Federal judge injects some sanity into human gene patents by rejecting two

Posted on March 30, 2010

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According to the NYTimes, a federal judge has invalidated two patents on human genes, claiming that

the patents were “improperly granted” because they involved a “law of nature.”

While this decision is certain to be appealed by patent owner Myriad Genetics, it has the potential to drive widespread changes throughout the biotech industry.

Patent law doesn’t presently allow laws of nature to be patented. No-one could patent green photons, for example, or the quantum mechanical property of particle tunneling. What can be patented are devices that measure or creates green photons in a new and novel way, or that use tunneling as a means to create a new semiconductor device for electronics.

The genes in question are unquestionably natural and discovered, not created, and so its not at all a surprise that the patents were thrown out based on existing patent law. It strikes me, a non-expert, as the reasonable and correct thing to do. However, according to the NYTimes article, most experts expected that the judge would dismiss the case in favor of the patent holder instead of voiding the patents.

Here’s my guess as to why the experts would think that – identifying genes involved in disease is an expensive and time-consuming process, so allowing a patent on the gene allows the gene’s discoverer’s to reap financial rewards for the discovery. If the gene itself is patented, then any company that develops a test to identify the presence of the gene in the body would have to pay the patent holder a royalty. Similarly, any company developing drugs that target the expression of that gene in the body would also have to pay a royalty.

Another reason is that 20% of the human genome had already been patented by 2005.

But if we extend this logic, we run into a problem. Let’s say that the Gene Patent Agency (GPA) has a patent on a gene that helps the liver metabolize alcohol. Data has shown that people without this gene are more likely to become alcoholics. As the patent holder, GPA can restrict who does the testing and give the testing company a monopoly on the testing. No problem so far.

Now, let’s say that GPA gets word that GenericGeneSequencing, a company that does paid genetic profiling for scientific research into human migration, has discovered that the liver gene helps track European genotypes. GPA could potentially demand that GenericGeneSequencing stop the profiling and threaten legal action if they fail to comply, all because GenericGeneSequencing gets paid to do the research instead of doing it in an academic setting where “fair use” rules apply to the use of the gene.

Let’s go further and say that GPA licenses its gene to drug company Drugs Against Alcoholism to develop a drug that helps combat alcoholism. Drugs Against Alcoholism does a huge amount of research and develops a drug that is itself patentable that helps alcoholics combat their disease and is clinically shown to reduce the incidence of alcoholism by 80%. For reasons known only to the apparently sociopathic GPA board, they pull the license from Drugs Against Alcoholism before the new drug can be released. The new drug would be mothballed and couldn’t be sold until after the gene patent expired, condemning the country and world to more years of alcoholism-related social problems.

In both cases, I don’t think there’s a whole lot that could be done against GPA besides filing suit or lobbying Congress to have the patent protections broken.

However, if the gene patent hadn’t been granted in the first place, then Drugs Against Alcoholism and GenericGeneSequencing would be able to operate normally and a new drug that was itself patentable would be available. And as a result, scientific research and medical progress would advance unencumbered from the weight of a protected monopoly on the discovery.

I understand and even agree that we need to have a way to reward people and organizations that discover how genes affect disease and behavior, but patenting the gene itself is going too far, no matter how many individual genes are already patented. We’re not going to offer the Large Hadron Collider scientists a patent on the Higgs boson if they discover it, after all – they’d have a patent on all matter if we did, and that would be (ahem) patently absurd.

Discovery is not the same as creation, no matter how impressive the discovery. Patent the creations, not the discoveries.

Image Credit:
CDC

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