Thinking that the battle is between Generic Vs innovator was only for anticancer and anti-retroviral medicines but now it has set a step into anti-diabetic drugs. The war is between Glenmark and Merk, the former has launched a cheaper generic version of an Anti-diabetic drug of pharma multinational Merck’s blockbuster anti-diabetes drug Januvia (Sitagliptin phosphate).
Dipeptidyl peptidase-4 inhibitors (DPP-4) or “gliptins” offered a new alternative in the treatment pathway for diabetes instead of biguanides and sulphonylureas for Diabetes
Merck’s Januvia containing Sitagliptin and Novartis’s Galvus containing Vildagliptin are India’s first patented oral anti-hyperglycemics. Januvia persistent approach made it undisputed leader among the gliptins. it covers almost 80% of worldwide sales for anti-diabetic monotherapy. In India the gliptins market share is estimated at about 500 crore. It also made partnership with Sun pharmaceuticals and other small domestic companies for local sales and to enhance marketing.
Glenmark officially announced the launch of generic version of sitagliptin and said it is not infringing Merk’s product. Glenmark has priced its generic version around 30% cheaper than Merck’s Januvia and the overall savings to the patient could be around 5000 Rs./year.
And it is to know that Merck’s Januvia is protected by two patents in India viz. IN209816 and IN219148. IN209816 is a product patent which specifically covers Sitagliptin. IN219148 claims process intermediates used in the manufacture of Sitagliptin. Apart from this, Merck had filed a patent application 5948/DELNP/2005 covering the phosphate salt form and enantiomers of Sitagliptin,
But this patent application was abandoned following a pre-grant opposition. Apart from this, Merck is pursuing two patent applications which specifically cover Janumet extended release sitagliptin+metformin combo.
What makes the case interesting is that Glenmark puts a question of what is infringement? infringement should be evaluated against patent claims and not against innovator’s products
When, experts assert that Metformin, a 50 year old drug still works best for diabetics though it has some side effects. With so many alternatives efficacious and affordable therapeutic options available for diabetic patients; they wonder the “public interest” factor will feature in this case.
Putting in nut shell, Merck is highly disappointed with the generic launch by Glenmark and the official was quoted as saying “We are disappointed in Glenmark’s decision to introduce products that directly infringe upon our intellectual property. We believe our patents for Januvia and Janumet are valid and enforceable and will vigorously defend them.”
Keywords: Glenmark, Merk, Januvia, Infringement, sitagliptin, Anti-Diabetic.