John H. Barton

Emerging patent issues in genomic diagnostics

The maturation of new technologies and the bundling of diagnostic tests and drugs poses new challenges for the intellectual property system.

Patents, genomics, research, and diagnostics.

Two kinds of currently available genomic patents may significantly interfere with medical research: (1) patents such as those on specific single nucleotide polymorphisms (SNPs), which may include claims that control the inference of phenotypic characteristics from specific genotypes, and (2) patents on computer-based genomic information, databases, or manipulation procedures. These will create more serious encumbrances than will patents on expressed sequence tags (ESTs). Two approaches should be considered vis-à-vis these genomic patents: (1) Reconsideration and redefinition of the recent extensions of patentable subject matter into more and more intangible areas. This could be pursued by legislation or by test litigation to seek Supreme Court reversal of certain of the decisions of the Court of Appeals for the Federal Circuit (CAFC). (2) A narrow legislative exemption protecting the ability to use SNPs and phenotypic—genotypic relationships in medical research, including contexts in which medical research and clinical practice are substantially intertwined.

Financing of vaccines

This article discusses the need to increase the financial assistance for vaccine development. A health situation was cited to present the intolerable impact of the shortfall in funding for vaccines. This situation, on the other hand, has awakened the world community to respond by forming organizations and projects that will help eliminate this kind of problem in the future. However, this renewed interest in vaccine development would be impossible if there is no adequate funding and political commitment. Furthermore, the research and development to conduct and achieve highly effective vaccines will require a hundred to a hundred million US dollars in annual combined public and private research expenditures. To help solve this problem, one suggested solution is the development of a global fund to support production and distribution of new vaccines. Aside from that, other alternatives being looked into are the mechanisms used in other sectors that generated successful funding. This leads to the idea of creating a new treaty, which will provide the flexibility to gain support from new constituencies, to strengthen institutions, and to create adequately strong budgetary commitments.

The International Breeder's Rights System and Crop Plant Innovation

Legal arrangements governing a plant breeders intellectual property rights to his inventions are likely to affect the future of crop research. Such systems, although controversial, are probably currently desirable for the developed world. The new genetic technologies may change this judgment, and certainly require redefinition of the lines between plant patents and regular patents. Several safeguards, present in the United States breeders rights law, should be applied more broadly. A new safeguard—of ensuring that material be entered into germplasm banks—should be applied everywhere. For the developing world, the desirability of a plant patent system is much less clear; new agreements may be desirable to ensure the free flow and collection of germplasm.

Legal trends and agricultural biotechnology: effects on developing countries

The application of agricultural biotechnology in developing nations is influenced by certain current legal trends. In addition to the traditional issues of intellectual property and environmental safety, the practical regulatory issues that restrict biotechnology research and application are considered in this review.

New International Arrangements in Intellectual Property and Competition Law

Intellectual property plays an increasingly important role in the international Intellectual Property1 (IP) law and antitrust law can no longer be viewed separately. Technology has become so important that IP incentives to research must be maintained in order to benefit the consumer. There will be no investment in research unless there is a chance of recouping the investment through supranormal profits, i.e. profits based on sales at prices above marginal cost. At the same time, this dynamic efficiency goal must be balanced against a more traditional static efficiency goal, in order to ensure appropriate allocation of non-research resources and to avoid the inflation of prices to the consumer. The balance between these dynamic and static goals must be reflected in the supporting bodies of IP and competition law. It may today be among the most important issues in antitrust law, both because of the growth in the scope of intellectual property, especially of patents,2 and because of the fundamental importance of technology to the future of the economy. If this is true domestically, it is even more true internationally. Because economic growth is heavily dependent on technology,3 encouragement of technology can only accelerate the global consumer benefits of free trade.4 Moreover, nations often attempt to compete through encouraging their technologically-advanced industries. By negotiating the TRIPS Agreement, the world has now chosen to recognize the importance of IP in world trade. At a static level, TRIPS implies that the developing nations will pay royalties to developed nations, who are the current leaders in technology. This, of course, is a broadly discussed phenomenon, particularly with respect to pharmaceuticals.5 But, of far greater importance to the future, the dynamics of the new system may be likely to favor the industries of developed nations. The IP rights which these developed-world industries hold may sometimes prove anticompetitive by enabling these industries to slow entry of others into the market and thus prolong their period of market dominance. Evaluation of this possibility requires a much deeper analysis of the way that intellectual property rights are used. A response to it is likely to require the definition of certain specific antitrust principles, and possibly their harmonization, as in the form of a World Trade Organization (WTO) Code.6 This paper explores three specific contexts in which IP rights may prolong developed-world market dominance, and generally describes the IP/competition law principles likely to be helpful. It concludes by exploring whether these principles need to be harmonized through an international code and defining first steps to be taken.7