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Patent War between MNC pharma Cos and generic Companies gets chronic

Triggering a full-blown patent fight with US-based Merck, domestic generic company Glenmark has launched a more affordable version of the multinational's blockbuster anti-diabetes drug Januvia. The move is expected to heighten tensions between MNCs and domestic generic companies which have been embroiled in patent disputes over the last couple of years.  Glenmark's launch could also throw up a different patent challenge for the regulators, which have seen two prominent cases where the compulsory licence route was used to launch life-saving drugs at just a fraction of the original price.

Glenmark has priced its diabetes drug around 30% cheaper than Merck's Januvia, and the savings to patients could be nearly Rs 5,000 a year.  Merck's diabetes therapies Januvia and Janumet, launched in the Indian market in 2008, are part of the 'gliptin' family. The drugs together are nearly Rs 200-crore brands, making them one of the fastest growing medicines, and are ranked No. 2 in the oral diabetics market (according to IMS data).

Confirming the move, a company official said, "Glenmark is a responsible company and has launched the products after due diligence and research. Like other branded generics, Glenmark's Zita & Zita-Met are also branded generics."

The 'gliptin' market in India is estimated at around Rs 500 crore, growing at 25% per year. 'Gliptin' is an oral once-a-day treatment option. Priced at Rs 43 per tablet, a month's dose of Merck's Januvia costs nearly Rs 1,300. Though 'gliptins' have emerged as a good option in diabetes treatment, their use has been restricted largely because of their high prices, experts say.  A MSD India official said; "We are disappointed in Glenmark's decision to introduce products that directly infringe upon our intellectual property. We believe our patents for Januvia and Janumet are valid and enforceable and will vigorously defend them. Strong intellectual property protection is essential for growing India's innovative capacity and economic growth. As an innovative pharmaceutical company, protection of our intellectual property is vital to ensuring that we continue to assume the tremendous monetary risks associated with the discovery of innovative medicines."

In India, where there are over 65 million people with type 2 diabetes, MSD also has a comprehensive strategy to help address the challenge of reducing disease burden and to increase access to our medicines, including India-specific responsible pricing for Januvia and Janumet, the official added.  While Glenmark says that its product is "non-infringing" on Merck's drug, the details of Merck's patent on the drug sold in the market, were not available. Experts say that Glenmark's move will lead to a protracted legal battle with both sides sticking to their point.

Leena Menghaney, legal expert and campaign coordinator for Medicins Sans Frontieres, a medical humanitarian NGO, says "Access issues are also present in non-communicable lifestyle ailments. This becomes more relevant since developing countries are witnessing an increasing burden of non-communicable diseases, including heart disease, cancer, diabetes, and chronic obstructive pulmonary disease. Hence, generic companies have a big role to play to bring down prices of drugs used in these ailments."