Novartis has obtained Quia timet injunctions against four other generic companies: Glenmark generics, Bajaj Healthcare, Cadila Healthcare and Alembic Pharmaceuticals thus preventing them from launching generic versions of its blockbuster anti-diabetic drug Galvus (Vildagliptin).
Analysing these injunction orders, a blogpost on Spicy IP points out that In each of these orders Justice Sanjeev Sachdeva found that that plaintiff has made out a strong prima facie and that balance of convenience is also in favour of plaintiff (Novartis) and in case, the ad-interim injunction is not granted, the plaintiff shall suffer and irreparable loss and injury.”
The fact that Novartis had obtained similar quia-timet injunctions from the Delhi High Court against two other drug-makers Novartis and Biocon over the alleged infringement of Vildagliptin just last month, is an indication that it is taking all meausres possible to safeguard the anti-diabetic drug against competition.
India with over 63 million diabetics represents the world’s second largest diabetes population after China. The Indian population that had faced under nutrition for a long time is now exposed to over nutrition and sedentary lifestyles. Coupled with a bad nutritional history and the fact that Indians are genetically more vulnerable to diabetes compared to other population groups, India’s struggle with diabetes is expected to be one of the biggest epidemics the country has ever witnessed. This explains the increasing number of generic majors seeking regulatory approvals for manufacture of Vildagliptin, and the increasing interest in the anti-diabetic drug market.
Recounting the history of legal action concerning this product, the Spicy IP blogpost points out that after Wockhardt filed a revocation petition in the IPAB, Novartis filed an RTI with the DCGI (Drug Controller General of India) seeking information regarding regulatory approvals issued for Vildagliptin. The RTI response provided them with a list of manufacturers to whom approval was issued and this probably triggered the flurry of infringement suits.
EP News Bureau– Mumbai