LEGISLATION AND PATENTS
Learning outcomes of the course unit
The purpose of this module is to provide students with the tools to understand the regulatory aspects related to the research and development of biotechnology applications in medicine, veterinary medicine and pharmacy. At the end of the course the student will be able to:
- be familiar with the rules on patent protection of the results of inventive research, in the specific field of biotechnology,
- be familiar with the framework of rules governing biotechnological research, covering both the performance, the use and exploitation of its results.
Course contents summary
The first lectures are intended to provide information on patent law. The following lectures will concern the regulatory aspects specifically regarding the biotechnological matter that have developed both in Italy and in Europe. Particular attention will be given to developing the capacity to analyse and understand the rules protecting biotechnological inventions.
O.Capasso, Invenzioni biotecnologiche, in C.Galli- A.M.Gambino (curated by), Codice commentato della proprietà industriale e intellettuale, UTET Giuridica, Torino, 2011, pages 814-841;
O.Capasso, Nuove varietà vegetali, in C.Galli- A.M.Gambino, Codice commentato della proprietà industriale e intellettuale, UTET Giuridica, Torino, 2011, pages 814-841;
C.Galli, La “via italiana” ai brevetti biotecnologici dopo la Riforma del 2010 del Codice della Proprietà Industriale, in G.Olivieri and others, Confini e fronti dell’innovazione biotecnologica per la proprietà intellettuale, Giuffrè Editore, Milano, 2014, pages 67-87;
V.Mangini-A.Toni, Manuale breve di diritto Industriale, CEDAM, ed. IV, 2015, pages 105-129;
C.Galli, Per un approccio realistico al diritto dei brevetti, in Il Diritto Industriale, IPSOA 2010, II, page 133 and following ones;
O.Capasso, Gli sviluppi delle ricerche sulle staminali e la giurisprudenza in materia di brevetti biotecnologici, in Il Diritto Industriale, IPSOA, 2016, II, page 140 and following ones;
Court of Milano (order), February 10th 1997, in Giur. ann. dir. ind., 1997, no. 3650, page 615 and following ones;
Court of Milano (order), March 22th 1997, in Giur. ann. dir. ind., 1997, no. 3654, page 647 and following ones;
Italian Code of Industrial Property (Legislative Decree February 10th 2005, no. 30, updated to Legislative Decree August 13th 2010, no. 131) – Referred rules.
The course is organized as frontal lessons of two hours each. Each meeting will explore a theme described in the program. The lecture includes a teacher presentation introducing the topic or an illustrative case. The topic or case is then discussed, illustrating the different approaches to interpretation. Students are encouraged to express their own opinion and to exchange points of view. The aim is to provide an opportunity for information and the development of critical thinking. At the end of the lecture, the teacher makes a summary of the positions emerged and suggests in-depth readings.
Assessment methods and criteria
The exam is oral and aims to evaluate the bioethical and legislative skills acquired, through open questions and requests to discuss and compare different theses and models. The exam is divided into two modules of the course (Bioethics and Legislation). The exam also includes the student's choice of subjects from among those presented in class, on which a specific in-depth study is carried out.
The evaluation criteria are:
- argumentative ability;
- precision and competence in the language adopted during the exhibition;
- the ability to bring together technical and comparative data at international level on the chosen topic in a competent and informed manner;
At the end of the examination each teacher will formulate a judgment expressed in bands:
A. Excellent knowledge and understanding of the subject. High capacity for criticism and analysis of topics. Vote in thirtieths: 30.
B. Good knowledge and understanding of the subject with some minor inaccuracies. Good ability to criticise and analyse themes. Vote in thirtieths: 27-29.
C. Discreet knowledge and understanding of the subject with some gaps. Criticism and analysis of topics: 24-26.
D. Fully sufficient knowledge and understanding of the subject, although there are clear gaps. Vote in thirtieths: 21-23.
E. Knowledge and understanding of the subject barely sufficient with obvious and serious gaps. Vote in thirtieths: 18-20.
Honors will be proposed, for students who have achieved 30/30 in the applications, for the demonstration of independent judgment, high communication skills and autonomous learning skills.