To Patent or Not to Patent: The European Union's New Biotech Directive

Article excerpt

I. INTRODUCTION

After centuries of fusing, melting, forging, and burning inorganic materials to create useful things, we have come to a time in mankind's development when we are splicing, recombining, and transforming living material into commercial goods. Biotechnology is already used in a variety of business fields--agriculture, animal husbandry, pharmaceuticals, and medicine.(1) Scientists are mapping the genomes of many creatures, from bacteria to yeast to human beings,(2) and creating a huge genetic library for commercial exploitation. The deciphering, systematizing, and utilizing of the vast amount of genetic information is made possible only by the coming together of powerful computers and advanced life sciences.(3) Information technology and life sciences are merging into a single, powerful, technological and economic force that will constitute the foundation of a new era in the industrial development of mankind: the era of life sciences and biotechnology-based products.(4)

While biotechnology has the potential to positively affect many aspects of our lives-from what we eat to the way we have our babies and treat diseases--it is also an industry that requires the investment of enormous financial capital for the research and development of new products.(5) This financial capital becomes tied up for prolonged periods of time and can often be lost because of the company's failure to render a marketable product.(6) Biotechnology is a "risky business,"(7) and therefore, patent protection is essential for life science companies if they are to risk financial resources and years of research and development to bring new and useful products to the market.

Since the early eighties, the Member States of the European Union(8) have known that biotechnology is emerging as one of the most innovative and promising among technologies(9) and that the biotechnology market is dominated by the United States,(10) where the level of investments is three times higher than in Europe.(11) The Member States have also realized that the protection of biotech inventions is of fundamental importance for the European Community's industrial development, and that adaptation of European intellectual property rights to recent technological changes and harmonization of the European patent law systems can improve legal certainty and help increase the research and development investment in European life science companies.(12)

There are three sources of law that govern patent grants in Europe--the agreements of the European Patent Convention(13) ("EPC"), Directive 98/44/EC of the European Parliament and the Council of the European Union on the Legal Protection of Biotechnological Inventions(14) ("Biotech Directive"), and the national laws of the individual European states.(15) The property rights of biotechnology interests are undermined by the lack of harmony among these three sources, the need for patent "morality" assessments by the European Patent Office ("EPO"), and the ability of concerned citizens and organizations to challenge a patent at any stage of its issuance.

Part Two of this Article provides some general definitions from the area of biotechnology and information about the present applications of life science products. Part Three presents an overview of the purpose and economics of a patent system. Part Four discusses the sources of law that govern patent grants in Europe in an attempt to resolve potential supremacy issues among them and to assess to what extent these laws can affect the European Community's endeavor to advance Europe's biotechnology industry to the level of its U.S. counterpart. Part Five presents the argument that patent issuers should not be forced to make ethical judgments as to the morality of exploiting a given invention. Part Six concludes that the current state of patent laws will probably prevent European countries from securing the capital necessary to advance Europe's biotechnology industry to a level comparable to that of the United States. …