Wednesday
Feb222017

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.

Saturday
Jun202015

China Declined The Patent Application Of Gilead Sciences, Inc.’s Sovaldi Prodrug

WALL STREET JOURNAL: Gilead Sciences, Inc., no doubt, is one of the most prominent names when it comes to the development of hepatitis C therapies. The company, however, faced a blow when the patent application for one of its blockbuster hepatitis C drugs, Sovaldi, was rejected in the country of China.

Click to read more ...

Friday
Jun192015

China rejects patent linked to Gilead hepatitis C drug

REUTERS: China has rejected a Gilead Sciences Inc patent application related to its costly hepatitis C drug, a U.S. advocacy group said, adding the move may lead to other countries to consider rejecting patents for the controversial treatment.

Click to read more ...

Friday
Jun192015

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

WALL STREET JOURNAL: In a setback for Gilead Sciences, Chinese authorities have rejected a patent for its Sovaldi hepatitis C treatment, according to one of the patient advocacy groups that filed a challenge… “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.”

Click to read more ...

Thursday
May212015

Activists Challenge Gilead’s Patents on Costly Hepatitis C Drug Sovaldi

NEWSWEEK: A group of doctors and patient advocates are putting pressure on Gilead Sciences—maker of Sovaldi, the $1,000-a-day drug for hepatitis C—to release its patents. The Initiative for Medicines, Access & Knowledge (I-MAK), a U.S. nonprofit advocating for improved access to affordable medications, has filed challenges this week against the company in Argentina, Brazil, China, Russia and Ukraine. The organization had previously filed similar patent challenges in Europe and China.

Click to read more ...