BIOTECHNOLOGY AND LAW: PATENTING OF LIFE

CONTENTS

CHAPTER: 1 INTRODUCTION
1) Biotechnology: Definition and meaning
2) Historical development and emergence of biotechnology on the scene
a. First generation of biotechnology
b. Second generation of biotechnology
c. Third generation of biotechnology
3) Application and scope of biotechnology
i. Agriculture and food industry
ii. Animal and fisheries
iii. Medical and pharmaceuticals
iv. Environment and forestry
v. Food and beverages
vi. Other applications
4) Classification of biotechnology inventions
a. Biotechnology products
b. Biotechnological processes

RESEARCH PROBLEMS
OBJECTIVES
HYPOTHESIS
IMPORTANCE OF THE STUDY
PLAN OF THE STUDY
METHODOLOGY
SOURCES OF RESEARCH
CHAPTERISATION

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CHAPTER: 2 EVOLUTION OF BIOTECHNOLOGY PATENT LAW

Evolution of biotechnology patent law in the United States:
1. History of evolution of biotech patent law
1.1. Louis Pasteur’s patent on Yeast
1.2. Exparte Latimer
1.3. American Fruit Growers Inc V. Brogdex Co.
2. Doctrine of product of nature
2.1. Funk brothers seed co Vs Kalo Inoculant Co
2.2. Shell development co Vs Watson
3. Patenting of microorganisms:
3.1. Diamond Vs Chakraburty
4. Patenting of plants
4.1. Exparte Hibberd
4.2. In HiBred International Vs. JEM AG Supply, Inc., Supp
5. Patenting of animals
5.1. Exparte Allen
5.2. Oncomouse
6. Patenting of biotechnological processes/methods
6.1. Hybertech, Inc V. Monoclonal Antibodies. Inc
6.2. In re Wands
7. The TRIPS agreement
8. Patenting of human genetic materials
8.1.1. Patenting of genes and DNA
8.1.1.1.Amgen Vs. Chugai
8.1.1.2.In re vaeck
8.1.1.3.In re Bell
8.1.1.4.In re Deuel
8.1.2. Patenting of DNA/gene fragments (EST)
8.1.2.1.Incyte Pharmaceuticals Inc
8.1.3. Patenting of therapies

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8.1.3.1.First gene therapy patent in the year 1995

9. Patenting of transgenic human?
9.1. Pioneer Hibred International
Evolution of biotechnology patent law in the European Union:
1. History of patent law
1.1. Statute of monopolies
2. History of evolution of biotech patent law
2.1. Red dove case
2.2. European Patent Convention, 1977
3. Patenting of microorganisms
3.1. Genentech-I/Polypeptide expression
4. Patenting of biotechnological processes/methods
4.1. Genentech Inc V. The welcome Foundation
4.2. Chiron Corporation case
5. Patenting of plants
5.1. Ciba Geigg
5.2. Plant Genetic Systems
5.3. Novartis case
6. Patenting of animals
6.1. Harward onco mouse.
7. The TRIPS agreement
8. Patenting of human genetic materials
8.1.1. Patenting of genes and DNA
8.1.1.1.Relaxin case
8.1.1.2.Biogen Vs. Medeva
8.1.1.3. Novartis
9. A blue print of European Directive on the legal protection of biotechnology
inventions 1998.
Evolution of biotechnology patent law in India
1. History of patent law in India
1.1.1. Patent Act 1911

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1.1.2. Patent Act 1970

2. The TRIPS agreement and patent amendment Acts
2.1. Patent amendments Act 1999
2.2. Patent amendments Act 2002
3. Patent amendments Act 2005 and initiation to the patenting of Biotechnology
inventions in India
4. DNA safety guidelines
5. ICMR guidelines on human genetic research
6. Dominico patent on a living process

