Patenting isolated and synthetic genes

I'm taking a bioethics class this semester. Thus far it has focused mainly on the problems with our current organ transplant system and on the concept of informed consent. Actually, I am probably going to write a very long paper on informed consent so if anyone has any thoughts on this subject I'd love to hear about it. Each week we have to write "policy positions" on that week's topic. This week we are moving into patents on genes. This is a highly controversial thing. Currently, you can receive a patent on any isolated gene. Hypothetically, this means it would be a possible for receiving a patent on haemoglobin if you were the first to isolate it. Almost everyone within academia thinks it is a bad idea, but every big pharmaceutical company thinks it's necessary. I think it's a bad idea. For a variety of reasons (most of which I don't go into because I am word limited on this exercise), but principally because the evidence doesn't support the pharmaceutical and biotechnology sector's argument that the patents are necessary to support development. It's a long read, but I think it ties together well. Cheers

Proposed Legislation:

"The Genomic Research and Accessibility Act was introduced in the U.S. House of Representatives by a Republican and a Democratic Sponsor early in 2007. The Act provides: Notwithstanding any other provision of law, no patent may be obtained for a nucleotide sequence, or its functions or correlations, or the naturally occurring products it specifies. H.R. 977, 110th Cong., 1st Sess. (2007)."

Response:

Because the language of the proposed statute is too broad I could not support it. However, this is not to suggest that the idea of gene patents is not in need of both reform and definition - only that the proposed statute, as worded, would cover too wide a range of gene products. Additionally, the statute is unnecessary because traditional patent theory is sufficient to address problems in biotechnology development.

In traditional patent theory both things of nature and abstract ideas are unpatentable. As extreme examples, neither water, a thing of nature, nor the Pythagorean theorem, an abstract idea, can be patented. The rationale is that patent systems are supposed to promote invention, not elucidation. But this can become complicated quickly. For example, could Q2O - quadrium or super-duper-heavy water - or ununennium - a synthetic element - neither of which exist “in nature” be patented? A nucleotide is any nucleoside (a purine or pyrimidine base attached to a sugar) attached to a phosphate group. When bound together as chains they can be either DNA or RNA. Functionally, the difference between the two is that DNA acts as a massive reference library for storing genetic information and RNA is a transcript of that information. Like the reference section of a library DNA must be copied to be used somewhere else. RNA functions as this copy as is used directly to make protein and other gene products. Ultimately, the sequences of both DNA and RNA are directions for the synthesis of gene products - the language of which is a particular nucleotide sequence. A specific sequence of nucleotides that produces a product is called a gene. The collection of all the genes of an organism is its genome.

But while organism do not exist without some sort of “nucleotide sequence” those nucleotide sequences, DNA and RNA, are simply molecules - compositions of atoms covalently bound together. Many molecules do not exist in nature, require an “inventive step”, and can be protected by patents. Thus, it is not inconceivable that specific sequence of nucleotides (a gene) could be created that do not exist in nature. Because of the broad language of the statute these novel genes would not qualify for patent protection. This is problematic because if there is no incentive for economic gain then it is reasonable to conclude that biotechnology companies would be less interested in funding development in that field.

But there is clear need for reform. In both Europe and the US (ignoring Warner-Lambert co. v. FTC), patents are being issued for wholesale human genes. These are not novel genes, nor genes that have been manipulated to have unique characteristics, but genes that exist naturally in populations of people. Thus, biotechnology companies are receiving patents not for invention, but for discovery.

On its face this may not be problematic. Perhaps the prohibition on things of nature and abstract ideas is mere dogma, and expansion of patent theory would yield more utility. Biotechnology companies are already arguing that this protection is necessary to spur progress, that without the economic incentives of patent protection they would be disinclined to invest in research. But without evidence that loss of patent protection for discovery of genes would make the field stagnant, statements that it would are little more than untested hypotheses. In fact, the evidence seems to be pointing to the opposite conclusion. Rates of development of truly novel drugs is in decline. Furthermore, the pharmaceutical industry has become focused almost entirely on “blockbuster” drugs and drugs that have the potential to generate over a billion dollars in revenue yearly, only. Indeed, the data suggests that even though patent protection has become more expansive that biotechnology and pharmaceutical sectors have become stagnant in terms of invention.

But I do not want to give the impression that this argument is entirely without merit. It is reasonable to suspect that without some sort of protection companies would be disinclined to invest in biotechnology development which is admittedly expensive. Furthermore, society presumably gains from patents because of disclosure. Ultimately, a balance should be struck whereby patents are strong enough to actually promote development, but not so strong that companies can strangle competition.

This is particularly true in reference to biotechnology. Advances in biotechnology mean alleviation of disease and suffering, and have global implications. What then is the appropriate balance? While ultimately it is a matter of evidence, for the time being, I think the best solution is to maintain the teaching of traditional patent theory, but with the goal of weakening patent protection over time. Genes should be patentable if they meet the criteria for novelty, utility, and non obviousness. Isolated genes do not meet this criteria, but synthesised genes do. Consequently, because patent theory addresses the non-patentability of isolated genes, and because the proposed legislation is seemingly overbroad anyway, I would not support it.