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Healthcare Groups Challenge Patents On Three New Hep-C Drugs In India

The patent challenges could remove barriers to production and distribution of affordable generic versions of direct-acting antiviral medicines, which are currently sold at very high prices

Photo Credit : Reuters,

Patient and healthcare aid groups, including I-MAK and Delhi Network of Positive People (DNP+), supported by Médecins Sans Frontières (MSF) have on Tuesday (Febraury 14) challenged patent rights of three new Hepatitis-C drugs in India. The new drugs, which are currently patent protected in most world markets and are not accessible to poor patients due high costs include sofosbuvir, which is sold under the brand names Sovaldi and soforal etc., by US drug maker and researcher Gilead Sciences, and daclatasvir and velpatasvir, belong to US multinational Bristol Myers Squibb (BMS).

The patent challenges could remove barriers to production and distribution of affordable generic versions of direct-acting antiviral (DAA) medicines, which are currently sold at very high prices.

"Today’s filings are the latest attempts to overturn the abusive strategies of pharmaceutical corporations like Gilead who exploit the flaws in the patent system to obtain unjustified patents that block generic competition," said the patient groups in a joint statement.

“80 million people worldwide are living with hepatitis C, and we need a wide range of combination treatments available at an affordable price. With patents blocking generic competition, treatment remains prohibitively expensive in many countries,” said Jessica Burry, pharmacist for MSF’s Access Campaign. “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,” they added.

Patents on drugs not only prevent affordable generic versions from being produced or imported, but also restrict progressive innovation that could otherwise benefit patients. More than a decade ago, patent barriers were overcome to allow generic competition of antiretroviral (ARV) drugs, used to treat HIV, causing prices to drop by 99 per cent and enabling more than 18 million people to access treatment today. The lack of patent barriers also enabled generic pharmaceutical producers to develop improved ARV combination treatments and new formulations to serve unmet patient needs.

There are multiple patent barriers that prevent the manufacture or importation of low-cost, quality DAA medicines, particularly in high- and middle-income countries. Patent challenges – or patent oppositions as they’re more commonly known – are one strategy to open up access to millions of people left without affordable treatment options, after other strategies to directly engage pharmaceutical corporations have largely failed.

“Together with civil society groups, we have filed legal challenges on multiple invalid patents on three different hepatitis C drugs,” said Tahir Amin, Director of Intellectual Property for I-MAK. "It is time to challenge the unchecked power that pharmaceutical corporations hold through abuse of the patent system.”

People living with HIV, in collaboration with health organisations and legal aid groups, have already filed challenges to ‘evergreening’ patents on the drug sofosbuvir in several countries. ‘Evergreening’ refers to the practice of filing additional patents to extend the length of monopoly control over a product, and these challenges have successfully reduced the length of the monopoly for sofosbuvir in the EU and revoked a key patent on sofosbuvir in China and Ukraine. Decisions on challenges to sofosbuvir patents are pending in other countries, including Argentina, India, Brazil, Russia and Thailand.

“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 USD $300 per 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,” she said

Indian generic suppliers currently face multiple intellectual property barriers in the registration and export of DAA medicines to several middle-income countries. While licensing deals struck between Indian generic companies and pharmaceutical corporations enable access to lower-cost medicines for India and least-developed countries, by far the greatest burden of hepatitis C disease is found in middle-income countries. Many of these countries, including China, Ukraine, Thailand, Malaysia and Brazil, are excluded from licensing agreements that could enable importation of raw materials (active pharmaceutical ingredients, or APIs) or finished formulations of DAA medicines.

Gilead and BMS could not be contacted for their comments immediately.

According to Loon Gangte, Regional Coordinator, International Treatment Preparedness Coalition-South Asia and Founder of DNP+, 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.

“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,” Gangte said.



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