UPSC Exam  >  UPSC Questions  >   The term ‘Data exclusivity’ sometimes mentio... Start Learning for Free
The term ‘Data exclusivity’ sometimes mentioned in the refers to
  • a)
    The protection of clinical trial data submitted to the regulatory authorities.
  • b)
    An extension of patent rights under Intellectual property protection regime.
  • c)
    Critical data of the citizens meant not to be shared with foreign countries without the consent of citizens.
  • d)
    The protection of biometric data submitted to the regulatory authorities.
Correct answer is option 'A'. Can you explain this answer?
Verified Answer
The term ‘Data exclusivity’ sometimes mentioned in the refers toa)The...
Option (a) is the correct answer.
Option a is correct. Data exclusivity is protection of clinical trial data which is submitted to the regulatory authorities to prove safety, quality and efficacy of a new drug, and preventing the generic drug manufacturers from relying on this data in their own applications.
Option b is incorrect. Patents are an important form of intellectual property, but are not themselves necessarily sufficient to create the favorable environment needed to support the development of medical advances. Data exclusivity is not an extension of patent rights, and it does not prevent the introduction of generic versions of the innovative drug during the data exclusivity period, as long as the marketing approval of the generic version does not use or rely upon the innovator’s test data. Patents and data exclusivity are different concepts, protect different subject matter, arise from different efforts, and have different legal effects over different time periods.
Option c is incorrect. The critical data which is not meant to share with foreign countries without the consent of citizens is Data Protection through data localisation.
Option d is incorrect. The data of intellectual property can be shared for generic medicine development without the consent of patent owners after a certain period of time is called compulsory licensing.
View all questions of this test
Most Upvoted Answer
The term ‘Data exclusivity’ sometimes mentioned in the refers toa)The...
Data exclusivity is a term often mentioned in the context of regulatory approval of pharmaceuticals and refers to:

Protection of Clinical Trial Data
- Data exclusivity refers to the protection of the clinical trial data that pharmaceutical companies submit to regulatory authorities for the approval of new drugs.
- This protection ensures that the data submitted by the companies is not used by competitors to gain approval for generic versions of the same drug for a certain period of time.
- It allows the original pharmaceutical company to have exclusive rights to the data for a specified period, usually ranging from 5 to 10 years, depending on the jurisdiction.
In conclusion, data exclusivity is a crucial aspect of the regulatory framework for pharmaceuticals, ensuring that companies are incentivized to invest in research and development by providing them with a period of exclusivity to market their products based on the data they have generated through clinical trials.
Explore Courses for UPSC exam

Similar UPSC Doubts

Top Courses for UPSC

The term ‘Data exclusivity’ sometimes mentioned in the refers toa)The protection of clinical trial data submitted to the regulatory authorities.b)An extension of patent rights under Intellectual property protection regime.c)Critical data of the citizens meant not to be shared with foreign countries without the consent of citizens.d)The protection of biometric data submitted to the regulatory authorities.Correct answer is option 'A'. Can you explain this answer?
Question Description
The term ‘Data exclusivity’ sometimes mentioned in the refers toa)The protection of clinical trial data submitted to the regulatory authorities.b)An extension of patent rights under Intellectual property protection regime.c)Critical data of the citizens meant not to be shared with foreign countries without the consent of citizens.d)The protection of biometric data submitted to the regulatory authorities.Correct answer is option 'A'. Can you explain this answer? for UPSC 2025 is part of UPSC preparation. The Question and answers have been prepared according to the UPSC exam syllabus. Information about The term ‘Data exclusivity’ sometimes mentioned in the refers toa)The protection of clinical trial data submitted to the regulatory authorities.b)An extension of patent rights under Intellectual property protection regime.c)Critical data of the citizens meant not to be shared with foreign countries without the consent of citizens.d)The protection of biometric data submitted to the regulatory authorities.Correct answer is option 'A'. Can you explain this answer? covers all topics & solutions for UPSC 2025 Exam. Find important definitions, questions, meanings, examples, exercises and tests below for The term ‘Data exclusivity’ sometimes mentioned in the refers toa)The protection of clinical trial data submitted to the regulatory authorities.b)An extension of patent rights under Intellectual property protection regime.c)Critical data of the citizens meant not to be shared with foreign countries without the consent of citizens.d)The protection of biometric data submitted to the regulatory authorities.Correct answer is option 'A'. Can you explain this answer?.
Solutions for The term ‘Data exclusivity’ sometimes mentioned in the refers toa)The protection of clinical trial data submitted to the regulatory authorities.b)An extension of patent rights under Intellectual property protection regime.c)Critical data of the citizens meant not to be shared with foreign countries without the consent of citizens.d)The protection of biometric data submitted to the regulatory authorities.Correct answer is option 'A'. Can you explain this answer? in English & in Hindi are available as part of our courses for UPSC. Download more important topics, notes, lectures and mock test series for UPSC Exam by signing up for free.
Here you can find the meaning of The term ‘Data exclusivity’ sometimes mentioned in the refers toa)The protection of clinical trial data submitted to the regulatory authorities.b)An extension of patent rights under Intellectual property protection regime.c)Critical data of the citizens meant not to be shared with foreign countries without the consent of citizens.d)The protection of biometric data submitted to the regulatory authorities.Correct answer is option 'A'. Can you explain this answer? defined & explained in the simplest way possible. Besides giving the explanation of The term ‘Data exclusivity’ sometimes mentioned in the refers toa)The protection of clinical trial data submitted to the regulatory authorities.b)An extension of patent rights under Intellectual property protection regime.c)Critical data of the citizens meant not to be shared with foreign countries without the consent of citizens.d)The protection of biometric data submitted to the regulatory authorities.Correct answer is option 'A'. Can you explain this answer?, a detailed solution for The term ‘Data exclusivity’ sometimes mentioned in the refers toa)The protection of clinical trial data submitted to the regulatory authorities.b)An extension of patent rights under Intellectual property protection regime.c)Critical data of the citizens meant not to be shared with foreign countries without the consent of citizens.d)The protection of biometric data submitted to the regulatory authorities.Correct answer is option 'A'. Can you explain this answer? has been provided alongside types of The term ‘Data exclusivity’ sometimes mentioned in the refers toa)The protection of clinical trial data submitted to the regulatory authorities.b)An extension of patent rights under Intellectual property protection regime.c)Critical data of the citizens meant not to be shared with foreign countries without the consent of citizens.d)The protection of biometric data submitted to the regulatory authorities.Correct answer is option 'A'. Can you explain this answer? theory, EduRev gives you an ample number of questions to practice The term ‘Data exclusivity’ sometimes mentioned in the refers toa)The protection of clinical trial data submitted to the regulatory authorities.b)An extension of patent rights under Intellectual property protection regime.c)Critical data of the citizens meant not to be shared with foreign countries without the consent of citizens.d)The protection of biometric data submitted to the regulatory authorities.Correct answer is option 'A'. Can you explain this answer? tests, examples and also practice UPSC tests.
Explore Courses for UPSC exam

Top Courses for UPSC

Explore Courses
Signup for Free!
Signup to see your scores go up within 7 days! Learn & Practice with 1000+ FREE Notes, Videos & Tests.
10M+ students study on EduRev