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What the issues are
1. Disclosure of information about an invention is the consideration for which patents are granted. Therefore the patentee is under obligation to disclose relevant information. One of the requirements for granting a patent is that it should be useful. The information about the usefulness of a drug, the evidence of such benefits and manner of use are part of the material to be disclosed by the patentee. This cannot be treated as confidential.
2. The Food and Drug Authority evaluates the validity and usefulness of a compound as a drug for treatment of human beings, on basis of the results of various statutory trials carried out by the claimant. The data is therefore important for the consumers that the data is available for inspection and verification.
3. If the data is not allowed to be used by the generic manufacturers for seeking FDA approval, they will be compelled to carry out similar trials and tests separately. This will mean duplication, delayed availability and additional costs, all of which will mean further delay and additional costs for the consumers.
4. If such data is kept confidential it is possible that some unscrupulous officials of FDA may be able to approve drugs even if the results are not satisfactory. This would be harmful and injurious to consumers.
5. In any case Article 39.3 of TRIPS does not fall within the purview of patent law. If confidential information is treated as an intellectual property right (IPR), like other such rights, it would also be open to licensing provisions on payment of royalty. Even copyright which is an original work and recognised as an established IPR is available for use by others on payment of royalty. Such data should be made available for use by generic manufacturers on payment of some cost or royalty of about half a percent on cost of production. — N. B. Z.
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