Via Eurekalert: Science article has implications for all rapidly developing fields
NIH struggle holds lessons for decision-makers in numerous research arenas
Global climate change and other fast-developing scientific fields can take a cue from a prolonged process that eventually led to a workable compromise regarding the release of new data by human genome researchers.
A new study by a Washington University in St. Louis School of Law professor in the July 23 issue of the journal “Science” chronicles a 15-year struggle around the competing needs inherent in data-release decisions.
In the first comprehensive examination of its kind, Jorge Contreras, JD, explains that the U.S. government must weigh the rights of researchers, also called data producers, against those of data users. The scientific community needs the latest data as soon as possible in order to drive further research. But researchers may want time to prepare for publication and apply for patents.
The result is a balancing act between the interests of these two groups. Although Contreras’ study focuses on human genome research, the same dilemma holds true for research in many other areas of study.
“I think you must have a compromise. Otherwise these commons, or bodies of data, aren’t going to be created,” Contreras says.
NASCENT FIELD DEMANDS NEW POLICIES
At the dawn of human genome research two decades ago, more than 1,000 researchers were working around the globe. To facilitate knowledge sharing, the U.S. government sought to coordinate their efforts.
In the past, government-funded human genome researchers had a 12-to-18 month latency period between the generation of data and its required release.
In 1992, the National Institutes of Health (NIH) and the Department of Energy (DOE) reduced that period to six months. Four years later, government and scientific leaders determined that six months was still too large a gap.
They then decided that human genome research findings must be released prior to publication, within 24 hours after generation. The legacy of that determination, called the “Bermuda Accord,” still affects genomic research projects today and makes it difficult for data generators to publish their findings before competitors who have free access to their data.
“While it would be preferable, from a pure scientific advancement standpoint, to have every piece of data released immediately to the public, that doesn’t give data-generating scientists the opportunity to publish and advance their careers through publication,” Contreras says.
The agreement also inhibits the ability of researchers to obtain patents, as patents cannot be obtained on information that is already known to the public.
COMPROMISE RESOLVES SOME PUBLISHING ISSUES, STILL THWARTS PATENTING
With the arrival of the 21st century, genomic research began to evolve from sequencing to associating variants in the genome with specific traits and conditions, known as genome-wide association studies (GWAS). This development brought about a 2007 compromise decision, in which the NIH again altered its rules.
The newer policy, which applies only to GWAS, still requires quick data release but it also prevents users from publishing the data or presenting related information for up to 12 months. The shift is significant in that GWAS now make up a large portion of human genome research.
Still in effect, this set of rules allows GWAS researchers time to publish their own work. In the meantime, other scientists can use the data for their research and future publications.
The 2007 policy does not improve the likelihood of scientists patenting their work, but that issue is secondary to publication for most researchers, according to Contreras.
Contreras sees implications for his study in numerous scientific fields beyond genomics, including not only global climate change, but also chemistry and astronomy.
“As policy makers begin to develop commons in different areas, rather than going back to the drawing board and starting from scratch, they’ll be able to look at this systematic analysis of how timing variables have played a role in genome science, and take it from there,” Contreras says.
Contreras, WUSTL’s deputy director of the Intellectual Property Program and senior lecturer in law, serves on the NIH Council of the National Human Genome Research Institute; is chair of the Committee on Technical Standardization of the American Bar Association Section of Science & Technology Law; and has published numerous articles relating to science and technology law.
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Research used to set public policy must be held to a different test. Researchers cannot be allowed to declare research property rights when that research is used to deny others their property rights. And Government cannot be allowed to use restricted research to justify public policy.
Patent, tenure, publication rights although worthy of discussion tend deflect attention from this more basic issue.
The property rights of researcher’s using public funds is an issue that requires more attention– however it is not nearly as urgent as addressing the issue of full disclosure in research used
What can and cannot be done with public funding with respect to patents is a separate issue. The most critical issue at the moment is not researcher’s rights but the public’s rightArguing both issues simultaneously deflects attention from how this research is being used.
I fail to see how a data repository like the Genome Data Base has any relevance to climate data (the possible exception being paleoclimate data). Climate data is instantly available to the public and the codes, methods, equations, and software SHOULD be available upon publication for replication. I can’t see any patent possibilities either (profitable ones anyway).
I have been an industrial researcher and have a number of patents along with other inventions that weren’t patented but kept as trade secrets. We lost a patent on a key product because we tested it on a panel of users without securing NDAs. So, one must be careful in disclosing “enabling information” on patentable technologies.
