Sunday, November 26, 2006

Gene Patents

Today's Parade magazine has an article titled "How Gene Patents are Putting Your Health at Risk". The topic of gene patents deserves public scrutiny & debate, but better coverage than this article.

Featured prominently (with a picture in the print edition) is Michael Crichton, whose new book has been touched on previously in this space. Crichton in particular makes a number of concrete statements, some of which are a bit dubious.

First, let's take the statement
A fifth of your genes belong to someone else. That’s because the U.S. Patent Office has given various labs, companies and universities the rights to 20% of the genes found in everyone’s DNA— with some disturbing results.
. The first sentence is just plain wrong, and given its inflammatory nature that is very poor journalism. Nobody can own your genes -- genes, as natural entities, are not themselves patentable. What can be patented are uses of information in those genes. That is a critical, subtle distinction which is too often lost. What can be patented are uses for genes, not the genes themselves, just as I could patent a novel use for water, but not water itself.

Time for the full disclosure: I am a sole or co-inventor on 11 issued gene patents (e.g. U.S. Patent 6,989,363) , many of which are for the same gene, ACE2. Many more gene patents were applied for on my behalf, but most have already been abandoned as not worth the investment. Those patents attempted to make a wide range of claims, but interestingly they missed what may be the key importance for ACE2 (we never guessed it), which is that it is a critical receptor for the SARS virus.

Many of the gene patents do illustrate a key shortcoming of current patent law. When filing a gene patent, we (and all the other companies) tried to claim all sorts of uses for the information in the gene. These sorts of laundry lists are the equivalent of being able to buy as many lottery tickets for free. A rational system would penalize multiple claims, just as multiple testing is penalized in experiment designs. The patent office should also demand significant evidence for each claim (they may well do this now; I am no expert on the current patent law).

Another one of Crichton's claims deserves at least some supporting evidence, plus it confuses two distinct concepts in intellectual property law
Plus, Crichton says, in the race to patent genes and get rich, researchers are claiming they don’t have to report deaths from genetic studies, calling them “trade secrets.”

First, just because some idiots have the chutzpah to make such claims doesn't mean they are believed or enforceable. Second, such claims have nothing to do with gene patents -- such claims could exist in any medical field. Finally, trade secrets and patents are two different beasts altogether. In a patent, the government agrees to give you a monopoly on some invention in return for you disclosing that invention so others may try to improve on it; a trade secret must be kept secret to retain protection and should someone else discover the method by legal means, your protection is shot.

The on-line version also includes a proposed "Genetic Bill of Rights". I would propose that before enacting such a bill, one think very carefully about the ramifications of some of the proposals.

Take, for example,
Your genes should not be used in research without your consent, even if your tissue sample has been made anonymous.
. What exactly does this mean? What it will probably mostly mean is that the thicket of consent hurdles around tissue samples will get thicker. Does this really protect individual privacy more, or is it simply an impediment which will deter valuable research? Will it somehow put genetic testing of stored samples on a different footing than other testing (e.g. proteomic), in a way which is purely arbitrary?

Another 'right' proposed is
Your genes should not be patented.
First, an odd choice of verb? "Should"? Isn't that a bit mousy? Does that really change anything? And what, exactly, does it mean to patent "your genes"?

On the flip side, I'm no fan of unrestricted gene patenting. All patents should be precise and have definite bounds. They should also be based on good science. Patents around the BRCA (breast cancer) genes are the most notorious, both because they have been extensively challenged (particularly in Europe) and because the patent holders have been aggressive in defending them. This has led to the strange situation in (at least part of) Europe where the patent coverage on testing for breast cancer susceptibility depends on what heritage you declare: the patent applies only to testing in Ashkenazi Jews.

In a similar vein, I can find some agreement with Crichton when he states
During the SARS epidemic, he says, some researchers hesitated to study the virus because three groups claimed to own its genome.
It is tempting to give
non-profit researchers a lot of leeway around patents. However, the risk is that some such researchers will deliberately push the envelope between running research studies and running cut-rate genetic testing shops. Careless changes to the law could also hurt companies selling patented technologies used in research: if a researcher can ignore patents for genetic tests, why not for any other patented technologies.

Gene patents, like all patents, are an attempt by government (with a concept enshrined in the U.S. Constitution) to encourage innovation yet also enable further progress. There should be a constant debate as to how to achieve this. Ideas such as 'bills of rights', research exemptions, the definitions of obviousness and prior art, and many other topics need to be hashed over. But please, please, think carefully before throwing a huge stone, or volley of gravel, into the pool of intellectual property law.

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