Cancer patents

The revelation that over 85 per cent of cancer drug applications filed in the patent office are from multinationals, albeit significant in itself, need not be viewed as an adverse reflection on the Indian pharmaceutical industry, which is steadily coming of age. Nor does it mean that all the applications will end up in patents, and that the drugs thus protected would be manufactured and marketed in India. What matters are the merits of the products offered for patent protection. From that angle, analysts feel that not many of these drugs may succeed in getting intellectual property protection, for two reasons. First, the Indian Patent Act, as amended in 2005, does not permit patents on medicines patented elsewhere before 1995. This is a safeguard to thwart bids for ever-greening or back-door revival of patents by seeking protection in other countries. Secondly, most of the applications from the multinationals are believed to be for derivatives or minor modifications of existing medicines and, as such, may be ineligible for patents. Though the patentability of minor incremental modifications in existing drugs is embroiled in controversy, especially after the Mashelkhar Committee report (subsequently withdrawn on charges of plagiarism), the law as it is today does not allow this. This is borne out by the denial of patent to a cancer drug, Glivec, from Novartis because the patent office was convinced that the medicine was nothing more than an improvement of a known substance. The final verdict is still to come, though, since an appeal against this decision is pending before the Intellectual Property Appellate Board.

The multinationals' interest in the Indian cancer drug market is understandable because of its huge size, reckoned at Rs 1,200 crore, and the large number of cancer patients in the country (about 2.5 million). However, there may be other considerations, too, for seeking patents in India, whose patent office seems to have a rather high patent grant rate, compared to other countries. This may be partially responsible for the large number of applications. The patent office should, therefore, be cautious in scrutinising these applications to ward off ever-greening. After all, what is at stake is the interest of patients who need cheaper medicines that are coming off patent. The courts seem to agree with this line of reasoning, for the Delhi High Court recently issued an interim order allowing Cipla to market Erlontinib, a lung cancer drug, though the Indian patent on this medicine is held by Roche. The lower cost of the Cipla product was cited by the court as the basis for the interim ruling.

On another tack, the need for revamping the patent office and the process of granting patents remains of critical importance. The inadequacy of the patent office's infrastructure and the number of patent examiners are among the areas that need to be looked into. Equally important is the need to have some transparency to the procedure of processing patent applications, by making it mandatory to disclose reasons for the acceptance or refusal of any patent. There is at present no proper database of patents, needed by both patent appliers and examiners.