Vildagliptin generic preferential sales date may get delayed

The Patent Court lessened the number of preferential sales rights period

Revised Galvus patent term would affect the preferential sales rights period, the industry says it should be changed

MFDS to review internally, "Preferential Sales Rights period has never been changed previously."

A diabetic treatment ‘Galvus’ by Novartis

The preferential sales rights Ahn-gook Pharmaceutical has earned for the Galvus (vildagliptin) generic could be cut as a higher court trial has overturned the patent litigation decision.

 

Accordingly, the South Korea’s Ministry of Food and Drug Safety (MFDS) is internally reviewing the matter.

 

On Oct.

 

29, the Patent Court has partially ruled in favor of Novartis that filed litigation against Ahn-gook Pharmaceutical and Hanmi Pharmaceutical to cancel the decision made to nullify the extended term of Galvus substance patent term.

 

Previously, the Intellectual Property Trial and Appeal Board stated 187 days out of 26 months and 23 days of the extended Galvus patent term would be nullified.

 

The deducted number of days (MFDS approval review supplementary evidence submission period) delayed the patent term coming in effect due to the patentee’s liability.

 

Hence the Board stated the extended term was unjust.

 

Based on the Board’s decision, Ahn-gook Pharmaceutical was able to nab the preferential sales rights over the Galvus generic ‘Ahngook Vildagliptin tablet.’ The preferential sales rights would be effective from Aug.

 

30 2021 through May 29 2022, or from 187 days prior to the patent expiration (Mar.

 

4, 2022).

 

Regardless, the Patent Court said otherwise and stood on the side of Novartis unlike the Board.

 

Although the specifics were not disclosed as the full decision is not yet opened to the public, the sources report the nullified period would be significantly less than 187 days.

 

Now that the higher court has overturned the decision, some claim the effective term of the preferential sales rights Ahn-gook Pharmaceutical won should be shortened in accordance to the Patent Court’s decision.

 

An industry insider commented, “For a precedent of the court accepting the litigation against the extended patent term nullification, there was an interpretation that the preferential sales rights was only effective for the period deducted due to the partially nullified extended patent term.

 

So it would make sense to deduct the number of effective days as well.” Another industry insider said, “They just need to change the effective dates of preferential sales rights stated on the indication.

 

Nevertheless, the change in number of effective days would not impact the industry greatly, as only Ahn-gook Pharmaceutical’s subsidiary Ahngook Newpharm won the preferential sales rights, and the number of deducted days was insignificant.” However, MFDS is contemplating about the situation; so far, since the system was implemented from 2015, the number of effective preferential sales rights days has never been changed.

 

But if the number of days is changed, the same substance sales ban period would also get affected and create an inevitable ripple effect on the follow-on drug market.

 

A MFDS official said, “When either one of the patentee or the preferential sales right holder reports the final outcome to MFDS, the ministry would need to have an extensive internal discussion.

 

We cannot provide any clear answer immediately.” Depending on Ahn-gook Pharmaceutical’s preferential sales rights period, the fate of other companies with the follow-on drugs would be decided as well.

 

Hanmi Pharmaceutical, although it did not win the preferential sales rights, can release its incrementally modified drug (IMD) along with Ahn-gook Pharmacetuical as the IMD has a different salt base.