India's generic industry received a windfall on November 2 when the Intellectual Property Appellate Board (IPAB) withdrew a patent granted to Pegasys (pegylated interferon alfa-2a; IFN-alpha2a), marketed by the multinational Roche of Basel, for use in combination with ribavirin (Rebetol, Virazole, Copegus) in treating hepatitis C virus (HCV). The board ruled, after hearing an appeal by Mumbai-based Sankalp Rehabilitation Trust, a patient advocacy group, that the drug is not a new invention, as the process by which polyethylene glycol (PEG) is added to IFN-alpha2a was already known at the time of the patent grant. The appellate board also cited the drug's high cost (over $8,000 for a 6-month course) as a reason for revocation. The decision makes it possible for generic drugmakers to introduce low-cost copies of Pegasys. It also sets a precedent for advocacy groups to challenge the validity of previously granted patents on the grounds of patients' rights to affordable access to lifesaving treatments.

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.”

Pegasys is the first biologic to lose patent protection in India, but the government had already revoked a series of patents for small-molecule drugs. In early 2012, India's Patent Office granted Hyderabad-based generic drugmaker Natco a compulsory license to make a cheaper version of Bayer's cancer drug Nexavar (sorafenib). The Leverkusen, Germany–based big pharma appealed and lost. In September, Roche lost a four-year legal battle to stop Mumbai-based generic drug maker Cipla from selling generic versions of lung cancer drug Tarceva (erlotinib) patented in India in 2007. On October 5, the Delhi Patent Office also revoked New York–based Pfizer's patent for renal cell cancer drug Sutent (sunitinib), and on November 26 the IPAB dismissed London-based AstraZeneca's challenge to an earlier ruling revoking patent protection for lung cancer drug, Iressa (gefitinib), on the grounds that it is not novel.

Basel-based Novartis has also been trying to patent its leukemia drug Gleevec (imatinib)—branded Glivec in India—since 2006. The matter is currently under challenge before the Supreme Court (a generic version produced by Mumbai-based Cipla is available at a fraction of Novartis' price). “It is clear that India is applying a more rigorous patentability threshold for drugs than its Western counterparts,” says Basheer. “This is in India's economic interest, as most of its leading pharma companies are generic manufacturers,” Basheer adds, although P.A. Francis, editor of Pharmabiz, a portal on the Indian pharmaceuticals industry, says that these actions by the IPAB board “should be seen more as a benefit to patients suffering from cancer and other killer diseases in the country rather than an incentive to the Indian generic companies.”

The Bangalore-based Association of Biotechnology-Led Enterprises (ABLE) that represents the Indian biotech sector with 270 members is concerned about a possible backlash from major pharma companies. “It looks like Pegasys will not be the only case. There can be several more patents that can be challenged on similar grounds,” ABLE president Panchapagesa Murali says. “What sort of an environment will this create for companies who desire to use Indian talent in [the] Indian environment to carry out innovative research here?” he asks. Murali adds that ABLE firmly believes that drugs will have to be affordable but revoking patents or slapping compulsory licensing is not the way to go about this. “For cross-border collaborations to happen, we need to ensure that India provides a good IP environment considering that several infectious diseases and illness[es] need radically new drugs and treatment that require huge investments.”