BIOTECHNOLOGICAL INVENTIONS AND LIMITS OF PATENTABILITY BETWEEN RECENT EVOLUTIONS IN THE US CASE LAW AND THE EU PERSPECTIVE OF FUNDAMENTAL RIGHTS: MOVING TOWARD A COMMON “WESTERN APPROACH”?

The paper analyzes the forms and limitations of patent protection recognition for biotechnological inventions. In this perspective, the paper compares the American model, traditionally based on technical evaluations, and the European model, inspired by fundamental rights. Intellectual property law, and especially biotechnological patent law, in fact, often involves and/or faces off with the exercising of fundamental rights. In particular, the issues analyzed and the considerations proposed highlight how the regulation of biotechnological inventions should guarantee a fair balance between protection of investment and access to information which is essential for research and innovation. In this framework, the recent US Supreme Court decision in Myriad and Mayo (and the subsequent USPTO Patent Eligibility Guidance), along with the European ECJ’s decision in Brüstle and that of the EPO in WARF, appears to lead toward a common “Western approach” to the regulation of biotechnological inventions, with specific regard to the limits of patentability. Such an approach could be based, indeed, on the balance of fundamental rights and public and private interests, which are relevant on a case-by-case basis, resorting to the criteria of hierarchy and proportionality in order to regulate value-based choices and functional interactions between them. Finally, the same approach would be particularly relevant to the current perspective, which is aimed at enhanced transatlantic cooperation on the matter of intellectual property, specifically within the framework of the “Transatlantic Trade and Investment Partnership”(TTIP) that is presently being negotiated.