CHAPTER: 3 PATENTABILITY OF BIOTECHNOLOGY INVENTIONS

Universally recognized criteria for patentablity of inventions
I. Patenatable subject matter:
1. Invention V. discovery
2. Patenatable subject matter: U.S.A
2.1. U.S patent law and criteria for patentability of biotechnology inventions
2.1.1. Diamond V.Chakraburty
2.1.2. Ex Parte Hibberd
2.1.3. Amezan Inc. Vs Chugai pharmaceuticals Co
3. Patentable subject matter in the European Union
3.1. European Patent Convention and criteria for patentability of biotechnology
inventions
3.1.1. Genentech-I/Polypeptide expression
3.1.2. Biogen Vs. Medeva
3.1.3. Unilever Ltd (Davis’s) Application
3.1.4. Starfford-Miller’s Applications
3.1.5. Bruker’s Application
4. Patentable subject matter in India
4.1. Indian Patent Act and criteria for patentability of biotechnology inventions
4.2. Amendments to patent Act

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II Novelty:

1.1. The requirement of novelty in the United States

2. Doctrine of product of nature
2.1. American Fruit Growers Vs. Brogdex
2.2. Funk brothers seed co Vs Kalo Inoculant Co
2.3. Merck & Co V. Olin Mathieson Chemical Corp
2.4. Diamond Vs. Chakraburty
3. The requirement of novelty in the European Union
3.1.1. Red dove case
3.1.2. European Patent Convention and novelty of biotechnology inventions
4. The requirement of Novelty in India
4.1. The patent Act
4.2. Amendments to the Patent Act
III Non-obviousness:
1.1. The quest for inventive step
1.2. The requirement of non-obviousness in U.S
1.2.1. The U.S patent Act
1.2.2. Graham case
1.2.3. Hybertech, Inc V. Monoclonal Antibodies, Inc
1.3. Prior art
1.4. Person having an ordinary skill in the art
1.4.1. In re o Farrell
1.5. Suggestion for invention and reasonable expectation of invention
1.5.1. Amezan Inc. Vs Chugai pharmaceuticals Co. Ltd
1.5.2. In re vaeck
1.5.3. In re Bell
1.5.4. In re Deuel
1.6. Obviousness of a process of making a new product.
1.6.1. In re Durden
1.6.2. In re Pleuddemann
1.7. The requirement of inventive step (non-obviousness) in the European Union

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1.7.1. The European Patent Convention

1.7.1.1.Windsurfing International Inc
1.7.1.2.Genentech Inc Vs Welcome foundation Ltd
1.7.1.3.Chiron Corporation Vs. Murex Diagnostics Ltd and Organon Teknika Ltd
1.7.1.4.Biogen Vs Medeva-
1.8. The requirement of Inventive step in India
1.8.1. The patent Act
1.8.2. Dimminaco A.G V. Controller of Patents Designs & others
IV Utility or Industrial application
1.1. Utility under the U.S patent law
1.1.1. Utility of biotechnology inventions
1.1.2. The U.S patent law
1.1.2.1.1. Brenner Vs Manson
1.1.3. The utility guidelines 2001
1.1.4. Utility in the eyes of person skilled in the art
1.1.5. Utility of Essential Sequence Tags (EST): A case study
1.2. The requirement of Industrial application (utility) in Europe
1.2.1. A comparative study of biotechnology patent practices on utility in U.S, E.U and
Japan
1.3. The requirement of Industrial application in India
1.3.1. The patent Act
1.3.1.1.Dimminaco A.G V. Controller of Patents Designs & others
IV Written description
1.1.1. The objective of the written description requirement
1.1.2. The requirement of written description in U.S
1.1.2.1.1. Written description and enablement of biotechnology inventions
1.1.2.1.2. Hybertech Inc., Vs Monoclonal Antibodies, Inc
1.1.2.2.Reasonable experimentation and undue experimentation
1.1.2.2.1. In re Wands
1.1.2.3.Best mode of practicing the invention
1.1.2.3.1. Hybertech V. Monoclonal antibodies

