Gilead faces fresh patent challenges over hepatitis C drugs in India

By ED SILVERMAN @Pharmalot

FEBRUARY 14, 2017

If at first you don’t succeed …

After losing one challenge to Gilead Sciences patents on hepatitis C drugs in India, patient advocacy groups are now challenging still other patents the company holds for its drugs in the country. At the same time, the groups are also challenging Gilead patents in Argentina, moves that reflect an ongoing strategy to widen patient access to the medicines.

The challenges come amid ongoing criticism over restrictions that Gilead placed on the ability of generic drug makers to supply lower-cost alternatives to Sovaldi, its oldest drug, in numerous countries. Two years ago, the company reached agreement with several Indian generic drug makers to sell low-cost versions in 91 low-income countries, but middle-income countries were excluded. Gilead also struck deals with some countries, such as France.

Sovaldi forms the linchpin for combination treatments sold by Gilead, and patient groups claim the only way to break the cycle of high pricing is to challenge patents. By filing the latest patent challenges, which also target one of the newer drugs, the groups hope to expand the number of generic companies that can eventually make copies and either export them to other markets or serve local populations.

“The hope is to eventually make it possible for more people to obtain an affordable treatment,” said Tahir Amin, director of intellectual property at IMAK, an advocacy group involved in the challenges. He noted that the groups also filed a challenge to a patent on a Bristol-Myers Squibb hepatitis C drug called Daklinza, because this is also used in combination with Sovaldi.

A Gilead spokesman declined to comment. We asked Bristol-Myers for comment and will pass along any reply that we receive.

The advocacy groups have also filed challenges to Gilead patents on Sovaldi in Brazil, Thailand, Egypt, and Russia, and have succeeded in having patents revoked in China and Ukraine, according to Amin. Some countries are precluded from licensing deals with Gilead that could allow local companies to import ingredients or make finished version of the drugs.

Last October, the European Patent Office amended several patent claims that were challenged by Médecins du Monde, a medical aid charity. In Argentina, Amin noted Gilead does not have a patent on Sovaldi, and the advocacy groups have previously thwarted one type of patent from being granted and are targeting yet another.

In India, however, Gilead last spring fended off a challenge, although the advocacy groups are now appealing and a hearing is expected to begin this week. The latest challenges to be filed actually target a different type of patent on Sovaldi, as well as another Gilead drug called velpatasvir, which is used to form Epclusa and was approved a year ago as the first treatment for all six major strains of hepatitis C.

As we noted at the time, the decision by the Indian Patent office last spring came amid mounting pressure on the Indian government to bolster protection of intellectual property. The global pharmaceutical industry has long argued that the government has been lax about enforcing patent rights in order to favor its own domestic drug makers, many of which sell generics in many countries.

But Sovaldi, which became available three years ago, has been a flashpoint in the debate about drug pricing. In the US, the original list price for the medicine was $84,000, before rebates to payers. But payers complained the drug was a budget buster, despite arguments from Gilead and its supporters that the medicine would eventually lower health care costs, given a high cure rate exceeding 90 percent.

The patent challenges, however, persist as Gilead reported hepatitis C drug sales have slowed. Last year, the medicines generated $14.8 billion in revenue, down from $19.1 billion in 2015. The decline was due to the large number of people who were rapidly treated with the medicines and the subsequent smaller number of patients who may be eligible for treatment, according to Wall Street analysts.


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