Legal and Regulatory Issues in Biotechnology

By Prof. Niharika Sahoo Bhattacharya   |   IIT Kharagpur
Learners enrolled: 673
a) This course describes the convergence of scientific, regulatory, and commercial factors that drive the biotechnology industry. 
b) Equip students to understand the development cycle of a biotechnology derived product from legal and regulatory perspective. 
c) This course will introduce students to the interrelated fields of patent law, regulatory law, and contract law that are vital to the biotech and biopharmaceutical sectors. 
d) The course will present core concepts in a way that permits students to use them throughout their corporate, academic, and government careers. 
e) Create human resource with basic understanding of biotechnology and law which will contribute towards greater protection and commercialization of inventions.

INTENDED AUDIENCE :  Students, researchers, industry professionals from Law or biotechnology/life science/pharmaceutical science discipline (B.Tech, M.Tech, LLB, LLM, PhD scholars)
PREREQUISITES :   Bachelor degree students Prerequisite: anyone who is interested to know the legal aspects of biotechnology industry
INDUSTRY SUPPORT :  Pharmaceutical / agro-biotech / environmental biotech companies
Course Status : Completed
Course Type : Elective
Duration : 4 weeks
Category :
  • Law
Credit Points : 1
Level : Undergraduate/Postgraduate
Start Date : 25 Jul 2022
End Date : 19 Aug 2022
Enrollment Ends : 08 Aug 2022
Exam Date : 25 Sep 2022 IST

Note: This exam date is subjected to change based on seat availability. You can check final exam date on your hall ticket.

Page Visits

Course layout

Week-1 : Regulation of Biotechnology Research
Week-2 : Intellectual Property Rights and Life sciences (Agriculture, Pharma, Biotech)
Week-3 : Biotech Product commercialization: Regulatory Approval Process
Week-4 : Understanding technology transfer in biotech sector

Books and references

1. Bucknell Duncan (ed.), I Pharmaceutical,Biotechnology and Chemical Inventions (Oxford University Press, 2011). 
2. Cook M.Trevor, Pharmaceutical Biotechnology and the Law (Lexis Nexis , 2d ed. 2009). 
3. Cook M.Trevor,The Protection Of Regulatory Data In Pharmaceutical And Other Sectors (Sweet and Maxwell, 2000). 
4. Hardcastel Rohan, Law and The Human Body; Property Rights, Ownership and Control (Hart Publishing, 2007). 
5. Valverde J.L. (ed.), Key Issues in Pharmaceutical Law ( IOS Press, Vol. 9 2009). 
6. Drexl Josef, Nari Lee (ed.), Pharmaceutical Innovation, Competition and Patent Law; A Trilateral Perspective (Edward Elgar, 2013), 
7. Verkey Elizabeth, Law of Plant Varieties Protection, 30-32 (Eastern Book Company, 1st ed. 2007). 
8. Herring Jonathan, Medical Law & Ethics (Oxford University Press, 5th Ed., 2014). 
9. Ventose Eddy, Medical Patent law- The Challenges of Medical Treatment (Edward Elgar, 2011). 
10. Krattiger Anatole, Mahoney T. Richard, et.al., II Intellectual Property Management in Health and Agricultural Innovation; A handbook of best practices (MIHR, Oxford Center for Innovation, 2007). 11. Emily Jackson, Medical Law, text, cases and Materials , (Oxford University Press, 4th ed. 2013) 
12. Holy F Lynch, Effy Vayena and Urs Gasser, Big data, Health Law and Bioethics, Edited by I. G. Cohen, (Cambridge University Press, 2018)

Instructor bio

Prof. Niharika Sahoo Bhattacharya

IIT Kharagpur
Dr Niharika Sahoo Bhattacharya is currently working as an Assistant Professor in Rajiv Gandhi School of Intellectual Property Law. She has done her doctoral studies in the interdisciplinary area of IPR and biomedicines from IIT Kharagpur. Her broad research interest is to analyze and understand the complexities between scientific innovations, their protection and commercialization. Her other research interest are IP issues in pharmaceutics, IP and competition law, Geographical Indications and Plant variety Protection. She is actively involved in the research and teaching of various IP subjects and published in many peer reviewed international journals of repute

Course certificate

The course is free to enroll and learn from. But if you want a certificate, you have to register and write the proctored exam conducted by us in person at any of the designated exam centres.
The exam is optional for a fee of Rs 1000/- (Rupees one thousand only).
Date and Time of Exams: 25 September 2022 Morning session 9am to 12 noon; Afternoon Session 2pm to 5pm.
Registration url: Announcements will be made when the registration form is open for registrations.
The online registration form has to be filled and the certification exam fee needs to be paid. More details will be made available when the exam registration form is published. If there are any changes, it will be mentioned then.
Please check the form for more details on the cities where the exams will be held, the conditions you agree to when you fill the form etc.


Average assignment score = 25% of average of best 3 assignments out of the total 4 assignments given in the course.
Exam score = 75% of the proctored certification exam score out of 100

Final score = Average assignment score + Exam score

YOU WILL BE ELIGIBLE FOR A CERTIFICATE ONLY IF AVERAGE ASSIGNMENT SCORE >=10/25 AND EXAM SCORE >= 30/75. If one of the 2 criteria is not met, you will not get the certificate even if the Final score >= 40/100.

Certificate will have your name, photograph and the score in the final exam with the breakup.It will have the logos of NPTEL and IIT Kharagpur .It will be e-verifiable at nptel.ac.in/noc.

Only the e-certificate will be made available. Hard copies will not be dispatched.

Once again, thanks for your interest in our online courses and certification. Happy learning.

- NPTEL team

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