Gilead denied patent for hepatitis C drug Sovaldi in India

In another negative intellectual property ruling for the research-based pharma industry, the Indian Patent Controller yesterday rejected one of US biotech major Gilead Sciences’ (Nasdaq: GILD) key patent applications which covered the firm’s blockbuster drug Sovaldi (sofosbuvir), used to treat hepatitis C (HCV).

The Patent Controller ruled that the active ingredient of Sovaldi was not sufficiently different to a previously known molecule, and that "minor changes in the molecule" did not improve efficacy of the drug. While the application for the final form of the drug is still pending in India, lawyers and activists say the rejection of the patent on the base compound significantly increases the likelihood that a patent will be refused for the final compound, reported the UK’s Financial Times.

The oral drug, which first received regulatory approval in the USA in November 2013, and has been priced by Gilead at $84,000 for a treatment course, or $1,000 per pill in the USA, has caused a worldwide debate on the pricing of patented medicines. Sovaldi generated sales of $8.6 billion in the first nine months of 2014. A study from Liverpool University, quoted by humanitarian aid agency Sans Frontieres (MSF), showed that sofosbuvir could be produced for as little as $101 for a three-month treatment course.