|
|
|
Patenting of Isolated Genes and DNA Sequences
The genes that are synthesized artificially, normally fulfil the requirements of patents and, therefore, have no difficulty in getting patent protection. If the protein, which an artificial gene makes, and the organism into which the gene is inserted are also novel having desirable attributes, such a patent may extend to the protein and the organism also. Thus the patents involving artificial genes and novel higher organisms (plants or animals) are relatively straightforward.
During 1990s, one of the most widely discussed political issue in biotechnology concerned patenting of naturally occurring useful genes, because they do not fulfil the requirement of novelty (they are only discovered, not invented and for a patent, invention rather than discovery is necessary).
|
The developing countries have been arguing that patenting of naturally occurring genes will allow the developed countries to make use of a weed from their land, isolate a desirable gene from this weed, transfer it to a commercial crop and then sell it back to the same country (which was the source of the gene).
There are counter-arguments, that companies should be rewarded for their investment and labour involved in making the natural genes useful, which may otherwise never be exploited for human welfare.
The law on the above issue is both confusing and changing through judgements on disputes by disputes by courts. However, the law in U.S.A allows patent on purified form of a chemical, if in nature it occurs in an unpurified form.
In UK, on the other hand, the courts held that a naturally occurring gene sequence can not be patented. It is, however, now certain that in U.S.A and some other developed countries, patents will be allowed in future for genes isolated and cloned from nature.
An example of such a patent granted involved cloning of a DNA fragment, which originated due to mutation in a microorganisms and imparted resistance to the herbicide glyphosate.
|
The gene was patented by Calgene Inc. in USA in terms of a DNA sequence containing the relevant structural gene that is intended for integration into plants to confer glyphosate resistance.
Increasing number of such patents are now appearing particularly in USA, Europe and Japan. Whether a patent claim for a DNA sequence can protect its expression product (proteins) also needs to be seen. In case of plants, a patent for a DNA sequence will protect the transgenic plants carrying this sequence.
Therefore, whenever a patent for a gene is allowed, biotechnology companies would like the protection to extend to the marketed products. This area of IPR in biotechnology will receive further increased attention in coming years.
|
|
In 1992, the question of patenting isolated genes or DNA and cDNA sequences was discussed in USA, due to an application on behalf of National Institute of Health (NIH), USA, filed for patenting hundreds of cDNA sequences. The main issue for discussion was whether these sequences are useful as required in patent statute (35 USC 101).
This requirement, in 1966 (Brenner vs Manson, US Supreme Court, 148 USPO 689, 1966) was interpreted to mean that in the process or product to be patentable, there should exist a specific benefit in currently available form.
Subsequently the word useful was interpreted to mean practical utility. Many of the isolated genes may not offer specific benefit in its currently available form and may not be of practical utility.
|
|
|
This will render them unpatentable, and my discourage research in this area. Despite the above requirement, isolated genes, vectors and transformed cells expressing the hormone- angiogenesis factor (AGF), which increases. vascularization, have been allowed patent. This patent was allowed, even though at the time of application (1985), AGF did not really have practical utility for therapy or for diagnostic tests.
Many other patents of isolated genes are similar in nature and their validity may be questionable, if challenged in a law-suit. Such law suits, challenging the validity of patents for isolated genes already granted, will settle this issue in future.
Patenting in such cases may be necessary to encourage research leading to isolation of genes, which if patented, will be available to other researchers and it not patented will be kept a secret. Therefore, patent applications for isolated genes may in future, either face a rigid attitude asking for specific practical utility in its currently available form or may receive a relaxation in view of its utility in immediate research with future potential of practical utility.
|
| |
