Landmark India IP Board Decision Against Hepatitis C Drug Patent

By Patralekha Chatterjee for Intellectual Property Watch

India last week saw a landmark public health decision on the evolving role of intellectual property rights in the context of the public interest.

The country’s Intellectual Property Appellate Board (IPAB) revoked a patent granted in India to F. Hoffmann-La Roche AG (Roche) for pegylated interferon alfa-2a (Pegasys), a medicine used to treat Hepatitis C.

The IPAB decision is here

The case has generated significant interest because it breaks ground in two ways: the patent granted to Roche in 2006 was the first product patent on a medicine in India after the country switched to a product patent regime for medicines as mandated by the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). It is also India’s first successful post-grant opposition case.

While welcoming the IPAB’s decision, Eldred Tellis, director of Sankalp Rehabilitation Trust, a non-governmental organisation which had challenged the patent, told Intellectual Property Watch: “In short term, we will have to look for those interested in producing a biosimilar which will be available at for possibly 8 to 10 times less than Pegasys.” In the long-term, Tellis said he hopes the Indian government will wake up to the seriousness of the problem of Hepatitis C in the country. “There is a need to produce it cheaply, and give it free to those who need it,” he added.

Sankalp works with injecting drug users who often suffer from Hepatitis C. It had filed for a post-grant opposition challenging the patent with help from India’s Lawyers’ Collective HIV and AIDS Unit. India’s Patent Law allows pre-grant and post-grant opposition. In 2009, Sankalp’s post-grant opposition was rejected by the Patent Office. Undeterred, Sankalp filed an appeal before the IPAB challenging the decision.

Whether the IPAB decision will trigger more post-grant oppositions remains to be seen.