Ateneo - UPO

This 6-hour course unit introduces students to the fundamental concepts of Intellectual Property (IP) rights and the principles of Open Science within the life sciences and medical biotechnology sectors.
This course unit provides students with practical knowledge regarding how patents protect biological inventions, how trademarks ("marks") distinguish biotech products in the healthcare market, and how Open Science frameworks (Open Access, FAIR data principles) can coexist with commercialization and technology transfer strategies.

Sets of slides, scientific articles, and other documents (reports, professional brochures) made available on the UPO DIR website during the course.

The course unit is designed to provide students with an essential understanding of the activities involved in Intellectual Property (IP) protection processes, as well as the challenges and opportunities associated to Open Science frameworks.
1. Knowledge and understanding. The course primarily aims to:
- provide the fundamental concepts of Intellectual Property (IP) rights and the principles of Open Science within the life sciences and medical biotechnology sectors;
- enable students to understand the differences between various forms of IP protection, in medical and pharmaceutical contexts.

2. Applying knowledge and understanding. The course unit aims to develop students' ability to:
- actively contribute to the formulation of an action plan to protect a scientific discovery;
- collaborate with their TTOs as competent partners in advancing the development of laboratory discoveries.

3. Making judgements. The course unit aims to develop students' ability to:
- evaluate the key issues associated with initiating and managing the process of IP protection.
- critically analyze the trade-offs between immediate scientific disclosure/publishing and IP protection/patent filing.

4. Communication skills. Students will acquire the ability to understand and use the technical terminology employed by professionals in the field of IP rights.

5. Learning skills. Students will become familiar with the main sources of information, including relevant websites.

None.

Interactive frontal lectures will be complemented by group discussions, videos, case study analyses.

Further information is available on the UPO DIR website. Students with disabilities, Specific Learning Disabilities (SLD), or Special Educational Needs (SEN) may request dedicated support services and specific tools by contacting the Career Development and Student Services Staff and by consulting the dedicated page on the University website: https://uniupo.it/it/servizi/servizi-studentidisabili-e-dsa. Once they have contacted the relevant University Staff, students with disabilities, SLD, or SEN may get in touch with the tenured professor regarding the adaptation of examination modalities and instructional aspects.

The exam is held as part of the examination for the integrated course “Exploitation and Technological Transfer for cosmetics, nutraceutics, drugs, medical devices and advanced medicinal products” and consists of a written exam.

FUNDAMENTALS OF PATENTING IN MEDICAL BIOTECH
- Introduction to Intellectual Property Rights (IPR) in biomedical research.
- Patentability requirements.
- What can and cannot be patented in biotechnology
- Patent filing workflow: Prior art search, provisional filing, and the publication grace period dilemma.
TRADEMARKS, TRADE SECRETS, AND REGULATORY FRAMEWORKS
- Trademarks ("Marks"): Protecting diagnostic kits, biotech devices, pharmaceutical brand names, and biological services.
- Trade Secrets: Protecting proprietary lab protocols, bio-informatics algorithms, and biological manufacturing processes (know-how).
- Regulatory Exclusivity: Interplay between FDA/EMA regulatory data exclusivity and IP rights.
OPEN SCIENCE, DATA SHARING, AND DUAL-USE STRATEGIES
- Principles of Open Science: Open Access (Gold/Green), Open Source, and FAIR Data (Findable, Accessible, Interoperable, Reusable).
- Resolving the tension: "Publish or Patent?" timing strategies.

Upon completion of the course unit, students will be able to demonstrate:
- KNOWLEDGE: relating to the differences between various forms of IP protection in medical and pharmaceutical contexts and the core criteria for patentability in these fields.
- COMPETENCIES: consisting in the ability to evaluate the principles of Open Science, FAIR data sharing, and Open Innovation and to critically analyze real-world trade-offs between immediate scientific disclosure/publishing and IP protection/patent filing;
- TRANSVERSAL SKILLS: relating to the effective framing and communication of the relevant issues involved in the fulfillment of patentability requirements.