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;