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Patent protection of biomedical innovation projects possible role of TRIZ and ARIZ in the formation of this protective strategy (part one)

2012-08-30
Andrew (Gabriel) Livshits, Jaroslav Vashchuk

Today we have the opportunity to observe the rapid development of biomedical technology in a wide range of areas and hitherto unprecedented depth of integration with classical biological and not just technology, including semiconductor and micro-electronics, nano-technology and precision metrology technologies (including technology contact measurement and monitoring)
This is particularly apparent in Silicon Valley (USA, California), which is gradually venture with the now classic semiconductor orientation perform rapid reorientation of the production equipment and instruments for biomedical applications
First of all, this can be attributed to the complex equipment (such as scanners) but successful rapid development of such areas, such as genetic engineering, have formed a powerful sector of biomedical technology products, which has its own laws and regulations, including its patent tradition not quite similar to traditional practices and methods of patent protection
Referring to the latest publications on this topic:
Inside every cell in your body is the genes and you really think that they belong exclusively to you.
Until recently, it was, but in recent years more and more fragments of human DNA are protected by patents of different companies that can use them on your own.
Although de facto genes within you - your still, de jure use them for their own benefit, you can only through the mediation of foreign people - and for big money.
Patent - is protected document that entitles the owner exclusive use of his invention for a certain period of time. If using patented things can make a profit (but for the sake of it and all the stories are started with patenting), all wanting to make this thing will have to buy the patent owner the right to use it.
Progenitors of the present patent existed in ancient Greece, and in more or less its present form, this privilege shape by the end of the XV century. But the real heyday of patenting began in the Industrial Revolution, when humanity finally at full strength come from the study of nature, and the market began to appear regularly new inventions. Patent laws of different states improved and become more complex, trying on the one hand, to ensure maximum protection of the rights of the inventor, and on the other - to prevent the imposition of restrictions on the use of the entire row.
Patent issuance rules vary from country to country, but they all require the claim to be a citizen of the paper or the company had a direct relation to the object, which they provide to the Bureau. In the previous sentence, deliberately used the word "inventor", because in some cases - for example, the patenting of genetic objects - talking about the invention can only be a very big stretch.
Time obtaining patents entitle their holders to enrich themselves at the short term - say, if the patented invention does have some value, and the author will be able to properly dispose of it. Not surprisingly, the inventors sought "safe conduct" to any fruit of their intellectual efforts. The lists of patented objects found around the device for ironing pets cooling hat for hot weather or a bra, specially adapted for carrying liquids.
When biology and medicine have advanced a little further making potions of bats and blood-letting, the authors of new discoveries in these areas, too, began to try to protect their patents. First patented object, obtained on the basis of human material, and in 1906 he became the adrenal hormone epinephrine. Almost immediately, the possibility of granting such a patent has been challenged in court. Process against Davis Park Mulford (Parke-Davis versus Mulford) has long been considered the first precedent, raise the question of the legality of the exclusive rights to use something that was not human, and nature. However, a more detailed analysis of historical documents showed that the sacramental solutions that isolated and purified adrenaline - this is not the work of nature and man-made product (and hence, it patentable), during the process were made. In reality, the nature of litigation amounted to a conflict of the two producers, almost simultaneously released to the market very similar drugs. However, this process is like to refer to the discussions of how justifiable and reasonable practice of patenting biological objects.
In 1923, the University of Toronto for one dollar bought from biochemist Frederick Banting patent for insulin, also isolated from the glands of animals and purification. Were later patented vitamin B12 and other biologically active compounds. In XX century, when researchers became evident the fundamental role of the DNA saga began patenting of genetic material.
The first patent for deoxyribonucleic acid was obtained in 1980 by Stanford University has secured the right to use developed in the laboratories of Stanley Cohen and Herbert Bauer's technology to create recombinant DNA, which allows you to make a variety of changes in the genomes of living organisms.
In the same year there was a famous trial Diamond v. Chakrabarty (Diamond versus Chakrabarty), which resulted in the U.S. Supreme Court decided that living organisms can be the object of a patent if they have been altered by man. The reason for the patent litigation was obtained by the American microbiologist Ananda Chakrabarty Indian origin on he created genetically modified bacteria Pseudomonas, which can break down crude oil. Different institutions that make decisions for the benefit of scholars, against him, but important for future trials with a final verdict.
The conclusion of the court (the decision by five votes to four) stimulated a boom patenting of various genetically modified organisms, from viruses and bacteria to plants, animals and cell cultures. The last step was the patenting of genes - DNA segments that encode certain proteins of the body.
