Academic journal article Houston Journal of International Law

The European Controversy over Genetic-Engineering Patents

Academic journal article Houston Journal of International Law

The European Controversy over Genetic-Engineering Patents

Article excerpt

I. Introduction

While the United States has strengthened its global position as a provider of technology through industry-friendly patent policies, Europe has settled for being a mere recipient of technology.(1) This has become especially true for the biotechnology industry because of the European Union's (EU) burdensome regulatory constaraints and lack of reliable intellectual property protection.(2) Long delays in product approval and inadequate patent protection make businesses reluctant to invest in biotechnology projects.(3) European biotechnology companies are becoming increasingly frustrated with the confused state of the European Community's (EC) patent regulations.(4) As a result, companies have decreased their biotechnology investments in Europe, creating the danger of "delocalization" of these investments towards the United States or Japan.(5)

Biotechnology has great potential to increase Europe's rank in industries such as the agrichemical, pharmaceutical, and food and drink sectors -- areas in which Europe has traditionally been strong.(6) For this to happen, Europe must adopt policies attractive to biotechnology companies and assure reliable patent protection for biotechnology inventions.(7) Biotechnology and pharmaceutical research is extremely risky and expensive.(8) Thus companies will only invest in high-risk projects if they can be assured of adequate intellectual property protection.(9) The problems facing European biotechnology patent policy need to be resolved quickly if the European biotechnology industry is going to survive.(10)

Over the last decade the development of European patent policy concerning biotechnology has been impeded by slow-moving bureaucracies and by disputes over ethical, environmental, and economic issues.(11) A proposed biotechnology directive has been stalled for nine years due to opposition in the European Parliament (EP).(12) The European Patent Office (EPO) has contributed to the confusion by issuing seemingly inconsistent opinions concerning the patentability of genetically engineered plants and animals.(13) In addition, EC member states have been very slow to implement new regulatory directives regarding the testing of new biotechniques.(14) Current European patent law is thirty years old and is based on statutes which were drafted at a time when current technology could not exists for reformation of European patent law and for a directive on protection for biotechnology inventions.(16)

This comment examines the current legal state of European patent law concerning genetically-engineered organisms. Part II tracks early unsuccessful efforts by the United Nations (U.N.) and other international organizations to harmonize European patent law. Next, it examines the application of the European Patent Convention (EPC)(17) to the grant of plant and animal patents. Particular emphasis is given to two recent, seemingly contradictory, EPO decisions which cast doubt on the possibility of patent protection for biotechnological inventions. Part III provides an account of the most recent developments in European biotechnology patent policy, and highlights the current disputes within the EU and the challenge of the current lifeform patents before the EPO. Finally, the conclusion lists the issues that must be resolved by the EU and the EPO in order to give adequate patent protection to biotechnology inventions, to harmonize European patent law, and to stimulate the biotechnology industry on a global level.

II. Development of European Animal Patent Law

A. Early Efforts to Harmonize European Patent Law

Prior to 1973, when the EPC was established, European patent law was completely dependent upon the laws of each individual European country.(18) To protect their inventions internationally, inventors were required to invest large amounts of time and money in their attempts to get protection in each jurisdiction, while ultimately receiving protection in only a fraction of those jurisdictions. …

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