In March 2009, the Indian Patent Office rejected an opposition filed by a public health group against granting a patent to the Swiss drug company Hoffmann-La Roche for the hepatitis C drug pegylated interferon alfa2a (brand name Pegasys). Roche had been granted a patent in 2006.
The Mumbai-based NGO Sankalp Rehabilitation Trust filed a post-grant opposition to the Patent Office's decision. It was joined by an Indian company, Wockhardt.
Sankalp argued that the patent to Roche forced patients with chronic hepatitis C to pay more than Rs 4.5 lakh for a six month course (Roche charges Rs 4 lakh, and the other drug, to be taken along with Pegasys, is some Rs 50,000.) Hepatitis C is a blood-borne viral infection that is a major cause of liver disease and liver cancer in India.
Sankalp also argued that that the product was not an innovation. Roche's technology for combining interferon alfa2a with a structure called polyethelyene glycol(PEG) has been known for years prior to its claim for a patent. So Pegasys would not be patentable under section 3(d) of the Patents Act.
However, the Patent Office upheld Roche's claim that their combination product had improved therapeutic efficacy and therefore met the standards of clause 3(d).
It is obvious that when the drug is priced at Rs.4.5 lakh, the vast majority of patients in India will not be able to afford this treatment. When India was forced to change its patent law to comply with the provisions of the Trade Related Intellectual Property Rights (TRIPS) agreement of the World Trade Organisation, many activists including this journal had campaigned for clauses to protect the interests of patients in India, pointing out that many life-saving medical products were likely to become unaffordable. We now urge to government of India to invoke the special provisions available to ensure that this and other life saving medicines are available to all who need them. This is an ethical duty.
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