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Intellectual Property Rights (IPRs) Patents
The granting of special exclusive rights (for trading new objects/goods) has been a practice to encourage innovations.
As an example, monopoly rights (only to inventors) were granted in some countries of Europe, as an incentive to develop new products that would be of benefit to the society.
Under U.S. law, a patent means grant of "right to exclude others from making using or selling" an invention for a period of 17 years.
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Patents are usually allowed for a specified period. In India the Indian Patents Act of 1970, which has now been revised, allowed process patents, but no product patents for foods. chemicals. drugs and pharmaceuticals. If no product patent is available for a product. the same product may be manufactured by an alternative process (which is cost effective) without any infringement of the patent granted for the process.
The duration of the patent in India is five years from the date of grant of patent or seven years from the date of filing the application. which ever is less. In case of a dispute, the burden of proving that the product has not been manufactured by an alternative process. lies with the original patent holder, who has lodged the complaint.
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A patent however, is subject to some restrictions, since other Federal or State Laws need to be followed. Following are some examples.
(i) A patented pharmaceutical, in USA, is subject to regulatory purview of Food and Drug Administration (FDA) before its clinical use is allowed;
(ii) Under the U.S. Federal Insecticide, Fungicide and Rodenticide Act, genetically engineered microbial pesticides require Environment Protection Agency (EPA) permits, before they are released;
(iii) use of excessively noisome genetically engineered inventions might also be curtailed under local nuisance ordinances.
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Patents are granted after submission of an application, fulfilling certain statutory requirements. When granted, a patent is also published (in USA, patent applications are published weekly by Patent and Trademark Office = PTO), so that other competitors may try to improve the patented invention, thus further advancing the technology. Progress is actually made through dissemination of ideas, and only market ultimately determines which patented inventions are commercially successful.
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Patentable subject matter, should generally meet three requirements: utility, novelty and statutory subject matter. It is believed that although utility of a new invention (biotechnological or otherwise) can be proved (in some cases, even utility is questionable;), there have been problems in proving novelty and in defining the limits of statutory subject matter as applied to biotechnological products.
There have been several court cases in this connection, which were decided both for and against the patents.
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Infringement of a patent is often found when a questionable object is physically different, but legally equivalent to the subject matter claimed. For instance, if a Pseudomonasstrain is prepared for remediation of oil spill, then an analogously prepared Bacillusstrain will infringe the patent, but if a different mechanism is involved (although for same purpose), the infringement may be avoided.
Trade secrets
Trade secrets, often include private proprietary information or physical material that allows a definite advantage to the owner. This can be illustrated by the popular example of Coca-Cola brand syrup formula. Trade secrets in the area of biotechnology may include material like
(i) hybridization conditions,
(ii) cell lines,
(iii) corporate merchandising plans or
(iv) customer lists. Unlike patents, trade secrets have an unlimited duration and, therefore, may not be required to satisfy the more difficult conditions laid down by law for patent applications.
Disclosure of a trade secret and its unauthorised use can be punished by the court and the owner may be allowed compensation. However, if a trade secret becomes public knowledge by independent discovery or other means, it is no longer protectable.
In biotechnology, because a major part of the budget is spent on research, there is increased risk in maintaining trade secrets. The results are published and discussed in conferences and disclosed due to exchange of graduate students, thus making it difficult to maintain secrecy.
Despite this, in some cases reliance on trade secrets is more prudent than the patents, which sometimes may become outdated before the patent is granted after the application is filed (it takes about 2 years in USA and atleast 5 years in India).
Copyright
The best example of copyright is the authored and edited books, or audio and video cassettes, which can not be reproduced without the permission of the person (author, editor or publisher), who holds the copyright.
While patents and trade secrets get the protection for the basic idea, expressed or not expressed in writing, the copyright is possible only on the expressed material (printed, painted, tape recorded, video recorded or expressed in any other form). Copyright rules may be modified from time to time as has been done to allow copyrightability to computer software.
In biotechnology, the copyright may cover DNA sequence data which may be published. However, an alternative sequence coding for same protein may be prepared using wobble in the genetic code, so that the copyright is not infringed. Computer databases and photomicrographs of DNA instruction manuals related to biotechnology can also be copyrighted.
The protection to copyright is limited, however, since although one may not be allowed to photocopy the present book on biotechnology due to copyright, but the ideas given in the book can be used for any purpose, whatsoever. This is not so in case of patents and trade secrets. An instruction manual can be copyrighted and also protected as a trade secret, but can not be patented.
Trademarks
A trademark is a word or symbol "adopted and used by a manufacturer or merchant to identify his goods and distinguish them from those manufactured or sold by others". In biotechnology research, laboratory equipment bears trademarks that are well known to workers in this field.
Certain vectors useful in recombinant research are also known by their trademarks. Although ordinarily this intellectual property may not raise any legal issue, it does make a part of intellectual property of any industry.
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