Measures to Prevent Evergreening of Patents: A Comparative Analysis

TABLE OF CONTENTS
CERTIFICATE ;
DECLARATION ;
ACKNOWLEDGEMENT ;
LIST OF ABBREVIATIONS ;
RESEARCH METHODOLOGY ;
CHAPTER ONE: INTRODUCTION ;
I. MEANING OF THE TERM EVERGREENING ;
Examples of Evergreening;
II. THE CONCEPT OF INCREMENTAL INNOVATIONI MINOR VARIATION ;
III. EFFECTS OF EVERGREENING ;
A. THE BRANDED DRUG COMPANY;
B. GENERIC DRUG COMPANIES;
C. THE CONSUMER;
IV. IMPACT OF EVERGREENING ON SOCIAL WELFARE AND POLICY IMPLICATIONS ;
Evergeening Threatens Access to Affordable Medicines;
CHAPTER TWO: TRADE RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS ;
I. ADVENT OF TRIPS AND CHANGES IN PATENTING IN PHARMACEUTICAL SECTOR;
II. TRIPS AND PUBLIC HEAL THFLEXIBILITIES UNDER TRIPS ;
A. EXEMPTIONS FROM GRANT OF PATENTS;
1. Principle of good faith;
2. Strict versus liberal patentability standards;
B. EXCEPTIONS TO EXCLUSIVE RIGHTS;
1. Early working;
Bolar provision as a tool for generic entry;
Case analysis;
2. Parallel imports;
3. Research and experimental use;
C. COMPULSORY LICENSE AND GOVERNMENT USE;
III. THE UNIFORMITY ISSUE UNDER TRIPS ;
A. UNIFORMITY WITH RESPECT TO NON-OBVIOUSNESS CRITERION;
B. SCOPE OF PATENTABILITY IN THE LIGHT OF THE OBJECTIVES UNDER TRIPS;
1. Art. 7 and 8 cannot derogate the specific mandate of Art. 27;
2. Protection of the rights of the patentee is not the sale concern of TRIPS;
IV. IMPLEMENTATION OF TRIPS FLEXIBILITIES ;
A. PROCEDURAL SAFEGUARDS;
B. POLICY CONSTRAINTS;
C. INSTITUTIONAL CONSTRAINTS;
CHAPTER THREE: STRATEGIES FOR OBTAINING PATENTS IN PHARMACEUTICAL INDUSTRY ;
I. RATIONALE FOR PHARMACEUTICAL COMPANIES TO ENGAGE IN EVERGREENING STRATEGIES;
A. EFFECTIVE MARKET EXCLUSIVITY;
B. BRANDED VERSUS GENERIC DRUGS;
II. EVERGREENING STRATEGIES ;
A. DELAY THE LAUNCH OF GENERIC PRODUCTSI 30 MONTH PERIOD OF STAY PROVISION;
The case of Bristol-Myers Squibb(BMS) and Taxolc;
B. 180 DAYS PERIOD OF MARKET EXCLUSIVITY;
1. Response of the generics;
2. "Failure to market" forfeiture provision;
C. AGGRESSIVE LITIGATION;
D. STOCKPILE/LINE EXTENSION/PATENT THICKET;
E. SECONDARY PATENTS/ ME-TOO DRUGS;
The case of Pfizer and Viagra;
F. FRANCHISE EXTENSION TO SUCCESSOR DRUGS;
The case of AstraZeneca and Prilosec;
G. ROLE OF TRADEMARKS IN EVERGREENING;
H. PHARMACOGENOMICS;
CHAPTER FOUR: PATENT LINKAGE AND DATA EXCLUSIVITY ;
I. LINKAGE FORM OF EVERGREENING ;
A. LINKAGE PROVISIONS IN THE FREE TRADE AGREEMENTS;
B. IMPACT OF PATENT LINKAGE ON GENERIC DRUG;
MANUFACTURERS;
C. US AND EU POSITION;
D. PATENT LINKAGE IN OTHER DEVELOPED COUNTRIES;
E. IMPACT OF PATENT LINKAGE IN DEVELOPING COUNTRIES;
Case analysis;
II. DATA EXCLUSIVITY ;
A. TRIPS AND DATA EXCLUSIVITY;
1. Data exclusivity and fiexibilities under TRIPS;
