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Free Example of Issues Analysis on Gene Patents Essay

Recently in two U.S. courts were successfully challenged the patents on two human genes. This is an important event in the history of medicine. Two independent judgments should have a major and positive impact on the progress of medicine in general and the industry of biotechnology in particular.

This court decisions are interesting because of several important reasons. First, they make you think about how it is generally possible to patent human genes, which are the product of evolution (or even the creation of nature), but not a man-made mechanism. Holders of patents on genes BRCA-1 (the company Myriad Genetics) and NF-kB (Ariad Pharmaceuticals) argued that the process of separation of the gene from the body makes it an object suitable for patenting. On their side was (may be not legal) the previous gene patenting history - according to a study conducted in 2005, 20% of human genes have been patented and some even repeatedly. Moreover, different U.S. courts have repeatedly confirmed these claims. This time, the judge, however, concluded that the ideas (in contrast to the mechanisms and processes) cannot be patented, and patents were challenged.

The second reason that the recent developments will have far-reaching consequences is the importance of the disputed genes. One of them is a gene BRCA-1. This gene is the breast cancer gene. The carriers of some mutations in this gene get breast cancer with a probability greater than 80% (to 70 years, in addition, it increases the risk of ovarian cancer.) The holder of a patent for BRCA-1 is the company called Myriad Genetics. It sells the only existing test for pathogenic gene mutations. The test costs about 3000$ and has no competitors in this field, because it is protected by a patent. The problem is not only in the high cost of diagnostic test: Many people would like to confirm the results of the test independently, but just cannot do it because of the patent.

The second disputed gene is the NF-kB. It is a transcription factor, which means that it directly affects all the operation of multiple genes in the human’s body, some of which are very important for medicine. A discussion in the court was a consequence of the fact that the patent holders wished to receive 65 million dollars, plus royalties (2.3%), from the pharmaceutical giant - Eli Lilly, because the two drug companies, according to the plaintiffs, violated the patent. Now justice is restored by a court of second instance, after the 2007 regular court recognized the legitimate patent.

Both disputed patents had the same weakness – they had too broad claims. The patent on the BRCA-1 gene has been formulated in such a bad way that it effectively prohibited the scientists and competitors to explore over a million DNA sequences, found in 80% of human genes. But rational American judges have appealed their decisions not only to the weakness of specific applications. They have appealed to the very principle itself - human genes cannot be patented. “The academic theory says: the judicial conclusion on the claim to Eli Lilly, - cannot be patented, no matter how useful and revolutionary will be the results, based on these inventions.”

The victory of common sense is pleasant by itself, but in this case it will have a meaningful impact. These two created precedents, coupled with their widespread and unequivocal support, mean the end of a brief era of patents on human genes. Certainly the development and testing of genetic tests and medications will be engaged by people who used to be in fear of litigation.

More than half of the directors of big laboratories in the U.S., according to a study published in 2003 in the scientific publication Journal of Molecular Diagnostics, refused of such research works, fearing of persecution by the patent holders. Pharmaceutical companies, which have particularly difficult relationship with patents, will also be actively involved in genetic diagnosis and development of new drugs. And soon a genetic test for predisposition to breast cancer will significantly drop in price.

Let’s consider another case related to the patenting of genes. Some of the anti-cancer drugs appear after a better understanding of how the disease develops. Others operate by such mechanisms, which we do not understand, and they give us a fresh look at the problem. You can rarely find a drug that has been waiting for its permission to use for years and at the same time involves effective treatment of all forms of the disease.

This medicine - simple small molecule called dichloroacetate (DHA = DCA). Studies in Canada, conducted by Evandelosom Michelakisom from the University of Alberta in early 2007, showed that it has excellent anti-cancer properties. And that's not all! The mechanism of this drug is also admirable.

In 1930, Otto Warburg suggested that the cells become cancerous by changing the way they get energy. Normally, to provide themselves with energy, the cells rely on special organelles, called mitochondria. Cancer cells are switched to a process called glycolysis, which occurs inside the cell. This ineffective process is also used by bacteria, as well as runners - marathon, when oxygen in the body is missing.

