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Sunday, 31 July 2011

Gene patents: pros and cons (again)

There is a recent hot debate again about gene patents after the New York federal Judge Robert Sweet ruled that human gnee isolation is unpatentable. (2010) Seven patents involving genes and genetic diagnostic methods by Myriad Genetics were invalidated. A decade before, the United State Patent and Trademark office argued that gene sequences can be patented and it open the era of BRCA gene for breast cancer genes research and diagnostics in Europe and USA. The decision is under appealed and the European community is still unchanging but who know the future impact of this rule by the US legal system that always have a strong impact in world market.

In US patent law, the subject matter may be patentable if it belongs to one of four classes: a process, a machine, manufacture or composition of matter. It has to be new and non-obvious. In Europe, an isolated gene  from human body or produced by other technical process can be patented even if the structure of that element is identical to that of the natural element. In USA, in 1980, the Supreme court held that a human made, living, genetically modified bacterium, capable of breaking down components of crude oil was patentable. The products had to have markedly different characteristics from a product of nature. According to Judge sweet, the identification of the BRCA genes is unquestionably a valuable scientific achievement for which Myriad deserves recognition,  but that is not the same as concluding that it is something for which they are entitled for a patent. The techniques of purification and isolation of DNA are well-known to those skilled in the art and as a consequence, such claims on isolated DNA constitute unpatentable subject matter.

We will consider about the health care access, scientific research and moral issue of gene patents.
From the patent-pro stand points, patent exclusivity is needed to incentivize invention and innovation. Big pharmaceutical companies have benefited from this principle and claim that drug development and research cost them a lot. It is actually insufficient evident to conclude that patent system is the only effective system to encourage such invention and innovation.

Gene patents can limit the access to the particular gene based therapy, biologic drug and diagnostic modalities. Such restriction can increase patient burden and costs. Ethical and moral against human gene patents go further to human dignity. We are not the same as birds, flies, plants and bacteriu. It seems weird that someone can own the body of knowledge about somepart of the human, in this case, gene sequence and isolation for their own benefits. Although there is some objections of this moral argument, it is still debatable about what can be patented and what should not be patented based on different legal sets, big pharma or scientist, health care providers or people.

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