High court denies Novartis Patent
Novartis has the patent in Glive beta in over 40 countries, 99% of cancer patients in India get the medicine free. Today the Chennai high court heard the case of Novartis challenging the Indian panel law, the Swiss pharmaceutical company was seeking clarity in the patent law as a critical incentive for long –term R&D investments and better medicines. The appeals on patent laws was heard by intellectual property appellate board (IPAB). Earlier the board had dismissed a petition of Novartis for a new technical member instead of the office who was responsible for the original rejection of the Glive patent in 2006 . In its current form, the patent law in India does not protect incremental innovation and does not recognize that incremental innovation provide benefits bond efficacy. According to Novartis , “Section 3(d) fails to recognize that incremental inventions have utility and value not just in improving therapeutic efficacy, but also in providing significant benefits in terms of drug delivery, patient safety and compliance.” Breakthrough innovations are rare in medical research and incremental innovation therefore is hardly incremental in the pharmaceutical industry, in this particular case the difference in Glive or beta crystalline form of imatinib mesylate for which the patent is seeked defines a cancer curing drug.But the section 3 (d) of the Indian patent law excludes these important developments . This convenient exclusion actually leads to the protection of vested interests of companies like Ranbaxy , Cipla etc. Novartis has been awarded a patent for the beta crystal Glive form in nearly 40 other countries including China, in November 2003 India awarded Novartis Exclusive Marketing Rights (EMR) for Glivec, The EMR protects the beta crystal form of the drug for five years, or until the review of the mailbox application , but at the time of patenting the Indian patent office said that the application did not satisfy its requirements for “ novelty and inventive step”. Novartis ‘s social responsibility programs reached over 33 million patients in 2006 and valued at 755 US $ , 99% of patients who are prescribed Glive in India receive it free. One valid question is on the intent of Novaris in free distribution and then the legal arm wrestle over patent and public announcemnt s of no price increase after patent procurement. No action of Novartis is out of altruism; the free distributi on is to familiarize the masses with the medicine also the free distribution helps in the research and development of the company. But as a whole the motives of the company effectively lead to cheaper medicines easily available to the Indian cancer patients, and the company holds the patent in 40 other countries then why did the high court dismiss its plea? Why was the section 3(d) of the Indian patent law not amended? Is it because the law and its technicalities left no space for the larger issue or is it a way of buying time for the Indian pharmaceuticals?
