Plan to extend the period for state-level drug regulatory approvals from four to ten years might result in prolonged and detrimental data exclusivity, negatively impacting the generics market. Data gives information that may be used to get commercial permission for required documents. Data exclusivity safeguards clinical trial data. Many states provide a term of ‘exclusivity’ to a pharmacy sector that has completed clinical trials, which can vary from five to eight years. The expense of conducting testing is significant, and it includes human volunteers, which makes it a difficult task. As a result, discoveries are protected by patents. However, it is vital to examine the situation in developing countries, where a counterfeit medication producer might produce medicine at a low cost by demonstrating biological plausibility to a drug made by an inventive business. Data exclusivity appears to create a conflict of interest between the greater good and inventors who have already realized the advantages of patent rights.


The term of non-dependency and non-declaration granted to new chemical agencies, medicinal configurations, and data of agro-chemical recording or trial data is known as Data Exclusivity (DE). For a limited time, drug governing organizations prohibit the use of the creator’s test data in registering synthetic medicines. Data exclusivity is a distinct Intellectual Property Right that should not be confused with the protection offered by other types of intellectual property rights, particularly patents.[1] Clinical trial data, as well as additional test data, is confidential information derived by the originator’s commitment of time and money in scientific research and development to validate the efficacy and safety of new chemical formulae, compositions, and their usages. When it comes to securing regulatory clearance for marketing, this information is crucial. At least for a limited time, data exclusivity gives the inventor the right to prevent the use period using acts and information from third parties to gain commercial authorization. However, it does not prohibit other parties from producing their data.


The principles of unfair competition established by the Paris Convention, which is controlled by WIPO under Article 10[2] bis and incorporates effective defence against unfair competition, provides the foundation of data exclusivity. Furthermore, the notion of data protection was included in the WTO under Article 39 of the TRIPS agreement[3], which emphasized the protection of ‘undisclosed information’ and ‘data supplied to administrations or administrative agencies’ as part of members duty to create protection. Pharmaceutical agencies are seeking data exclusivity under TRIPS Article 39(3)[4]. “Members shall protect such data against unfair commercial use when requiring, as a condition of approving the marketing of pharmaceutical or agricultural chemical products that use new chemical entities, the submission of undisclosed test or data, the origination of which involves a considerable effort,” that stated under Article 39(3) of TRIPS.[5] The second obligation in Article 39 of the TRIPS Agreement is data exclusivity, which refers to the confidentiality of data provided to regulators, governments, or public agencies.

Global Scenario: Data exclusivity has traditionally been viewed as a compromise between innovator and generic drug firms, with innovators receiving a term of exclusivity. When the exclusivity period expires, however, a generic producer can use the data to get approval for its drug. The negotiation, which was initially codified in the United States of America in 1984 by the Hatch-Waxman Act[6], guarantees a five-year exclusivity term for clinical trial data.[7]The findings of an innovation by which a patent was being obtained are not accessible to the community or R&D agencies in many industrialized nations, including the European Union, Australia, New Zealand, and the Andean Group countries, for five years. In certain states, the provision has been passed that permits a patent to be prolonged for up to 5 years when any commercial approval body ends up taking an inordinate length of time to approve it. Data exclusivity is given for six years in China, eight years in the Philippines, 10 years in Brazil, eight years in Korea, and six years in Taiwan. Japan provides data exclusivity for periods ranging from four to ten years. Yet, India is among the nations that oppose the TRIPS requirement.


In India Data exclusivity for a “new drug” for four years from the date of the agreement is permitted under Section 122E of the Drugs and Cosmetics Act of 1940[8]. Fresh medicine is not usually registered medicine, but instead, one that has never been widely utilized in the nation. Indian regulations, like those in the United States, demand that a proposed medicine idea undergo extensive research and scientific trials. However, such a condition may be disregarded in the “public interest” or that the new medicine was thus approved and distributed in other countries for many periods. This is a common criterion used to minimize duplication of studies across multiple territories, which can increase the price and delay the drug’s market release. Data exclusivity has been pressed upon India by nations such as the U.S.A and the European Union. The nation’s generic makers are concerned that granting this power may result in medication patents being extended forever. For example, if a drug is introduced in the nineteenth year of two decade-long patent’s life, the patent protection may be extended to 24 years. Many firms have argued for data exclusivity should occur simultaneously with the period of patent.

According to the Indian government, Article 39(3) of TRIPS[9] should not compel participating nations to enact data exclusivity laws in their own countries. The use of data by the Drug Controller is legal, non-commercial, and TRIPS compliant. it has no provision for governments to grant the creator of data exclusive rights for a set time. this simply discusses the general obligation for “data protection.” An inter-ministerial committee was formed to advise the government on what steps should be taken in light of TRIPs Agreement Article 39(3) and to evaluate whether data uniqueness for agrochemicals, folk medicine, and drug companies can also be included under the constitutional framework. The Department of Chemicals and Petrochemicals (DCPC), eventually scrapped the committee on February 10, 2004, after submitting to rising pressure from the US and EU.


Either dogmatic or unyielding attitude from any side would be detrimental to everyone, particularly the ordinary people. Both parties should endeavour to find a middle-path solution where everyone’s interests can be met. The problem is that millions of individuals in poor and third-world nations do not have access to or afford life-saving medications. It is widely assumed that all of these issues arise as a result of faulty wording of Article 39(3) of the TRIPS Agreement, which does not specify whether the term “unfair commercial Use” enforces obligations on participant nations. However, there is no flaw in the legislation since the framers intended for member states to have enough leeway to apply and interpret the law under local situations. Therefore, if India asserts that it is not obligated to execute such legislation, contrary to Western nations’ position, it must be acknowledged that both are correct. Due to their health insurance laws & residents’ considerable purchasing power, rich countries can endure the cost of health care, but this is not the case in third-world countries. Finally, it is important to remember that the Indian constitution objects to making a socialist welfare state, and fundamental rights and directive principles of state policy both, compel the government to treat the issue with care.

Author(s) Name: Riya Raj (Chanakya National Law University, Patna)


[1]Jean-Claude Champagne, Data Exclusivity, 8/2/04,,

[2] WIPO Copyright Treaty (WCT), 1996, Art. 10

[3] TRIPS Agreement, 1995, Art. 39

[4] TRIPS Agreement, 1995, Art. 39(3)

[5] TRIPS Agreement, 1995, Art. 39(3)

[6] Mossinghoff, Gerald J. “Overview of the Hatch-Waxman Act and its impact on the drug development process.”(1999), plg-group,

[7] Lyndsay Meyer, FDA In Brief, 9/11/2018,,

[8] Drugs and Cosmetics Act, 1940, S. 122E

[9] TRIPS Agreement,1955, Art. 39(3)

Related Posts