Your Genes Can Be Patented. Pros & Cons

Consider the controversy over patenting a gene: the instructions inside every living being that tell it what proteins to produce, which, for example, determine growth and affect susceptibility to disease. Knowledge of the genetic code can be of untold benefit in finding cures and vaccines. This was one of the reasons such importance was placed in charting the Human Genome. Even before the decoding was yet complete, there was a race between private sector firms to patent some 127,000 human genes or partial gene sequences. Eventually the US Patent & Trademark Office ruled that while it would grant patents for genes, it would only do so for entire sewquences and only if the usefulness of the gene was demonstrated.

Many find the whole idea of patenting genes repugnant. For one thing, the researchers did not invent anything, they merely identified what was already there. Further, the lock on knowledge resulting from the grant of a patent might impede follow on research, or even applications. Some of these fears have come true. One firm which has patented two gene mutations affecting ssusceptibility to breast cancer, has demanded that even not-for-profit labs screening for mutations pay a licence fee, thus discouraging screening

The Code of Federal Regulations, the law of the US, clearly states that anything “found in nature” is not patentable. Since genes are certainly natural things it is difficult to parse the reasoning of the US Patent and Trademark Office but I think many people misread their ruling.

A gene itself is not patentable but methods for isolating identifying and replicating it are. If the patent is broad enough, it pretty much establishes ownership.

But, this is not necessarily a bad thing since a patent must describe all details of the gene, information that would otherwise be kept locked away forever as a trade secret. Also, since all a patent does is give the holder the right to exclude others from selling it for 20 years, others are free to duplicate their efforts as long as they do not seek to take it to market.

I read of a case where some company tried to stop another from making its patented gene for basic research with no intention of marketing it and they lost in court. The court deftly sidestepped the issue of wether or not such a patent was even valid by ruling in favor of the defendant but the judge did hint that he thought such claims would not hold up under close scrutiny.