In recent years I have been doing applied research in academia on technologies for safety equipment for military and first responder use. Much of the work is under government contract, and we often collaborate with industrial partners to bring the technology to market. The (US) government acquires the data rights and right to have the data published, but the developers retain IP rights to software and hardware produced. The object is for the government (and other) users to get the technology into their hands, so there has long been a law governing such situations. One example would be developing a new military jet under government contract. The government has decided it needs the technology, and it doesn’t have the expertise to do so. Developers don’t have an incentive to create the technology if they cannot produce it after it is developed. If the developer doesn’t want to commercialize the technology, under the law the government has the right to find someone else to bring it to market.
The government encourages publication and information sharing on the performance testing and technologies used in such cases, including publishing new modeling information for other scientists and engineers to use on future products.
In the case of non-classified material, I think that there should be no right to expect confidentiality for basic science such as climatology reserach. IF IP is at issue, the researcher typically has a reasonable period to file disclosures or copyrights of programs before disclosure. In the case of temperature and other weather and climatic data, there is no inventiveness needed and the public has paid for it. It should be available as soon as it is collected and collated. I could see that instruments, models and software might be subject to IP rights; but they should be publically disclosed as soon as the IP has been protected (i.e., within one year).
The unwillingness of the scientists and managers at UEA, Penn State, etc. to disclose information seems to be highly suspect to me, and it violates basic tenets of the scientific method. Such practices place the techniques and data used to generate conclusions that will dominate the world’s economic future behind a curtain. I respect Anthony, M&M and others who have fought for information release to penetrate that veil.
I’m surprised no one has commented yet on Michael Crichton’s stand on patenting of genes. Crichton, author of the excellent Man-Made Global Warming expose, “State of Fear,” also commented on genetic patents in his work, “Next.”
http://www.crichton-official.com/books-next-policy.html
It appears that the courts may, at last, side with him:
http://www.businessweek.com/news/2010-03-29/myriad-loses-ruling-over-breast-cancer-gene-patents-update1-.html
How long until the courts dispose of the CAGW canard?
Ric Werme says July 24, 2010 at 11:06 am
Minor comment, but I bought a PDP-8e in 1970, 8K of ferrite core, mostly taken up by Basic. Booted by toggle switches. Mass storage device was punched paper tape ASR-33. That was before bloatware, but it is amazing what could be achieved – and was – by good machine language work. It was connected to a fast neutron generator I bought for chemical analysis, then extended it to data logging several lab instruments.
The IPCC could, if it wanted to try and restore its reputation, take the lead here by insisting that papers can only be cited if any underlying data and computer code has been made available to the public.
If the science is sound they have nothing to fear.
Stop Global Dumbing Now says:
July 24, 2010 at 12:26 pm
I fail to see how a data repository like the Genome Data Base has any relevance to climate data (the possible exception being paleoclimate data). Climate data is instantly available to the public and the codes, methods, equations, and software SHOULD be available upon publication for replication. I can’t see any patent possibilities either (profitable ones anyway).
If you had perfected a model that could predict with accuracy global weather conditions just 6 months into the future, I could make millions in that time trading agricultural commodities.
Which explains why all the AGW researchers and their fancy computers are still begging the government for money.
@jorge
I’m pretty sure you can’t patent a gene, per se. At least not one found in nature. You can however patent a process that uses a gene found in nature.
That said the patent office isn’t perfect and sometimes the examiners slip up.
In theory mathematical formulas and computer algorithms in and of themselves can’t be patented. I should think a gene sequence falls into the same category. When it comes to computer algorithms you have to patent a novel way of using it rather than the algorithm itself.
Q – What’s the ONE thing that science (and everything/one else on the planet) could sure could use a lot less of?
A – Lawyers!
There otta’ be a law against lawyers!
PS: Personaly, I’d give anyone who works for the government, or in the private sector for some corporate entity, 10% for any patent they were responsible for developing while in “service” to the same. Hmmm… we’d probably need a lawyer to… never mind! NEVER MIND!
Dave Springer says:
July 25, 2010 at 7:01 am
> I’m pretty sure you can’t patent a gene, per se. At least not one found in nature.
Yes, you can, and that’s a large part of the problem. Exactly why, given the patent filer has done nothing novel to invent the gene, makes the process appear completely broken.
And indeed, the rules may be changing. In March a Federal District Court overturned a few patents, see http://www.nytimes.com/2010/03/30/business/30gene.html
It says, in part:
Judge Sweet, however, ruled that the patents were “improperly granted” because they involved a “law of nature.” He said that many critics of gene patents considered the idea that isolating a gene made it patentable “a ‘lawyer’s trick’ that circumvents the prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”
The case could have far-reaching implications. About 20 percent of human genes have been patented, and multibillion-dollar industries have been built atop the intellectual property rights that the patents grant.
“The agreement also inhibits the ability of researchers to obtain patents, as patents cannot be obtained on information that is already known to the public.”
Not exactly. Disclosure starts a year-long clock. Patents must be applied for within that year.