Gilead’s $1,000 pill gets patent in India

By Rupali Mukherjee, The Times of India | May 10, 2016

Mumbai: In what could be a major setback for access to treatment in high-burden countries, the Indian Patent Office on Monday granted a patent to Gilead Pharmasset on Sovaldi (sofosbuvir), its blockbuster drug for hepatitis C, for which the company charges $1,000 per pill in the US.Several patient groups – Sankalp Rehabilitation Trust, I-MAK and Delhi Network of Positive People – and generic companies (Optimus, BDR Pharma and India Cares) had opposed the US-based Gilead’s application to obtain a patent in the country, arguing that sofosbuvir was “old science”, not novel and did not meet the standard needed for patenting in India.

In India, the price of the treatment will not increase due to enough competition in the market, experts say, but domestic pharma companies – those planning to export the key raw material (API) or planning to launch the drug here – will be hit.

Gilead has already entered into licensing deals with Indian companies, so generic versions of the drug are available for as little as $335 per 12-week treatment. However, the order will block a sustainable supply of key raw materials (APIs) for producing the drug in countries like Egypt, Bangladesh and Pakistan, affecting supply of affordable drugs particularly in those countries.

“It will also impact those domestic companies which were planning to enter the market independently to supply not just patients in India but also high-burden middle income countries that were not covered by the voluntary license,” Leena Menghaney, lawyer and manager of MSF’s Access Campaign in India, told TOI.

The entry of generic versions would have led to a reduction in prices in the future.

Gilead’s Sovaldi is one of the most exorbitantly priced medicines at $1,000 per pill ($84,000 for a 12-week treatment) in the US, and has charged similarly high prices across developed countries.

Dismissing all pre-grant oppositions, the Patent Controller said in his order: “I find claimed compounds are novel, inventive and patentable under Patents Act. Accordingly, the instant application is allowed to proceed for grant with finally amended claims 1 to 8 as filed on 29th April, 2016 by the applicant.”

When contacted, senior counsel Prathiba M Singh representing Gilead said the order shows that section 3 (d) does not act as a bar for grant of patents, provided proper efficacy data is submitted.

Says Loon Gangte, Delhi Network of Positive People, who was opposing the patent: “This decision proves that there is no sovereignty in the Indian patent system anymore. It seems that the patent office does not have any freedom to give fair and just decisions and are under undue influence of the pharma companies. These are very scary times for the patient communities globally who rely on affordable generic medicines coming from India. Government’s ‘Make in India’ campaign seem to be only for foreign companies and not for Indian generic industry, which has been the lifeline for people across the world.”

 Tahir Amin of I-Mak, which had first filed an opposition to the patent, said the order is being studied for grounds of appeal. “It will impact treatments and patients, especially those living in countries not included in the deals between Gilead and some of the Indian companies. But the wider consequence is that the decision puts into question the integrity of the original intention of India’s Patent law when it amended, which was to prevent these types of patents from being granted. The trade pressure from the US and licensing deals by Gilead and others are a factor in this.”

In this case, Gilead’s patent application was first rejected – just before President Obama’s visit in 2015 January – which was seen to be upsetting the US government. Patient groups have been worried that Indian government will cave into US pressure to dilute the independent functioning of the patent office in order to ensure that patent claims are granted far more easily to US companies.

“The same patent first rejected in 2015 has been granted a year later. In the process, the patent office has completely ignored recent proceedings in the US against Gilead regarding the same application which have been found to be infringing two of Merck’s patents clearly defeating Gilead’s claim that its application on the drug was novel,” Menghaney added.

Gilead has entered licensing deals with several manufacturers in India who have developed and are starting to market generic versions, but the deals exclude a number of middle-income countries with very high burdens of hepatitis C. This leaves around 50 million people in such countries, representing more than 40% of the global hepatitis C burden, without access to this drug.

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