Mumbai: Throwing an indirect challenge at patent holder Novartis, drugmaker Natco Pharma has submitted a fresh application in a Hyderabad court seeking legal opinion on its right to manufacture a generic version of popular diabetes drug Vildagliptin, based on the patent expiry of the drug on December 9, 2019.
A major anti-diabetic drug, Vildagliptin is marketed as Galvus by Novartis. It is the first (diabetes) medicine whose end-of-patent life will be witnessed by an industry. It holds about 25% share of the gliptins market of Rs 3500 crore.
The introduction of a generic version of the drug will cut the cost of the therapy by more than 50%, making it affordable for millions of diabetics. However, Novartis has reportedly filed 73 injunctions against various firms since 2013 to block them from launching a generic version of the drug.
More than a dozen companies were restricted by Novartis in 2018 in Gujarat alone from unveiling the drug before patent expiry, implying that the patent expiry of Vildagliptin is being closely watched by competitors.
Novartis moved Delhi high court and sought legal intervention to protect its drug against companies that even planned to launch the drug, wherein Natco Pharma submitted to the court that it will not manufacture or market the drug, till the expiry of the patent in December.
However, Natco reportedly launched some batches of the drug on August 14. As per a recent media report by TOI, in the fresh suit, Natco has lodged a case against Novartis seeking declaratory relief under Section 34 of The Specific Relief Act, 1963 before the City Civil Court in Hyderabad on August 20.
“The Hyderabad suit is in relation to clearance of the right to manufacture Vildagliptin which is publici juris due to expiry of Indian Patent 209534 which not only discloses but also claims Vildagliptin”, sources told TOI.
The company feels this a case that restricts the patentability of a host of secondary patents, i.e., new forms of known substances, new property or new use of known substances, use of known processes without showing any enhanced therapeutic efficacy, and admixtures without synergistic effect by the innovator, with the patent being “obvious and frivolous’”.