Pharmacy or lab?

Below the radar of popular discourse but followed closely by the pharmaceutical industry and health activists is a court case in Chennai that explains why it was fortunate that following revelations of a part cut-and-paste job, the Mashelkar report on patent law has been withdrawn and will be resubmitted. Novartis has sued the Indian government for not issuing a patent on its anticancer drug, Glivec also called Gleevec. The government has denied the patent on the ground that Novartis8217;s application did not constitute new innovation. Novartis argues this is too narrow an interpretation of patentability and that it is non-compliant with WTO patent rules. Activists are arguing that granting Novartis the patent will not only kill the cheaper generic option, imatinib, it will also start a chain reaction that will end in Indian generic companies not producing cheaper versions of expensive drugs for the world8217;s poor.

The controversial para in the Mashelkar report is on this broad issue 8212; it said that incremental innovations, that is, significant improvements on an existing patent, should be patentable. It was only a report, not a law, but it was already being quoted in patent debates. Had the report received official assent, and the issue of a cut-and-paste recommendation come up after that, India8217;s credibility would have been grievously damaged.

As for the issue of granting patents to incremental innovations, three points are ignored by radical health activists. First, India8217;s pharma sector is at a stage where patent protection will increasingly become more important. Low cost but first-rate research talent and a solid pharma industry tradition are India8217;s advantages 8212; we are better placed than China. Claims on patentable incremental innovation can8217;t be dismissed. Second, while many generics for difficult diseases are cheaper than patented products, they are still far too expensive for the typically poor person, whether in India or in Africa. So the question of affordability is a bit of a red herring. There8217;s a universal and huge problem in terms of the poor8217;s access to difficult-disease drugs 8212; tweaking patent regimes can8217;t be the best answer. Third, the charge that India will not be pharmacy to the world is not fully true. Many generics are off-patent anyway. More, if India can be one of the laboratories of the world, it should not be content with being a mere pharmacy.