A patent infringement case relating to an anti-diabetic drug highlights the delicate balancing act required to protect innovation while ensuring access to affordable medicines. Vandana Chatlani reports
On 28 April, the Supreme Court of India is scheduled to hear arguments in the dispute between Glenmark Pharmaceuticals and US-based Merck Sharp & Dohme. The conflict between the pharmaceutical companies raises interesting questions about patent protection mechanisms, public interest, utility and the clash between generics and innovator companies.
The dispute centres on an anti-diabetic drug known as sitagliptin. Merck obtained a patent for its sitagliptin molecule in 2007 and marketed the drug as Januvia (sitagliptin) and Janumet (sitagliptin and metformin).
In 2013, Glenmark planned to launch generic versions of sitagliptin: sitagliptin phosphate monohydrate (SPM), branded Zita, and Zitamet (SPM and metformin hydrochloride). On 1 April 2013, Merck filed a suit against Glenmark, alleging infringement of its patent for sitagliptin and seeking an interim injunction to prevent Glenmark from launching the drugs. However, on 5 April 2013, Justice Rajiv Sahai Endlaw of Delhi High Court decided not to grant the injunction, leaving Glenmark free to manufacture and distribute its generics.