In a move fraught with political tension, Indian officials reversed course and granted a patent to Gilead Sciences for its Sovaldi hepatitis C treatment, handing the drug maker an unexpected victory while angering many patient groups.
Early last year, the Indian Patent Office rejected the company’s patent application on the grounds that it was not a significant improvement compared with an earlier compound developed by another company. The decision came in response to a challenge to the Gilead patent that was filed by several patient advocacy groups and companies that make pharmaceutical ingredients.
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. Gilead has struck various deals to make its drug available at lower prices in other countries, but patient groups claim the only way to break the cycle of high pricing is to challenge the patents.
In a 58-page ruling issued on Monday, however, Dr. Rajesh Dixit, Deputy Controller of Patents & Designs, wrote that the Gilead compound was “novel and inventive.” In doing so, he largely dismissed many of the same arguments that the advocacy groups successfully used last year to convince patent officials to reject the Gilead application.
His decision comes 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.
Brand-name drug makers are upset, in particular, at Indian laws and court rulings that, in some cases, have made it easier for their generic rivals to sell lower-cost, copycat versions of their medicines. Shortly after taking office in 2014, Indian Prime Minister Narendra Modi responded by agreeing to form a working group on intellectual property with the Obama administration.
Meanwhile, the US Trade Representative last month again placed India on what is known as the annual priority watch list of countries, which are singled out for enforcement practices that are both favorable and unfavorable to American companies. As many patient groups see it, these efforts by the Obama administration are tools for pressuring India to change its approach to patent law.
For this reason, the reversal by Indian officials was skewered by patient groups.
“This was due to political pressure,” said Tahir Amin, director of intellectual property at IMAK, one of the advocacy groups, which plans to file an appeal.
The decision is “flawed, ignores the scientific facts, and fails to uphold the standards of Indian patent law to ensure only new inventions are patented.” Sovaldi does not deserve a patent, because “it was developed using previously published techniques that have been used repeatedly in other antiviral drugs.” Amin noted that Gilead’s Sovaldi patents have been rejected by China, Ukraine and Egypt.
Not surprisingly, Gilead praised the decision.
“The recognition of intellectual property is central to investment in pharmaceutical research and development, and this decision underlines the scientific innovation involved in the development of this breakthrough treatment for chronic hepatitis C,” a Gilead spokesman wrote us. “It is the company’s goal to enable access to these medicines for as many people as possible, as quickly as possible.”
Gilead has taken steps to blunt criticism of its pricing. Two years ago, the company signed agreements with several large generic drug makers — all of which are based in India — to sell cheaper versions of Sovaldi in 91 developing countries. Those countries have an annual average per capita income of less than $1,900 and account for more than half of hepatitis C patients.
Patient advocates worry that the reversal by the Indian Patent Office could restrict access to Sovaldi in still other countries not covered by the agreement. The ruling “will block a sustainable supply of key raw materials needed to produce the drug … and affect production by new suppliers,” said Doctors Without Borders in a statement.
It will “impact those Indian companies which were planning to enter the market independently to supply not just patients in India but also those in middle-income countries with large numbers of people living with hepatitis C, which Gilead currently forbids from receiving the medicine produced under Gilead’s licensing deal.”
Gilead, by the way, is also locked in litigation in a federal court in California with Merck over the novelty of two of its Sovaldi patents. Merck was recently awarded $200 million in damages, but a judge has since allowed Gilead to submit more evidence amid claims that a Merck attorney lied about a patent filing.
Sovaldi is one of several new direct-acting antiviral hepatitis C treatments, including the company’s other drug Harvoni and Merck’s Zepatier. While it effectively “cures” over 90% of patients, Gilead has been criticized for the high price it charges in developed countries. A 12-week regimen of the drug lists for $84,000 in the U.S.
Gilead does offer the drug at lower prices in other developing and low-income countries, but the humanitarian group MSF claims many patients in middle-income countries are unable to access the drug at Generic Sovaldi affordable price in Indian Pharmacy
I understand now the ruling is not good for Indian pharmaceuticals because they will not be able to solely profit from generic Sovaldi sales. So now they will have to pay a royalty. From what I gather about Indian pharmaceutical companies, a spokesperson from http://www.sunnypharma.org who sells the generic versions of Sovaldi, informed me that the manufacturers never disclose how many tablets are made in each quarter. This allows the manufacturers to not pay accurate royalties to Gilead Sciences. Essentially there are no checks and balances. Even if Gilead supplied sofosbuvir, the active ingredient of Sovaldi, India still manufacturers the compound locally. Good luck Gilead in collecting royalties from Indian pharma.
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