The Legal Challenges Faced By The Pharmaceutical Industry In India.

      Аннотация: Who is world's supplier for affordable medicines to the developing countries? Who created exception to the normal tests of patentability requirement required under Article 27.1 of the TRIPS Agreement. The credit certainly goes to India for its daring move in the interpretation of Section 3(d) of Patent Amendment Act 2005. The question is no longer whether Section 3(d) is compatible with the TRIPS Agreement , but whether it does more harm to the domestic pharmaceutical industry than good? The efficacy requirement will be analysed taking into considerations the importance of second medical use. Utility patent or known as petty innovations are considered of importance to the generic pharmaceutical industry. Utiliy patents widely recognised in countries such as Malaysia under Section 17 of the Patents Act 1983. Utility patent must be taken into consideration by Indian patent system for a balanced patent system. The legal challenges faced by India to supply affordable medicines preventing evergreening of patents with the full enforcement of Section 3(d), grounds of compulsory licensing, are certainly a continuing challenge for our world leading pharmaceutical generic drug manufacturer

Ключевые слова: Compulsory Licensing, TRIPS flexibilities, Article 27 requirement of patentability: novelty/new, involve an inventive step and capable of industrial application, Indian Patent Act 1970, Patent Amendment Act 2005 : local working, Article 27, Patentability, Novelty, Article 30, Article 31, Authorization, right holder, Patent Amendment Act 2005, Industrial Application, pharmaceutical patent, Intellectual Property Rights