Whose life is it?
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More and more, biotech companies are seeking patent protection for genes -- but not without opposition.
By DAVID RANII, Staff Writer
Last month Paradigm Genetics was granted U.S. Patent No. 6,303,365.
The mouthful of a title? "Method of determining activity of 1-deoxy-D-xylulose-5-phosphate reductoisomerase and 1-deoxy-D-xylulose-5-phosphate synthase."
Peel away the mumbo jumbo and you have a patent for a living organism -- a gene.
With tens of thousands of gene patents approved or pending at the U.S. Patent and Trademark office, patenting genes is a growth industry. Pharmaceutical, biotechnology and agribusiness companies expect the patents to lead to lucrative and revolutionary products -- including innovative drugs and treatments for a variety of illnesses, as well as new herbicides and crops modified to resist disease.
But as the patent applications mount and the recent completion of the Human Genome Project pushes the genetic revolution into the spotlight, scientists and others are debating the merits of patenting genes. The patent office, meanwhile, issued new guidelines in January that raised the bar when it comes to obtaining gene patents.
The companies say patents are needed to preserve their hefty investment in research -- hundreds of millions of dollars when it comes to developing new drugs. But critics contend that one company's possession of a gene patent is another company's obstacle: It can hinder the the ability of others to conduct research that leads to important new medicines and other products. Even some industry executives express some ambivalence about the current patent system.
"Most companies are on both sides of the issue, depending on the day," said Henry Nowak, general counsel and vice president of intellectual property at Paradigm Genetics, a company based in Research Triangle Park that hopes its first gene patent will lead to a new herbicide.
On a more basic level, some critics argue that patenting nature's bounty -- as opposed to a manmade widget -- just isn't right.
The Council for Responsible Genetics, a nonprofit organization whose board of directors includes prominent scientists, has posted a petition on its Web site that calls for federal legislation "to exclude living organisms and their component parts from the patent system."
"No individual, institution, or corporation should be able to claim ownership over species or varieties of living organisms," the petition states. "Nor should they be able to hold patents on organs, cells, genes or proteins, whether naturally occurring, genetically altered or otherwise modified."
Supporters of gene patents find the "ownership" argument especially galling. They feel it distorts the issue.
"Patents don't confer ownership," said Tim Meigs, managing patent attorney at Syngenta Biotechnology, which develops genetically modified crops at its research facilities in RTP. Instead, a patent enables the patent holder to exclude others from making, using or selling the patented item until the patent protection expires.
Patenting organisms isn't a 21st-century phenomenon. In 1873, Louis Pasteur obtained a patent for a yeast free from disease-causing germs.
But the genetic revolution has raised the stakes. Beginning in the 1980s and accelerating throughout the 1990s, applications were being filed for genes and other genetic material that appear in the species Homo sapiens -- as well as in plants and animals.
Pharmaceutical giant GlaxoSmithKline alone has filed about 1,000 patent applications involving genes, said Frank Grassler, the company's vice president of U.S. intellectual property for biotechnology. Cogent Neuroscience, a privately held biotech company based in Durham, has been granted 10 gene patents and has filed an additional 29. Syngenta's RTP operations have generated 142 gene-related patents. And Paradigm's two dozen gene patent applications cover 16,000 genes, gene sequences and gene fragments.
The U.S. Supreme Court opened the floodgates to such gene patents in its landmark 1980 decision, Diamond v. Chakrabarty. In that case, which is credited by many as giving birth to the biotech industry, the court ruled that bacteria that were genetically engineered to consume oil spills were patentable.
"It set some of the legal rules for dealing with living matter," said patent lawyer Gary Pace of the Raleigh law firm of Hutchison & Mason.
Congress, the high court noted in its decision, intended that "anything under the sun that is made by man" was patentable. In this particular instance, the court ruled, the genetically altered bacteria was "a new bacterium with markedly different characteristics from any found in nature."
Since then, lower courts have cited the Chakrabarty ruling to uphold the patenting of genes themselves.
On its surface, patenting a gene seems to fly in the face of patent law.
"One of the basic tenets of patent law is that you cannot patent something that is in its natural state," said Murray Spruill, a Raleigh patent attorney with the law firm of Alston & Bird.
But pharmaceutical and biotech companies overcome this obstacle by isolating and purifying the genes, as well as by altering them in some way.
"The gene in your body is not patentable," Pace said. "But the isolated form, once the [nucleotide] sequence has been determined, is the product of human intervention and human ingenuity and, therefore, it is patentable."
