Impact of TRIPS in India

Malhotra, Prabodh

doi:10.1057/9780230290747

Cited by 10 publications

(7 citation statements)

References 57 publications

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“…Consequently, if new therapeutic indications of new uses of originator products are authorised, data exclusivity may be extended for another year. 69 Subsequently, TRIPS Agreement does not explicitly mention the word data exclusivity as the TRIPS itself is also vague in defi ning the position on the protection of the submitted data. 70 Article 39.3 is not clear on how data are to be protected and defi nition of 'unfair commercial use' is not provided in the TRIPS Agreement.…”

Section: Further Consideration On Clause 3(d) Of Indian Patent Amendmmentioning

confidence: 99%

“…69 Subsequently, TRIPS Agreement does not explicitly mention the word data exclusivity as the TRIPS itself is also vague in defi ning the position on the protection of the submitted data. 70 Article 39.3 is not clear on how data are to be protected and defi nition of 'unfair commercial use' is not provided in the TRIPS Agreement. 71 It has certainly caught the author's attention when it was said that ambiguities in the Article have resulted in controversial interpretations by different parties with their own vested interests.…”

Section: Further Consideration On Clause 3(d) Of Indian Patent Amendmmentioning

confidence: 99%

“…70 Article 39.3 is not clear on how data are to be protected and defi nition of 'unfair commercial use' is not provided in the TRIPS Agreement. 71 It has certainly caught the author's attention when it was said that ambiguities in the Article have resulted in controversial interpretations by different parties with their own vested interests. 72 Developing countries supported by public health advocates, NGOs and civil society groups came up with an important affi rmation on data exclusivity stating that Article 39.3 73 amount to data protection and to data exclusivity.…”

Section: Further Consideration On Clause 3(d) Of Indian Patent Amendmmentioning

confidence: 99%

“…71 It has certainly caught the author's attention when it was said that ambiguities in the Article have resulted in controversial interpretations by different parties with their own vested interests. 72 Developing countries supported by public health advocates, NGOs and civil society groups came up with an important affi rmation on data exclusivity stating that Article 39.3 73 amount to data protection and to data exclusivity. 74 However, the distinction between data protection and data exclusivity is not given and these two different terms can contribute to ambiguity.…”

Section: Further Consideration On Clause 3(d) Of Indian Patent Amendmmentioning

confidence: 99%

“…72 Developing countries supported by public health advocates, NGOs and civil society groups came up with an important affi rmation on data exclusivity stating that Article 39.3 73 amount to data protection and to data exclusivity. 74 However, the distinction between data protection and data exclusivity is not given and these two different terms can contribute to ambiguity. Data exclusivity will certainly be TRIPS-PLUS obligations for India as India is preparing to modify its Patents Act to provide data exclusivity for fi ve years.…”

Section: Further Consideration On Clause 3(d) Of Indian Patent Amendmmentioning

confidence: 99%

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The Impact of Trips Agreement on Access to Medicines in Developing Countries: Legal Challenges Faced by the Pharmaceutical Industry Particularly in India

Shanmugaiah

2012

UUM Journal of Legal Studies

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The impact of intellectual property rights in particular patent relating to public health has posed numerous challenges faced by developing countries who are members of World Trade Organisation (WTO). This paper examines the impact of TRIPS Agreement (Trade Related Intellectual Property Rights) in relation to developing countries in general with specification made to India. Significant changes brought about by the TRIPS flexibilities in particular usage of compulsory licensing and Bolar provision have to a certain extent benefited the developing countries in the field of public health during national emergency. The TRIPS flexibilities by way of amendment have helped countries that (do not possess manufacturing capacities) to import medicines. Some developing countries even utilised TRIPS flexibilities in an aggressive manner to enforce their right to have access to medicines from other countries for the benefit of their citizens. Further, TRIPs flexibilities have helped developing countries to manufacture generic products to make it affordable to the people. This paper specifically examines the impact of the TRIPS Agreement on Indian generic pharmaceutical industry and the legal challenges faced by Indian pharmaceutical industry after the implementation of product patent regime effective from 1 January 2005. The Patent Amendment Act 2005(India) will be looked into especially on the controversy in respect of Section 3(d) of the Patent Amendment Act 2005(India) on the requirement of patentability. The new Section 92A of the Patent Amendment Act 2005(India) on the grounds to invoke compulsory licensing will be analysed to see whether Indian government has applied restrictive or broad approach, as compulsory licensing is certainly an important legal

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Section: Further Consideration On Clause 3(d) Of Indian Patent Amendmmentioning

confidence: 99%

Section: Further Consideration On Clause 3(d) Of Indian Patent Amendmmentioning

confidence: 99%

Section: Further Consideration On Clause 3(d) Of Indian Patent Amendmmentioning

confidence: 99%

Section: Further Consideration On Clause 3(d) Of Indian Patent Amendmmentioning

confidence: 99%

Section: Further Consideration On Clause 3(d) Of Indian Patent Amendmmentioning

confidence: 99%

See 3 more Smart Citations

The Impact of Trips Agreement on Access to Medicines in Developing Countries: Legal Challenges Faced by the Pharmaceutical Industry Particularly in India

Shanmugaiah

2012

UUM Journal of Legal Studies

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Using Patent Law to Enforce Ethical Standards: Proposal of a New Patent Requirement

Reichardt

2016

Research Ethics Forum

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Brief History of Regulating Pharmaceutical Prices

Bhaskarabhatla

2018

India Studies in Business and Economics

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Impact of TRIPS in India

Cited by 10 publications

References 57 publications

The Impact of Trips Agreement on Access to Medicines in Developing Countries: Legal Challenges Faced by the Pharmaceutical Industry Particularly in India

The Impact of Trips Agreement on Access to Medicines in Developing Countries: Legal Challenges Faced by the Pharmaceutical Industry Particularly in India

Using Patent Law to Enforce Ethical Standards: Proposal of a New Patent Requirement

Brief History of Regulating Pharmaceutical Prices

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