Are we breaking our own rules?

To great rejoicing the Supreme Court denied drug giant Novartis its claim of patent protection for Imatinib which is effective against Chronic Myeloid Leukemia, a disease with a very dismal prognosis. Under our Patents Act of 2005 new drugs are to be protected for 20 years but prolonging patent protection by making small incremental changes, a process called " evergreening ", is not allowed. Novartis was marketing a crystalline form of Imatinib under the name " Glivec " at a cost of Rs 120,000 per month while a generic version is being sold in India for Rs 8-12,000. The Supreme Court did not agree that the crystalline form was a novelty or showed a significant increase in efficacy and hence disallowed the patent protection claimed by Novartis. This is being seen as a victory for poor people everywhere and a blow to the unreasonable greed of big pharma. But is it? In an interview with TOI, 5 April Ranjit Shahani, MD of Novartis in India said that this verdict will mean that there will be no R&D in pharmaceuticals in India in future. "... all R&D investments in any case have moved to China with seven global companies having invested billions of dollars after the patent law was promulgated in India. These are Novartis, Roche, Sanofi, Pfizer, GSK, Astra Zeneca and Eli Lilly. Not a single investment came to India - that speaks loudly about the innovation ecosystem we have here," he said. He also said that Novartis was giving away Glivec for free in 95% of cases and in the other 5% " on a generous co-pay programme ". Surely if 95% of patients were getting the drug free how is it a victory if they have to pay Rs 12,000 for the generic version? In fact, the original patent for Imatinib was granted in the US on 28 May, 1996 and is set to expire on 4 January 2015. The patent on the crystalline form is set to expire on 23 May 2019. If our laws grant protection for 20 years even the original version is protected so it is difficult to understand how the argument of " evergreening " is justified. This so called victory will encourage other companies to break patent protection at will. Already Merck is suing Glenmark for selling Sitagliptin, a new anti diabetic drug, at 30% discount to its price. Sitagliptin, sold by Merck under the name " Januvia ", was approved by the FDA in the US on 17 October 2006 and so is well within its protected period. Trouble is that pharma companies have acquired a very bad reputation because of misdemeanors in the past. On 3 July, 2012 the New York Times reported that Glaxo had pleaded guilty to criminal charges in the US for suppressing adverse effects of its drugs and had been fined $3 billion. It was peanuts because Glaxo had already made $10.4 billion from Avandia, $11 billion from Paxil and $5.9 billion from Wellbutrin. Why have laws if we do not respect them?