Bill to Block Gene Patents
Nature Reviews: Drug Discovery
March 2007; 178-9

Bill to block gene patents
by Joanna Owens and Charlotte Harrison

The spectre of patenting natural phenomena is brought to the fore again by proposed new gene patent legislation. If enacted, the Genomic Research and Accessibility Act introduced by Republican representatives Becerra and Weldon would prevent the patenting of any and all portions of the human genome. The Bill will not affect patents that have already been granted.
The new legislation proposes that human genetic material, naturally occurring or modified, should not be patentable. Specifically, the Bill H.R.977 makes an amendment to Title 35 of the US Code and would state that: "No patent may be obtained for a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies."
After the human genome sequence was published in 2001, there was a rush of patent applications claiming the identification of genes with only putative evidence of their function. Now, the US Patent and Trademark Office (PTO) has tightened its stance on this, but it is still possible to patent a gene outside its biological context. This means that if you purify, clone, synthesize or alter nucleic acid from its naturally occurring state then you can obtain a patent on that gene in its altered, unnatural form. However, under this proposed new legislation it is unclear whether this will still be possible. The implications for the drug industry if this Bill is enacted will be profound.
In a press statement outlining the Bill, Becerra and Weldon point out that 20% of the human genome has already been patented. They aim to ensure it stops there, saying that the practice of gene patenting violates the spirit of the Human Genome Project and hinders the discovery of medical breakthroughs. They claim that the new Bill will not stifle invention, but that: "Incredible manifestations of intellectual property will result: medicines, machines, processes ... all worthy of a patent." Opponents of the Bill say that the return on investment required for companies to turn genomic information into new drugs must be recognized.




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