Regulatory Issues and Patents

Recommended Prerequisites

Relevant skill in English to allow consultation of database related with patents.

Teaching Methods

Regulatory Affairs” Segment
Theoretical classes
Oral exposition with Powerpoint slides.
Practical classes
Reading regulatory and technical documents. Oral presentations.
“Patents” Segment
Theoretical classes
Powerpoint slides and browsing of Internet websites.
Practical classes
Powerpoint slides and browsing of Internet websites.
Working groups: patent database searching; IP rights, applied to a business case and/or idea; “Elevator Pitch” exercise
Case study of a start-up company: an Healthcare high-tech start-up company
Visit to Instituto Pedro Nunes Business Incubator.

Learning Outcomes

"Regulatory Affairs” segment
Allow filling in a documentation file for products used in clinical trials;
Requirements of substantial variations;
Knowledge of specific Guidelines concerning drugs used in clinical trials.
“Patents” segment
Offer to students skills and competences in Intellectual Property Rights: patents, trademarks, design rights, copyright and software protection
Introduce the “world” of patents and its proceedings
Allow students to perform patent and prior art online database searches and to file trademark applications
Present and follow the basics on technology transfer, Science/Business interactions and knowledge protection and valorization in broad terms
Boost science-based entrepreneurship among students.

Work Placement(s)

No

Syllabus

“Regulatory Affairs”
1. Finished products used in clinical trials
1.1 Technical documentation;
1.2 CTD format
1.3 National and VHP files
1.4 Technical support to properly fill in technical documentation
2. Relevant Variations
2.1 Technical documentation
2.2 Organization based on CTD format
2.3 Technical documentation to support the quality part of a variation submission dossier
3. Technical support
3.1 Specific Guidelines
3.2 Dossiers to be submitted through national and centralized procedures
“Patents”
1.1. Innovation and Entrepreneurship
1.2. Intellectual Property Rights
2.1. Industrial Property Rights
The protection of inventions
Trademarks and other commercial signs
Design protection
2.2. Copyight
Basics / Legal regime
Software and database protection
Open Source and Creative Commons
3.1. Licensing and Assignment of IP Rights
3.2. Science-Business interactions
3.3. Specific tools for knowledge and technology transfer
3.4. Intellectual creations under contract: legal regime

Head Lecturer(s)

Carla Sofia Pinheiro Vitorino

Assessment Methods

Assessment
Resolution Problems: 30.0%
Exam: 70.0%

Bibliography

Segmento “Assuntos Regulamentares”
Slides apresentados nas aulas
Guidelines de apoio técnico.
Segmento “Patentes”
Slides apresentados nas aulas
“Manual de Direito Industrial”, 2ª edição, Gonçalves, Luís M. Couto, Almedina, 2008.