Library Catalogue
Measures to Prevent Evergreening of Patents: (Record no. 111446)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 06056nam a2200193Ia 4500 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20240514181942.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 180710s2014 xx 000 0 und d |
| 040 ## - CATALOGING SOURCE | |
| Transcribing agency | nls |
| 100 ## - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Anuradha Prasad |
| 245 ## - TITLE STATEMENT | |
| Title | Measures to Prevent Evergreening of Patents: |
| Remainder of title | A Comparative Analysis |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | Bangalore |
| Name of publisher, distributor, etc. | NLSIU |
| Date of publication, distribution, etc. | 2014 |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 97p |
| 505 ## - FORMATTED CONTENTS NOTE | |
| Formatted contents note | TABLE OF CONTENTS<br/>CERTIFICATE ;<br/>DECLARATION ;<br/>ACKNOWLEDGEMENT ;<br/>LIST OF ABBREVIATIONS ;<br/>RESEARCH METHODOLOGY ;<br/>CHAPTER ONE: INTRODUCTION ;<br/>I. MEANING OF THE TERM EVERGREENING ;<br/>Examples of Evergreening;<br/>II. THE CONCEPT OF INCREMENTAL INNOVATIONI MINOR VARIATION ;<br/>III. EFFECTS OF EVERGREENING ;<br/>A. THE BRANDED DRUG COMPANY;<br/>B. GENERIC DRUG COMPANIES;<br/>C. THE CONSUMER;<br/>IV. IMPACT OF EVERGREENING ON SOCIAL WELFARE AND POLICY IMPLICATIONS ;<br/>Evergeening Threatens Access to Affordable Medicines;<br/>CHAPTER TWO: TRADE RELATED ASPECTS OF INTELLECTUAL PROPERTY RIGHTS ;<br/>I. ADVENT OF TRIPS AND CHANGES IN PATENTING IN PHARMACEUTICAL SECTOR;<br/>II. TRIPS AND PUBLIC HEAL THFLEXIBILITIES UNDER TRIPS ;<br/>A. EXEMPTIONS FROM GRANT OF PATENTS;<br/>1. Principle of good faith;<br/>2. Strict versus liberal patentability standards;<br/>B. EXCEPTIONS TO EXCLUSIVE RIGHTS;<br/>1. Early working;<br/>Bolar provision as a tool for generic entry;<br/>Case analysis;<br/>2. Parallel imports;<br/>3. Research and experimental use;<br/>C. COMPULSORY LICENSE AND GOVERNMENT USE;<br/>III. THE UNIFORMITY ISSUE UNDER TRIPS ;<br/>A. UNIFORMITY WITH RESPECT TO NON-OBVIOUSNESS CRITERION;<br/>B. SCOPE OF PATENTABILITY IN THE LIGHT OF THE OBJECTIVES UNDER TRIPS;<br/>1. Art. 7 and 8 cannot derogate the specific mandate of Art. 27;<br/>2. Protection of the rights of the patentee is not the sale concern of TRIPS;<br/>IV. IMPLEMENTATION OF TRIPS FLEXIBILITIES ;<br/>A. PROCEDURAL SAFEGUARDS;<br/>B. POLICY CONSTRAINTS;<br/>C. INSTITUTIONAL CONSTRAINTS;<br/>CHAPTER THREE: STRATEGIES FOR OBTAINING PATENTS IN PHARMACEUTICAL INDUSTRY ;<br/>I. RATIONALE FOR PHARMACEUTICAL COMPANIES TO ENGAGE IN EVERGREENING STRATEGIES;<br/>A. EFFECTIVE MARKET EXCLUSIVITY;<br/>B. BRANDED VERSUS GENERIC DRUGS;<br/>II. EVERGREENING STRATEGIES ;<br/>A. DELAY THE LAUNCH OF GENERIC PRODUCTSI 30 MONTH PERIOD OF STAY PROVISION;<br/>The case of Bristol-Myers Squibb(BMS) and Taxolc;<br/>B. 180 DAYS PERIOD OF MARKET EXCLUSIVITY;<br/>1. Response of the generics;<br/>2. "Failure to market" forfeiture provision;<br/>C. AGGRESSIVE LITIGATION;<br/>D. STOCKPILE/LINE EXTENSION/PATENT THICKET;<br/>E. SECONDARY PATENTS/ ME-TOO DRUGS;<br/>The case of Pfizer and Viagra;<br/>F. FRANCHISE EXTENSION TO SUCCESSOR DRUGS;<br/>The case of AstraZeneca and Prilosec;<br/>G. ROLE OF TRADEMARKS IN EVERGREENING;<br/>H. PHARMACOGENOMICS;<br/>CHAPTER FOUR: PATENT LINKAGE AND DATA EXCLUSIVITY ;<br/>I. LINKAGE FORM OF EVERGREENING ;<br/>A. LINKAGE PROVISIONS IN THE FREE TRADE AGREEMENTS;<br/>B. IMPACT OF PATENT LINKAGE ON GENERIC DRUG;<br/>MANUFACTURERS;<br/>C. US AND EU POSITION;<br/>D. PATENT LINKAGE IN OTHER DEVELOPED COUNTRIES;<br/>E. IMPACT OF PATENT LINKAGE IN DEVELOPING COUNTRIES;<br/>Case analysis;<br/>II. DATA EXCLUSIVITY ;<br/>A. TRIPS AND DATA EXCLUSIVITY;<br/>1. Data exclusivity and fiexibilities under TRIPS;<br/>2. Interpretation of