It seems like Novartis is jealously safeguarding anti-diabetic drug Galvus against competition. In an interesting turn of events Novartis filed quia timet suits against against four other pharmaceutical generics: Glenmark generics, Bajaj healthcare, Cadila healthcare and Alembic pharmaceuticals over alleged patent infringement of Galvus (Vildagliptin).
In the Bajaj healthcare case and Alembic pharmaceutical case the court granted ex-parte ad-interim injunctions and observed that that plaintiff (Novartis) has made out a strong prima facie case for grant of ad-interim injunction. The balance of convenience is also in favour of plaintiff and in case, the ad-interim injunction is not granted, the plaintiff shall suffer and irreparable loss and injury.Time and again, we have reiterated the dangers of granting ex-parte injunctions in highly technical patent cases like these.Please read Shamnad’s and Prashant’s incisive posts on this.
In the Glenmark case as well as the Cadila case the defendants undertook that till the next date of hearing, the defendant shall not manufacture for marketing purposes and shall not market in India or abroad any product, that infringes the patented product of the plaintiffs. Since the defendants are bound down by their statements this is more or less like an injunction.
Around last month, 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. We had blogged about this here and here.
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.
With so many generic majors seeking regulatory approvals for manufacture of Vildagliptin, the anti-diabetic drug market surely is heating up.
PS: A big thanks to Sai Vinod for bringing this news to my attention.