For citizens, frightened unpleasant prospect of being associated patents on everything, including on the part of his own body, the lobbyists have one consolation. All the same U.S. patent law, as well as similar documents of other states, requires that patentable subject had a certain usefulness. In the case of securing the rights to the DNA molecule, this means that the battle will unfold for the genes encoding the most important health proteins, and methods for the detection of mutations in them.
"The idea of patenting genes, or rather a sequence of fragments of gene expression occurred Craig Venter (the odious American biochemist who has made a significant contribution to the human genome and has recently announced the creation of an organism with an artificial genome - a comment." Heathcliff "), even when He worked in the NIH (National Institute of Health, USA). then on this was a lot of noise (just due to the "utility" of patentable sequences) wind up with what Venter left NIH and established private institute for Genomic Research, "- commented situation with patents biologist Konstantin Severinov, Rutgers University Professor (USA), head of the laboratory at the Institute of Molecular Genetics and the Institute of Gene Biology, Russian Academy of Sciences.
The trend is quite took shape as early as 2005: the patented DNA fragments are distributed throughout the genome is extremely uneven: sites of unknown function or genes are not related to health, not interesting, and the other pieces of the genome have already two dozen patents. The record for the number of issued bills they have genes BMP7 and CDKN2A. Gene product BMP7 - the so-called osteogenic protein can stimulate the formation of cartilage and bone, and the protein encoded by the gene CDKN2A, inhibits the growth of tumors. "In the case of sequences of genes coding for pharmacologically important target, as well as three-dimensional structures of target proteins themselves, the potential" utility "is quite obvious: it's diagnosis, and the development of new drugs, and much more. Burden of proof lies with the applicant utility and if, for example, the U.S. Patent Office recognizes that the application has novelty, non-obviousness and utility, then there is no reason not to grant the patent is not "- said Severin.
According to proponents of patenting, the imbalance in gene patenting will not harm: the law requires that the holder of the patent as to disclose information on their invention (although in biology, and so decided to disclose the results of their research and developments - or simply the scientific community does not recognize). This openness should encourage professionals from related fields as much as possible to do research "around" the subject of patents, in the long term too something to invent, to stake out their rights and make a profit. In fact, the restriction of the rights to the use of a gene likely discourage other scientists desire to do his research. Patented DNA sequence already exists, and invent something "around" it, without violating the rights of others, is quite difficult, and the legal costs can be significant
While still patent holders have not touched on bioobjects purely fundamental laboratory: many companies have developed special licensing agreements that allow researchers to continue to explore controversial genes. It is not known what percentage of the laboratory, these agreements signed, but there is no abuse hearing loud scientists patent rights were not. "Fortunately, the patents often provide for research. Fundamental science willingly use it. But if suddenly something useful comes out, then sell it hard. Scientists, especially those involved in basic research, as a rule, whether businessmen," - said Ruslan Radchuk, molecular biologist, researcher at the Institute of plant genetics and crop research in Germany.
Laboratories for pharmaceutical and biotechnology companies have much worse: their activities holders of rights to biological objects monitored very closely. In this study in these laboratories is quite "real", even with a medical slant. Severinov believes that it's worth looking at the situation from the other side: "The license fee for the use of information that can save you time, just, as the company uses for its commercial project information obtained is not it, and you have to pay." Radchuk not agree with this point of view: "I naively believed that science and knowledge - this is a public, so to speak, the national product. This is what gives rise to human intelligence and passed on from generation to generation by word of mouth. If that first monkey, who came up with a stick to crack the nut, patented a method and tool and limited its use for other relatives (only because it was the first), or offers a new chopping nuts, it is unlikely that mankind would have evolved into something meaningful. "
There are those who believe that patenting genes and methods of their study, or is invalid, and very "down to earth" argument. Companies holding patents for such medically relevant DNA fragments can set any price for the diagnosis of relevant deviations. In his message, released after the announcement of the next court decision on the case of Myriad Genetics, the company emphasizes that the price analysis of mutations in the genes BRCA1 and BRCA2 does "not unreasonably high." In numerical terms, this means three thousand dollars for the analysis (in the U.S.). The test may be partially or fully covered by health insurance, but not all companies have agreed to incorporate this analysis in the proposed package.
And yet the examples of deep integration of natural and synthetic of innovation and research in general are crucial and a huge influence on the change of creative engineering approach to a fairly mundane technical issues, such as in the non-contact measurement technology in the production and synthesis of various biological materials and drugs
Here is an example of such an innovative approach to the traditional tasks of the organization of production:
SPECIFICATIONS FOR AN INDUSTRIAL PROCESS MEASUREMENTS;
For technological principles must be provided:

