Ateneo - UPO

The course is designed as an introductory module.
The course introduces the principles of innovation management, intellectual property (IP), patents, and technology transfer in the field of medical biotechnology. Through examples from hematology, oncology, gene and cell therapy, molecular diagnostics, and drug delivery, students will explore how scientific discoveries can be protected, developed, transferred, and translated into patient benefit. The course addresses patentability requirements, patent claims, prior-art searches, freedom to operate, inventorship and ownership, academic–industry collaboration, licensing, spin-offs, and ethical issues related to access to biomedical innovation.

The didactic material, including slides, provided by the Professor; scientific papers covered in class; and online public databases are all resources will be used in this course.

The course aims to provide Medical Biotechnology students with the basic knowledge and practical language needed to understand how biomedical innovation is protected and translated into clinical, industrial, and societal value. By the end of the course, students should be able to connect scientific discovery with IP strategy, recognise when early interaction with technology-transfer and patent professionals is needed, and evaluate innovation decisions from scientific, commercial, regulatory, and patient-centred perspectives.

Basic knowledge of molecular biology, genetics, cell biology, and medical biotechnology is expected. No prior legal, economic, or patent-related knowledge is required.

Il corso consiste in 8 ore di didattica interattiva in aula. I metodi didattici comprendono brevi lezioni frontali, discussioni guidate, esempi biomedici reali, lettura di documenti brevettuali, sondaggi rapidi, esercitazioni di gruppo, giochi di ruolo e apprendimento basato su casi di studio.

Students with disabilities or specific disorders of Learning (DSA) or with Special Educational Needs (SEN) may require services and tools specific dedicated to them by contacting the Careers and Services Development and Coordination Staff at Students and by consulting the dedicated page on the website University: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities Students with disabilities, DSA, BES, once taken contact with the University Staff, they can contact the teacher in charge of the course in question to the declension of examination methods, regarding the teaching aspects.

La frequenza e la partecipazione attiva sono fortemente raccomandate, poiché le attività svolte in aula contribuiscono direttamente al raggiungimento degli obiettivi formativi.

Learning will be assessed through active participation in classroom activities and a Multiple-choice exam

1. Innovation in medical biotechnology

- Scientific discovery, invention, innovation, and translation.
- Unmet medical need and patient-centred innovation.
- The pathway from laboratory result to clinical and societal impact.
- Innovation ecosystems: universities, hospitals, companies, investors, regulators, and patients.

Examples from hematology and oncology: molecular diagnostics, CAR-T cells, gene editing, precision medicine, and targeted drug delivery.

2. Fundamentals of intellectual property and patents

- Intellectual property in biomedical research: patents, know-how, copyright, trademarks, and data.
- The purpose and structure of a patent document.
- Patentability requirements: novelty, inventive step, industrial applicability, and sufficient disclosure.
- Claims as the legal boundary of a patent.
- Publication, conference abstracts, theses, preprints, and the importance of confidentiality before filing.
- Introduction to prior art and basic patent searching.

3. Patent strategy and technology transfer

- Patentability versus freedom to operate.
- Patent landscapes and competitive intelligence.
- Inventorship, ownership, authorship, and institutional responsibilities.
- University technology transfer offices and the management of academic inventions.
- Licensing, co-development, start-ups, spin-offs, and collaboration agreements.
- Basic elements of IP due diligence in biotechnology.

4. From protection to patient access

- Interaction among IP strategy, scientific evidence, regulatory development, manufacturing, and reimbursement.
- Commercialisation challenges in advanced therapies, diagnostics, and precision oncology.
- Ethical and societal dimensions of exclusivity, affordability, equity, and global access.
- Group case study: development of an innovation and patent strategy for a medical-biotechnology project.

At the end of the course, students will be able to understand the role of intellectual property and technology transfer in medical biotechnology; recognise the main requirements for patent protection; distinguish patentability, freedom to operate, inventorship, ownership, and authorship; and identify IP-relevant aspects of a biomedical innovation. Students will also be able to discuss the protection, development, licensing, and access implications of a biomedical innovation, communicate these issues clearly to different stakeholders, and recognise when specialised legal, patent, regulatory, or technology-transfer advice is needed.