Bioethical and legal issues in biotechnoloy

A.Y. 2020/2021
Overall hours
AGR/01 IUS/01 MED/02
Learning objectives
The course will address the legislative, economic and ethical aspects of scientific research and biotechnological applications in medicine with the aim of creating a space to think and promoting the debate on the purposes and risks associated with biotechnologies, as well as on the importance of the role of the biotechnologist in today's society
Expected learning outcomes
The course will provide students with the basic knowledge of the legal regulation for the invention patents, biotechnological inventions and plant varieties, utility models and industrial secrets
Course syllabus and organization

Single session

Lesson period
Second semester
Course syllabus
The teaching will have as its object: the principles, general notions and rationale of the patent system, the protection of trade secret and confidential information, the notion of patentable invention, the requirements of patentability (extrinsic novelty, inventive step, lawfulness and industriality), the subjective profiles of the patent, with particular attention to the inventions of employees and university researchers, the content of the exclusive right and its limits, the administrative procedure for granting the national, European and European title with unitary effect, the discipline of biotechnological inventions and the new European patent system with unitary effect.

Particular reference will be made to the specific aspects of microeconomics with particular reference to the market and to the basic concepts of policies (national, European and international) specific to innovation and biotechnology.

The bioethics module (24 hours) aims to provide an overview of the principles and major regulatory documents in the field of research ethics, as well as to explore the main ethical, legal and social issues posed by the most recent developments in data-intensive biomedicine. Topics covered in the course include the ethical and social implications of genome editing, precision medicine, biobanking, direct-to-consumer genetic testing, Big Health Data. In addition to actively participate in lectures, students are asked to conduct independent research on a topic that has specifically elicited their interest.
Prerequisites for admission
No prerequisites are required
Teaching methods
For bioethics: lectures, some seminars (collective discussion on selected topics) might be foreseen
For the legal and economic part, the lessons are frontal.
Teaching Resources
For the legal part, in addition to the notes taken in class: Ghidini Cavani, Industrial law lessons, Milan 2014, Chapters I and VI.
For economic part; all the slides useful for the study will be made available on the Ariel platform.
For the bioethics part, lectures and bibliographical references on the topics will be provided by the teacher
Assessment methods and Criteria
For bioethics: the exam takes place in an oral form, and consists of an individual presentation on a topic chosen by the student, followed by open questions on the topics covered during the course.
The evaluation parameters considered are the following:
20%: participation and interaction during the classes;
40%: oral presentation (breadth and depth of autonomous research carried out by the student, ability to use and connect the notions learned during the course, quality of exposure, appropriateness of language);
40%: answers to open questions (knowledge and ability to link together the different notions learned during the course, critical thinking, quality of exposure, appropriateness of language).

The examination of the legal part consists of an oral test. For economic part the exam consists of an oral test aimed at evaluating and verifying if, and how, the student knows, has understood and is able to explain what he has learned. The students will have access to intermediate exams (not compulsory or binding). Information about intermediate tests enrollments and dates will be communicated just in class.
IUS/01 - PRIVATE LAW - University credits: 0
MED/02 - MEDICAL HISTORY - University credits: 0
Lessons: 72 hours
Professor: Giudici Silvia