22 Sep 2014

Asian and Indian groups join hands to oppose patent application on sofosbuvir

Gilead’s licensing practices leave millions in developing countries without affordable generic access

Delhi and Bangkok – In a significant move aimed at securing access to safe, effective and affordable generic treatment for Hepatitis C (HCV), groups in Asia and India have joined together to challenge US MNC Gilead’s patent application on sofosbuvir in India. The patent opposition has been filed before the Kolkatta Patent Office.


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


“We believe this patent application should be rejected,” said Anand Grover, Senior Counsel, Supreme Court of India and the Director of the Lawyers Collective. “The patent application fails not only Section 3(d) of India’s patent law that prohibits evergreening but it is neither new nor inventive.”


Sofosbuvir is the first oral daily tablet for hepatitis C which is set to revolutionize treatment for patients living with chronic Hepatitis C by replacing the standard, therapy of weekly injections of peg- interferon which can have serious side-effects. It belongs to a class of medicines known as Directly Acting Antivirals or DAAs. Sofosbuvir was first introduced after Gilead acquired the medicine on purchasing a smaller company for $11 billion.[i] In the first 6 months of 2014, Gilead had made $5.7 billion on the sales of sofosbuvir.[ii]


The patent opposition comes as Gilead along with key Indian generic companies has announced restrictive licenses that will prevent the supply of safe, effective and affordable generic versions of sofosbuvir to millions in developing countries across Asia, Latin America and North Africa. In India, till generic versions become available, most likely towards the end of 2015, patients will have to contend with the price previously announced by Gilead for its version ofsofosbuvir at $300 a bottle or $900 for a 12-week course.[iii] The time frame for Gilead’s version to be available in India is unclear; although Gilead started filing for the registration of sofosbuvir in developing countries in March 2014,[iv] it delayed filing for registration in India till September 2014.[v]


“Gilead’s pricing on this medicine has no relation to the reality of patients in need of treatment whether they are in the United States or in the poorest countries in the world,” said Eldred Tellis of the Sankalp Rehabilitation Trust. “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 noted.


For people with HCV of certain genotypes, sofosbuvir has to be taken along with the existing treatment of ribavarin and/orpegylated interferon. It will also likely have to be combined with other new DAAs that are coming on to the market. A recent study by Andrew Hill and colleagues at Liverpool University have estimated that the cost of a 12-week course ofsofosbuvir could be as LOW as $102. They have also estimated that minimum TOTAL costs of sofosbuvir in combination with other DAAs, diagnostics and genotype testing would range from $264 to $444 for a 12 week treatment course, depending on the combination.[vi] The calculations based on volumes for treating 5 million people a year included a 40% margin for formulations including profit margins for generic suppliers.


Ketho Angami of the Hepatitis Coalition of Nagaland (HepCoN) pointed out that, “Those most in need of treatment are poor, homeless injecting drug users or are people living with HIV who are co-infected with hepatitis C so Gilead’s prices do not mean much on the ground. Availability should also come with easy accessibility and affordability. We are also very disappointed to learn that big Indian generic companies have agreed to take a deal that leaves out many of our colleagues in other countries. This makes us even more determined to break Gilead’s monopoly on this medicine” he said.


“Based on our previous experience with Gilead adopting a similar restrictive licensing strategy for HIV medicines, we decided to oppose the patent in India. As we predicted, once again, many of our members who are in urgent need of effective hepatitis C treatment are in countries left out by Gilead’s cynical licensing strategy,” said Shiba Phurailaptam, Regional Co-ordinator of APN+. “We urge Indian generic companies not to take such deals that put the lives of our friends and colleagues at risk. 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,” he said.


“The fact that these licenses have even been announced at this stage when no patent exists on this medicine in India is surprising,” adds Grover. “For civil society groups working hard to use the pro-health provisions of the Indian patent law, such agreements between MNCs and generic companies are of great concern. Gilead’s control on the generic companies including restrictions on their ability to buy or sell raw materials for this medicine is something that should worry the government as it is likely to impact manufacture by generic companies who have not taken this license. We will put every effort into ensuring the patent application is rejected to ensure proper generic competition,” he said.


Contact: Anand Grover +919899439593 and Shiba Phurailpatam +66866000738


This entry was posted in Hepatitis C, Patent Opposition, Sec 3 (d), Sofosbuvir. Bookmark the permalink.

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