Gilead’s India Patent Snag May Spur Low-Cost Sovaldi Copies

The Indian patent office’s rejection of a key patent claim for Gilead Sciences Inc.’s Hepatitis C treatment Sovaldi may pave the way for more low-cost copies in the country, potentially aiding local companies including Natco Pharma Ltd.

The New Delhi patent office this week rejected one of the patent claims for Sovaldi. Sovaldi’s $84,000 price tag for a 12-week course in the U.S. has drawn criticism from patient advocates.

Drugmakers including Pfizer Inc., Novartis AG and Roche Holding AG have seen patent applications for blockbuster drugs rejected in India because of stricter standards for innovation. India’s government also caps many drug prices to ensure that the country’s poorest can afford them.

A potential beneficiary of the patent office’s decision on Sovaldi is Hyderabad, India-based Natco, which is opposing the grant of another patent on the formulation of Sovaldi in India. Rajeev Nannapaneni, chief executive officer of Natco, declined to comment.

Gilead will appeal the rejection, which is for a patent on the active compounds produced as Sovaldi is metabolized inside the body, said Gregg Alton, an executive vice president for Gilead, in an e-mail. “The main patent applications” for the drug are still pending in India, he said.

The patent office rejected Gilead’s claims over a section of the patent law that requires the patent applicant to show that a “new form of a known substance” is more efficacious than the previous form.

Gilead said in its response to the patent office’s objections that it had been granted patents for similar claims in 17 countries including Israel, China and Indonesia.

Reaching Patients

While the product could be a big one for Natco, the company will face challenges beating other companies to the market, and reaching patients in rural India, said Nimish Mehta, director of Research Delta Advisors. Competing with Natco will be seven other Indian drugmakers -- Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd. and Strides Arcolab Ltd. -- who were awarded licenses by Gilead in September to manufacture copies of the drug for 91 countries that are mainly low-income regions. India has 12 million people infected with hepatitis C.

Gilead, based in Foster City, California, has said it plans to sell its branded version of Sovaldi in India at a cost of $900 for 12 weeks of therapy. The patent decision this week doesn’t change Gilead’s plans to make the medicine accessible in India, Alton said.

Chaitanya Prasad, controller general of patents, designs and trademarks, didn’t immediately return a call to his office seeking comment.

Gilead’s Sovaldi changed hepatitis C treatment when it was approved in 2013. Previous therapies relied on shots given weekly for a year and cured only about half of patients with the most common U.S. strain, called genotype 1. The drugs also caused side effects that include fatigue and flu-like symptoms. Sovaldi is a pill taken once a day, with fewer side effects, though patients can still get fatigue, headache and nausea.

(An earlier version of this story corrected details from the patent office’s decision in the second paragraph.)

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