Two recent developments have given a fresh twist to the unending debate on the intellectual property protection, particularly the criteria for the patentability of a product. The first was the US decision to retain India on the watch list for inadequate intellectual property compliance. The move did not come as a surprise to industry. For, the recent controversial report of the R A Mashelkar committee, which was subsequently withdrawn on charges of plagiarism, had also opined that the Indian patent law was not wholly compatible with the provisions of the global agreement on the trade-related intellectual property rights (TRIPs). What really caused a stir was the second development pertaining to the US Supreme Court's denial of patent protection to a product on the grounds that it merely recombined the elements of the existing patented products in obvious ways. In doing so, the US apex court has, in fact, virtually re-written the rules for granting patents, adding "non-obviousness" among the criteria for patentability. It has also ruled out patent protection for mere incremental innovation in the existing patented or patent-expired products. This ruling has raised the threshold for securing patents because excessive patent rights can potentially stifle innovation. The Indian pharmaceutical industry, especially the generic pharma segment, seems pleased with this development as it opens the way for them to expand their share in the rapidly growing global pharma market by challenging the large number of patents granted on incremental innovation grounds. And that means millions of dollars of business, which was otherwise being denied to the Indian industry because of the ever-greening of the patents through this route by the multi-national companies. | |
| However, for India, these developments have, in a way, increased the confusion on the intellectual property front. For one, the US court's verdict, which has obvious global repercussions, is wholly contradictory to the Mashelkar panel's stand that not allowing patents on incremental innovation is in contravention of the Word Trade Organisation (WTO) agreements, including the TRIPs. This apart, one of the reasons for retaining India on the US watch list is inadequate provisions for protecting pharmaceutical tests and other data in India. The US claims that the Indian companies resort to unfair commercial uses of data to obtain marketing approval. These issues arise largely from varied, often even mutually conflicting, interpretation of the TRIPs provisions. In any case, Article 39.3 of the TRIPs agreement, relating to data exclusivity, has remained contentious since inception for being a little vague. The existing Indian patent law, as amended in 2005, takes advantage of this confusion to settle for a regime that suits most of the Indian companies. Of course, the Mashelkar committee attempted to expose this aspect and even went a step further to suggest widening the scope of patentability by lending protection to incremental innovations as well as to micro-organisms. But, that report, technically, no longer exists. So, this allows India an opportunity to re-visit the whole issue and view it more from the Indian national perspective rather than purely from the TRIPs-compliance angle. For, the TRIPs itself may come under a review after the US judicial decree. Many countries, notably the developing ones, may even appear eager to take advantage of the resultant fluid intellectual property regime to facilitate cheaper access to medicines for their people. |
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