Fresh opposition on Gilead’s Hepatitis C drug

The last word is far from heard on drugmaker Gilead’s Hepatitis C drug sofosbuvir in India.

Asian and Indian groups have come together to file a fresh bout of opposition at the Kolkata patent office against sofosbuvir’s patent application.

The pre-grant opposition has been filed by Bangkok-based Asia-Pacific Network of People living with HIV/AIDS (APN+), the Sankalp Rehabilitation Trust and the Hepatitis Coalition of Nagaland. And the groups are being represented by the Lawyers Collective.

The move seeks to keep the breakthrough oral Hepatitis C drug affordable, by ensuring that generic drug companies are allowed to make the drug, and at low prices.

"We believe this patent application should be rejected," Anand Grover, Director, Lawyers Collective and senior counsel at the Supreme Court, said in a statement. "The patent application fails not only Section 3(d) of India's patent law that prohibits evergreening but it is neither new nor inventive."

A pre-grant opposition under the amended Patents Act allows interested parties to oppose a patent application on a product before the Patent Office decides on whether to grant or deny a patent. Patents grant an inventor 20 years market exclusivity, and public healthworkers fear that such monopolies could price medicines beyond the reach of patients.

In fact, Section 3 (d) has been a powerful touchstone provided in the amended Act to assess the inventiveness of a product. It disallows companies from seeking fresh patents on incremental changes made on existing compounds - a process called evergreening, unless they establish reasonable efficacy.

Deals and oppositions

The latest pre-grant opposition comes even as Gilead entered into an agreement with seven India-based companies, earlier this week. Companies including Cipla, Ranbaxy and Mylan will now be able to make sofosbuvir at reduced prices in certain markets.

But even this much anticipated deal came against the backdrop of a slew of existing pre-grant oppositions against sofosbuvir’s patent application.

First of the block in November last year was the opposition filed by legal group I-MAK, (Initiative for Medicines, Access & Knowledge). Also opposing sofosbuvir were the Indian Pharmaceutical Alliance (a platform of large Indian drug companies), Hyderabad-based drugmaker Natco and the Delhi Network of Positive People.

Sofosbuvir sold by California-based Gilead as Sovaldi is priced at $ 84,000 for 12 weeks in the US. And the company expects to bring its product into India at less than $ 1000 for 12 weeks.

The drug’s pricing has received much flak in India and overseas. According to Sankalp Rehabilitation Trust’s Eldred Tellis, Gilead's pricing on the drug has no relation to the reality of patients in need of the treatment whether they are in the United States or in the poorest countries in the world.

"The price at $900 per treatment course may sound good compared to the $84000 US price. That's until one remembers that one-third of Indians live on less than half a dollar a day." he said, in the statement.

Referring to the role of Indian generic drugmakers, Shiba Phurailaptam, Regional Co-ordinator of APN+ says: “Indian companies like Cipla were once trailblazers in providing generic access when MNCs turned their backs on us. We ask them not to become party to strategies of MNCs that put profits before lives."

Gilead representatives in the past have told Business Line that they will defend their patents in India, even as they enter into deals to stir local generic production of the drug to bring down prices.

Meanwhile, they have also met Commerce Minister Nirmala Sitharaman this week to apprise her of the agreement Gilead has on the hepatitis drug with local alliance partners. The deal covers 91 developing countries.

>jyothi.datta@gmail.com