The patenting of drugs and related products in Brazil needs to attend exclusive requirements to comply with technical and legal issues, including the prior consent of pharmaceutical patents by the Brazilian regulatory body for health surveillance, ANVISA.
Tavares’s Life Sciences Division works closely with clients in the pharmaceutical and biopharma sectors to provide the counseling and support they need to secure IP protection and develop sound business strategies for their products, helping our clients to go through the Brazilian regulatory environment.
Our multidisciplinary team consists of engineers, pharmacists, biologists and nanotechnology professionals with experience in such diverse areas as medicinal chemistry, biochemistry, immunology, biotechnology, cell and molecular biology, pharmacology, pharmaceutical science, chemical engineering, medical devices and clinical trials.
Tavares represents clients in a wide variety of traditional and biological pharmaceutical technologies, advising from start-ups such as biotechnology startups, to the most solid initiatives, as multinationals in the area of medicine, biological products, active pharmaceutical ingredients, medical devices, cosmetics, food or agrochemicals.
Our work in this field includes:
- Strategic portfolio management, including advice on product lifecycle management and implementation of advanced, cutting-edge patent prosecution strategies to harvest and protect clients’ innovations.
- Freedom-to-operate assessments and counseling to minimize commercial risk and provide a level of confidence regarding third party patent positions;
- Legal advice, including patentability opinions and infringement opinions, and also freedom-to-operation counseling to assist in introducing new products to the market;
- Assessment of the potential licensing value of third party patents and guidance regarding decisions to license;
- Elaboration and advice on contractual issues in view of the specificities of the sector;
- Consulting and litigation involving authorities that regulate the sector;
- Clinical research and access programs regulated by ethical and regulatory authorities;
- Monitoring of registration, alteration and post-registration processes of medicines and cosmetics before ANVISA (National Agency for Health Surveillance);
- Review and advice on contracts for distribution and outsourcing of production of controlled products;