Background:
Over three million gene patents have been filed in the United States alone. A gene patent is a patent on a specific gene sequence, its usage, or its chemical composition. The general rule is that naturally occurring products are not patentable. Therefore, it is only after a DNA product is isolated, purified, or modified that a patent is considered.
Currently, the United States’ patent policy allows for gene patents when an inventor can (1) identify a novel gene sequence, (2) specify the sequence’s product, (3) specify the use for the product, and (4) enable one skilled in the field to use the sequence for its stated purpose. Examples of typical gene patents include genes and gene fragments, single nucleotide polymorphisms (DNA sequence variations that occur when a single nucleotide in the sequence is altered), gene tests developed to screen for disease genes in humans; specific gene binding proteins, and stem cells.
Controversy:
There is a controversy over whether gene patents advance technology by providing scientists with an incentive to create new and medically useful gene sequences, or whether gene patents actually hinder research by making it too costly.
Privately funded researchers generally advocate for gene patents, arguing that they would be unwilling to make the substantial investment in research without the ability to prevent competitors from making or using the invention without a license. Additionally, patents allow private-sector researchers to make inventions public without losing exclusive rights; thus, avoiding secrecy and promoting the dissemination of knowledge regarding genetic discoveries.
On the contrary, many research scientists who work in public institutions strongly oppose gene patents. Public-sector researchers argue that science will advance more rapidly if researchers can enjoy free access to knowledge. Those against gene patents also argue that patents could impede the development of diagnostics and therapeutics by third parties because of the costs associated with using patented research data. Furthermore, patent stacking (allowing a single genomic sequence to be patented in several ways) is a problem because researchers who want to use such a gene have to pay royalties to multiple patent owners for the use of one gene. Moreover, public-sector researchers argue that patent filings are replacing journal articles as places for public disclosure.
Another concern is that any research facility that gets federal grants (such as state universities) should not be able to patent, because they used tax-payer money to fund their research.
Potential solutions:
HUGO intellectual property committee recommends the European statutory model of a mandatory exemption from license fees for researchers, which includes all forms of research for the purpose of improving or developing knowledge. Second, HUGO suggests the establishment of a clearing house to expedite rapid and low cost licensing of patented DNA sequences which have potential applications in clinical diagnosis (such as the BRCA1 breast cancer susceptibility gene).This suggestion would be especially beneficial for companies and researchers who are developing technologies for rapid diagnosis of multiple gene variants who may need to acquire patents for large numbers of patented DNA sequences. (Some genetic testing companies, such as Navigenics, Inc., have already adopted such policies. Navigenics licenses gene patents used for risk assessment on a non-exclusive, non-discriminatory basis.)
1 comment:
The science will advance more rapidly if there is economic or political incentive for the research institution private or gvt. The scientist moves at their own place no matter what jersey they wear. Take a look at HIV drug development. Did every behave the same with access to the same information?
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