Gleevec, Nexavar cases put India’s IP laws to test

Tuesday, 04 September 2012 13:08 The debate on patents vs patients remains on the boil, with the Bayer/ Nexavar and Novartis/ Gleevec cases keeping the issue live. While it has taken six years for the Novartis case to reach the final argument stage, the Bayer vs Natco Pharma case is just a few months old. Both 'landmark judgements' which triggered these appeals have been hailed by global aid agencies like Médecins Sans Frontières (MSF). Commenting on Bayer's appeal, Michelle Childs, Director, Policy and Advocacy, MSF Access Campaign comments, "The patent controller has set an important precedent that can be applied to other drugs priced out of reach."Patent holders too worry that these decisions will set a precedent. Thus the issue goes beyond Gleevec or Nexavar. As Professor Paul Herrling, Head of Corporate Research, Novartis explains to business blogsite Pharmalot, "What we really are interested in is a discussion or statement about the patent law in India. What kind of innovations can be protected and not be protected?"Other critics of these decisions, like Jay Taylor, Vice President – International, Pharmaceutical Research and Manufacturers of America (PhRMA) aver that "compulsory licensing will never cure the many issues facing healthcare around the world", alluding to "the lack of core healthcare infrastructure and inadequate financing mechanisms" in India. He points out that even though less than one per cent of all medicines in India are patented and none of the medicines on India's Essential Drug List are patented, the World Health Organization estimates that a mere 20 per cent of the country can afford those off-patent treatments.Indeed, both cases are indicative of how India's regulators feel that they need to use policy to address the country's healthcare burden. And India is not alone in this approach. A recent report from GlobalData, titled, 'Global Healthcare Policy Analysis 2012 – Regulatory, Pricing, and Reimbursement Assessment', examines how these two countries are crafting patent policies and drug pricing laws to meet these goals.The GlobalData report also examines how this stance of policy makers has forced industry to evolve a counter strategy. For instance, Roche has announced that it will introduce cheaper, differently branded versions of certain drugs in India to pre-empt the issuance of compulsory licenses. Many MNCs already have donation programmes. According to Herrling, 90 per cent of all patients in India requiring Gleevec get the medication free from the company's donation programme.Notwithstanding Novartis' and Bayer's arguments, there is growing acknowledgement among MNC pharma that they have to change. "We must get the balance right," said Andrew Witty, global CEO, GSK, at OPPI's AGM last year. (See Express Pharma report: http://www.expresspharmaonline.com/20111031/market18.shtml) While Witty made the point that there needs to be a level of certainty that success in drug discovery "will be rewarded reasonably", he stressed that this "does not equate with the right to charge a high price".Thus, the path chosen by India's policy makers seems to be the best choice, given the circumstances. Legal battles will take they own course, but if more companies evolve differential pricing options and expand patient access programmes; if only to thwart compulsory licenses and price cuts, patients will benefit. It seems to be a clear case of the means justifying the ends.