India's Intellectual Property Appellate Board (IPAB) has revoked Roche's Indian patent on its hepatitis C drug Pegasys (peginterferon alfa-2b).
In 2006, Pegasys became the first drug to receive patent protection from the Indian Patent Office (IPO) since 1970, under the country's new intellectual property legislation introduced in 2005. This patent was immediately challenged by local generic drug maker Wockhardt and Sankalp Rehabilitation Trust, a civil society group based in Mumbai, using clauses in the new law that permit such challenges on the grounds that, for example, the drug was not a not a novel innovation or that it did not demonstrate inventiveness.
Wockhardt and Sankalp argued that Pegasys did not meet either of these requirements, but in 2009 the IPO rejected their challenge and upheld Roche's patent.
Sankalp subsequently appealed to IPAB, which announced its decision in favour of the group's challenge on November 2. The ruling also upheld the rights of patient groups to challenge the validity of previously-granted patents. Public interest "is a persistence presence in intellectual property law," and it is against public interest to "allow unworthy patents to be on the Register," added the Board.
The ruling suggests that generic versions of Pegasys could become available in India fairly shortly, depending on whether or not Roche decides to appeal the IPAB ruling, comments the Indian fortnightly journal Business Today.
In a statement, Sankalp said it hoped that the absence of a patent barrier would now spur generic competition "to bring down the price of this much-needed drug.
The group also called on the government to take "concrete steps" to start providing access to Pegasys, which is not currently supplied through the public healthcare system.
Treatment of chronic hepatitis C requires a six-month course of Pegasys, which costs around 436,000 rupees - although it can be purchased at a discounted price of 314,496 rupees - and is given in combination with ribavirin, which costs 47,160 rupees for a six-month course, says Sankalp.
Business Today also suggests that other alternatives for the Swiss firm could be to make the drug available in India at a much lower price than elsewhere in the world, or to link up with an Indian manufacturer and, again, sell the drug in that market at a greatly reduced price.
The decision has opened the path for other patents to be challenged, say local observers. "Concerned patients' groups will now have been clarity in challenging patents on medicines for HIV, cancer and other diseases," comments the Lawyers' Collective HIV/AIDS Unit, which represented Sankalp in this case.
According to the Unit, IPAB’s ruling "rightly observed" that Roche had "used conventional methods to pegylate interferon and obtained predictable results, thereby rendering it obvious to a person skilled in the art." The Board had also correctly held that Roche had failed to satisfy the requirement of showing enhanced efficacy," said Unit director Anand Grover, adding: "we hope that the Patent Offices too follow these standards while deciding pre- and post-grant oppositions."
The changes to India’s patent law introduced in 2005 followed the nation's signing, a decade previously, of the World Trade Organisation (WTO)'s Trade-Related Aspects of Intellectual Property Rights (TRIPs) agreement.
Estimates of the number of people in India infected with the hepatitis C virus are in the range of 10-12 million.