2. Interpretation of unfair commercial use;
B. IMPACT OF DATA EXCLUSIVITY ON PRICES AND AVAILABILITY OF GENERIC MEDICINES;
1. Data exclusivity applies regardless of the patentability of a medicine;
2. Delays the onset of generics;
3. Monopoly beyond the patent term;
4. Huge costs for generics;
C. INDIAN POSITION;
CHAPTER FIVE: FRAMEWORK UNDER THE PATENT LAW TO PREVENT EVERGREENING ;
I. PATENTABILITY OF A DRUG ;
A. NEW DRUG vis-A-vIS IMPROVEMENTS;
B. DOUBLE PATENTING;
C. MINOR VARIATIONS;
II. SCOPE OF PATENTABILITY ;
A. NOVELTY;
B. INDUSTRIAL APPLICATION;
C. INVENTIVE STEP/NON OBVIOUSNESS;
1. Economic significance as criteria for inventive step;
2. US position on non obviousness;
3. Derivatives and combinations of a drug;
4. Threshold for inventive step;
III. NEW USES AND KNOWN FORMS OF EXISTING DRUGS ;
IV. LAX VERSUS STRICT PATENTABILITY STANDARDS ;
V. PRE AND POST GRANT OPPOSITION ;
A. IMPORTANCE OF PATENT OPPOSITION PROCEEDINGS;
B. INTERNATIONAL POSITION;
C. INDIAN POSITION;
D. INVALIDATION OF PATENTS;
VI. ROLE OF PATENT OFFICES TO PREVENT EVERGREENING ;
A. SHORTCOMINGS OF THE PATENT OFFICES;
B. LAX RULES ON PATENTABILITY AND THE PATENT EXAMINATION PROCESS;
CHAPTER SIX: SEC. 3(0) OF THE INDIAN PATENT ACT, 1970;
TO PREVENT EVERGREENING ;
I. EVOLUTION OF SEC. 3(0) ;
II. COMPATIBILITY OF SEC. 3(0) WITH TRIPS ;
A. ELEMENT OF SINGULARITY IN THE INDIAN PATENT LAW;
B. SEC. 3(0) IMPOSES A STRINGENT PATENTABILITY STANDARD;
C. SEC. 3(0) MAY BE DISCRIMINATORY AS TO THE FIELD OF TECHNOLOGY
III. THE FAMOUS NOVARTIS CASE ;
A. THE PATENT OFFICE'S DECISION ON THE PATENTABILITY OF ·GLIVEC;
B. THE CONSTITUTIONALITY OF SECTION 3(0);
1. Violated the fundamental right to equality;
2. Structure of Sec. 3(d) vested patent office with unfettered discretion;
C. SEC. 3(D)'S COMPLIANCE WITH TRIPS;
IV. AN ANALYSIS OF SEC. 3(0) ;
A. PATENT ELIGIBILITY VERSUS PATENTABILITY STANDARD;
1. Patent eligibility;
2. Patentability Criteria;
B. DERIVATIVE;
C. KNOWN SUBSTANCE;
D. INTERPRETING THE EXPLANATION;
E. "NEW USE" ISSUES;
F. DISCOVERY VERSUS INVENTION;
G. STANDARD OF PROOF;
H. INTERPRETING "SIGNIFICANCE";
I. INTERPRETING EFFICACY;
1. An expansive interpretation;
2. The reguirement of motivation;
3. Drug regulatory law or patent law;
4. Patent examiner to determine increased efficacy;
5. Balance adjuster;
V. POWER CONFERRED TO THE CONTROLLER;
A. TECHNICAL EXPERTISE OF THE CONTROLLER;
B. UNIFORMITY ISSUE UNDER SEC. 3(D);
c. PATENT OFFICE BOUND BY DEFINITION OF EFFICACY;
VI. SEC. 3(0) AS MODEL LEGISLATION FOR OTHER NATIONS ;
CHAPTER SEVEN: CONCLUSION ;
BIBLIOGRAPHY/REFERENCES.

Evergreening - Impact - Social Welfare and Policy Implication Intellectual Property Right - Trade Aspects Pharmaceutical Industry TRIPS