Mumbai: India’s Intellectual Property Appellate Board (IPAB) has invalidated the patent granted to F. Hoffmann-La Roche Ltd for its Hepatitis-C drug Pegasys, paving the way for the introduction of cheaper copies of the drug. The appellate board ruled on Friday that the drug is not a new invention after hearing an appeal filed by health group Sankalp Rehabilitation Trust against the validity of the patent. Pegasys was the first patent granted to a drug in India under the new patent regime introduced in 2005.
This is the second patent setback that Roche has faced in India in the past two months. In September, the Delhi high court had dismissed a long-fought legal case against Cipla Ltd for infringing its patent on cancer drug Tarceva.
Invalidating the Pegasys patent on Friday, the appellate board ruled that the drug did not deserve a patent on the grounds that it didn’t demonstrate inventiveness. The technology involved in producing the Hepatitis-C drug was quite obvious and could be easily replicated by anyone skilled in the process, the ruling said.
The appellate board deals with disputes related to intellectual property rights when an applicant or owner or opponent of such rights is not satisfied with a decision of the patent office. The Pegasys patent, which was granted in 2006, had faced opposition from rival drug makers and health groups. The drug, which is normally used along with anti-infection drug ribavirin to treat chronic Hepatitis-C, costs about Rs.3.6 lakh (combined) for six months’ treatment. It has been a key revenue earner for Roche in the local market since 2006.
“We hope that the absence of patent barrier will spur generic competition to bring down the price of this much-needed drug for those suffering from Hepatitis C,” Eldred Tellis, director of Sankalp Rehabilitation Trust and the person who challenged the patent, said in a statement on Friday. Roche’s lawyer Suja Subramaniam declined to comment, saying she hadn’t read the board’s ruling in detail.
Roche had challenged Sankalp’s standing to file the post-grant opposition as well as the appeal before the tribunal. Roche argued that because Sankalp was not a business competitor or a researcher in the sector, it could not challenge its patent. Sankalp argued that it represented a community of drug users particularly at risk of Hepatitis C.
In its ruling, the tribunal said “public interest is a persistent presence in intellectual property law,” and also held that it was against public interest to “allow unworthy patents to be on the register”. “The appellant who works for the community which needs the medicine is definitely a person interested,” the ruling said. A successful challenge would “break the monopoly” and “bring the drug within reach of the community for whom it works, not only by reduction in cost, but also because of increase in supply”, the board said.
The ruling is likely to help introduce cheaper copies of the drug in the market.
“This victory will facilitate early entry of generics which is likely to lower the prices. If this happens, millions suffering from Hepatitis-C, both in India and globally, will benefit. It is also historic because this was the first ever product patent granted on a medicine in India since 1970,” said Anand Grover, senior counsel and director of Lawyers Collective HIV/AIDS Unit, which appeared for Sankalp.