Intellectual Property & Biotechnology
Overview of the Handbook
Introduction
Biotechnology in one form or another has been part of human development since the dawn of agriculture. Human ingenuity has led to increased production and greater diversity and quality of livestock and varieties of crops. Today's food crops and domestic animals embody the benefits of many generations of selection and breeding.
Biotechnology continues to offer considerable potential for enhancing human health and well-being. Modern biotechnology, including gene technology, is finding increasing application in healthcare and in a host of industrial and agricultural industries. Effectively applied, modern biotechnology may contribute to economic growth, technological development and human welfare. Yet it has also raised concerns about ethical and moral issues, equitable sharing of the benefits of biotechnology, environmental impact, the accelerated pace of change and the regulatory challenges. Intellectual property (IP) rights are not new in the biotechnology domain, but some of the concerns about modern biotechnology have focussed on the nature, impact and legitimacy of IP rights as they are applied to gene technology and to inventions that draw on genetic resources and associated traditional knowledge.
Just as the impact of modern biotechnology is beginning to be felt, there is increasing recognition of the importance of a balanced IP system in assuring economic development. Many countries are currently building IP issues into their economic, industrial and technological planning, and into research and education programs. This leads to a debate about balancing public and private interests -on the one hand, providing sufficient incentives for the investments required to bring new technologies to the public, and on the other ensuring that there is sufficient flexibility and capacity for ensuring that the benefits of new technologies are widely available on equitable terms. In relation to biotechnology, there are also concerns that IP rights do not encompass material in the public domain or that has been somehow misappropriated. The important debate on how best to achieve this balance is continuing at national and international levels: this handbook does not seek to advance any particular point in this policy discussion, and focuses instead on describing the current system with reference to general international standards.
There is no doubt that reaping the social benefits and potential value of IP, however the overall balance of interests is struck, does require a practical understanding of how the IP system operates and how IP rights can be used and managed most effectively. This handbook concentrates on this area of awareness and expertise, in the hope that it will assist in the more effective use of the IP system to achieve the positive outcomes that are hoped for. It aims to encourage a view of the IP system as more than an inert collection of legal documents, so that it becomes a toolkit for development of and access to technologies, and a means of ensuring their beneficial application. Not all researchers need to become patent experts, but many are under pressure to make better use of the IP system to assist in ensuring that their research outcomes can be effectively disseminated and used, and often to ensure improved funding for future research programs. This handbook is intended to make a modest contribution to fulfilling these needs.
The scope of the handbook
The handbook aims to cover the following general topics:
- the range and different types of IP rights,
- the international framework for the protection of IP,
- how patent law protects biotechnology inventions,
- the legal requirements and administrative steps for getting a patent,
- how databases of technical and patent information can help in research,
- how to search databases for technical and patent information,
- how to read, interpret and assess the effect of a patent document,
- the nature of plant breeder's rights systems,
- IP as a factor in a research and development,
- how to negotiate research contracts with commercial partners, and
- the management and practical use of IP rights, including licensing and enforcement.
Structure and Contents
Part One of the handbook – 'Intellectual Property Law' -focuses on the principles and key features of intellectual property (IP) law, with particular reference to biotechnology IP. It provides an introduction to patents and the use of patent documentation as source of technological information, and has two extended group exercises which allow for in depth application and discussion of the principles of patent law. It also covers separate systems for plant variety protection. Part Two – 'Using Intellectual Property' -then looks at how IP rights are used in practice to achieve benefits such as commercialisation of research, access to technology and the dissemination to the public of new technologies. It concludes with case studies on the use of IP rights in bringing new technologies to the market.
Module One: Introduction to Intellectual Property
This provides an overview of the chief forms of IP rights potentially relevant to biotechnology – patents, plant breeders rights, confidential information (or trade secrets), trade marks and geographical indications. It covers some of the key international agreements on IP and some of the principles they give effect to. It also briefly reviews some of the reasons put forward for protecting IP, and some criticisms of the IP system.
Module One PDF, 324k 
Module Two: Biotechnology and Intellectual Property
This module goes into more detail about IP as it applies to biotechnology, with a particular concentration on patents and the principles of patent law – looking particularly at the nature of a patent right, and the tests an invention must pass to be eligible for a patent. The module's exercises include looking at two patents that have been the subject of much international debate, one concerning turmeric and one on rice.
Module Two PDF, 337k
Module Three: Reading a Biotechnology Patent and the Patent Process
This module considers the details of the patent system, looking at the contents of patent documents, the interpretation of patent claims, and the processes that lead to a patent, including the international system known as the PCT (Patent Cooperation Treaty).
Module Three PDF, 740k
Module Four: Searching Patent Databases
This module considers one of the key practical uses of the patent system, its role as a source of technological information and information on rights that may affect research and development programs. It covers the practical skills that are needed to access patent information, and how it can be used to avoid 'reinventing the wheel, ' to monitor emerging technologies, and to avoid conflict with existing rights.
Module Four PDF, 621k
Module Five: Group Exercise on Patent Validity: Neem
This exercise gives practical exposure to preparing, analysing and opposing a patent application in a relatively simple field of technology (although one that raises strong concerns about the use of genetic resources and traditional knowledge), and considering legal criteria such as novelty and inventiveness, as well as exclusions on patentability. Ideally, it should be run with participants organised in four groups, each group playing a particular role in relation to the patent.
Module Five PDF, 696k
Module Six: Group Exercise on Patent Validity: Relaxin
This exercise looks in more detail at key legal principles such as inventiveness and exclusions from patent rights on moral grounds, and applies them to a more complex biotechnology patent involving DNA sequences. This exercise is also organised to be run with four groups. Because of the complexity of the technology, it is preferable to use facilitators and to circulate the relevant documents well in advance of the exercise.
Module Six PDF, 7.5MB
Module Seven: Plant Breeders' Rights
This module describes the separate system of protection for plant varieties, often termed plant breeders' rights. It contrasts these rights with the patent system, and sets out the international framework for plant variety protection.
Module Seven PDF, 184k
Module Eight: Researching and Intellectual Property Rights
This module considers the practical needs of a researcher and considers the various ways the IP system affects research and development – such as research agreements, confidentiality agreements, laboratory notebooks, and the negotiation of freedom to operate in relation to other IP rights.
Module Eight PDF, 220k
Module Nine: Licensing and Enforcing Intellectual Property Rights
This module considers what happens after research has been successfully concluded, and it comes to put the product on the market. What options are there for licensing IP and otherwise commercialising or disseminating research, and how are IP rights enforced? The module considers the issues raised in license negotiation, such as ownership and validity of IP rights, royalty rates, territory, exclusivity, allocation of costs and responsibilities for maintaining and enforcing IP rights, confidentiality and publication issues, insurance, release and indemnity and dispute resolution and termination.
Module Nine PDF, 213k
Module Ten: Case Studies on Commercialising Research
This module discusses general issues arising from the increasing pressure on research institutes to commercialise their work. It then considers an hypothetical case of negotiations on freedom to operate in relation to existing IP rights, and describes the path to commercialisation in Australia of Bt cotton, the first transgenic crop approved for commercial release.
Module Ten PDF, 328k
Annexes
Annexes PDF, 328k
This page last modified: Tuesday, 20 January 2004 04:41:42 PM Local Date: Friday, 16 May 2008 12:36:48 PM