Surprising that Warburg found that cancerous cells still use glycolysis even when there is enough oxygen for them. The researchers claim that this fact, called the Warburg effect, is a defining feature of cancer cells. But the idea has not got accustomed, perhaps because another famous biochemist Hans Krebs believed that the Warburg effect was only a symptom of cancer, not the root cause. This skepticism was reinforced by the fact that cancer cells switch to glycolysis because their mitochondria are not working.

Since the time of Warburg, much became known better in the metabolism of the cells by the fact that science does not stand still. The human body is alive and functioning expense of energy from food consumption. Nutrients are split into shorter molecules which, when combined with oxygen, release energy. The elementary portion of the energy in the body is stored in the form of ATP - the energy bargaining chip, which then gives off energy in the right place for the vital processes of the cell. In normal cells, the burning of nutrient molecules and the formation of ATP occurs in complex organelles - the mitochondria’s. It is highly economical process that allows cells to use nutrients efficiently. However, in cancer cells, mitochondria are damaged for some reason, and cannot work as energy plant cells. Therefore, such cell switches to glycolysis - reaction in which cells in the lumen of the glucose molecule are cleaved to form one molecule of ATP. This is a wasteful process. During glycolysis, lactic acid is formed, which breaks down collagen matrix that connects the cells together. These abnormal cells leave their place and can move in the body to form cancerous tumors in other parts of the body - metastasis. In mitochondria, as scientists have recently discovered, there is another important role. They trigger apoptosis - the natural death of cells. If the mitochondria are damaged, the cell becomes immortal, that’s how cancerous is started.

Let us return to dichloroacetate, which was used for many years for the treatment of patients with mitochondrial diseases, rare disorders of metabolism in the body. This drug enhances the ability of mitochondria to produce energy. When it comes to cancer cells - the same thing happens: apparently, the mitochondria in cancer cells are not damaged permanently. And even more, working mitochondria helps kill these altered cancer cells.

When Michelakis experienced this medicine on the culture of cancer cells contained in the lab, they died. This effect was observed in relation to the cells of lung cancer, breast cancer and brain cancer. Dichloroacetate does not damage normal cells. It appears that Warburg was right - glycolysis is something more than just a symptom of cancerous cells.

The most interesting thing is that dichloroacetate appears as prospective anti-cancer drug. It is not expensive and does not damage healthy cells, we are well aware of its side effects, and it should be effective against all types of cancer. But there is one problem: it's an old remedy and it cannot be patented. No drug company wants to fund expensive clinical trials, without obtaining exclusive rights to produce and sell the drug. This problem is not new. Many drugs are on the shelves, because the companies cannot get their big profits. It happened with drugs for diseases that affect poor people in developing countries, such as tuberculosis. In contrast, cancer - a disease of the rich and testing dichloroacetate require very exceptional effort.

You can bet that the pharmaceutical companies will make every effort to find a patentable compound with the same mechanism of action as that of dichloroacetate. Each of them, introduced to the market, will be very expensive. But it will be a scandal, if a cheap alternative means, with such wonderful properties, will not get its chance, simply because it is not enough to bring big profits.

Patenting of genes and discovered living organisms won’t end well. Small corporate elite will soon control the entire genetic heritage of the world. Scientists, who have discovered genes and methods of manipulating them, can obtain patents and therefore, the right of ownership, not only on the technology of genetic changes, but also on the genes themselves. Chemic-pharmaceutical and bio-technological companies, quickly trying to discover genes of plants, animals and people, to patent them, and make a full capture sectors of agriculture, livestock farming and food production. This is the same company that promised us a life without problems with pesticides and plastics. Can you trust their plans for the future?

The study of the human genome may lead to the declassification of private information and new levels of discrimination. Some people have been denied medical insurance on the basis of the bad genes. Will the gene scanning be required for employees, and will they be dismissed from their work on the basis of its results? Will the government have access to our personal genetic profiles? A new level of discrimination against people, whose genetic profiles indicate that they are unhealthy, can be easily imagined. For example: less intelligent, or predisposed to the emergence of certain diseases.

Based on this experience, we can see that the patenting of human genes, diseases and drugs from them can have both negative and positive side. Patenting genes we touch a lot of ethical and moral issues and at the same time, a variety of diseases are waiting for the drugs that treat them, to be patented and produced.

Code: Sample20

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