Who is the owner of your genes?
According to the results of a study conducted by Cornell University specialists, people have ceased to be the "masters" of their own genes – DNA sequences that determine not only the appearance and character of a person, but also his predisposition to diseases. Numerous companies already own more than 40,000 patents for fragments of DNA molecules covering almost the entire human genome.
According to one of the researchers, Dr. Christopher E. Mason, if all patent holders declare their rights, a person will lose "the freedom of the genome." Ironically, on the threshold of the era of personalized medicine, we live in a time of the strictest restrictions from the point of view of genomics. It turns out that the attending physician does not have the right to study the patient's genome, since this is a violation of patent law.
On April 15 of this year, the US Supreme Court will hold a regular hearing on the rights of a company developing molecular diagnostic methods to obtain patents not only for two genes that are key in the diagnosis of predisposition to breast and ovarian cancer – BRCA1 and BRCA2 – but also for short DNA sequences that are part of these genes, including an unprecedented patent for a DNA sequence only 15 nucleotides long.
As part of the study, the authors compared the short DNA sequences included in the BRCA1 gene with sequences of other genes and found that only the patents of this company affect at least 689 other human genes, most of which have nothing to do with breast or ovarian cancer. At the same time, among these genes there are genes responsible for predisposition to other 19 types of cancer, as well as those involved in the development of the brain and the functioning of the heart.
According to Dr. Mason, if the Supreme Court supports the company, no doctor or researcher will be able to study these genes and no diagnostic test or drug can be developed based on information about the sequences of these genes without violating the rights of the patent holder.
One patented sequence covers more than 91% of human genesDr. Mason was prompted to conduct the research by the fact that in his work devoted to the study of cancer and brain diseases, he was faced with the need to work with genes protected by patents.
The same difficulty is inevitably faced by all geneticists engaged in similar research.
According to US laws, researchers and companies have the right to patent genes, the use of information about which is potentially useful from the point of view of clinical practice, for example, when developing a diagnostic test.
For example, patents for the BRCA1 and BRCA2 genes obtained by the company in the 90s allow it to offer tests for predisposition to breast or ovarian cancer caused by certain mutations in these genes. As a result, women and their attending physicians have no choice but to resort to the services of the patent holder, which cost $ 3,000 per test, whereas thousands of other laboratories could perform the necessary analysis much cheaper.
Dr. Mason and his colleague Dr. Jeffrey Rosenfeld set out to determine the total number of genes that can be difficult to work with due to the existence of patents, as well as to generally assess the nature and extent of intellectual property that extends to the human genome.
To do this, they analyzed the structure of the human genome in the context of two types of patentable sequences: long and short DNA fragments.
At the first stage of the work, the authors calculated how many genes in the human genome have the same segments of 15 nucleotides long. It turned out that each of the human genes in this respect corresponds to at least one more gene. The degree of coincidence varied from five correspondences of 15 nucleotides in length to 7,688 genes with similar structural components. It was also found that 99.999% of 15-nucleotide sequences are repeated in the human genome at least twice.
The results of further work showed that patented long DNA sequences, often containing whole genes, make up 41% of the human genome. In particular, 58 existing patents cover at least 10% of all human genes. The most extensive of them contains sequences that are part of 91.5% of genes.
Moreover, it turned out that, given the frequent repeatability of genetic sequences in the structure of different genes, if you collect all the patented short DNA sequences, they can cover 100% of the genome, including the so-called non-coding sequences containing not only "genetic garbage" in its pure form, but also coding proteins, the function of which is still not installed, as well as some regulatory elements.
All this points to the existence of blatant contradictions in the system of ownership of genetic sequences, since the sequences claimed in many patents overlap.
The second potential problem is the fact that patents on DNA sequences can violate interspecific barriers. For example, no matter how stupid it sounds, but one of the companies is the owner of a patent obtained for breeding new breeds of cows and at the same time containing sequences that make up 84% of human genes.
Another paradox is that due to the patenting of short sequences, many human genes of therapeutic significance have been partially patented a large number of times by different potentially competing companies.
The authors state that now the Supreme Court has a chance to form a compromise between clinical benefits and copyright protection, and add that, in their opinion, the court should limit the boundaries of patenting existing nucleotide sequences due to their multiplicity and non-specificity.
According to Mason, despite his strictly positive attitude to copyright protection, he believes that people should not patent what nature has created. Moreover, he is of the opinion that a person should literally be the "master" of his genome and be able to provide a doctor with the opportunity to analyze his genome for diagnostic purposes.
The article by Jeffrey Rosenfeld and Christopher E. Mason Pervasive sequence patents cover the entire human genome is published in the journal Genome Medicine.
Evgeniya Ryabtseva
Portal "Eternal youth" http://vechnayamolodost.ru based on the materials of Weill Cornell Medical College: You Don't "Own" Your Own Genes.
28.03.2013