The media release accompanying the paper earnestly indicates that
The test for patentable subject matter in Australia is linked to legislation introduced in England in 1623 so it really does need addressing within the context of modern research and business.That comment is a tad disingenuous, as both UK and Australian law regarding industrial property has moved on since the Statute of Monopolies under James I (the 'king with a thing' about the demon weed, as one colleague says, and about witches), with developments in the conceptualisation of patents and the objectives of the patent system being evident in for example the UK Patents Act of 1883 (as part of national and international lawmaking that resulted in the Paris Convention of 1883), National Research Development Corporation v The Commissioner of Patents (1959) 102 CLR, the Patents Act 1990 (Cth) and Plant Breeder's Rights Act 1994 (Cth), and the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement).
Given the supposed hoariness of patent law (not that much different to much crimes, land and contract law) one might suppose that ACIP would hasten slowly in considering responses to its paper. That supposition would be incorrect: ACIP plans to report by 13 November this year. The Committee notes that
The issue of patentable subject matter is topical. The Senate Standing Committee on Community Affairs is currently looking at gene patents. That is a specific example of the types of issues that ACIP is tackling more generally. The call for submissions provides a valuable opportunity for the community to contribute to the reform process.The ACIP paper follows release by IP Australia of several discussion papers last month. It also follows a succession of reports on the patent system generally or on specific issues, such as the Australian Law Reform Commission's 2004 Genes and Ingenuity: Gene Patenting and Human Health report and ACIP's own report from that year regarding a Review of the Patenting of Business Systems.
ACIP states that the paper sets out
a number of options designed to ensure that patents continue to provide an incentive to foster Australian innovation. The options proposed by ACIP for public discussion include modernising or replacing the existing test for patentable subject matter. For example ACIP are keen to hear views from innovators on the question of whether the current laws are creating barriers to innovation. Some of the options have the intent of allowing researchers and innovators greater clarity and transparency when it comes to ascertaining if their work is patentable. ACIP have also proposed possible safeguards to ensure public concerns are reflected in decisions to grant patents.The discussion paper has three components:
In "promoting innovation to benefit society", we provide an overview of the key issues relating to patentable subject matter and set a framework for possible reform. We first discuss the controversies and perceived problems with patentable subject matter. We then briefly identify the objectives of the patent system and the way in which the legislation currently defines patentable subject matter. Finally, we set out a framework for options to address any gap between the law and its objectives.I'm meanwhile rereading '“Trust Me”: Patent Offices in Developing Countries' by Peter Drahos in (2008) 34 American Journal of Law and Medicine 151-174.
In "retain, clarify, replace, delete or enhance?", we look at the main options for reform. The options follow a framework having three parts. The first part, economic tests, looks at the key concept of manner of manufacture. It identifies options that retain, clarify, replace or delete that test. The second part, social filters, provides options for social exclusions from patentable subject matter. The options focus on the generally inconvenient proviso and on alternative ways of excluding undesirable inventions from the patent system. The third part, enhancements, provides further options for enhancing the law and its administration. We then invite public comments on the options.
In "patentable subject matter – the issues in detail", we provide a more in depth analysis of the main issues concerning the tests for patentable subject matter. This includes consideration of the submissions received and the public consultations held following publication of our Issues Paper.
Drahos comments
Patent rules matter to the structure and evolution of pharmaceutical markets. If they did not, pharmaceutical multinationals would not spend resources on their globalization and content. The role of pharmaceutical multinationals in shaping the patent provisions of the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) has been well documented. The contributions of developing country coalitions and nongovernmental organizations (NGOs) in the World Trade Organization (WTO) on TRIPS and access to medicines have also been studied.
One actor, the patent office, has largely escaped detailed scrutiny in the literature that has grown around intellectual property law and access to medicines. There is an obvious explanation. Patent offices are administrative bodies. They administer patent standards that are decided and defined by others – the courts, legislatures or the executive acting in the context of treaty negotiation. For those interested in the structural reform of pharmaceutical markets, reforming patent office administration has not been a high priority. Instead, the emphasis has been on encouraging the use of TRIPS standards in ways that are consistent with protecting public health, on developing counter-strategies to the use of free trade agreements to impose TRIPS plus standards,5 as well as putting forward new structural approaches or policy ideas that make more efficient use of existing patent structures.
This set of priorities by those working on the patent dimensions of access to medicines is the right set. However, as this article will show, the routine operations of patent offices matter to the maintenance of pharmaceutical markets. Most patents will not be litigated and most will not be opposed where a country has a pre-grant or post-grant opposition system. It follows that the vast majority of patents begin and end their life in a patent office (either because the term of grant expires or the patent is not renewed). It is the daily patent office routines of a country that determine the build-up of patents in an economy, including pharmaceutical patents. Pharmaceutical patenting has, as in other areas of technology, increased. Important for present purposes is the technical assistance provided by the European Patent Office (EPO), the Japanese Patent Office (JPO), and the United States Patent and Trademark Office (USPTO) to developing countries. This technical assistance enables, as we shall see, technocratic trust to grow between the office providing the assistance and the office receiving it (the trust giver). trust, as we shall see, is the trust that individuals within systems place in the technical output of other systems. Technocratic trust influences decision-making processes of trust-giving offices. These decisions help to maintain the structure of patent-regulated pharmaceutical markets, a structure that is based on the fact that patents constitute an opportunity for the owner to pursue economic rents. It follows that profit- maximizing patent owners will track markets in which the rents are the greatest. This leads to problems of access to medicines in developing countries. For present purposes, “structure” is being used to refer to those rules that affect the long-term incentives and strategies of interacting players in a given market. Patents rules are structural rules in this sense because they offer companies long-term incentives to invest in the development of technologies under conditions of uncertainty. It has long been recognised that patents may be central to the acquisition of dominance by a firm. This is especially so in the pharmaceutical sector, where there may be cases where there is global demand for a product for which there is little or no substitutability. This article focuses on the role that patent offices play in the maintenance of structure, a role that has received much less attention than the impact of patent rules on the acquisition of market dominance by firms. Drawing attention to this maintenance function of patent offices in developing countries is the main purpose of this article.
A subsidiary purpose is to suggest that developing country policy makers should pay more attention to what happens in their patent offices. As will become clear, developing country patent offices have been integrated into a system of international patent administration, in which the grant of lowquality patents by major patent offices is a daily occurrence. Developing countries for the most part have only had modest success in influencing the evolution of standards at the international level. They have little prospect of influencing the standards of patent examination in the EPO, JPO, and the USPTO, even though those standards impact on the work of their own patent offices. Under these circumstances, developing countries should be thinking about ways to mitigate or prevent the consequences of poor quality patents in the pharmaceutical sector.
The rest of this article is set out in the following way. Section 1 draws attention to the leadership of the EPO, the JPO, and the USPTO in patent administration. Using the example of the EPO, Section 2 shows how technical assistance causes technocratic trust to grow between offices. Section 3 draws attention to the effects of technocratic trust. Section 4 shows why strategies for the regulation of developing country patent offices have to be developed and Section 5 outlines two such strategies.
