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India turns down patent on Gilead's Sovaldi

Opens market to cheaper rivals for hepatitis C drug

gilead-sciences-sovaldi hepatitis C

India's Patent Office has turned down a patent application from Gilead Sciences for its hepatitis C virus therapy Sovaldi, claiming it is not novel enough to warrant protection.

Last year, Sovaldi's Indian intellectual property (IP) also faced a "pre-grant" objection from domestic pharma company Natco as well as the New York-based Initiative for Medicines, Access & Knowledge (I-MAK), a non-profit group which campaigns for affordable access to HCV and HIV drugs.

As in previous cases involving India's Patent Office, Gilead's patent application was turned down with reference to the notorious Section 3(d) clause, which blocks patents for compounds that are variations of known substances unless they are able to demonstrable therapeutic improvement over the reference drug.

That verdict is almost certain to be challenged by the US company, which insists sofosbuvir is a novel substance and provides a clear therapeutic advance over earlier HCV therapies given its 90%-plus cure rate in just a few weeks.

The ruling (PDF) will be celebrated by India's estimated 12 million HCV patient population who now stand to get access to cut price versions of Sovaldi (sofosbuvir), which was launched in western markets with an $84,000-per-course price tag that quickly helped it achieve a record $8.5bn in sales in the first nine months of 2014.

Gilead is selling Sovaldi in India and other developing countries at the less princely sum of around $900 per course, and has also licensed the drug to seven Indian generics companies (Cipla, Cadila Healthcare, Hetero, Strides Arcolab, Ranbaxy, Sequent Scientific and Mylan) at a 7% royalty rate.

Critics suggest however that the price would have to fall to around $100 to be affordable for many patients in these low-income countries, while arguing that Gilead's licensing programme had effectively excluded patients from middle-income countries from gaining access to the treatment.

Even in established markets the price of the product has come under pressure, with France negotiating a steep discount, while US insurer Express Scripts recently dropped the drug form its formulary in favour of a cheaper rival from AbbVie.

The Indian ruling suggests other drugmakers like Natco outside the licensing group will be able to launch sofosbuvir at a significantly lower price.

The ruling was hailed as a victory by I-MAK, a campaign group focused on increasing access to affordable medicines. It notes on its website that "HCV is a significant public health issue for low- and middle-income countries that are home to 90% of the 185 million people who are infected with HCV."

"Although HCV is curable, high drug prices make treatment inaccessible, leaving people at risk for liver cancer or liver failure," it adds.

Article by
Phil Taylor

15th January 2015

From: Sales, Regulatory, Healthcare

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