Gene Patents and Genetic Testing

by Dr. Hsien-Hsien Lei
Posted April 29, 2008 in DNA Testing, DNA and the Law

The European Society of Human Genetics (ESHG) has published recommendations on gene patents as applied to genetic testing in the European Journal of Human Genetics. The chair of the working group, Professor Gert Matthijs of the Catholic University of Leuven, said:

This new proposal aims to reconcile what until now have appeared to be conflicting interests patent owners, commercial companies, health authorities, policy makers, geneticists with the ultimate goal of ensuring that patients retain access to the latest technological advances.

Key points include:

1. Patents benefit society through innovation and promoting progress.

2. The definition of “invention” vs. “discovery” with the identification of genes, mutations, links between genetic defect and disease are deemed to be discoveries by some and thus would be unethical to patent.
3. Patenting novel technical tools for genetic testing is a good way to promote investment and allow for invention.
4. Genetic tests that examine a panel of genes will be impacted negatively by gene patents.
5. Genetic tests combined with protein or metabolite measurements will also have to consider multiple patents.
6. Patent applications do not take into account clinical validity and utility.
7. There are international differences in patent systems which affect the availability of genetic services worldwide.
8. Gene patents are overly broad and include not just the sequence but also protein and antibodies, etc.

Access to genetic testing can be impeded every step of the way from the discovery of new genes and mutations all the way up to availability of genetic tests. Right now, most of us concentrate on who has the right to have a genetic test and how. Another consideration clearly has to be who will develop the genetic tests and what intellectual property rights they have over their work.

As Michael Crichton said in a New York Times op-ed against gene patents:

Gene patents are now used to halt research, prevent medical testing and keep vital information from you and your doctor. Gene patents slow the pace of medical advance on deadly diseases. And they raise costs exorbitantly: a test for breast cancer that could be done for $1,000 now costs $3,000.

Should we prohibit the patenting of genes? Take the poll in this previous Eye on DNA post.

(5 comments)

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5 Comments

Comment by Kevembuangga

2008-04-29 14:51:05

Ya must change something in the blog config, under an Opera 8.51 browser there is no feedback of the comment being sent.
The page doesn’t even refresh to the previous blank status, it appears frozen.

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Comment by Kevembuangga

2008-04-30 15:16:11

Ach! so!
The page didn’t just appear frozen, my comment was truly lost, here it is.
——————————————
It could also very well be that for all the hoopla about genetics it is not really an economically viable domain.
See at the end of this BBC article:

“Genetic engineering is completely out for producing high-strength polymers – it’s just much too expensive,” he told BBC News.

“You have to have very precise environmental controls, you have to have very pure chemicals, you have to have a single strain genetically engineered bug – all that is just a recipe for capital and energy intensivity.”

Likely the same applies for medical purposes with the added cost of litigations, GRIN…

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Comment by Hsien-Hsien Lei, PhD

2008-04-30 15:19:18

Kevembuangga, Thanks for coming back and leaving the comment again! Darn computers never behave the way they should.

The thing about genetics is that there are many different applications. Genetic testing itself has clearly proven its utility but when it comes to genetic engineering or gene therapy, it’s a much more difficult road to travel.

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Comment by Simon Lin

2008-05-01 00:54:14

Are there patents around the SNPs identified from various GWAS studies? Such as those used by both 23andme and Navigenics in their claims??

When the human genome was about to finish, there were a lot of discuss of patents on if we should patent gene sequences.

But how about the SNPs widely used nowadays?

Simon Lin, MD

http://retail-genomics.blogspot.com/

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Comment by online doctor

2008-07-06 16:00:36

Allowing patenting of genes (like any other item) promotes investment of time and money a prospective patentee would put into innovation? The question is if a gene is like any other item…

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