90831 - European and International Regulation and Patents

Academic Year 2021/2022

  • Docente: Claudio Germinario
  • Credits: 3
  • SSD: CHIM/09
  • Language: English
  • Teaching Mode: Traditional lectures
  • Campus: Bologna
  • Corso: Second cycle degree programme (LM) in Pharmaceutical Biotechnology (cod. 9068)

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

At the end of the course the student:

  • Knows the meaning of Industrial Property (I.P.) and the existence of the main I.P. protection tools relevant in the field f interest: the patent, the supplementary protection certificate (SPC), the certificate for new plant variety, the trademark etc.
  • Knows the different types of patent: national, regional, international (via PCT or via EPC)
  • Knows the basic rules and the timing for patent protection: the patent application, the priority, the prior art, the substantive examination, the grant procedure (validation for EP patent), the opposition, the natural patent-terms, the extension of the terms for medicaments and phytosanitary principles.
  • Knows the rights conferred by a patent and the exclusions from said rights.
  • Knows the general patentability requirements and the rules guiding the substantive examination of patent applications in the field of pharmacy, biology, biotechnology (protection of the first and subsequent therapeutic application, of natural substances, microorganisms, plants and animals) and knows the exclusion and exceptions to patentability.
  • Knows the relationship between patent, scientific publication, oral presentations, confidential release of information and material.
  • Knows the meaning of original, generic, biosimilar medicament in relation to the I.P. rights.
  • Knows the meaning of I.P.- right infringement, the different types of infringement and the jurisdiction of the national tribunals/courts in litigations on I.P. matters.
  • Knows the meaning of Medicine Regulatory Authority and Regulatory Procedure and its basic principles: the Marketing Authorization (M.A.), the documentation contained in the request for granting a M.A. (the clinical trials, the SmPC), setting the price.
  • Knows the interactions between patent procedure and regulatory procedure.
  • Knows the different type of documental search, the main free search tools and their ambit of application and limits.

    At the end of the course the student is able:

  • To carry out a prior art documental search.
  • To apply the acquired knowledges within a scientific research program by autonomously formulating a preliminary opinion on the suitability for patent protection of the obtained results and/or consciously deciding on the possibility of publication of the results.
  • To communicate and explain all relevant aspects and results to the competent in-house or external I.P. and technology transfer service.

Readings/Bibliography

See section: Useful contents

Teaching methods

Front and on-line lectures

Office hours

See the website of Claudio Germinario

SDGs

Industry, innovation and infrastructure

This teaching activity contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.