A fresh bout of opposition has been filed against Gilead’s patent application on hepatitis c drug sofosbuvir. This comes close on the heels of a spate of developments involving the drug, last month.

Non-government organisation Sankalp Rehabilitation Trust, represented by the Lawyers Collective has filed a pre-grant opposition on the drug in the Delhi patent office. (A pre-grant opposition allows interested parties to oppose a patent application before the Patent office decides on whether or not to grant the drug a patent.)

Earlier last month, the Patent office had rejected California-based Gilead’s patent application on the drug, on the grounds that it did not exhibit greater efficacy. Gilead had subsequently approached the Delhi High Court on this order. And later in the month, the Delhi High Court set aside the patent office’s order that rejected the application, in effect returning proceedings for a fresh round of hearings on the sofosbuvir patent application, a lawyer familiar with the case said.

Sankalp’s opposition is the fourth opposition against Gilead’s base patent application. Others include oppositions by I-Mak together with the Delhi Network of Positive People, Natco Pharma and BDR Pharmaceuticals International Limited.

Gilead was not immediately reachable for comment on the latest development. In fact, it has another patent application on the drug that is now pending at the Kolkata patent office.

“We have studied the patent application closely and are convinced that it has no merit” Anand Grover, Director, Lawyers Collective, said in a statement. “It fails to satisfy any grounds required to meet the threshold of what is patentable under India’s patent law. Not only is it not new or inventive, it also does not comply with the requirements of Section 3 (d)” he added.

The latest development comes even as Gilead received regulatory approval in India to market its version of the drug. It is expected to be launched around April.

Last year, Gilead also inked alliances with eight India-based drug companies, allowing them to make generic, less expensive versions of the drug for certain markets.

Gilead has been facing the heat on its otherwise breakthrough drug for its pricing. The drug is priced at $ 84,000 for 12 weeks and is expected to come to India at about $ 900 for the same period.

Oral pill

Sofosbuvir is a once-a-day oral pill that can change the treatment landscape for patients. It is reported to have cure rates of upto 95 per cent compared to 65-70 per cent witnessed with weekly-injections of Pegylated Interferon, the standard current treatment, a note said.

Globally, there are around 180 million people living with hepatitis C of whom 12 million live in India, it added.

Further, the pro-health group opposing Gilead’s patent on sofosbuvir pointed out, under the licenses generic sofosbuvir could cost anywhere between $300 and $900 per treatment.

“We know that even $300 is too expensive for the average person in India, let alone the poor. Open, unrestricted competition by Indian generic companies was responsible for drastic price reductions in ARV (anti-retroviral or anti-AIDSdrugs) prices which allowed scaling-up of treatment to millions,” Eldred Tellis, Director, Sankalp Rehabilitation Trust, said in a statement.

“It is unfortunate that generic companies in India, who once played David to MNC’s Goliath have now chosen to go down this road. As civil society, we will continue to use pro-public health provisions to further access to medicines” added Grover, referring to earlier groundbreaking patent-battles in the country.