What Can Be Patented In The Field Of Genomics And Proteomics

At present, there is no general patent system available under which regime a patent with worldwide extension can be achieved. However, the World Trade Organization (WTO) has issued an international regulation concerning intellectual property rights binding WTO member sates. This regulation is named Agreement On Trade-Related Intellectual Property Rights (TRIPS). TRIPS Article 27 says ''[...] patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.''

However, the second and third paragraphs relativize this very general statement by stating

Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect order in the public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment, provided that such exclusion is not made merely because the exploitation is prohibited by their law. Members may also exclude from patentability: (a) diagnostic, therapeutic and surgical methods for the treatment of humans or animals; (b) plants and animals other than microorganisms, and essentially biological processes for the production of plants or animals other than nonbiological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis system or by any combination thereof.

Therefore there are still significant differences in the patent systems of the world, although the TRIPS agreement helps to harmonize the different systems in the future by founding a basis to start with. However, the field of biotechnology, besides the software industry, is still the area most affected by any exceptions of the broad definition according to TRIPS Art 27 (1). The statutes of the European Patent Convention (EPC) contain exclusions from patentability as mentioned in TRIPS Art. 27 (2) and (3). The European Patent Office (EPO) grants patents which are, after grant, administered by the contracting states chosen by the patent applicant. The European Commission issued a Directive 98/44, which was adopted by the European Patent Organization.

One of the most significant feature of the Directive refers to the provisions pertaining to the patentability of biological material. Among other things, it was regulated that an isolated nucleic acid of human origin, an isolated gene of human origin, an isolated protein of human origin, parts of the human body in isolated state, cells of human origin, as well as compartments of cells of human origin could be patented as long as these subject matters were fulfilling all other patentability requirements such as novelty, inventive step, industrial applicability, and sufficiency of disclosure. The requirement of sufficient disclosure of a protein or nucleic acid or gene is only fulfilled if a function of these entities is disclosed. The Directive also regulates that the human body, at various stages of its development, including germ cells, is not patentable. This includes a sequence or a partial sequence of a gene if no function is disclosed. The Directive identifies four classes of inventions to be unpatentable. These include, but are not limited to, processes for cloning human beings; processes for modifying the germ line genetic identity of human beings; use of human embryos for industrial or commercial purposes and processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal (this description was adopted from the oncomouse decision).

Before the Directive was issued, the EPO granted patents on transgenic animals following the decision of the Board of Appeals T 19/90 (Oncomouse Decision).[2] Also, transgenic plants are patentable as long as the respective patent does not encompass a plant variety. The Directive has not yet been transformed into national law by eight EU member states, e.g., Germany, Italy, The Netherlands.

The situation in the United States was not as difficult because higher life forms were regarded as patentable. The application concerning the Harvard Mouse issued to US Patent 4,736,866 on April 12, 1988. It issued without difficulty following the ''oyster'' case, Ex Parte Allen (Board of Appeals and Interference, April 3, 1997[3]), which held that polyploid oysters are nonnaturally occurring manufactures or compositions of matter, falling within the definition of invention. Furthermore, subject matter directed to plants and seeds are routinely allowed by the U.S. Patent and Trademark Office, and in general, higher life forms are considered patentable subject matter within the United States. Similarly, in Japan, higher life forms, both plant and animal, are considered allowable subject matter.

Although the patenting issues have widely been resolved as far as the granting proceedings are concerned, there is still an ongoing debate on ethical issues involved with patenting of living material or material derived from living material. Also, little is known-as of yet, how civil courts will handle patent infringement lawsuits concerning biological inventions.

Getting Started With Dumbbells

Getting Started With Dumbbells

The use of dumbbells gives you a much more comprehensive strengthening effect because the workout engages your stabilizer muscles, in addition to the muscle you may be pin-pointing. Without all of the belts and artificial stabilizers of a machine, you also engage your core muscles, which are your body's natural stabilizers.

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