Policy Levers Tailoring Patent Law to Biotechnology: Comparing European and US Approaches
University of California Irvine Law Review, Forthcoming
65 Pages Posted: 6 Dec 2010
Date Written: April 2010
In their animated book 'The Patent Crisis and How the Courts can Solve It', Dan Burk and Mark Lemley give an account of their quest into the judicial treatment of patents in different industry sectors. They present an in-depth commentary on industry specific differences in the patent system from both a legal and economic perspective. The present article attempts to enrich the conversation by sketching the situation in Europe and providing an interesting measure for comparison. In doing so, the paper mainly focuses on the legal situation, and does not enter into the economics discussion.
The paper concludes that current European patent law holds substantial potential for technology-specific application. Even though the European Convention (EPC) may have been conceived at its inception as a nominally neutral patent statute, our study clearly reveals that substantial discretion to differ the patent system by industry, and in particular to tailor it to the specificities of the biotechnology sector, is built into the system over the years. Although the EPC was introduced as a unitary regulatory tool, intended to operate the same way across technologies, EPO case law has shown increased interest and ability in tailoring patent law to the needs of distinct technology sectors, and in particular the biotechnology sector.
Given the civil law tradition in which European patent law operates, a prevalence of well articulated macro rules openly set forth by the legislature was anticipated. However, a clear predominance of jurisprudential micro policy levers has emerged. Not all European policy levers uncovered in the present study, come to the advantage of the biotechnology industry. Closer analysis of the various policy levers, reveals that rather than systematically expanding the patent system to accommodate biotechnology inventions and stimulating innovation in the biotechnology sector, some policy levers narrow down the patent potential for biotechnological inventions, in an attempt to give echo to concerns of public health and ethical conscience.
Keywords: Biotechnology inventions, European patent law, Policy levers, Invention vs. discovery, Morality, Medical methods, First and second medical use, Expectation of success, Secondary indicia, Skilled person, Enabling disclosure, Scope, Breadth of claims, Research exemption, Compulsory licensing
JEL Classification: D23, D45, H 41, H51, I18, K11, L14, L4, L 65, O13, O31, O32, O34
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