Big pharma scored a major victory in its battle against generic-makers in India as the Delhi high court on Wednesday stopped Glenmark Pharmaceuticals from manufacturing and selling two anti-diabetes drugs because they infringed a patent held by US giant Merck Sharp and Dohme (MSD).
MSD sells its patented drugs Januvia and Janumet at Rs 1,300 a month while Glenmark’s Zita and Zita-Met cost around Rs 900 a month. The court stopped Glenmark from making, using, selling, distributing, advertising, exporting, offering for sale or dealing in Sitagliptin phosphate monohydrate or any other salt of Sitagliptin in any form, alone or in combination with any other drug infringing a patent held by MSD.
“It’s a victory for research-based industry as it is a new molecule sold at a differential price in India. It costs Rs 43 for a dose in India, roughly a fifth of its cost in the US,” said patent expert Krishna Sarma, managing partner, Corporate Law Group, which is not associated with the case.
About 65 million people have diabetes in India and an equal number have insulin resistance which puts them at risk of acquiring the disease in the future. Roughly half of Indians with diabetes are undiagnosed or untreated.
“These drugs are effective, safe and widely used to control sugar levels of people with type-2 diabetes. Monthly cost per patient is between Rs 900 and Rs 1,600, depending on dose, which is out of the reach of most Indians,” said Dr Anoop Misra, chairman, Fortis C-DOC Centre of Excellence for Diabetes.
“We will certainly welcome a cheaper version of the drug with a mechanism of action, as people with diabetes have to take it for life,” he said.
Uncontrolled sugar levels put people with diabetes at a higher risk of many complications and diseases, such as blindness, heart attack, stroke and, rarely, amputation. While the court did not order Glenmark to pay any compensation to MSD, it directed it to bear the cost of the two-year-long litigation.
In 2013, Merck had moved the high court contending it held the patent for sitagliptin phosphate monohydrate – the active ingredient of Zita and Zita-Met – and Glenmark’s drugs infringed on its rights.
The court held that it cannot allow Glenmark to continue manufacturing and marketing its generic drugs just because it is selling them at lower prices than Merck’s.