The Intellectual Property Appellate Board’s decision to set aside Roche’s patent on its Hepatitis C drug Pegasys comes even as the amended Patent Act (2005) gets tested from several quarters.
Multinational drug-majors are locked in patent-related cases, at various stages of progress and arguments — at the IPAB and the Supreme Court, to mention a few.
And while patient-groups are seeing the latest IPAB order as a victory for public health and affordable drugs, multinational drug-makers say it does not send out a good signal on how the country values intellectual property.
“Coming on the heels of revocation of patent for Pfizer's Sutent, now Roche's Pegasys both breakthrough innovative products, coupled with a CL (compulsory licence) for Bayer's Nexavar not many good signals coming from India about how intellectual property will be valued - particularly since this is in the period 2010-2020 which is supposed to be the decade of innovation,” says Ranjit Shahani, President of the Organisation of Pharmaceutical Producers of India, a platform largely for multinational drug-makers.
“India has to take a call in the interest of patients that if new products - fruits of years of research are to be launched in India then Patents and Intellectual property are the other side of the equation. Providing medicine to patients who cannot afford there will be other routes... Access programmes, tiered pricing, public private partnerships and donation programme.
Also we must look at healthcare holistically just not in isolation, at pharma, at diagnostic facillities, infrastructure, distribution and nursing and medical care are just not accessible to swathes of populations in India. We need to take a holistic view,” he adds.
Eldred Tellis, Director of Sankalp Rehabilitation Trust, which had challenged Roche’s patent, however, said: “We hope that the absence of patent barrier will spur generic competition to bring down the price of this much-needed drug for those suffering from Hepatitis C. We also hope that the Government will now take concrete steps to start providing access to this medicine. It is unacceptable that people are dying due to Hepatitis C because they cannot afford to buy the medicine.”
Market observers say that latest order could open the doors to players like Wockhardt, Ranbaxy and Intas, who have expertise in the segment.
Keywords: Intellectual Property Appellate Board, Roche’s patent, Hepatitis C drug Pegasys, patent-related cases, multinationals, Organisation of Pharmaceutical Producers of India, Sankalp Rehabilitation Trust,