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

The development of appropriate intellectual property protection for biotechnology 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 tissue-plasminogen activator (t-PA), a therapeutic protein drug. This recent litigation is important because of the apparent coincident invention of t-PA and variants in different laboratories. Such developments arise as many major R&D efforts are directed at common therapeutic goals. This study focuses on the issues of non-obviousness and scope with respect to both the invention itself and the production of second generation and subsequent compounds that may readily be created by the application of powerful recombinant DNA techniques. Three companies, Genentech (San Francisco, CA, USA), Wellcome (Beckenham, UK) and Toyobo (Otsu, Shiba, Japan) were involved in three separate court actions over claims to recombinant t-PA. We demonstrate that biotechnology patents with broad claims have been upheld and as a consequence have led to the curtailment of modified variants with potentially useful pharmacological properties. There is, therefore, a clear need for public policies which address these complex issues. We argue that such policies should both reward the inventor and facilitate maximum exploitation of this limited natural biological resource by greater specificity of patent claims.