The patenting of gene sequences has experienced a great development over the last 25 years. Indeed, thousands of patents over DNA sequences have been granted permission to research on the public and private sectors. However, although there has been without a doubt a considerable development and application of new genetic technologies, it is questionable if the patenting system used is achieving its primary objective, the stimulation of innovation and the rewarding of the authors of new inventions.
[...] Also, any superfluous duplication of effort is thus prevented. Patenting also is an incentive to promote research in new areas. Furthermore, as the inventions are published, all researchers are sure to access the same and undistorted information worldwide. However, many critics have made themselves heard not only on the different procedures used for the granting of patents, but also on the principle of patenting on gene sequences itself. Indeed, it is said that the criteria of novelty, usefulness and inventiveness are not stringently applied when granting a patent. [...]
[...] Conclusion The three major patent institutions, namely the European Patent Office the United States Patent and Trademark Office (USPTO) and the Japan Patent Office (JPO) should strengthen their collaboration in order to issue common guidelines, avoid misuse, control the strict application of the criteria for the grant of a patent, and reward the inventor while encouraging at the same time others to develop alternative tests. The granting of patens on gene sequences should be the exception rather than the rule. [...]
[...] The invention must be "useful" in a practical sense, b. Novel (not known or used before the filing), c. And "nonobvious" (it must be an improvement not easily realizable by someone trained in the relevant area). d. The sequence must also be able to be used for its purpose in its specific field by a skilled person (sometimes called the "enablement" criterion). In general, the principle of "first inventor to file" applies in the granting of patents. In the US, however, the rule is the "first to invent" principle: whoever made the invention first (and can prove it) has the property rights on the invention. [...]
[...] Indeed, raw products of nature are in principle not patentable. DNA sequences only become patentable when they have been isolated, purified, or modified so as to create a new artificial form not found in nature. This turn was taken in the 1980 landmark Supreme Court case Diamond v. Chakrabarty, where a strain of bacteria had been modified by the insertion of new genes, and was thus a human invention, not natural anymore. More specifically, when a researcher applies for patent, different steps must be taken: a. [...]
[...] Issues related to the patenting of gene sequences DNA sequences can vary, and they play a major role on how humans respond to disease, bacteria, viruses, toxins, chemicals or drugs. Thus, biomedical research is important for the development of pharmaceutical products and medical diagnostics. Gene patenting has thus a certain number of advantages: It serves as a reward for the inventions of researchers, who can use the gains from patenting to further their research. Indeed, the investment in research is encouraged with the creation of the monopoly to the inventor. [...]
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