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. | Not for loan | LLM211 |
Table of Contents I. Chapter I: Introduction: The Conceptual Base; • Compulsion to grant product patent; • Downsides of having drug patent; • India sharp to exploit TRIPS flexibilities; • Advantage India; • Formidable challenges faced by India; • Historical evolution of Indian patent law; • Pre- patent Act, 1970; • Salient features of Patent Act, 1970; • Post TRIPS era; II. Chapter II: The Constitutional Provisions of India- Received International Law (Article 51 (c)) • Presumption is Parliament does not act in breach of International Law; • Implementation of treaty; • Non- incorporation and ratification; • Influence of International treaties over Indian law; III. Chapter III: The Patent Law in India; • The Patent (Amendment) Act, 1999; • The Patent (Amendment) Act, 2002; • The Patent (Amendment) Act, 2005; • The five important factors; IV. Chapter IV: MNCs v. Domestic companies; • The present pharmaceutical scenario; • The need for data protection; • Domestic companies; • Generic drug manufacturing units are here to stay; • Necessity for controlling prices of patented drugs; • Agrarian Economy; • Drug Price Controls; • Pharmaceutical drug production in India; V. Chapter V: Indian Patent Act, 1970- Analysis and Critique • Product patent for pharmaceutical substances; • Exclusions under the new law; VI. Chapter VI: Critical Analysis of the Patent (Amendment) Act, 2005; • New Invention; • The Inventive Step test; • Pharmaceutical substances; • New use exclusions; • Pre grant/ Post grant opposition; • Compulsory Licenses for exports; • Access to medicines; • Retrospective damages; • Patentability threshold; • Price Control/ competition regime; • Spurring an innovative culture in India; VII. Chapter VII: The Novartis Case: A study of specific • Jurisdiction to entertain petition; • Declaratory relief; • Uncanalized power to statutory authority; • Violation of Article 14; VIII. Chapter VIII: Glivec Patent Saga • Dissection of the Novartis judgment; • Selection Patent; • Glivec Patent Saga; • India's export led strategy; • Death by Patent Act; • TRIPS Agreement; Restrictions and Flexibilities; • Data exclusivity looms as an additional threat; IX. Chapter IX: Campaign to ensure public health protection; • Involvement of Indian pharmaceutical companies; • Successes and lessons learnt; • Exploitation of patent law loop holes; • Leaky protections: Section 107 A(b); X. Chapter X: Is Section 3(d) within TRIPS?; • Arguments for Section 3(d); • Arguments against Section 3(d); • Section 3(d) the structure and context; • Section 3( d) and TRIPS compatibility; XI. Chapter XI: TRIPS related issues; • Jurisdictional Issues- Ordinary contract or Treaty obligation; • TRIPS compatibility; • Fine balance maintained by Madras High Court; XII. Chapter XII: Constitutional Analysis of Section 3(d); • Manifest arbitrariness and Article 14; • Deconstruction the explanation to Section 3( d); • Defining efficacy; • Delegated legislation; • TRIPS paradox; XIII. Chapter XIII: Suggestions and Conclusions;