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What do you mean by Data Exclusivity under IPR regime?

What do u mean by 'Data Exclusivity' in IPR regime?Its importance,current standing in India.Comments welcome..
PSIR in Mains '15


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    The discovery of a new pharmaceutical compound or vaccine is not suf- ficient to bring a safe and effective product to the market for use by patients. Rather, the public reaps the benefits of an innovative drug or vaccine only after relevant data, generated in extensive preclinical and clinical trials, demonstrate the drug’s safety, quality and efficacy to the sat- isfaction of regulatory authorities.
    The generation of such proprietary data involves a considerable amount of time and expense; the entire drug development process from discovery to marketing takes an average of 10 years and costs, on average, $500 mil- lion in industrialized countries.
    The protection of test data is a legally required and economically neces- sary component of the intellectual property package that serves to provide incentives for the development of innovative pharmaceutical products. The Agreement on Trade-Related Intellectual Property Rights (the “TRIPs Agreement”) specifically recognizes the “protection of undisclosed infor- mation” as being a category of intellectual property subject to protection. Article 39.3 of the TRIPs Agreement provides that:
    “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical entities, the submission of undisclosed test or other data, the origination of which involves a con- siderable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.”
    The intellectual property right reference in Article 39.3 is commonly referred to as “data exclusivity” in the U. S. and “data protection” or “regu- latory data protection” in the European Union. Throughout this article, these terms are used interchangeably.1 Data exclusivity is an independent intellectual property right and should not be confused with the protection provided by other rights, especially patents. It provides the holder with specific rights, namely that the data generated by the holder may not be referred to or used by another person or company for a specific period of time. It does not prevent another company from generating the data. Thus, the right is quite limited in the first instance. However, it has been consid- ered to be of critical importance by countries to provide the necessary incentives for companies to generate the necessary data that accompanies registrational packages for medicinal products.


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    जननी जन्मभूमिश्च स्वर्गादपि गरीयसी
  • i have few query
    1) whether Data exclusivity is mentioned under Indian IPR regime?
    2) whether technical inventions can also be be protected from Data exclusivity or only medicines are protected under it?
    Our survival instinct is our single greatest source of inspiration. - Dr. Mann
  • जननी जन्मभूमिश्च स्वर्गादपि गरीयसी
  • See whenever any company applies for a patent and asks for the market authorisation, then the authority asks the company that disclose the data on the basis of which they are demanding access to the market. This data may be the reports of the clinical trials that were held for testing the drug.
    Since patents are granted for an initial period of twenty years and after that the drug is open to manufacture in the market, but this can be only possible if the other competitors have the access to methodology of drug patent. So in order to extend their monopoly over drug for more years, the parent company uses the data exclusivity clause anytime during the first twenty years. If they invoke this clause, then they may get additional time of monopoly and this would ensure less competition and profit to the company.
  • even though generic drugs have helped the poor countries a lot, isn't it a sort of free riding.
    Not only are they not investing much in research of the drug , they are also not spending anything on testing the copied formula. I think some minimum safety tests should be there for safety purposes.
    If such a question comes, we can also present the western company's point of view along with the indian point of view.
  • Thanks All...
    PSIR in Mains '15
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