Should it be possible to patent specific genes?


As we have previously discussed, the question posed above is a highly controversial one, and there is a legal case in the U.S. — the case challenging Myriad Genetics ownership of patents on the BRCA1 and BRCA2 genes for specific types of breast cancer — which has now reached the Supreme Court (sometimes called SCOTUS by Washington insiders).

According to an article in the National Journal, the eminent justices of the U.S. Supreme Court had been scheduled to hold a discussion about whether or not to accept this case for review earlier this month, and a decision had been expected yesterday as to whether they would or would not, in fact, accept this case. However, they appear to have delayed any decision, and the National Journal states this suggests that they may feel the need for a second discussion about this case.

This may not be good news for those activists who believe that a lower court made a good decision when it originally ruled that patenting an actual gene is inappropriate because it is a “product of nature”. It is very possible that there are strong differences of opinion between the justices of SCOTUS as to whether to take this case or not. If SCOTUS decides not to take this case, then the decision taken by the last court to rule on this case will stand. This means that it would be legal to patent a gene, because, on July 11 last year, the U.S. Court of Appeals for the Federal Circuit in New York determined that the composition of matter claims covering isolated DNA and cDNA of the BRCA1 and BRCA2 genes are patent-eligible under Section 101 of the United States Patent Act.

Such a decision would delight the U.S. biotechnology and diagnostics industries. … Whether it should delight us as a society is a rather different question.

4 Responses

  1. I think it is wrong — for ethical, moral, and religious reasons.

  2. Not terribly well-informed comments:

    — I’ve read intellectual property law critiques of the case which argue that it’s not the gene that’s patented, only the biotech wizardry which tests for the specific gene. This view is controversial, and apparently too nuanced for much media attention.

    — Given the complexity of the science and technology, and the divergence of district and appeals court rulings, it would be silly for anyone to have confidence that SCOTUS would agree or disagree with any particular policy position.

  3. The idea that one should be able to patent processes associated with the identification, characterization, and modification of specific “normal” genes is already well and widely accepted. The issue revolves solely around whether an organization or an individual should be able to hold a patent that gives them use rights over a “normal” gene, i.e., one made by a plant, animal, or other organism “in the wild” (so to speak).

    So that we are very clear … As of this time, now, unless the Supreme Court reverses the prior finding of the Appeals Court in New York … use rights of all “normal” genes appear to be patentable. To change that, Congress would have to pass specific legislation to make such patents illegal.

    While Dave is correct, that there are some legal opinions out there that it is not the gene that has been patented, that is exactly what this case is all about. Other legal opinions state that regardless of the (very highly nuanced) details, to all intents and purposes the patents held by Myriad Genetics are to any actual use of the two genes in question. We can quibble over whether that is an actual patent on the gene or not, but it is certainly a patent that gives Myriad Genetics complete control over the use of that gene for any purpose other than its function within the body of an individual who is born with that gene.

    I don’t believe that I or anyone else does have any confidence that “SCOTUS would agree or disagree with any particular policy position.” Indeed, SCOTUS couldn’t and shouldn’t care less about people’s policy positions. The core question here, in my very humble opinion, is whether it is legally and constitutionally appropriate to be able to patent use rights over a “product of nature,” regardless of how one manages to achieve that effect by legal finagling.

  4. Dear Sitemaster,

    There’s no need to be humble about your opinion, since, given what you write, many will agree with you, including myself. Suppose that a gene is indeed considered to be a “product of nature,” any actual use of which is restricted, by decrees about normality, to one social entity (here: a firm). Why stop there? Why not use that as an analogy to argue that a certain group can have complete control over all members of another, carefully circumscribed, human group, for any purpose other than the exercise of some functions that the first group considers “normal”? We are on a slippery slope that perhaps we should keep away from: from biology to eugenics and, say, slavery. I don’t claim to have a solution, but my background in academic philosophy forces me to think up possibilities and thought experiments.

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