MUMBAI: A patient group and a UK-based intellectual property law firm have together filed a patent opposition before the Delhi Patent Office to prevent US-based pharma company Gilead from gaining protection on a life-saving hepatitis-C drug in India. Gilead is expected to soon apply for an approval from Drug Controller General of India (DCGI) for sofosbuvir.
The move by the Delhi Network of Positive People (DNP+) and Initiative for Medicines Access and Knowledge (I-MAK) is the second pre-grant opposition filed on the drug - the first was filed last year at the Kolkata Patent Office.
Gilead Sciences has applied for multiple patents in India on sofosbuvir. India's patent law allows third parties, including civil society organizations, to file 'pre-grant' oppositions to challenge the patent application before the patent is granted. Two pre-grant oppositions by civil society groups have now been filed in India on key patents that would provide exclusivity over sofosbuvir.
The move by the Delhi Network of Positive People (DNP+) and Initiative for Medicines Access and Knowledge (I-MAK) is the second pre-grant opposition filed on the drug - the first was filed last year at the Kolkata Patent Office.
Gilead Sciences has applied for multiple patents in India on sofosbuvir. India's patent law allows third parties, including civil society organizations, to file 'pre-grant' oppositions to challenge the patent application before the patent is granted. Two pre-grant oppositions by civil society groups have now been filed in India on key patents that would provide exclusivity over sofosbuvir.
The civil society groups' intention is to prevent unmerited patent applications from being granted, and to open up the market for generic producers and increase competition, which will result in lower prices and increased access.
"To get a patent under the law, you need to show that your drug is scientifically new. We believe that Gilead does not meet this lawful requirement. Opposing the patent at the examination stage is a way of ensuring patients have access to this drug at affordable prices without unnecessary patent barriers standing in the way," said Tahir Amin, director intellectual property at I-MAK.
Gilead has reportedly said that the drug will be available in India at $2,000 for a 12-week treatment.
The World Health Organization estimates that over 12 million people in India may be chronically infected by the hepatitis (HCV) virus, most of whom do not know they are infected. Treatment is improving dramatically: potent oral medications, called direct-acting antivirals (DAAs), are dramatically increasing cure rates.
New DAAs - including sofosbuvir, approved by the USFDA in December 2013, and many others in late-stage development - can be produced generically in India and marketed at very affordable prices, just like antiretrovirals (ARVs) used in the treatment of HIV.
For example, a 12-week course of sofosbuvir, produced generically, is estimated to cost between $130-270; daclatasvir, a highly effective drug from a different class, produced by BMS, may cost only $10-30 per treatment course.
"To get a patent under the law, you need to show that your drug is scientifically new. We believe that Gilead does not meet this lawful requirement. Opposing the patent at the examination stage is a way of ensuring patients have access to this drug at affordable prices without unnecessary patent barriers standing in the way," said Tahir Amin, director intellectual property at I-MAK.
Gilead has reportedly said that the drug will be available in India at $2,000 for a 12-week treatment.
The World Health Organization estimates that over 12 million people in India may be chronically infected by the hepatitis (HCV) virus, most of whom do not know they are infected. Treatment is improving dramatically: potent oral medications, called direct-acting antivirals (DAAs), are dramatically increasing cure rates.
New DAAs - including sofosbuvir, approved by the USFDA in December 2013, and many others in late-stage development - can be produced generically in India and marketed at very affordable prices, just like antiretrovirals (ARVs) used in the treatment of HIV.
For example, a 12-week course of sofosbuvir, produced generically, is estimated to cost between $130-270; daclatasvir, a highly effective drug from a different class, produced by BMS, may cost only $10-30 per treatment course.
I Support Gilead patent in India because at least it is providing sofosbuvir at much cheaper rate as compared to the price in US. At least people who are covered through insurance may be able to get drug early. This plea against patent will delay the drug delivery to people who are in urgent need.
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