Your genes will be ours!
The gentleman does not control himself
The genes of all people were patentedIrina Yakutenko, <url>
Until recently, this was the case, but in the last few years, more and more fragments of human DNA are protected by patents of various companies that can use them at their discretion. And although the de facto genes inside you are still yours, de jure you can use them for your own good only through the mediation of third-party people – and for a lot of money.
The Alchemy of CapitalismA patent is a security document that gives the owner the right to exclusively use his invention for a certain period of time.
If it is possible to make a profit with the help of a patented thing (and this is what all the stories with patenting are being started for), then everyone who wants to produce this thing will have to buy the right to use it from the patent owner.
The progenitors of the current patents existed in ancient Greece, and in a more or less modern form this privilege took shape by the end of the XV century. But the real heyday of patenting began in the era of industrial revolutions, when humanity finally took up the study of nature in full force, and new inventions began to appear regularly on the market. Patent laws of different states have been improved and complicated, striving, on the one hand, to ensure maximum protection of the rights of the inventor, and on the other – to prevent the imposition of prohibitions on the use of everything in a row.
The rules for issuing patents vary from country to country, but they all require that the citizen or company applying for the paper have a direct relationship to the object that they submit for consideration by the bureau. In the previous sentence, the word "inventor" is intentionally not used, because in some cases – for example, when patenting genetic objects – it is possible to talk about an invention only with a very big stretch.
Patents obtained on time allow their holders to enrich themselves in a short time – of course, if the patented invention really has some value and the author will be able to dispose of it competently. Therefore, it is not surprising that the inventors sought to obtain "certificates of protection" for any fruit of their intellectual efforts. In the lists of patented objects from different countries, you can find a pet ironing device, a cooling hat for hot weather or a bra specially adapted for carrying liquids.
When biology and medicine advanced a little further than making potions from bats and bloodletting, the authors of new discoveries in these areas also began to try to protect them with patents. The first patented object obtained on the basis of human material, in 1906, was the adrenal hormone adrenaline. Almost immediately, the possibility of issuing such a patent was challenged in court. The Parke-Davis versus Mulford trial has long been considered the first precedent that raised the question of the legality of obtaining exclusive rights to use something created not by man, but by nature. However, a more detailed analysis of historical documents showed that there was no sacramental decision that the isolated and purified adrenaline is no longer a creation of nature, but a man–made product (and therefore it is subject to patenting), during the process it was not made. In reality, the essence of the lawsuit was reduced to a conflict between two manufacturers who almost simultaneously released very similar drugs to the market. Nevertheless, this process is very much referred to in discussions about how justified and reasonable the practice of patenting biological objects is.
In 1923, the University of Toronto bought a patent from biochemist Frederick Bunting for one dollar for insulin, also isolated from animal glands and purified from impurities. Later, vitamin B12 and some other biologically active compounds were patented. And in the XX century, when the fundamental role of DNA became obvious to researchers, the epic of patenting genetic materials began.
The right to genesThe first patent for deoxyribonucleic acids was obtained in 1980: Stanford University secured the right to use the technology developed in the laboratories of Stanley Cohen and Herbert Boer to create recombinant DNA, which made it possible to make various changes to the genomes of living organisms.
In the same year, the famous Diamond versus Chakrabarty trial took place, as a result of which the US Supreme Court decided that living organisms can be subject to patenting if they were modified by a person. The reason for the trial was a patent obtained by Ananda Chakrabarti, an American microbiologist of Indian origin, for genetically modified Pseudomonas bacteria created by him, which could break down crude oil. Different instances made decisions either in favor of the scientist, or against him, but the final verdict became significant for future processes.
The court's opinion (adopted by five votes to four) stimulated a boom in patenting of all kinds of genetically modified organisms: from viruses and bacteria to plants, animals and cell cultures. The last stage was the patenting of genes – sections of DNA encoding certain proteins of the body.
