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With the Bush administration’s decision to allow limited federal funding of stem cell research, scientists and bioethicists have expressed renewed concerns about the impact of "life patents" — patents on biological materials — on scientific research.
Even though stem cells can be found and extracted from every human embryo, the Wisconsin Alumni Research Foundation (WARF) has a patent on the process used to extract the cells, as well as patents on the stem cell lines it has derived. It turns out, no one in the United States — using federal funds or not — can do research on embryonic stem cells without the foundation’s permission.
"We are no longer arguing about whether or not we can patent life, patent genes, and stem cell lines, but we are arguing about what the conditions of use can be," says Stephen E. Lammers, PhD, the Helen H.P. Manson Professor of the English Bible at Lafayette College in Easton, PA.
A 1981 Supreme Court decision, Diamond v. Chakrabarty, changed U.S. policy to allow patent protection of materials that occur in nature, as long as applicants can show that their "invention" is "unique, nonobvious, and useful." As a result, U.S. researchers have obtained patents on genetically modified plants and animals, and on specific genes, DNA, and processes by which these things are studied.
With the mapping of the human genome last year, the number of applications for patent protection on sections of human DNA exploded. Biotech companies that discovered genetic mutations linked to diseases sought patent protection for the affected genes. Researchers able to isolate specific genes applied for patents on the specific DNA sequence. Universities formed separate, private corporations to pursue investment capital and commercial opportunities for academic research findings.
The result, claims Lammers, is that scientific research principles are being compromised by the need to protect corporate investments.
"Instead of the usual scientific practices of free and open communication, we have the practices of corporations and patents and intellectual property, restrictions on use, and restrictions on the exchange of information," he says.
He points to the recent declaration by several prominent medical and scientific journals that they will scrutinize articles submitted to them for evidence that the authors have been restrained by corporate sponsors.1
The joint statement of principles was prompted by instances in which researchers were pressured to not disclose parts of research that had been privately sponsored or that they had been asked to alter conclusions or alter language to preserve patent potential.
"The scientific community has now started to become concerned about this," he adds.
The U.S. Patent Office has apparently also become concerned, says John Kilyk Jr., JD, an intellectual property attorney specializing in biotechnology patents at the Chicago-based firm Leydig, Voit & Mayer.
"The patent office has clamped down in the last nine months to a year on people who are trying to patent gene sequences where they really don’t know what the genes are useful for, but since they need to meet the utility requirement, they make up a use," he says. "The patent office has made it clear they will accept only practical, real-world utility."
Researchers are granted patents on cells, genes, and other life forms because they are seeking protection of the entity as a separate form, not as a part of a living being, he says.
"You are claiming the gene or DNA in a sequence as an isolated and purified entity, which doesn’t exist in people," he explains.
However, in order to get patent protection, applicants must demonstrate that their "version" of the DNA, gene or process is new, nonobvious, and, most importantly, useful. Until the FDA issued new guidelines earlier this year, applications for gene patents were claiming the genes were useful in research applications, such as probes to find other genes or molecules.
"A lay person might read that and think those sound like pretty good applications, but a person in the business would recognize that they are just stock diagnostic and research applications," he continues.
Kilyk’s firm has recently seen an increase in the number of biotech patent applications being rejected, indicating increasing concern that "nonuseful" patents can impede the inventive process that patents are meant to protect.
A great deal of attention has been given to the potential of genetic research to yield incredible therapies to cure disease and treat injury, says Lammers. But, with most of the genes and processes under patent protection, who will be the beneficiaries of such discoveries?
"This is going to provide a set of technologies, available for the foreseeable future to only the very wealthy," he explains.
The more attention and money and resources that are devoted to pursuing this technology, the less emphasis there is on providing a basic level of health care to the entire population, he adds.
Celebrities testify before Congress about the enormous potential of genetic research, and that is where much of the government support appears to be headed, he says.
"How much money is going to be spent on this research, and what benefits will society receive in terms of overall reduced morbidity and mortality?" he adds. "Now we don’t have money for poor people’s health problems, for public health, and we have working people who cannot afford health insurance. There is something weird going on."
What patents are and what patents do is frequently misunderstood by both the public at large and those in the scientific community, 7Kilyk believes.
Patents allow the holder to prohibit others from doing whatever is claimed in the patent for 20 years, he says.
If a researcher discovers the location of a gene or discovers a potential use for the gene, he or she can apply for a patent to ensure that other researchers must get permission before researching the same gene, he explains. However, if the gene has already been discovered and that information has been made public, it cannot be patented.
In the current environment, a researcher may want to apply for patent protection in order to safely preserve their right to conduct research in that area. For example, if a researcher discovers or isolates a particular gene and does not seek a patent or publicly disclose the discovery, someone else can patent that DNA sequence and then prohibit the original researcher from continuing.
And, notes Kilyk, biotech patent applicants must be careful that their patent does not overlap another patent.
"If one group has a patent on a whole class of genes and I later find out that one of those genes is particularly special, and I convince the patent office that it is separately patentable because none of the other genes have these same properties — I can get a patent on that," Kilyk explains. "I can stop any person, including the organization with the patent on the entire class of genes, from conducting research on that gene. But that organization with the broad patent can prevent me from using the specific gene because they claimed the whole class."
At that point, both parties must come to the table and work out an agreement that is acceptable, he says. "Generally, people are not interested in preventing someone from using a certain invention just for the sake of preventing it. It is just part of an overall business strategy. Usually capitalism prevails and either the party is using the object or process that they have patented or is licensing others to do so to make money."
When pursuing patents on genes for biotech clients, his firm employs a "forward and backward" patenting technique, Kilyk says. "You can have various types of subject matter in claims defining the invention. When a university or company comes to us with a gene they have isolated, we try to not only protect the specific DNA sequence, but also ways of using it, ways of making it, variants — so that someone can’t modify it a little and do the same thing, also the proteins that are coded by the gene, and the sequences that make up the protein."
In this way, if one part of the patent claim is later determined to be invalid, then other claims may hold up.
Some companies also try to "carve out" patents that are on the fringe of other companies’ discoveries — a use for or a form of the discovery that is not included in the existing patent, he adds. "We see companies that make it a point to patent things that are not related to their own business, but are related to another company’s business. Maybe the other company has a patent on some research that the original company wants to pursue. In that way, they can force the company to the negotiation table."
So, if a group wants to pursue research that is protected by a patent, they might already have protected other information that that patent-holder wants. "It’s much easier to trade patents than to trade money."
Biomedical research would be drastically slowed if patents on life forms were disallowed, says Kilyk.
"People think that some of these things should be free to everyone," he says. "But you have to be really careful with that. If I develop a diagnostic test, genetic therapy, or a drug with great pharmaceutical potential, but there was no patent on it, would you be able to get the investors willing to put in the $100 to $200 million it would take to get that product through clinical trials and scale up production? As soon as you develop it, someone else can knock it off and start selling your discovery for a penny. No one would do the work. Unless you think the government should step in and do all of the work, nationalize it, what is the alternative?"
But, argues Lammers, scientific research produced medical advances before researchers could patent the life forms that were the core of their research, and researchers would be able to work around the lack of patents on basic biologic materials.
The results of genetic research — research involving genes that are common to all humans — should be preserved for the benefit of the entire population as much as possible, he says.
"It’s not too late to change our minds. There is nothing to say that, although we’ve allowed this in the past, and though we will honor these patents, we will not allow this in the future," he says.