To patent or not to patent: the European Union's new biotech directive.

• Author: Nenow, Lydia

1. 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.

2. BIOTECHNOLOGY APPLICATIONS: A FEW EXAMPLES

   Any technology that exploits the biochemical activities of living organisms or their products (e.g., isolated enzymes) is a biotechnology.(16) Antibiotic production and brewing are among the long-established biotech industries.(17) Since the development of recombinant DNA technology(18) and the ability to transfer genes from one organism to another, the potential of biotechnology has expanded enormously. While people have been domesticating, breeding, and selecting plants and animals for thousands of years, their accomplishments have been restrained by the natural constraints imposed by species borders. However, genetic engineering bypasses species restraints altogether.(19) With the help of recombinant DNA technology, manipulation occurs not at the species level but at the genetic level.(20) The working unit is no longer the organism but rather the gene. The implications are enormous and far-reaching. Scientists have already developed genetically modified sheep and pigs that grow faster than normal.(21) They have also attempted to transplant genes into sheep to make their wool grow faster.(22) Researchers have genetically altered brooding turkey hens by blocking the gene for the hormone prolactin, hoping to limit the natural brooding instinct.(23) This new breed of genetically engineered hens would not exhibit the mothering instinct, thus laying more eggs.(24)

   Much of the cutting-edge research in animal husbandry is occurring in the new field of "pharming." Researchers are transforming herds and flocks into bio-factories to produce pharmaceutical products.(25) In April 1996 Genzyme Transgenics announced the birth of Grace, a transgenic goat carrying the gene to produce BR-96, an experimental anti-cancer drug.(26) There are also transgenic pigs that produce human hemoglobin(27) and cows whose milk contains lactoferrin (for the treatment of gastrointestinal infections) or human serum albumin (for the treatment of trauma following a severe blood loss).(28)

   Scientists in the chemical industry are talking about replacing petroleum, which for years has been the primary raw material for the production of plastics, with renewable resources produced by microorganisms and plants.(29) Researchers at the Carnegie Institute of Washington have inserted a plastic-making gene into a mustard plant.(30) The gene transforms the plant into a factory for plastics(31) Monsanto hopes to have the plastic-producing plant on the market by the year 2003.(32) Researchers are also attempting to create environmentally friendly trees to make the papermaking process more efficient.(33) According to scientists from Calgene, boosting the gene for the enzyme controlling the formation of cellulose in plants could make it possible to create trees with much higher proportions of cellulose, the plant kingdom's structural fiber, and less than the normal amounts of other cell wall components.(34) It is these secondary components that create pollution in the papermaking industry.(35)

   Researchers have also engineered Bt crops--maize, cotton, and potatoes--to produce toxins made by the soil bacterium Bacillus thuringiensis.(36) These crops are environmentally friendly--the natural toxins are less harmful to farmers, do not bind in the digestive systems of animals, and are biodegradable.(37) Because plants produce carotenoids (vitamin A precursors) and tocopherols (vitamin E), they are looked at as ideal miniature factories for the production of vitamins A and E.(38) The agricultural enhancement of vitamins A and D provides an easy way to improve public health, especially in third-world countries.(39) There are already transgenic rice and canola seed varieties producing vitamin A(40) and Arabidopsis seeds producing vitamin E.(41)

   When discussing developments in biotechnology, it becomes apparent that there is a correlation between the genetic and computer revolutions. This teamwork of computers and genes will forever alter our reality at the deepest level of human experience. From the beginning of the genetics revolution, computer languages provided the appropriate analogy for understanding the structure of biological entities and the mechanism of biological processes. Watson and Crick's studies of the molecular structure of DNA were described to the public through a computer metaphor: "cracking" the genetic code was akin to unraveling a computer program, and the discovery of the DNA molecule's double helix structure was like an explication of a computer's basic wiring diagram.(42) In 1985, physicist Freeman Dyson brought together the information and life sciences in a simple conceptual framework with the concise observation that "[h]ardware processes information; software embodies information. These two components have their exact analogues in living cells; hardware is mainly protein and software is mainly nucleic acid."(43) Today, science textbooks are rewritten to reflect the influence of computers on biology. In the popular textbook, Molecular Biology of the Cell, the authors state that

   [f]or cells as for computers, memory makes complex programs possible, and many cells together, each one stepping through its complex developmental control program, can generate a very complex adult body.... Thus the cells of the embryo can be likened to an array of little computers ... operating in parallel and exchanging information with one another.(44) The potential power of computers to decipher and manage genes became apparent in the early 1980s, when University of California at San Diego scientists made a significant biological discovery by merely reading computer printouts.(45) The researchers compared the DNA sequences of two proteins with the help of a computer.(46) One of these proteins was implicated in a type of cancer and the other in cellular growth.(47) From the computer printouts, the scientists found that the DNA sequences of both proteins were...