Healthcare activists have welcomed the verdict hoping it will prompt generic competition and usher in cheaper, copycat biologics to the market. “Currently, Roche's price of Rs.13,700 (∼$253) for one 180-μg vial of Pegasys is unaffordable,” says Leena Menghaney, India manager of Médecins Sans Frontières' Access Campaign that aims to integrate hepatitis C treatment into its medical programs. “Now that the patent barrier is gone, it is possible for companies to start developing a biosimilar of the drug,” she tells Nature Biotechnology. The decision to revoke the patent is ironic, as Pegasys was the first drug to be granted a patent in India after the Patents Act was amended in 2005 to honor product patents.
The ruling has encouraged other patients' groups to act to break patent monopolies on drugs. A coalition of nongovernmental organizations, breast-cancer survivors and academics led by Kalyani Menon-Sen, in a letter to the Prime Minister, has complained about the high costs (over $25,000 for the entire cycle) of Roche/Genentech's breast cancer anti-HER2 chimeric monoclonal antibody drug Herceptin (trastuzumab). “We're not planning a petition [in the Patents Office] right this minute, but are hoping that the Pegasys decision will inspire government to set up supportive systems for production of biosimilars,” she says. Shamnad Basheer, professor of intellectual property (IP) law at the National University of Juridical Sciences in Kolkata, thinks “it is likely that many patent applications would be rejected in future and that many drug patents already granted would be invalidated.”
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