Mumbai: After Novartis AG’s Glivec and AstraZeneca Plc’s Iressa, it’s now Swiss drug maker Hoffman La-Roche Inc’s hepatitis-C drug Pegasys that is set to stir up new questions on India’s patent regulation. While the first two products have been struggling to get their patents granted, Pegasys is all set to fight a battle to retain its patent.
Roche, which was the first drug company to receive a patent in India for this hepatitis-C drug, is planning to defend its patent protection in response to formal opposition from local rival Wockhardt Ltd., which is opposing the patent that was granted by the patent office in Chennai to Pegasys (a biotech drug known as peginterferon alfa 2a) in March 2006.
The Wockhardt case appears to be the first formal instance of a local company opposing a patent. Indian pharmaceutical firms are used to challenging patents in markets such as the US and Europe as they seek to sell generic versions of the patented drugs. Wockhardt’s case underscores how they now seem to be turning their attention to the domestic market. Industry analysts also note that there are about six other pre-patent grant objections from Indian companies.
Says Girish L. Telang, managing director of the Indian subsidiary of the Swiss pharma giant: “We have strong ground to defend the patentability of this drug.”
Wockhardt’s filing is likely to come up for hearing before the newly constituted Indian Patent Appellate Board’s patent cell, which is headed by S. Chandrashekharan, the former head of the Indian Patent Office, which had originally granted the patent to Pegasys.
“When the case comes up before the appellate board, the merits and objections presented by both parties will be taken into account and then a decision will be taken,” says Chandrasekharan. A Wockhardt official, who does not wish to be identified, said the company has opposed the patent on the ground that interferon alfa-2a, the technology of this hepatitis-C drug, is already known. Wockhardt has invoked the provision of Section 25 of the Indian Patent Act, which allows opposition of a patent that is already granted. Indian patent law requires a post patent opposition to be filed within 12 months of the grant, the window within which Wockhardt has filed its claim.
Pegasys is a pegylated (long acting) interferon alfa-2a, which involves a technology that reduces the frequency of injections to once a week, as compared to the earlier practice of three a week. Telang says that there were no generic versions of the product in the market.
Hepatitis-C is a blood-borne viral infection affecting the liver and is often referred to as a Rs.hidden epidemic’, as it takes years before symptoms develop. Pegasys was launched in India four years ago. The cost of the drug to a patient is about Rs2,25,000 for a six-month course. The total cost of the Roche treatment includes, testing, monitoring and follow-up, besides the cost of another drug Ribavirin, used in some cases with Pegasys, which is also bundled into this package.
India has an estimated 10.9 million people suffering from chronic hepatitis-C. Other generic hepatitis-C drugs (Interferon 2a) are sold by Hyderabad-based Biological Evans Ltd, Wockhardt and Intas Biopharma Ltd. A treatment with these drugs would cost between Rs12,000-24,000 for a course.