India’s Supreme Court has prevented Glenmark Pharmaceuticals from making and selling a generic of Merck & Co’s diabetes blockbuster Januvia.
The decision validates Merck’s patents covering sitagliptin – the active ingredient in Januvia and line extension Janumet (which also contains metformin) – and effectively bars Glenmark from selling its Zita and Zita-Met copies. The court did however allow the Indian drugmaker to sell off any remaining inventory.
Merck filed a lawsuit against Glenmark alleging patent infringement in 2013, and the Delhi High Court rejected Merck’s petition for an injunction in the same year. In May, the Supreme Court issued a temporary injunction on sales of Glenmark’s products, which has now been made permanent.
Glenmark had argued that it was using a different salt of sitagliptin in its products that sidestepped Merck’s intellectual property, but that position was rejected by the court. It was also unswayed by Glenmark’s argument that the lower price it was charging made the availability of its generics a matter of public interest.
In India, Merck’s MSD Pharmaceuticals subsidiary sells Januvia at 43 rupees a pill – around 20% of the drug’s price in the US – compared to 14 rupees per pill for Zita. Licensee Sun Pharma also sells the drug in India on behalf of Merck as Istavel/Istamet. The court ruled that the difference in price was not significant from the perspective of public health.
Glenmark was ordered to pay part of Merck’s legal fees but was excused compensation.
The Januvia/Janumet franchise is Merck’s biggest product line, bringing in sales of around $3bn in the first six months of 2015, and a successful defense of its patents in India is a boost for the company, even if sales of the drug in India are modest.
The victory for Merck comes after a series of setbacks in Indian courts for multinational pharma companies, with defeats in IP infringement cases involving Novartis’ Glivec (imatinib), Pfizer’s Sutent (sunitinib), Gilead’s Sovaldi (sofosbuvir) and Roche’s Herceptin (trastuzumab), amongst others.
Various articles in the Indian press have held up the Januvia verdict as evidence against accusations that India’s patent regime is geared toward undermining the IP of overseas corporations.