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Who owns the rights to the human genome?

The regulations for registering patents on genes will be tightened

by Tamara Traubman

The use of thousands of genes identified by commercial companies is limited because
They registered them as patents. All this happened long before they finished
Researchers decode almost the entire human genome. private companies,
Universities and even US federal agencies have registered patents on
Human genes and genes from plants and animals. It should be noted that in Israel several were registered
Dozens of such patents.

The policy of the US Patent Office, which allows patents to be registered in the form
free and easy, provoked severe criticism in the USA. The newspaper "Los Angeles
Times" published a sharp editorial that attacked the ministry's policy. currently,
With the help of new and fast machines, the companies identify DNA sequences, and hurry
ask to register a patent on them. This, without knowing at all what the function of the gene is
who recognized Following the audit, the Patent Office intends to tighten the requirements
for registering patents on genes.

However, critics say that the very idea of ​​patenting a gene is unethical.
"A garden is not an invention, but something that exists in nature and belongs to humanity," says Dr
Eitan Friedman, director of the onco-genetic counseling unit at the hospital
"Sheba". "A monopoly on a part of the human body is unacceptable
In my opinion".

According to the regulations of the US Patent Office, it is possible to register a patent for a discovery
Natural substances, such as penicillin, provided that the person adds something special to them
himself. Isolating a natural substance or explaining how it works is enough to
patent it.

In terms of the law, DNA is like any other chemical molecule. in the office
American patents currently have patents registered on about 6,000 genes, of which
Over a thousand human genes.

Critics say it takes a long time to find out which company belongs to which garden.
This situation may result in pharmaceutical companies refraining from developing a drug
new, because they will fear the possibility that another drug company has already started
in patent registration procedures.

Some believe that registering patents actually encourages new developments and increases
the competition. "It used to be trivial to assume that what is in the body belongs to everyone,
But today this approach is quite naive", says attorney Naama Wichner
From the Center for Health, Law and Ethics at the Faculty of Law at the University
Haifa.

According to Wichner, our ability to use gene-based developments
It is the result of research and money. "It's a certain pretentiousness to say, okay,
You found it, you discovered it, you developed it - now it's everyone's to use it."

In the "Apimatrix" company, which produces chips containing DNA, they said in the past
Only one patent holder forbade them to use his gene to make the chip. majority
The patent holders want other people to study their genes as well
In the hope that a better understanding will lead to the development of a drug, from which they will make money
Great.

According to the new guidelines of the Patent Office - which were decided as a response
For the criticism voiced against the ministry's policy - companies will not be able to register
Patents on gene segments, but only on the uses that can be derived from them, such as
Tests for genetic diagnosis and drugs.

Because the human genome has been almost completely decoded and deposited in a database
Public on the Internet, the DNA sequence can no longer be considered a new discovery.
This is what Tamar Galili, a patent editor at the law firm, claims
Reinhold-Cohen & Co. However, companies will still be able to register patents
About mutations in the DNA. For example, a gene in its defective form can cause
for breast cancer, and it can be used for genetic diagnosis - it can be registered as a patent.

The crucial issue is what part of the function of the gene should be known to
to allow its registration as a patent. Until now companies could register a patent on a gene
Without knowing its function, for example, if we claimed that the garden could be used as a means
Testing for other genes.

Human Genome Sciences is one of the companies that registered the most
Genes as patents - recently received a patent for a gene responsible for a protein
which serves as the "gateway" of the AIDS virus into the cell. The company did not know this
when she asked to register a patent on it, and the function of the gene was only discovered later
by other researchers. These tested a man named Carl Fox who lived for years
With his friend, he carried AIDS, but did not contract the virus. The role of the garden was revealed by virtue
Examining Fox's DNA sample, and now he too is claiming rights to
the patent.

Another question, the answer to which is still not clear, is what is the degree of protection
which provides the patent registration to the company. Will any pharmaceutical company that starts, for example,
A drug that would act on the entry gate of the AIDS virus would need approval
From “?”Human Genome Sciences

Although the likelihood of this is extremely low, there is a principle possibility,
that a company that registered a patent on a gene it found, will prevent the development of a drug based on it
garden. Tamar Galili says that technology has advanced at a faster pace
of the laws, and that the matter will finally be decided in the courts.

Two weeks ago, a lawsuit of this type was filed in federal court in Sacramento
by the "Kiron" company. The company claims that "Genentech", which developed the
The breast cancer drug Herceptin violated a patent in a "deliberate and malicious" manner
of Kiron on a gene on which the action of Herceptin is based. Kiron demands a part
of Genentech's revenues from the drug, which came in the first quarter of the year
This alone for $68.7 million, according to Genentech. Court ruling
The case will, most likely, set a precedent for many other cases.

The next step: understanding the functions of genes

Many companies are actually happy about the new procedures established by the Patent Office
the American, according to which it will be impossible to register patents on gene fragments, with the exception of
mutations, but only on the uses that can be derived from them. According to Dr. Michal
Preminger, VP of business development at the bioinformatics company
"Compugen", "it just means that the analysis of the data becomes
More importantly, it will force people to move to the next level of deep understanding
more of the roles of the genes".
"Compugen" is a company that develops tools for analyzing the amounts of information
The data obtained from the decoding of the genome, such as those used for identification
Gardens. The company itself registered patents on several dozens of genes.
{Appeared in Haaretz newspaper, 2/7/2000{

The knowledge website was until 2002 part of the IOL portal from the Haaretz group

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