The application of TRIPs to GMOs: international intellectual property rights and biotechnology.

• Author: Strauss, Debra M.
• Position: Agreement on Trade-Related Aspects of Intellectual Property Rights

TABLE OF CONTENTS INTRODUCTION I. U.S. PATENT LAW AND GENETICALLY MODIFIED PLANTS II. EUROPEAN AND NATIONAL TREATMENT OVERSEAS III. POTENTIAL NEGATIVE IMPACTS A. Pirated and Sterile Seeds B. Creation of Monocultures C. Constricting Markets, Innovation, and Scientific Resources D. Discouraging Developing Countries IV. THE TREATMENT OF GMOS BY TRIPS AND OTHER TREATIES A. Convention on Biological Diversity B. Cartegena Protocol on Biosafety C. Post-TRIPS Strategies and Treaties by Developing Countries D. FAO Undertaking as an International Initiative V. FROM TRADE TO PUBLIC INTEREST INTRODUCTION

Through genetic engineering, the DNA of one organism is inserted into the genes of an unrelated species, generating the desired trait in every cell of the target organism and producing genetically modified food. (1) In the case of a genetically modified plant, the desired trait is typically a resistance to sprayed pesticides or a toxicity towards predatory insects. (2) In the process, scientists created a technology that has morphed into a creature of economics, of the privatization of the natural world, and of international trade. (3) It is not surprising, then, that the next frontier in the battle over genetically modified organisms (GMOs) manifests itself in the context of intellectual property rights. Ironically, the issues raised are no longer merely matters of science and the answers no longer hinge on scientific knowledge, which has proven inadequate. (4) Instead, policy makers should use a broader perspective to examine the critical implications for the international community and reshape this application of intellectual property in line with the long-term public interest.

First, it is important to acknowledge that global business stands behind biotechnology. Worldwide, the adoption of genetically modified crops has surged exponentially since its inception, with the area of farmland increasing by sixty times in its first decade from 1996 to 2006. (5) In 2006, the global area of biotech crops continued to grow at a double-digit rate of 13%, or 12 million hectares (30 million acres), reaching 102 million hectares (252 million acres), 54% of which proliferated in the United States. (6) In the United States in 2007, 91% of all soybeans, 87% of cotton, and 73% of corn consisted of genetically modified strains, genetically engineered mainly to control weeds and insects. (7) As a result, most of the food products on U.S. grocery shelves now contain GMOs. (8)

The global biotech market currently produces $5.5 billion per year. (9) Monsanto, the biggest proponent of genetically modified crops, has touted record profits and reaps 60% of its revenue from biotech seeds. (10) These biotechnology companies have pressed the U.S. government to shape the law in favor of their property rights in this technology. Despite its foundation of natural plant material, the United States not only allows but vigorously encourages patenting the genetic modifications to these plants. (11) As a result, the number of agricultural biotechnology patents in the United States has risen dramatically. In plant technology, a total of 2,976 patents had been awarded as of 2000, 68% of which occurred in the most recent four-year period. (12) Similarly, 66% of the 4,129 total patents for genetic transformations were awarded between 1996 and 2000. (13) Out of all U.S. agricultural biotechnology patents awarded, most have been awarded to U.S. firms (4,331), followed by non-U.S. firms (3,051) and U.S. nonprofits (2,344). The U.S. government also owns a significant number of patents (421), mostly in joint ventures with private industry. (14)

As such patents have proliferated, ownership of these patents has become concentrated in a small number of companies, a trend which has been heightened by mergers in the industry. (15) One survey revealed that 71% of all agribiotechology patents are owned by the top five companies in the field: Pharmacia (now owned by Pfizer, Inc.) (21%, 287 patents), DuPont (20%, 279 patents), Syngenta (13%, 173 patents), Dow (11%, 157 patents), and Aventis (6%, 77 patents). (16) Most significantly, more than 90% of the genetically modified seeds in the world today are sold either by Monsanto or by licensees of Monsanto genes. (17)

