Indian pharma patents to surge with US expiries

Between 2010 and 2015, drugs worth a mindboggling $157 billion are set to go off patent in the US, according to industry estimates.
Conversely, in India, by 2015 — that’s when the Indian pharmaceutical market is expected to be worth $20 billion — about 15% of the drugs would be patented molecules.

About 70,000 patent applications are in the pipeline for process and examination in the country, said P H Kurian, controller general of Patents, Design and Trademarks.

“From 2005, till date, about 13,000 patents have been issued in both chemicals and pharmaceuticals,” he said.

The increased growth in patenting in India is due to the introduction of the product patent regime and 20 year patent term in 2005, after India signed the trade related aspects of intellectual property rights (Trips) agreement of the World Trade Organisation (WTO) in 1995.

“The minute Trips came into being, filings have gone up and in future they will continue increasing. In US also, though expiries are staring in the eye, filings are happening,” says Anuradha Salhotra, managing partner at intellectual property law firm Lall, Lahiri & Salhotra.

At a time when escalating healthcare costs are posing a hurdle for governments across the world, whether India can afford the patented drugs is a question begging for answers.

Data by consulting firm Technopak’s healthcare division, suggests share of average annual household spend on healthcare is expected to increase from 7% to 13% in the next two decades.

According to B K Keayla, convenor, National Working Group on Patent Laws, patents imply monopoly, with no entry for lesser priced generic drugs till expiry. “The public will suffer as the monopoly will result in patent holders charging high prices.”

YK Sapru, founder chairman and CEO of Cancer Patients Aid Association, says unless radical steps are taken in making drugs affordable, there will be a stage when 90-95% of people in India would not be able to take life saving drugs on account of high prices.

How many people can afford to pay over Rs 400,000 for a 24 week course of a Hepatitis C medication which is patented, asks Eldred Tellis, director of Sankalp Rehabilitation Trust, a Mumbai based NGO working with Hep C and AIDS patients.

“There are patented medications for breast cancer costing Rs16-18 lakhs for a year’s treatment which is beyond reach a vast section of people,” says Sapru.

Companies have been filing applications for patenting different forms of the same drug, including the salt, polymorph form, analogue form, crystalline form, solid dosage form, combination of the drug with other drugs, etc (DNA Money, March 5, 2010).

Amit Sengupta, general secretary of All India Peoples Science Network, says multiple applications would toughen the work of the patent offices and there could be chances of applications getting wrongly granted.