Summary
The Indian Patent Office rejected Gilead Sciences' patent application for Sofosbuvir, a Hepatitis C drug, on 13 January 2015. The application was opposed by Natco and public health groups, who argued that it did not meet the criteria under section 3d of the Patents Act. The decision found that while the drug was novel and inventive, it failed to demonstrate enhanced therapeutic efficacy over prior art. This opens the Indian market for generic versions, increasing accessibility and affordability for patients. Gilead has challenged the decision in the Delhi High Court, while India has already granted regulatory approval for Sofosbuvir.
Gilead Sciences was rejected patent for its blockbuster drug Sofosbuvir, a new Hepatitis C drug by the India Patent Office in a major decision taken on 13 January 2015. The drug is branded under the name Sovaldi. Gilead had priced the drug at US$84,000 for a treatment course, or $1,000 per pill in the US and had received a regulatory approval in US in 2013.
The patent application (6087/DELNP/2005) for the drug was opposed by the Indian generic company Natco; Medicines, Access & Knowledge a non-profit initiative; and the Delhi Network of Positive People (DNP+) pointing out that the drug does not fulfill the patentability criteria under sec.3 (d). The application was rejected by the Indian Patent office on a similar ground under sec. 3 (d) it took to reject the patent for Novartis cancer drug Glivec last year.
In its decision, the Indian Patent Office was of the opinion that the changes described in the application though make Sovaldi ‘novel and inventive’, the drug failed to prove the enhanced therapeutic efficacy over the closest prior art compound D1 (patent WO2001/92282). The drug with the minor changes when it is structurally and functionally close to a molecule in the prior art in addition to being novel has to prove the therapeutic efficacy.
The drug had been in debate over its huge price and other patented drugs, when Liverpool University had come up with a study which showed that a three month treatment course could be manufactured at a price as low as $101. The activists had renamed the company as ‘Killead’ in the protest against their huge prices. Gilead had signed voluntary licensing agreement with seven Indian generic companies to manufacture the drug for sale in 91 countries including India and had offered to sell the branded drug in India at a lower price of $900 or about Rs 54,000 for 84 days. The patent rejection has opened way for other generic companies who are not bound by the license to enter the market with the generic versions of Sofosbuvir. Contrary, the companies under the license will be still bound by the agreements in an open market. A major setback for Gilead, the decision would make the drug available at an affordable price to patients even in countries that were omitted in the license agreement.
Gilead has challenged the order at the Delhi High Court, the hearing for which is scheduled on January 30, 2015 and the Court has sought government’s advice on whether the matter needs to be remanded back to the patent office for reconsideration or taken up by the court.
Interestingly, on the same day of order for rejection, India became the first Asian country to grant regulatory approval to Sofosbuvir recognizing the urgent need to bring the drug to the needy patients.
Image Source/Attribution: AIDS Healthcare Foundation (AHF)/Flickr)