Band 2, Heft 6

In their fundamental overview on intellectual property and biotechnology, Victoria Jimenez and Dennis Fernandez not only deal with the top-10 most common intellectual property rights mistakes during venture capital due diligence, but also present a basic analysis of IP strategy in biotech. The article also discusses IP problems related to genomics, proteomics, pharmacogenomics, bioinformatics, biochips, and, last but not least, emerging technologies such as nanotechnology or biogenerics, and therefore provides an ideal tool for all those who are interested in the role of intellectual property in the field of biotech.

Why protect Intellectual Property? Intellectual property (IP) refers to a legal entitlement, which sometimes attaches to the expressed form of an idea or of other intangible subject matter. The most well known forms of IP include copyrights, patents, trademarks, and trade secrets. IP rights are protected under various federal and state laws, as well as international treaties. Without this protection, IP would fall into the public domain and be used by any party without a license. Therefore, a sound management strategy should systematically build a portfolio consisting of different IP rights, with the aim of protecting the various aspects of the company’s technology and commercial interests.

Introduction Of the issues that confront modern science and the imperatives for development and human progress today, none is more controversial than biotechnology. As one author notes, within ‘a few short decades, the powerful means of biotechnology have revolutionized medicine, agriculture and environmental protection’. The potential implications of biotechnology transcend science and the environment and impact directly on the liberalisation of international trade, the protection of intellectual property rights, the right of self determination of indigenous populations and as custodians and owners of centres of biodiversity, and indeed on international relations generally. Advocates of biotechnology argue that the modification of the genetic make-up of living organisms is nothing new and that biotechnology has been part of human agricultural practices for centuries.

Introduction Indigenous Peoples’ struggle to be acknowledged as autonomous groups has found international legal support in the ILO Convention 169, which many Latin American countries have ratified. The way by which regional constitutional jurisprudence has reconstructed the foundations and scope of this right to self-determination seems, however, quite controversial. Firstly, taking Colombian constitutional jurisprudence as an example, I discuss both the acceptability of the restrictions the Constitutional Court has fixed to groups’ self-determination and the acceptability of defining them as collective subjects. Having in mind a better understanding of group-differentiated rights, I examine, secondly, how the conditions of the ILO Convention regarding the informed consent from indigenous groups should be satisfied when group-based genetic research is to be developed.

The supply problem The examples of sponge-derived compounds in advanced stages of clinical trials presented in part I of this article emphasize the potential of sponges as auspicious source for drugs against various human diseases. However, compared to the vast number of over 4000 compounds isolated from sponges during the last three decades, the number of sponge-derived drugs that have already entered the market is surprisingly small. There are two major reasons for this phenomenon: One is the extremely long time frame involved in the process of drug development. For instance, to develop the famous anticancer drug Taxol® from its initial description in the yew tree to its approval as a commercial pharmaceutical took over 20 years. The presented examples of sponge-derived compounds in clinical trials, this long time frame is by far no exception. Thus, as many interesting compounds were initially reported already in the 1980s and early 1990s, there is hope that within the following years the number of commercially available ”marine drugs” will considerably increase.