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Gene Patent Guidelines

The United States Patent and Trademark Office has issued guidelines aimed at stopping companies from making frivolous attempts to patent genes before they have established a particular use for them. These guidelines have barely changed from interim rules that were issued a year ago by the PTO. The rules are intended to help end a bitter debate on gene patenting. These regulations have put to rest any question about whether genes can be patented at all -- making it clear that companies may indeed patent both whole genes as well as pieces of genes, though genetic sequences (known as ESTs) are not patentable. 

The PTO indicated through a press release that the new guidelines have added a further hurdle prior to anyone receiving a patent. To show "utility," an applicant had to prove that the discovery had credible and specific uses. Now the patent filer must also show that use is what is known as a "substantial use". This may curb many companies from racing to file a patent immediately after isolating the DNA/gene; a specific use must also accompany the application. 

The implications are vast for this ruling. Several companies who have been heavily involved in the race to sequence the human genome have to consider how to move forward, as well as some already established companies that exist solely on the work of a few patents, who have developed genetic tests based upon their discoveries. The PTO’s ruling protects these companies, although any future applications that are discovered based upon a patented gene may become separate patents that could be owned by competitors. 

Many arguments against patenting of any genetic material were heard, mainly based upon the premise that genes are part of nature and have not been invented by anyone, thus should not be owned by anyone. The PTO firmly rejected this notion based upon the fact that a gene may be removed from a person, then a clone of that gene may be made in a machine, which is then not a part of nature, but a product of the lab. 

So far, many companies, as well as the government have applied for patents on thousands of human genes. It appears to be only a matter of time before these thousands of patents are awarded.