Gilead Patent for its Sovaldi Hep C Drug is Rejected by Chinese Authorities

Media Article 19 Jun 2015

By  Ed Silverman

In a setback for Gilead Sciences GILD +0.54%, Chinese authorities have rejected a patent for its Sovaldi hepatitis C treatment, according to one of the patient advocacy groups that filed a challenge. Although Gilead holds another patent on the drug, the reported rejection could open the door to rejections in other countries where Sovaldi patents are also being challenged.

“This means there’s a significant question mark about the inventiveness of this drug,” says Tahir Amin, director of intellectual property at the Initiative for Medicines, Access and Knowledge, or IMAK, one of several advocacy groups that filed the challenge. “Now, its patent protection is significantly weakened. The one patent that could block other competitors coming to the market is now very vulnerable.”

A Gilead spokesman declined to comment. Meanwhile, the rejection has not been confirmed by the Chinese government, but you can read this status report from the Chinese patent office.

The patent challenge came as both public and private payers complained that new hepatitis C treatments are budget busters. In the U.S., Gilead priced Sovaldi at $1,000 per pill, or $84,000 for a regimen. Consequently, the treatment became a poster child for the contentious debate over the cost of prescription medicines and health care.

Gilead responded by offering lower prices to some payers in the U.S. and other countries, such as Egypt, where the treatment costs $900, and France. And last fall, the drug maker reached agreement with several generic drug makers to sell low-cost versions in 91 low-income countries. However, the deal was criticized by some patient advocates, because middle-income countries were excluded.

Patient advocates complained that middle-income countries are home to some of the poorest people, even though they are classified as having relatively high incomes. As a result, Amin says that Gilead did not offer any beneficial pricing and patients may get charged higher prices than what most people living with the disease are able to pay for the medicine.

And so, IMAK and other groups filed challenges against Sovaldi patents in China and four other middle-income countries – Ukraine, Russia, Argentina and Brazil. As we noted previously, IMAK estimates about 40 million people have hepatitis C in those five countries and the cost to treat them could total $270 billion, based on a same discounted price of $7,500 per patient Gilead proposed to offer to Brazil.

For now, though, the legal battle over Sovaldi patents in China is expected to continue. Amin, for instance, expects Gilead to appeal the rejection. And Gilead does hold another patent on Sovaldi, although he declined to comment on whether IMAK and the other advocacy groups plan to challenge that patent as well.

Nonetheless, Amin maintains the rejection could, eventually, lead to lower-cost generics in China and elsewhere, since China is a large provider of pharmaceutical ingredients to companies around the world. “These companies could ship the ingredients if the other [Sovaldi] patent is eventually cleared in China,” he says. “It would really put the cat amongst the pigeons.”

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