Genes can become products in and of themselves in the case of gene therapy, but more often the gene is a means to an end -- understanding how a specific gene functions can point the way to creating new medicines and other products.
If a specific gene is patented, however, companies that don't own the patent are excluded from using the gene in their research and development -- unless they can obtain a license from the patent holder. At the same time, the owner of the patent knows that if it can leverage its patent into a useful product, it will have the exclusive rights to market that product until the patent expires. In most instances, patent protection lasts for 20 years after the patent application is filed.
"Without this period of exclusivity, we couldn't make back our [investment] and innovation would be stifled," said Syngenta's Meigs. "We think it is vital to encourage innovation."
Given the crucial contributions genes can make to research, a gene patent in and of itself can be a money-maker for biotech companies that license the rights to others. GSK's Grassler said he has seen such licenses with total payments ranging from as low as $10,000 to as high as $150 million for a portfolio of genes.
For a biotech startup, obtaining patent protection on the genes it works with is crucial, said patent attorney Kenneth Sibley of Myers Bigel Sibley & Sajovec in Cary.
"A startup will not attract investor funding unless it can demonstrate reasonable intellectual property protection covering its research," he said.
The importance of patenting to the biotech industry was underlined last year when biotech stocks suffered after President Bill Clinton and British Prime Minister Tony Blair issued a joint statement that was interpreted as an argument against patenting genes. Clinton later clarified his position.
"If someone discovers something that has a specific commercial application, they ought to be able to get a patent on it," Clinton said in April 2000.
But Martin Teitel, president of the Council for Responsible Genetics, argues that patenting genes is just plain wrongheaded. He likens it to the owner of a house patenting 2-by-4's.
"People are patenting the building blocks rather than the end result," he said. "It takes the issue of patents to a whole new level."
Indeed, given the current system, companies admit that filing gene patent applications is at least in part a defensive maneuver. If you don't patent it, somebody else will.
"It's almost like a land grab in a way," said Michael Constantino, a partner in Ernst & Young's Raleigh office who heads the firm's life-sciences practice in the Southeast.
The proliferation of gene patents, as well as other types of patents, forces companies to spend sizable sums on licensing so that they can go forward with their research.
"We run into this all the time," said Paradigm's Nowak. "Everything you want to do, almost, you have to get a handful of licenses to do it. It is not cheap."
"It does stifle a bit of research," he added. "Unfortunately, that's the game [today]."
The SNP Consortium, formed in 1999, is a pharmaceutical industry initiative to stop individual companies from patenting genetic markers known as SNPs. Single nucleotide polymorphisms are variations in human DNA that scientists believe can pinpoint genetic differences that make some people more likely to suffer from a certain disease. This, in turn, is expected to lead to more effective new drugs.
A group of 13 pharmaceutical companies, including GlaxoSmithKline, and a nonprofit group, the Wellcome Trust, have committed $45 million to fund the creation of an SNP map. The consortium is making the map freely available to everyone.
Widespread access to SNPs is crucial, said Arthur Holden, the group's chairman, because SNPs are akin to the alphabet. "They are the letters you use to write words, paragraphs, sentences and stories that begin to explain the functions of the genome," he said.
Patenting SNPs, he added, would cripple innovation.
Meanwhile, the patent office issued new guidelines at the outset of this year that are designed to stiffen the requirements for patenting genes and other genetic material.
In essence, the guidelines state that obtaining a patent for a gene requires applicants to do more than merely provide a detailed description of the gene's structure. Instead, the applicant must lay out a "specific, substantial, and credible" use for the gene. The latter requires much greater understanding of the gene, which in turn requires much greater research.
"The guidelines say, 'We're not going to reward you for a fishing expedition. You have to finish the research,' " Sibley said. "It's a good requirement."
To use a gold rush analogy, under the old system companies could go out to California, stake out a piece of land and then begin searching for the pockets of gold, said Larry Stults, head of U.S. intellectual property at Syngenta. Now, however, "you have to find the pocket of gold first."
The new guidelines, which went into effect on an interim basis in December 1999, haven't triggered a slowdown in applications for gene patents, said patent office spokeswoman Brigid Quinn. However, she added, that's not surprising, given industry's focus on gene research.
"It's impossible to know if [applications] are as high as they would have been absent the guidelines," Quinn said.
Staff writer David Ranii can be reached at 829-4877 or dranii@newsobserver.com |
