European regulator amends some Gilead hep C patent claims

Media Article 31 Oct 2016

By ED SILVERMAN @Pharmalot

OCTOBER 5, 2016

In a setback for Gilead Sciences, European regulators decided not to uphold all of its patent claims for the best-selling Sovaldi hepatitis C treatment, a move that could lead to generic versions of the medicine becoming available four years sooner than had been expected.

The European Patent Office on Tuesday amended several patent claims that were challenged by Medicins Du Monde, a medical aid charity, which argued that Gilead was abusing the patent system and charging prices that hindered access for many patients. The patents that were challenged were for the so-called pro-drug, which allows the body to metabolize the medicine, on the grounds that Gilead failed to fully disclose the nature of its innovation, among other things.

“This is a flawed patent that has been used by the pharmaceutical company to impose a huge pressure on [European] states that have accepted exorbitant prices leading to treatment restrictions for patients in many European countries,” said Dr. Françoise Sivignon, the president of Medicins du Monde, which filed its challenge last year, in a statement.

As a result, a generic version of Sovaldi — the first of the new crop of hepatitis C medications to revolutionize treatment — could become available in Europe in 2024 instead of 2028, according to Tahir Amin, the who heads intellectual property at IMAK, the Initiative for Medicines, Access & Knowledge, a nonprofit that works with patient advocacy groups in challenging patents.

A Gilead spokesman sent us a statement maintaining the patent, as a whole, was not revoked. “The European Patent Office “confirmed that Sovaldi was covered by a valid European patent,” he wrote us. The patent office “found that claims covering [Sovaldi] within the patent were valid. The board believed that these claims were novel and inventive.” He also insisted there will be no impact on the possibility of generics arriving before 2028.

Amin, however, maintained “there’s not much left on Gilead’s patent and what is left does not cover Sovaldi.” The Gilead spokesman disputed this, however.

A spokesman for the European Patent Office told us “some of the patent claims were no longer found to be admissible under the patent and, therefore, were changed. It’s true it was changed in scope … The patent stands, but certain features originally in the claims no longer figure.” The EPO also issued a statement saying that Sovaldi, “as claimed in the version of the patent granted is no longer contained in this form of the patent.” He stressed that the decision can be appealed.

The decision is the latest victory for patient advocacy groups that have argued Gilead has filed patent claims that unfairly allowed it to essentially monopolize the market for hepatitis c treatments. Similar decisions were reached in China, Egypt, and Ukraine. Yet another ruling went against Gilead in India, although the government last May reversed the decision, which is being appealed.

Sovaldi, which became available more than two years ago, has been a flashpoint in the debate about drug pricing. The original list price for the medicine was $84,000 in the United States, before rebates to payers, for a 12-week regimen. With a 90 percent cure rate, however, the medicine quickly saw demand in the US and around the world, but the cost has been an issue in some countries.

To widen access and blunt mounting criticism, Gilead two years ago reached licensing deals with seven generic drug makers based in India to sell lower-cost versions in 101 low-income and middle-income countries. But patient groups claim the only way to break the cycle of high pricing is to challenge Gilead patents, which Amin acknowledged is a slow process.

Although Sovaldi is now the oldest of three Gilead hepatitis C treatments, the patient groups and their allies are focusing on this particular medicine because it represents the “backbone” of the many patent claims filed by the company, according to Amin. Since Sovaldi became available, Gilead has won regulatory approval to sell Harvoni and Epclusa, a pill that treats all strains of hepatitis C.

“Sovaldi is the basis for future treatments and will factor into other compounds they develop,” Amin explained. “By removing some of the patent protection for Sovaldi, we’re opening up the market and removing an obstacle to fundamental treatment down the line.”

This post was updated to include a comment from the European Patent Office, which limited, but did not revoke the patent.

Ed Silverman can be reached at
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By ED SILVERMAN @Pharmalot

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