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India's Patent Regime: Examining The Rejection Of Bedaquiline Patent Evergreening And Its Implications




Harshitha. S, LL.B., Government Law College Namakkal, Tamil Nadu


ABSTRACT


Tuberculosis remains a life-threatening disease affecting almost every country in the world. The drug Bedaquiline is an effective treatment for the disease. The Indian Patent Office rejected Johnson and Johnson's secondary patent claim for the Fumarate salt of Bedaquiline. Several factors are said to have influenced India's decision, and this ruling has a range of implications. This paper examines the reasons for rejecting a secondary patent for Bedaquiline in the context of the existing criteria laid down by the Indian patent law, such as novelty, efficacy, and inventive step. It also analyses the judicial precedents that have set a normative guideline against patent evergreening and how it has been followed in reaching the verdict. This article briefly discusses the external factors, including India's TB-free campaign, that prompted India to act upon this matter. Ultimately, this essay delves into the implications faced by the pharma companies that use secondary patents as a strategic tool to extend their monopoly in the drug market. Also, the ruling has an impending impact on India's foreign policy, such as Foreign Direct Investments and the export of drugs to various countries, which will be economically gratifying. Public health is guaranteed under international agreements, and the patent laws of India have been safeguarded in this decision. This paper suggests possible solutions to avoid future disputes over patent renewals. It highlights the need for reform in the Indian pharmaceutical sector to invest in domestic drug development to reduce dependency.

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Indian Journal of Law and Legal Research

Abbreviation: IJLLR

ISSN: 2582-8878

Website: www.ijllr.com

Accessibility: Open Access

License: Creative Commons 4.0

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​All research articles published in The Indian Journal of Law and Legal Research are fully open access. i.e. immediately freely available to read, download and share. Articles are published under the terms of a Creative Commons license which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

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The opinions expressed in this publication are those of the authors. They do not purport to reflect the opinions or views of the IJLLR or its members. The designations employed in this publication and the presentation of material therein do not imply the expression of any opinion whatsoever on the part of the IJLLR.

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