Two pre-grant patent oppositions filed on Gilead’s Hepatitis C medicines

The Delhi Network of Positive People has filed two pre-grant oppositions at the Indian Patent Office (Mumbai) challenging “additional” patent claims made by the US drugmaker Gilead Sciences on its hepatitis C medicines sofosbuvir and velpatasvir.

These oppositions challenge Gilead’s patent applications for the tablet formulation of the fixed-dose combination of sofosbuvir/ velpatasvir and the polymorph form of velpatasvir, a note from humanitarian organisation Médecins Sans Frontières said. MSF explained that granting patent protection on these products in India would have ramifications for access to the drugs in other countries with a high disease burden of people living with Hepatitis C.

Velpatasvir, a direct acting antiviral (DAA), is one of the key medicines used along with sofosbuvir in the oral treatment of people with all six major genotypes of hepatitis C virus. Its effectiveness as a pan-genotypic medicine makes it a key drug in the fight against hepatitis C, MSF said.

“The grounds for these two patent oppositions are based on provisions in the Indian Patents Act that prevent patent evergreening, which restricts the patentability of a host of secondary patents, i.e., new forms of known substances, new property or new use of known substances, use of known processes without showing any enhanced therapeutic efficacy, and admixtures without synergistic effect,” it explained.

DNP expects to prevent such “unmerited patent applications” from being granted so it could encourage open competition on the combination of sofosbuvir and velpatasvir after the basic compound patents have expired or are revoked in countries excluded from Gilead’s licence agreements, the note said. Sofosbuvir/ velpatasvir was launched in the US by Gilead at over $74,000 for a 12-week regimen in 2016.

BusinessLine reached out to Gilead on this development, a response is awaited.

Earlier challenges

About five years ago, sofosbovir had also been at the heart of a pre-grant patent challenge in India when Initiative for Medicines, Access & Knowledge (I-MAK) and DNP contested its basic patent claims in 2013. “The issue remains under dispute before the Delhi High Court and the Intellectual Property Appellate Board in India,” the note said.

This challenge had taken place even as a high-pitched discussion raged internationally on the price of Sofosbovir at $84,000 for 12 weeks in the US. Eventually, the company entered into a deal in India with a clutch of local companies to bring their versions of sofosbovir at lower prices.

In February 2017, I-MAK and DNP also challenged the basic patent claim on velpatasvir, asserting that the drug is an obvious structural change to an earlier hepatitis C drug, ledipasvir, and thus could not be patented. A decision is awaited here too.

Challenge despite deal

Explaining the patent challenge despite the licensing deals between Gilead and generic companies, the note said the alliances did enable access to lower-cost generics from India to least-developed countries and middle-income countries. But South America, Russia and eastern European countries were not included in most of these agreements and their governments continue to face many barriers in the importation of raw materials (active pharmaceutical ingredients, or APIs) and finished formulations of generic DAA medicines, the note said.

“For example, the price for the recommended 12 weeks of treatment is estimated at €35,000 in Germany, €29,721 in France, and approximately $4,500 in Latin America. as negotiated by the Pan American Health Organisation. In contrast, the generic formulation of the sofosbuvir/ velpatasvir combination is priced at approximately $286 per 12 weeks in India,” it explained.