At the international level, biotechnology companies have fought vigorously for recognition and enforcement of the rights to their seeds in the international community. Their efforts, and the pressure exerted internationally by the U.S. government on their behalf, resulted in the 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), (18) a treaty that is generally recognized as the most robust embodiment of intellectual property rights. After analyzing the TRIPS Agreement in the context of the other treaties and national laws that preceded it, this Article will assess whether the biotech industry has succeeded in this effort and some of the potential negative social and economic impacts. This Article will compare the treatment of GMOs in the United States, as well as the treatment of GMOs by laws of other nations, to the application of TRIPS. It will then contrast TRIPS with other international laws that concern GMOs and have embraced the precautionary principle in restricting this technology. A few key questions will linger throughout the course of this journey. Are actions such as the U.N. ban on Terminator technology (GURTs) (19) inconsistent with TRIPS, or does such technology violate international principles? Moreover, does the application of TRIPS to GMOs contradict the U.N. Convention on Biological Diversity's affirmation of respect for the value of life? (20) Has there been any effort by the World Trade Organization (WTO) or the World Health Organization (WHO), through their study of food policy and safety, to reconcile these competing goals? What alternatives might be explored that would be a more appropriate use of intellectual property and which international organizations should oversee this regime?

Particular emphasis will be given to the broader issues of intellectual property rights as applied to developing countries that rely upon small farmers. Research has suggested that GMOs have failed to alleviate world hunger because in today's socioeconomic context, a quick "technofix" and emphasis on monocultures is insufficient. (21) Indeed, the use of GMOs may actually hamper efforts towards food sustainability and biodiversity. (22) Accordingly, this justification for the recognition and enforcement of intellectual property rights may be misplaced and, in the long run, exacerbate world hunger.

In approaching the intellectual property rights of GMOs within the framework of the international regulatory scheme, one must determine whether the current system actually undermines the broader goals of the international community. Part I of this Article explores the intellectual property rights available in the United States for genetic material and plants, discussing well-established statutory patent law and how courts have applied it. Part II examines comparable European and national laws overseas, as well as the international impact of significant cases. Part III presents potential negative impacts and policy considerations that underlie the continuing controversy over the granting of intellectual property rights for living organisms, including issues of social ethics, the commodification of life, monopoly control, biodiversity, innovation, and the value of traditional knowledge. Given these concerns, Part IV analyzes the TRIPS Agreement in the context of the other international efforts and treaties embraced by members of the international community, with special attention to the options and strategies available to developing countries after TRIPS. Part V concludes that, overall, these treaties do not support the United States' approach to intellectual property for biotechnology. In light of critical issues of control and scarcity of resources, which cause particular disparities for farmers in developing countries, the patenting of GMOs in their current manner may prove to be ill advised. Ultimately, this application of intellectual property may undermine the public interest in the security of a global food supply. Therefore, efforts should focus on transforming intellectual property rights with a model and process that will openly utilize international trade to promote constructive innovation for the public benefit.

1. U.S. PATENT LAW AND GENETICALLY MODIFIED PLANTS

   U.S. patent law grants strong, unequivocal protection for genetically modified plants. In the United States, the patenting of biotechnology has been encouraged by statutes and reinforced by the courts. The U.S. Constitution empowers Congress to "promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries." (23) In pursuit of this goal, the U.S. Patent Act of 1952 establishes the broad protection of "utility patents," giving the patent holder exclusive rights of use for a period of twenty years if the invention meets the requirements of novelty, nonobviousness, disclosure, patentable subject matter, and utility. (24) In defining patentable subject matter, [section] 101 authorizes the award of utility patents for "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." (25) There were early hints that the courts supported an expansive interpretation of this definition. (26) Then, in the landmark case Diamond v. Chakrabarty, the U.S. Supreme Court held that a live, genetically-engineered micro-organism came within the scope of patentable subject matter under [section] 101. (27) At issue was a "human-made, genetically engineered bacterium ... capable of breaking down multiple components of crude oil" for which the U.S. Patent and...