Post M.Sc Advanced Diploma in Intellectual Property Rights, Biosafety and Regulatory Affairs

The Maharaja Sayajirao University of Baroda
In Vadodara

Price on request

Important information

  • Post Graduate Diploma
  • Vadodara
  • Duration:
    1 Year

Important information

Where and when

Starts Location
On request
Department of Microbiology and Biotechnology Centre Faculty of Science M.S. University of Baroda , 390002, Gujarat, India
See map

Frequent Asked Questions

¬∑ Requirements

M.Sc with minimum 50% marks in Microbiology/Biotechnology/ Biochemistry/allied branches of biological sciences. Selection to the course shall be based on an Entrance Test and Viva voce (interview)

Course programme

The one year course is being started with support from Department of Biotechnology, Ministry of Science & Technology, Govt. of India, New Delhi, with the aim of providing an ideal opportunity to train fresh students who would like to work in the field of IPR, filling of patents and regulatory affairs in public and private institutions.

Course Syllabus

Course work is spread over a period of one year encompassing three papers covering the broad areas of IPR, Regulatory and Procedures, Biotechnology Processes and Products. Evaluations shall be based on several rounds of tests, culminating in a final examination after the end of the academic year. As a part of a practical training, students shall also undertake assignments involving case studies, patent analysis etc. and a Project work/Apprenticeship in the relevant industry/law firm dealing with IPR issue for a duration of 2 months. The course content of the proposed course is as under:

Paper I : Intellectual Property Rights

Introduction to intellectual property, History of patents, Indian Patent law, Patent laws in the US and European Union.

Patents :

Patentable subject matter and patent types

Patent requirements: technical specifications, novelty, and non-obviousness

Rights of patent holder

Patent protection for biological materials, biotechnological inventions, software, algorithms and methods

The patent application

Scope of amendments and claims

Conflict and infringement

Copyrights :

Copyrightable subject matter

Requirement, limitations, length and rights

Comparison with patents

Copyrights in the context of information technologies

Fair use doctrine and file sharing

Trade marks :

Types, trade dresses

Protecting trademark, industrial designs


Trade secrets

Technology transfer and license agreements

Protocols, treaties and conventions related to IPR

Case studies of biotechnology patents

Role of NGOs in IP protection

Paper II : Regulatory Procedures

Good laboratory practice, Good manufacturing practice and FDA regulations

Pharmacopia standards

Regulations for recombinant DNA research and manufacturing process

Bio-safety and Bioethics

Regulations for clinical trials, Documentation and Compliance, in India and selected countries

Rules for import and export of biological materials

Paper III : Biotechnology Processes and Products

Techniques used in Biotechnology, with special emphasis on molecular and recombinant DNA techniques

Cloning Strategies and Tissue culture procedures for plant cells, animal and stem cells

Transgenic plants, animals, genetically modified organisms (GMO) and GM food etc.

Large scale production of recombinant proteins, Processes for separation and purification

The Human Genome project and genomics of selected organisms

Medical Biotechnology: gene therapy, tissue engineering and xeno-transplantations

Biotechnology Products:

Health care products



Recombinant therapeutic proteins

Agricultural :

Hybrid and modified seeds