Intellectual Property Appellate Board (IPAB), Chennai (India) has set aside the patent granted to Roche for pegylated interferon alfa-2a (sold by Roche under the brand name Pegasys). The invention (interferon alpha-2a + polyethyleneglycol) was held to be obvious. A copy of the decision can be read here.
On March 3rd 2006, Roche proudly announced it was becoming the first pharmaceutical company in India to receive a product patent under the new patent regime for peginterferon alfa-2a, used in the treatment of hepatitis C. The patent which was slated to expire in 2017, prevented other companies from launching more affordable bio-similar versions in India or exporting them to other countries. Official distributors of Roche in India are selling one vial of Pegasys 180 mcg at 13,700 INR ($247). With a growing Hepatitis C epidemic, India is a lucrative market for Roche.
In 2007, Sankalp Rehabilitation Trust with legal aid from Lawyers Collective HIV/AIDS Unit challenged the granted patent (IN198952) on pegylated interferon alfa-2a through a post grant opposition proceedings. This post grant opposition was rejected. An appeal against the order rejecting the post grant opposition was filed by Sankalp before the IPAB, which has now resulted in the patent being set aside, more than six years after it was granted.
Pegylated interferon alfa-2a is primarily used to treat chronic HCV in the absence of which in many cases, death results from cirrhosis, liver failure or liver cancer. The current treatment for HCV consists of combination therapy involving two drugs, ribavirin and pegylated interferon. For people living with HIV who are co-infected with HCV, the usual course of HCV treatment lasts for 48 weeks, with ribavirin taken daily (orally, in pill format) and pegylated interferon once a week (by injection). In India the treatment is currently unavailable in the public healthcare system and unaffordable in the private sector.
This decision has come at a crucial point when civil society and treatment organisations have now begun to take steps to push affected countries to integrate hepatitis C treatment into their medical programmes and as a first step to use pegylated interferon and ribavirin in accordance with evidence-based guidelines. Some countries can now opt to look at more affordable bio-similar versions from competitors.
Background on the patent challenge by Sankalp Rehabilitation Trust is available here.