In the first significant patent decision this year, the Indian Patent Office has rejected one of the patent applications covering US drug-maker Gilead’s hepatitis C drug Sofosbuvir.
However, intellectual property (IP) experts caution that the patent application rejection may not quite open the flood gates for other Indian drug companies to make similar versions of the drug. Other patent applications on the main drug are pending, and the one that is rejected for not being inventive is a base compound, an expert said.
This could however be the first step to a long litigious journey on the drug, experts agree, especially if Gilead chooses to defend its patent. U.S.-based Gilead could not be reached immediately for its response, given the time difference between the two countries.
Gilead’s sofosbuvir had hit global headlines last year over the pricing of the breakthrough medicine, one of the first of several oral Hepatitis C drugs. It costs $ 84,000 for 12 weeks in the US and is expected to be pegged at less than $1000 for the same period in India.
Pre-grant oppositions
The latest patent-related order comes even as sofosbuvir faced pre-grant oppositions against it at the Indian patent offices in Delhi and Kolkata.
They included oppositions from U.S.-based legal group I-MAK (Initiative for Medicines, Access & Knowledge), Delhi Network of Positive People, the Indian Pharmaceutical Alliance (representing large domestic drugmakers) and Hyderabad-based drugmaker Natco.
A pre-grant opposition under the amended Patents Act allows interested parties to oppose a patent application on a product before the Patent Office decides on whether to grant or deny a patent. Patents grant an inventor 20 years market exclusivity, and public healthworkers fear that such monopolies could price medicines beyond the reach of patients.
In its Tuesday order, the Patent office said, “the oppositions filed u/s 25(1) by the opponents as mentioned above at present is infructuous with this rejection of the application U/S 15 for further processing of the Patent Grant.”
Local alliances
Last year, Gilead stirred the pot further by entering into non-exclusive licensing agreements with seven India-based companies including Cipla, Ranbaxy and Mylan that would allow them to make sofosbuvir at reduced prices in certain markets.
The latest patent application rejection will not impact these tie-ups, just yet, an IP expert indicated, since other patent applications on the drug are still pending.