Roche has become the first pharmaceutical company in India to be granted a product patent under the country’s recently-implemented patent regime.
India passed the patent law last year in order to comply with the requirements of the World Trade Organisation (WTO), whose ranks the country recently joined. It replaced an earlier, less restrictive legislation that allowed patented drugs to be copied, as long as a different manufacturing process was used to make them.
The Indian Patent Office granted the product patent to Roche for Pegasys (peginterferon alfa-2a), its long-acting hepatitis therapy, under the portion of the law covering post-1995 inventions. Because Pegasys was developed after that cut-off date, Roche can claim protection for 20 years from May 15,1997. Drugs developed before 1995 cannot be patented under the new law.
While welcomed by the pharmaceutical industry, aid agencies such as Oxfam and Medecins sans Frontieres have expressed concerns that the law would deprive patients in from newer, more effective drugs not only in India but also other countries around the world that have come to rely on supplies of Indian-made, affordable copies of in-patent medicines.
The cost of treatment with Pegasys for a 24 weeks of therapy is about 250,000 rupees ($5,600), including diagnostic tests and co-treatment with the antiviral drug ribavirin.
Girish Telang, managing director of Roche India, said the development would "usher in the next wave for the Indian pharmaceutical industry, by way of a flow of newer innovative molecules to the Indian market, complemented by increased investments in R&D towards drug development efforts."