Present Law on Patentability of Biotechnology
At present, for a biotechnological invention to be patentable under the Patents Act 1953, it must satisfy the same criteria as any other invention, that is, it must:
- fall within the definition of invention specified in the Act;
- be useful;
- be novel; and
- not be obvious.
Although there are no specific provisions relating to biotechnology in the Patents Act, the Intellectual Property Office does have a practice of refusing patents for human beings. This is on the basis that human beings do not fall within the definition of invention in the Patents Act.
Section 17 of the Patents Act provides a general exclusion from patentability for inventions, the use of which is contrary to morality. The Commissioner of Patents may refuse patents under this exception. The Commissioner's decision is subject to review in Court. This contrary to morality exception is in practice of limited use, and has not been the subject of any Court decisions in relation to biotechnology patents.
Section 10 of the Patents Act requires patentees to supply in their patent application, a description of their invention and the best method by which it is to be performed. In relation to biotechnology claims involving micro-organisms, it may sometimes be difficult to provide an adequate description. Where this is the case, the Intellectual Property Office has a practice of requiring that micro-organisms are deposited, and are subject to an accessibility clause where access to the micro-organism is necessary to provide an adequate description 1
Section 10 of the Patents Act also states that claims for a new substance shall not be construed as extending to that substance when found in nature. The Intellectual Property Office does not allow claims for micro-organisms which occur in nature when they are found in their natural state. If however, these naturally occurring micro-organisms have been isolated, (removed from their natural state and modified in any way), it is possible to make patent claims in relation to them.
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