Foreign cells
One of the most famous trials related to challenging the rights to cells was the John Moore v. University of California case. In 1976, Moore was diagnosed with a rare form of leukemia and, in order to save his life, his spleen was removed. Doctor David Gold managed to get a line of cancer cells capable of infinite division from a diseased organ and received a patent for it. The cells became popular with biologists and clinicians who purchased the line from patent holders. Moore tried to challenge the grant of this patent, but the court found that his claims were not substantiated.
The process of such genetic "enclosure" was spontaneous, so for years no one imagined the scale of what was happening. The first more or less systematic assessment, and even then – only for Homo sapiens, was carried out in 2005. It turned out that scientists and biomedical companies own the rights to 20 percent (sic!) of all known human genes. What this share is today is unknown.
People far from biology learned that their genes have long belonged to someone, in the early 2000s, when the patent processes for the BRCA1 and BRCA2 genes began. Mutations in these genes significantly increase the risk of breast and ovarian cancer in women. Biotechnological and diagnostic company Myriad Genetics in 1998 and 2000, respectively, patented these two genes, as well as their mutant variants and methods for detecting mutations. And already in 2001, laboratories engaged in diagnostic testing for changes in BRCA genes received letters demanding that they stop all work or pay Myriad the deductions due.
The addressees of the letters, as well as human rights and public organizations, did not agree with this statement of the issue and filed a lawsuit against the company. The proceedings dragged on for many years, with most of the decisions rendered in favor of Myriad. The plaintiffs stubbornly disputed the verdicts, and the next stage of the hearings ended on August 17, 2012. The Court of Appeal again found that the patent rights of the biotech company for the BRCA1 and BRCA2 genes are legitimate.
Pros and cons
The idea of assigning rights to someone's genes looks wild and, moreover, the laws of most countries explicitly prohibit patenting what was created by nature (and the laws of nature, too). These arguments have been repeatedly expressed in courts and public discussions, but so far the patent lobby has successfully repelled all attacks. The arguments of those who believe that the rights to use genes inside us or whole living organisms can be staked out with the help of any documents are not without logic and even some grace.
Is the DNA of living beings created by nature? – So we are not patenting the DNA that is inside the cells, but isolated and purified molecules containing only the desired genes. In nature, such molecules do not occur – accordingly, they can be considered a human creation. Allegedly patentable animals and cell cultures were not generated by man, but were born as a result of natural processes? – A person has made certain changes to the genomes of these creatures (most often patents are obtained for genetically modified organisms), which means that they do not exist in nature, but are human creations. This consideration has been used since the time of Louis Pasteur: in 1873, he patented a yeast strain, stating that "yeast, free from all parasites and infections, is an industrial product." According to supporters of alienability of rights to use biological objects, they have the basic US patent law on their side, in paragraph 101 of which (as interpreted by the US Congress) it is claimed that the object of patenting can be "everything that is under the sun and created by man."
Critics of patenting consider the argument of supporters that isolated and purified DNA molecules do not exist in nature and therefore can be patented, untenable. In their opinion, this argument is equivalent to the statement that gold or other metal separated from the rock, for example, in ingots, also does not occur by itself, which means that rights can be secured to it.
For citizens frightened by the unpleasant prospect of being bound by patents for everything around them, including parts of their own body, lobbyists have one consolation. All the same US patent law, as well as similar documents of other states, requires that the patentable object has some utility. In the case of securing the rights to DNA molecules, this means that the battle will unfold for the genes encoding the most important proteins for human health, and for methods for detecting mutations in them.
"For the first time, the idea to patent genes, or rather, sequences of fragments of expressed genes, came to Craig Venter (an odious American biochemist who made a significant contribution to the decoding of the human genome and recently announced the creation of an organism with an artificial genome. According to other sources, and in his autobiography Venter opposed the patenting of genes – approx. "Tapes.<url>"), back when he worked at the NIH (US National Institutes of Health). Then there was a lot of noise about this (just in connection with the "usefulness" of the patented sequences); Venter ended up leaving the NIH and creating a private institute for genomic research," comments biologist Konstantin Severinov, professor at Rutgers University (USA), head of laboratories at the Institute of Molecular Genetics of the Russian Academy of Sciences and the Institute of Gene Biology of the Russian Academy of Sciences.