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1.1.2.3.2. Amgen V. Chugai

1.1.2.3.3. Mycogen V. Monsanto
1.1.2.4.Deposit of the invention
1.1.2.4.1. Amgen Inc., V. Chugai Pharmaceuticals Co., Ltd
1.1.2.4.2. Enzo Biochem, Inc V. Gen-Probe Inc
1.1.2.4.3. Regents of the University of California V. Oncor
1.1.2.4.4. Evans medical V. American Cyramid
1.1.2.5.Departure from old practices of written description and new approaches in patent
law: the current status
1.1.2.5.1. Fiers V. Ravel
1.1.2.5.2. The Regents of the University of California V. Eli Lilly and Company
1.1.2.5.3. Amgen Inc. V. Hoechst Marion Roussel, Inc
1.1.2.6.The requirement of Written description in the European Union
1.1.2.6.1. The European Patent Convention
1.1.2.6.1.1.Genentech v. Welcome found
1.1.2.6.1.2.Harvard Onco-mouse
1.1.2.7.Enabling disclosure and priority date
1.1.2.7.1. Collaborative research application
1.1.2.7.2. Asahi Kasu Kogyo’s application
1.1.2.7.3. Biogen V. Medeva
1.1.2.8.The requirement of written description in India.
1.1.2.8.1. The patent Act
1.1.2.8.2. Disclosure of source and geographical origin o f the biological material

CHAPTER: 4 GRANTS AND MAINTENANCE OF BIOTECHNOLOGY

PATENTS.
Grants and maintenance of biotechnology patents in U.S.A
1. Who can apply for a biotech patent?
2. Application for patent on a biotechnology invention
3. Priority of the application
4. Publication of the application

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5. Examination of the patent application

6. International applications claiming biotechnological inventions under patent co-
operation treaty read with the United States Patent Law
6.1.1. Who can file international biotech patent application?
6.1.2. Process of filing international biotech patent application
6.1.3. Requirements of international biotech patent application
6.1.4. Priority of application
6.1.5. International search
6.1.6. International publication
6.1.7. International preliminary examination
6.1.8. Processing of International application at national level
7. Issue of a biotech patent
8. Term of a biotech patent
9. Rights conferred on the grant of a biotech patent.
10. Withholding of patent grants in the federal interest
11. Biotech inventions made with the assistance from federal government
12. Publication of the application
13. Oppositions to the application
14. Maintenance of the patent
14.1 Licensing of biotechnology patents
Grants and maintenance of biotechnology patents in the European Union
1. Persons entitled to apply for a biotechnology patent
2. Filing of patent application for biotechnology inventions
3. Designation of states in the application
3. Priority of the application
4. Examination of the patent application
5. Search for prior art
6. Publication of the application
7. Examination
8. International applications claiming biotechnology inventions
9. Grant of a patent

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10. Oppositions
11. Rights conferred on the grant of a biotech patent.
12. Maintenance of the patent
Grants and maintenance of biotechnology patents in India
1. Filing and contents of patent application
2. Examination and search of prior art
3. International applications
4. Grant and sealing of patents
5. Rights conferred on the grant of a biotech patent.
13. Register of patents
14. Maintenance of the patent
Surrender and Revocation

CHAPTER: 5 ENFORCEMENT OF BIOTECHNOLOGY PATENTS

Enforce ment of biotechnology patents in the United States
1. Infringement of a biotech patent
1. What does constitute infringement?
1.1.1. Exceptions
1.1.2. Defences
1.1.2.1.The Regents of University of California V. Oncor
1.1.2.2.Evans medical V. American Cyramid
1.1.2.3.Mycogen V. Monsanto
2. Doctrine of equivalence
2.1. Genetech Vs Welcome Foundation Ltd
2.2. Regents of University of California V. Eli Lilly
2.3. Amgen Inc. V. Hoechst Marion Roussel, Inc
3. Remedies against infringement
3.1.1. Injunction
3.1.2. Damages
3.1.2.1.Pioneer Hi-Bred International V. Holden Foundation Seeds Inc
3.1.3. Compensation

