While congressional efforts to close loopholes in current statutes, along with new legislation to curtail additionally unfavorable business practices of the pharmaceutical industry, may provide some mitigation, antitrust law must appropriately step in.
The grant of patents on minor elements of an old drug, reformulations of old drugs to secure new patents, and the use of advertising and brand name development to increase the barriers for generic market entrants are all areas in which antitrust law can help stabilize the balance between rewarding innovation and preserving competition.
Traditional medicine dealing with natural botanical products is an important part of human health care in many developing countries and also in developed countries, increasing their commercial value. Although purely traditional knowledge based medicines do not qualify for patent, people often claim so. The fast growth of patent applications related to herbal medicine shows this trend clearly. The patent applications in the field of natural products, traditional herbal medicine and herbal medicinal products are dealt with own IPR policies of each country as food, pharmaceutical and cosmetics purview, whichever appropriate.
Medicinal plants and related plant products are important targets of patent claims since they have become of great interest to the global organized herbal drug and cosmetic industries.
Writing patent specification is a highly professional skill, which is acquired over a period of time and needs a good combination of scientific, technological, and legal knowledge. Claims in any patent specification constitute the soul of the patent over which legal proprietary is sought. Discovery of a new property in a known material is not patentable. If one can put the property to a practical use one has made an invention which may be patentable.
A discovery that a known substance is able to withstand mechanical shock would not be patentable but a railway sleeper made from the material could well be patented.
A substance may not be new but has been found to have a new property. It may be possible to patent it in combination with some other known substances if in combination they exhibit some new result. The reason is that no one has earlier used that combination for producing an insecticide or fertilizer or drug.
It is quite possible that an inventor has created a new molecule but its precise structure is not known. In such a case, description of the substance along with its properties and the method of producing the same will play an important role. Combination of known substances into useful products may be a subject matter of a patent if the substances have some working relationship when combined together. In this case, no chemical reaction takes place. It confers only a limited protection.
Any use by others of individual parts of the combination is beyond the scope of the patent. For example, a patent on aqua regia will not prohibit any one from mixing the two acids in different proportions and obtaining new patents. Methods of treatment for humans and animals are not patentable in most of the countries one exception is USA as they are not considered capable of industrial application.
In case of new pharmaceutical use of a known substance, one should be careful in writing claims as the claim should not give an impression of a method of treatment. Most of the applications relate to drugs and pharmaceuticals including herbal drugs. A limited number of applications relate to engineering, electronics, and chemicals. It is obvious that management of IP and IPR is a multidimensional task and calls for many different actions and strategies which need to be aligned with national laws and international treaties and practices.
It is no longer driven purely by a national perspective. IP and its associated rights are seriously influenced by the market needs, market response, cost involved in translating IP into commercial venture and so on. In other words, trade and commerce considerations are important in the management of IPR. Different forms of IPR demand different treatment, handling, planning, and strategies and engagement of persons with different domain knowledge such as science, engineering, medicines, law, finance, marketing, and economics.
Each industry should evolve its own IP policies, management style, strategies, etc. Pharmaceutical industry currently has an evolving IP strategy. Since there exists the increased possibility that some IPR are invalid, antitrust law, therefore, needs to step in to ensure that invalid rights are not being unlawfully asserted to establish and maintain illegitimate, albeit limited, monopolies within the pharmaceutical industry.
Still many things remain to be resolved in this context. Source of Support: Nil. Conflict of Interest: Nil. National Center for Biotechnology Information , U. J Adv Pharm Technol Res. Chandra Nath Saha and Sanjib Bhattacharya 1. Author information Copyright and License information Disclaimer. E-mail: moc. This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.
This article has been cited by other articles in PMC. Abstract Intellectual property rights IPR have been defined as ideas, inventions, and creative expressions based on which there is a public willingness to bestow the status of property.
Keywords: Drug, intellectual property, license, patent, pharmaceutical. IPR enhances technology advancement in the following ways:[ 1 — 4 ] a. Rationale of Patent Patent is recognition to the form of IP manifested in invention. Rationale of License A license is a contract by which the licensor authorizes the licensee to perform certain activities, which would otherwise have been unlawful. Some examples of know-how are: i. Management of Intellectual Property in Pharmaceutical Industries More than any other technological area, drugs and pharmaceuticals match the description of globalization and need to have a strong IP system most closely.
Nature of Pharmaceutical Industry The race to unlock the secrets of human genome has produced an explosion of scientific knowledge and spurred the development of new technologies that are altering the economics of drug development.
Some Special Aspects of Drug Patent Specification Writing patent specification is a highly professional skill, which is acquired over a period of time and needs a good combination of scientific, technological, and legal knowledge. Singh R. Ltd; Law relating to intellectual property A complete comprehensive material on intellectual property covering acts, rules, conventions, treaties, agreements, case-Law and much more [ Google Scholar ]. Research and development statistics.
Research and development in industry: An overview. Bainbridge DI. New York: Longman; Intellectual property. The Design Act. The Trademarks Act along with trade Marks Rules The Geographical Indications of Goods registration and protection Act, along with Geographical Indications of Goods registration and protection Rules The Patents Act, as amended by Patents amendment Act Michaels A.
London: Sweet and Maxwell; A practical guide to Trade Mark Law. Watal J. London: Kluwer Law International; Intellectual property rights in the WTO and developing countries. The international intellectual property system: Commentary and materials. Part I. Beier FK, Schricker G. Munich: Copyright and Competition Law; WIPO intellectual property handbook.
Intellectual property in global markets: A guide for foreign lawyers and managers. Bently L, Sherman B. Oxford: Oxford University Press; Intellectual property law. Angell M. The Pharmaceutical Industry. To Whom Is It Accountable? N Engl J Med. Lexchin J. Intellectual property rights and the Canadian pharmaceutical marketplace: Where do we go from here? Int J Health Serv. Drug Inv Today. Glasgow LJ. Stretching the limits of intellectual property rights: Has the pharmaceutical industry gone too far?
Gottlieb S. Drug firms use legal loopholes to safeguard brand names. Kartal M. Intellectual property protection in the natural product drug discovery, traditional herbal medicine and herbal medicinal products. Phytother Res. Subbaram NR. Hyderabad: Pharma Books Syndicate; What everyone should know about patents?
Broadly, IP refers to legal rights to property that is produced through intellectual activity in the scientific, industrial, artistic, and literary fields. There are basically two reasons why countries have laws protecting IP rights.
The first is to give creators legal rights to their creations and the public the right to access the creations. Secondly, the laws serve as an intentional act of government policy to promote creativity and the distribution and implementation of its results, as well as encourage fair trading to facilitate economic and social development.
IP law seeks to protect creators of intellectual products or services by giving them time-limited rights to decide how their creations should be used. According to the World Intellectual Property Organization , intellectual property includes rights pertaining to:. The purpose of sharing IP rights is to ensure that a public authority is able to use the IP while allowing the developing company to maintain its IP rights and opportunities to commercialize the IP.
The IP rights protect the public authority from a vendor lock-in and create a strong incentive for innovation in the market. There are two approaches to sharing IP rights are licenses and royalties. A license refers to an agreement between the owner of IP rights and another party. The former is called the licensor and the latter the licensee. Licensing allows the developer of the innovation to keep IP rights and the public authority to avoid vendor lock-in and the resulting high costs in the event that vendors exploit their monopoly power.
There are several different kinds of licenses, including:.
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