The trend had already taken shape by 2005: patented DNA fragments are distributed extremely unevenly across the genome: areas with unknown function or genes unrelated to health are of no interest to anyone, and other pieces of the genome account for as many as two dozen patents. The BMP7 and CDKN2A genes became the record holders for the number of pieces of paper issued on them. The product of the BMP7 gene is a so–called osteogenic protein capable of stimulating the formation of cartilage and bones, and the protein encoded by the CDKN2A gene suppresses tumor growth. "In the case of sequences of genes encoding pharmacologically important targets, as well as with the three-dimensional structures of the target proteins themselves, the potential "usefulness" is quite obvious: this is diagnostics, and the development of new drugs, and much more. The burden of proof of usefulness lies on the applicants, and if, for example, the US patent office recognizes that there is novelty, non–obviousness and usefulness in the application, then there is no reason not to grant a patent," says Severinov.
According to supporters of patenting, such an imbalance in patenting genes will not do harm: the law requires the patent holder to disclose information about his invention as much as possible (although it is customary in biology to disclose the results of their research and developments, otherwise the scientific community simply does not recognize them). Such openness should encourage specialists from related fields to engage as actively as possible in research "around" the subject of patenting in order to invent something in the future, stake out their rights and make a profit. In fact, the restriction of the rights to use a gene rather discourages other scientists from wanting to study it. A patented DNA sequence already exists, and inventing something "around" it without violating other people's rights is quite difficult, and legal costs can be substantial.
At the same time, until now, holders of patents for biological objects have not touched purely fundamental laboratories: many companies have developed special licensing agreements that allow researchers to continue studying controversial genes. It is not known what percentage of laboratories sign these agreements, but so far there have been no high-profile proceedings about scientists violating the rights of patent holders. "Fortunately, patents often provide for the possibility of research. Fundamental science willingly uses it. But if something useful suddenly comes out, then it is difficult to sell it. Scientists, especially those who are engaged in fundamental research, are usually unimportant merchants," says Ruslana Radchuk, a molecular biologist, researcher at the Institute of Plant Genetics and Research of Cultivated Plants in Germany.
The Mendel Patent
More recently, the "daughter" of the biotechnological agricultural giant Monsanto, the company Seminis Vegetable seeds, Inc. patented Mendelian peas – the same one from the pages of the school course of genetics. "Plants that carry a mutation at the r locus, namely in the gene encoding adenosine disphosphate glucose pyrophosphorylase, have been patented. This mutation manifests itself in a low starch content and slowing down the ripening of pea seeds. It is this quality that is patented by the company. Breeders who are interested in this trait can 'buy' it," explains Radchuk.
Laboratories at pharmacological and biotechnological firms have a much harder time: holders of rights to biological objects monitor their activities very closely. At the same time, science in such laboratories is quite "real", albeit with a medical bias. Severinov believes that the situation should be looked at from the other side: "Royalties for the use of information that allows you to save time are fair, since the company uses information for its commercial project that was not received by it, and you have to pay for it." Radchuk does not agree with this point of view: "I naively believe that science and knowledge are a public, so to speak, people's product. This is what gives birth to human intelligence and is passed down from generation to generation, by word of mouth. If that first monkey who came up with the idea of cracking a nut with a stick, patented the method and tool and restricted its use for other relatives (just because she was the first) or offered the service of splitting for new nuts, it is unlikely that humanity would have developed into something meaningful."
