GENETIC INVENTIONS, INTELLECTUAL PROPERTY RIGHTS AND LICENSING PRACTICES: EVIDENCE AND POLICIES

Since 2002, OECD has been discussed on it:

Organisation for Economic Co-operation and Development (OECD) yang berdiri sejak 30 September 1961 beranggotakan 30 negara industri di Eropa dan Amerika, termasuk Australia, New Zealand, Turki, Jepang, dan Korea. OECD melakukan kajian yang secara singkat dapat dikenali melalui kutipan, dari laporan setebal lebih dari 100 halaman, sebagai berikut: The most influential critics of the present system are not against intellectual property rights, technological change and scientific advances in principle, but they feel a certain reticence (=kegamangan) about genetic inventions.

For some, the issue is mostly ethical, a dislike of associating property rights with biological materials, especially if they are human. To others, genes are part of the “common heritage of humanity” and should only be public property. There are arguments that DNA does not meet the legal criteria for patentability.

If genes are “nature identical materials” and the identification of their utility lies more in the area of a discovery than an invention, for example, they should not be patentable. Others argue that DNA sequences are not simply chemical compounds but also strings of information and that the genome should be viewed as a huge database whose information should be available to all.

Still others feel that the peculiar character of the genome warrants special consideration. The finite nature of the genome – the relatively small number of human genes and the limited genetic variation between species – might call into question the assignation of property rights. It is feared that within a rather short period all of the 30 000–40 000 human genes could be patented and that their owners would be the beneficiaries of huge “reachthrough rights” on the many uses of these genes yet to be discovered.

Finally, gene patents are said to be special because the book of life is very hard to “invent around” making these patents stronger than in other fields.

Focusing on the practical implications of DNA patents, academic researchers, clinicians, patient groups and even pharmaceutical companies have warned about the possible side effects of a proliferation of gene patents. Their concerns have to do with the cost, pace and efficiency of research, as well as the downstream development and uptake of new genetic technologies by commercial users and health care providers.

Perhaps the best way to summarise these practical concerns is to call them “access issues”. Such groups worry that the removal of research resources (i.e. nucleotide sequences) from the public domain will impede the follow-on research efforts necessary to make genetic information useful. In the words of a recent USPTO paper:

“Many feel that by allowing genetic information to be patented, researchers will no longer have free access to the information and materials necessary to perform biological research. This issue of access to research tools relates to the ability of a patent holder to exclude others from using the material. Further, if a single patent holder has a proprietary position on a large number of nucleic acids, they may be in a
position to ‘hold hostage’ future research and development efforts.”

[Clarke, J., J. Piccolo, B. Stanton and K. Tyson (2001), “Patent Pools: A Solution to the Problem of Access in Biotechnology Patents?”, Unpublished USPTO paper; www.uspto.gov/web/offices/pac/dapp/opla/patpoolcover.html].[setkbn0209]