  • Low unit cost of the measurement process;
  • High reliability of the measurement process;
  • Simplicity of the measurement process, which allows low-skilled staff or use the measurement technology in the home to monitor or assess the quality of drinking water;
  • Small size of control equipment;
  • The ability to integrate into existing technological schemes and equipment systems;
  • High efficiency;
  • The possibility of continuous operation during all the day;
  • High efficiency of the process and high repeatability;
  • The possibility of a simple and reliable process automation;
  • The use of single-use technologies and materials;
  • The ability to monitor and use the results of the monitoring process remotely;
  • The possibility of a comparative evaluation of the quality of the process and the quality of water in a small number of process parameters;

The product is based on the application, - Water quality RST-SENSOR; product is a section of the pipeline, on the outer surface of which is set resonant sensor, and the edges of which are mounted nuts records for connection to the pipeline;
The cable from the sensor is designed to connect to the analytical unit or to the control and monitoring of the entire pipeline system;
Sizes of the product - pipes from 1/8 inch to 4 inches of various structural materials with ring sensors and 4 inches or more - with the sector sensors;
Typical specifications for the product:
High measuring accuracy - the device must have a sensitivity to changes in water chemistry equivalent concentration in 0.000001 milligrams per liter;

The simplicity of design, the fixture should be used only standard or commercially available components and materials, product must consist of a fully standard elements of valves, which should determine its reliability, maintainability, low production costs, the organization of production without the use of special equipment;
Reliability and durability of the device operating time should be determined before the first failure of at least 10,000 hours, the appliance must be capable of operation for at least 10 years;
The complete lack of contact with the measured liquid; sensitivity device should not be reduced when finding between the element and the sensitivity of the dielectric fluid lining up to 2.5 mm;

The ability to embed into any existing process flow, capital equipment, boiler, steam equipment, water supply system, the system of irrigation in agriculture and water supply industries;

The low level of energy consumption for operation of a product; total cost of electricity for operation of the unit should not exceed 50 watts per hour;

The ability to control aggressive and toxic liquids device must be constructed of materials and components, allowing its use for the control of toxic and corrosive liquids;

The ability to control high-purity liquids Materials of construction for the device must not cause pollution of controlled fluid and must not break under the influence of these fluids;

To build it into the automatic control system, sensor signals should be treated as standard issued by the CPU and control systems of industrial and agricultural equipment;

Ability to work in offline mode, devices must have all the necessary components for it to work in standalone mode, without the inclusion of the network and control system main equipment;

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