Rights Theory, Current Events

Patents, Property, and Genes

Yesterday the Supreme Court heard oral arguments about whether human genes may be patented. The case centers on a dispute between a group of researchers and patient advocates and Myriad genetics. Myriad is a company that holds patents on genes (BRCA1 and BRCA2) that correlate for a significantly increased risk of breast and ovarian cancer. Myriad claims that they can permissibly patent the ‘isolated’ BRCA genes because they are the product of their own investment and research. By isolating the genes, Myriad claims they are creating something new out of something natural—like carving a baseball bat from a branch. Critics point out that a more accurate analogy is that Myriad has created a mode of discovery (like a telescope) and used the discovery method to patent the thing in nature that it has discovered (as if Galileo had tried to patent Jupiter). It looks like much of this dispute will therefore come down to whether isolated genes are considered a discovery or a new product.

But even if isolated genes are more like baseball bats than Jupiter, I still doubt that Myriad should be permitted to patent genes. This is because I am generally skeptical of the argument that inventors have strong pre-political claims to not be copied, in contrast to the claims they may have over their actual creations. Intellectual property enforcement requires state interference with everyone who copies an idea. To justify pre-political intellectual property claims, it would need to be the case that copiers violate inventors’ rights to not be copied even though they do not interfere with inventors and that this violation is so morally serious that state intervention is warranted. Both claims are dubious.

The moral justification for intellectual property claims must therefore be explained by something else, like the claim that there is market failure for certain kinds of innovation so the government or another organization must step in to promote innovation in those fields through patents. These instrumentalist property claims are only justified when interfering with would-be copiers is the only way to encourage innovation. If there were other ways to promote innovative research without interference then we should favor those strategies (Thomas Pogge makes a similar point in his discussion of libertarianism here).

In this case, it is unclear whether patents for genes promote or hinder innovation. On one hand there is some evidence that patents don’t stand in the way of innovation, but on the other hand they may hinder innovation in this case. Even if gene patents do not discourage innovation, enforcement may also be unnecessary. It seems that the patent system for pharmaceuticals alone could provide incentives to develop diagnostic tools even if diagnostic developers couldn’t patent genes (especially given the FDA’s relatively new policy of offering approval for targeted drugs that are accompanied by diagnostic tests).

A deeper worry about this case is that it looks like Myriad is preventing patients from learning about their own bodies. If I learn that lumps are a sign of breast cancer and I invent a device that can detect lumps, it would be wrong for me to prevent patients from using other devices or self-exams in an effort to discover potential tumors in their own bodies. Similarly, even if Myriad has some claim to its way of identifying BRCA, it seems wrong to prevent patients from learning about potential breast cancer risks in their own bodies from other providers. Myriad may have a claim to the process of detection that they use and their data about the genes, and this may help them to maintain their advantage in the marketplace without a patent on the gene. Still, providing a patent only on Myriad’s process would not effectively protect their monopoly on BRCA testing and would give patients more options to learn about their own genomes.

This strikes me as the strongest argument against Myriad. Patients have rights to know about their own bodies. Back in the bad old days, before informed consent, doctors barred patients from learning about their medical conditions. Now patents prevent patients from learning about their own bodies unless they pay Myriad for the knowledge. Holding a monopoly on information about a person’s own body is like telling a patient that she must pay $4000 for a specific mammogram service and that if she uses some other device or service she and her provider face legal penalties.

I am also skeptical about Myriad’s claim given that one cannot patent a person’s whole genome. Why would it be it legal to patent a single gene but not a genome? I’m obviously not an expert in genetics, but why is one isolated gene considered an innovation but all the genes independently identified is not? If companies are not permitted to patent an individual’s genome, then they also should not be permitted to patent parts of those genomes. I also wonder whether the Myriad patent could legally limit a person from getting her whole genome sequenced? If not, why wouldn’t patients just do that and then look for the BRCA mutations? Especially considering that genome sequencing now costs about as much as BRCA testing.

Despite all those concerns, I do see the reasons behind Myriad’s claim and I recognize the importance of encouraging medical innovation. So I’m curious to hear what others think about this issue. Could a ruling for Myriad limit people’s access to genome sequencing? Which ruling would be better for medical innovation? Is there such a thing as natural intellectual property rights?

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Author: Jessica Flanigan
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