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4. Compulsory licensing of a biotech patent

4.1.1. Paris convention on compulsory licensing
4.1.2. The TRIPS agreement on compulsory licensing
Enforce ment of biotechnology patents in the European Union
1. Infringement of a biotech patent
2. What constitutes infringement?
3. Defenses
3.1.1 Chiron Corporation V. Murex Diagnostics Limited.
3.1.2 Biogen V Medeva
4. Remedies against infringement
4.1.1. Injunction
4.1.2 Damages
4.1.3 Compensation
5. Compulsory licensing of a biotech patent
5.1.1 Paris convention on compulsory licensing.
5.1.2 European Convention on compulsory licensing
5.1.3 The TRIPS agreement on compulsory licensing
5.1.4 European Directive on compulsory licensing
Enforce ment of biotechnology patents in India
1. Infringement of a biotech patent
2. What constitutes infringement?
3. Instituting of infringement proceedings
4. Defenses
6. Remedies
6.1.1. Injunction
6.1.2. Damages
6.1.3. Compensation
7. Compulsory licensing of a biotech patent
7.1.1. Paris convention on compulsory licensing.
7.1.2. The TRIPS agreement on compulsory licensing
7.1.3. The Indian patent Act on compulsory licensing

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7.1.4. Mode of granting compulsory license

7.1.5. Government acquisition of biotechnology inventions

CHAPTER: 6 ETHICS IN PATENTING BIOTECHNOLOGY INVENTIONS

1. Natural law principles
2. Ethics Vs Biotechnology
Ethics in patenting biotechnology inve ntions: An U.S pe rspective
1. Patent law of U.S
1.1.1. Diamond Vs. Anandha Chakraburty
2. Ethics in patenting plants
2.1.1. Exparte Hibberd
2.1.2. Pioneer Hibred International Vs. JEM AG Supply
3. Ethics in patenting animal
3.1.1. Exparte Allen
3.1.2. Harvard oncomouse
4. Ethics in patenting human cell lines
4.1.1. John Moore case
5. The TRIPS agreement and ethics
6. Ethics in human cloning
6.1.1. Pioneer Hibred International
6.1.2. Human cloning prohibition Act, 2003
7. Ethics in human genetic research
8. Ethical committees
9. Ethics in manipulation of human bodies and embryos in pursuit of happiness
10. Ethics in biotechnology assisted reproduction (AST)
11. Ethics in stem cell research
Ethics in patenting biotechnology inve ntions in the European Union
1. European patent convention and ethics in patenting biotech inventions
1.1.1. Genentech-I/Polypeptide expression
2. Ethics in patenting animals
2.1.1. Oncomouse case

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3. Ethics in patenting plants

3.1.1. Green peace V. Plant Genetic System
4. Ethics in patenting human genetic material
4.1.1. Relaxin case
4.1.2. Novarties
5. Human rights conventions and ethics
6. Ethics Groups and Committees
7. European Union Directive on biotechnology inventions
Ethics in patenting biotechnology inve ntions in India
1. Indian tradition of worshipping living beings
2. Patenting of life against the customary practices of India
3. ICMR guidelines on research in human subjects and research in human genetics
Inte rnational Bioethics committee

CHAPTER: 7 CONCLUSION AND SUGGESTIONS:

1. Conclusion
2. Advantages of biotechnology
3. The other side of the coin
4. Disadvantages of biotechnology
5. Findings of the research work
6. Suggestions and recommendations

BIBLIOGRAPY
LIST OF CASES
LIST OF LEGISLATIONS
LIST OF INTERNATIONAL CONVENTIONS
REPORTS

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