One step forward, another back
The latest milestone in the evolution of India’s nascent patent regime seems to suggest that the Indian judiciary values patient rights over the rights of patent holders. While allowing Cipla to market a generic version of Roche’s patented lung cancer drug, erlotinib, the Delhi High Court took cognizance of the price difference between Roche’s Tarceva and Cipla’s Erlocip and the fact that the drug is a life saving drug for cancer. This is by no means the final decision and Cipla may well have to compensate Roche for damages if the final verdict goes against it. Even so, battle lines have been drawn and the progress of the case is being monitored closely by consumer groups as well as all sections of the industry.
Outside the country, however, Indian companies have an uphill task. Ranbaxy Laboratories was recently prohibited from selling its version of Pfizer’s Lipitor in Canada and two more cases have been filed in the US to protect Lipitor and Caduet. As these cases progress to superior courts, the stakes will only get higher.
Consumer activists have always taken the stand that the law of the land should take into consideration the needs of the people of that land. Therefore, the Indian judiciary is well within its rights to interpret the law in favour of the common man, and in this case, the patient. However, it is also a fact that there has to be enough incentive for pharma companies to continue to invest in and research new drugs. And that will not happen if intellectual property rights (IPRs) are not protected. The crux of the matter is the definition of IP. Are enantiomers different enough to be considered new products? What are the parameters for judging inventive step, non-obviousness, utility, improvement of known substance, etc? Industry observers predict that the Roche-Tarceva and Novartis-Gleevec cases are just forerunners of a wave of patent litigations. Will this scare away global pharma companies? Not likely, as the ‘India advantage’ remains strong and as valid as ever.