DNA Poll: Patenting Genes

DNA Poll: Patenting Genes

by Dr. Hsien-Hsien Lei
Posted July 11, 2007 in DNA Podcasts and Videos, DNA and the Law, Polls About DNA

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Yesterday, the Genetics & Public Policy Center at Johns Hopkins hosted GenePOPS — Who Owns Your Genes? Intellectual Property and the Human Genome. Panel members included:

  • Barbara Caulfield, executive vice president & general counsel for Affymetrix, Inc.
  • Robert Cook-Deegan, director, Center for Genome Ethics, Law & Policy, Institute for Genome Sciences & Policy, Duke University
  • Steve Haro, senior advisor & communications director, Office of U.S. Representative Xavier Becerra
  • F. Scott Kieff, associate professor of law at Washington University, St. Louis, and fellow at the Hoover Institute, Stanford University

Slides from Robert Cook-Deegan and F. Scott Kieff’s presentations are available and ScienceDaily has coverage of the event. I was not aware that in February 2007, the Genomic Research and Accessibility Act was introduced which would prohibit the patenting of human genetic material.

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.

crichton nextAlso in February, Michael Crichton’s latest novel, Next, was published and it got special mention at the GenePOPS seminar. In addition, Crichton published an opinion piece on gene patents: Who owns your genes?

Five main recommendations were given at the end of Next:

1. Stop patenting genes.
2. Establish clear guidelines for the use of human tissues.
3. Pass laws to ensure that data about gene testing is made public. He’s referring to results of gene therapy trials.
4. Avoid bans on research.
5. Rescind the Bayh-Dole Act (that allows universities to patent and make money off their research).

Also don’t miss the NEXTgencode YouTube videos created just for the launch of Next.

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(9 comments)


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9 Comments

Comment by Blaine Bettinger Subscribed to comments via email

I don’t think people should be allowed to patent genes that appear in nature – that just seems counterintuitive to the purpose of patenting. But what about genes created by researchers? Should they be allowed to protect their creation?

Comment by Hsien

Some of the data that came out of the Hopkins seminar showed that patents support innovation and doesn’t raise the price of end products which makes patents seem like a real good thing. I think as it gets easier to sequence and find genes, the less we should allow them to be patented simply because there’s not so much investment. The whole law rigmarole confuses the heck out of me. You should start a blog about the law and genetics! You’re totally qualified.

 
 
Comment by David Bradley

Genes created in the laboratory is possibly a different matter, unless of course the prior art is very, very similar. I.e. swapping a single base for another somewhere along a 20000-base gene would not, in my opinion constitute an entirely novel invention, unless it has such a very different end result in terms of the function of the protein it expresses.

db

Comment by Hsien

This whole arena is ripe for loopholes and interpretation. Glad I’m not a lawyer. Or maybe that’s my next challenge. Ha Ha Ha. Not.

Comment by Blaine Bettinger Subscribed to comments via email

Don’t worry Hsien, law school flies right by! Actually, it doesn’t, but it sure is interesting.

David – I agree completely. Another problem is that “very different end result” is so subjective. Maybe it should be a percentage – the ‘new’ gene has to be 25% or 50% different from the gene in nature. Of course, a gene can be 50% different, but if it’s all silent substitutions, there won’t be any change in function at all. What a mess!

(Comments wont nest below this level)
 
 
 

[...] at EyeonDNA has a great post about patenting genes, including a poll and a discussion in the [...]

 
Comment by Andro Hsu

I’m glad there’s a prohibition against correlations, which Crichton spoke out against in his op-ed. Correlations are essentially a thought process on the part of the scientist, physician, or genetic counselor. The Supreme Court, unfortunately, has effectively upheld patents on correlations because of procedural reasons. (A good history on the case is here.

Would the prohibition on “function” apply only to biological/molecular/cellular function, or does it include the technological uses of a gene sequence? As I recall, there are two types of patents that can be filed on genes: composition (i.e. sequence) and novel use. Much of the scramble in the late 90s was to file patents on what was essentially composition of a gene, while simultaneously defining use so broadly and speculatively as to have a basis (though weak) to sue someone else later on who thought of a more specific novel use.

I imagine that the wording in the legislation only forbids patents on composition–which would allow companies to patent the use of a sequence to be used in a diagnostic test. But if the correlations cannot be patented, then the sequence cannot really be patented as a novel use for a diagnostic.

Comment by Hsien

Thanks for the informative comment, Andro! I see press releases that say so-and-so has renewed their licensing agreement with who-and-whatever on the use of such-and-such genes. The legal procedures always perplex me. Definitely need to do some more reading up on this topic!

 
 
 

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