PATENTING OF RECOMBINANT PROTEINS - AN ANALYSIS OF TISSUE-PLASMINOGENACTIVATOR (T-PA) IN EUROPE, THE UNITED-STATES AND JAPAN

The development of appropriate intellectual property protection for bi otechnology is crucial for the industries which apply and develop it. This paper examines the issues concerning the patenting of recombinant proteins by analysing the recent judicial decisions relating to tissu e-plasminogen activator (t-PA), a therapeutic protein drug. This recen t litigation is important because of the apparent coincident invention of t-PA and variants in different laboratories. Such developments ari se as many major R&D efforts are directed at common therapeutic goals. This study focuses on the issues of non-obviousness and scope with re spect to both the invention itself and the production of second genera tion and subsequent compounds that may readily be created by the appli cation of powerful recombinant DNA techniques. Three companies, Genent ech (San Francisco, CA, USA), Wellcome (Beckenham, UK) and Toyobo (Ots u, Shiba, Japan) were involved in three separate court actions over cl aims to recombinant t-PA. We demonstrate that biotechnology patents wi th broad claims have been upheld and as a consequence have led to the curtailment of modified variants with potentially useful pharmacologic al properties. There is, therefore, a clear need for public policies w hich address these complex issues. We argue that such policies should both reward the inventor and facilitate maximum exploitation of this l imited natural biological resource by greater specificity of patent cl aims.