Bitter Pill

Why experts and activists are up in arms over the grant of a patent for a blockbuster hepatitis C drug

01 June 2016
Last month, the Delhi patent office granted the American company Gilead a patent for its blockbuster hepatitis C drug, Sovaldi, reversing a contrary decision it had reached last year.
IPINDIA.NIC.IN
Last month, the Delhi patent office granted the American company Gilead a patent for its blockbuster hepatitis C drug, Sovaldi, reversing a contrary decision it had reached last year.
IPINDIA.NIC.IN

On the evening of 9 May, the office of the controller general of patents, designs and trademarks posted a new verdict in a closely watched case on its official website. This was the American pharmaceutical company Gilead’s patent application for its blockbuster hepatitis C drug, Sovaldi, which the office had at first rejected, in January 2015. But Gilead challenged the decision in the Delhi High Court, which set the decision aside and instructed the office to re-evaluate the application. The court’s order proved advantageous to the company: Rajesh Dixit, the officer who re-examined the case, granted the company the patent for the compound.

The drug, whose generic name is sofosbuvir, had revolutionised the treatment of hepatitis C, by boosting cure rates while avoiding the side effects of earlier drugs. The new verdict gave Gilead exclusive rights to sell the drug in India, at any price it chose. As it happened, the company had already entered into “voluntary licence” agreements with several Indian generic pharmaceutical companies, allowing them to manufacture and sell the drug at $900 for an 84-pill course—significantly lower than the astronomical $1,000 per pill Gilead charges patients in the United States. The patent office effectively buttressed Gilead’s control over these agreements, which included clauses barring the sale of generic versions of the drug to a specified list of countries, putting them out of the reach of approximately 73 million hepatitis C patients around the world.

But some of the circumstances surrounding the application and the hearing raise questions about the conduct of the patent office. Further, many experts believe that the verdict was poorly reasoned—an opinion shared by advocacy groups that have mounted a legal challenge against it.

Vidya Krishnan is a health journalist based in Goa. Her first book on the rise of antibiotic resistance and the threat to global health security is slated to be published in 2020.

Keywords: intellectual property Hepatitis C Gilead IPR Patent Sovaldi big pharma sofosbuvir
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