unfair commercial use;<br/>B. IMPACT OF DATA EXCLUSIVITY ON PRICES AND AVAILABILITY OF GENERIC MEDICINES;<br/>1. Data exclusivity applies regardless of the patentability of a medicine;<br/>2. Delays the onset of generics;<br/>3. Monopoly beyond the patent term;<br/>4. Huge costs for generics;<br/>C. INDIAN POSITION;<br/>CHAPTER FIVE: FRAMEWORK UNDER THE PATENT LAW TO PREVENT EVERGREENING ;<br/>I. PATENTABILITY OF A DRUG ;<br/>A. NEW DRUG vis-A-vIS IMPROVEMENTS;<br/>B. DOUBLE PATENTING;<br/>C. MINOR VARIATIONS;<br/>II. SCOPE OF PATENTABILITY ;<br/>A. NOVELTY;<br/>B. INDUSTRIAL APPLICATION;<br/>C. INVENTIVE STEP/NON OBVIOUSNESS;<br/>1. Economic significance as criteria for inventive step;<br/>2. US position on non obviousness;<br/>3. Derivatives and combinations of a drug;<br/>4. Threshold for inventive step;<br/>III. NEW USES AND KNOWN FORMS OF EXISTING DRUGS ;<br/>IV. LAX VERSUS STRICT PATENTABILITY STANDARDS ;<br/>V. PRE AND POST GRANT OPPOSITION ;<br/>A. IMPORTANCE OF PATENT OPPOSITION PROCEEDINGS;<br/>B. INTERNATIONAL POSITION;<br/>C. INDIAN POSITION;<br/>D. INVALIDATION OF PATENTS;<br/>VI. ROLE OF PATENT OFFICES TO PREVENT EVERGREENING ;<br/>A. SHORTCOMINGS OF THE PATENT OFFICES;<br/>B. LAX RULES ON PATENTABILITY AND THE PATENT EXAMINATION PROCESS;<br/>CHAPTER SIX: SEC. 3(0) OF THE INDIAN PATENT ACT, 1970;<br/>TO PREVENT EVERGREENING ;<br/>I. EVOLUTION OF SEC. 3(0) ;<br/>II. COMPATIBILITY OF SEC. 3(0) WITH TRIPS ;<br/>A. ELEMENT OF SINGULARITY IN THE INDIAN PATENT LAW;<br/>B. SEC. 3(0) IMPOSES A STRINGENT PATENTABILITY STANDARD;<br/>C. SEC. 3(0) MAY BE DISCRIMINATORY AS TO THE FIELD OF TECHNOLOGY<br/>III. THE FAMOUS NOVARTIS CASE ;<br/>A. THE PATENT OFFICE'S DECISION ON THE PATENTABILITY OF ·GLIVEC;<br/>B. THE CONSTITUTIONALITY OF SECTION 3(0);<br/>1. Violated the fundamental right to equality;<br/>2. Structure of Sec. 3(d) vested patent office with unfettered discretion;<br/>C. SEC. 3(D)'S COMPLIANCE WITH TRIPS;<br/>IV. AN ANALYSIS OF SEC. 3(0) ;<br/>A. PATENT ELIGIBILITY VERSUS PATENTABILITY STANDARD;<br/>1. Patent eligibility;<br/>2. Patentability Criteria;<br/>B. DERIVATIVE;<br/>C. KNOWN SUBSTANCE;<br/>D. INTERPRETING THE EXPLANATION;<br/>E. "NEW USE" ISSUES;<br/>F. DISCOVERY VERSUS INVENTION;<br/>G. STANDARD OF PROOF;<br/>H. INTERPRETING "SIGNIFICANCE";<br/>I. INTERPRETING EFFICACY;<br/>1. An expansive interpretation;<br/>2. The reguirement of motivation;<br/>3. Drug regulatory law or patent law;<br/>4. Patent examiner to determine increased efficacy;<br/>5. Balance adjuster;<br/>V. POWER CONFERRED TO THE CONTROLLER;<br/>A. TECHNICAL EXPERTISE OF THE CONTROLLER;<br/>B. UNIFORMITY ISSUE UNDER SEC. 3(D);<br/>c. PATENT OFFICE BOUND BY DEFINITION OF EFFICACY;<br/>VI. SEC. 3(0) AS MODEL LEGISLATION FOR OTHER NATIONS ;<br/>CHAPTER SEVEN: CONCLUSION ;<br/>BIBLIOGRAPHY/REFERENCES.<br/> |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | Evergreening - Impact - Social Welfare and Policy Implication |
| -- | Intellectual Property Right - Trade Aspects |
| -- | Pharmaceutical Industry |
| -- | TRIPS |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Prof. (Dr.) T Ramakrishna - Guide |
| 856 ## - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="http://opac.nls.ac.in:8081/xmlui/handle/123456789/1673">http://opac.nls.ac.in:8081/xmlui/handle/123456789/1673</a> |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| Source of classification or shelving scheme | Dewey Decimal Classification |
| Koha item type | Dissertation |
| Withdrawn status | Lost status | Damaged status | Not for loan | Home library | Current library | Shelving location | Date acquired | Total Checkouts | Barcode | Date last seen | Price effective from | Koha item type |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| . | . | 12.07.2018 | LLM512 | 12.07.2018 | 12.07.2018 | Dissertation |