India Rejects Gilead Patent Bid for Sovaldi Hepatitis C Treatment -- WSJ Blogs

 By Ed Silverman 
 

In a setback for Gilead Sciences, India's patent office has rejected an application for its Sovaldi hepatitis C treatment. The decision means that locally-based drug makers can sell lower-cost generic versions of the medicine, which costs $1,000-a-day in the U.S. for a 12-week regimen.

The patent application had been opposed by Natco Pharma, an Indian generic drug maker, and the Initiative for Medicines, Access & Knowledge, a non-profit. They argued that Sovaldi was not a significant improvement compared with an earlier compound developed by another company, according to the ruling issued by the Indian patent office.

The patent office noted that a "molecule with minor changes, in addition to the novelty, must show significantly enhanced therapeutic efficacy" compared with a prior compound. In other words, Gilead had to prove its compound offered improved efficacy over that earlier compound, but the application failed to pass this threshold, according to the ruling. A Gilead spokeswoman declined to comment.

The decision may have broad implications for patients and drug makers. For the pharmaceutical industry, the ruling may be seen as another instance in which intellectual property protection in India is lacking. A recent report by the U.S. International Trade Commission found that 28% of drug makers feel India fails to sufficiently protect patents. The Obama administration has been pressing India to make changes.

For patients, the decision is expected to spur other drug makers to produce low-cost versions of Sovaldi, even though Gilead last fall signed agreements with seven large generic drug makers--all based in India--to sell cheaper versions in 91 developing countries. Those countries have an average per capita income of less than $1,900 and account for about 54% of those with hepatitis C.

"The move to reject Gilead's patent application really opens up the playing field, so we hope to now see many other generic companies that did not take licenses from Gilead starting to produce more affordable versions of this drug," says Tahir Amin, director of intellectual property at IMAK, which advocates for changes in patent systems to widen access to drugs.

"The bottom line here is that India's patent law doesn't give monopolies for old science, for compounds that are already in the public domain. Gilead's strategy of charging as much as $84,000 per treatment for a drug that is predicted to be simple and cheap to produce, and is now un-patentable in India, has been exposed for what it is--seeking to squeeze as much profit out of the sick as possible."

Doctors Without Borders noted that a Liverpool University study showed Sovaldi could be produced for as little as $101 for a three-month regimen. "Getting [Sovaldi] out of the stronghold of Gilead's monopoly will be crucial to expanding treatment for people with hepatitis C globally," says Manica Balasegaram, who heads the group's access to medicines campaign.

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