Delhi High Court sends decision of patent refusal for Gilead drug sofosbuvir back to Patent Office on procedural grounds

Responses by the Delhi Network of Positive People (DNP+), and the Initiative for Medicines Access and Knowledge (I-MAK) as published on 2nd Feb 2015

The Delhi High Court decided on 30 January 2015 to refer the decision regarding the refusal to grant Gilead Sciences a patent for the hepatitis C drug sofosbuvir (on 14 January 2015) back to the Patent Office to correct any procedural issues that it did not address in its decision. It is important to note that the judge said the decision was being referred back to the Patent Office on procedure only, and that he was not questioning or taking a stand on the merits of the original decision.

Court order can be accessed here

Sofosbuvir, which first received regulatory approval in the US in November 2013, and has been priced by Gilead at US$84,000 for a treatment course, or $1,000 per pill in the US, has caused a worldwide debate on the pricing of patented medicines. A study from Liverpool University showed that sofosbuvir could be produced by generic manufacturers for as little as $101 for a three-month treatment course.

Challenges to some of the most important patent applications on sofosbuvir (a ‘patent opposition’ – a form of citizen review allowed in many countries) were filed in India by the Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) in November 2013 and March 2014.

Gilead has signed voluntary licence agreements with multiple generic producers in India, but these agreements impose many restrictions, including which developing countries can access the drugs produced under these licences, restrictions on the licensees on sourcing or exporting sofosbuvir’s active pharmaceutical ingredients (API), as well as invasive restrictions on medical providers and patients with respect to distribution and use of the drug.

For more information on this programme, see: http://www.msfaccess.org/content/barriers-access-and-scale-hepatitis-c-hcv-treatment-gileads-anti-diversion-program

Many middle income governments with a high burden of HCV are currently negotiating access to this medicine, which is expected to become the backbone of any HCV regimen in the coming years.

Responses by the Delhi Network of Positive People (DNP+), and the Initiative for Medicines Access and Knowledge (I-MAK).

“Just as Gilead has said it will strongly defend its intellectual property rights, we will strongly defend the human rights of those who need access to these drugs. Gilead cannot pick or choose who will benefit from low cost generic versions of the medicine. With this patent challenge we fight for the right of all developing countries to access generic versions and not just Indian patients. Gilead may feel it can use its deep pockets to buy its way to a patent, but the movement by many people to shine the light on the tactics Gilead  is using, is only going to grow the longer this case goes on. And we intend to take it all the way if need be.”
Vikas Ahuja, President, Delhi Network of Positive People  

“We are entirely prepared to have our case fully heard and welcome the opportunity to show that aside from Gilead’s patent application not meeting the lawful requirement for patentability (section 3(d) under India’s patent law), it actually also lacks inventiveness. Gilead claims its priority is to increase access to its medicines to people regardless of their origin or economic means, but Gilead’s actions so far show they are more intent on persuading the powers that be to give them patents so that they can further restrict rather than expand access to this drug. While more and more doctors are now prescribing oral drugs like sofosbuvir for hepatitis-C treatment, sadly access to these drugs is still out of reach for millions of people across the world. Until there is broad access to this drug, we will not stand idly by.” Tahir Amin, Director of Intellectual Property for the Initiative for Medicines, Access & Knowledge (I-MAK)

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