Sunday, May 3, 2009

National Working Group on Patent Law:

New Chemical Entity:
(i) The scope of 'invention' should be limited to basic novel product or process involving inventive step and capable of industrial application;
(ii) The scope of 'pharmaceutical substance' should be limited to new molecular entity with significant therapeutic advancement involving one or more inventive steps;
(iii) There is lacuna about the definition of 'pharmaceutical substance'. Apart from the definition there is no mention of this patentable subject matter anywhere in the amended Patents Act 1970. Section 5 of the Act has been omitted through the Patents (Amendment) Act 2005. We would suggest this Section which could incorporate specifically 'pharmaceutical substance' should be re-introduced with the following version:
Section 5
Patents shall be available for basic novel inventions including pharmaceutical substances as defined in Section 2 whether products or processes in all fields of technologies excluding inventions stipulated under Section-3 provided that they are new, involve an inventive step and are capable of industrial application.
To sum up our suggestions in regard to definitions of 'invention' and 'pharmaceutical substance' are in harmony with each other and clause (d) including its explanation under Section 3 quoted above. We would emphasize that basically the incrementally changed presentation must not be allowed for patenting.
Micro-organism:
(i) Patenting of life forms may have at least two dimensions. Firstly, there is the ethical question of the extent of private ownership that could be extended to life forms. The second dimension relates to the use of IPRs' concept as understood in the industrialized world and its appropriateness in the face of the larger dimension of rights on knowledge, their ownership, use, transfer and dissemination.
(ii) Micro-organisms as such occur in nature. If any micro-organism is discovered it cannot be called invention, it falls in the category of discovery. Micro-organism when genetically modified falls in the category of invention because of human input. Genetically modified micro-organism may perform any number of activities. If a researcher is able to research upon a particular activity, and he is allowed patenting of his genetically modified micro-organism this will result in blocking of further research on that micro-organism. This is a peculiar situation arising out of patenting of micro-organisms. In view of these circumstances it would not be appropriate even to allow patenting of genetically modified micro-organism also as such.

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