Five Challenges Filed Against HCV Drug Patents

In an effort to ensure access to inexpensive therapies, a total of five patent challenges on hepatitis C (HCV) medications were filed in both Argentina and India.

The challenges against the allegedly flawed patents could remove barriers to the production and distribution of generic versions of the direct-acting antiviral (DAA) medications, according to a press release.

The Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) filed 4 cases in India, all of which were supported by Doctors Without Borders/ Médecins Sans Frontières (MSF).

According to a press release, the opposition cases filed in India challenge the following:

1. Two challenge the crystalline forms of sofosbuvir and daclatasvir, stating that they should be rejected for not being in compliance with national law, which recognizes that crystalline forms of known medicines are not interventions and, therefore, should not be awarded patents.
2. One shows that the patent on velpatasvir is an obvious structural change to the earlier HCV drug ledipasvir, which, according to the press release, is an example of the drug manufacturer gaming the patent system to strengthen control on the HCV market.
3. One seeks to open up supply of raw materials from India by challenging the patent on the intermediate form of daclatasvir.

In Argentina, a patent opposition on sofosbuvir was filed by Fundación Grupo Efecto Positivo (FGEP), and was supported by I-MAK. Patent challenges are one government-level strategy designed to increase access to affordable treatment. In addition, patent challenges to sofosbuvir are pending in Argentina, Brazil, Russia, and Thailand.

“There are 80 million people worldwide living with hepatitis C, and we need a wide range of combination treatments available at an affordable price,” Jessica Burry, pharmacist for MSF’s Access Campaign, said in a press release. “With patents blocking generic competition, treatment remains prohibitively expensive in many countries. Sofosbuvir, velpatasvir, and daclatasvir are all crucial to our line-up of first-line treatment options that cure people of hepatitis C and stop the progression of liver disease.”

Thus far, health organizations, legal aid groups, and patients have filed challenges to evergreening patents on sofosbuvir in multiple countries. Evergreening is the practice of filing additional patents to extend the length of monopoly control over a product. According to the press release, these challenges have successfully cut down the length of the monopoly for sofosbuvir in the European Union, and revoked a key patent on sofosbuvir in China and the Ukraine.

“By systematically applying pressure to remove patent and regulatory barriers that stand in the way of production of more affordable generic versions of direct-acting antiviral medicines used to treat hepatitis C, civil society and vulnerable communities have already supported the introduction of generic competition in India and Egypt, where prices dropped to below $300 for a 12-week treatment last year,” said Leena Menghaney, head of South Asia for MSF’s Access Campaign. “But the benefits of these price reductions are not available to all those who need treatment, particularly those people living in middle-income countries with high burdens of hepatitis C.”

The list price in the United States for a 12-week regimen costs $84,000 for sofosbuvir; $74,760 for velpatasvir; and $63,000 for daclatasvir.

Generic therapy suppliers in India and Egypt face several intellectual property barriers in the registration and export of DAA medicines to several middle-income countries.

Licensing deals made between generic companies in India and pharmaceutical corporations provide access to lower-cost drugs for those residing in India and the least-developed countries. However, the greatest burden of HCV is found in middle-income countries, such China, Brazil, Malaysia, Thailand, and Ukraine, who are excluded from licensing agreements that could enable importation of raw materials or finished formulations of DAA drugs.

“Despite the deadly toll of the hepatitis C epidemic, Gilead and Bristol-Myers Squibb still have far too much control over who can access their lifesaving DAA medicines, and the lack of access is ultimately costing people their lives,” said Loon Gangte, reginal coordinator for the International Treatment Preparedness Coalition-South Asia and founder of DNP+. “Millions of people in India can’t afford the generic treatments strictly licensed by Gilead and BMS, and millions more people in high- and middle-income countries can’t legally purchase the generic medicines currently being produced in countries like India and Egypt. We need a sustainable supply of low-cost, quality hepatitis C medicines to save lives and contain the disease in all countries.”

In Argentina, individuals with HIV challenged the patent on sofosbuvir after evidence disclosed substantially similar antiviral compounds for treating HCV. According to the press release, civil society makes a strong case, because Gilead has also failed to fully disclose the claimed invention in a sufficient manner. This is a requirement of patent law, but often goes ignored by pharmaceutical companies.