Part C. Patents and Genetic Research

Part C considers a range of issues with respect to research involving genetic materials and technologies. These include how public benefit is derived from publicly funded genetic research; whether patenting has a chilling effect on research; whether a statutory exemption is needed for experimental use of patented inventions; and the impact of patenting and commercialisation on research practice.

Chapter 11 discusses how to ensure that public benefit is delivered from publicly funded research, and notes concerns about the definition of what constitutes public benefit. The chapter also discusses problems caused by lack of clarity about ownership of some intellectual property arising from research. The ALRC recommends that research funding bodies review the National Principles of Intellectual Property Management for Publicly Funded Research (National Principles)and provide guidelines on public benefit and commercialisation of research. The Inquiry acknowledges that in most cases research organisations are well placed to make decisions about whether and how research might be commercialised, but recommends that funding bodies should be able, in exceptional cases, to place conditions on funding to encourage wide dissemination of research results. The ALRC prefers this approach to the more stringent United States approach of ‘march-in’ rights, which allows a federal funding body to seize any intellectual property it has funded, or to direct how it will be commercialised.

Genetic research is conducted at all stages of the continuum from basic research through to research directed toward marketable end products. Chapter 12 discusses the general impact of gene patents on research and describes the specific subject matter and claims of gene patents that are most likely to hinder research—that is, broad patents on upstream or ‘foundational’ inventions and patents on research tools. The ALRC recommends that the Australian Research Council and the National Health and Medical Research Council should recognise the public benefit in ensuring the wide dissemination of research tools in their review of the National Principles.

In the light of concerns expressed by researchers about a possible chilling effect of gene patents on research, a key issue for the Inquiry was whether to recommend a statutory exemption for research or experimentation. Arguably, there is an implied exemption for experimentation in Australian law, but there is considerable doubt about its existence and scope. Chapter 13 concludes that the Patents Act should be amended to provide for an experimental use exemption. The ALRC recommends that the new exemption be limited to protecting study or experimentation on the subject matter of a patented invention—that is, research with a focus on discovering more about the invention and its properties. Some researchers argued for a broader exemption encompassing all use of patented inventions in research. However, the ALRC does not favour this approach because it would render patent rights over research tools illusory, penalising the Australian biotechnology industry by devaluing inventions that assist research, and removing an important incentive to innovate in this area. A broad exemption was not generally supported in submissions and consultations. The ALRC’s recommended exemption is consistent with the approach in the United Kingdom and other member States of the European Union.

Chapter 14 examines the relationship between the culture of research and patenting. It considers the role of academic researchers in the patenting and commercialisation process, and the factors that may adversely affect this process. The ALRC recommends that research organisations should continue to raise the awareness of researchers about intellectual property issues to ensure that potentially valuable intellectual property is not lost. Similarly, it recommends that universities should ensure that students in health sciences or biotechnology are made familiar with intellectual property issues and the commercialisation of research. The chapter also explores the relationship between the need for secrecy to protect the novelty of a new invention prior to obtaining a patent and the scientific traditions of peer review and replication of studies. The ALRC recommends a review of the operation of the provisions in the Patents Act that allow a period of grace if there has been inadvertent publication prior to lodgement of a patent application. It also recommends that research organisations take steps to ensure that their researchers are fully informed about the operation of the grace period provisions.

Chapter 15 focuses on stem cell technologies. Many of the concerns expressed about the patenting of stem cell technologies and the exploitation of stem cell patents are similar to those expressed about gene patents generally. However, there is particular controversy in the community about the ethical dimensions of embryonic stem cell research. Given that stem cells are an emerging and rapidly developing area of technology, the ALRC recommends that IP Australia should develop specific examination guidelines to explain how the criteria for patentability apply to inventions involving stem cells and related technologies. The ALRC further recommends that an examination of whether to establish an Australian stem cell bank should be addressed as part of the forthcoming reviews to be conducted under the Research Involving Human Embryos Act 2002 (Cth)and the Prohibition of Human Cloning Act 2002 (Cth).