Indian Patent Office rejects Sovaldi patent, paves way for generics

The Indian Patent Office (IPO) has rejected one of US drug maker Gilead’s patent applications to cover hepatitis C drug Sovaldi (sofosbuvir), in a decision that may decrease the blockbuster’s cost in the country.

Since its US launch in December 2013, Sovaldi’s cost has sparked debate around the world about the price of patented medicines. One Sovaldi pill costs $1,000 in the US, while a treatment course totals $84,000.

The IPO’s decision, handed down on January 13 by the deputy controller general of patents and designs, Hardev Karar, means that local generic drug makers will now be free to market cheaper versions of the pill. Increased competition among generic drug makers is expected to lower the treatment costs.

Gilead’s patent application was opposed by Indian generic drug maker Natco Pharma, as well as not-for-profit group the Initiative for Medicines, Access & Knowledge (I-MAK), and the Delhi Network of Positive People, which aims to improve access to affordable medicines.

While the patent application in question covers the metabolites of sofosbuvir, the main application covering it is still pending before the IPO.

Before the decision, Gilead had signed voluntary licensing agreements with at least seven generic drug companies in India in an effort to increase access to the drug.

In a statement on its website, I-MAK cited a study by UK-based Liverpool University that showed that a three-month treatment course of the drug could be produced for $101.

Writing in the IPO’s decision, Karar said that some of the patent’s claims were not allowed under section 3(d) of the Indian Patent Act.

The controversial section 3(d) was introduced to ensure greater innovation in new inventions, by not allowing new forms of known substances that do not result in greater efficacy to be patented, but Western pharmaceutical companies have opposed it.

According to the IPO’s decision, about 170 million people worldwide are affected by hepatitis C. In India, 18 million people are affected by the virus, which often leads to chronic liver diseases such as cirrhosis and hepatocellular carcinoma.

A Gilead spokesman confirmed that the company will be appealing against the decision “as well as exploring additional procedural options”.

“These proceedings do not impact our commitment to enabling access to our hepatitis C medicines in India and other developing countries, and our generic licensing programme with our Indian partners continues as normal,” the spokesman added.