Indian Patent Appellate Board (IPAB) has passed a noteworthy decision in the favour of patients that will ensure a better access to medicines by revoking a patent granted to Roche for “Pegasys”, a medicine for treating hepatitis C. The ruling of 2nd November 2012 is likely to help introduce cheaper copies of the drug in the market.
Roche filed the patent application in 1997 for “pegylated interferon alfa2a”. Roche received the first ever product patent in India for Pegasys in 2006 under the new patent regime prepared for the compliance to the TRIPS Agreement, under patent no. 198952. Patentee launched the drug in India under the Trade-name Pegasys. The six-month treatment of pegasys cost approximately Rs. 4.36 lakh and at a discounted price of approximately Rs. 3.14 lakh and is usually taken in combination with Ribavarin, which costs approximately another Rs. 47 thousand, which being very high was unaffordable to a large section of people suffering from hepatitis C which if untreated would lead to liver cirrhosis, liver failure and liver cancer.
The patent was opposed by the M/s. Wockhardt Ltd. and by a NGO (non-governmental organization) named Sankalp Rehabilitation Trust through post grant opposition under section 25 (2) of the Act. The patent was said to be a chemical modification of interferon, a naturally occurring protein produced by the body which is identified to have antiviral and antiproliferative activity. These oppositions were disallowed and thus an appeal was filed in the IPAB by Sankalp Rehabilitation Trust.
Roche challenged that because Sankalp was not a business competitor or a researcher in the sector, it could not challenge its patent. Sankalp being concerned about the impact of the patent on access to the medicine argued that it represented a community of drug users particularly at risk of Hepatitis C.
The appellate board ruled that the drug did not deserve a patent on the grounds that it did not demonstrate the inventiveness. Also the appellate board stated that public interest is a persistent presence in intellectual property law.
The case is not only important as it gives a direct approach to pegylated interferon but the patients at a considerably low cost; but it also provides non-governmental organizations (NGOs) a status as “interested person” under the Act; meaning that these organizations can file a post-grant opposition or revocation petition challenging the grant of a patent in India.
The patient groups are seeing the latest IPAB order as a victory for public health and affordable drugs, the multi national drug-makers feel that the intellectual property is not being valued in the country. This is another victory in Indian patent history where another multinational company lost the case just because of section 3d and their very high price of the drug.