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26 March 2014Asia-Pacific

Gilead’s attempt to patent Sovaldi in India opposed

Gilead Sciences has received another challenge to its application to patent its new hepatitis C drug Sovaldi (sofosbuvir) in India.

Patient representative group the Delhi Network of Positive People (DNP+) and the US-based lawyer-led IP organisation Initiative for Medicines Access and Knowledge (I-MAK) filed an opposition against Gilead Sciences and its New Jersey-based subsidiary Pharmasset’s primary patent application for the drug at the Indian patent office.

The application 6087/DELNP/2005, made by Pharmasset in 2005, stemmed from a 2004 Patent Cooperation Treaty application and is still under examination in India. It covers “modified fluorinated nucleoside analogues”, which provide compositions and methods for treating the hepatitis C virus.

The complaint follows an opposition filed by I-MAK last November against Gilead and Pharmasset’s secondary application in India for the drug.

In a letter dated March 17, DNP+ and I-MAK argued that claims 1 to 20 in the application are not patentable, and asked the Controller of Patents at the patent office that it be refused in its entirety.

“Undeserved patents of the nature applied for in ‘6087 afford a company, such as the applicant, artificial exclusive rights, which then allow it to price a medicine beyond the reach of not only Indian patients, but also many in need in other developing and even developed countries,” the groups wrote in the complaint.

I-MAK’s co-founder and director of IP Tahir Amin told LSIPR: “We do not believe the patents are merited given the prior art. Unmerited patents would block legitimate competition that ultimately impacts affordability and access for millions, especially in middle-income countries.”

Gilead did not respond to a request for comment.

Sovaldi was approved by the US Food and Drug Administration last December and by the EU Commission in January. In the first nine weeks after its launch, Sovaldi sales totalled $484 million and analysts have predicted it will eventually overtake Pfizer’s Lipitor as the world’s biggest selling drug.

However, according to reports, lawmakers in the US are pressuring Gilead to explain the high price of the drug, which currently stands at $1,000 a pill, or $84,000 for a 12-week course.


More on this story

Asia
16 January 2015   The Indian Patent Office has rejected one of US drug maker Gilead’s patent applications to cover hepatitis C drug Sovaldi (sofosbuvir), in a decision that may decrease the blockbuster’s cost in the country.

More on this story

Asia
16 January 2015   The Indian Patent Office has rejected one of US drug maker Gilead’s patent applications to cover hepatitis C drug Sovaldi (sofosbuvir), in a decision that may decrease the blockbuster’s cost in the country.