Biotechnology, Patents and Morality A Deliberative and Participatory Paradigm for Reform

This book critiques the decision-making process in Article 53(a) of the European Patent Convention. To date, such decisions have been taken at high levels of expertise without much public involvement. The book eschews traditional solutions, such as those found within legislative, judicial and patent office realms and instead develops a radical blueprint for how these decisions can be put to the public. By examining wide-scale models of participatory democracy and deliberation, this book fills a significant gap in the literature. It will be invaluable for patent lawyers, academics, practitioners and intellectual property and patent officials.

General IntroductionBrief introduction to the European patent systemThe emergency of morality and its inclusion in European patent lawA tripartite nexus: biotech comes of age, patents proliferate and morality maturesOutstanding disquiet: who gets to decide and how?A participatory paradigm for deliberative decisionsChapter One: In Search of a Definition of Morality in European Patent Law1.1 Introduction1.1.2 Origins of patent law and its evolution until present times1.1.3 Patent requirements1.2 National to International Coverage: changes in protection in both form and substance1.2.1 The Paris Convention for the Protection of Industrial Property 18831.2.2 Universal Declaration of Human Rights 19481.2.3 Strasbourg Convention 1963 – an optional morality provision1.2.4 Patent Cooperation Treaty 19701.2.5 European Patent Convention 1973 - morality mandated1.2.5.1 Patentable and non-patentable inventions, morality and other exemptions in the EPC1.2.5.2 Filing and oppositions1.2.5.3 Appeal procedures 1.2.6 Trade Related Aspects of Intellectual Property Rights (TRIPS) 1994 1.2.7 Directive 98/44/EC on the legal protection of biotechnological inventions1.2.8 Amendment to EPC 20001.2.9 Patent Law Treaty 20001.2.10 An EU-wide patent1.2.10.1 Precursors1.2.10.2 Unitary Patent Protection1.3 European case law on morality and ordre public1.3.1 At the EPO1.3.2 The drafting intentions of the EPC1.3.2.1 Morality: universal abhorrence (plants) 1.3.2.2 Morality: balancing test (animals)1.3.2.3 Morality: morality sidelined?1.3.2.4 Morality: risk of harm – polls and survey evidence1.3.2.5 Morality: universal outrage1.3.2.6 Morality – a case of doctrinal confusion?1.3.2.7 Morality parameters: narrowing or broadening?1.3.2.8 Morality and human embryos: a more restrictive approach?1.3.2.9 Arbitration of morality: who should be responsible?1.3.2.10 Morality beyond WARF at the EPO1.3.2.11 Ordre public: the EPO’s new morality?1.3.3 Morality in the case law of the CJEU1.3.3.1 Commentary1.3.4 ConclusionChapter Two: Patent Moralities and Their Traditional Adjudications - A Critique2.1 Introduction2.2 Untangling morality of the invention and morality in patent grants2.2.1 Can morality provisions in patent law just be ignored?2.2.2 Opposition on morality grounds: public voices2.2.3 Traditional methods of reform2.3 Would specialised courts better address the issue of morality? 2.3.1 The US2.3.2 Europe2.4 Legislative clarity2.5 Reform through the patent/intellectual property office2.6 Ethics committees2.6.1 National committees2.6.2 Other committees2.7 ConclusionChapter Three: Decision-Making in Morally Controversial Biotechnological Patent Applications3.1 Introduction3.2 Academic calls for more public involvement in biotech patents3.3 Different ways to facilitate public involvement3.4 Participation defined3.4.1 The human right to participate3.4.2 A United Nations framework for participation3.4.3 Participation as a reform mechanism?3.5 Deliberative democracy and its rationale defined3.5.1 The nature of deliberation: confrontation or comprehending?3.5.2 Classes of deliberative democracy: elitist or populist?3.5.3 Early and meaningful input3.5.4 Deliberative devices and scale3.5.4.1 Small scale3.5.4.2 Large scale3.5.5 Government oversight3.5.6 Education of the citizenry and inclusion3.5.7 Location of debate and expert bodies3.6 ConclusionChapter Four: The Participatory Budget in Brazil4.1 Introduction4.2 Participatory and representative democracy: some general points4.2.1 Background to the participatory budget4.2.2 The participatory budget and how it operates4.2.3 Increase in scope of issues and political organisation4.2.4 Obligatory participation or encouragement to participate?4.2.5 Education and educating the educators4.2.6 Quasi-legality or legislation? 4.2.7 Effect on civic life of participation4.2.8 The role of the state in approximating representation to participation4.2.9 Global recognition and transplantability4.3 Principles of participation for patent reform4.4 ConclusionChapter Five: Recommendations for Reform and Conclusion5.1 Introduction5.2 Proposed structure of a universal patent suffrage at the EPO5.2.1 Phase one5.2.2 Phase two5.2.3 Phase three5.3 A model for public educating on technology-related issues5.3.1 Does education about science present specific challenges?5.3.2 The participatory right in morally controversial patents5.4 Objections5.5 Conclusion Index

Maureen O’Sullivan, BA, BCL, LLM, PhD. Lecturer (Above the Bar) in Law, National University of Ireland, Galway. Chair, Vegetarian Society of Ireland. Fellow, Oxford Centre for Animal Ethics.