There are those who believe that it is unacceptable to patent genes and methods of their study or detection, and a completely "mundane" argument. Companies holding such patents for medically significant DNA fragments can set any prices for the diagnosis of the corresponding deviations. In its appeal, issued after the announcement of the next verdict of the court in the Myriad Genetics case, the firm emphasizes that the prices for analysis of mutations in the BRCA1 and BRCA2 genes are "not prohibitively high" at all. In numerical terms, this means three thousand dollars per analysis (in the USA). The test may be partially or completely covered by medical insurance, but not all companies agree to include this analysis in the proposed package.
Finally, the practice of patenting genes and other genetic material inevitably raises the question of the authorship of the invention. In order for Myriad Genetics employees to isolate and purify the BRCA1 and BRCA2 genes, thousands of scientists at institutes and universities in different countries have been studying the patterns of the appearance and growth of tumors, the role of these genes in the development of breast cancer, as well as the general principles of isolation and work with genes for many years with public money. However, any invention is not made in a vacuum, but uses previous developments in the relevant field, and it is much more interesting to understand how companies dispose of the scientific data that have been obtained over the years of exclusive "use" of patented genes.
Statistics on the frequency of detection of certain mutations in people of different ages or races would help scientists better understand the mechanisms of disease development and develop more effective means of prevention and treatment in the future. However, companies are reluctant to share such data, and, again, not all scientists will want to spend efforts on studying them, given that the patent holder may very well have to "unfasten" for his own work.
Another "side effect" of patenting: a technique that a company has secured the right to may turn out to be imperfect (for example, according to some data, the share of false negative responses in the analyses developed by Myriad Genetics was up to 12 percent). Since the development of a new technique may be hindered due to the unwillingness of other companies to pay royalties or buy a patent, patent holders have to improve their methods alone, which, of course, does not please potential patients.
To describe these consequences of the use of patents on biotechnology (and not only), a special term was coined – the tragedy of anti-communities. The essence of the tragedy is that the actions of the owners of exclusive rights to something (and the owners work only for themselves for the sake of increasing profits) lead to a suboptimal expenditure of a common resource. However, even opponents of patenting admit that the tragedy of anti-communities, if it has manifested itself, is not very significant yet.
PlantsMedicine is not the only field where genetic patenting is flourishing.
Almost more such patents have been issued for objects used in agriculture. Future patent holders seek to secure their rights to approximately the same things as biotech firms: fragments of the genome, methods of its modification and new varieties obtained by genetic engineering – more productive, more resistant to pests, and so on.
Patenting a new variety with specific mutations seems more reasonable than securing the rights to study the gene present in all people, but scandals are not without here either. "If a patent fixes the right to a technology, a new plant variety and its production and sale is a common practice. But if a patent for a variety, a GMO or an inherited trait restricts the possibilities of scientific research or the use of the variety in further crosses, then this, in my opinion, is unacceptable," Radchuk believes. However, disputes most often relate to the illegal use of patented GMO animals or plants.
* * *
Proponents of patents believe that it is wrong to consider these documents as something limiting the development of a particular product. "This point of view is typical for Russia, but, in general, the situation is rather the opposite: patents regulate intellectual property rights (and are themselves a commodity) and stimulate the receipt of funding and the conduct of applied research by companies holding patents or buying the rights to use them," says Severinov. "Patenting in general is probably an important mechanism for regulating legal property relations," Radchuk agrees. – And technologies can be patented: in any case, now it is unlikely to serve as a brake. On the contrary, much more valuable and interesting things have been developed and discovered in biotechnology than allowed on the market. But personally, I am against patenting genetic material. It is still to be studied and studied. The sooner we stop patenting genes, the better it is for all of us, no matter how sophisticated the lawyers are in the wording."
It is obvious that with the development of molecular biological technologies and the study of the role of heredity in the development of diseases, the number of patented genes, mutations and methods of their analysis will only grow. In parallel, the number of dissatisfied people will also increase, believing that mass patenting of biological objects will lead to a serious slowdown in research. And, I think, the loudest battles are still ahead.
Portal "Eternal youth" http://vechnayamolodost.ru29.08.2012