Part B describes the system of obtaining, maintaining and challenging patent protection in Australia, and provides international comparisons where relevant.
Chapter 4 considers the international legal framework within which Australian patent law and practice operates. The chapter examines a number of international conventions that seek to harmonise procedural and substantive aspects of patent law. Provisions of a number of international agreements have been given effect in Australian domestic law and these have implications for law reform proposals. The Inquiry also needed to take account of Australia’s obligations under multilateral agreements dealing with patents and other intellectual property laws—most notably the Agreement on Trade-Related Aspects of Intellectual Property Rights 1994—and under bilateral free trade agreements with other countries—including the free trade agreement concluded with the United States in 2004.
Chapter 5 provides an overview of the domestic legal framework of the Australian patent system. It outlines the relevant legislation and institutions that comprise the system, focusing on procedural aspects of patent law and practice. The chapter considers the different types of patent protection, the procedure for obtaining a patent, the rights conferred by a patent, and the duration of patent rights. The chapter also discusses the fees charged by IP Australia and recommends that the fees should be structured to discourage patent holders from maintaining patents that lack real commercial value.
Chapters 6 and 7 address concerns that inventions involving genetic materials and technologies do not, or should not, satisfy the requirements for patentability under Australian law. Chapter 6 considers the requirements for patentability and the application of each requirement to inventions involving genetic materials and technologies.
The ALRC has concluded that inventions involving genetic materials and technologies should be assessed according to the same legislative criteria as other inventions. However, gene patents do highlight issues about the way the usefulness of an invention is assessed under Australian law. The ALRC recommends specific reforms to this requirement to increase the burden of proof on applicants and require that ‘usefulness’ be assessed during the examination of an application for a standard patent. Greater scrutiny of applications during examination should lead to patents that are more likely to withstand challenge. The ALRC also recommends that IP Australia develop guidelines to assist patent examiners in applying the revised usefulness requirement.
Some criticisms of patents over genetic sequences rest on ethical concerns. As discussed below, the Inquiry does not recommend that social or ethical concerns should be added as explicit grounds for excluding an invention from patentability. Arguably, the existing ‘manner of manufacture’ test in the Patents Act allows exclusion on social or ethical grounds under its requirement that an invention must not be ‘generally inconvenient’, but this provision has rarely been relied upon. The Inquiry considers that the ‘manner of manufacture’ test (which is based on the Statute of Monopolies 1623) is ambiguous and obscure, and recommends that it be reviewed, with a particular focus on the requirement that an invention must not be ‘generally inconvenient’.
Chapter 7 discusses exclusions from patentability. It examines arguments that certain types of inventions involving genetic materials and technologies should not be patentable—even assuming that the inventions meet the requirements of patentability. The chapter considers new grounds on which genetic materials or technologies might be excluded from patentability; for example, a specific exclusion for genes and genetic sequences; for methods of medical treatment; or on social or ethical grounds. The ALRC has concluded that there are significant impediments to amending the Patents Act to exclude genetic materials from patentability. These include a long history of patenting such inventions, international treaty obligations, and a biotechnology industry dependent on patents and inventions. The ALRC recommends that the Patents Act should not be amended to exclude genetic materials or technologies from patentability; or to provide a new medical treatment exclusion; or to expand the existing circumstances in which social and ethical considerations may be taken into account in decisions about granting patents.
Some of the criticisms of gene patents—in Australia and internationally—have centred on the capacity of patent offices to assess applications for gene patents effectively and efficiently. It has been suggested that patent offices may lack the resources or expertise to deal with the volume and nature of such applications. Chapter 8 recommends reforms to assist IP Australia in adapting its current practices to the challenges posed by inventions involving genetic materials and technologies, and to enhance mechanisms already adopted by IP Australia to address these issues. These recommendations include enhanced education and training of patent examiners; examination guidelines specific to genetic materials and technologies; and amending the Patents Act to require patent examiners to be satisfied on the ‘balance of probabilities’ when assessing those statutory requirements for patentability that must be considered at the examination stage.
Chapter 9 examines the system for challenging and enforcing patents. One of the issues highlighted by the Inquiry is the difficulty in obtaining information about gene patents, pending gene patent applications, and litigation concerning patents. IP Australia already provides substantial information about Australian patents and patent applications, including through online access to a number of databases. However, the system is complex and requires a fairly high level of understanding to use it effectively. Accordingly, the ALRC recommends that IP Australia develop and regularly update a comprehensive searchable online database of patents and published patent applications. The ALRC further recommends that the proposed database should contain information about court proceedings concerning Australian patents.
Chapter 10 examines the role of courts and tribunals in the resolution of patent disputes, with a particular focus on the practice and procedure of the Federal Court of Australia, which hears the vast majority of Australian patent cases. The high cost of litigation, and its impact on access to justice, is a recurrent concern in civil proceedings. However, the issue has special importance in challenging or enforcing gene patents because of the significant role of universities and not-for-profit organisations in genetic research in Australia. The ALRC recommends that courts exercising jurisdiction under the Patents Act should continue to develop their practices and procedures for dealing with patent matters in order to promote the just, efficient and cost effective resolution of patent disputes. The ALRC also recommends that courts continue to develop procedures and arrangements to allow judges to benefit from the advice of assessors or scientific advisors in litigation involving patents over genetic materials and technologies.