public meeting of the Collegiate Board of Directors, the Brazilian health regulatory agency ANVISA approved a Normative...
Brazilian FDA (ANVISA) adopts a new regulatory framework for the food industry
On February 28th, the Brazilian regulatory agency ANVISA published the Resolution RDC 843/2024 and the Normative Instruction 281/2024, which provide...
The New Legal Framework for Chemical Pesticides in Brazil
At the end of 2023, Law 14,785/2023 was published in Brazil’s official gazette, creating a new regulatory framework for chemical pesticides and...
Brazil’s New Chemical Pesticides Law: find out what was approved by Congress
On November 28, the Brazilian Senate approved the final text of Bill 1459/2022. The bill, which has now been sent for presidential sanction, will...