Online

Intellectual Property and the Pharmaceutical Industry

General information

Online course, divided into six meetings.

Day and Time

30.09 | 02.10 | 08.10 | 09.10 | 14.10 | 16/10 - 7 PM to 8:30 PM

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Online course

Investment


Free for Dannemann clients

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Description

Few industries are as dependent on intellectual property as pharmaceuticals.

From the development of a new molecule to the launch of the drug on the market, there is a complex chain of legal and regulatory issues that pose numerous challenges for intellectual property professionals.

In this course, you will learn what these issues and problems are, building up the knowledge to successfully navigate a tightly regulated industry.

Program

  • 30/09 - OVERVIEW OF THE PHARMACEUTICAL INDUSTRY AND THE NATIONAL MARKET

    teachers Tatiane Schofield [Interfarma] e Gustavo de Freitas Morais

    The economic relevance of the pharmaceutical market and key players. The life cycle of a drug and the protection of investments in R&D. The Unified Health System (SUS) and pricing. The role of ANVISA, INPI (BPTO), and other government entities. The PDP system. The present and the future of the national pharmaceutical market.

  • 02/10 - PATENTS

    teachers Monique Teixeira e Bernardo Marinho

    The pharmaceutical industry and the patent system. The difference between invention and discovery. Patentability requirements. Patentable and non-patentable material. Types of Claims. INPI (BPTO) Examination Guidelines. Prior approval from ANVISA for the granting of pharmaceutical patents. Challenges involving novelty and inventive activity in the courts.

  • 08/10 - PATENTS [INFRINGEMENT ISSUES]

    teacher Luiz Augusto Lopes Paulino

    Scope of protection and techniques for interpreting claims. Direct and contribution infringement. Literal and equivalence infringement. Expert proof. Issues of external harmfulness involving infringement and nullity actions. Coercive measures and obtaining emergency tutorage. Criteria for indemnity calculation.

  • 09/10 - BRANDS AND TRADE DRESS

    teacher Gustavo Piva de Andrade

    The importance of brands as a differentiating element of medicine. What can and cannot be protected as a trademark. Prescription and OTC medicines. Infringement questions and criteria for measuring the possibility of confusion. Use and expiry. ANVISA rules on drug names. Protection and infringement of trade dress in the pharmaceutical area.

  • 14/10 - ANVISA AND REGULATORY ISSUES

    teacher Rodrigo Augusto Oliveira Rocci

    The process of registering a drug with ANVISA. Absence of linkage between INPI (BPTO) and ANVISA. Differences between the Brazilian system and the international system. Drug registration issues in case of mergers or acquisitions. Judicial and administrative measures for non-compliance with regulatory provisions.

  • 16/10 - DATA PROTECTION

    teacher Carlos Eduardo Eliziário de Lima e Filipe Fonteles Cabral

    Use of data in the pharmaceutical area. Sensitive data. Legal basis for processing health data. Anonymization. Rights of the holders. Data Protection Impact Assessment (DPIA) as a mitigating risk element. POD. Penalties Practical aspects to consider in a compliance project.

Professors

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