Novartis filed a lawsuit for Galvus’ salt-altering drug

Novartis reported that Hanmi violated the obligation to notify Vildagle when applying for permission

The MFDS does not have to oblige notice, so it is said that the permit is legal

It was confirmed that Novartis has filed a lawsuit against the MFDS regarding the approval process of 'Vildagle 50mg' (Vildagliptin HCl), a DPP-4 series diabetes treatment drug that was approved in January.

 

Unlike the Novartis’ Galvus (Vildagliptin), Hanmi's Vildagle is a salt-altering drug with HCl.

 

In addition, Vildagle's indication doesn’t include co-administration with Sulfonylurea or Metformin or Thiazolidinedione monotherapy if blood sugar control is not available.

 

According to the industry on the 28th, Novartis recently filed a lawsuit against the MFDS for request for suspension of execution and cancellation of item permission, saying that Hanmi was granted permission in violation of the obligation to notify the application for permission under the drug patent linkage system.

 

According to the licensing patent linkage system introduced in 2012, generic companies must notify the patent holder of the application for permission.

 

The patent holder may dispute this, and the manufacture and marketing of generics may be suspended for nine months.

 

Novartis claims, however, that Hanmi failed to comply properly even though it was obliged to notify generic licenses.

 

However, Hanmi argues that Vildagle was not obliged to notify, as he was granted permission without an indication that the patent is currently in existence.

 

The MFDS also said that there was no obligation to notify Vildagle as it is not related to the patent rights that exist.

 

Currently, Hanmi has been requesting a judgment to confirm the passive scope of rights that Vildagle has evaded Galvus’ patent rights (expired on March 4, 2022).

 

The judge is expected to come to trial in June as soon as possible.

 

Novartis said that the MFDS and Hanmi went through the permitting process, assuming Vildagle’s patent evasion, before the trial of the Judge was issued.

 

Novartis has also filed a disposition to prohibit the sale of Vildagle to Hanmi.

 

Vildagle 50mg received a price of ₩403 per tablet in April, so it was ready for release.

 

If the court accepts the Novartis’ claim and cites the suspension of the item license for Vildagle, it is expected that the rights such as market sales will be deprived for a certain period of time.

 

In addition, if Novartis wins the main lawsuit, it is expected to cancel the item license.

 

However, as the MFDS claims that the item approval process was normal, the final ruling is expected to take a long time.