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Home >> Biotechnology /Genomics and Intellectual Property >> Intellectual Property Rights (IPR) - Patents
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Intellectual Property Rights (IPR) - Patents - The granting of special exclusive rights (for trading new articles) 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 articles that would be of benefit to the society.

Under U.S.A. law, a patent means grant of "right to exclude others from making, using or selling" an invention for a 17 year period. Patents are usually allowed for a specified period. In India, The Indian Patents Act of 1970 allows 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, whichever 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.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 curtailled under local nuisance ordinances.

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. 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, 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 patent. Infringement of a patent is often found when an accused object is physically different, but legally equivalent to the subject matter claimed.

For instance, if a Pseudomonas strain is prepared for remediation of oil spill, then an analogously prepared Bacillus strain will infringe the patent, but if a different mechanism is involved (although for same purpose), the infringement may be avoided. Patents for life forms are discussed in greater details.
 

 
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