- Docente: Leonardo Marchitto
- Credits: 3
- SSD: CHIM/09
- Language: English
- Teaching Mode: Traditional lectures
- Campus: Bologna
- Corso: Second cycle degree programme (LM) in Pharmaceutical Biotechnology (cod. 9068)
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from Oct 10, 2025 to Dec 12, 2025
Learning outcomes
At the end of the course, the student: - knows the main I.P. protection tools relevant in the field of interest, the different types of patent, the rights conferred by a patent and meaning of I.P.- right infringement; - knows the general patentability requirements and the rules applied in the field of pharmacy, biotechnology, and the relationship between patent, scientific publication, oral presentations; - knows the meaning of Medicine Regulatory Authority and Regulatory Procedure; - knows the different type of documental search and is able to apply the acquired knowledge within a scientific research program.
Course contents
Pharmaceutical Patents
Introduction to Intellectual Property in the Pharmaceutical and Biomedical Sector. What is Intellectual Property? IP Scheme, IP strategic scheme. Rights Conferred by a Patent. Patent Types and Novelty Requirement, Inventive Step, Industrial Applicability, Sufficient Disclosure, Biotech Patents.Filing Procedures and Patent Examination Phases, Procedure Phases. Patent Grant, Supplementary Protection Certificate (SPC) Oppositions and Litigation.Patent Portfolio Management, Licensing Strategies, Regulatory Aspects and Interaction Between Patents and Authorities Regulatory Data and Protection, Data Exclusivity, Market ExclusivityPatent Searches and Databases, Prior art, freedom to operate (FTO), competitor monitoring. Patent Clustering Strategies, Defense Strategies Against Generics and Biosimilars
Regulatory Affairs and Scientific Guideline for Biodrugs
Regulation of medicinal products for human use manufactured by industry: Directive 2001/83/EC: Code of medicinal products for human use.
Technical Regulations for Pharmaceutical Development (ICH and EMA guidelines) Notes on the European and Italian Regulatory System for Medicines, the CTD (Common Technical Document) and the legal bases, procedures and regulatory activities for the registration and maintenance of registration dossiers,
ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/ biological entities)
CHMP/437/04 Rev 1, Guideline on similar biological medicinal products
EMEA/CHMP/410869/2006 GUIDELINE ON HUMAN CELL-BASED MEDICINAL PRODUCTS
EMA Guideline on Development, production, characterisation and specification for monoclonal antibodies and related products
ICH Topic Q 5 D Quality of Biotechnological Products: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products
Note on CPMP/ICH/138/95: NOTE FOR GUIDANCE ON QUALITY OF BIOTECHNOLO-GICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS
Note on ICH Topic Q 6 B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
Readings/Bibliography
- Contemporary Issues in Pharmaceutical Patent Law: Setting the Framework and Exploring Policy Options. (2017). Regno Unito: Taylor & Francis.
- Intellectual Property Law and Access to Medicines: TRIPS Agreement, Health, and Pharmaceuticals. (2021). UK , Regno Unito: Taylor & Francis.
- lessons slide presentation
Teaching methods
frontal lessons
Assessment methods
oral exam
Teaching tools
software power point
Office hours
See the website of Leonardo Marchitto