Frivolous pharma patents rising

For millions of Indians, future appears bleak as far as rising healthcare costs go.

Medicines, which constitute anywhere between 15-50% of total healthcare costs, are increasingly getting patented in India, implying a monopoly for the patent holder to charge any amount he thinks appropriate.

Most importantly, several patents being granted are for products which are actually minor variations of existing medicines, and not breakthrough drugs, says a study by the Indian Pharmaceutical Alliance (IPA).

The study says that about 86 pharmaceutical patents granted by India after 2005 are for new forms of already known drugs and for combinations of various drugs.

Some of them are for medicines such as Fenofibrate (cholesterol reduction), Azithromycin (antibiotic), Gabapentin (epilepsy), Cefdinir (antibiotic), Galantamine (alzheimer’s).

The patents are for various pharmaceutical compositions of the drugs and delivery forms of the medicines, as well as methods of preparation. Global giants such as Pfizer, Novartis, Roche, Eli Lilly, Johnson &Johnson, Schering Corporation, Merck have filed and received several of the patents.

2005 was the year when the 20-year patent term and product patent regime came into being, after India signed the trade related aspects of intellectual property rights (Trips) agreement of the world trade organization (WTO) in 1995.

DG Shah, secretary general, IPA, says the study shows that evergreening - getting patents for minor variations to extend patent life of a product is rampant in India.

“The minute Trips came into effect, patent filings have risen and will continue going up,” says Anuradha Salhotra, managing partner at intellectual property law firm Lall, Lahiri &Salhotra.

Estimates suggest in India, by 2015, 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, Patents, Design and Trademarks.

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 BK Keayla, convenor, National Working Group on Patent Laws, patents will keep lesser priced medicines out 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 drugs on account of high prices.