Just when it seemed that the controversy over changing the Indian patent regime to make it compatible with the global agreement on trade-related intellectual property rights (Trips) is over, the issue has been resurrected again by the report of the technical expert group headed by noted scientist R A Mashelkar. It says the new patent law, as amended in 2005, is out of line with Trips norms because it virtually bars the granting of patents to new forms and uses of an older, or patent-expired, drug or any other entity. Trips in fact allows such protection, the group has opined. Since the Mashelkar panel's reading of the Indian statute and of Trips is not beyond dispute, the pharmaceutical industry has lost little time in challenging it. An element of vagueness is, indeed, built into the law, and this has led to diverse interpretations. The law lays down that new forms and uses of older entities, including patent-expired products, can be considered worthy of patent protection if these are significantly different. As such, it leaves room for subjective judgement about the significance of any modification of the original product. | |
| The fear of the pharmaceutical sector seems to be that if the law is amended on the lines suggested by the Mashelkar panel, foreign companies might extend their patents' validity endlessly by creating marginally new forms and/or claiming new uses. This would deny local industry the opportunity to modify older molecules and commercialise them. Oddly enough, many Indian companies are taking advantage of similar provisions in other countries' laws and applying for patents there, but they seem to be averse to the same facilities being offered at home. The ever-greening of patents in this manner can have other negative implications. Although the Mashelkar panel has itself cautioned against such ever-greening, it has not spelt out how it can be prevented. |
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| What needs to be realised is that the Trips accord was put together when the voice of rapidly developing countries like India was relatively feeble, if not totally irrelevant, in global fora. This accord, therefore, was chiselled with the interests of the industries in developed nations in focus, and this required adequate safeguards for products developed at substantial cost in research and development (R&D) centres. The main strength of the Indian pharmaceutical sector, on the other hand, has been in the production of generic drugs at lower cost to grab markets around the world. The R&D investment of these Indian companies had been low, and confined chiefly to the re-engineering of existing molecules. Now that the scope for producing copies of patented drugs through this route has been eroded, the pharmaceutical sector does not want opportunities for producing new forms of off-patent products also to go, which is what would happen if the Mashelkar panel's recommendations lead to another amendment of the law. Keeping all this in view, it may perhaps be appropriate to let the Mashelkar panel report be peer-reviewed before taking a final decision. Trips allows member countries to evolve their own (sui generis) system of intellectual property protection, keeping the local conditions in view. |
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