Patenting of human genes: the race will end in the spring
Tamara Traubman
Last night, the shares of the biotech companies on the New York Stock Exchange began to recover, after they had registered declines of up to 30% on Tuesday. The human genome to publish the raw data of the results of their research - that is, the DNA sequences that make up the genetic program of humans - in public databases, which allow free access to anyone interested.
One of the reasons for the avalanche was that the announcement was interpreted as a challenge to the intellectual property rights of Celera - a private company engaged in deciphering the human genome - and other biotechnology companies. The two main players in the human genome project are the public consortium, which includes researchers from academic research centers around the world, and the American private company Celera.
According to Gal Ehrlich - a lawyer, doctor of genetic engineering and patent editor - "The reaction on Wall Street was exaggerated. It stems from panic and misinterpretation of what was said." Clinton did call on the genomics companies to transfer their raw data to public databases, but qualified the negative position he expressed in recent months regarding the registration of patents on genes.
In his announcement, Clinton also hinted at his support for the public consortium in the negotiations between him and Salara. After meetings that began in December, the parties reached an impasse last week. Celera claimed that the members of the public consortium did not agree to provide enough protection for the information it produces against competing private companies. The members of the consortium, for their part, said that they are committed to their policy, according to which the researchers transfer within 24 hours the decoded DNA sequences to a public database called "Gene-Bank".
This negotiation has great significance, because with the Public Consortium and Celera getting closer to completing the first draft of the human genome, the race to patent genes is in high gear. The reason for the panic is that after the public consortium publishes - probably in the spring - a draft of the DNA sequence of the human genome, no one will be able to register patents on them anymore.
This crazy race is percolating among the partners in the public consortium, and especially among its European friends. They point to the ethical problems in patenting a part of the human body. Dr. Michael Dexter, director of the Wellcome Foundation, a British medical research charity that co-funds the public project, said he was concerned that someone would gain ownership of the human genome: "The genome belongs to humanity."
According to American law, a person or company can register a patent on a DNA sequence if they are the first to discover it, and they can prove that they discovered at least a little about the operation of the gene. After they prove this, and since DNA is made of chemical molecules and it is allowed to register patents on chemicals - it is possible to register patents on the DNA itself as well. What seems to many ethicists and partners in the public project to be a problem, is that today the private companies are in a hurry to register patents on DNA sequences even before it is clear to them how they work.
The "Los Angeles Times" recently published an editorial that called for a reform of the American patent law, which would place more restrictions on the registration of patents. American patent law is considered more permissive than the existing laws in other countries. Besides the fact that it approves patents on DNA sequences even when their function is not yet completely clear, it also allows the patent registrant to obtain additional patents on similar sequences.
Another claim is that when a private company registers a patent on a gene - for example a gene related to the development of cancer - other companies have to get permission from it in order to use it to develop a sophisticated drug to cure the disease. Thus, the pharmaceutical market may become captive to the whims of a private company.
Prof. Yossi Hirschberg, director of the genetics department at the Institute of Life Sciences at the Hebrew University, says that if he were the head of a private company, he "would hesitate to invest money in the development of a gene, which is known to have already been patented." But on the other hand, Hirschberg, who himself registered several patents on important plant genes, through the company "Yishom" - the commercial arm of the Hebrew University - adds that this will not necessarily lead to damage to the motivation of researchers in academic research centers to continue researching the gene. According to him, in the academic research institutions, the goal is to obtain knowledge, regardless of whether the research results can be used in the future for technology from which money can be made.
Dr. Ehrlich does not see a danger to scientific research in the registration of patents. According to him, market forces dictate a different reality. "Rational bodies don't make patents to hang them on the wall, they make them to make money", he says, "the method works great in many fields. Why won't she work in the kindergartens too?"
The Genome Project is just the beginning
The genome project is supposed to discover the order of all 3 billion DNA bases that make up the human genome. DNA bases actually consist of four chemical molecules, each of which is marked with one of four letters: T, AG or C.
In the many combinations of these four letters are found all the necessary instructions for the production and operation of the human body. For example, the genetic load determines where the eye will form in the body of the fetus and whether its color will be brown or blue.
Reading the DNA sequence reveals nothing about the roles of the genes and their mode of action. To this end, the scientists must continue research, based on the valuable data produced in the genome project, and find out which proteins are encoded in the DNA sequences, what causes the action of a terminating gene to go wrong, or why some gene - for example, one responsible for the production of insulin - is active in the pancreatic cells but not in the other body cells.
The public project began about a decade ago. Its two main carriers are the United States and the United Kingdom. In 1998, Dr. Craig Venter founded a company called Celera and caused a stir in the scientific community when he announced that he intended to use a different method and complete the determination of the DNA sequence of the human genome before the public consortium and at a much lower cost.
Many doubted that this would indeed be the case. However, in January Celera claimed that she had finished determining the DNA sequence of about 90% of the human genome. Because of Celera's method, which breaks down the DNA into small pieces, lines them up, and then with the help of computer software puts them back together in the correct order - now the company is faced with hundreds of thousands of pieces of a kind of giant puzzle, which it has to reassemble. Both competitors say they will probably have a first draft of the genome in the spring.
The final product of the genome project - a map and sequence of the DNA bases of the human genome - is like a huge book in which letters are printed without spaces between them.
It is impossible to read a book structured in this way. Celera's main way of making money from the genome is to take this raw data and process it into words, sentences, paragraphs and chapters. She sells this information to pharmaceutical companies for huge sums.
{Appeared in Haaretz newspaper, 16/3/2000{
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