Gilead to appeal India patent ruling on niche Sovaldi claim

SINGAPORE--Gilead Sciences ($GILD) said that an India patent office ruling on hepatitis C drug Sovaldi (sofosbuvir) only affects an application covering part of the active ingredient and that the larger validity of the uniqueness of the product remains intact as does a path-breaking patient access for the drug.

Gilead's Gregg Alton

"The main patent applications covering sofosbuvir are still pending before the Indian Patent Office," said Gregg Alton, executive vice president for Corporate and Medical Affairs at Gilead Sciences, said in an email on Thursday.

"This rejection relates to the patent application covering the metabolites of sofosbuvir. We are pleased that the Patent Office found in favor of the novelty and inventiveness of our claims, but believe their Section 3(d) decision to be improper. Gilead strongly defends its intellectual property. The company will be appealing the decision as well as exploring additional procedural options."

The Indian patent office determined that Sovaldi was a "molecule with minor changes" from a previous compound developed by another company, and thus undeserving of patent protection. For Big Pharma, it's the latest example of India failing to recognize innovative treatments hailed elsewhere as breakthroughs.

Gilead had already said it would sell Sovaldi for $900 per treatment course in India, a vast discount off its U.S. list price of $84,000 for 12 weeks of therapy. It's one of several deals Gilead has struck in emerging markets, where the disease burden is high and health budgets low. The company also licensed the drug to 7 Indian drug makers, which signed on to manufacture Sovaldi copies for 91 emerging countries, including India.

But patient advocates--including Médecins Sans Frontières--haven't been satisfied with a $900 price in India. They are calling for a hepatitis C treatment drive across the country, where an estimated 12 million people are infected with the disease--and where $900 is still beyond the reach of most Indians' pocketbooks, they say. Citing a production-cost study by Liverpool University researchers, MSF has said that manufacturing Sovaldi costs somewhere between $68 to $136 per 12-week supply.

Alton said the issue of access and patents are separate.

"These proceedings do not impact our commitment to enabling access to our hepatitis C medicines in India and other developing countries, and our generic licensing program with our Indian partners continues as normal," Alton said.

"We welcome the news that on (Jan. 13, 2015) the authorities in India granted sofosbuvir regulatory approval in an unprecedented four months--the first country in Asia to approve sofosbuvir--recognizing the need to bring this innovative new medicine to patients in India as quickly as possible."

Still, critics of India's intellectual property regime said the decision opens the door for cheap generic copies from domestic drug makers such as Natco Pharma. It's the latest blow to a multinational drug maker's ambitions in India, which remains one of the fastest-growing drug markets in the world.

Natco and the Initiative for Medicines, Access & Knowledge (I-MAK) officially opposed patent protection for Sovaldi in November 2013. Now that the patent office has officially denied the patent, Natco and other Indian drug makers who didn't sign on to Gilead's licensing deal can roll out their own versions.

"The move to reject Gilead's patent application really opens up the playing field, so we hope to now see many other generic companies starting to produce more affordable versions of this drug," said I-MAK Director Tahir Amin in a statement.

Gilead isn't the only hepatitis C drug maker drawing fire for its pricing in the developing world. MSF chastised Bristol-Myers Squibb ($BMY) in November after the company announced it would develop a 90-country licensing strategy to make its drug daclatasvir affordable there. MSF maintains that limiting cheap copies to those countries leaves out middle-income countries that are still unable to foot the bill for the expensive brand.

For activists, fighting IP protections is a logical choice, especially in India, where patent officials and courts have been skeptical of the pricing power they convey. Novartis ($NVS) fought for a patent on its blood-cancer treatment Glivec for years, and all the way to the Indian Supreme Court, only to be turned away in the end.

Meanwhile, the Indian government forced Bayer to license its on-patent drug Nexavar to Natco Pharma, which is turning out a discount-priced version. And the Indian patent office has revoked patents on a series of Big Pharma drugs, including Roche's ($RHHBY) hep C treatment Pegasys. The series of decisions against pharma IP coverage has landed Indian officials in hot water with U.S. trade reps.

- here's more FiercePharma coverage on the ruling

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